[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
ATSDR: PROBLEMS IN THE PAST,
POTENTIAL FOR THE FUTURE?
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON INVESTIGATIONS AND
OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
----------
MARCH 12, 2009
----------
Serial No. 111-10
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Printed for the use of the Committee on Science and Technology
ATSDR: PROBLEMS IN THE PAST, POTENTIAL FOR THE FUTURE?
ATSDR: PROBLEMS IN THE PAST,
POTENTIAL FOR THE FUTURE?
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON INVESTIGATIONS AND
OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
MARCH 12, 2009
__________
Serial No. 111-10
__________
Printed for the use of the Committee on Science and Technology
Available via the World Wide Web: http://www.science.house.gov
----------
U.S. GOVERNMENT PRINTING OFFICE
47-718 PDF WASHINGTON : 2009
For sale by the Superintendent of Documents, U.S. Government Printing
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800;
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Washington, DC 20402-0001
COMMITTEE ON SCIENCE AND TECHNOLOGY
HON. BART GORDON, Tennessee, Chair
JERRY F. COSTELLO, Illinois RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas F. JAMES SENSENBRENNER JR.,
LYNN C. WOOLSEY, California Wisconsin
DAVID WU, Oregon LAMAR S. SMITH, Texas
BRIAN BAIRD, Washington DANA ROHRABACHER, California
BRAD MILLER, North Carolina ROSCOE G. BARTLETT, Maryland
DANIEL LIPINSKI, Illinois VERNON J. EHLERS, Michigan
GABRIELLE GIFFORDS, Arizona FRANK D. LUCAS, Oklahoma
DONNA F. EDWARDS, Maryland JUDY BIGGERT, Illinois
MARCIA L. FUDGE, Ohio W. TODD AKIN, Missouri
BEN R. LUJAN, New Mexico RANDY NEUGEBAUER, Texas
PAUL D. TONKO, New York BOB INGLIS, South Carolina
PARKER GRIFFITH, Alabama MICHAEL T. MCCAUL, Texas
STEVEN R. ROTHMAN, New Jersey MARIO DIAZ-BALART, Florida
JIM MATHESON, Utah BRIAN P. BILBRAY, California
LINCOLN DAVIS, Tennessee ADRIAN SMITH, Nebraska
BEN CHANDLER, Kentucky PAUL C. BROUN, Georgia
RUSS CARNAHAN, Missouri PETE OLSON, Texas
BARON P. HILL, Indiana
HARRY E. MITCHELL, Arizona
CHARLES A. WILSON, Ohio
KATHLEEN DAHLKEMPER, Pennsylvania
ALAN GRAYSON, Florida
SUZANNE M. KOSMAS, Florida
GARY C. PETERS, Michigan
VACANCY
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Subcommittee on Investigations and Oversight
HON. BRAD MILLER, North Carolina, Chair
STEVEN R. ROTHMAN, New Jersey PAUL C. BROUN, Georgia
LINCOLN DAVIS, Tennessee BRIAN P. BILBRAY, California
CHARLES A. WILSON, Ohio VACANCY
KATHY DAHLKEMPER, Pennsylvania
ALAN GRAYSON, Florida
BART GORDON, Tennessee RALPH M. HALL, Texas
DAN PEARSON Subcommittee Staff Director
EDITH HOLLEMAN Subcommittee Counsel
JAMES PAUL Democratic Professional Staff Member
DOUGLAS S. PASTERNAK Democratic Professional Staff Member
KEN JACOBSON Democratic Professional Staff Member
TOM HAMMOND Republican Professional Staff Member
JANE WISE Research Assistant
C O N T E N T S
March 12, 2009
Page
Witness List..................................................... 2
Hearing Charter.................................................. 3
Opening Statements
Prepared statement by Representative Bart Gordon, Chair,
Committee on Science and Technology, U.S. House of
Representatives................................................ 30
Statement by Representative Brad Miller, Chair, Subcommittee on
Investigations and Oversight, Committee on Science and
Technology, U.S. House of Representatives...................... 5
Written Statement............................................ 6
Statement by Representative Paul C. Broun, Ranking Minority
Member, Subcommittee on Investigations and Oversight, Committee
on Science and Technology, U.S. House of Representatives....... 28
Written Statement............................................ 29
Panel I:
Mr. Salvador Mier, Local Resident, Midlothian, Texas; Former
Director of Prevention, Centers for Disease Control
Oral Statement............................................... 31
Written Statement............................................ 33
Biography.................................................... 166
Dr. Randall R. Parrish, Head, Natural Environmental Research
Council (NERC) Isotope Geosciences Laboratory, British
Geological Survey
Oral Statement............................................... 166
Written Statement............................................ 168
Biography.................................................... 232
Mr. Jeffrey C. Camplin, President, Camplin Environmental
Services, Inc.
Oral Statement............................................... 233
Written Statement............................................ 235
Biography.................................................... 240
Dr. Ronald Hoffman, Albert A. and Vera G. List Professor of
Medicine, Mount Sinai School of Medicine; Director,
Myeloproliferative Disorders Program, Tisch Cancer Institute,
Mount Sinai Medical Center
Oral Statement............................................... 240
Written Statement............................................ 243
Biography.................................................... 247
Discussion
Explanations of ATSDR's Deficiencies........................... 248
Peer Review.................................................... 248
More Explanation of Deficiencies............................... 249
Potential Fixes................................................ 249
Geographic Prevalence of Deficiencies.......................... 251
Public Awareness............................................... 252
Asbestos....................................................... 253
Local Health Protection........................................ 254
Vieques, Puerto Rico........................................... 254
Colonie, New York.............................................. 256
Animals as Sentinels of Human Health........................... 259
Panel II:
Dr. Ronnie D. Wilson, Associate Professor, Central Michigan
University; Former Ombudsman, Agency for Toxic Substances and
Disease Registry
Oral Statement............................................... 260
Written Statement............................................ 262
Biography.................................................... 263
Dr. David Ozonoff, Professor of Environmental Health, Boston
University School of Public Health
Oral Statement............................................... 264
Written Statement............................................ 266
Biography.................................................... 268
Dr. Henry S. Cole, President, Henry S. Cole & Associates, Inc.,
Upper Marlboro, Maryland
Oral Statement............................................... 269
Written Statement............................................ 271
Biography.................................................... 301
Discussion
More Animals as Sentinels of Human Health...................... 302
Peer Review.................................................... 302
Information Access............................................. 303
Difficulty With Epidemiology................................... 303
Potential Fixes................................................ 304
Panel III:
Dr. Howard Frumkin, Director, National Center for Environmental
Health and Agency for Toxic Substances and Disease Registry
(NCEH/ATSDR)
Oral Statement............................................... 307
Written Statement............................................ 309
Biography.................................................... 317
Discussion
More on Animals as Sentinels of Human Health................... 318
More on Peer Review............................................ 319
Hindrances to ATSDR's Performance.............................. 320
More on Potential Fixes........................................ 321
More on Vieques, Puerto Rico................................... 322
Changes in Response to Criticism............................... 323
Closing........................................................ 324
Appendix 1: Answers to Post-Hearing Questions
Mr. Salvador Mier, Local Resident, Midlothian, Texas; Former
Director of Prevention, Centers for Disease Control............ 326
Dr. Randall R. Parrish, Head, Natural Environmental Research
Council (NERC) Isotope Geosciences Laboratory, British
Geological Survey.............................................. 334
Mr. Jeffrey C. Camplin, President, Camplin Environmental
Services, Inc.................................................. 338
Dr. Ronnie D. Wilson, Associate Professor, Central Michigan
University; Former Ombudsman, Agency for Toxic Substances and
Disease Registry............................................... 342
Dr. Henry S. Cole, President, Henry S. Cole & Associates, Inc.,
Upper Marlboro, Maryland....................................... 347
Dr. Howard Frumkin, Director, National Center for Environmental
Health and Agency for Toxic Substances and Disease Registry
(NCEH/ATSDR)................................................... 351
ATSDR: PROBLEMS IN THE PAST, POTENTIAL FOR THE FUTURE?
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THURSDAY, MARCH 12, 2009
House of Representatives,
Subcommittee on Investigations and Oversight,
Committee on Science and Technology,
Washington, DC.
The Subcommittee met, pursuant to call, at 10:05 a.m., in
Room 2318 of the Rayburn House Office Building, Hon. Brad
Miller [Chair of the Subcommittee] presiding.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
hearing charter
SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
ATSDR: Problems in the Past,
Potential for the Future?
thursday, march 12, 2009
10:00 a.m.-12:00 p.m.
2318 rayburn house office building
Purpose
Chairman Brad Miller of the Investigations and Oversight
Subcommittee of the House Committee on Science and Technology will
convene a hearing at 10:00 a.m. on Thursday, March 12, 2009, to examine
the Agency for Toxic Substances and Disease Registry's (ATSDR). Last
year, the Subcommittee held a hearing and issued a staff report on how
the Agency came to issue a scientifically flawed formaldehyde health
consultation for the Federal Emergency Management Agency (FEMA). The
flawed report and ATSDR's botched response resulted in tens of
thousands of survivors of Hurricanes Katrina and Rita remaining in
travel trailers laden with high levels of formaldehyde for more than
one year longer than necessary.
This hearing will consist of three panels and eight witnesses,
including Dr. Howard Frumkin, Director of ATSDR. It will examine
ongoing problems at ATSDR, specific cases where local community
members, scientists and physicians are critical of the Agency's
scientific methods, conclusions and lack of follow-up actions. The
hearing will also hear from individuals who have either worked for or
with the Agency in the past, including the former ATSDR ombudsman, who
will provide their insight into the cause of systematic problems at the
Nation's public health agency and potential remedies.
The hearing will explore why ATSDR has refused to change portions
of a health report, described by the EPA as ``questionable'' and
``misleading,'' regarding asbestos contamination on a beach on Lake
Michigan in Chicago. There will be testimony from a well-respected
medical expert on a rare type of cancer who says the Agency has refused
to acknowledge a link between a cancer cluster in Pennsylvania and
environmental contamination despite persuasive evidence.
In addition, a British scientist will describe the flawed methods
ATSDR used to investigate depleted uranium exposures among residents in
Colonie, New York and how he and colleagues succeeded in discovering
depleted uranium exposures among 20 percent of the resident population
they tested there. A local resident from Midlothian, Texas, known as
the cement capital of the world, will explain how and why he and the
local community have lost faith in ATSDR's ability to independently and
scientifically investigate the health problems that the town's
population, particularly its children and animals, have been suffering
from that they believe have been caused by the one billion pounds of
toxic emissions the town's industries have unleashed into the
environment since 1990.
Witnesses:
Panel I
Mr. Jeffrey Camplin, President, Camplin Environmental
Services, Inc.
Dr. Ronald Hoffman, Professor, Tisch Cancer
Institute, Department of Medicine, Mount Sinai School of
Medicine, New York
Dr. Randall Parrish, Head, NERC Isotope Geosciences
Laboratory, British Geological Survey
Mr. Salvador Mier, Local Resident, Midlothian, Texas,
and Former Director of Prevention, Center for Disease Control
Panel II
Dr. Henry S. Cole, President, Henry S. Cole &
Associates, Inc.
Dr. David Ozonoff, Chair Emeritus, Department of
Environmental Health, Boston University School of Public Health
Dr. Ronnie Wilson, Former Ombudsman, Agency for Toxic
Substances and Disease Registry
Panel III
Dr. Howard Frumkin, Director, National Center for
Environmental Health/Agency for Toxic Substances and Disease
Registry
Chair Miller. This hearing will now come to order.
Good morning and welcome to today's hearing. The title is
ATSDR: Problems in the Past, Potential for the Future? The
stated mission of the Agency for Toxic Substances and Disease
Registry, ATSDR, is to serve the public by using the best
science, taking responsive public health actions and providing
trusted health information to prevent harmful exposures and
disease-related exposures to toxic substances.
The relatively obscure Federal Government agency first came
to this subcommittee's attention a year or so ago as a result
of ATSDR's health assessment for formaldehyde exposure by
Katrina and Rita victims living in FEMA trailers. Government at
all levels failed the victims of Katrina and Rita in many ways,
but ATSDR's failure was perhaps the most unforgivable. ATSDR's
health assessment certainly failed any test of scientific rigor
but ATSDR's failure was worse than just jackleg science.
ATSDR's failure was a failure not just of the head but of the
heart.
FEMA requested the health assessment to use in litigation
and requested that the assessment assume an exposure of less
than two weeks, knowing that Katrina and Rita victims had
already been exposed to formaldehyde fumes for more than a
year, and that there was no end in sight to their exposure.
Stunningly, ATSDR obliged. Their report gave FEMA just what
FEMA asked for. Let me repeat that to let it sink in. FEMA came
to ATSDR and said we have been sued, we need a health
assessment for exposure to formaldehyde fumes. The folks that
have been exposed to those fumes have been exposed for more
than a year already and God only knows how long they will be
exposed into the future but we want you to assume they were
exposed for less than two weeks, and ATSDR said no problem,
okay, we can do that. Now, obviously I have had to shorten that
story a little bit, but the facts that I have left out are not
exculpatory. They are more damning still.
It gets worse from there. FEMA touted the assessment to
assure families living in the FEMA trailers that the
formaldehyde fumes were nothing to worry about. Dr. Howard
Frumkin, who is here today and will be a witness today, was
then and is still the director of ATSDR. Dr. Frumkin held a
dozen senior staff meetings on the formaldehyde issue over a 6-
month period after ATSDR issued the report in February 2007.
Only after unflattering scrutiny by Congressional committees
including this subcommittee did ATSDR correct the health
assessment.
Since then, this subcommittee has heard from many sources
of other examples of jackleg science by ATSDR and a keenness to
please industries and government agencies that prefer to
minimize public health consequences of environmental exposures.
Our sources have included outside scientists, residents of
communities exposed to various chemicals, and ATSDR's own
scientists. Now, one ATSDR staff scientist told our
subcommittee staff, ``It seems like the goal is to disprove the
communities' concerns rather than actually trying to prove
exposures.''
Today we will hear about a small number of the cases that
have been called to our attention and about problems at ATSDR
that date from the Agency's creation.
And then there is the question of what to do about ATSDR.
When federal agencies fail in their mission, the problem is
usually a lack of resources. There is no reason to believe that
more funding or more staff for ATSDR would result in anything
other than a greater volume of jackleg assessments saying not
to worry.
We hope that the Obama Administration will take a hard look
at ATSDR and we may want to consider legislative fixes. First,
there is a possibility of peer review, outside, independent
peer review. The statute now neither requires nor forbids ATSDR
from getting an independent peer review, and in fact, ATSDR
very rarely, if ever, gets a peer review. Most scientists see
peer review as helpful, as constructive criticism. ATSDR on the
other hand apparently sees opinions of outside scientists as
unwelcome, meddling, and as a result, according to the
scientists we have talked to, the research design and
methodology is often flawed and the research is frequently not
sound, accurate or complete. Congress may well want to consider
requiring peer review, at least in some circumstances, by
legislation. It is hard to know, however, how Congress can
require ATSDR's leadership to have the guts to resist political
pressure and insist of scientific integrity.
The American people deserve better and so do the many
scientists at ATSDR who have dedicated their lives to
protecting the public health and devoutly wish that ATSDR
faithfully and effectively perform the Agency's stated mission.
[The prepared statement of Chair Miller follows:]
Prepared Statement of Chair Brad Miller
The stated mission of the Agency for Toxic Substances and Disease
Registry (``ATSDR'') ``is to serve the public by using the best
science, taking responsive public health actions, and providing trusted
health information to prevent harmful exposures and disease related
exposures to toxic substances.''
The relatively obscure Federal Government agency first came to this
subcommittee's attention a year and a half or so ago as a result of
ATSDR's health assessment for formaldehyde exposure by Katrina and Rita
victims living in FEMA trailers. Government at all levels failed the
victims of Katrina and Rita in many ways, but ATSDR's failure was
perhaps the most unforgivable. ATSDR's health assessment certainly
failed any test of scientific rigor, but ATSDR's failure was worse than
just jackleg science. ATSDR's failure was a failure not just of the
head but of the heart.
FEMA requested the health assessment to use in litigation, and
requested that the assessment assume an exposure of less than two
weeks, knowing that Katrina and Rita victims had already been exposed
to formaldehyde fumes for more than a year and that there was no end in
sight to their exposure. Stunningly, ATSDR's report gave FEMA just what
FEMA asked for.
FEMA touted the assessment to assure families living in the FEMA
trailers that the formaldehyde fumes were nothing to worry about. Dr.
Howard Frumkin, then and still the Director of ATSDR, will testify
today. Dr. Frumkin held a dozen senior staff meetings on the
formaldehyde issue over a six-month period after ATSDR issued the
flawed report in February 2007. Only after unflattering scrutiny
congressional committees did ATSDR correct the health assessment.
Since then, this subcommittee has heard from many sources of other
examples of jackleg science by ATSDR and a keenness to please
industries and government agencies that prefer to minimize public
health consequences of environmental exposures. Our sources have
included outside scientists, residents of communities exposed to
various chemicals, and ATSDR's own scientists. One ATSDR staff
scientist told our subcommittee staff ``It seems like the goal is to
disprove the communities' concerns rather than actually trying to prove
exposures.''
Today we will hear about a small number of the cases that have been
called to our attention, and about problems at ATSDR that date from the
Agency's creation.
Then there is the question what to do about ATSDR. When federal
agencies fail in their mission, the problem is usually a lack of
necessary resources. There is no reason to believe that more funding or
more staff would result in anything other than a greater volume of
jackleg assessments saying ``not to worry.''
We hope the new Obama Administration will take a hard look at
ATSDR. We may also consider legislative fixes. ATSDR was exempted from
forced peer review for its ``health assessments,'' but the statute
never forbid scientific review and the vast majority of ATSDR's health
reports do not go through independent review today. Most scientists see
peer review as helpful, constructive criticism. ATSDR, on the other
hand, apparently sees the opinions of outside scientists as unwelcome
meddling. As a result, ATSDR's research design and methodology is often
flawed, according to other scientists, and ATSDR's research is
frequently not sound, accurate or complete. Perhaps Congress could
require peer review by legislation. But it is hard to know how Congress
can require ATSDR's leadership to have the guts to resist political
pressure and insist on scientific integrity.
The American people deserve better, and so do the many scientists
at ATSDR who have dedicated their lives to protecting the public's
health, and devoutly wish that ATSDR faithfully and effectively perform
the Agency's stated mission.
Chair Miller. I will recognize Mr. Broun in a second, but
first we will include the staff report that this subcommittee
staff has prepared and will be included along with my statement
in the record.
[The information follows:]
The Agency for Toxic Substances and
Disease Registry (ATSDR): Problems in
the Past, Potential for the Future?
Report by the Majority Staff of the
Subcommittee on Investigations and Oversight
Committee on Science and Technology
U.S. House of Representatives
to Subcommittee Chairman Brad Miller
March 10, 2009
Introduction
Last April the Subcommittee on Investigations and Oversight held a
hearing on the Agency for Toxic Substances and Disease Registry
(ATSDR), a sister agency of the Centers for Disease Control and
Prevention (CDC). The hearing looked at how the Agency produced a
scientifically flawed and misleading health consultation on the health
hazards of potential formaldehyde exposures by survivors of Hurricanes
Katrina and Rita living in travel trailers provided by the Federal
Emergency Management Agency (FEMA).\1\ Last September the Subcommittee
issued a detailed staff report on our investigation which found that:
``The leadership of ATSDR obfuscated their role in reviewing and
approving the February 2007 health consultation and attempted to
abdicate their own responsibility for the Agency's fundamental failure
to protect the public's health. Most disturbingly, as the Agency's
troubled response to the formaldehyde fiasco unraveled, the leadership
of ATSDR attempted to shift blame for the inappropriate handling of the
incident to others, primarily [whistleblower Dr. Chris] De Rosa and his
staff.'' \2\ Unfortunately, the poor scientific integrity of ATSDR's
formaldehyde health consultation and the weak leadership at the Agency
that permitted the production of this misleading report which went
uncorrected for so long--keeping the public in harm's way for a year
longer than necessary--was not an isolated incident.
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\1\ ``Toxic Trailers: Have the Centers for Disease Control Failed
to Protect Public Health?,'' Hearing before the Subcommittee on
Investigations and Oversight, Committee on Science and Technology, U.S.
House of Representatives, April 1, 2008, available here: http://
science.house.gov/publications/
hearings-markups-details.aspx?NewsID=2133
\2\ ``Toxic Trailers--Toxic Lethargy: How the Centers for Disease
Control and Prevention Has Failed to Protect the Public Health,''
Majority Staff Report, Subcommittee on Investigations and Oversight,
Committee on Science and Technology, U.S. House of Representatives,
September 2008, available here: http://democrats.science.house.gov/
Media/File/Commdocs/
ATSDR-Staff-Report-9.22.08.pdf
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The Agency's mission ``is to serve the public by using the best
science, taking responsive public health actions, and providing trusted
health information to prevent harmful exposures and disease related to
toxic substances.''\3\ On paper, according to ATSDR, the Agency is
deeply involved with the local communities it is intended to help
protect, it makes independent, objective health decisions based on the
best science available, it conducts exposure investigations to assess
health impacts of environmental toxins and it provides and explains the
results of their evaluations, medical consultations and investigations
to local communities and tribes.\4\ In reality, across the Nation local
community groups believe that ATSDR has failed to protect them from
toxic exposures and independent scientists are often aghast at the lack
of scientific rigor in its health consultations and assessments. The
studies lack the ability to properly attribute illness to toxic
exposures and the methodologies used by the Agency to identify
suspected environmental exposures to hazardous chemicals are doomed
from the start.
---------------------------------------------------------------------------
\3\ ``Statement of Mission,'' Agency for Toxic Substances and
Disease Registry, undated, available here: http://www.atsdr.cdc.gov/
about/mission.html
\4\ ``What You Can Expect From ATSDR,'' Agency for Toxic Substances
and Disease Registry, May 2002, available here: http://
www.atsdr.cdc.gov/COM/expect.pdf
---------------------------------------------------------------------------
The Subcommittee staff is not suggesting that ATSDR find problems
where none exist or that ATSDR should or can identify the sources of a
possible cancer cluster, disease or other health hazard in every
instance or where the potential source of toxic exposures are ambiguous
or elusive. Yet time and time again ATSDR appears to avoid clearly and
directly confronting the most obvious toxic culprits that harm the
health of local communities throughout the Nation. Instead, they deny,
delay, minimize, trivialize or ignore legitimate concerns and health
considerations of local communities and well respected scientists and
medical professionals.
Many independent scientists, medical professionals, local
environmental groups and public health advocates believe that rather
than objectively and aggressively trying to identify the source of
reported health problems, ATSDR often seeks ways to avoid linking local
health problems to specific sources of hazardous chemicals. Instead,
says one current ATSDR scientist who spoke to the Committee on the
condition of anonymity: ``It seems like the goal is to disprove the
communities' concerns rather than actually trying to prove exposures.''
None of these problems are new to ATSDR but it will require a new will
and desire to fix them on the part of ATSDR's leadership.
Background
In 1980 Congress created the Agency for Toxic Substances and
Disease Registry (ATSDR) through the enactment of the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980
(CERCLA) (Public Law 96-510) commonly referred to as ``Superfund.''
CERCLA authorized the Environmental Protection Agency (EPA) to clean up
nationally identified toxic waste (Superfund) sites and Section 104(i)
required the Department of Health and Human Services' (HHS) Public
Health Service to establish a new agency to carry out health-related
activities at these waste sites.\5\ Thus, ATSDR was created to help
determine the potential human health consequences of releases of toxic
chemicals at these sites.
---------------------------------------------------------------------------
\5\ ``Interim Report on Establishment of the Agency for Toxic
Substances and Disease Registry and the Adequacy of Superfund Staff
Resources,'' U.S. General Accounting Office, GAO/HRD-83-81, August 10,
1983, p. 1, available here: http://archive.gao.gov/f0302/122111.pdf
---------------------------------------------------------------------------
Although ATSDR was created with the best of intentions, it had an
extremely difficult birth and has struggled ever since. The EPA and HHS
provided it with little support and at times tried to subvert it. It
took three years after enactment of the law that authorized the
creation of ATSDR for the Agency to actually emerge. By June 1983 the
HHS' Public Health Service ``had developed few detailed procedures
concerning the new agency and how the Superfund responsibilities would
be carried out,'' according to a report from Congress's investigative
arm, the U.S. General Accounting Office (GAO).\6\ ``HHS objected to
establishing a separate agency to carry out its Superfund
responsibilities, contending it was not necessary.'' \7\ In fact, HHS
never wanted ATSDR to have its own staff and tried to reign in the new
agency's independence by detailing CDC staff to ATSDR and forcing it to
use CDC's administrative and support structure.\8\
---------------------------------------------------------------------------
\6\ Ibid, p. 3, available here: http://archive.gao.gov/f0302/
122111.pdf. The name of the General Accounting Office was changed in
2004 to the Government Accountability Office (GAO).
\7\ Ibid, p. 2, available here: http://archive.gao.gov/f0302/
122111.pdf
\8\ Ibid, p. 3, available here: http://archive.gao.gov/f0302/
122111.pdf
---------------------------------------------------------------------------
In addition, because the Office of Management and Budget (OMB)
reduced the number of HHS requested staffing positions in 1984 to
ATSDR, CDC officials told GAO's investigators that because of limited
staff ``they expected to eliminate virtually all [of ATSDR's planned]
long-term health studies, [health] registries, and laboratory
projects.'' \9\ During this same time-frame both EPA and OMB
consistently reduced ATSDR's annual budget.\10\ Three years after ATSDR
was physically established, a new law was passed, the Superfund
Amendments and Reauthorization Act of 1986 (SARA) that set an arbitrary
deadline of December 1988 for the Agency to conduct health assessments
at 951 Superfund sites. The law was necessary at the time, many
believed, because ATSDR had made zero headway in accomplishing these
tasks. As a result of the new law ATSDR developed ``initial mandate
assessments'' at 950 sites within a little over two years. The Agency
achieved a quantitative victory in producing so many assessments is so
little time.
---------------------------------------------------------------------------
\9\ Ibid, p. 7, available here: http://archive.gao.gov/f0302/
122111.pdf
\10\ ``SUPERFUND: Funding for the Agency for Toxic Substances and
Disease Registry,'' U.S. General Accounting Office, GAO/RCED-87-112BR,
March 1987, p. 2. available here: http://archive.gao.gov/t2pbat22/
132595.pdf
---------------------------------------------------------------------------
But Congress's desire to force the new understaffed agency to
become more effective, efficient and responsive to fulfilling its
initial mandate had unintended qualitative consequences. In order to
prepare health assessments on 951 Superfund sites within this time
period ATSDR wrote 785 assessments in 15 months and ``labeled 165
previously prepared documents in its files as health assessments'' even
though some were several years old, according to GAO. To accomplish
this massive effort, ATSDR ignored ``its own guidance requiring visits
to sites'' and instead conducted ``desk'' assessments, GAO found. The
Agency, for instance, labeled previously produced documents not
intended to be full health assessments as ``assessments.'' ``In the
rush to complete these assessments, ATSDR dropped plans to do full
internal quality checks on its assessments, and no review was made by
outside experts,'' according to GAO.\11\
---------------------------------------------------------------------------
\11\ ``Superfund: Public Health Assessments Incomplete and of
Questionable Value,'' General Accounting Office, RCED-91-178, August 1,
1991, p. 13, available here: http://archive.gao.gov/t2pbat7/144755.pdf
---------------------------------------------------------------------------
When GAO reviewed the quality and usefulness of ATSDR's health
assessments in 1991 they hired five independent experts to evaluate 15
of the Agency's assessments. What they found was that the initial
mandate assessments ``were seriously deficient overall.'' Although
follow up assessments were improved over the earlier assessments GAO's
expert reviewers ``continued to find deficiencies in evidence or
analysis, such as unsupported conclusions.''
GAO concluded that ATSDR needed to improve its quality controls and
to establish ``some independent peer review.'' It found that ATSDR
should involve local communities more in developing assessments. The
GAO panel also found the reports it reviewed contained ``(1) inadequate
descriptions or analyses of health risks, (2) failures to indicate
whether communities had been exposed to contaminants, (3) overly
general recommendations, and (4) inattention to the sufficiency of
data.'' \12\ One of the GAO panel members said that ``regardless of the
wide diversity of sites that we studied [the assessments] come up with
the same conclusion: that there is a potential problem.'' Incredibly
out of the 951 initial assessments ATSDR conducted it found just 13
sites as posing a ``significant health risk.'' \13\
---------------------------------------------------------------------------
\12\ Ibid, p. 18, available here: http://archive.gao.gov/t2pbat7/
144755.pdf
\13\ Ibid, p. 28, available here: http://archive.gao.gov/t2pbat7/
144755.pdf
---------------------------------------------------------------------------
In the rush to push out nearly 1,000 health assessments in two
years time the Agency developed a check-box mentality that helped to
undermine virtually everything the Agency did. Quality became an after-
thought to the ability to produce public health documents quickly. The
integrity of the data, assessment of the public health risks and
credibility of the conclusions all suffered deeply as a result.
Unfortunately, the past problems identified by GAO have not
disappeared. Reviews of the FEMA trailer health consultation on
formaldehyde, as well as other health reports from ATSDR, appears to
suggest the Agency has never recovered from the initial problems that
overshadowed its birth. Internally, many ATSDR employees have told the
Subcommittee over the past year that the Agency lacks appropriate
quality controls, it conducts inadequate analyses of health risks to
local communities and they often do not collect and analyze the most
relevant and revealing data about potential environmental health
hazards. Externally, the local communities that ATSDR was created to
help protect often believe the Agency does more harm than good by
offering them reassuring but unfounded and unsound advice and analysis
which simply creates an artificial perception of safety to the public
that is not supported by scientific inquiry or independent examination.
Investigating environmental public health issues is a difficult and
daunting task. Local communities expect State or federal public health
agencies to identify the cause of their specific health concerns,
provide medical or other support and eradicate the environmental
hazard. In some cases it is exceedingly difficult to establish a
definitive link between specific toxic exposures and health problems.
In other cases it may be difficult to quantify an actual health problem
and in some instances the scientific evidence may not identify any
problem let alone the specific cause of a health problem. But in many,
many cases ATSDR seems to get the science wrong, ignores community
complaints or both.
Midlothian, Texas--Cement Kilns
Mr. Sal Mier is a local resident of Midlothian, Texas and former
official at the Centers for Disease Control and Prevention (CDC).
Midlothian is known as the cement capital of the world and is home to
three cement plants and one steel mill. These plants have released
nearly one billion pounds of toxic chemicals into the local environment
since 1990. The Texas Commission on Environmental Quality (TCEQ) began
environmental monitoring in Midlothian in 1991. In June 2005, the Texas
Department of State Health Services (DSHS) completed a review of the
Texas Birth Defects registry and found that one type of birth defect
related to urinary tract development (hypospadias or epispadias) was
statistically elevated. The previous month DSHS completed a cancer
cluster investigation that found no elevation in cancers when it
examined residents in three zip codes in Midlothian and two other
towns.\14\ But by expanding the pool of individuals in this
investigation to those outside of Midlothian, critics say the study
diminished the ability to specifically identify increased rates of
cancers among Midlothian residents.
---------------------------------------------------------------------------
\14\ ``Birth Defects Monitoring 2005 Report Summary,'' Texas
Department of State Health Services and ``Cancer Registry 2005 Report
Summary,'' Texas Department of State Health Services both available
here: http://www.dshs.state.tx.us/epitox/midlothian/reports.shtml
---------------------------------------------------------------------------
In 2005, Mr. Mier petitioned ATSDR to look into health issues in
Midlothian. In August 2005, ATSDR agreed to conduct a health assessment
on the potential health effects of toxic substances released from
Midlothian's cement kilns. Under a cooperative agreement with ATSDR,
DSHS would conduct the health investigation along with some support,
review and final concurrence by ATSDR. In December 2005, DSHS said that
the health consultation would be completed and reviewed by ATSDR and
released for public comment by ``the first part of February 2006.''
\15\ In February 2006 the document's release date was pushed back to
March 2006 ``due to the large volume of information to be reviewed.''
\16\
---------------------------------------------------------------------------
\15\ ``Midlothian Petition Community Site Update, Texas Department
of State Health Services, December 2005, available here: http://
www.dshs.state.tx.us/epitox/midlothian/december-update.pdf
\16\ ``Midlothian Petition Community Site Update, Texas Department
of State Health Services, February 2006, available here: http://
www.dshs.state.tx.us/epitox/midlothian/update206.pdf
---------------------------------------------------------------------------
In December 2007, 27 months after ATSDR began their investigation,
the Agency finally released a ``draft'' health consultation for
``public comment.'' The report found that for the vast majority of
chemicals they examined there was no public health hazard. They
concluded, for instance, that there was ``no evidence to suggest that
adverse health effects would be anticipated as a result of any of the
short-term or peak exposures to VOCs [Volatile Organic Compounds] or
Metals'' being emitted from the plants in Midlothian. The Agency's
overall conclusion was that the air in Midlothian posed an
``Indeterminate Public Health Hazard.'' \17\ A ``final'' version of
that study is planned to be released in the next couple of months--more
than three and one half years after the investigation began.
---------------------------------------------------------------------------
\17\ ``Health Consultation: Public Comment Release, Midlothian Area
Air Quality Part 1: Volatile Organic Compounds & Metals, Midlothian,
Ellis County, Texas, December 11, 2007, available here: http://
www.dshs.state.tx.us/epitox/midlothian/updates.shtm
---------------------------------------------------------------------------
Mr. Mier received comments on this document from several
independent scientists who concluded it was deeply flawed. Dr. Stuart
Batterman, Associate Chairman of the Department of Environmental Health
Sciences, School of Public Health at the University of Michigan, wrote:
``The Health Consultation is biased. It contains overarching statements
that discount all indications that emissions from local industry and
environmental conditions might or do pose a health concern in the
community.'' Dr. Peter L. deFur, a Research Associate Professor in the
Center for Environmental Studies at Virginia Commonwealth University
agreed. ``Throughout the document, ATSDR attempts to marginalize or
disregard data that indicate that compounds produce human health risks.
ATSDR has more than enough data to classify the site as a ``Public
Health Hazard.'' For the past fifteen months ATSDR has been reviewing
these and many other public comments they received on their draft
health consultation and intend to release the final version of their
report in the next couple of months.
It is clear that the release of toxic material from the three
cement plants and steel mill in Midlothian has been enormous over the
years. Using State and federal records from the Environmental
Protection Agency's (EPA) Toxics Release Inventory (TRI) and TCEQ's
Emission Inventory two graduate students at the University of North
Texas, Amanda Caldwell and Susan Waskey, conducted a study of the local
emissions from Midlothian for the local environmental non-profit group
Downwinders At Risk. The study found that between 1990 and 2006 these
four industrial plants released more than one billion pounds of toxic
emissions to the environment. The emissions were a brew of toxic
substances, including millions of pounds of manganese, lead and
sulfuric acid, as well as hundreds of thousands of pounds of
trichloroethylene, zinc compounds, mercury, benzene, hydrochloric acid,
formaldehyde, toluene and other hazardous chemicals.\18\ Tying down
specific health effects to individual industrial plants in Midlothian
would be a difficult undertaking. But Midlothian residents are
frustrated that ATSDR has ignored critical signs of potential health
problems in the community and has essentially given the community a
clean bill of health despite many indications that the community may be
suffering from health problems due to exposures to industrial
pollutants.
---------------------------------------------------------------------------
\18\ Amanda Caldwell and Susan Waskey, ``Midlothian Industrial
Plant: Emission Data,'' Geography Special Problems, University of North
Texas, July 25, 2008.
---------------------------------------------------------------------------
Sue Pope, a Midlothian resident and one of the creators of
Downwinders At Risk, had hair samples of 55 people living in or near
Midlothian, many of them infants and young children, analyzed for toxic
substances between 1988 and 1993. What the tests revealed was that many
of the residents had high levels of aluminum, lead, cadmium and nickel.
She turned over copies of these documents to Texas State authorities
who were investigating health issues in Midlothian, but she says
nothing ever came of it.
Other residents and independent scientists have chronicled health
problems in Midlothian too. In 1998, scientists led by Dr. Marvin
Legator at the University of Texas Medical Branch, Division of
Environmental Toxicology published a peer-reviewed paper in the journal
Toxicology and Industrial Health titled: ``The Health Effects of Living
Near Cement Kilns; A Symptom Survey in Midlothian, Texas.'' The study
found that respiratory illnesses in Midlothian were three times more
common than in neighboring Waxahatchie.\19\
---------------------------------------------------------------------------
\19\ Marvin Legator, et al., ``The Health Effects of Living Near
Cement Kilns; A Symptom Survey in Midlothian, Texas,'' Toxicology and
Industrial Health, Vol. 14, No. 6, 1998.
---------------------------------------------------------------------------
Two years earlier, Legator published an editorial in the Archives
of Environmental Health, titled: ``A Deliberate Smokescreen,'' which
criticized the scientific integrity of ATSDR's studies and the methods
ATSDR uses in an attempt to investigate potential environmental
exposures. In the article Legator and a colleague recommended ``that
careful evaluation be made of a significant number of ATSDR or ATSDR-
sponsored studies to determine how well the victims of chemical
exposure and our taxpayers have been served by this agency.'' \20\
---------------------------------------------------------------------------
\20\ Marvin S. Legator and Amanda M. Howells-Daniel, ``A Deliberate
Smokescreen,'' Archives of Environmental Health, Vol. 49 (No. 3), May/
June 1994.
---------------------------------------------------------------------------
Last December USA Today ran an in-depth special report titled ``The
Smokestack Effect: Toxic Air and America's Schools,'' that used the
same EPA data as the report on Midlothian's toxic emissions by Caldwell
and Waskey to track the path of industrial pollution and then mapped
the locations of almost 128,000 schools to determine the levels of
toxic chemicals in their path. The USA Today report's interactive map
of the United States shows that of the nine schools located in
Midlothian, Texas, two of them were ranked in the 1st percentile of the
schools exposed to the most toxic chemicals in the Nation, three of the
schools were ranked in the third percentile and each of the others were
ranked in the 6th, 14th, 21st and 32nd percentiles. According to the
USA Today report only 174 of the Nation's 127,809 schools they ranked
had worse toxic air exposures than the Mt. Peak Elementary School in
Midlothian, for instance.\21\
---------------------------------------------------------------------------
\21\ USA Today Special Report, ``The Smokestack Effect: Toxic Air
and America's Schools,'' December 8, 2008, http://content.usatoday.com/
news/nation/environment/smokestack/index? loc=interstitialskip
---------------------------------------------------------------------------
Anecdotally, many Midlothian children apparently have severe cases
of asthma, cancer cases are wide-ranging among the population and there
has been a history of poor health problems among cattle, horses and
other animals in the area. Debra Markwardt, a local Midlothian dog
breeder, recently suggested to ATSDR's Director, Dr. Howard Frumkin,
that his agency examine her dogs as an indicator of what is happening
to the human population in Midlothian. Markwardt moved to Midlothian in
1988. Her dogs soon started experiencing a wide-range of disturbing
health problems. The photos of her dogs are troubling. Some were born
with missing limbs, many had skin problems, and others were born with
organs outside of their bodies and entire litters died shortly after
birth. Most surprisingly, dogs that were sold and moved off of her
property with severe skin problems began to regain their health within
months but those that stayed continued to suffer from ill-health
effects. (See photos of Markwardt's dogs in attachment).
Recently, Markwardt had herself and some of her dogs tested for
heavy metals. Over the past few years, veterinarians have found high
levels of aluminum in her animals, she says. In May 2007, Ms.
Markwardt's own doctor wrote: ``She has lived in a home that has very
high levels of aluminum in the soil and in the dust that is found in
the home. She has had a urinalysis that shows her aluminum level to be
markedly elevated and it should be zero,'' wrote her doctor. Last July,
her veterinarian wrote: ``It is my opinion that these dogs need to be
moved off of the property. Since nothing medical has helped, it is
highly probable that this is an environmental problem.''
On December 19, 2008, Dr. William Cibulas, the Director of ATSDR's
Division of Health Assessment & Consultation (DHAC) wrote to Ms.
Markwardt on behalf of Dr. Frumkin. ``ATSDR is sympathetic toward the
plight of your animals, however, veterinary and animal issues are
outside of our mandated domain,'' he wrote. Clearly frustrated by this
response Ms. Markwardt exchanged some more e-mails with ATSDR.
On January 22, 2009, Markwardt wrote back to ATSDR and copied Dr.
Frumkin on the e-mail. ``Please do not tell me again that veterinary
and animal issues are outside of [your] mandated domain. You know full
well (or should) that the potential impact on people is the issue that
I raised,'' wrote Markwardt. ``All that we have asked you to do is to
provide trusted health information. Do you feel that an honest
conclusion in the Midlothian Public Health Consultation can be reached
by pretending what is happening to these animals is not happening;
therefore, it cannot be an indicator of what is happening to human
health?''
The next day, on January 23, 2009, a technical officer in DHAC,
Alan Yarbrough, responded. ``Again, ATSDR is sympathetic to the plight
of your animals,'' he wrote, ``but studies involving animals, even as
sentinels for human health issues, are not activities engaged in or
funded by our agency.''
In 1991, however, the National Academies of Sciences' Committee on
Animals as Monitors of Environmental Hazards was charged by ATSDR ``to
review and evaluate the usefulness of animal epidemiologic studies for
human risk assessment and to recommend types of data that should be
collected to perform risk assessments for human populations.'' In their
final 176-page report for ATSDR, the academy wrote that animals can be
``used to monitor concentrations of pollutants'' and ``can yield a
better evaluation of hazard to humans'' than ``mechanical devices
can.'' In fact, the academy concluded: ``An investigator planning an
environmental assessment should always consider using an animal
sentinel system, when it is practicable, as an adjunct to conventional
assessment procedures. Animal sentinel data are likely to be especially
useful in circumstances where the conventional procedures are most
prone to uncertainty, including assessing accumulated chemicals,
complex mixtures, complex exposures, uncertain bioavailability, and
poorly characterized agents.'' \22\
---------------------------------------------------------------------------
\22\ ``Animals as Sentinels of Environmental Health Hazards,''
Committee on Animals as Monitors of Environmental Hazards, National
Research Council, National Academy Press, Washington, D.C., 1991,
available here: http://www.nap.edu/
catalog.php?record-id=1351
---------------------------------------------------------------------------
Since then ATSDR has published numerous health consultations
involving animals. In April 2003 under a cooperative agreement with the
California Department of Health Services, ATSDR released a health
consultation regarding contamination in the private water wells of
residents near the Pacific Gas and Electric Facility in Hinkley,
California, made famous by environmental investigator and activist Erin
Brockovich. In that instance, the health consultation did examine the
potential health impact on horses, cows, dogs and cats from the
exposures to Nitrate, Lead, Thallium and Chromium.\23\ In March 2005,
ATSDR released a health consultation that investigated potential
exposures from TCE in private well water of both humans and animals in
the City of Cliff Village, Missouri. The investigation began after
several residents and domestic animals in the Cliff Village area
experienced unusual health problems that resulted in the death of a
domestic animal.\24\ In December, 2005, ATSDR issued a health
consultation that investigated the poisoning of a 97-pound Siberian
Husky in Des Moines, Iowa.\25\
---------------------------------------------------------------------------
\23\ ``HEALTH CONSULTATION: Response to Community Inquires
Regarding Nitrate, Lead, Thallium and Chromium Levels in Water from
Private Domestic Wells near the Pacific Gas and Electric Facility in
Hinkley, California--Pacific Gas and Electric Facility, Hinkley, San
Bernardino County, California,'' Prepared By: California Department of
Health Services, Under a Cooperative Agreement with the Agency for
Toxic Substances and Disease Registry, April 25, 2003, available here:
http://www.atsdr.cdc.gov/HAC/pha/pganderesp/pge-toc.html
\24\ ``HEALTH CONSULTATION: Cliff Village Wells Site, City of Cliff
Village, Newton, Missouri, March 21, 2005, Agency for Toxic Substances
and Disease Registry, available here: http://www.atsdr.cdc.gov/HAC/pha/
CliffVillageWellsSite/CliffVillageWellsHC.pdf
\25\ ``HEALTH CONSULTATION: Pesticide Contamination of Residential
Soil--Des Moines, Polk County, Iowa,'' December 8, 2005, U.S.
Department of Health and Human Services, Public Health Service, Agency
for Toxic Substances and Disease Registry, available here:
www.atsdr.cdc.gov/HAC/pha/PesticideContamination120805/
PesticideContaminationSoilHC120805.pdf
---------------------------------------------------------------------------
The above cases were gleaned from a cursory search of ATSDR's web-
page by the Subcommittee. Why ATSDR refused Debra Markwardt's request
is unclear, but there is certainly precedent for ATSDR to examine
animals, particularly when there health and safety are closely tied to
the health and safety of people.
On February 6, 2009, ATSDR's Yarbrough responded again to Ms.
Markwardt. But this time, the Agency's rationale for refusing to
investigate the health of Markwardt's dogs changed slightly.
Originally, Markwardt was told ``veterinary and animal issues are
outside of our mandated domain,'' wrote ATSDR. This time, Yarbrough
wrote: ``ATSDR's enabling legislation does not prohibit our conduct of
animal studies; however, ATSDR and the Texas Department of State Health
Services do not have the expertise to conduct the appropriate animal
studies,'' he wrote. Instead, ATSDR told Markwardt that they referred
her case to two veterinarians with Texas A&M. But the researchers do
not yet have any funding to support an investigation and they have not
yet contacted her.
Polycythemia Vera Cancer Cluster in Eastern Pennsylvania
Dr. Ronald Hoffman, MD, is Professor of Medicine, Hematology/
Oncology Section, at the Tisch Cancer Institute and Professor of Gene
and Cell Medicine at Mt. Sinai School of Medicine in New York. He is
also the former President of the American Society of Hematology. Dr.
Hoffman is a leading expert on a rare cancer called polycythemia vera
(PV). He had never heard of ATSDR before being called by ATSDR staff in
2006 to lend his expertise to an investigation it was conducting in
eastern Pennsylvania examining a potential cluster of PV cases.
In October 2006, ATSDR began assisting the Pennsylvania Department
of Health in investigating the high number of reported PV cases in
three counties in Pennsylvania--Carbon, Luzerne and Schuylkill
counties. The area ATSDR investigated is home to seven Superfund
hazardous waste sites that are either closed or in the process of being
remediated and seven waste coal burning power plants, which emit
polycyclic aromatic hydrocarbons (PAHs). Recent research has suggested
PAHs may potentially contribute to polycythemia vera.
The local community has suspected that environmental pollution in
the area has a contributor to health problems there for a long time. By
the fall of 2007, ATSDR had confirmed more than three dozen cases of PV
in the area, more than four times the level outside the region. The
Agency also discovered four cases of PV on one two-mile stretch of road
not far from the former McAdoo superfund site. None of the PV patients
on Ben Titus Road in Northeast Schuylkill County were blood relatives.
Two of them, who both passed away last year, were husband and wife. The
environmental significance of this tight grouping of PV cases on a
single road and the proximity to a hazardous waste site seemed obvious
to many, including Dr. Ronald Hoffman.
But that connection did not appear so obvious to ATSDR. The lead
ATSDR official in charge of the investigation, Dr. Steven Dearwent,
described it to Subcommittee staff as ``compelling'' information, but
nothing more. On October 24, 2007, ATSDR released a ``media
announcement'' regarding their PV investigation. The Agency confirmed
more than three dozen cases of PV in Schuylkill, Luzerne and Carbon
counties in Pennsylvania but assured the public: ``ATSDR found no link
between environmental factors and PV in this area.'' \26\ The Agency
also failed to mention in the media announcement the four PV cases it
found along Ben Titus Road near a former Superfund site, although they
had already confirmed these cases at the time.
---------------------------------------------------------------------------
\26\ ``Federal Agency Releases Results of Polycythemia Vera
Investigation,'' ATSDR Media Announcement, Agency for Toxic Substances
and Disease Registry, October 24, 2007, available here: http://
www.atsdr.cdc.gov/NEWS/schuykillpa102407.html
---------------------------------------------------------------------------
So, when Dr. Hoffman presented an abstract of the PV investigation
at the annual meeting of the American Society of Hematology in Atlanta
in December 2007 titled: ``Evidence for an Environmental Influence
Leading to the Development of JAK2V617F-Positive Polycythemia Vera: A
Molecular Epidemiological Study,'' this apparent contradiction did not
sit well with some ATSDR officials. The Agency says the paper, which
included the names of ATSDR scientists, did not go through ATSDR's
``clearance process.''
In December 2007, the Associated Press reported that ATSDR was
distancing itself from Dr. Hoffman and his paper. Dr. Dearwent, the
senior ATSDR official in charge of the PV cluster investigation told
the AP: ``We're going to have to retract the abstract to correct the
record because it is erroneous information.'' Dr. Dearwent claimed that
the abstract had been written early in the summer and that subsequent
analysis of the data did not support the conclusion of an environmental
link.\27\ In fact, it seems nothing had actually changed regarding the
data but that ATSDR did not feel comfortable drawing any connection
between the PV cluster and potential chemical exposures in the
environment. Dr. Dearwent told Subcommittee staff that because Dr.
Hoffman is a ``clinician'' and not an epidemiologist he may have viewed
the PV cluster differently than the Agency. Dr. Dearwent said that ``we
had nothing telling us at the time nor do we now'' that this cluster is
somehow linked to environmental exposures.
---------------------------------------------------------------------------
\27\ Mike Stobbe and Michael Rubinkam, ``Feds hedge on
environmental link to Pennsylvania illnesses,'' Associated Press (AP),
December 7, 2007, available here: http://www1.phillyburbs.com/pb-dyn/
articlePrint.cfm?id=1452897
---------------------------------------------------------------------------
To his credit, Dr. Hoffman presented his abstract at the American
Society of Hematology conference despite efforts by ATSDR to interfere
with his presentation. Last year, ATSDR posted an oddly worded
statement about the abstract on its website. The Agency said that the
conclusions in the abstract differed from what ATSDR told the public in
October 2007 and that it ``prematurely'' inferred certain conclusions
about the PV cluster. Yet, it concluded: ``The presentation made at the
American Hematology Society meeting accurately reflected ATSDR's
current assessment of the data.'' \28\
---------------------------------------------------------------------------
\28\ ``Response to the American Hematology Society Abstract,''
Agency for Toxic Substances and Disease Registry, available here:
http://www.atsdr.cdc.gov/sites/polycythemia--vera/abstract.html
---------------------------------------------------------------------------
In January 2008 Dr. Hoffman e-mailed Dr. Howard Frumkin, the
director of ATSDR, about his experience with the PV investigation. ``I
believe that some members of your staff are unable, incapable or
unwilling to objectively looking [sic] at this data,'' wrote Hoffman.
``This nonscientific approach has led to a state of denial and
paralysis in you [sic] organization which has resulted in the present
confusion about this matter in the community and the press. There are
important issues here and objectivity is required,'' wrote Hoffman. ``I
hope that the cynical and nihilistic behavior of some of your staff is
not a reflection of the scientific veracity of the Agency[.]''
In this case, ATSDR finally acknowledged that a cancer cluster
existed in the area of Eastern Pennsylvania they investigated. The
Agency released the final results of their investigation last August
and found residents in the three counties in Pennsylvania that they
assessed were more than four times more likely to develop polycythemia
vera than people living outside those counties. And while ATSDR said
``There were potential environmental exposure sources common to some of
the high-rate areas,'' they concluded that: ``It is not known whether a
relationship exists between any of these sources and the PV cases.''
\29\ The Agency said future studies may attempt to investigate the
environmental connection further. Dr. Hoffman says that ATSDR
continually sought to downplay and minimize any links between the PV
cases and the environment suggesting it was just an unusual
circumstance. He described their behavior as ``very odd and counter-
intuitive.''
---------------------------------------------------------------------------
\29\ Polycythemia Vera Investigation, Agency for Toxic Substances
and Disease Registry, http://www.atsdr.cdc.gov/sites/
polycythemia-vera/
---------------------------------------------------------------------------
Interestingly, in 1993 ATSDR conducted a public health assessment
on the McAdoo Associates Superfund site. That site had ceased
operations in 1979, was remediated and taken off of the Superfund list
in 2001. The 1993 ATSDR public health assessment of the site found:
``Site-related contamination poses no public health hazard because
there is no evidence of current or past exposures, and future exposures
to contaminants at levels of public health concern are unlikely.'' \30\
Ben Titus Road where ATSDR investigators discovered four unrelated PV
cases is close to this site. But conceding that there may be an
environmental health hazard present in this community today could put
ATSDR in the awkward position of acknowledging mistakes with their past
public health conclusions.
---------------------------------------------------------------------------
\30\ ``Public Health Assessment, McAdoo Associates, McAdoo,
Schuylkill County, Pennsylvania,'' Prepared By: Pennsylvania Department
of Health Under Cooperative Agreement with the Agency for Toxic
Substances and Disease Registry, September 29, 1993, available here:
http://www.atsdr.cdc.gov/HAC/pha/mcadoo/mca-p1.html#SUMMARY
---------------------------------------------------------------------------
In the wake of internal disagreements between Dr. Hoffman and ATSDR
regarding the potential link between environmental contamination and
the PV cluster, Dr. Hoffman says he pushed to publish a peer-reviewed
article of the PV investigation's findings, fearing that ATSDR was not
willing or able to acknowledge the significance of the PV cluster in
Pennsylvania. Last month the work of Dr. Hoffman, ATSDR scientists and
other colleagues at the University of Illinois College of Medicine,
published their findings in the journal Cancer, Epidemiology,
Biomarkers and Prevention. The paper reported that the risk of
developing PV was 4.3 times greater for the residents living inside the
three Pennsylvania counties they examined than for those living outside
the area. The article concluded: ``The close proximity of this cluster
to known areas of hazardous material exposure raises concern that such
environmental factors might play a role in the origin of polycythemia
vera.'' \31\ Dr. Dearwent, who was not an author on the paper, contends
that ``some of the language in the manuscript that we opposed made it
back in to the paper.'' Dr. Hoffman and other authors of the paper deny
that.
---------------------------------------------------------------------------
\31\ Dr. Vincent Seaman, et. al., ``Use of Molecular Testing to
Identify a Cluster of Patients with Polycythemia Vera in Eastern
Pennsylvania,'' Cancer Epidemiology Biomarkers & Prevention, 18(2),
February 2009, available here, http://cebp.aacrjournals.org/cgi/
content/abstract/18/2/534
Asbestos Beach--Illinois State Beach Park in Chicago
Mr. Jeffery Camplin is President of Camplin Environmental Services
and technical consultant to the Dunesland Preservation Society in
Illinois. Since 2003 he has been investigating asbestos contamination
on the Illinois shoreline of Lake Michigan and has filed several
complaints with ATSDR regarding the inadequacies of their studies of
asbestos contamination at the Illinois State Beach Park in Chicago. He
is a certified safety professional (C.S.P.), certified professional
environmental auditor (C.P.E.A.) and has been an accredited instructor
in asbestos abatement by the Environmental Protection Agency (EPA) for
more than 20 years. In 2006 he was named Environmental Safety
Professional of the year by the American Society of Safety Engineers
(ASSE). He is also the lead safety volunteer for the Illinois Medical
Emergency Response Team (IMERT).
In Illinois there has been a long history of asbestos containing
materials and fibers washing up on the shoreline of Lake Michigan for
more than one decade. The Johns-Manville Corporation built a large
plant on the shore of Lake Michigan that produced insulation products
containing asbestos beginning in the 1920s. The plant, which included a
150-acre asbestos disposal area containing approximately three million
cubic yards of asbestos-containing waste, was declared a Superfund site
in 1983 and ceased operations in 1998. The asbestos disposal area was
covered with soil to prevent its spread. But since then seven areas
containing asbestos-containing material from the plant were discovered
off-site.\32\
---------------------------------------------------------------------------
\32\ ``Region 5 Superfund (SF) National Priorities List Fact Sheet:
Johns-Manville Corp.,'' Environmental Protection Agency, Last Updated:
June, 2008, available here: http://www.epa.gov/region5superfund/npl/
illinois/ILD005443544.htm
---------------------------------------------------------------------------
Around the same time as the plant's closure, asbestos debris began
washing up along the shoreline at the Illinois Beach State Park, the
state's most popular park at two to three million visitors per
year.\33\ In May 2000, the Illinois Department of Public Health under a
cooperative agreement with ATSDR released a public health assessment
regarding asbestos contamination at the State park. The report did find
that asbestos containing material had been found scattered along the
beach at the park and that material containing ``low asbestos levels''
had been discovered, but not at levels that would be expected to cause
adverse health effects in Park workers or visitors,'' it said. The
report concluded: ``no apparent public health hazard exists related to
asbestos contamination at Illinois Beach State Park.'' \34\
---------------------------------------------------------------------------
\33\ See: ``Asbestos washes up on beach at state's most popular
park,'' Associated Press, February 3, 1998; and Charles Nicodemus,
``State moves in on asbestos//4 agencies study danger to beach,''
Chicago Sun-Times, February 4, 1998.
\34\ ``Public Health Assessment: Asbestos Contamination at Illinois
Beach State Park,'' Prepared by: Illinois Department of Public Health
Under Cooperative Agreement with the Agency for Toxic Substances and
Disease Registry, May 23, 2000, available here: http://
www.atsdr.cdc.gov/HAC/pha/illinoisbeach/ibp-toc.html
---------------------------------------------------------------------------
But the discovery of asbestos material on the public beach at the
State park never ceased. Portions of the State park were cleared of
asbestos in March 2006. In the summer of 2006 ATSDR used grading
equipment to churn up the sand and air filters to capture and measure
any potential asbestos fibers. The tests discovered fibers of amphibole
asbestos, the most toxic kind of asbestos.
In 2007 ATSDR wrote a draft health consultation based on their
findings which said there was no health hazard from the asbestos. In
April 2007, local EPA officials submitted written comments of the
report to ATSDR. The letter, written by Brad Bradley, the EPA's
Remedial Project Manager in the Agency's Region 5 section and the EPA's
lead asbestos expert covering Illinois, Indiana, Michigan, Minnesota,
Ohio, and Wisconsin, was written to Mark Johnson, ATSDR's regional
representative in Chicago, on behalf of the entire EPA Region 5 staff.
The letter identified 13 items they believed needed clarification or
correction. Many of them were not subtle editorial fixes but
significant issues revolving around safety and health issues and the
scientific integrity of the ATSDR report. The letter said many of the
statements by ATSDR were ``misleading,'' ``questionable'' and contained
``inconsistencies.'' \35\
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\35\ Letter from Brad Bradley, Remedial Project Manager,
Environmental Protection Agency, Region 5, to Mark Johnson, Regional
Representative, Agency for Toxic Substances and Disease Registry, April
24 2007.
---------------------------------------------------------------------------
``The paragraph on page 12, which states that ``Based on the bulk
analysis of sand samples collected, the sand in [and] of itself does
not appear to pose a significant source of asbestos fibers'' is a
little misleading,'' wrote Bradley. ``The air samples near the beach
grading equipment were significantly elevated; therefore, this would
indicate that there might be a problem with this statement,'' he wrote.
But the final ATSDR health consultation read: ``Based on the bulk
analysis of sand samples collected, the sand does not appear to pose a
significant source of asbestos fibers.'' The public health agency
ignored the EPA's concerns about the public's health.
The EPA noted other problems that ATSDR also simply chose to
ignore. In his April 2007 letter, Bradley wrote: ``13) Regarding the
human health safety statements in the Report, the Executive Summary
states that it is within the acceptable risk range under certain
conditions to use the IBSP [Illinois Beach State Park] beaches for the
general public BUT for maintenance activities they should be conducted
when sand surface is wet or closed to the public. It is also stated
that the IDNR [Illinois Department of Natural Resources] should
continue asbestos removal from the beach. These inconsistencies and the
actual air monitoring results raise concerns regarding the safety of
human use of the beaches. There is ACM [Asbestos Containing Material]
on the beach and it should be removed, the maintenance workers should
take precautions but it is OK for the public and especially children to
play with and on the beach. What is going on here, either the beach is
safe or the safety is questionable,'' Bradley wrote. But ATSDR cleared
up the answer to that question in their final report. ``What are the
conclusions of the EI [Environmental Exposure Investigation]?'' asked
ATSDR. ``The activities simulated at the beaches at IBSP pose no
apparent public health hazard,'' they declared.
In an interview with Subcommittee staff ATSDR's Mark Johnson
acknowledged that his agency did not include all of the suggestions
submitted by the EPA officials. It is an ATSDR document, he said, and
the ultimate decision of what is in the health consultation rests with
the Agency for Toxic Substances and Disease Registry. ATSDR is now in
the process of reviewing new sampling data of the beaches and expects
to release their new health consultation any day, according to ATSDR.
Depleted Uranium (DU) Contamination in Colonie, New York
Professor Randall R. Parrish, Ph.D., is the head of the British
Geologic Survey's Natural Environment Research Council's (NERC) Isotope
Geoscience Laboratories in Nottingham, England and Professor of Isotope
Geology at the University of Leicester. In 2007 he was the lead author
of a peer-reviewed journal article that investigated depleted uranium
(DU) inhalation exposures in Colonie, New York, home to National Lead,
Inc., which produced depleted uranium for U.S. military munitions from
1958 to 1984, when the site was closed due to violations of
environmental emission standards.\36\ In 2006, the Federal Government
completed a $190 million cleanup of the site.
---------------------------------------------------------------------------
\36\ Randall R. Parrish, et al., ``Depleted uranium contamination
by inhalation exposure and its detection after 20 years: Implications
for human health assessment,'' Society of the Total Environment,
September 2007, available here: http://www.albany.edu/news/
pdf-files/Depleted-Uranium-Article.pdf
---------------------------------------------------------------------------
A 2004 ATSDR health consultation found that past emissions from the
site ``could have increased the risk of health effects--especially
kidney disease--for people living near the plant'' and found that ``the
combination of inhaling DU dust and cigarette smoke could have
increased the risk of lung cancer.'' But because the plant had ceased
operating, ATSDR concluded that there was ``no apparent public health
hazard.'' In addition, they rejected a request to conduct a health
survey because they said it would not ``answer the community's
questions about whether or not the NL plant impacted their
health.''\37\ In 2007, however, Professor Parrish and researchers at
the University of Albany--using a newly developed method--detected DU
exposures in 100 percent of the former workers at the site they tested
and 20 percent of the residents they tested, in addition to DU in the
soil found miles away from the site.
---------------------------------------------------------------------------
\37\ ``Health Consultation: Colonie Site (Aliases: Colonie Interim
Storage Site and Formerly National Lead Industries) Colonie, Albany
County, New York, Agency for Toxic Substances and Disease Registry,
October 5, 2004, available here: http://www.atsdr.cdc.gov/HAC/pha/
ColonieSite100504-NY/ColonieSite100504HC-NY.pdf
---------------------------------------------------------------------------
Parrish's paper said that the ``ATSDR Health Consultation concluded
that further investigations were unjustified because it would be
impossible to determine the incidence of DU contamination after such a
long period of time since the inhalation hazard no longer existed.''
But Parrish's paper showed it was possible and the authors recommended
that ATSDR do a follow-up study with a larger group of nearby residents
to access their ``potential health outcomes.'' Although ATSDR's mission
statement says it ``serves the public by using the best science,''
scientists at ATSDR told Subcommittee staff that they are unswayed by
Professor Parrish's findings and say they do not see a need to re-
examine the Colonie, New York residents for potential DU exposures.
They say that the amount of depleted uranium detected in the residents
was so small that it would not result in any health hazard, thereby
confirming the conclusions of their earlier health consultation.
Professor Parrish says this argument does not take into account what
these individuals were exposed to in the past. Parrish says that with
further analysis of his work scientists can attempt to calculate the
cumulative exposures of individuals to help determine what their
exposures were in the past and what the health risk to them might be
today.
Vieques Island, Puerto Rico
For years, ATSDR has investigated potential environmental hazards
on and off the coast of the island of Vieques in Puerto Rico. The U.S.
Navy engaged in live bombing practice activities on and off the coast
of Vieques from 1941 to 2003 spreading munitions containing depleted
uranium and other toxic chemicals into the sea and local ecosystem. In
November 2003, ATSDR issued a summary of its work on the island.
``Residents of Vieques have not been exposed to harmful levels of
chemicals resulting from Navy training activities at the former Live
Impact Area,'' ATSDR concluded. ``It is safe to eat seafood from the
coastal waters and near-shore lands on Vieques,'' they said.\38\
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\38\ ``A Summary of ATSDR's Environmental Health Evaluations for
the Isla de Vieques Bombing Range, Vieques, Puerto Rico,'' Agency for
Toxic Substances and Disease Registry (ATSDR), November 2003, available
here: http://www.atsdr.cdc.gov/sites/vieques/
vieques-profile.pdf
---------------------------------------------------------------------------
Many independent scientists and health experts question those
findings. Most recently, Professor James Porter, Associate Dean at the
Odum School of Ecology, University of Georgia, presented findings at a
conference last month that found unexploded munitions from the U.S.
Navy around the island were, in fact, leaking toxic cancer causing
substances into the ocean endangering sea life. Professor Porter found
that sea urchins and ``feather duster worms'' closest to unexploded
bombs or bomb fragments off the coast of Vieques had extraordinarily
high toxic levels of various chemicals. Some of the materials were
nearly 100,000 times over established safe limits. Professor Porter
cautioned that he performed a ``point source study,'' meaning he took
measurements close to the residual bomb materials and that ATSDR has
performed ``broad spectrum'' tests that measure toxic chemicals in a
much wider arena.
That explains the discrepancies in what Professor Porter found and
what ATSDR discovered. Although Professor Porter cautioned that it is
still unclear what sort of impact these toxins have had on the dinner
plate some studies have shown that residents on Vieques Island have a
23 percent higher cancer rate than those on the main island of Puerto
Rico.\39\ Other studies have found that plants on the island have high
concentrations of lead, mercury, cadmium, uranium, cobalt, manganese
and aluminum.\40\ Vieques residents question the integrity of the
studies conducted by ATSDR, as do many Puerto Rican and other
independent scientists.
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\39\ See: ``Link between unexploded munitions in oceans and cancer-
causing toxins determined,'' the University of Georgia, News Release,
February 18, 2009, available here: http://www.uga.edu/aboutUGA/
research-bombs.html; Maria Miranda Sierra, ``Carcinogens found in
marine life in island of Vieques in Puerto Rico,'' Caribbean Net News,
February 21, 2009, available here: http://www.caribbeannetnews.com/
news-14429-21-21-.html; John Lindsay-Poland,
``Health and the Navy in Vieques,'' Fellowship of Reconciliation,
Puerto Rico Update, Number 32, Spring 2001, available here: http://
www.forusa.org/programs/puertorico/archives/0401healthnavy.html; Azadeh
Ansari, ``Undersea bombs threaten marine life,'' CNN, February 26,
2009, available here: http://www.cnn.com/2009/TECH/science/02/26/
undersea.munitions.cleanup/index.html
\40\ Dr. Arturo Massol-Deya, et. al., ``Trace Elements Analysis in
Forage Samples from a U.S. Navy Bombing Range (Vieques, Puerto Rico),
International Journal of Environmental Research and Public Health,
August 14, 2005; available here: http://www.mdpi.com/1660-4601/2/2/263
Kelly Air Force Base, San Antonio, Texas
Issuing public health documents that fail to include relevant
information, are based on incomplete or deficient investigations, or
omit critical public health data can contribute to the environmental
exposure of the public. In 1999 an ATSDR report that examined cancer
incidence around the Kelly Air Force Base in San Antonio, Texas, found
increased levels of liver and kidney cancer as well as leukemia.\41\
But none of ATSDR's studies on the former Air Force Base linked the
illnesses to the toxins from the base that have leached into these
neighborhoods.
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\41\ ``Public Health Assessment, Kelly Air Force Base, San Antonio,
Bexar County, Texas,'' Prepared by Agency for Toxic Substances and
Disease Registry, September 9, 1999, available here: http://
www.atsdr.cdc.gov/HAC/pha/kelly/kel-toc.html
---------------------------------------------------------------------------
In a critique of the ATSDR report, Dr. Katherine Squibb, a
toxicologist at the University of Maryland, found that the Agency's
conclusions were based on minimal information, some Air Force studies
ATSDR relied on for its conclusions failed to measure important
exposure pathways, and ATSDR failed to conduct an adequate assessment
of whether or not some chemicals migrated off-base. ``It is
questionable as to whether ATSDR's conclusion that no public exposure
to contaminants occurred through the domestic use of groundwater in the
past is correct,'' wrote Squibb.\42\
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\42\ ``Technical Review of the Public Health Assessment, Phase I
for Kelly Air Force Base, San Antonio, Bexar County, Texas, Conducted
by Division of Health Assessment and Consultation, Agency for Toxic
Substances and Disease Registry (ATSDR), Released for Public Comment,
September, 1999,'' Prepared by Katherine S. Squibb, Ph.D., Program in
Toxicology, University of Maryland, Baltimore (undated), available
here: https://afrpaar.lackland.af.mil/ar/getdoc/KELLY/
KELLY-AR-3299.pdf
---------------------------------------------------------------------------
In a 2002 critique of another ATSDR report on the Kelly Air Force
Base, Squibb found that ATSDR did not evaluate cumulative risks of
exposure for certain chemicals.\43\ She also told a local reporter that
ATSDR examined health risks from exposure to soil from a part of the
base only after the site had been cleaned up and remediated. ``It does
not appear that ATSDR has considered health risks associated with soil
that migrated from this site prior to remediation,'' said Squibb.\44\
---------------------------------------------------------------------------
\43\ ``Review of ATSDR Petitioned Public Health Assessment, Kelly
Air Force Base,'' Conducted by Katherine S. Squibb, Ph.D., Program in
Toxicology, University of Maryland, Baltimore, June 11, 2002, available
here: https://afrpaar.lackland.af.mil/ar/getdoc/KELLY/
KELLY-AR-3278.pdf
\44\ Roddy Stinson, ``Round on the Kelly-toxins mystery trail:
`dioxins and furans,' '' San Antonio Express-News, March 26, 2002.
---------------------------------------------------------------------------
Seven years after Dr. Squibb's comments, the issues of off-site
contamination at Kelly Air Force Base were still swirling around the
local community. ``I don't know much about science,'' San Miguel, one
local resident said last month, ``but there are 13 homes on this block
and 11 of those families have had someone die from cancer. That is what
is bothering me,'' he said. ``Where did that come from?''\45\
---------------------------------------------------------------------------
\45\ Anton Caputo, ``Kelly area homes retested by EPA,'' San
Antonio Express-News, February 6, 2009, available here: http://
www.mysanantonio.com/news/environment/39182822.html
Trichloroethylene (TCE) Groundwater Contamination in Elkhart, Indiana
Earlier this month, ATSDR released a draft Public Health Assessment
(PHA) on groundwater contamination from trichloroethylene (TCE) and
other chemicals at what is known as the Lusher Avenue Site in Elkhart,
Indiana. Contamination in the area has stretched back to the mid-1980s
and last year EPA designated it a Superfund site and placed it on the
National Priorities List (NPL). There are a number of potential sources
of environmental pollution in the area including a rail yard,
pharmaceutical manufacturer, plastic and metal fabrication plants and a
musical instrument fabrication facility. The area has a population of
2,597 people, including 286 children six years old or younger.\46\
---------------------------------------------------------------------------
\46\ ``Public Health Assessment for Lusher Avenue Groundwater
Contamination, Elkhart, Elkhart County, Indiana,'' Public Comment
Release, Prepared by: U.S. Department of Health and Human Services,
Agency for Toxic Substances and Disease Registry, March 1, 2009, p. 21,
(hereafter referred to as ATSDR Lusher Site PHA, available here: http:/
/www.atsdr.cdc.gov/NEWS/lusher-03022009.html
---------------------------------------------------------------------------
In 1989, EPA established a drinking water standard or Maximum
Contaminant Level (MCL) for TCE of five parts-per-billion (5 ppb).
Municipal water systems are required to test water for TCE
concentrations every three months. If any levels exceed the MCL, they
are required to notify the public via newspapers, radio, TV networks
and other means and to provide alternative drinking water supplies to
the public.\47\ In the past, TCE contamination in the drinking water
systems in Lusher were discovered in many of the several hundred
private wells in the area. Residents were provided with alternative
water supplies or filtration systems were installed. A new round of
sampling in 2005 and 2006 found some wells had TCE levels of up to 700
ppb, exposing an estimated 200 people to these contaminants.
---------------------------------------------------------------------------
\47\ ``Consumer Factsheet on: TRICHLOROETHYLENE,'' U.S.
Environmental Protection Agency, available here: http://www.epa.gov/
OGWDW/dwh/c-voc/trichlor.html
---------------------------------------------------------------------------
The recent ATSDR health assessment concluded that: ``Most adverse
health outcomes are not anticipated at Lusher because the TCE
concentration in most private wells is less than 100 ppb.'' \48\
However, ATSDR's own 1997 Toxicological Profile on trichloroethylene
cites several studies showing associations between exposures to much
lower levels of TCE exposure and health effects, such as neural tube
defects, for instance.\49\ In addition, it cites another study of
residents in Tucson, Arizona that were exposed to TCE levels between
six and 239 ppb. The study found that the children of mothers who lived
in this area in their first trimester of pregnancy were two and one-
half times more likely to develop congenital heart defects than
children of mothers not exposed to TCE during pregnancy.\50\ Yet, the
ATSDR health assessment says that there have been exposures at the
Lusher site as high as 700 ppb, ``However, most TCE exposures at Lusher
were and are less than 100 ppb and indicate little to no risk for heart
defects in newborns.'' [Emphasis in the original].\51\
---------------------------------------------------------------------------
\48\ ATSDR Lusher Site PHA, p. 12.
\49\ ``Toxicological Profile for Trichloroethylene,'' U.S.
Department of Health and Human Services, Agency for Toxic Substances
and Disease Registry, September 1997, p. 84, (hereafter referred to as
ATSDR TCE Tox Profile) available here: http://www.atsdr.cdc.gov/
toxprofiles/tp19.pdf
\50\ ATSDR TCE Tox Profile, p. 85.
\51\ ATSDR Lusher Site PHA, p. 13.
---------------------------------------------------------------------------
The ATSDR assessment does say: ``People drinking well water which
contains TCE at levels greater than 300 ppb have an increased risk of
developing cancer.'' It bases this assertion on another ATSDR study
that examined a cancer cluster in Woburn, Massachusetts in 1986 and
found that there were more than twice as many childhood cases of
leukemia as expected while the TCE contamination in the water was only
267 ppb. How ATSDR now justifies asserting that there is no increased
risk of cancer below 300 ppb or that there is no risk of heart defects
in newborns from the exposures in Lusher appears to be scientifically
unfounded and misleading.\52\
---------------------------------------------------------------------------
\52\ ATSDR Lusher Site PHA, pp. 14-15.
---------------------------------------------------------------------------
The Public Health Assessment also failed to mention a 1994 study
cited in ATSDR's own Toxicological Profile of trichloroethylene. The
study found that in a review of 1.5 million residents in 75 towns
monitored for TCE levels between 1979 and 1987, females exposed to
drinking water in excess of the EPA maximum contaminant level (MCL) of
five ppb had a significant elevation of total leukemias, including
childhood leukemias, acute lymphatic leukemias, and non-Hodgkin's
lymphoma. The recent ATSDR report also failed to mention that a 1996
study by the Massachusetts Department of Health found that the risk of
leukemia in the group of Woburn, Massachusetts women exposed to TCE in
utero were eight times higher than a control group.\53\
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\53\ ATSDR TCE Tox Profile, pp. 90-91.
---------------------------------------------------------------------------
While none of these studies in and of themselves are conclusive
evidence of clear links between TCE exposures and these specific health
problems, they are part of the scientific public health record on these
issues. Omitting them from a public health document that is trying to
assess the public health threats from TCE to the community in and
around the Lusher site appears short-sighted at best and scientifically
misleading.
In the end, ATSDR's conclusions on the Lusher site seem fuzzy at
best. Inconsistencies in other ATSDR reports have been a long standing
frustration by both local communities and other federal agencies,
particularly EPA. In its conclusions on the Lusher site, for instance,
ATSDR wrote: ``ATSDR categorizes the site as a past public health
hazard. Due to uncertainties concerning sources, continuing migration
of contaminants, and private well use, the site could pose a future
public health hazard. Currently, exposure has been mitigated or
lessened through provision of alternate water and filter systems for
private well users with contaminated water. However, there may be
private wells that still need to be tested.'' \54\ Until ATSDR begins
to focus on the scientific integrity and basic clarity of its public
health documents with renewed energy, care and focus the Agency will
continue to be mired down in problems and garner distrust from the
local communities it is supposed to serve.
---------------------------------------------------------------------------
\54\ ``Public Health Assessment for Lusher Avenue Groundwater
Contamination, Elkhart, Elkhart County, Indiana,'' Public Comment
Release, Prepared by: U.S. Department of Health and Human Services,
Agency for Toxic Substances and Disease Registry, March 1, 2009, p. 21,
available here: http://www.atsdr.cdc.gov/NEWS/
lusher-03022009.html
Dr. Frumkin's National Conversation
In recent weeks Dr. Frumkin has unveiled an NCEH/ATSDR initiative
he calls: ``The National Conversation on Public Health and Chemical
Exposures.'' He has grand plans. ``[N]ow is an opportune time to
revitalize the public health approach to chemical exposures,'' he wrote
recently in the Journal of Environmental Health.\55\ As part of this
effort he wants to have a broad dialogue that aims to identify gaps in
the public health approach to chemical exposures and identify solutions
for strengthening the public health approach to chemical exposures.
---------------------------------------------------------------------------
\55\ Howard Frumkin, M.D., M.P.H., Dr.P.H., ``The Public Health
Approach to Chemical Exposures: A National Conversation,'' Journal of
Environmental Health, Volume 71, Number 7, March 2009.
---------------------------------------------------------------------------
Dr. Frumkin has held several internal ATSDR ``all hands meetings''
where he has briefed agency employees on his initiative and he
organized a small meeting in Washington, D.C. on Friday, March 6th with
environmental organizations. He has personally met with many public
health and environmental groups in an attempt to drum up support for
his initiative.
A few weeks ago he met with Stephen Lester, Science Director of the
Center for Health, Environment and Justice and its Executive Director,
Lois Gibbs, the local activist from Love Canal in New York who
spearheaded an environmental investigation when she discovered her
children's elementary school was built on a toxic waste dump. Dr.
Frumkin was apparently seeking advice on how to help reorganize or
reform ATSDR to make it more responsive to the concerns of local
communities. Lester told him that all he needed to do was follow the
recommendations he and other local community groups gave to ATSDR back
in 1990. Virtually nothing has changed, Lester says. The problems, as
well as many of the solutions, remain the same. Lester had been through
this once before and is not very hopeful that any real change will come
to the Agency.
For a twelve-year period from 1986 to 1998, Dr. Barry Johnson
served as the Assistant Administrator of ATSDR and by all accounts he
was a deeply dedicated and compassionate public servant. In 1990 he
attempted to reach out to local community groups to begin a dialogue in
order to help rectify the Agency's poor image and to move the Agency
into a new direction, producing scientifically valid studies,
identifying causes of environmental contamination causing harm to human
health and obtaining the respect and trust of the local communities
ATSDR is supposed to protect. Dr. Johnson had contacted the Center for
Health, Environment and Justice (then called the Citizen's
Clearinghouse for Hazardous Wastes). Because of Lois Gibbs' presence,
the organization had clout with many local environmental groups and
communities.
There were several meetings between ATSDR and local community
groups as a result of Barry Johnson's organizing efforts. The groups
produced a long-list of problems, observations and recommendations.
Many of them seem to have withstood the test of time and are equally
relevant and significant today. ``Health officials look for every
possible reason other than the obvious as the causative factor in
evaluating health problems.'' ``Studies do not address problems and do
not lead to action; instead they seem to look for ways to dismiss
problems.'' One asked: ``Is there a need for ATSDR? Should ATSDR exist
given that it is not providing what citizens want and need.'' \56\
---------------------------------------------------------------------------
\56\ ``Report on a Meeting Between ATSDR and Community
Representatives,'' Citizen's Clearinghouse for Hazardous Wastes, June
30, 1990, Washington, D.C.
---------------------------------------------------------------------------
The momentum from those meetings soon faded. Four years later
Lester wrote: ``Today we continue to see many of the same investigation
strategies that ATSDR and CDC has been using for years--investigating
health problems with scientific methods that are highly questionable
and inappropriate. They consistently ask the wrong questions, use
inappropriate comparison groups, dilute exposed populations with
unexposed populations, eliminate exposed people from their studies and
use other ill-conceived scientific methods to evaluate health problems
in communities. In the end, they find no health problems because they
used methods destined to fail from the beginning and because their
studies are often ``inconclusive by design.'' \57\
---------------------------------------------------------------------------
\57\ ``Promises, Promises: ASTDR . . . Don't Ask . . . Don't Tell .
. . Don't Pursue,'' Stephen Lester, Science Director, Citizens
Clearinghouse for Hazardous Waste (renamed Center for Health,
Environment and Justice), Everyone's Backyard Newsletter, March/April
1994, p. 15-16.
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The integrity of the data ATSDR produces is critical to gaining the
public's trust and successfully addressing important environmental
public health issues. These flawed reports have very direct impacts on
the safety and health of the public. The public health documents
emanating from ATSDR should adhere to a clear, consistent and
scientifically credible and defensible standard. Yet, in far too many
instances that is not the case.
ATSDR's Leadership Today
Many of the challenges that ATSDR faces every day are not simple.
Accurately assessing public health implications from environmental
contamination is difficult. The state of the science may not be able to
determine the exact cause of a cluster of illnesses no matter how many
hours are invested or how high a priority investigating the issue is to
ATSDR, a local community or anyone else. But these are not now, nor
have they ever been the criticisms that have been leveled against the
Agency. The criticisms swirl around the simple mistakes, the careless
research, the critical scientific omissions, the poorly contrived
methods used by the Agency to identify the cause of a community's
public health concerns and the lack of appropriate fundamental agency
policies, such as having a thorough and independent review of ATSDR's
public health documents before they are released to the public.
None of these problems will ever evaporate or disappear until ATSDR
has strong leaders who are committed to ensuring that the Agency
fulfills its mission and at the same time creates a public health
culture that is bolstered by sound science, careful review and an
eagerness to actually identify the potential environmental causes of
illnesses, ailments or diseases that impact local communities and
affect their health and safety. The problems that embroil ATSDR have
been present for many years and did not simply emerge under the
leadership of Dr. Frumkin.
However, it is apparent from both Dr. Frumkin's handling of the
formaldehyde issue as well as other incidents that Dr. Frumkin's
actions have contributed to a culture where scientific integrity
appears to take a back seat to political expediency and uncomplicated
conclusions regardless of their accuracy or potential impact upon the
public's health. As the Subcommittee said in its staff report on
formaldehyde last year: ``It seems unlikely that ATSDR will be capable
of fulfilling its core mission of protecting the public health until
they have capable leaders willing and able to lead the Agency and serve
the public.'' The cases below all reveal the approach taken by the
current leadership and their commitment to scientific integrity.
Camp Lejeune, North Carolina
In 1990 ATSDR published a public health assessment that showed a
dry-cleaning facility just outside of Camp Lejeune in North Carolina
had inappropriately disposed of trichloroethylene (TCE) which
contaminated the base's water supply.\58\ In 1997 ATSDR wrote a public
health assessment on the potential environmental exposures of U.S.
military personnel and veterans who had served at Camp Lejeune in North
Carolina and were potentially exposed to TCEs and a host of other toxic
substances.\59\ The report, based on flawed data that was available at
the time, showed that the levels of exposures believed to have occurred
would not pose a health hazard for adults. But it did recommend a
follow-up study to evaluate potential health effects to mothers exposed
during pregnancy and their children.\60\ ATSDR has conducted numerous
health studies on Camp Lejeune since then.\61\
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\58\ ``Public Health Assessment for ABC One Hour Cleaners,
Jacksonville, Onslow County, North Carolina,'' Department of Health and
Human Services, Agency for Toxic Substances and Disease Registry, 1990.
\59\ ``Public Health Assessment for U.S. Marine Corps Base at Camp
Lejeune, Military Reservation, Camp Lejeune, Onslow County, North
Carolina,'' Agency for Toxic Substances and Disease Registry, 1997,
available here: http://www.atsdr.cdc.gov/HAC/pha/usmclejeune/
clej-toc.html
\60\ For a good summary of the environmental issues at Camp Lejeune
see: J. Wang, et. al., ``Camp Lejeune (NC) Environmental Contamination
and Management,'' Multimedia Environmental Simulations Laboratory,
Georgia Institute of Technology, available here: http://
mesl.ce.gatech.edu/RESEARCH/CampL-GW.htm
\61\ ``Camp Lejeune, North Carolina: Home,'' Agency for Toxic
Substances and Disease Registry, available here: http://
www.atsdr.cdc.gov/sites/lejeune
---------------------------------------------------------------------------
In 2003 a Camp Lejeune veteran wrote to the Department of Health
and Human Services requesting records referenced in ATSDR's 1997 public
health assessment on Camp Lejeunne under a Freedom of Information Act
(FOIA) request. The response he got back said the records ``are no
longer in CDC's possession. Specifically, the records were lost during
a 1998 office move,'' an HHS official wrote. ``As a result, CDC no
longer has records that would respond to your request, other than the
public health assessment itself.'' \62\ However, an ATSDR FOIA officer
offered a slightly different explanation. On June 2, 2003, she wrote,
``A search of our record failed to reveal any documents pertaining to
your request. Program staff stated that the referenced material was
either destroyed or misplaced during an agency physical move this past
October [2002].'' \63\
---------------------------------------------------------------------------
\62\ Letter from William A. Pierce, Deputy Assistant Secretary for
Public Affairs/Media, Department of Health and Human Services to Mr.
Thomas Townsend, November 25, 2003.
\63\ Letter from Lynn Armstrong, CDC/ATSDR FOIA Officer, Office of
Communication, Department of Health and Human Services, Centers for
Disease Control and Prevention (CDC) to Thomas Townsend, June 2, 2003.
---------------------------------------------------------------------------
Finally, Dr. Frumkin responded to Camp Lejeunne veteran and
activist Jerry Ensminger about the FOIA responses and the validity of
the 1997 Public Health Assessment on May 4, 2007. ``As a scientific
public health agency, it is important to us that our reports contain
the most current and scientifically correct information available at
the time,'' wrote Dr. Frumkin. ``We acknowledge that the references
used for the development of the 1997 public health assessment are no
longer available in the Agency for Toxic Substances and Disease
Registry's (ATSDR) files. A move of ATSDR staff resulted in our files
of Camp Lejeune-related documents being temporarily relocated. A
private contractor mistakenly disposed of the documents,'' said Dr.
Frumkin. ``Although unfortunate that the material referenced in the
public health assessment is no longer available in ATSDR's files, the
original information and data, with the exception of original ATSDR
references, may still be available from their original sources.''
Mr. Ensminger legitimately questions how the leader of a federal
scientific public health agency can stand behind a document which
contains no supporting information or data. He is particularly
perturbed by how cavalier Dr. Frumkin has been to this and other
critical public health issues. The impact of ATSDR's work has real-
world implications for U.S. Veterans and other members of the public.
In this instance, the U.S. Veterans Administration has specifically
cited the flawed ATSDR public health assessment to deny at least one
veteran medical benefit's for illnesses they believe were due to toxic
exposures while based at Camp Lejeune on several occasions.\64\
---------------------------------------------------------------------------
\64\ Denita L. McCall, Represented by Disabled American Veterans
before Department of Veterans Affairs, Rating Decision, January 17,
2007.
Brush Wellman, Elmore, Ohio--Beryllium Tests
However, in some instances it is clear that Dr. Frumkin and his
deputy Dr. Tom Sinks have intentionally tried to diminish the scope and
integrity of some of the Agency's health consultations. In one
investigation that examined potential exposures to beryllium in Elmore,
Ohio, Dr. Frumkin and Dr. Sinks clearly prevented ATSDR staff from more
adequately informing the local community about the availability of free
blood tests in order to test them for potential exposure. Publicly,
ATSDR said that it offered up to 200 free tests but that only about 20
individuals responded. But internally, e-mails obtained by the
Subcommittee show that Dr. Frumkin and Dr. Sinks intentionally limited
advertising the availability of the tests despite strong and repeated
arguments from some ATSDR staff scientists.
In February 2006, Dr. Dan Middleton was finally at wits end. In an
e-mail to Dr. Sinks, in which Dr. Frumkin and others were copied he
wrote: ``After a prolonged struggle to bring this investigation forward
and innumerable revisions, I find myself at a loss as to how to
proceed--I cannot in good conscience lead an investigation that has
little chance of success.'' Middleton said he would like to resolve the
issue constructively and suggested a meeting with Dr. Frumkin and Dr.
Sinks.\65\
---------------------------------------------------------------------------
\65\ E-mail from Dr. Dan Middleton to Dr. Tom Sinks (cc'd to Dr.
Howard Frumkin and other ATSDR officials), Tuesday, February 7, 2006,
9:38 a.m.
---------------------------------------------------------------------------
But Dr. Frumkin's reply to Dr. Sinks about the e-mail was less than
encouraging. ``Tom: Dan is probably right. We need a meeting. This is
because he clearly hasn't gotten the message. This study is OFF. There
will not be a study along the lines Dan has contemplated. There will be
a limited clinical service offered to those (probably few) members of
the community who want it. That service will consist of a blood test to
look for beryllium sensitization among eligible persons. The outcome
will be this: people who are sensitized will be informed of that fact
(as will those who are not sensitized), and if they wish their doctors
will also be informed. We will provide information to local doctors to
help them interpret and act on the results. With that we will be done.
Period. Howie.'' \66\
---------------------------------------------------------------------------
\66\ E-mail from Dr. Howard Frumkin to Dr. Tom Sinks, Tuesday,
February 7, 2006 11:15 a.m.
---------------------------------------------------------------------------
In mid-June, 2006 Dr. Middleton attempted to gain permission from
Dr. Sinks to specifically inform workers in one local machine shop
about the beryllium tests. ``Isn't it the right thing to do?'' Dr.
Middleton asked.\67\ In his e-mail response, Dr. Sinks wrote: ``good
try--no. Let's run the advertisement. It will include machinists and
they may call us.'' \68\
---------------------------------------------------------------------------
\67\ E-mail from Dr. Dan Middleton to Dr. Tom Sinks, Subject:
machine shop workers, Wednesday, June 14, 2006, 4:54 p.m.
\68\ E-mail from Dr. Tom Sinks to Dr. Dan Middleton, Subject: RE:
machine shop workers, Thursday, June 15, 2006, 5:02 p.m.
---------------------------------------------------------------------------
In the end, only a small number of individuals asked to be tested.
A week later, Dr. Sinks was informed by Dr. Middleton that they had
completed 27 interviews for the test and that 21 people are
eligible.\69\ Dr. Sinks then forwarded the e-mail to Dr. Frumkin with
the subject line: ``beryllium testing'' saying ``pretty good guess!''
Dr. Frumkin's reply to Dr. Sinks, ``Wow. I think 20 was our estimate,
no?'' \70\ The Subcommittee investigated the beryllium issue last
year.\71\
---------------------------------------------------------------------------
\69\ E-mail from Dr. Dan Middleton to Dr. Tom Sinks, Friday, June
23, 2006, 3:01 p.m.
\70\ E-mail from Dr. Howard Frumkin to Dr. Tom Sinks, Saturday,
June 24, 2006, 11:49 a.m.
\71\ ``Subcommittee Investigates CDC's Handling of Beryllium
Exposure Investigation,'' April 11, 2008, available here: http://
science.house.gov/press/PRArticle.aspx?NewsID=2154
---------------------------------------------------------------------------
The design of any scientific study is a critical element in
determining the validity of its outcome and ability of the study to
identify a problem. Until ATSDR has strong dedicated leaders who are
more concerned about the integrity of the reports the Agency produces
than the potential backlash the Agency may receive from corporations,
federal agencies or local environmental groups unhappy or dissatisfied
with the results of their work ATSDR will never gain the public's trust
or the confidence of independent scientists and public health
professionals.
Lead in Washington, D.C.'s Drinking Water
Based on almost two years of work, it is the Subcommittee's staff's
conclusion that Dr. Frumkin has shown a laissez-faire attitude towards
the scientific integrity of the documents and data his agency relies
upon to make critical public health decisions. In several instances he
has appeared to be more inclined to defend the agencies he directs, the
Agency for Toxic Substances and Disease Registry (ATSDR) as well as the
CDC's National Center for Environmental Health (NCEH), than protecting
the public's health by diligently investigating and analyzing potential
public health threats based upon sound scientific procedures and
methods. His inexcusable defense of the Agency's actions in the
formaldehyde issue is perhaps the most glaring example, but there have
been others.
In 2002 a change in the drinking water filtration system in
Washington, D.C. led to a sharp increase in the levels of lead in the
city's drinking water. This spike which may have presented a health
hazard to city residents was not reported by the Washington D.C. Water
and Sewer Authority (WASA) or the Environmental Protection Agency
(EPA). By early 2004 tests indicated that most homes tested had water
lead levels above EPA's recommended level of 15 parts per billion
(ppb). The public first became aware of the high lead levels in a 2004
story in The Washington Post.\72\
---------------------------------------------------------------------------
\72\ David Nakamura, ``Water in D.C. Exceeds EPA Lead Limit; Random
Tests Last Summer Found High Levels in 4,000 Homes Throughout City,''
The Washington Post, January 31, 2004, p. A1.
---------------------------------------------------------------------------
In March 2004, scientists at the CDC's National Center for
Environmental Health, which Dr. Frumkin came to lead the following
year, reported that of 201 residents from 98 homes with high water lead
levels they tested, none of them had lead levels in their blood that
reached a ``level of concern.'' \73\ Most people interpreted this CDC
report as claiming that there was no health threat from drinking
Washington, D.C.'s water. A WASA fact-sheet in February 2008, for
instance, said: ``According to the CDC report, there were no children,
from a sample group of 201, identified with blood lead levels above the
CDC level of concern (>10 micrograms/deciliter) that were not explained
by other sources, primarily the conditions of the household paint.''
\74\
---------------------------------------------------------------------------
\73\ ``Blood Lead Levels in Residents of Homes with Elevated Lead
in Tap Water--District of Columbia, 2004,'' Morbidity and Mortality
Weekly Report, MMWR Dispatch, Vol. 53/March 30, 2004, Department of
Health and Human Services, Centers for Disease Control and Prevention,
available here: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5312a6.htm
\74\ ``Important Facts For Lead Service Replacement: Program
Review,'' District of Columbia Water and Sewer Authority, February
2008, available here: http://www.dcwasa.com/site-archive/
news/documents/LSR%20Program%20Facts.pdf
---------------------------------------------------------------------------
But last month a peer-reviewed paper was released by Marc Edward, a
civil and environmental engineering professor at Virginia Tech and
collaborators at Children's National Medical Center that showed, in
fact, children in D.C. clearly had high levels of lead in there blood
as a result of the D.C. water crisis. They also found that 50 percent
of the data CDC relied on from the D.C. Department of Health regarding
the blood tests and water lead levels was flawed.\75\ In addition, it
was discovered that more than 6,500 blood tests for a critical period
in 2003 and 2004 were lost. Still, Dr. Frumkin told a reporter for
Environmental Science & Technology, the journal where the article was
published, that even if the data used for the CDC analysis was deeply
flawed it would not impact the CDC's conclusions. ``No public-health
database is perfect,'' he said. ``But this database is not so flawed
that it fails. We did a sensitivity analysis to see what happens if
data are misclassified. That sensitivity analysis shows that there
would need to be a very large amount of data misclassification to alter
the conclusions of the study,'' argued Frumkin.\76\
---------------------------------------------------------------------------
\75\ Marc Edwards, et. al., ``Elevated Blood Lead in Young Children
Due to Lead-Contaminated Drinking Water: Washington, DC, 2001-2004,''
Environmental Science & Technology, January 27, 2009.
\76\ Rebecca Renner, ``Mapping out lead's legacy,'' Environmental
Science & Technology, February 11, 2009, available here: http://
pubs.acs.org/doi/full/10.1021/es8037017
---------------------------------------------------------------------------
Dr. Frumkin's statement that a ``sensitivity analysis'' showed that
even flawed data would not change the conclusions of the CDC report
struck Professor Marc Edwards as incredible for the leader of a public
health agency. Professor Edwards says considering half of the data had
flaws in it, it seems highly unlikely that those flaws did not impact
the CDC's findings. He says his new report clearly shows that the data
and therefore CDC's conclusions were wrong. Dr. Frumkin and the CDC
began to back away from their initial claims that were widely
interpreted to mean the drinking water was safe.
In the aftermath of the criticism of the CDC report, Dr. Frumkin
said the report had a ``clear message,'' that ``there is no threshold
for lead exposure.'' Edwards, a civil and environmental engineering
Professor was named a MacArthur Fellow last summer by the John D. and
Catherine T. MacArthur Foundation and granted $500,000 (often called a
``Genius Grant'') to study drinking water safety issues. Edwards has
written several letters to the CDC alleging ``possible scientific
misconduct by CDC Scientists and Officials'' regarding the D.C. lead--
drinking water issue. He has not named Dr. Frumkin in these complaints.
But Dr. Frumkin's public response to his involvement in the D.C.
lead drinking water issue is remarkably similar to his actions and
inactions undertaken during ATSDR's response to the formaldehyde issue.
In that instance, he argued, after being confronted by Congress that it
was not his agency's fault for issuing a deeply flawed health
consultation, but FEMA's fault for ``misinterpreting'' the data in the
undeniably flawed report. On the D.C. lead issue, Dr. Frumkin e-mailed
Ralph Scott, the Community Project Director for the Alliance for
Healthy Homes, on Monday, February 16, 2009 and said: ``In the Post
article of February 11, WASA General Manager Jerry Johnson attributed
to CDC the view that ``residents' health had not been affected'' by
elevated lead levels in DC's water supply from 2001 to 2004. As I am
sure you agree, this persistent misstatement by WASA is regrettable,''
wrote Dr. Frumkin. He then went on to defend the CDC report on D.C.'s
lead level in drinking water saying the report actually said no levels
of lead are safe for children.
Like the formaldehyde report, the CDC report was simply
``misinterpreted'' by the public and apparently officials at the D.C.
Water and Sewer Authority, according to Dr. Frumkin. And like the
formaldehyde report, the CDC report on lead levels in D.C.'s drinking
water has had health related consequences. School officials in New York
and Seattle have cited the flawed CDC report as justification for not
appropriately responding to high levels of lead in their water, for
instance. Congress's investigative arm, the Government Accountability
Office (GAO) also cited the flawed CDC report and the Congressional
Research Service (CRS) used the flawed data in the CDC report because
they believed it was scientifically sound and accurate. ``None of the
201 persons tested who live in homes with the highest levels of lead in
drinking water (i.e., above 300 ppb) had blood lead levels above CDC's
levels of concern,'' the CRS report said.\77\ But Professor Edwards'
paper now shows that that conclusion was based on flawed data and is
wrong.
---------------------------------------------------------------------------
\77\ ``CRS Report for Congress: Lead in Drinking Water: Washington,
DC; Issues and Broader Regulatory Implications,'' Mary Tiemann,
Specialist in Environmental Policy, Resources, Science, and Industry
Division, Congressional Research Service, Updated January 19, 2005,
available here: http://ncseonline.org/NLE/CRSreports/05jan/RS21831.pdf
Scientific Integrity?
For a public health agency whose mission is to protect the health
of the public from toxic chemicals, the integrity of the science upon
which ATSDR bases their decisions and the scientific integrity of the
public health documents they release to the public should be
sacrosanct. But in its investigations of how ATSDR's leadership handled
its health consultation on formaldehyde for FEMA last year the
Subcommittee found a haphazard approach to clearing, vetting and
approving the release of its public health documents. In addition,
there was an astounding absence of independent scientific review of
documents that are supposed to play a critical role in protecting the
public's health and in establishing an appropriate federal response to
environmentally threatened communities.\78\ Largely in response to the
Subcommittee's investigation Dr. Frumkin asked ATSDR's Board of
Scientific Counselors to examine the Agency's ``Peer Review and
Clearance Policies and Practices.'' The board issued a draft report
last October.
---------------------------------------------------------------------------
\78\ ``Toxic Trailers--Toxic Lethargy: How the Centers for Disease
Control and Prevention Has Failed to Protect the Public Health,''
Majority Staff Report, Subcommittee on Investigations and Oversight,
Committee on Science and Technology, U.S. House of Representatives,
September 2008, available here: http://democrats.science.house.gov/
Media/File/Commdocs/
ATSDR-Staff-Report-9.22.08.pdf
---------------------------------------------------------------------------
The Agency's Office of Science, in charge of clearing agency
documents for public release, has a small staff and an enormous volume
of documents it is supposed to clear, the board's report said. As a
result, it lacks the ability to provide in depth scientific expertise
to review many documents. Several people told the board that they were
concerned that the reviews that took place above the division level
were ``cursory.'' In addition, the board wrote that ``scientists
expressed concern that in trying to achieve its objectives, the Office
of Communication Science's wordsmithing can change the intended
scientific message in a document.'' The board also found that there is
no clearly written guidance on what documents should be submitted for
external peer-review.
But the Board of Scientific Counselors was severely hampered in its
review. Interviews were conducted with groups not individuals, for
instance. ``[S]ome participants may have felt constrained in offering
their frank opinions,'' the board acknowledged. The board also
recognized that it received ``primarily a management perspective'' and
did not gather much insight into the concerns or worries of staff
scientists. ``Approximately 24 managers/team leaders and seven staff
scientists were interviewed across the three panels,'' according to the
board's report. ``Moreover, only one agency employee attended the open
session for walk-in comments,'' the report says.
In fact, it seems to the Subcommittee staff that the major focus of
the board's review, initiated at the direction of Dr. Howard Frumkin,
received an inevitably skewed assessment of these issues. It is unclear
if the board received an accurate portrayal of how ATSDR's public
health documents are vetted and released to the public by not hearing
from the staff scientists and other ATSDR employees who have expressed
deep and wide-ranging concerns about this issue for a long time. The
fact that a single employee showed up for the board's ``open session''
suggests that a large cadre of these scientists remains fearful about
raising critical issues with ATSDR's leadership involving the
scientific integrity of the Agency's public health documents and
perceived flaws in the scientific design and methodology used to
investigate potential public health hazards. In the past year, for
instance, the Subcommittee has received numerous communications from
ATSDR staff scientists who have raised serious concerns about the
willingness, ability and desire of ATSDR's leaders to ensure that only
well vetted public health documents based on scientifically defensible
positions and assumptions are released to the public.
Conclusion
Protecting the public's health from potential exposures to toxic
substances is not an easy task. It can be scientifically challenging,
time consuming and resource intensive. The Subcommittee staff suggests
that legislative fixes may be necessary to address long-standing
structural, procedural and technical issues that appear to have
hampered ATSDR's effectiveness and harmed the communities it is
supposed to protect.
But more than anything, it is apparent that no fundamental changes
will occur until the nearly thousand employees at the NCEH and ATSDR,
the vast majority of whom are truly dedicated and committed to
protecting the public's health, have leadership that they can follow.
The longer ATSDR continues to pursue its role in protecting the
public's health as it has for the past three decades, issuing deeply
flawed scientific reports, not responding to the concerns of local
communities and approaching potential environmental exposures with a
mindset that endeavors to disprove any link between the public's ill-
health effects and potential exposures to environmental contaminants or
toxins, the more people will suffer. After four years leading ATSDR,
not only has Dr. Frumkin taken no effective steps to confront those
issues, on some specific cases he has contributed to the problems
detailed in this staff report. In many instances, ATSDR seems to
represent a clear and present danger to the public's health rather than
a strong advocate and sound scientific body that endeavors to protect
it. Without a leader able and willing to confront those issues, the
public's health will continue to be harmed.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Chair Miller. Dr. Broun, the Ranking Member.
Mr. Broun. I thank the Chair.
Good morning. I want to welcome the witnesses here today
and thank the Chair for holding this hearing. I share the
Chair's concern with public health and safety issues not only
as a legislator but also as a physician and a scientist. Our
constituents deserve to know whether their families are being
exposed to harmful levels of toxic chemicals.
As the Chair noted, ATSDR is no stranger to this committee.
The Subcommittee's previous inquiry into the health
consultation report for FEMA regarding formaldehyde in trailers
and the Agency's work regarding toxic releases into the Great
Lakes region pointed to weaknesses in ATSDR's scientific review
process as well as how they convey information to the public.
Because of these concerns, ATSDR initiated several internal
reviews of these efforts and the Committee asked GAO to review
the Agency's processes. Dr. Frumkin will update us on his
agency's efforts today, but we will have to wait for GAO's
results for a few months. Until then, I hope the witnesses here
today can help this committee and the general public better
understand the Agency's original mandate and how it has evolved
since its inception, the public's expectations for the Agency
and the effects of an increasing number of petitions to the
Agency.
Understanding and communicating these fundamental points
are the first steps in evaluating the effectiveness of ATSDR.
While the work of the Agency is critically important, it is
also very difficult. Determining causation and making health
risk determinations is not always black and white. Despite the
complexity of their work, the public deserves to have an agency
that they can trust. The issues that we discuss today are not
simply academic.
Much like the witnesses on the first panel today, many of
my constituents turn to ATSDR for answers about the effects on
their local environment and on their families' health.
Recently, Jill McElheney, a constituent of mine, contacted me
regarding her experiences with ATSDR, the EPA and the State of
Georgia. The heartbreaking story of her son's battle with
childhood leukemia and the possibility that chemicals from a
nearby industrial facility could have influenced his condition
is cause enough for all of us to take notice.
I hope this hearing will help us shed light not only on how
the Agency can better protect public health and safety but also
how it can adapt to its evolving mission and the
appropriateness of this evolution. Additionally, I hope the
witnesses can help us understand how the Agency can better
coordinate with community organizations, other executive branch
agencies and State and local departments of health as well as
other government facilities on the State and local level. Aside
from assuring the science is always at the center of the
Agency's work, understanding expectations and effectively
communicating with the public is key to making sure that ATSDR
is an effective agency in the future.
In closing, I want to thank our witnesses for appearing
here today as well as all the hardworking folks at ATSDR.
Thank you, Mr. Chair, and I yield back the rest of my time.
[The prepared statement of Mr. Broun follows:]
Prepared Statement of Representative Paul C. Broun
Good morning. I want to welcome our witnesses here today, and thank
the Chairman for holding this hearing. I share the Chairman's concern
with public health and safety issues, not only as a legislator, but
also as a physician. Our constituents deserve to know whether their
families are being exposed to harmful levels of toxic chemicals.
As the Chairman noted, Agency for Toxic Substances and Disease
Registry (ATSDR) is no stranger to this committee. The Subcommittee's
previous inquiry into the health consultation report for the Federal
Emergency Management Agency (FEMA) regarding formaldehyde in trailers,
and the Agency's work regarding toxic releases in the Great Lakes
Region, pointed to weaknesses in ATSDR's scientific review process as
well as how they convey information to the public.
Because of these concerns, ATSDR initiated internal reviews of
these efforts and the Committee tasked GAO to review the Agency's
processes. Dr. Frumkin will update us on his Agency's efforts today,
but we will have to wait for GAO's results for a few more months.
Until then, I hope the witnesses here today can help this
committee, and the general public, better understand:
the Agency's original mandate and how that has
evolved since it's inception,
the public's expectations for the Agency, and
the effects of increasing numbers of petitions to the
Agency.
Understanding and communicating these fundamental points are the
first steps in evaluating the effectiveness of ATSDR. While the work
the Agency does is crucially important, it is also very difficult.
Determining causation and making health risk determinations is not
always black-and-white. Despite the complexity of their work, the
public deserves to have an agency they trust.
The issues we discuss today are not simply academic. Much like the
witnesses on the first panel today, many of my constituents turn to
ATSDR for answers about the effects of their local environment on their
family's health. Recently, Jill McElheney, a constituent of mine,
contacted me regarding her experiences with ATSDR, the EPA, and the
State of Georgia. The heartbreaking story of her son's battle with
childhood leukemia and the possibility that chemicals from a nearby
industrial facility could have influenced his condition is cause enough
for all of us to take notice.
I hope this hearing will help us shed light not only on how the
Agency can better protect public health and safety, but also how it can
adapt to its evolving mission, and the appropriateness of this
evolution. Additionally, I hope the witnesses can help us understand
how the Agency can better coordinate with community organizations,
other Executive Branch Agencies, and State and local health
departments. Aside from ensuring that science is always at the center
of the Agency's work, understanding expectations and effectively
communicating with the public is key to making sure ATSDR is an
effective agency in the future.
In closing, I want to thank our witnesses for appearing here today,
as well as all the hard-working folks at ATSDR. Thank you Mr. Chairman,
I yield back the rest of my time.
Chair Miller. Thank you, and I look forward to working with
Dr. Broun on this committee. I welcome his expertise, his
scientific expertise, and if I was able to get along with Mr.
Sensenbrenner, I certainly think I can get along with Dr.
Broun.
Mr. Broun. I look forward to working with the Chair. There
are some theoretical scientists on our scientific committee
that don't think that physicians are scientists but I will take
exception to that because we do scientific theory, et cetera,
and I appreciate the opportunity of working with the Chair.
Chair Miller. As a recovering lawyer, I am certainly in no
position to sneer at your scientific credentials. I will
certainly accept you as a scientist.
I understand Mr. Wilson has no opening statement but we
will accept opening statements for the record without objection
that may be included later.
[The prepared statement of Chair Gordon follows:]
Prepared Statement of Chair Bart Gordon
I want to thank Mr. Miller for calling this hearing. This
subcommittee has done good work in keeping the pressure on the Centers
for Disease Control and the Agency for Toxic Substances and Disease
Registry (ATSDR) to get the science right when protecting the public's
health.
Chemicals of all kinds pollute our water, our air, our soil, and
also enter the food chain. Some are benign and some are dangerous.
For a community that has had a toxic spill or long-standing
pollution issues, worrying that you or your family may get sick because
of something they eat or breath or drink is a part of your everyday
existence. If you live in such a place, you live with worry and fear
and maybe even a sense of guilt that by choosing to live there you are
exposing your family to something that could make them sick or even
kill them.
When Congress established ATSDR in the 1980s, we hoped that it
would be like the cavalry riding over the horizon to come and tell a
community that everything was alright, or at least to let you know how
bad the situation is. We expected them to use the best science and
develop ever more innovative ways to establish whether some
environmental problem was becoming a public health problem.
Unfortunately, ATSDR seems to be the gang that can't shoot
straight. They come into local communities, often ignore the health
complaints of local citizens, seem to ignore obvious ways to determine
what might be happening, and more often than not go away saying there
is nothing to worry about because they couldn't find anything. As
witnesses today will testify, ATSDR seems to resist developing new
scientific methods for doing their work.
The American public deserves better than this for their $74 million
a year--that is ATSDR's budget--and I believe this agency can do
better.
There are many, many dedicated public health professionals at ATSDR
who would love to call it as they see it.
There is ample room to improve the Agency's scientific methods, and
to be more creative in how they do science, so that the public is
better served.
It is past time that we hold this agency to higher standards.
Panel I:
Chair Miller. It is now my pleasure to introduce our first
panel of witnesses. Dr. Salvador Mier is the former Director of
Prevention for the Centers for Disease Control and a local
resident of Midlothian, Texas. Professor Randall Parrish is the
head of the British Geologic Survey's Natural Environmental
Research Council's Isotope Geoscience Laboratories in
Nottingham, England. I hope he doesn't repeat all that at every
cocktail party. He participated in an innovative study of
community exposure to depleted uranium in Colonie, New York.
Mr. Jeffery Camplin is the President of Camplin Environmental
Services Incorporated, a safety and environmental consulting
firm in Rosemont, Illinois, and is a licensed asbestos
consultant for the Illinois Dunesland Preservation Society. Dr.
Ronald Hoffman is the Albert A. and Vera G. List Professor of
Medicine at the Mount Sinai School of Medicine, the Director of
Myeloproliferative Disorders----
Mr. Broun. If you need some help with that, I will----
Chair Miller. Perhaps Dr. Broun could introduce Dr.
Hoffman. I think it is easier now. Programs at the Tisch Cancer
Institute at Mount Sinai and formerly the President of the
American Society of Hematology.
It is the practice of the Subcommittee to take testimony
under oath. Do any of you have any objection to being sworn in?
We also provide that you may be represented by counsel. Are any
of you represented by counsel today? We ask you these questions
to put you at ease.
If you would now all rise and raise your right hand. Do you
swear to tell the truth and nothing but the truth? Let the
record reflect that each of the witnesses responded in the
affirmative. You now have five minutes each for your spoken
testimony. Your full written testimony will be included in the
record of the hearing. When you complete your testimony, we
will begin with questions and each Member will have five
minutes to question the panel.
Mr. Mier, please begin.
STATEMENT OF MR. SALVADOR MIER, LOCAL RESIDENT, MIDLOTHIAN,
TEXAS; FORMER DIRECTOR OF PREVENTION, CENTERS FOR DISEASE
CONTROL
Mr. Mier. Thank you, Chair Miller, Dr. Broun and other
Committee Members. Because other Midlothian residents,
Midlothian, Texas, were not able to be here today at this
hearing, they asked me to bring a short video that depicts some
of the animal and dog health issues that we have had concern
with, and I would like to request your permission, sir, to show
that brief video.
Chair Miller. Thank you. I believe that we have talked
about this at the staff level but the video is only a little
more than three minutes, three and one-half minutes.
Mr. Mier. Three minutes.
Chair Miller. And what I propose is to allow Mr. Mier to
show the video and have that not counted against his five
minutes for testimony. Without objection, Mr. Mier.
[Video.]
Mr. Mier. Our community is on a treadmill to nowhere. Our
human and animal health issues have been festering for years.
Our environmental agency declares industrial emissions are
harmless and our health agency uses this as a refuge to look no
further. In my 40-year public health career, mostly with CDC, I
never experienced such a lack of will to determine sources of
illnesses. There was never a quarrel about finding a cause
caused by a bacteria or a virus, but when a potential source is
involved in industry, dynamics change drastically.
For answers I look toward my former employer, CDC. Thus we
petitioned ATSDR for a public health assessment in July 2005.
But instead of getting the trusted health information promised
by ATSDR in their mission statement, we ended up further from
the truth. ATSDR has demonstrated they are not committed to the
responsibilities inherent in their mission statement or they
are not willing to overcome external pressures and act
independently to abide by the commitments of this mission
statement.
Midlothian, Texas, is a small town with one of the largest
steel mills in the United States and the highest concentration
of cement manufacturing in the Nation with three plants, one of
which is the largest in the United States. These industries, in
addition to traditional fuel and other refuse, incinerate whole
and shredded tires and hazardous waste, tons of hazardous
waste, in kilns never designed for burning hazardous waste.
Daily, tons of toxic emissions pour out of 10 cement kilns and
two steel industry stacks. Using an EPA screening model in
2005, Toxic Release Inventory, USA Today in collaboration with
researchers and scientists at the University of Massachusetts,
Johns Hopkins and the University of Maryland ranked all schools
in Midlothian in the upper third percentile of the Nation's
most toxic schools. Two ranked in the first percentile and two
ranked in the third. After hazardous waste became a fuel source
in Midlothian, physicians began seeing more patients
complaining of upper respiratory problems. Ranchers reported
breeding problems, aborted fetuses and deformed offspring in
both horses and cattle. A statistically significant cluster of
Down Syndrome babies was identified in 1995. A study of
respiratory illnesses in Midlothian performed by the University
of Texas surfaced a 35 percent higher incidence of respiratory
problems in Midlothian as compared to a control group. A study
in 2005 found the prevalence of overall birth defects for
Midlothian was one and a half times that of Texas, and the
prevalence of hypospadias and epispadias, congenital defects in
which the urinary outlet opens above or below the penis or on
the perineum, was three and a half times that of the State of
Texas. A local dog breeder experiences in her animals large
number of immune-deficiency illnesses, deformed offspring,
litters born dead, cancers and failure to thrive. Questions
about a suspect air monitoring system were dismissed. What
about all of the empirical evidence that was surfacing? No
answers came.
When ATSDR agreed to do the assessment, they said they
would ask the State health department to help. Once the state
became involved, the assessment morphed into a consultation and
the responsibility for making the decision was relegated to the
state. The same individuals who had for years declared our
environment posed no health problems were going to look at once
more. Furthermore, the decision was to be based on State
monitoring data, the same questionable data. By morphing the
assessment to a consultation and using the same data, the same
folks could pretend not to see or totally ignore health
problems and empirical evidence by using the same familiar
refuge. Air monitoring does not support any one being sick.
ATSDR never intended to be an active participant with this
consultation. We were never going to get off that treadmill, at
least not with ATSDR's help.
The consultation was finally released for public comment
December 11, 2007. Scientists who reviewed it made the
following comments. Dr. Stewart Batterman, University of
Michigan, states, ``The health consultation is biased. It
contains overarching statements that discount all indications
that emissions from local industry and environmental conditions
might or do pose a health concern in our community. It should
not be issued by ATSDR.'' Dr. Peter deFur, of Virginia
Commonwealth University, states, ``ATSDR's classification of
this site as an indeterminate public health hazard is in direct
contradiction with the data the Agency presents in the report.
Throughout the document ATSDR attempts to marginalize or
disregard data that indicate that compounds produce human
health risk. ATSDR has more than enough data to classify the
site as a public health hazard.'' Dr. Neil Carman, a scientist
who formally worked at the Texas State Environmental Agency,
states, ``It fails to seriously acknowledge the numerous gaps
in the ambient air monitoring in the Midlothian area.''
We naively expected an objective and scientific evaluation
that would provide trusted health information. We were wrong.
Instead, ATSDR abdicated its responsibilities to the state and
never questioned the science behind the collection of the data
and the reliability for making public health determinations. If
ATSDR does not have commitment or capacity to objectively
temper and counter external forces that dissuade them from
their mission to serve the public by using the best science and
provided trusted health information, then ATSDR needs to get
out of the public health and consultation business. To maintain
the status quo will only continue to risk the public health of
many U.S. communities.
[The prepared statement of Mr. Mier follows:]
Prepared Statement of Salvador Mier
We are on a treadmill to nowhere. Our community's human and animal
health issues have been ``festering'' for a long time. Time and time
again the Texas Department of State Health Services (TDSHS) tell
citizens of Midlothian the Texas Commission on Environmental Quality
(TCEQ) affirms toxic emissions from industries are too low to endanger
public health--hence there is no point in looking at their health
issues. Pleas for help die at EPA, TDSHS and TCEQ doorsteps.
In my 37-year public health career--most of which was with the
Centers of Disease Control (CDC)--I never experienced such a reluctance
or lack of will to determine sources of illnesses. There was never a
quarrel about finding the source when you were dealing with a bacteria
or a virus. But when the potential source involves an industry,
dynamics change drastically. This is why I decided to look back towards
my prior employer (CDC) for answers. Thus, we turned to ATSDR, the
purported ultimate environmental public health agency, for help.
Instead of getting help promised by ATSDR in their mission
statement, we found ourselves catapulted right back on to that
treadmill and further from the truth.
ATSDR has demonstrated they either do not want the responsibilities
inherent in their mission statement or they do not have the will and
commitment to overcome external pressures and act independently to
abide by the promises of this mission statement.
The Industries
Midlothian, Texas, has the largest concentration of cement
manufacturing in the United States. The town and schools are nestled
amid three cement manufacturers--Dallas-based TXI's Midlothian cement
plant, with five kilns, boasts to be the biggest in the U.S.; Ash Grove
of Kansas, with three older wet kilns and Swiss company Holcim, with
two kilns, are nearby. Limestone, cement's main component, is mined
locally. Cement kiln dust is buried in local unlined quarries. These
industries incinerate, among traditional fuels and other refuse,
petroleum coke, whole and shredded tires, and hazardous waste--tons of
hazardous waste--in kilns never designed to burn hazardous waste.
Adjacent to TXI, Brazilian-owned Gerdau Ameristeel, one of the
largest steel mills in North America, melts trainloads of scrap metal
and crushed cars into new structural steel.
Daily, tons of toxic emissions pour out of ten cement kilns and two
steel industry stacks.
In late 1980 TXI became one of the Nation's largest hazardous-
waste-combustion facilities accepting commercial hazardous waste.
Cement kilns were authorized by EPA in a 1996 MACT rule to operate
under weaker, less protective MACT standards for Hazardous Waste
Combustors (HWC) compared to hazardous waste incinerators.
In a statement (attached) Dr. Neil Carman, Ph.D., comments:
``Cement kilns burn up to 1,000 degrees hotter than
incinerators and a concern is they may burn too hot for metals
causing higher mass emissions due to greater metal volatility
at higher temperatures. . . . Exposure to toxic metals is
consistent with some health problems reported at Midlothian.''
Contradictions in Data
In a report ``Midlothian Industrial Plant Emission Data,'' Amanda
Caldwell and Susan Waskey, two University of North Texas (UNT) graduate
students added up all emission reports submitted to State and Federal
Government by the three cement plants and adjacent steel mill in
Midlothian. They spotlighted differences in reported volumes of air
pollution when industry submits emissions reports to the State versus
the Federal Government. These students discovered:
``A cursory examination of EPA air release data in Figure 56
(Total Air Releases per Firm 1990-2006) and TCEQ air release
data in Figure 60 (Total Hazardous Air Pollutants per Firm
1990-2006), show strikingly different results. For this
reporting period, the EPA data shows TXI to be the firm with
the largest amount of toxic chemicals released to the air
(5,287,384 lbs.), while the state's data show Holcim to be the
largest emitter of hazardous air pollutants (1,507,663 lbs).
According to the plants' TRI [Toxic Release Inventory]
reports, there were almost 48,000 pounds of lead air pollution
released by all four facilities over the entire 16 years,
versus the over 90,000 pounds of lead the same plants reported
sending up their stacks to the TCEQ and its predecessors during
the same period.
According to the plant's TRI reports, there were approximately
5,000 pounds of Mercury air pollution released by all four
facilities from 1990 to 2006 versus the approximately 10,000
pounds of Mercury air pollution reported to the state over the
same time.''
EPA has recently acknowledged total mercury emissions from cement
plants in the U.S. are twice as high as reported to the TRI. Based on
the two UNT students report, TRI emissions appear not to match State
records. Differences like these should give rise to questions.
Midlothian Schools
Approximately 7,000 students attend nine schools situated in
Midlothian.
USA Today in collaboration with the University of Massachusetts,
the University of Maryland and Johns Hopkins University employed EPA
Model, ``Risk Screening Environmental Indicators,'' in an attempt to
measure the extent of chemicals children were being exposed to while
attending school. This model relied on EPA TRI data for calendar year
2005. In this analysis, all schools rated in Midlothian ranked in the
upper third percentile of the Nation's most toxic schools. Two ranked
in the first percentile of the Nation's most toxic schools, two ranked
in the third percentile. Their findings ``Toxic Air and America's
Schools'' were published in the USA Today December 2008.
Risk Assessments
In order to allay community anxiety caused by the burning of
hazardous waste, in November 1995, the TNRCC (now TCEQ) prepared the
Screening Risk Analysis for the Texas Industries (TXI) Facility in
Midlothian, Texas and the Critical Evaluation of the Potential Impact
of Emissions From Midlothian Industries: A Summary Report.
The American Lung Association contracted with Dr. Stuart Batterman,
Ph.D., Environmental and Industrial Health, University of Michigan, to
do an evaluation of this risk analysis. In Dr. Batterman's 70-page de
novo analyses he warns:
``. . . Based on risk assessment techniques, other
environmental impact assessment methodologies, and an
assessment of existing environmental monitoring data, we
conclude that the environmental and health impacts have and are
likely to occur in the Midlothian area from industrial
activity, including the combustion of hazardous waste at TXI.
That TXI, the other cement kilns and steel smelter in
Midlothian cause impacts is inescapable.'' [emphasis mine]
Dr. Batterman further states:
``. . . Some of the monitoring programs appear entirely
reasonable. . .. Others, however, are highly deficient with
respect to study design, execution, data quality and data
analysis. Overall, the monitoring program is not impressive
given the scale of industry and waste combustion in Midlothian
and the degree of public concern.''
``. . . The serious deficiencies in the Screening Risk
Analysis and Summary Report indicate that the ability of the
TNRCC to conduct an objective assessment is compromised, and
the record demonstrates significant concerns regarding the
effectiveness of the TNRCC in regulating the combustion of
hazardous waste at TXI.''
Illness Surfacing
Beginning in the late 1980's and early 1990's, shortly after TXI
started burning hazardous waste:
Physicians began observing increases in office visits
from patients complaining of upper respiratory problems.
Ranchers started reporting breeding problems, aborted
fetuses and deformed offspring in both horses and cattle.
A Statistically Significant cluster of Down syndrome
babies was identified in 1995.
A peer-reviewed study of respiratory illnesses in
Midlothian, conducted by University of Texas Medical Branch and
authored by Dr. Marvin Legator in 1996, concluded a 35 percent
higher incidence of respiratory problems in Midlothian than the
control group.
Based on a study completed in 2005, the prevalence of
overall birth defects from 1999 through 2003 for Midlothian was
150 percent that of Texas and the prevalence of hypospadias/
epispadias (congenital defects in which the urinary outlet
opens above or below the penis or on the perineum) in
Midlothian was 350 percent that of the State.
Since 1990 and continuing, Ms. Debra Markwardt, a
local dog breeder experiences large numbers of illness in her
animals that are related to immune system deficiency issues,
aborted fetuses, failure to thrive, cancers and deformed
offspring. Local veterinarians have attributed these problems
to environmental factors. (See addendum for her statement.)
In 1994 a group of mothers concerned for their
children and the community pleaded with EPA that EPA at least
do an animal health study. Poorly planned and based on a
questionable methodology of execution, EPA initiated an animal
health survey. Ultimately, the survey was abandoned and no
conclusions drawn. The study did, however, identify an apparent
high level of animal health problems in the study area in
horses at one ranch. This rancher had seven to ten horses in
any given year and reported between 50-88 percent of the
animals had reproductive health problems during the survey
period. The majority of these horses had estrous/cyclic
problems. One mare repeatedly had problems giving birth or
keeping the foals after birth. This horse died shortly before
the survey was conducted and a necropsy was performed. An
inflamed ovary and a cyst on the ovary were discovered. There
was also chronic enlargement of the lymph glands in the head,
neck and under the throat. The mare exhibited a muscular line
on the side of the abdomen indicative of labored breathing
problems. (Note: Problems experienced by this rancher are
similar to problems experienced by Ms. Markwardt and other
livestock owners.)
ATSDR, TDSHS, TCEQ refuse to look at or even acknowledge the
existence of any empirical evidence for fear a link may be related to
industrial emissions and some responsibility may ensue. They instead
take refuge in theoretical mathematical computations based on
questionable air monitoring data.
Seeking Answers
For years, citizens turned to TDSHS for help. TCEQ eagerly and
staunchly declared emissions from industries were safe and TDSHS used
this as a refuge to look no further. No answers came.
Questions about a suspect air monitoring system and how air
monitors not placed in predominant wind patterns could produce valid
readings went unanswered. What about all the empirical evidence that
was surfacing? No answers came. Year after year this cycle kept
repeating. The search for a scientifically validated response could not
get off the treadmill.
To many in the community, TCEQ's methodology for collecting air
monitoring data appeared to be designed to avoid major emissions and to
create an illusion of ambient air purity. Could this data's reliability
to assess community impact and public health withstand the scrutiny of
objective unbiased scientists? We thought we would find that
objectivity when we turned to ATSDR.
ATSDR Involvement
In July 2005, our petition went before an ATSDR panel. The panel
deemed it met the criteria for a public health assessment.
On August 10, 2005, we received a letter from ATSDR stating that
``they'' would be doing a Public Health Assessment as authorized under
the CERCLA. ATSDR indicated that they planned ``to ask TDSHS for help''
responding to our concerns. This was disconcerting; however, ATSDR was
a federal health-based agency with a mission statement that promised
the use of the best science and to provide trusted health information--
and they would be in control. ``So, maybe,'' we thought, ``there was
hope.''
Sadly, as the assessment started to slowly roll out, objectives
began to morph into paths that dodged addressing critical issues such
as the need for a scientific assessment of the monitoring data and an
evaluation of the empirical evidence. Example:
1. Initially ATSDR promised to do a Public Health Assessment
``to more fully characterize the emissions from multiple large
industries in the area and evaluate potential health risks
resulting from individual and aggregate chemical exposures.''
2. Once the State became involved, things started to morph.
The ``Public Health Assessment'' changed to something new. On
Sept. 12, 2005, we received a letter from ATSDR stating that
because of ``*community health concerns'' they would be
conducting instead a health consultation. They further implied
that a health consultation would allow for a ``timely response
(early 2006).'' In this letter ATSDR indicated that they were
deferring the decision back to the State. ATSDR would review
and certify it. In addition (even though one major concern we
expressed was the inadequacy of the State monitoring data for
evaluating public health issues) they stated they would rely on
State monitoring data to make conclusions. It was at this point
I realized we were catapulted right back on to that treadmill
going nowhere.
(*Note: I am still puzzled about what ATSDR meant by
``community health concerns.'' The community was concerned that
no one was looking at their health issues and asking the
question, ``Could something by awry with the monitoring data in
which TDSHS and TCEQ take refuge to declare there were no
public health issues?'' Obviously the community's ``health
concerns'' and ATSDR's health concern did not run a parallel
path.)
An assessment requires a closer examination of community
health issues and may even entail some epidemiological
activities; whereas, theoretically a consultation is done when
time is of essence and a rapid decision is necessary. The value
of a consultation from ATSDR's/TDSHS' perspective would be that
if air-monitoring data did not support any adverse health
effects, the job ends there. All empirical evidence and
epidemiological data can then be ignored. All other red flags
indicating health problems such as high birth defects, immune
system deficiencies, animal issues, UTMB Study on Upper
Respiratory illness, etc., can be dismissed as irrelevant.
Since ATSDR/TDSHS were going to accept monitoring data at face
value and if this monitoring data is purported to reflect the
cleanest air in Texas, the simplicity of the conclusions was
promising.
3. To further simplify the task, the scope of the consultation
narrows to looking at air data only.
4. Toxins in the air can be tricky--entering a body in more
ways than one. So to avoid any possible complications, the
scope must now be further narrowed to the ``inhalation''
pathway only.
Empirical evidence and epidemiological data has been deemed non-
relevant for this consultation. It has been treated like an untouchable
pariah. To include it would mean someone would have to address whether
something is awry. This is a challenge that apparently ATSDR nor the
State want to face.
I finally realized that regardless of what arguments are made or
regardless of what empirical evidence is presented, the bottom line on
this public health consultation was determined before it even began.
The entire process would just be a matter of making documentation
support the bottom line.
We needed input from objective unbiased reputable scientists.
Shortly before the consultation was due to be released, I reached out
begging for help. Six scientists responded and offered their time and
skills to critique the draft consultation report.
A draft decision with an ``Indeterminate Public Health Hazard'' was
finally posted for comments on December 11, 2007.
What the Scientists Said
The scientists who reviewed the draft were all highly critical of
the product.
Dr. Stuart Batterman, Ph.D., Professor of Environmental Health in
the School of Public Health and Professor of Civil and Environmental
Engineering at the College of Engineering, both at the University of
Michigan, comments: ``. . . This Health Consultation has so many
omissions, inconsistencies, and inadequate, flawed, or misleading
analyses and language that my best suggestion, given in advance of my
comments, is that it should not be issued by ATSDR. . . . The Health
Consultation is biased. It contains overarching statements that
discount all indications that emissions from local industry and
environmental conditions might or do pose a health concern in the
community. The Health Consultation should be objective yet maintain the
health-protective stance which is appropriate for health-based agencies
like ATSDR. . . . The Health Consultation relies exclusively on air
quality monitoring results measured at four monitors. It does not
discuss, in any coherent way, the adequacy of the spatial and temporal
coverage of this network. This includes, for example, the ability to
identify hotspots, the appropriateness of the network, the adequacy of
the monitored parameters, the quality of the data, and the need for
additional monitoring sites. . . . There is little mention of
meteorology. The area shows very persistent and directional winds,
which means that monitors that are not directly downwind are likely to
not show impacts from local sources. The Health Consultation should
include appropriate wind roses and other analyses that indicate the
likely impact areas vis-a-vis monitoring sites. . . . In its present
form, however, I find so many biases and deficiencies that I do not
believe that the Health Consultation achieves its aims and, as stated
above, I would urge that ATSDR reconsider its issuance.
I do hope that ATSDR sponsorship and oversight provides a means to
correct these problems . . ..''
Dr. Peter L. deFur, Ph.D., and Kyle Newman, Environmental
Stewardship Concepts, comment: ``. . . ATSDR's classification of this
site as an ``Indeterminate Public Health Hazard'' is in direct
contradiction with the data the Agency presents in the report.
Throughout the document, ATSDR attempts to marginalize or disregard
data that indicate that compounds produce human health risks. ATSDR has
more than enough data to classify the site as a ``Public Health Hazard.
. . . The problems with this assessment are numerous, and the most
serious problem with the interpretation is that ATSDR discounts their
own metrics of health effects, ignoring the data that exceed health
levels.
For a number of chemicals, the air concentrations are in excess of
the health levels, but ATSDR dismisses the excess toxic chemicals as
not a problem because the number or people harmed is small, despite the
fact that the risks exceed the levels used to protect people from
environmental threats (i.e., one in a million) . . .''
Dr. Neil Carman, Ph.D., Program Director, Lone Star Chapter of
Sierra Club and former employee of the Texas State environmental
agency, comments: ``I find the report highly inadequate for a variety
of reasons [listed in full in comments] and fails to seriously
acknowledge the numerous gaps in the ambient air monitoring in the
Midlothian area. . . . A basic concern here is that asthma, allergies,
immune system deficiencies, and other health problems in adults and
children are not being evaluated and yet these kinds of adverse health
effects are being reported by Midlothian residents . . .''
Dr. Dennis Cesarotti, Ph.D., Northern Illinois University,
comments: ``It appears that the DSHS (State Public Health) set out to
prove that there were no health issues in Midlothian, Texas.''
Dr. Al Armendariz, Ph.D., Environmental Engineer, Southern
Methodist University comments: ``The report lacks an analysis of the
impact of dioxin and furan emissions from local industry to the public
health of the community . . . however, dioxin and furan emissions are
an extremely significant component of the emissions from the local
industry. . . . a significant fraction of the mercury emitted by the
industrial sources in the area is likely to be emitted in gaseous form,
given the volatile nature of mercury, and the temperatures of the stack
gases. The gaseous mercury will not be collected in the particulate
filters, leading to further underestimates of the true atmospheric
concentrations of mercury. In addition, the gaseous mercury will not be
detected by the techniques used to identify the VOC compounds.''
Debra L. Morris, Ph.D., Adjunct Assistant Professor in the
Department of Preventive Medicine and Community at the University of
Texas Medical Branch in Galveston, comments: ``A symptom survey of
residents in the geographical area that this document covers has been
conducted and published (Legator et al., 1998). The results of this
study showed that residents in this area had more respiratory symptoms
than individuals in a control region. However, I am unaware that any
attempt has been made to follow up on the results of the study using
methodology that directly addresses and measures the health concerns of
the community. Because the individuals in this area are exposed to a
combination of chemicals, studies of health effects in this population
would be much more revealing than an approach that makes mathematical
approximations of the health risks based on measurements of individual
chemicals.'' [Dr. Morris was a participant in this study.]
TCEQ Response
The Texas environmental agency (TCEQ) was highly critical of the
``Indeterminate'' finding. In comments to EPA, posted on their website
TCEQ complains:
``POTENTIAL IMPACT ON TCEQ: The Indeterminate Public Health
Hazard finding regarding air toxics in Midlothian may lead
citizens and elected officials to believe the air quality is
causing health impacts when air toxics monitoring in the
Midlothian area not only indicates acceptable air quality but
also better air quality than most monitored areas of the
country. This concern could lead to pressure on TCEQ to shift
resources from areas of concern in order to expend more
resources in the Midlothian area.''
As of this date (March 12, 2009), the public health consultation
has not been finalized.
Due to this Administration's proposed strategy to rebuild the
Nation's infrastructure, the steel and cement industries are in a
position to boom. In the last year, however, all local industries in
Midlothian have severely cut back on production of concrete and steel.
As of October 2008, TXI has temporarily, idled its four older wet kilns
and has temporarily suspended burning hazardous waste. What is coming
out of the industries now does not represent what the community has
been exposed to or what they will be exposed to once production
accelerates and once burning of hazardous waste resumes. If you want a
less than adequate picture of emissions to which the public has been
exposed and to which they will be exposed--now is the time to monitor.
In an effort to get the ``Indeterminate Public Health Hazard''
lifted, TCEQ embarked on a $349,000 project purportedly to ``answer
some of the community's questions'' and determine the percent of
chromium-6 in the identified chromium emissions (a major unknown factor
that lead to the indeterminate finding).
The first of four five-day monitoring periods scheduled over a year
took place in December 2008--right after TXI temporarily idled its four
older wet kilns and temporarily suspended incineration of hazardous
waste. ``TXI's status might affect the chromium's numbers depending on
whether the older kilns are operating during any testing,'' TCEQ
officials conceded to a reporter from the Dallas Morning News.
Any monitoring during the time hazardous waste is not being
incinerated would skew more than just the chromium numbers. It would
also not capture emissions with the highest levels of concern--those
resulting from the incineration of hazardous waste. What information
will this data provide? Perhaps it will provide a baseline for
comparison when hazardous waste incineration is revived.
The fact that this data will not be representative of actual
emissions to which the public was exposed, or will be exposed, appears
not to be a material consideration in the scheduling of air monitoring.
How ATSDR/TDSHS plan to retrofit this data into the conclusions of the
public health consultation remains questionable.
When ATSDR was questioned about the reliability of any data
collected during the idling of these kilns, during decline in
production, and during the temporary suspension of hazardous waste
incineration, the response was, ``We have no control over changes in
plant operations due to economic conditions. Couple this with the fact
that State agencies often have a limited window within which funds made
available for a project must be spent.'' Spending funds seemed more
important than the quality of the data and evaluating public health
impact to real exposures. What appears to be important is that the
money be spent now.
ATSDR critically missed the boat at step one. They failed to
validate the science behind the methodology used to determine the
placement of the air monitors. If they could not validate the data at
the initial step, of what value are any ensuing conclusions? The
deficiencies in this consultation indicate ATSDR's ability to conduct
an objective assessment is compromised.
We never asked anyone to find a problem if one did not exist. We
just wanted an unbiased objective assessment. We expected an assessment
incorporating the most recent science, logic, common sense and
objectivity. We did not get this.
Instead of exercising due diligence by becoming an active
participant in the evaluation, ATSDR relegated their responsibility
without question back to the State. The assessment of Midlothian's
public health ended up back in the hands of the same decision-makers
who over the years staunchly and flagrantly turned a deaf ear and blind
eye to the empirical evidence handed them. Science was not going to be
factored in.
It appears ATSDR divorced themselves from their mission statement.
There was no value added to ATSDR's involvement. ATSDR's involvement
only served to keep the public at bay for another four years. It was a
costly waste of taxpayers' money. This involvement only elongated a
process to nowhere and gave credence to impediments in the system that
block science and truth.
If ATSDR does not have the commitment or capacity to objectively
temper and counter external forces that dissuade them from their
mission to serve the public by using the best science and providing
trusted health information--then ATSDR needs to get out of the Public
Health Assessment and Consultation business. Maintaining the status quo
will only continue risking the public health of many U.S. communities.
U.S. communities desperately need an external environmental public
health entity able to carry out the mission assigned to ATSDR. Perhaps
contracting with a University or a School of Public Health would be a
better alternative. We need an entity that is proactive and not just
merely an acquiescing observer.
Addendum
1. March 17, 2009: Letter from Mr. Mier to the Honorable Brad Miller,
Subcommittee Chairman, Subcommittee on Investigations and Oversight.
2. Comments and photos of animals as sentinels for environmental
health hazards, from Ms. Debbie Markwardt, dog breeder and local
resident of Midlothian, TX.
3. January-February 2009: E-mails between Debbie Markwardt, Alan
Yarbrough, ATSDR, and John Villinaci, Texas Department of State health
Services, carbon copied to Dr. Howard Frumkin, Director, ATSDR.
4. March 11, 2008 letter: Sierra Club, Lonestar Chapter to Texas
Department of State Health Services, Re: Comments on 2007 Public Health
Consultation for Midlothian, Texas.
5. May 1, 1996 Risk Analysis: Executive Summary extracted from
evaluation of the Screening Risk Analysis for the Texas Industries (TXI
Facility) In Midlothian, Texas, released November 1995. Written by the
Texas Natural Resource Conservation Commission, And Other Materials
Related to the Texas Industries Facility by Stuart A. Batterman, Ph.D.,
Yuli Huang, M.S., Environmental and Industrial Health, The University
of Michigan.
6. March 9, 2009: Comments on ATSDR December 11, 2007 report, Health
Consultation--Midlothian Area Air Quality Park 1: Volatile Organic
Compounds and Metals'' from Stuart Batterman, Ph.D., Professor of
Environmental Health in the School of Public Health and of Civil and
Environmental Engineering, University of Michigan.
7. March 11, 2008: Comments on ATSDR Public Health Consultation of
Midlothian, Texas. Prepared by: Peter L. deFur, Ph.D., and Kyle Newman,
Environmental Stewardship Concepts, Richmond, VA.
8. March 2009: Written Testimony of Neil J. Carman, Ph.D., Former
State of Texas Air Pollution Control Agency Regional Field Investigator
of Industrial Plants Including Portland Cement Kilns and Waste
Incinerators in 1980s-90s: The EPA's Sham (Bifurcated) Hazardous Waste
Combustor MACT Rule and Enforcement Failures by EPA and State of Texas
are Related to Health Hazards from Toxic Waste Incineration in Cement
Kilns at Midlothian, Texas.
9. February 3, 2008: Sal and Grace Mier, Midlothian TX, response to
ATSDR/DSHS study on Midlothian Area Air Quality Park I: Volatile Organ
Compounds and Metals, December 11, 2007.
10. September 9, 2008: Not ``Just Steam'': A Review of ``Emissions
Data from Midlothian Industry'' for the Texas State Natural Resources
Committee.
11. June 29, 2005: Texas Department of State Health Services Birth
Defects Investigation Report--Birth Defects Among Deliveries to
Residents of Midlothian, Venus, & Cedar Hill, Texas, 1997-2001.
Prepared by Mary Ethen, Epidemiologist, Birth Defects Epidemiology and
Surveillance Branch, DSHS.
12. May 19, 2005: Midlothian Cancer Cluster Report #05026--Summary of
Investigation into the Occurrence of Cancer, Zip Codes 76065, 75104,
and 76084, Midlothian, Cedar Hill, and Venus, TX in Ellis, Dallas, and
Johnson Counties, Texas, from 1993-2002.
Addendum #1
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Addendum #2
Statement of Debra Markwardt
Midlothian, Texas
Area Dog Breeder
I am Debra Markwardt, a professional dog breeder since 1982. When I
moved my home and business to Midlothian in 1988 my animals were all
thriving. Over the years my animals started manifesting health issues.
They did not seem to thrive as well. Entire litters were dying. (Last
year I lost 75 percent of my litters.) Pups were being born with
strange birth defects that I had not previously seen in my animals.
Birth defects such as large domed heads, external intestines, extra or
missing limbs, blindness, missing testicles, distorted genitalia, no
visible signs of urinary outlet, etc., became common.
Hair analysis for me and for some of my animals was done. Varying
degrees of heavy metals have been identified in all of these tests.
Every one of these tests reflected extremely high levels of aluminum.
High aluminum in their systems causes extreme mineral imbalances
depleting their body of essential nutrients. Aluminum, lead, and
mercury go to the brain and nervous system, thereby poisoning every
organ of the body. As the immune systems deteriorate diseases manifest.
My animals also started manifesting severe problems with their
coats. They were becoming emaciated and failing to thrive. Problems
were more evident in the very young and in the older animals. Pups were
born with heavy metals in their system and weaker immune systems. If a
pup survived past six to eight months it survived relatively well. My
vet explained that some pups had stronger immune systems than others.
If their survival passed that critical period, it was an indicator of a
stronger immune system. I have lost about 75 young adult dogs since I
moved to Midlothian.
Ranchers in the community were having similar problems with their
livestock. Efforts to get these issues addressed died at the doorsteps
of EPA, Texas Department of State Health Services (TDSHS), and the
Texas Commission on Environmental Quality (TCEQ). TCEQ said our
environment in no way posed a problem and this was the reason TDSHS
could comfortably walk away.
When ATSDR became involved we had hopes that we finally had an
agency that would look at our problems and give us a scientific answer.
Midlothian is experiencing birth defects in their children at a
rate 150 percent that of the state. They are experiencing hypospadia/
epispadias at a rate 350 percent that of the state. I believe birth
defects in my animals parallel birth defects seen in children born in
Midlothian. I also felt that immune system deficiencies documented in
my dogs parallel problems people in the community were alleging.
I cannot understand why ATSDR and TDSHS do not believe what is
happening to my animals is relevant to the assessment of this
community's public health. What is happening to my animals could be
happening to the people of Midlothian. I keep getting a brush-off from
ATSDR with comments like ``. . . veterinary and animal issues are
outside of our mandated domain'' and ``. . . studies involving animals,
even as sentinels for human health issues, are not activities engaged
in or funded by our agency'' and ultimately ``. . . ATSDR and the Texas
Department of State Health Services do not have the expertise to
conduct the appropriate animal studies.''
I was not asking them to do an animal study. I offered my data for
use in the ATSDR public health consultation as possible sentinels to
what could and may be happening to the community. ATSDR firmly stated
that there would be no association of these animals with the public
health consultation they were doing for Midlothian. There are children
who are waiting to be born. These animals could be a key to their
future. Who will help these children?
Below, are examples of what I have been experiencing--different
birth defects, results of immune system deficiencies, and examples of
how animals with weakened immune system respond when raised away or
removed from Midlothian. I too am experiencing health problems. On the
last page is a statement from my doctor.
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Addendum #3
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Addendum #4
SIERRA CLUB
Lone Star Chapter
March 11, 2008
Environmental and Injury Epidemiology and Toxicology Program
Texas Department of State Health Services
1100 West 49th Street, Room T-702
Austin, TX 78756
Re: Comments on 2007 Public Health Consultation for Midlothian, Texas
Dear Texas Department of State Health Services Consultation staff:
I am writing to share serious concerns over the gaps and
inadequacies presented in the Texas Department of State Health Services
(TDHS) and the Agency for Toxic Substances and Disease Registry (ATSDR)
report titled ``Health Consultation--Midlothian Area Air Quality Part
1: Volatile Organic Compounds & Metals.'' I find the report highly
inadequate for a variety of reasons and fails to seriously acknowledge
the numerous gaps in the ambient air monitoring in the Midlothian area.
Background Levels: Waste Incineration Conducted at Kaufman, TX
``We obtained background levels for many of the contaminants from TCEQ
monitoring results for the town of Kaufman, TX, a
town of similar population size, no large industry,
and which is only rarely down-wind from
Midlothian.''
At least one serious concern about using Kaufman, TX is the fact
that relatively large-scale waste incineration has been conducted for
many years in this community. Incinerators operated in Kaufman include
municipal waste combustion facilities or medical waste incineration or
both, which emit many of the same products of incomplete combustion
(PICs) as do cement kiln hazardous waste incinerators such as Dioxins,
Dibenzofurans, Polychlorinated Biphenyls, Polycyclic Aromatic
Hydrocarbons and Metals. I recommend that you consult with TCEQ about
how many waste incineration facilities were operated or are still
operating in Kaufman, TX.
However, I have no details or information about the siting of the
TCEQ's Kaufman monitor relative to the waste incineration facilities
and whether the monitor was downwind or upwind of the incineration
facilities. But the fact that large-scale waste incinerators may have
been operating in Kaufman over many years indicates that the use of
Kaufman, TX is inappropriate for any comparisons to Midlothian, TX.
PART I
Sampling every six days for VOCs & metals. May 1981-March 2005.
1. Sampling site selection for TCEO ambient air monitoring raises many
issues. A number of the Midlothian and Ellis County TCEQ sampling sites
are not selected for suitable sampling suits as to be downwind of the
Midlothian industrial plant emissions plumes and will not provide valid
downwind ambient air concentrations to measure emissions from the
industrial plants. How many Midlothian and Ellis County TCEQ sampling
sites are actually in the general downwind area of the plants and how
far in feet are these?
2. Sampling frequency raises another set of ambient air monitoring
issues. Sampling on a once in six day sample duty cycle only looks at
most at 16.7 percent of the days for air pollution and excludes for
analysis 83.3 percent of the time period every year.
3. Sampling--protocol of flow rate and analytical limitations also
present a number of additional ambient air monitoring issues that need
to be addressed. Many air contaminants are excluded from laboratory
analysis and many are not detected due to minimum detection limits set
above threshold where many toxic air contaminants may be present such
as dioxins, dibenzofurans, polychlorinated biphenyls, polycyclic
aromatic hydrocarbons, and others.
A.1. While it is true that ``all the chemicals being released from
cement kilns and steel mills have not been fully identified,'' this
health consultation has evaluated 237 individual contaminants including
119 VOCs and 108 metals and other inorganic substances.
Another concern surrounds the question of whether the TDSHS
scientists have any prior experience in performing an evaluation of a
commercial or private hazardous waste combustion facility in Texas
before this current Midlothian effort. Since this is not a
responsibility typically involving the TDSHS scientists, the
consultation may be partly compromised by the inability to comprehend
the complex emissions hazards associated with such hazardous waste
storage, treatment and disposal facilities as exist at Midlothian. For
example, downwind air monitoring sites may be too far away from the
hazardous waste facilities to be able to detect ground level fugitive
hazardous waste emissions leaks from the transfer, storage and piping
system at such a facility. However, having myself visited Midlothian
many times and having been downwind of the hazardous waste facilities,
I definitely noticed during each visit that there were in my opinion
distinct fugitive gaseous emissions from these operations that produced
instant severe headaches. While I cannot state for certain if such
fugitive gaseous emissions were associated with the hazardous waste
operations, I did not notice similar fugitive gaseous emissions from
the two non-hazardous waste cement kilns at Midlothian. As a result, I
maintain that the fugitive gaseous emissions from the hazardous waste
cement kiln were associated with its hazardous waste operations.
Hazardous waste chemistry is highly complex and may become more
complex during and immediately after the incineration process.
Hazardous waste consists of toxic soup mixtures of innumerable organic
and inorganic chemicals, elemental chemicals, metals, acids, bases,
salts, waste water and other wastes from complex industrial
manufacturing processes.
Hazardous waste incineration has the potential to take the
thousands of organic and inorganic chemicals and chemically transform
them into thousands and thousands of incompletely burned compounds.
The consultation did not include consideration of the need to
sample the air, water and food chains for known species of the
following twenty groups of halogenated organic chemicals that are
toxicologically known to cause adverse biological effects through the
Ah-r-mediated mechanism of action:
Polychlorinated dibenzo-p-dioxins
Polychlorinated dibenzo-furans
Polychlorinated biphenyls
Polychlorinated naphthalenes
Polychlorinated diphenyltoluenes
Polychlorinated diphenyl ethers
Polychlorinated anisoles
Polychlorinated xanthenes
Polychlorinated xanthones
Polychlorinated anthracenes
Polychlorinated fluorenes
Polychlorinated dihydroanthracenes
Polychlorinated diphenylmethanes
Polychlorinated phenylxylylethanes
Polychlorinated dibenzothiophenes
Polychlorinated quarterphenyls
Polychlorinated quarterphenyl ethers
Polychlorinated biphenylenes
Polybrommated diphenyl ethers
Polychlorinated azoanthracenes
Cite: Table 4--Compounds that May, Based on Experimental Evidence
or Structure, Be Expected to Have the Potential to Cause Adverse
Effects through the Ah-r-mediated mechanism of action, p. 266 in
Chapter 9, ``Dioxins, Dibenzofurans, PCBs and Colonial, Fish-Eating
Water Birds'' by John P. Giesy, James P. Ludwig, and Donald E. Tillin,
published in Dioxins and Health edited by Arnold Schecter, Plenum
Press, New York, 1994.
There may be other possible organics including polybrominated
aromatic compounds, polychlorinated-brominated aromatic compounds,
polyfluorinated aromatic compounds, polychlorinated-fluorinated
aromatic compounds, and other polycyclic aromatic hydrocarbons (all
lumped together as ``dioxins'' here).
The large-scale hazardous waste incineration activities conducted
at Midlothian for approximately twenty years create unique
circumstances for producing the air emissions of a large number of
exceptionally toxic substances since there is no such thing as 100
percent combustion efficiency and total organic chemical destruction in
any incineration devices let alone cement kilns. A basic concern is
that the consultation has seriously underestimated and downplayed the
dangers of large scale incineration of hazardous waste for a local
community. The large scale incineration of hazardous waste has an
expected potential to create thousands of unusual byproducts of
incomplete combustion (some of these organic compounds are created by
partial thermal decomposition of the waste mixtures and other compounds
are created by rapid ``de novo synthesis'' in the cooling stack gas
phase) with many occurring at levels below the frequently used one part
per billion detectability limit in organic analytical equipment. But
most of these unusual byproducts of incomplete combustion are not
measured or identified due to their difficult chemical characteristics,
which need highly specialized analysis at extremely low concentrations
below most VOC analyzers. Of course, dioxin and dibenzofuran analytical
equipment go well below the 1.0 ppb level down in the low parts per
trillion levels and parts per quadrillion range. It's not feasible to
conclude if the 119 VOCs reviewed represent 50 percent of the total VOC
species emitted or 25 percent or 10 percent or less. Without a more
comprehensive VOC analysis of the total low part per trillion range VOC
species, highly toxic organics like the dioxins are being ignored
completely in the consultation.
Some of these VOCs will be bound to the particulate matter emitted
and this represents another fraction of the total VOCs in the ambient
air. But VOC sampling that collects only gaseous phase organics and not
the particle phase organics will miss a fraction of the VOC compounds
in the air.
Reviewers need to ask: What is the range of possible types of VOCs
produced from large-scale hazardous waste incineration? What is the
range of the possible concentrations of the VOCs produced from large-
scale hazardous waste incineration? Are these VOCs being detected? Yes,
some VOC byproducts are being detected as indicated by 119 VOCs, but
the concern is that many VOCs (several thousand more VOCs) are not
being detected due to the high detectability limits in the analytical
equipment such as 1.0 ppb and the potential for similar VOC species to
overlap.
The same applies to inorganic compounds and metals, and in many
monitoring sites, inorganic compounds and metals were not even
collected.
The TCEQ has no laboratory facilities specifically established for
conducting dioxin and dibenzofuran analyses, and due to the costs of
such analyses, it's typically not required by the TCEQ on most
environmental samples due to the expense of such laboratory analysis.
The EPA has recognized along with the organic chemistry science
that any form of chlorine (organic and inorganic) in combination with
carbon in a combustion process will produce the expected dioxins and
dibenzofurans by rapid ``de novo synthesis.'' The large-scale hazardous
wastes burned at Midlothian have routinely contained numerous organic
chlorinated residues and inorganic chemicals which would be expected to
produce certain stack concentrations of dioxins and dibenzofurans by
rapid ``de novo synthesis.'' Some dioxins and dibenzofurans may also be
present among the chlorinated hydrocarbons and inorganic chlorine
compounds in the large-scale hazardous wastes burned and could be
emitted as undestroyed chemicals.
A.2. It is also true that ``All the chemicals currently being
incinerated and released have not been tested for carcinogenicity and
endocrine disrupting potential.'' However, based on historical reviews
of cancer incidence and/or mortality rates in Midlothian and Ellis
County, no individual or aggregate cancer rates were significantly
elevated with respect to the rest of the state.
Several problems exist with the Texas Cancer Registry databases and
the conclusion of ``no individual or aggregate cancer rates were
significantly elevated with respect to the rest of the state'' seems
premature and an unscientific statements. The Cancer Registry is
significantly flawed itself in its omissions and tracking system. Many
people do not show up in this database.
The EPA's recent Endocrine Screening, Testing Advisory Committee
(EDSTAC) only recommended testing of potential endocrine disrupting
chemicals for interference in three human hormonal pathways of
estrogen, thyroid and androgen. All other hormones were excluded by
endocrine testing and screening.
A.4., C.3., & D.3. The community was concerned about the health effects
of dioxins, metals, and mixtures of compounds. Air data for dioxins are
not routinely collected in Texas; therefore it was not possible to
evaluate the potential adverse health effects associated with these
compounds. We evaluated available VOCs and metals air contaminant data
with respect to its potential for causing adverse health effects in
humans due to acute, intermediate, and/or chronic exposures. Only
manganese exceeded its health based screening value for chronic
inhalation exposures. However, based upon a review of the toxicological
data, we would not expect to see adverse health effects due to either
long-term or short-term exposure to manganese. Mixtures of compounds
also were evaluated in this consultation. Long-term aggregate exposures
to air contaminants in Midlothian are not expected to result in adverse
non-cancer or cancer health effects.
I find the conclusion on the VOC's seriously flawed and unsound
since too many organic chemicals are not even monitored for in
Midlothian. I don't think that TDSHS has any idea or even an
intelligent guess as to how many organic chemicals were not being
detected due to their presence below the detectability analytical
limits of the lab equipment or were not being analyzed for at all such
as all of the dioxin-related compounds. See more comments under A-1.
This conclusion is not scientific and is based on extremely limited
data that cannot logically support or confirm such a broad sweeping
conclusion: ``Mixtures of compounds also were evaluated in this
consultation. Long-term aggregate exposures to air contaminants in
Midlothian are not expected to result in adverse non-cancer or cancer
health effects.'' One reason is that not all of the mixtures can
possibly be determined without a great deal more ambient air monitoring
and far more sophisticated laboratory analyses looking at many more
products of incomplete combustion including levels in the parts per
trillion where many toxic dioxin-related compounds occur or even lower
levels.
A.5., A.7., & C.1. In this health consultation, DSHS has analyzed each
and every individual air sampling result collected from all TCEQ
sampling locations in the Midlothian area and has not relied on any
TCEQ-summarized data. Also, DSHS has not relied on any of the TCEQ's
effects screening levels (ESLs) for determining potential health risks
associated with exposures to airborne contaminants in Midlothian.
Significant limitations exist with the sampling and analysis
program in Midlothian.
A.6. & D.4. The community was concerned that the potential for adverse
health effects may be underestimated due to averaging of contaminant
data over time. The initial screening of the air data involved
comparing the maximum concentration for each contaminant to its most
conservative health-based screening value. Contaminants whose maximum
concentrations exceeded the most conservative health-based screening
value were evaluated for acute, intermediate, and long-term exposures.
None of the compounds examined (with the exception of benzene) had a
single 24-hour measurement that exceeded its acute exposure guideline.
The acute inhalation MRL for benzene was exceeded three isolated times
in 13 years. Consequently, after reviewing all of the available data
(which includes 94,932 individual 24-hour measurements), we find no
evidence to suggest that adverse health effects would be anticipated as
a result of any of the short-term or peak exposures to VOCs or Metals.
The potential for adverse health effects due to exposure to EPA's NAAQS
compounds will be evaluated in a future health consultation.
This conclusion is totally inconsistent with the real world
experiences of many Midlothian area residents as well as myself and
does not recognize the serious limitations of the available data.
Especially in view of the significant limitations exist with the
sampling and analysis program in Midlothian.
A.8., B.4., C.4., & D.1. The community was concerned about asthma,
allergies, immune system deficiencies, and other health problems in
adults as well as children. Data for these health problems are not
routinely collected in Texas. Therefore, we were not able to
systematically assess whether the levels of these conditions in
Midlothian are different than in other areas of the state.
A basic concern here is that asthma, allergies, immune system
deficiencies, and other health problems in adults and children are not
being evaluated and yet these kinds of adverse health effects are being
reported by Midlothian residents. The TDSHS should conclude no adverse
health effects are expected when so many types of health outcomes are
excluded from the consultation. Hazardous emissions and toxic
contaminants could certainly be contributing or causing adverse health
effects based on the information about many of these pollutants. Did
the consultation consider fatalities from asthmatic attacks or
allergies?
B.1., B.2., & D.2. Over the years, the Texas Cancer Registry and Texas
Birth Defects Registry have conducted incidence, mortality, and
prevalence investigations to determine if cancer and birth defect rates
were higher or lower in the Midlothian area compared to the rest of the
state (Appendix D). No statistically significant elevations of specific
or total cancers were found. The prevalences for a few birth defects
were higher than expected and for a few other birth defects were lower
than expected based on State rates. These higher prevalence rates were
not unique to Midlothian/Ellis County but were also observed throughout
Health Service Region 3 (which includes 18 other counties primarily
north and west of Ellis County). Because of the numerous factors
involved, it is not possible to determine if these increases are due to
environmental exposures or differences in reporting practices in this
region compared with the rest of the state. Furthermore, it should be
noted that only three of the 99 compounds with health based comparison
values (i.e., ethylbenzene, 2-butanone, and methyl isobutyl ketone)
listed ``developmental effects'' as the critical effect (i.e., the
first observable physiological or adverse health effect occurring at
the lowest exposure dose known to produce any effect at all). Hazard
quotients for those three compounds were 0.000352, 0.0000653, and
0.00000793 respectively, levels that are far below levels that might be
expected to result in an increased risk for birth defects.
This conclusion is somewhat illogical, especially in view of the
significant limitations that exist with the monitoring siting, monitor
distances, sampling and analysis program in Midlothian.
General Findings #1, #2, #3, and #4 are conclusions that are highly
deficient for their numerous omissions and flawed considerations of
data gaps.
Why am I concerned about industrial air pollution impacting the
Midlothian community and rural residents?
In the 1990s I developed a recognition that the industrial air
pollution at Midlothian was clearly causing significant adverse health
effects to area residents and often their animals based on my previous
professional experience as a State investigator for twelve years at
other types of industrial facilities, based on many visits to
Midlothian to investigate the conditions there, based on reviewing
emissions information and permits for the Midlothian plants, based on
analysis of monitoring information, and based on interviews with many
citizens. I emphasize this background because during my professional
experience with the Texas Air Control Board from 1980-1992, I
investigated about 1,000 citizen complaints of air pollution and
citizens generally complained when the industrial air pollution was so
egregious that people were suffering adverse health effects from
something in the air and therefore they were strongly compelled to file
complaints in order to seek action to abate the problems. Once
corrective measures occurred to reasonably abate the alleged air
pollution events effecting their health and their residences, citizens
typically complained less or no more at all. Nonetheless many residents
were trying to deal with local toxic nightmares of one degree to
another. In several cases, abatement of pollution events producing
citizen complaints required months and even several years before the
problems were reasonably abated.
In my opinion, the Midlothian toxic nightmare fits into a pattern I
have encountered elsewhere in Texas. Since leaving the Texas Air
Control Board in 1992 after inspecting industrial facilities for twelve
years in West Texas and which included a cement manufacturing plant
with two cement kilns, I have been regularly interacting with
Midlothian residents regarding their health and environmental concerns
with the significant toxic emissions from three local cement kilns and
the steel mill. I am familiar with the locations of each of the four
plant sites and have reviewed emissions associated with the facilities.
Although I previously worked for the state environmental agency known
as the Texas Commission on Environmental Quality (TCEQ), I have
developed grave concerns about the bias that routinely creeps into the
Agency's scientific efforts such as certain aspects of the ambient air
monitoring activities at Midlothian and the Agency's generally
egregious failure to protect public health from impacts due to exposure
to a range of toxic contaminants. In addition, I have experienced
severe headaches near the TXI facility during brief exposures to
industrial emissions next to the TXI facility, which for me raises
troubling questions about the abysmal lack of regulatory oversight by
the TCEQ and a lack of concerns about the health and safety of
Midlothian residents.
I have reviewed previous reports of November 2, 1995 report: The
Screening Risk Analysis for the Texas Industries (TXI) Facility in
Midlothian, Texas, by the Office of Air Quality/Toxicology and Risk
Assessment Section, Texas Natural Resource Conservation Commission, and
a November, 1995 report: The Critical Evaluation of the Potential
Impact of Emissions From Midlothian Industries by the Texas Natural
Resource Conservation Commission. Even the January 31, 1996 federal
report was severely flawed for similar problems and errors: Midlothian
Cumulative Risk Assessment Volume 1, by the Multimedia Planning and
Permitting Division, U.S. Environmental Protection Agency, Region 6,
Dallas, Texas.
Risk assessments in Texas (the TCEQ's Screening Risk Analysis and
the Summary Report, 1995 for Midlothian, TX) are poor starting points
for future studies and actions aimed at protecting public health and
the environment due to the innumerable flaws, omissions, gaps, poor
science and errors. However if viewed as ``technical support''
documents to justify EPA and State declarations of no substantial risk
to public health due to pollution in Midlothian, they must be
criticized due to their many serious omissions, inconsistencies and
inadequate or misleading analyses. The federal and State peer review
process is an abysmal failure in the Midlothian case.
Based on de novo analysis at TXI, we conclude that environmental
and health impacts have and are likely to occur in the Midlothian area
from industrial activity, including the combustion of hazardous waste
at TXI. There is high likelihood that the environmental and health
impacts are significant, as demonstrated by exposures and risks that
greatly exceed U.S. EPA target exposure levels for a variety of
exposure scenarios and source assumptions at a large number of sites.
Exceedances of acceptable risk levels for children at all residential
locations is especially noteworthy.
Because predicted health risks exceed target levels, continued
waste combustion at TXI requires more stringent controls, e.g., more
effective air pollution control technology, waste feed limitations,
and/or modified operating practices.
The serious deficiencies in the Screening Risk Analysis and Summary
Report for TXI indicate that the ability of EPA Region 6 to conduct an
objective assessment is compromised, and the record demonstrates
significant concerns regarding the effectiveness of the EPA Regions and
states like Texas in regulating combustion of hazardous waste at these
cement kilns.
The EPA Region with oversight for state like Texas must be strongly
criticized for the tendency to go far beyond what is scientifically
supportable by the existing data in making sweeping generalizations
regarding the present and future safety of waste combustion in
communities. Statements with little or a frail scientific basis show a
disregard for the protection of public health, and serve to diminish
the EPA's and states credibility among the public.
I strongly support concerns of local residents regarding hazardous
waste pollution emitted by cement kilns, which have already impacted
communities in the area and surrounding water and land use. In
addition, a potential for more far reaching environmental impacts to
air and water quality and ecological systems is a significant concern
of the Sierra Club and we support the obvious need to reduce emissions.
Respectfully yours,
NEIL J. CARMAN, PH.D.
Clean Air Program Director
Lone Star Chapter of Sierra Club
1202 San Antonio Street
Austin, Texas 78701
E-mail: Neil-[email protected]
Addendum #5
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Addendum #6
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Addendum #7
Midlothian, TX--Comments on ATSDR Public Health Consultation
Prepared by: Peter L. deFur, Ph.D. and Kyle Newman
Environmental Stewardship Concepts, Richmond VA 23238
March 11, 2008
Personal information:
We are submitting these comments on the ATSDR Public Health
Consultation for Midlothian, TX out of concern for the role of
scientific data in public health assessments and how data are used in
environmental management. We learned of this document from colleagues
in the area and reporters who asked if we had seen the report.
Environmental Stewardship Concepts (ESC) provides technical
consultation to citizen groups and agencies regarding the cleanup of
contaminated sites across the Nation. At present, our work includes
Superfund sites, RCRA sites, State cleanups, contaminated rivers under
TMDL cleanup, and operating permits for sites that handle contaminated
materials. We are intimately familiar with CERCLA and the work the
ATSDR has done regarding contaminated site health assessments.
Biographical sketches for Dr. deFur and Mr. Newman are appended at the
end of the comments.
Summary
ATSDR's classification of this site as an ``Indeterminate Public
Health Hazard'' is in direct contradiction with the data the Agency
presents in the report. Throughout the document, ATSDR attempts to
marginalize or disregard data that indicate that compounds produce
human health risks. ATSDR has more than enough data to classify the
site as a ``Public Health Hazard.''
The problems with this assessment are numerous, and the most
serious problem with the interpretation is that ATSDR discounts their
own metrics of health effects, ignoring the data that exceed health
levels. For a number of chemicals, the air concentrations are in excess
of the health levels, but ATSDR dismisses the excess toxic chemicals as
not a problem because the number or people harmed is small, despite the
fact that the risks exceed the levels used to protect people from
environmental threats (i.e., one in a million).
The most glaringly obvious example of ignoring relevant data is the
disregard of aggregate exposures on cancer health effect where ATSDR
claimed that even though risks exceeded the regulatory threshold,
results were inconclusive since the specific species of chromium
measured in the air could not be identified with any certainty. Since
the cement kiln is known to utilize hazardous waste fuel in its
operation, it is hardly an unreasonable assumption to assume that the
more toxic forms are being released. ATSDR also provides no information
to support the conclusion that if risks from chromium were excluded
cancer risks would no longer exceed the regulatory threshold. ATSDR's
own data do not support this attempt at marginalizing the risks.
Non-cancer health effects are dismissed just as easily. For
example, when health risks for manganese were found to be unacceptable,
ATSDR concluded that actual risks were low because health screening
values incorporated safety margins based on uncertainties in the
toxicity data. Lowering screening values based on uncertainty is common
practice at EPA and other agencies responsible for public health. Does
ATSDR disagree with this approach? The rational for dismissing risks
from manganese certainly implies that ATSDR is prepared to replace
EPA's official determination and EPA's scientific expertise with their
own. What exactly what does ATSDR believe the purpose of incorporating
uncertainty into screening values is? ATSDR was brought in to evaluate
health risks to the community of Midlothian, not to evaluate how human
health screening values are calculated. This dismissal, combined with
the approach for evaluating the non-cancer effects of aggregate
exposures that assumed compounds only target a single organ system
provides further evidence that ATSDR's evaluation and conclusions are
deeply flawed.
Background levels are inappropriately calculated and do not reflect
true background conditions. Urban concentrations are not appropriate
for a rural Texas community. ATSDR's decision to average these
background concentrations from highly industrialized areas no doubt
further inflated background concentrations. This error in methodology
in turn led to the dismissal of risks from a number of toxic chemicals
since they were ``not significantly above background levels.''
EPA did NOT conduct a cumulative risk assessment in the document
cited by ATSDR, per EPA official methodology. The EPA conducted an
exposure analysis as a case study or example for the Cumulative Risk
Framework. Dr. deFur chaired the peer review of the Framework document
and has subsequently worked on cumulative risk assessment
implementation. The analysis at Midlothian, TX did not follow the
Cumulative Risk Framework, nor could it have followed the Framework
because the Midlothian assessment was conducted before EPA finalized
the Framework.
Cumulative risk assessment (see the May 2007 issue of Environmental
Health Perspectives for a mini-monograph on cumulative risk) requires
more than an attempt to combine the air emissions from four major
sources. A proper cumulative risk assessment incorporates health
status, community infra-structure evaluations, examination of the
history of the sources and much more than was done for the exposure
analysis done by EPA at Midlothian, TX more than a decade ago.
The report makes no attempt to deal with the chemicals for which
there are no regulatory numbers, i.e., no HAL on which to base a health
evaluation. This omission is not even handled in an uncertainty section
that could be used to make up for the data gaps and weaknesses in
quantitative evaluation. The report further indicates an ability to
conduct an uncertainty analysis by using a Monte Carlo analysis, the
software for which would provide a feature for conducting a
quantitative uncertainty analysis. 59 organics and 28 metals or
inorganic chemicals had no health based screen but 16 organics and two
inorganics exceed background, per Table 3a.
The report also fails to grasp the biological basis for the action
of multiple chemicals acting over many years on the same people and on
the same physiological systems. The metals are mostly all neurotoxins
and affect the brain, especially the developing brain in fetuses and
young children. ATSDR could have sought at least a qualitative analysis
of the combined effects of so many neurotoxins over long periods.
It is unclear why the conventional air pollutants were not included
in the analysis. These data should be available now for the area, and
for all of Texas. In particular, PM2.5 is most
significant because of the toxic chemicals associated with the
particles, and because the particles themselves are deadly. Indeed,
recent health investigations in the peer-reviewed literature indicate
there is no threshold for PM2.5, thus any
exposure will cause such problems as increased heart attack, increased
stroke, and increased asthma attacks with possible mortality.
The report has no data on dioxins, furans, PCBs, phthalates,
pesticides, a number of other compounds and these are dismissed in the
text on page 70, A4, C3 and D3 response. Cement kilns are known sources
of dioxins and furans, according toe the most recent EPA Dioxin
Reassessment (see source and exposure section). Even if ATSDR did not
bother to spend the money and take air samples, the EPA database has
sufficient information on sources to make an informed estimate of
dioxin and furan emissions. As for the other chemicals, if ATSDR did
not take fresh samples, then they should have contacted EPA for data
that could be used to make an estimate.
The Monte Carlo analysis of data is not valid and is intended to
skew the interpretation of the data. I doubt that this analysis was
done according to EPA guidelines for probabilistic assessments, but
there are no methods given, so it is not possible to assess what ATSDR
did in the Monte Carlo analysis.
Specific Comments
Fig. 1 and 2: where is the wind rose? Where are the residences?
ATSDR should have used wind data from the facilities, the closest
weather station or airport.
Enough time has elapsed since the beginning of the investigation
that ATSDR could have installed a weather station in an appropriate
location in Midlothian.
Page 22: Why is there not a single list of chemicals? Code the
measured, above and below diction and which no toxicology data. Present
display is too hard to interpret--What are the Region III risk based
air levels and the numbers from the IRIS listing? The report needs to
provide these two sets of values that are commonly accepted as
applicable around the county.
Page 17: There is a big difference between ATSDR MRL values and the
IRIS listings. ATSDR MRL's are always higher, less protective, less
conservative than the IRIS values.
Page 19: Averaging the numbers from four collecting locations is
NOT conservative Taking the maximum value recorded is conservative.
Taking the upper 95 percent C.I. of all values is OK. But the data are
so oddly collected in time and space, and so skewed in distribution
that some adjustments should have been made to account for these
patterns and attempt to get some sense of representative data.
Tables 1a/1b show a sampling distribution that is skewed as to be
bizarre. Of the 13 sites, one has 9,294 samples in 11 years and 22,956
for organics for six of those years and another site had five metal
samples one year. Organics were sampled and measured only at four sites
and 13 years and not all the sampling was equal. The analysis must not
give all samples equivalency.
The 95 percent UCL of all samples is not useful when the data are
so clearly skewed in sampling distribution among locations and across
time (years).
The graphical depiction of actual data in Fig. 3-23 is useful and
when merged with data from Table 4b reveals the following information
on detections and levels that exceed the HAL's:
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
All of the chemicals listed above show maximum values that exceed
the HAC and the HAL. Many of these chemicals had many measurements in
excess of the concentration determined to be without effect--in essence
the level for protecting public health. In several cases, all
measurements exceeded the regulatory limit.
The interpretation by ATSDR that there is no health problem defies
logic and all sense of public health assessment. Citizens are exposed
to 19 chemicals at times in excess of cancer guidelines or non-cancer.
No attempt to put these all together. In spite of the CDC conclusion
that these is no safe lead exposure, ATSDR disagrees and is not
concerned with children developing neurological problems.
The non-cancer aggregate on p. 68 is wholly unsatisfactory in
method but even where found an HI greater than one, discounted because
Manganese is the chemical and the MRL is less than the NOAEL (animals
v. humans). So the MRL was ignored because ATSDR did not like the
answer or the method, or some other thing. What about children's
development?
ATSDR did not even report or measure PM2.5
for which there is no threshold for health effects.
Cancer p. 69: This statement is dismissive at best, callous and
wrong at worst. The 1x10-4 cancer threshold given
by ATSDR is for Superfund sites--Does ATSDR propose the residents of
Midlothian live on a Superfund site? I am sure there will be both
dismay and relief that some agency has finally admitted the nature and
magnitude of the problem. Now, clean it up and make the industries and
EPA pay.
This Monte Carlo is a joke. Where are the cumulative probability
distributions? Other data need to be displayed compared to ALL
regulatory levels. Most such analyses present the probability density
functions.
A8--Not measuring does not make the effect go away or diminish.
No soil sample results were presented by ATSDR, only a statement
that there was nothing wrong with the soil.
p. 74 Overall At best, the risks are hard to quantify on the basis
of the data presented. Most likely there are clear health effects, both
cancer and non-cancer, from the air emissions. The non-cancer effects
are likely neurological.
No where does ATSDR attempt to determine the effects of a lifetime
of breathing contaminated air--and let's add on PM2.5
to the toxic chemicals measured here.
Biographical Sketch for Peter L. deFur
Dr. Peter L. deFur is President of Environmental Stewardship
Concepts, an independent private consulting firm, and is an Affiliate
Associate Professor and Graduate Coordinator in the Center for
Environmental Studies at Virginia Commonwealth University where he
conducts research on environmental health and ecological risk
assessment. Dr. deFur has served on numerous State and federal advisory
committees.
Dr. deFur presently serves as technical advisor to citizen
organizations concerning the cleanup of contaminated sites at FUDS,
CERCLA and RCRA sites around the country. His projects include the
Housatonic River, MA; the Delaware River; Lower Duwamish River, WA;
Rayonier site in Port Angeles, WA; and the Spring Valley site in
Washington, DC. Many of these sites, and others on which he has worked
are contaminated with PCBs and/or dioxins.
Dr. deFur received B.S. and M.A. degrees in Biology from the
College of William and Mary, in Virginia, and a Ph.D. in Biology (1980)
from the University of Calgary, Alberta. He was a postdoctoral fellow
in neurophysiology in the Department of Medicine at the University of
Calgary, and an environmental fellow at AAAS in 1989. Dr. deFur held
faculty positions at George Mason University and Southeastern Louisiana
University before joining the staff of the Environmental Defense Fund
(EDF) in Washington, DC. In 1996, deFur formed ESC and accepted a part-
time position at VCU.
Dr. deFur has extensive experience in risk assessment and
ecological risk assessment regulations, guidance and policy. He served
on the NAS/NRC Risk Characterization Committee that prepared
Understanding Risk. Dr. deFur served on a number of scientific reviews
of EPA ecological and human health risk assessments, including the
Framework for Cumulative Risk Assessment, the assessment for the WTI
incinerator in Ohio and EPA's Ecological Risk Assessment Guidelines.
deFur served on three federal advisory committees for EPA's Endocrine
Disruptor Screening and Testing Program.
Kyle Newman has worked at Environmental Stewardship Concepts since
2004, where he has held the position of Environmental Scientist since
2006. He has worked in the environmental field since 1999 when he first
worked for the consulting company Advent Inc., and has developed
expertise in risk assessment, freshwater ecology, toxicology, soil
contamination, and conservation biology.
Kyle graduated from Virginia Commonwealth University in 2003 with a
B.S. in Biology. He is currently finishing his Masters of Science at
VCU's Center for Environmental Studies and performing research on the
relationship between ecological vulnerability and stream macro-
invertebrate community structure. In addition to his work at ESC, Kyle
is also the senior Recitation Leader for VCU's groundbreaking Life
Science 101 course on systems biology.
Addendum #8
Statement of Neil J. Carman, Ph.D.
Former State of Texas Air Pollution Control Agency Regional Field
Investigator of Industrial Plants Including Portland Cement Kilns and
Waste Incinerators in 1980s-90s
The EPA's Sham (Bifurcated) Hazardous Waste Combustor MACT Rule and
Enforcement Failures by EPA and State of Texas are
Related to Health Hazards from Toxic Waste
Incineration in Cement Kilns at Midlothian, Texas
The sham EPA MACT rule for toxic waste incineration has created a
tragic mess for communities like Midlothian, TX. In addition, State and
EPA enforcement failures have led to over a decade of unsafe air
pollution and plant upsets impacting citizens close to Midlothian
cement kilns that are allowed to incinerate up to 200 million pounds a
year of hazardous waste. Known kiln stack air pollutants include
carcinogenic metals. Result is Midlothian residents have been living a
fifteen-year toxic nightmare created by broken regulatory systems at
EPA and State of Texas both failing to fix dirty air problems. As a
former State of Texas air pollution investigator, the Midlothian
situation is as appalling as I have encountered in thirty years of
environmental work in Texas and other states.
Egregious toxic air pollution is due to a bad MACT rule and laxness
in fixing the upsets (24-hour baghouse failures) at Texas Industries,
Inc's (TXI) four cement kilns burning hazardous waste as fuels. In
1996, EPA made a regretful decision to allow cement kilns to serve as
commercial hazardous waste incinerators and, in hindsight, EPA's
decision was exceptionally poor public health policy for communities
like Midlothian's. It led to a serious failure under the Clean Air Act
and RCRA to protect public health. Adding to bad MACT rule-making is
EPA and Texas officials turned a blind eye to years of repeated citizen
complaints of health problems, alleging something was rotten at TXI's
plant because residents and their animals suffered serious illnesses
and their animals often died prematurely. Unsafe levels of air
pollution such as toxic metals and other substances from TXI's poorly
regulated toxic waste incineration are the primary suspect in my
opinion.
Incineration of wastes is a dangerous activity, but even more
dangerous is cement kilns incinerating hazardous waste under sham MACT
rules. Hazardous waste incineration is inherently dangerous, because
combustion of such waste produces thousands of toxic byproducts spewed
into the air. Cement kilns were not designed, built or intended for use
as commercial toxic waste incinerators since EPA has a RCRA program for
permitting of toxic waste incinerators. Cement kilns are designed to
make cement and possess different designs and operations from dedicated
hazardous waste incinerators. The EPA needs new MACT standards and
strict enforcement to fix its egregious 1996 MACT mistake.
Why are Cement Kilns unsafe to communities as quasi-hazardous waste
incinerators?
Cement kilns were authorized by EPA in a 1996 MACT rule to run
under weaker, less protective MACT standards for Hazardous Waste
Combustors (HWC) compared to hazardous waste incinerators. By
bifurcating the MACT rule and adopting weaker incineration rules for
cement kilns, EPA turned a small group of Cement plants (less than 20
percent in the U.S.) into dangerous toxic waste incinerators with
higher mass emissions of toxic substances than more stringently
regulated hazardous waste incinerators. The MACT HWC rule set standards
for Hazardous Air Pollutants such as mercury, arsenic, cadmium,
chromium VI, lead, dioxins, chlorine, total hydrocarbons (CO),
particulate matter, DRE of 99.99 percent, opacity, etc. Cement kilns
raced to get RCRA permits to burn toxic waste.
Cement kilns burn up to 1,000 degrees hotter than incinerators and
a concern is they may burn too hot for metals causing higher mass
emissions due to greater metal volatility at higher temperatures.
Adding to this concern is TXI had several baghouse failures lasting for
hours, and in my view higher toxic metal emissions would have likely
occurred. Exposure to toxic metals is consistent with some health
problems reported at Midlothian.
March 2009 Status of EPA's Hazardous Waste Combustor MACT rule:
(1) EPA's HWC rule is currently under review after Federal
Court litigation resulted in a remand back to EPA for agency
action to fix the sham HWC MACT rule;
(2) EPA having admitted that more than half the MACT emission
standards that the HWC rule contains are unlawful, the Agency
is now deciding whether to defend the rest or take the whole
HWC rule back to fix it;
(3) One of the issues raised in the HWC MACT rule-making is
whether EPA should keep the specially lenient standards that
allow cement kilns to burn hazardous waste; and
(4) EPA deliberately set MACT standards at a level that would
ensure new hazardous waste burning kilns would be built to keep
burning hazardous waste.
In my thirty years professional experience investigating industrial
plants and community health complaints from neighborhoods and downwind
residents, I interacted with many communities in Texas seeing first
hand how air pollution harms communities. I observed that toxic waste
burning cement kilns like Midlothian's are especially dirty facilities
spewing out a dangerous soup of toxins, known carcinogens, and harmful
chemical mixtures that are poorly known for human health effects.
Arsenic, aluminum, cadmium, chromium, lead, mercury, nickel and
selenium are among toxic heavy metals emitted by TXI due to receipt of
bulk hazardous waste and its incineration.
Conclusion:
As a former Texas investigator with 12 years inspecting over 200
industrial plants a year including waste incinerators and cement kilns,
I regard incineration as a dangerous activity based on investigations
of incinerators with problems while working for the State of Texas air
pollution control agency. Even more dangerous is cement kilns
incinerating toxic wastes classified as ``hazardous waste'' by EPA. EPA
needs to set more stringent MACT rules for all Hazardous Waste
Combustors, and notably cement kilns and protect public health in these
badly impacted communities. Note attached list of toxic substances
associated with hazardous waste incineration.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Addendum #9
Midlothian Area Air Quality Part I:
Volatile Organ Compounds & Metals
December 11, 2007
Response: Sal and Grace Mier, Midlothian, Texas: February 03, 2008
Preface:
We recognize that a great deal of valuable time, energy and
resources were expended in the development of this report. However, we
are generally very disappointed that an effort to make such critical
judgments regarding the public health of our community was based on
such poor and weak air monitoring data--and even more disappointing was
the fact that the primary author(s) of this Report do not appear to
have made any serious effort to validate and challenge the quality of
this data but nevertheless were comfortable in making sweeping
generalizations as if the data were sound.
Any product, whether it be a building, a document, or a report such
as this is only as good as the foundation upon which it is constructed.
Step one of this assessment should have been to assure the base (the
air monitoring data) upon which all analyses for this report would
evolve was solid and contained data that accurately reflected a
complete picture of emissions. Thus, it is perplexing and deeply
disappointing to discover that the Texas Department of State Health
Services (TDSHS) and the Agency for Toxic Substances and Disease
Registry (ATSDR) have produced a Public Health document which was based
on deficient air monitoring data, the collection of which was not
designed to analyze community impact and not designed to adequately
capture complete emissions.
It is not our intent to imply that it is ATSDR's or TDSHS' fault
that the proper air monitoring data upon which to base a sound public
health assessment does not exist. We assume that it was the best you
had available to you. However, we would like to believe that at step
one TDSHS would have attempted to verify the methodology incorporated
to position air monitors to optimally capture emissions (i.e.,
populace, wind rose patterns, etc.) and the impact on the community
before they proceeded. When you review selection of monitoring sites,
history, wind rose patterns, location of major emission sources, etc.,
it is obvious scientific methodology to capture community exposure and
impact was not a prerequisite to the placement of the Midlothian air
monitors. Consequently, TDSHS' attempt (with the enabling of ATSDR) to
retrofit a methodology and create the illusion of adequacy is extremely
disappointing and makes a statement that the true assessment of public
health in Midlothian many not have been the major priority.
We realize it is not within TDSHS' purview to dictate to TCEQ a
methodology for establishing an air monitoring system. However it is
TDSHS' responsibility to properly critique its adequacy for assessing
public health. If we cannot rely on our public health agencies to do
the right thing, rather than becoming a solution to the problem, they
become part of the problem.
We want to emphasize, we do not want you to find a problem if one
does not exist. However, it was our hope that we would get a solid,
sound, unbiased decision based on solid sound data. The foundation upon
which the findings of this report are based is seriously wanting and
flawed.
You have already pointed out many of the inadequacies of the
monitoring sites in this report.
(1) Tayman Drive: No metals and inorganic compounds were
collected at this site. (This is the one site that was best
positioned to capture emissions from all major industries, but
its data was limited.)
(2) CAMS-52: No metals and inorganic compounds were collected.
(This site is capable of capturing some emissions from TXI and
Chaparral Steel, but inadequately placed for capturing the
majority of emissions from the other industries.)
(3) CAMS-302: Metals and inorganic parameters were analyzed
from *PM10. (This site is not in a prevailing wind
pattern for any of the emission sources. No indication that TSP
was sampled for metal speciation.)
(4) CAMS-94: Not in a prevailing wind pattern for any of the
emission sources. This site was selected as a background
monitor for the DFW metroplex because it's south of and upwind
from all industries. *No speciation of metals from particulate
matter greater than PM2.5. (This may be
adequate for regulatory purpose; however, this data does not
present an adequate picture of local exposure.) Monitors
smaller than TSP monitors are not adequate for determining
level of heavy metals in ambient air.
TSP monitors were last used in 1998.
Insufficient data available to evaluate metals--Mercury as an
example: Reliable data to determine the amount of mercury in the
ambient air does not exist. Note the only readings reflected in the air
monitoring data for mercury were based on PM2.5
speciation for metals. These readings are for the most part ``non-
detect.'' Given the amount of mercury that is self-reported by the
industries these `non-detect' readings are questionable. In 2004 the
industries ``self-reported'' air release of mercury compounds per
pounds as follows: Chaparral Steel--709, Ashgrove--150, Holcim--59,
TXI--10. This demonstrates: 1) the inadequacy of the monitoring
location to capture complete emissions, and 2) the inadequacy of
relying on PM2.5 for speciation of metals.
*According to the Office of Air Quality Planning and Standards
(OAQPS) final staff paper released in December, there is a distinction
in TSP, PM2.5 and PM10 and the
adequacy of anything less than TSP to evaluate total lead in ambient
air. Refer to http://www.epa.gov/ttn/naaqs/standards/pb/data/
20071101-pb-staff.pdf on page 17 (2.3) Air
Monitoring. 2.3.1.1 Inlet Design (last paragraph) reads:
``Sampling systems employing inlets other than the TSP inlet
will not collect Pb contained in the PM larger than the size
cutpoint. Therefore, they do not provide an estimate of the
total Pb in the ambient air. This is particularly important
near sources which may emit Pb in the larger PM size fractions
(e.g., fugitive dust from materials handling and storage).''
With our petition, we submitted a document: Evaluation of The
Screening Risk Analysis for the Texas Industries Facility in Midlothian
by Dr. Stuart Batterman, et al. This document evaluates risk
assessments, monitoring, soil sampling, etc., done in Midlothian and
presented in this consultation as activities engaged in the assessment
of the community's public health. Dr. Batterman's evaluation reflects
many of our concerns regarding the quality of these activities.
Therefore, we are requesting that the entire document be considered as
part of our comments.
Inhalation is not the only exposure route for toxins in the air.
There is no indication in the analyses that skin absorption and
ingestion was factored in when evaluating impact.
Because of the critical deficiencies in the air monitoring data, to
comment any further on the analyses of public health impact of the
toxins would be an exercise in futility as we believe it to be a moot
issue. Therefore, we will make comments on general issues.
Response to Petitioner and Community Health Concerns
A.1. While it is true that ``all the chemicals being released from
cement kilns and steel mills have not been fully identified,'' this
health consultation has evaluated 237 individual contaminants including
119 VOCs and 108 metals and other inorganic substances.
Response: There are over 1,000 regulated chemicals; reviewing 237 is a
start. We appreciate the fact that this report has concluded that we
cannot disregard the potential impact of the unknown regarding the
remainder of the chemicals. However, should this statement simply read,
``Of the over 1,000 regulated chemicals, we are proud to state we have
evaluated 237''?
A.2. (1) It is also true that, ``All the chemicals currently being
incinerated and released have not been tested for carcinogenicity and
endocrine disrupting potential.'' (2) However, based on historical
reviews of cancer incidence and/or mortality rates in Midlothian and
Ellis County, no individual or aggregate cancer rates were
significantly elevated with respect to the rest of the state.
Response:
(1) We appreciate your acknowledgement of the deficiency in
the extent of chemical testing. We agree with you that many
chemicals (as well as heavy metals) being incinerated have not
been tested for endocrine disrupting potential; however, many
have been tested or are in the process of being tested. Recent
scientific studies have raised red flags regarding endocrine
disruption potential for many of the toxins already identified
and at levels significantly lower than the current ``No
Observed Adverse Effect Levels'' used in health risk
assessments. Recent science has cast doubt on the current
regulatory standards.
(2) How does the testing of chemicals for carcinogenicity and
endocrine disrupting potential correlate solely to cancer
incidence in Midlothian? There are illnesses other than cancer
that are of concern. (a) Birth defects (BDs) have consistently
been significantly higher in Ellis County than the State of
Texas for the five years (1999 through 2004). Health Region 3
has the highest overall BD rate of all the eleven health
regions in Texas--there appears to be a common denominator
here--and that is air pollution. Although we cannot say that
this higher rate of BDs is definitely attributed to air
pollution--we cannot definitely say that it is not. (b)
Collection of quality cancer data in the State of Texas is
still in its developing stages of surveillance. Unlike the BD
data collection system, Texas collection of cancer data is
passive. In other words the cancer surveillance system has to
depend on the good will of physicians, hospitals and treatment
facilities to report and many of these providers do not yet
have electronic databases to facilitate this reporting. (c)
Major complaints involve asthmas and other respiratory problems
as well as immune system deficiencies. A peer-reviewed study
regarding respiratory illnesses in Midlothian, ``The Health
Effects of Living Near Cement Kilns; A Symptom Survey in
Midlothian'' performed by UTMB and authored by Dr. Marvin
Legator, et al., was submitted as part of this petition. This
study reflected a higher incidence of respiratory problems in
Midlothian than the control group.
A.4., C.3., & D.3. The community was concerned about the health effects
of dioxins, metals, and mixtures of compounds. (1) Air data for dioxins
are not routinely collected in Texas; therefore it was not possible to
evaluate the potential adverse health effects associated with these
compounds. (2) We evaluated available VOCs and metals air contaminant
data with respect to its potential for causing adverse health effects
in humans due to acute, intermediate, and/or chronic exposures. Only
manganese exceeded its health based screening value for chronic
inhalation exposures. (3) However, based upon a review of the
toxicological data, we would not expect to see adverse health effects
due to either long-term or short-term exposure to manganese. (4)
Mixtures of compounds also were evaluated in this consultation. (5)
Long-term aggregate exposures to air contaminants in Midlothian are not
expected to result in adverse non-cancer or cancer health effects.
(1) TCDD is considered by science to be one of the most, if
not the most, toxic man-made substances. No safe level has been
identified. It has been shown to disrupt multiple endocrine
functions and has negative outcomes for the fetus. Although you
cannot evaluate it, you cannot disregard it.
(2) Based on the placement of the air monitors, it does not
appear assessing true community exposure was a factor in the
collection of the data analyzed. There are too many
deficiencies and weaknesses in the air monitoring data to make
an informed evaluation.
(3) Health issues are surfacing, whether you expect them or
not. Some such as respiratory problems, immune system
deficiencies, reproductive and birth defect issues in animals,
etc., remain ``anecdotal'' because our guardian agencies refuse
to acknowledge them. Others are well documented--for example,
the continually significantly higher incidence of birth defect
rates; increased respiratory symptoms in Midlothian documented
by Dr. Legator, et al.
(4) Did you mean to say, ``Additive effect of some mixtures of
compounds also were evaluated in this consultation''? As you
acknowledge only mixtures with available HAC values were
evaluated--and as if only an additive effect were possible.
There appears to be an apparent false presumption that
synergistic effects are not an issue. Synergistic effects were
not evaluated here. Can we assume dioxin (in addition to many
other chemicals) was not considered in the mix? When so many
factors are missing from the equation, how can you logically
compute data to make such a strong declaration, ``Long-term
aggregate exposures to air contaminants in Midlothian are not
expected to result in adverse non-cancer or cancer health
effects''? Perhaps this statement should read: If we knew
monitoring data accurately reflects industrial emissions and
community exposure, and if we assume there are no synergistic
effects of aggregate exposure, and if we can say no empirical
data exists that may indicate otherwise, we could assume long-
term aggregate exposures to air contaminants in Midlothian are
not expected to result in adverse non-cancer or cancer health
effects.
A.5., A.7., & C.1. In this health consultation, DSHS has analyzed each
and every individual air sampling result collected from all TCEQ
sampling locations in the Midlothian area and has not relied on any
TCEQ-summarized data. Also, DSHS has not relied on any of the TCEQ's
effects screening levels (ESLs) for determining potential health risks
associated with exposures to airborne contaminants in Midlothian.
Response: Thank you for not using the ESLs. It is obvious that you
reviewed a large amount of data. However, it is the adequacy of the
data that is of issue--not the quantity.
A.6. & D.4. (1) (2) The community was concerned that the potential for
adverse health effects may be underestimated due to averaging of
contaminant data over time. The initial screening of the air data
involved comparing the maximum concentration for each contaminant to
its most conservative health-based screening value. Contaminants whose
maximum concentrations exceeded the most conservative health-based
screening value were evaluated for acute, intermediate, and long-term
exposures. None of the compounds examined (with the exception of
benzene) had a single 24-hour measurement that exceeded its acute
exposure guideline. (3) The acute inhalation MRL for benzene was
exceeded three isolated times in 13 years. Consequently, after
reviewing all of the available data (which includes 94,932 individual
24-hour measurements), we find no evidence to suggest that adverse
health effects would be anticipated as a result of any of the short-
term or peak exposures to VOCs or Metals. (4) The potential for adverse
health effects due to exposure to EPA's NAAQS compounds will be
evaluated in a future health consultation.
Response:
(1) Although not listed here, A.6 Reflects our concern that
TCEQ monitors may not be representative of actual exposures
because collection sites may not be optimally positioned to
accurately characterize air emissions in Midlothian. This
remains our major concern and the Achilles hill of this report.
See our prior discussion regarding placement of air monitors.
(2) Averaging still remains a concern because in your analyses
this is actually what was done--except for even longer periods
of time--years. The toxicity of a given element depends upon
when and to whom it is delivered. A minute dose delivered at a
specific time in development (for example to the fetus) can
yield physical and mental abnormalities quite evident at birth,
or may not be detected until later in life. Exposure during
fixed time frames when programming of the endocrine system is
occurring may result in deleterious life altering effects.
There are too many questions and red flags raised by scientific
research related to the short ``windows of vulnerability'' when
chemical exposure can have a negative impact on the developing
fetus, a pregnant mother or the immune suppressed. Time frames
for these ``windows of vulnerability'' are generally measured
in days and weeks--not years. This extended averaging concept
removes life's reality from the formula.
(3) ``The acute inhalation MRL for benzene was exceeded three
isolated times in 13 years . . .''--that you know of! This is a
misstatement. It should read, ``Based on the limited available
data, the acute inhalation MRL for benzene was exceeded at
least three times in a 13-year period . . .'' The data that you
have represents snapshots by the monitors of selected short
periods in time and in ``select'' locations. There is a high
probability benzene exceeded the acute inhalation MRL also when
the monitors were not running. There is a higher probability
that if air monitors were methodically situated to gather data
based on prevailing winds, fallout patterns and community
exposure, results would be very different. At all three sites
(0007, 0015, 0016) the CREG was exceeded 94 percent, 98
percent, 99 percent (respectively) of the time with spikes up
to 118, 512, 319 (respectively) times higher than the CREG.
Exposure to benzene is Midlothian is consistent 24 hours per
day and long-term. Low-level long-term exposure (over two
years) has been shown to lead to anemia and affect the immune
system. A safe level for the fetus has not been established.
Benzene passes the placental barrier and cause breaks in
chromosomes and change in chromosome number. Animal studies
suggest benzene can cause low-birth weight, bone marrow damage,
and delayed bone formation in the fetus.
(4) Whether the analyses of the NAAQS data is an exercise in
futility or whether it produces a reliable indicator of the
impact on public health depends on several factors: (a)
direction and speed of prevailing wind for each sample; (b)
whether current science--not regulatory levels--are used to
determine impact on public health (c) whether readings of
upwind samples are averaged with readings from downwind samples
to dilute the impact (d) whether air monitors collecting NAAQS
data are capable of completely capturing total lead emissions.
A.8., B.4., C.4., & D.1. The community was concerned about asthma,
allergies, immune system deficiencies, and other health problems in
adults as well as children. Data for these health problems are not
routinely collected in Texas. Therefore, we were not able to
systematically assess whether the levels of these conditions in
Midlothian are different than in other areas of the state.
Response: Would it make any difference (other than to disregard it) if
you did have an assessment of this condition? There appears to be a
propensity in this report towards trivializing empirical data. There is
no indication that anyone is asking, ``Is there something we are
missing?'' Note the wording below.
B.1., B.2., & D.2. Over the years, the Texas Cancer Registry and Texas
Birth Defects Registry have conducted incidence, mortality, and
prevalence investigations to determine if cancer and birth defect rates
were higher or lower in the Midlothian area compared to the rest of the
state (Appendix D). No statistically significant elevations of specific
or total cancers were found. (1) The prevalence for a few birth defects
were higher than expected and for a few other birth defects were lower
than expected based on state rates. These higher prevalence rates were
not unique to Midlothian/Ellis County but were also observed throughout
Health Service Region 3 (which includes 18 other counties primarily
north and west of Ellis County). (2) Because of the numerous factors
involved, it is not possible to determine if these increases are due to
environmental exposures or differences in reporting practices in this
region compared with the rest of the state. (3) Furthermore, it should
be noted that only three of the 99 compounds with health based
comparison values (i.e., ethylbenzene, 2-butanone, and methyl isobutyl
ketone) listed ``developmental effects'' as the critical effect (i.e.,
the first observable physiological or adverse health effect occurring
at the lowest exposure dose known to produce any effect at all). Hazard
quotients for those three compounds were 0.000352, 0.0000653, and
0.00000793 respectively, levels that are far below levels that might be
expected to result in an increased risk for birth defects.
Response:
(1) Prevalences for only a ``few'' birth defects were higher? How
``few'' is few enough? The attempted play on words here is insulting
and appears to be an intent to downplay and obscure the significantly
higher impact of birth defects in the community and downwind neighbors.
This wording is reminiscent of the wording in the infamous ``Cafeteria
Talk'' (see discussion below under section Past DSHS & ATSDR
Involvement and Data Review). The fact is that the prevalence of total
birth defects for our entire region is significantly higher than the
State--that is the point we have been making. Ellis County's total
birth defect rate is higher than the region and has been significantly
higher than the State for all years 1999-2003. And there were no
``few'' significantly lower--there was only one in Public Health Region
3. In 2002 the unadjusted prevalence for birth defect rates in Ellis
County (689.1) was 186 percent that of Texas (370). In 2002 Ellis
County had the highest birth defect rate in Public Health Region 3.
(2) It is understandable if you contend that because of the numerous
factors involved you cannot say environmental exposure is (as well as
you cannot say it is not) involved--but the most perplexing excuse of
all is ``because it is not possible to determine if these increases are
due to environmental exposures or differences in reporting practices in
this region compared with the rest of the state.''
According to Texas DSHS own website: http://www.dshs.state.tx.us/
birthdefects/BD---data.shtm
``The Birth Defects Epidemiology and Surveillance Branch
(BDES) uses active surveillance. This means it does not require
reporting by hospitals or medical professionals. Instead,
trained program staff members regularly visit medical
facilities where they have the authority to review log books,
hospital discharge lists, and other records. From this review,
a list of potential cases is created. Program staff then review
medical charts for each potential case identified. If the
infant or fetus has a birth defect covered by the registry,
detailed demographic and diagnostic information is abstracted.
That information is entered into the computer and submitted for
processing into the registry. Quality control procedures for
finding cases, abstracting information, and coding defects help
ensure completeness and accuracy.''
Unlike the Cancer Registry, Texas BDES Registry does not depend on
the good will of medical facilities nor their ``better reporting
practices.'' Their data collection efforts and active surveillance have
been statewide since 1999. Because of the method of collection, this
database presents the best empirical evidence available to TDSHS to
determine whether and where health issues are surfacing.
(3) Furthermore, a multitude of teratogenic and mutagenic toxins being
emitted into the local air are known to cause birth defects and are
known endocrine disruptors. Current science continues to produce
evidence that raises questions regarding the adequacy of current levels
that are deemed safe. There are many unanswered questions regarding the
synergy of these toxins and their impact on the fetus during certain
stages of development. There is significant scientific evidence
surfacing that makes it impossible to state with the slightest degree
of certainty that these toxins that are known to be endocrine
disruptors and known to cause birth defects do not contribute to the
significantly higher birth defects in Ellis and the surrounding
downwind counties in Region 3. This statement is especially true when
you factor in the fact that you do not have a complete picture of the
emissions.
B.3. It has been suggested that the Down syndrome cluster reported in
Ellis, Hood, and Somervell Counties in 1991-1994 may have been related
to a cesium-137 source melt that occurred at Chaparral Steel on
September 16, 1993. This might seem plausible in that one of the risk
factors for Down syndrome is exposure of the mother or the father to
excessive radiation prior to conception of the child. However, the time
line is not right for this to have been a possibility, because the non-
disjunction of chromosome 21 that results in the manifestations of Down
syndrome would have had to have occurred prior to the date of the
cesium-137 source melt for 15 out of 18 of the reported Down syndrome
cases (based on the estimated date of conception for each of the
children with Down syndrome). Also, analysis of the wind rose patterns
for Midlothian during a similar time period to the cluster (i.e., 1992-
94), revealed that the wind would have been blowing in the direction of
one of the Down syndrome cases for less than two percent of the time
during the three-year period. Although the precise wind direction on
the exact day of the source melt in not known, the prevailing winds are
out of the SSE during September, which would have been blowing toward
none of the three Down syndrome cases whose estimated date of
conception was after the cesium-137 source melt (two of these cases
were from Granbury, which is approximately 44 miles west of Midlothian,
and the other was from Palmer which is 21 miles ESE of Midlothian). And
finally, although the exact quantity of radiation released is unknown,
modeling of this release as though the entire source (approximately 89
millicuries of cesium-137) was vaporized and released into the air (and
not caught in baghouse dust as most of it was), indicates that the
additional radiation would not have been detectable above background
radiation levels.
1. No one in this community raised the issue regarding the two other
Down Syndrome clusters in Somervell or Hood County. The only issue
raised was the cluster along FM 664 in northern Ellis County.
Furthermore, the lone ``September 1993'' incineration of cesium-137
correlation to this cluster surfaced solely in-house at TDSHS.
2. According to the study, the conception dates for the mothers in
Ellis County occurred in March 1991, February and March 1992, February
and March 1993 and February 1994. Ten of the 12 dates of delivery
occurred in 1993 and the first half of 1994. Documented in the study,
cesium-137 was reported to have been in scrap material that went into
the steel mill at Chaparral Steel in Midlothian on at least two known
occasions in 1991-1994. (Note reference above to timeline of exposure.)
The cluster along the Ovilla Road corridor is east and north of
Chaparral Steel. It is accurate that this area is not in a prevailing
wind pattern; however, what percentage of the time must the wind blow
in this direction for there to be a potential problem? [Incidentally,
the same concept regarding probabilities and wind patterns should be
applied when evaluating the adequacy of the air monitoring data.]
3. The study concluded that the median distance (12 miles) between
Chaparral Steel and the cluster was too far to be impacted by the
cesium-137 release--and this is also implied in your analyses above
regarding cases in Palmer and Granbury. It appears that cesium-137's
ability to stay aloft and travel long distances was disregarded.
4. The point to this issue has been missed. This issue was raised to
point out the gaps in our public health efforts, the inability or
reluctance to associate health issues with the environment and the too
often inaccurate characterizations related to the transport of
constituents via air. In this Down Syndrome study, traditional factors
were ruled out--the only factor that was not ruled out was the
environment. In this study, cesium-137 was disregarded because of the
distance between the Ellis County cases and the source. Cesium-137 was
raised as an example of a constituent associated with aneuploidy that
stays aloft and travels a long distance before it reaches the ground.
Below is an excerpt from our petition letter to Dr. Sanchez dated July
11, 2005.
The TDSHS also conducted one Down Syndrome study in Ellis
County. A concerned parent living in northern Ellis county
reported that he was aware of eight children with Down Syndrome
that had been born in the immediate area during 1992 to 1994;
an additional four cases were identified via the Texas
Department of Health Bureau of Vital Statistics. Eleven were
live births and one was a fetal death. The observed 12 cases
were 2.78 times the expected number of 4.32 cases. This finding
was considered ``statistically significant.'' Unlike the cancer
clusters identified in Ellis County, this cluster was deemed to
be ``statistically significant'' and thus progressed to a
higher level of epidemiological investigation. Other
traditional factors that have been known to be linked to Down
syndrome were reviewed but ruled out. Unfortunately the study
was not designed to review the potential association of
environmental factors to Down Syndrome; even though these are
probably the only major variables left to consider. The primary
investigator made the point that this cluster occurred several
miles away from the Midlothian industries and thus it was not
likely that there would have been an association. This
assertion could be correct but again, keep in mind that the
study was not designed to review the impact of environmental
factors. There could also have been some unlikely occurrences
related to wind direction and velocity that could have occurred
during the Spring of 1993 when most of the children were
conceived. Just because the ``prevailing'' winds are from south
to north doesn't mean that the winds blow in this direction 100
percent of the time. Also, some constituents are more
``persistent'' than others. For example, cesium-137 was known
to have been incinerated by Chaparral Steel during this time
period and this element has a known association to Down
Syndrome and leukemia. The ATSDR Public Health Statement on
cesium-137 also states that this element has the ability to
travel a long distance in the air before being brought back to
the Earth by rainfall and gravitational settlings. Cesium has a
half-life of 30 years. I am not saying that cesium-137 caused
the cluster of Down Syndrome, but this, again, emphasizes not
only the gaps in our air monitoring but the inaccurate
perceptions related to the transport of constituents via air.
We do not monitor for all elements and we do not take into
account the ability of certain elements to travel at time, rate
and speed beyond the ability of the monitors to capture their
full impact.
Also note: Author of this section (B.3) still seems to have an
inaccurate understanding of cesium-137's persistency to stay aloft for
long periods of time and to travel a considerable distance before being
brought back to earth. It is also known that shielded cesium-137
(example a gauge encased in lead) was difficult to detect prior to
incineration. Since a certain percentage of cesium-137 continued to
show up in the EAF dust one would question whether encased cecium-137
continued to be incinerated. Again, this is not to say that cesium-137
is the cause of these Down Syndrome babies--but to stress the gaps in
the system. [Again, the concern about wind rose patterns expressed here
is to be complimented. The same attitude should prevail when assessing
the adequacy of the monitoring data.]
C.2. This concern turned out to be unfounded, in that all three CAMS
monitoring locations have collected air sampling data on 97-99 of the
119 different VOCs, amounting to 60,396 individual contaminant
measurements. The CAMS-94 location collected air sampling data on 52
metals or other inorganics present in PM2.5
particulate matter amounting to 8,164 individual contaminant
measurements, and the CAMS-302 location collected air sampling data on
24 metals or other inorganics present in PM10 particulate
matter, amounting to 4,344 individual contaminant measurements. Only
the CAMS-52 location collected no air samples for metals or other
inorganics present in particulate matter. The confusion may have arisen
because the CAM sites only collect data for the NAAQS compounds on a
continuous basis (i.e., 24 one-hour-average levels per day). The other
contaminants (VOCs and metals) are collected noncontinuously as one 24-
hour-average level collected once every six days.
The concern that we were given conflicting data by TCEQ was not
unfounded. Refer to documentation (e-mails from TCEQ) in the petition
file. The source of confusion was not the petitioner but TCEQ. However,
you have pointed out one of the inadequacies of the data for 8,164
contaminant measurements for 52 metals and other inorganics collected
at CAMS-94 and 4,344 individual measurements for metals or other
inorganics collected at CAMS-302. PM2.5 and
PM10 are not adequate for determining the amount of metals
released into the ambient air because the larger particulate matter to
which these metals bind are screened out. This is particularly true in
assessing local impact since these larger particles have a tendency to
settle closer to the source. This data may satisfy regulatory
obligations, but is not reflective of true public exposure. Again, it
is quality not quantity that should be of essence here.
C.4. & D.5. (1) Health problems reported in domesticated animals and
livestock were shared with veterinarians at Texas A&M University. (2)
While DSHS does not have animal-species-specific health-based
comparison values to evaluate the risks for health effects in animals,
many of the health-based comparison values used in our evaluation of
human exposures are derived from animal studies and consequently, we
would expect these human HAC values to be equally conservative in
protecting animal health for most common domestic and farm animals.
(1) So you talked to veterinarians at Texas A&M . . . and? You
were presented with strong empirical evidence that should
prompt the following questions. ``Are these animals sentinels
to what may be happening to people? Are there deficiencies in
the data we are reviewing? Are we missing something?'' The
casual dismissal of this issue is extremely disconcerting
especially when some local veterinarians are pointing to the
environment as the potential source of the problems. We would
have expected that the inherent scientific curiosity (and
ethical obligation) of the author (s) of this report would have
automatically ``kicked in'' and that this issue would have been
aggressively pursued.
(2) This response avoids the issue as to why concerns of
health effects in animals have been surfacing throughout the
years. The community was concerned that the effects they were
seeing in the animals paralleled health problems in the
community. The question was, ``Are these animals canaries in
the coal mine?'' Animals are exhibiting immune symptoms,
reproduction problems, inability to carry offspring to term,
low birth weights, birth defects, etc. An example http://
midlothiannow.com/MY-DOGS---MYSELF.html.
This was some of the documentation provided with the petition.
Levels of toxins in the blood samples and hair analysis from
these animals and manifestation of disease do not match the
findings and ``assumptions'' of this report. Again, ``Are we
missing something?''
Past DSHS Health Data Reviews
(1) Maternal age- and race/ethnicity-adjusted prevalence rates for
total birth defects and for hypospadias/epispadias in Midlothian were
significantly elevated with respect to Texas. Similarly adjusted
prevalence rates for total birth defects and for craniosynostosis were
significantly elevated in Ellis County with respect to Texas. Similarly
adjusted prevalence rates for total birth defects, craniosynostosis,
microcephaly, hypospadias/epispadias, and obstructive genitourinary
defects were significantly elevated in Health Service Region 3 with
respect to Texas. (2) Similarly adjusted prevalence rates for pyloric
stenosis were significantly lower in Health Service Region 3 than in
Texas as a whole.
(1) We appreciate the fact that you acknowledge significantly
elevated birth defect rates in Midlothian, Ellis County and
Public Health Region 3.
(2) It is fascinating the number of times you have mentioned
this one insignificant fact in this report as if though it
should trivialize and negate the preponderance of evidence that
establishes the significantly higher birth defect rates.
General Findings
1. One hundred thirteen contaminants (47 VOCs and 66 metals or other
inorganic compounds) had no levels exceeding the most conservative HAC
value (or had no reported levels above the detection limit). No known
health effects are associated with exposure to these contaminants at
the concentrations measured in Midlothian; therefore, exposure to these
contaminants would not be expected to result in adverse health effects.
Response: . . . therefore, exposure to these contaminants would not be
expected to result in adverse health effects. Any respectable scientist
would question and challenge whether data reviewed represents true and
complete emissions and community exposure. Unless you can assure that
the data reviewed accurately captures emissions and reflects community
exposure, a statement like ``. . . therefore, exposure to these
contaminants would not be expected to result in adverse health
effects'' is without a solid scientific basis.
2. Health based screening values were not available for 87 contaminants
(59 VOCs and 28 metals or other inorganic compounds). Additional
information is needed to determine the public health significance of
these contaminants.
Response: We appreciate that you acknowledge screening values were not
available for a large number of regulated contaminants.
3. Thirteen VOCs had one or more measured level above the most
protective health-based screening value. Three of the VOCs (1,1,2-
trimethylbenzene; 1,3,5-trimethylbenzene; and m- and p-xylene) had one
or more level above the most conservative contaminant-specific non-
cancer screening value. Ten of the VOCs (benzene; 1,3-butadiene; carbon
tetrachloride; chloroform; 1,2,-dibromoethane; 1,2-dichloroethane;
methylene chloride; 1,1,2,2-tetrachloroethane; 1,1,2-trichloroethane;
and vinyl chloride) had one or more level above the most conservative
contaminant-specific cancer screening value.
Response: Statements like ``. . . had one or more level above the
most conservative contaminant-specific cancer screening value . . .''
although technically true, sound so trivializing, especially when the
data shows that benzene levels exceeded this ``most conservative
screening value'' over 97 percent of the time.
Again, the only issue is not just what you found. We remain
concerned about what may not have been identified due to the inadequacy
of data due to the placement of the monitors. Comment in #1. above
applies here.
4. Fourteen metals or other inorganic compounds had one or more
measured level above the most protective health-based screening value.
Four of the metals or other inorganic compounds [chlorine
(PM2.5), lead (TSP), manganese (TSP), and
manganese (PM10)] had one or more level above the most
conservative contaminant-specific non-cancer screening value. Ten
metals [arsenic (PM10), arsenic
PM2.5), arsenic (TSP), beryllium
(PM10), cadmium (PM10), cadmium
(PM2.5), cadmium (TSP), chromium
(PM10), chromium (PM2.5), and chromium
(TSP)] had one or more level above the most conservative contaminant-
specific cancer screening value.
Response: The response to item #1 above also applies here. Metal
speciation based on PM2.5 and PM10
does not adequately capture true levels of metals in the ambient air.
The last year metal speciation was based on TSP was 1998.
Individual Contaminants--Non-Cancer Health Effects Evaluation
Using reasonable maximum exposure scenarios, only manganese (both
as PM10 and as TSP) exceeded ATSDR's chronic inhalation MRL
by a small margin. After an in-depth review of the toxicological
information and the uncertainty factors used in deriving the chronic
inhalation MRL, we concluded that it is highly unlikely that the
manganese levels seen in Midlothian would result in any observable
adverse health effects, even after long-term exposure.
Response: The response to item #3 above also applies here.
Individual Contaminants--Cancer Health Effects Evaluation
Exposures Prior to 1982:
Based on ambient air samples collected prior to calendar year 1982,
the estimated excess lifetime cancer risks associated with reasonable
maximal exposure to arsenic (TSP), cadmium (TSP), and chromium (TSP)
ranged from 5.38x10-5 (a total of 1 excess cancer
in 18,597 people exposed for 70 years) to 9.30x10-5
(a total of one excess cancer in 10,748 people exposed for 70 years).
If these exposures were to continue for 70 years, they would pose a low
increased lifetime risk for cancer and would not be expected to result
in measurable harmful health effects. Past exposures to these compounds
(prior to 1982) therefore posed ``no apparent public health hazard.''
Response: ``Based on exposures prior to 1982 . . .'' Are you referring
to the 1981 monitoring at site 0001 (City Hall roof)? If yes, then this
should be stated as thus. Also, do you believe, based on prevailing
wind patterns, this monitor was adequately situated to capture true
emissions from Ash Grove, TXI and Chaparral Steel? It should be pointed
out: 1) that ambient air data prior to 1982 was limited to 1981 and was
scarce (practically non-existent) since monitoring for most heavy
metals and VOCS was not done and 2) there is insufficient data to make
an informed statement regarding public health impact. And why would we
say, ``. . . and if these exposures continue . . .'' when we know they
did not!--We know that population, industry, production, mobile
sources, etc. increased.
Exposures 1982 through 1992:
This time span should not have been omitted. It should be noted
that for a critical six-year period ambient air data for heavy metals
and VOC's is missing. This period is of particular concern to the
community because Ashgrove unsafely burned hazardous waste derived fuel
(HWDF) from 1986 to 1992. It was not until after Ashgrove's ``trial
burn'' in 1992 that it was determined that this facility could not
safely burn HWDF. Holcim went online in 1987. Also, during this period
EPA issued citations to TXI for violations involving hazardous waste
burning.
Exposures 1993 through 2005:
In the entire history of air monitoring in Midlothian, site 007
(Tayman Drive) was the only site in a prevailing wind pattern that had
the potential to facilitate capturing data from all industries. There
is no data from this site for metals. Data was collected only for 1993-
1997. A large number of samples were collected upwind of all the
industries at CAMS-94. Averaging in readings from CAMS-94 when the wind
is blowing out of the south only serves to dilute the true impact.
Ongoing Exposures:
It would be prudent to ask what monitoring is currently taking
place. Are the sites in position to collect data that accurately
reflects true public impact from all sources? The response may give
insight to TCEQ's intent and attitude regarding public health.
Overall Conclusions
We found that the majority of the risks associated with exposure to
the chemicals analyzed in this health consultation were low. However,
we are classifying this site as an Indeterminate Public Health Hazard
because further information is needed to fully characterize the extent
of the public health hazard posed by air contaminants in Midlothian.
This classification is based on the following facts:
Overall Response to this section:
Response: We truly appreciate the fact that it was recognized that
insufficient data exists to make a solid conclusion whether a public
health hazard does or does not exist. It is quite evident (through no
fault of ATSDR or TDSHS) that the collection of data to assess public
health or to capture a complete picture of emissions and true public
impact was not a factor in the placement of air monitoring stations.
Consequently, the data is insufficient and inadequate for this purpose.
Adequate data does not exist that would permit TDSHS to make a sound
analysis that would warrant a call in either a safe or unsafe
direction. Thus, it is quite disconcerting that an effort was made to
assess public health impact to any degree. This serves only to
discredit ATSDR's and TDSHS' purported mission to protect public
health.
Again, it is not our intent to insist a public health problem be
identified if one does not exist. However, it was our hope that all
conclusions or statements derived regarding the community's public
health would be based on the recent and developing science and on solid
data appropriate to identifying real public exposure.
1. Sixteen out of 59 VOCs and two out of 28 metals or other inorganic
compounds for which health-based screening values were not available
had average levels above average background (levels obtained from other
areas in Texas and/or the U.S.). Additional information is needed to
determine the public health significance of these contaminants.
2. While individual contaminants produced, at most, a low increased
lifetime risk for cancer and no apparent public health hazard, under
the aggregate exposure scenario, total excess lifetime cancer risk for
all cancers combined could be interpreted as posing a public health
hazard. However, this conclusion is based on the assumption that all
the chromium detected in the air is of the most toxic form [i.e.,
chromium (VI)], an assumption that is inconsistent with information
obtained from other areas of the state. The relative proportions of
chromium (III) and chromium (VI) will need to be determined in order to
accurately define the risk estimate for total cancer (all sites
combined).
3. While this health consultation reviewed the majority of the
contaminants measured in Midlothian air (119 VOCs and 108 metals and
other inorganics), EPA's NAAQS compounds still need to be evaluated in
a future consultation.
4. There are data gaps both in sampling locations and parameters of
interest. No air data for the analysis of VOCs were collected prior to
1993. Air data for the analysis of metals and other inorganic compounds
were collected at only one location from 1981 through 1984. No air data
for these contaminants were collected prior to 1981 and none were
collected between 1985 and 1992. For the time periods when air data
does exist, data were collected from a limited number of monitoring
stations and may not reflect conditions throughout the community. (2)
However, since the major monitoring locations were relatively close to
one or more of the primary emission sources, we do not anticipate that
air pollutant levels for much of the city would be too much higher than
those observed.
Response:
(1) You are right to assert ``. . . data was collected from a
limited number of monitoring stations and may not reflect
conditions throughout the community,'' because it definitely
does not. The only monitoring site capable of collecting
emissions from all sources was 0007 on Tayman Drive and its
data limitations are quite obvious.
(2) ``Relatively close'' does not suffice. Monitor placement
in relationship to both the source(s) and wind rose patterns
should be the criteria. Other than Tayman Drive (site 007), no
monitors were ``close to'' or in a prevailing wind pattern to
adequately capture emissions from Ashgrove and Holcim. Most of
the metals were monitored at CAMS-94 (site 0015) which is
upwind from all sources. Based on the wind rose patterns this
is the one spot that is least likely to capture data
representative of local emissions. The second site (based on
the wind rose patterns) least likely to capture emissions is
CAMS-302 which is west of TXI/Chaparral Steel and south of the
other industries. The majority of the VOC's were collected at
site 0015 and 0016. Site 0016 is south of Holcim and Ashgrove
and again (based on prevailing winds) not in an ideal location
to capture emissions from Ashgrove or Holcim. TSP monitoring
for metal speciation was limited before 1998 and non-existent
after 1998.
Recommendations
We have made the following recommendations in response to these
findings:
1. As resources allow, research the toxicology literature for
contaminants measured in Midlothian air for which health-based
screening values were not available, and determine the potential public
health impact of exposures to these substances.
2. Collect additional ambient air samples from previously sampled
locations to determine the specific distribution of chromium species
and to refine the risk estimates for this contaminant.
Response: Since previously sampled locations were obviously not
optimally situated to capture true emissions, is there some logic to
limiting collection to the previously sampled site?
3. Evaluate the levels of EPA's NAAQS compounds in the continuous air
monitoring data.
Response: Although we appreciate your efforts, if data was
collected at CAMS-94, which is obviously not in an ideal position to
capture true emissions from the industries, of what value would it be
when assessing public health impact? It would just be another exercise
in futility. Also, it is not possible to determine a community's true
lead impact from ambient air based on anything other than TSP readings.
4. Where possible identify and fill data gaps with additional data
from TCEQ to identify any additional air contaminants that might need
evaluation and/or sampling.
Response: This report has surfaced deficiencies in the system that
should already have been identified by TCEQ. Before we proceed to
identify additional air contaminants that need evaluation we need to
get a firm handle on the ones that have already been identified.
Current TCEQ monitoring does not give an accurate picture of total
emissions and public impact. If public health is a concern, and if
there is a serious intent to assess community impact, a methodology
based on wind rose patterns, terrain, emission sources, populace, etc.,
needs to be scientifically devised and implemented.
Actions Completed
Historically, the TCEQ has collected a vast amount of environmental
data in Midlothian, Texas, including air monitoring samples, soil
samples, vegetation samples, and others dating back to the early
1980's.
Response:
(1) Historically TCEQ has shown that this agency's ties and
loyalty lies with industry and that public health cannot be
allowed to trump economic welfare. The lack of monitoring sites
placed in and around Midlothian as a result of a methodology
scientifically based on prevailing winds, major emissions
sources, populace, etc., testifies to this. This brings us to
problems faced in this consultation--data that does not measure
true impact of emissions--data deficient for assessing public
health. One can only presume this was part of the design.
(2) The Evaluation of the Screening Risk Analysis for the
Texas Industries Facility in Midlothian, by Dr. Stuart
Batterman, et al., points out that the monitoring system was
deficient considering the scale of industry and waste
combustion. Furthermore this evaluation documents
inconsistencies and deficiencies/omissions in many of the
emissions and soil sampling/analyses. TCEQ was criticized for
its tendency to go far beyond what is scientifically
supportable by the existing data in making sweeping
generalizations regarding the present and future safety of
waste combustion in Midlothian. This document was submitted
with the petition and should have been a factor in the analysis
of data quality/adequacy of the TCEQ data.
2. Earlier data were analyzed by the TCEQ using EPA methodology and
TCEQ's screening levels [4, 10].
Response: Again, refer to The Evaluation of the Screening Risk Analysis
for the Texas Industries Facility in Midlothian, by Stuart Batterman,
et al. This was part of the petition package and part of the evidence
submitted. It should not have been ignored. It critically reviews the
documents referred to here [4, 10]. This evaluation points out TCEQ's
failures at times to use EPA methodology. It sheds a light on serious
omissions, inconsistencies, selective use of critical data; sampling
times, techniques and locations inappropriate to characterize impact;
meteorological and other data not presented to interpret monitoring
data; advance notice given to industry prior to ambient air monitoring,
etc.
3. DSHS staff reviewed summarized monitoring data (1993 through 1995),
attended numerous meetings with TCEQ staff and area residents, and
distributed questionnaires to see if there were consistent reports of
odors, or signs or symptoms of illnesses that might be related to
environmental pollution.
Response: See our response below under Past Environmental Sampling and
Data Review regarding actions and results of TDSHS involvement during
this period.
4. The Texas Cancer Registry analyzed cancer morbidity and mortality
data for Midlothian and Ellis County, looking for any significant
increases in cancer rates in this area over the period 1993 through
2002.
5. The Texas Birth Defects Registry analyzed birth defect data for
Midlothian, Ellis County, and Health Service Region 3, looking for any
significant birth defect elevations during the period 1999 through
2003.
6. ***
7. DSHS staff obtained detailed (not summarized) TCEQ air monitoring
data from 1981 through 1984 and from January 1993 through March 2005 in
an electronic format and created a database of monitoring results. With
the completion of this health consultation, DSHS has analyzed this data
for VOCs and metals or other inorganic compounds and compared these
data to health-based screening levels published by ATSDR and EPA. A
conservative exposure scenario was generated, and carcinogenic and non-
carcinogenic risk estimates were calculated, assuming 70-year lifetime
and/or chronic exposures at the *reasonable maximal exposure levels
seen in the Midlothian area.
Response: Sufficient data was not available to adequately determine
``reasonable maximal exposure levels seen in the Midlothian area.''
Actions Under Way
***
Actions Planned
1. DSHS and ATSDR will make this health consultation available to the
public, local industries, the local government, and State and federal
health/environmental agencies.
2. DSHS and ATSDR will continue to address the community's health
concerns relating to air quality.
Response: ``Continue . . .''? The only way to credibly address a
community's health concerns relating to air quality is to have an
adequate air monitoring system truly representative of air emissions to
which the community is exposed. A scientifically devised system based
on a methodology that incorporates prevailing winds as they relate to
emission sources, terrain, populace, etc. has never been in place in
Midlothian. More of the same is of little value.
3. ***
4. DSHS will discuss with TCEQ the potential for determining the
specific distribution of chromium species in Midlothian air. Hopefully
we will get a complete picture of the true emissions first.
5. DSHS will discuss with TCEQ the potential for identifying and
filling data gaps and identifying any additional air contaminants that
might need evaluation and/or sampling.
This community needs an adequate air monitoring system that is
based on a scientific methodology designed to capture the total
emissions as they impact the community. Then, and only then will our
health agencies be able to make a viable evaluation as it relates to
public health.
6. DSHS will complete the analysis of the hourly NAAQS data. If this
data was collected at upwind monitoring stations situated where the
majority of emissions will be missed, this will be an exercise in
futility. Also, unless data was collected at a site(s) where (based on
prevailing wind) true emissions from all sources are captured it will
be of little value in assessing impact on public health.
Appendix D--Birth Defects and Cancer Registries Report Summaries
Birth Defects Registry Report Summaries
A Down syndrome cluster investigation released in 1996 reported
that the number of Down syndrome cases in Ellis, Hood, and Somervell
Counties among deliveries in 1992 through 1994 was 3.4 times higher
than expected based on statewide rates [74]. Those results, which
included adjustment for maternal age, were statistically significant at
the 95 percent level. While that study did not provide evidence that
environmental factors were associated with the excess occurrence of
Down syndrome cases, its ability to do so was limited.
Response: We take this as a statement that the environment could not be
ruled out. We agree with this fact. Also, are we talking about three
separate clusters here that occurred in Public Health Region 3 during
the same period?
In response to a citizen request, the DSHS Texas Birth Defects
registry completed an additional review of birth defects registry data
in June 2005 [75]. They examined the occurrence of 48 specific types of
birth defects as well as ``any monitored birth defect'' among
deliveries to residents of Midlothian, Venus, and Cedar Hill over the
period from 1997 through 2001 and compared those rates to the state as
a whole (1999 through 2001). Adjusting for maternal age, the prevalence
rate for the occurrence of one type of birth defect related to urinary
tract development (hypospadias or epispadias) was approximately 3.7
times higher than the prevalence rate observed for Texas (1999 through
2001). Adjusting for maternal race/ethnicity, the prevalence rate for
hypospadias or epispadias was approximately 4.2 times higher than the
prevalence rate observed for Texas (1999 through 2001). These results
were statistically significant at the 95 percent level. Similarly, the
prevalence of any monitored birth defect among Midlothian residents
(1997 through 2001), adjusted for maternal age, was 1.5 times the
prevalence rate for Texas (1999 through 2001), and the result was
statistically significant at the 95 percent level. However, adjusting
for maternal race/ethnicity, caused the prevalence ratio to drop to
1.2, and the result was no longer statistically significant. It is not
clear what effect if any the different time periods for data inclusion
in Midlothian vs. Texas may have had on the birth defect prevalence
rates.
In response to additional inquiries in August and October 2006,
DSHS Texas Birth Defects registry completed an additional review of
birth defects registry data in November 2006. They examined the
prevalence of total birth defects as well as 48 specific types of birth
defects in the 11 Health Service Regions of Texas over the period from
1999 through 2003.
The standardized prevalence ratio (SPR) for any monitored birth
defect, adjusted for maternal age and race/ethnicity, in Health Service
Region 3 (which includes Ellis County and 18 other counties in the
Dallas-Fort Worth area) was found to be 18 percent higher than the
state as a whole, and those results were statistically significant at
the 95 percent level. Specific defects found to be significantly
elevated at the 95 percent level included hypospadias/epispadias
(SPR=1.14), obstructive genitourinary defects (SPR=1.11), microcephaly
(SPR=1.31), and craniosynostosis (SPR=1.33). [Pyloric stenosis was
significantly lower in Health Service Region 3 than Texas as a whole
(SPR=0.84). What is not mentioned here is that of all the eleven Health
Service Regions in Texas, Public Health Region 3 continues to reflect
the highest birth defect rate.
The maternal age and race/ethnicity adjusted prevalence rate (per
10,000 live births) for total birth defects in Ellis County was 483.66
compared with 360.70 in Texas as a whole (SPR=1.34); these results also
were statistically significant at the 95 percent level. Out of 48
specific birth defects (after adjustment for maternal age and race/
ethnicity), only craniosynostosis (SPR=3.61) was significantly elevated
in Ellis County with respect to Texas as a whole.
We assume you are referring to the cumulative average rates for
periods 1999 through 2003. An interesting point that should be made
here is that in 2002 the unadjusted prevalence for birth defect rates
in Ellis County (689.1) was 186 percent that of Texas (370). In 2002
Ellis County also had the highest birth defect rate in Public Health
Region 3.
Cancer Registry Report Summaries
The Texas Department of State Health Services completed cancer
incidence and/or mortality investigations . . .. The incidence and
mortality of the other cancer types were not significantly different
than what would be expected when compared to the rest of the state.
Response: This report made a comment that the higher birth defect rates
in Health Service Region 3 and Ellis County may be due to the
difference in reporting practices. Should not the same logic be applied
here to the cancer rates. Since, the cancer surveillance depends on the
good will of the health providers, is it not possible that there is a
difference in reporting practice in the rural areas such as Ellis
County and your picture of cancer case may not be complete?
Past Environmental Sampling and Data Reviews
Air monitoring data were collected every six days for a variety of
metals and other inorganic constituents of particulates in the
Midlothian area sporadically from 1981 to 1984 in accordance with the
national schedule. Samples were collected from the roof of the City
Hall on North 8th Street and were analyzed for approximately 30
different parameters including total suspended particulates (TSP)
adjusted for standard temperature and pressure (STP). No air data were
available for the time period from January 1985 through December 1992.
In 1991, the TNRCC initiated an environmental monitoring program in
and around Midlothian to evaluate soil, vegetation, slag, and stack
emissions for 18 different metals and/or polychlorinated dibenzo-p-
dioxins (PCDDs) and dibenzofurans (PCDFs). Of the 175 soil samples
collected between 1991 and 1995, one sample exceeded the TNRCC's soil
screening level for lead (400 ppm), and six out of 140 soil samples
exceeded the TNRCC's soil screening level for arsenic (20 ppm).
Measurements for all other soil metals were below their respective soil
screening levels.
Response: So based on tests taken 17 years ago, excessive lead and
arsenic were identified in the soil? What were the PCDD levels? This
paragraph is silent regarding findings in stack emissions. Refer to
Batterman, et al., Sections 5.2-5.3.1 analysis of these soil sampling.
See Section 4.3.9 Dioxin/furans. These sections all point out
questionable quality assurance/quality control and raises questions
regarding discrepancies between various soil sampling techniques and
discrepancies in airflow and temperatures during stack testing for
dioxins/furans, etc.
Additional samples were collected in the vicinity of Chaparral
Steel. Results from these samples show that two out of 22 soil samples
collected just outside of the Chaparral property line exceeded the
TNRCC's soil screening level for lead (400 ppm), and one out of 22 soil
samples exceeded the soil screening level for cadmium (40 ppm) [4, 10].
All other soil metals were below the TNRCC's respective soil screening
levels.
Response: So excessive levels of lead and cadmium were identified in
the soil.
Among 60 soil samples tested, the Toxicity Equivalency Quotient
(TEQ) for PCDDs and PCDFs ranged from 0.3-17.9 parts per trillion
(ppt); all were below the ATSDR's health-based soil guidance level of
50 ppt.
Response: It appears that dioxin was identified in all 60 soil samples.
Dioxin is the deadliest of all man-made chemicals. There is no known
safe level for dioxins--what is ATSDR's basis for deeming a ``safe''
level? How is PCDD's synergistic effects and the endocrine disrupting
factor calculated into this ``safe level''?
Slag (a by-product of steel production) samples were collected and
analyzed for 13 different metals; none exceeded their respective soil
screening levels.
As part of the Chaparral Steel special study, hay, wheat, and other
vegetation samples were collected from the fields surrounding the steel
mill. With the exception of aluminum, cadmium, and iron in samples
collected in the field immediately south of Chaparral, all measured
metal concentrations were below their respective maximum tolerable
levels for cattle.3
Response: So an issue with aluminum and cadmium and iron
surfaced? What about lead?
A letter regarding this study from Dr. Lund dated September 22,
1994 states: ``Soil samples collected from the hay field contained
elevated levels of cadmium, manganese, and lead. Cadmium, manganese,
and lead levels exceeded the human soil ingestion comparison values by
up to 2.1, 1.1, and 6.2 times respectively. Human ingestion of soil
from the hay field with the measured metal concentrations may result in
adverse health effects. In addition to exposure through hay and
vegetation consumption, animal ingestion of soil during grazing may
increase the total metal exposure in the animal.
This letter also indicates eight additional hay-bale samples (four
0-3 inch depth samples and four 3-6 inch depth samples were collected
from the rows of hay-bales stored at site #8. The results show that
iron, manganese, cadmium, lead and titanium levels in surface samples
(0-3 inch depth) were significantly greater than samples collected from
three to six inches within the hay bales. These results suggest aerial
deposition of the metals.
Stack samples were collected from all three cement manufacturing
facilities while they were burning different combinations of coal,
HWDF, and/or tire-derived fuel. The total 2,3,7,8-
Tetrachlorodibenzodioxin (TCDD) Toxicity Equivalency Quotient (TEQ)
concentrations estimated for each of the test conditions were all below
the TNRCC's screening levels.
Response: Again, TCDD is the deadliest of all man-made chemicals. There
is no known safe level for dioxins--what level does TCEQ (TNRCC) ESLs
deem acceptable.
Starting in 1993, the TNRCC began collecting air samples for VOCs,
particulates, metals, and other inorganic compounds from various
locations or Continuous Air Monitoring Stations (CAMS) around the city
as follows (see Appendix E, Tables 1a & 1b and Appendix C, Figure 2):
Tayman Drive (Site 0007): PM10 Total Particulates (0 to
10 mm), 1993 through 1996 (231 results) Metals & Inorganic Compounds,
None VOCs (78 species), 1993 through 1997 (11,135 results)
CAMS-94 (Site 0015): PM10 Total Particulates (0 to 10
mm), 1994 through 2004 (690 results) PM2.5 Fine
Particulates (0 to 2.5 mm), 2002 through 2004 (157 results) Metals &
Inorganics in PM2.5 (52 species), 2002 through
2004 (8,164 results) VOCs (98 species), 1999 through 2005 (22,955
results)
CAMS-52 (Site 0016): PM10 Total Particulates (0 to 10
mm), 1994 through 2004 (685 results) Metals & Inorganic Compounds, None
VOCs (99 species), 1997 through 2004 (34,842 results)
CAMS-302 (Site 0017): PM10 Total Particulates (0 to 10
mm), 1999 through 2004 (262 results) Metals Inorganics in PM10
(24 species), 2001 through 2004 & (4,344 results) VOCs (97 species),
2004 through 2005 (2,599 results)
Note: Tayman Drive (007) is the only location (based on prevailing
wind patterns) capable of capturing ambient air data representative of
public exposure. All others are upwind of Holcim and Ashgrove. CAMS-94
is upwind of all industries and metal speciation is based on
PM2.5 only. There does not appear to be any TSP
monitoring for metal speciation at any of these sites.
In 1996, the United States Environmental Protection Agency (EPA)
conducted a cumulative risk assessment using air modeling data based
upon estimated emissions for the industries in the area during 1985 and
1987 through 1990. In their report, no increased risk for developing
cancer or potential for developing non-cancer health effects were
identified above the EPA's regulatory standards for acceptable risk
[11].
Response: The EPA assessment was a theoretical mathematical model
conducted for regulatory purposes and should not be relied upon to
determine public health implications. This assessment was based on
estimated data that was already 6-11 years old when the report was
issued. How were permit violations factored in? Was Ashgrove's permit
violation and failed efforts at burning of hazardous waste in its wet
kilns factored in? Much has changed since 1990. Production has
increased. Types of fuels have changed. Incineration of hazardous waste
and tire-derived fuel has increased. Mobile emissions sources have
increased. Population has increased. Emissions have increased. Findings
are obsolete. Empirical data should trump any theoretical estimate.
Past DSHS and ATSDR Involvement and Data Reviews
(2) Between 1992 and 1995 TDH and ATSDR periodically evaluated the air
monitoring data collected in the Midlothian area and attended community
meetings. The majority of samples were below the (1) screening levels
considered to be health protective at that time [12]. (3) Although no
consistent pattern of symptoms or illnesses were noted among area
residents, there were common complaints among the residents about
sulfur odors and excessive dust. At the request of various citizens
groups, DSHS Birth Defects and Cancer Registries have analyzed data
from Midlothian, Venus, Cedar Hill, Ellis County, and Health Service
Region 3 to determine prevalence rates for various types of birth
defects and the standardized incidence and mortality rates for various
types of cancers in the aforementioned areas. Reports were written by
the respective registries and summaries of those reports are presented
in Appendix D.
(1) What do you know about screening levels now that you
didn't know then? It is noted that data available for review at
that time was very limited. However VOC collection on Tayman
Drive indicated that 94 percent of the benzene emissions
exceeded the CREG values and benzene emissions spiked to an
acute chronic inhalation RfC of 20.57 ppb in May 1995. Ashgrove
burned hazardous waste derived fuel (HWDF) from 1986 to 1992.
It was not until after the ``trial burn'' in 1992 that it was
determined that this facility could not safely burn HWDF.
Holcim went online in 1987. Also, it was during this period
that EPA issued citations to TXI for violations involving
hazardous waste burning. Refer to ``Cafeteria Talk'' below and
how this was trivialized.
(2) The results of these visits that culminated in the
infamous ``Cafeteria Talk'' presented November 2, 1995 at the
Midlothian Middle School Cafetorium was a source of extreme
frustration and disappointment for the community. It was not
just in the dismissive and condescending manner in which it was
presented with sweeping generalizations and statements not
apparently supported by science. (Statements like: ``Contrary
to some of the claims you may have heard . . . dioxin exposure
is not a significant health risk in Midlothian.'' ``ESLs are
generally 100 fold or more lower than the LOAEL.'' ``If it has
been determined that environmental pollutants in an area are
not consistently elevated into a range expected to cause
adverse health-effects, then it is a foregone conclusion that
differences in disease prevalences cannot be validly attributed
to environmental pollution.'' ``After 120 years of study, there
are no reports in the medical/scientific literature linking
Down Syndrome to any sort of chemical exposure or industrial
pollution.'')
What was even more frustrating was that the community's concerns
regarding lack of adequate monitoring and health problems surfacing in
both the people and the livestock were trivialized. Results of a poorly
designed and analyzed questionnaire was embraced to rule out the
alleged asthma and breathing problems while the only peer-reviewed
study, The Health Effects of Living Near Cement Kilns: A Symptom Survey
in Midlothian showing a higher incidence of respiratory problems in
Midlothian was totally ignored. A poorly executed and failed Animal
Health Survey (which incidentally did surface breeding problems) was
abandoned as a failure. The eagerness to place emphasis on the negative
and the dismissiveness of potential links was very worrisome.
Troubling are statements made during this ``Cafeteria Talk'' (like:
``The TNRCC's environmental sampling program in Midlothian has been
unprecedented!'' ``Never before in history has the Agency, or its
predecessor, the Texas Air Control Board collected so many
environmental samples, from so many different media, from so many
sampling locations, analyzing for so many different compounds and
finding so few of even the mildest of health concerns.'') This is
troubling, not only from the perspective that the review of the
environmental data (especially the air monitoring data) reveals
significant gaps and deficiencies that should have been obvious then.
But, what is most troubling and of great concern is whether the author
of this ``Cafeteria Talk'' could develop and maintain sufficient
objectivity to adequately evaluate the currently available data and
arrive at objective scientific conclusions without bias in this current
public health consultation.
(3) It was acknowledged that levels of sulfur compounds were
``on occasion'' above the odor threshold levels. The complaints
regarding excessive odors (not given credence then) were
substantiated.
Methods Used in This Consultation
Because of the diversity of the health and environmental concerns
and the volume of data available for the Midlothian area, several
health consultations will be needed to address these concerns. In this
consultation we reviewed available air monitoring data with respect to
volatile organic compounds (VOCs), metals, and other inorganic
compounds. Subsequent consultations are planned to address EPA's
National Ambient Air Quality Standards (NAAQS) compounds and (*)
consideration of wind patterns and other weather data. Additional
consultations may be added based on the results of these analyses.
Response: *This holds promise. This same consideration/logic should be
applied to the data analyzed for this report.
Environmental Data
We reviewed air monitoring data collected by the TCEQ in the
Midlothian area from 1981 through 1984 and from January 1993 through
March 2005. Air data were not available prior to 1981 or between
January 1985 through December 1992. These data, collected every six
days in accordance with the national schedule, include 119 VOCs
collected from four different monitoring locations and 108 particulate
and metal parameters collected from 13 different sampling locations
(most data were collected from six locations) in and around Midlothian.
Current sampling locations and historical sampling sites are shown in
Appendix C, *Figures 1 and 2. Monitoring site locations and the number
of measurements made for VOCs and for metals/inorganic compounds at
each site are shown in Appendix E, Tables 1a and 1b, respectively.
Response: See our prior remarks regarding adequacy of monitoring sites
to capture complete emissions. *Reference figure 2. The ``artist'' that
overlayed this aerial photo with king-size pictures of canisters should
be complimented with his ability to create an illusion. At first
glance, one is inspired by what really looks like heavy monitoring in
most of the critical spots is taking place. Unfortunately a review of
the actual air monitoring data and what each of these ``canisters''
represents, burst the bubble.
Quality Assurance/Quality Control
We obtained detailed (not summarized) ambient air quality data that
TCEQ collected in the Midlothian area from May 1981 through March 2005.
In preparing this report, DSHS/ATSDR relied on the data provided to us
by the TCEQ and (1) assumed adequate quality assurance/quality control
(QA/QC) procedures were followed with regard to data collection, chain
of custody, laboratory procedures, and data reporting. (2) For the
purpose of analysis, concentrations reported as ``ND'' (or not
detected) were assigned numerical values equal to one half the
detection limit for the compound.
(1) Assuming QA/QC is a leap of faith especially when it comes
to public health issues versus industrial welfare.
(2) When direction of wind and fallout patterns would not
support a reading other than a possible non-detect, the non-
detect readings should have been discarded. Including them only
serves to dilute true concentrations and distort findings. This
is true even with uncustomarily low concentrations reflected on
days when (based on wind direction) a true measurement cannot
be expected.
Health-Based Assessment Comparison (HAC) Values
Media-specific health-based assessment comparison (HAC) values for
non-cancer health effects are generally based on ATSDR's minimal risk
levels (MRLs), EPA's reference doses (RfDs), or for air, EPA's
reference concentrations (RfCs). MRLs, RfDs, and RfCs (1) all are based
on the assumption that there is an identifiable exposure dose for
individuals including sensitive sub-populations, such as pregnant
women, infants, children, the elderly, or the immuno-suppressed, that
is likely to be without appreciable risk for non-cancer health effects
even if exposure occurs for a lifetime [13].
When a substance is listed as a carcinogen, the lowest available
HAC value usually proves to be the cancer risk evaluation guide or
CREG. CREGs are based on EPA's chemical specific cancer slope factor
(CSF) and represent the concentration [for airborne contaminants,
usually expressed as micrograms per cubic meter (mg/m3)]
that would result in a daily exposure dose [expressed as milligrams per
kilogram per day (mg/kg/day)] and theoretical lifetime cancer risk
level of one additional cancer case in one million people exposed (a
risk of 1x10-6), assuming a 70 kg person breathes
an average of 20 cubic meters (m3) of air per day over a 70 year
lifetime [13].
Response: This does not appear to be true of all constituents. Take
lead for example. An exposure dose that is likely to be without
appreciable risk for health effects (even for short periods of time--
such as the ``window of vulnerability for the fetus'' or for a child in
his first few years of life) has not been identified. A provisional
RfC) 0.375 mg/m3 was created for evaluating lead based on a
long-ago outdated level (quarterly average) 1.5 mg/m to protect a long-
ago outdated once acceptable blood lead level of 30 mg/dl. In addition
a blood lead level of 10 mg/dl was used as a comparative value of
safety when all reputable science and even CDC say it is not an
acceptable level of lead poisoning.
According to the Office of Air Quality Planning and Standards
(OAQPS) final staff paper, evidence of a differing sensitivity of the
immune system to Pb across and within different periods of life stages
indicates a potential importance of exposures as short as weeks to
months duration. For example, the animal evidence suggests that the
gestation period is the most sensitive life stage followed by early
neonatal stage, and within these life stages, critical windows of
vulnerability are likely to exist.
OAQPS final staff paper indicates (based on peer-reviewed
scientific studies) that for neurological effects on the developing
nervous system), no threshold levels can be discerned from the
evidence. OAQPS concludes, ``Thus, to the extent one places weight on
risk estimates for the lower standard levels, we believe these risk
results may suggest consideration of a range of levels that extend down
to the lowest levels assessed in the risk assessment, 0.02 to 0.05 mg/
m3.''
OAQPS states: ``In conclusion, staff judges that a level for the
standard set in the upper part of our recommended range (0.1-0.2 mg/
m3), particularly with a monthly averaging time) is well
supported by the evidence and also supported by estimates of risk
associated with policy-relevant Pb that overlap with the range of IQ
loss that may reasonably be judged to be highly significant from a
public health perspective, and is judged to be so by CASAC. A standard
set in the lower part of the range would be more precautionary in
nature in that it would place weight on the more highly uncertain range
of estimates from the risk assessment.''
In general, comparison values are derived for substances for which
adequate toxicity data exist for the exposure route of interest. All
substances were evaluated as if inhalation was the only exposure route.
Breathing is not the only exposure route for toxins in ambient air to
enter the body. Toxins in the air are also absorbed by dermal exposure
and ingestion. This is especially relevant to toxins that are
persistent in the environment and are continually re-suspended.
Comparison values may be available for up to three different
exposure durations: acute (14 days or less), intermediate (15 to 365
days), and chronic (more that 365 days). Usually, HAC values based on
long-term exposure guidelines are lower (more conservative) than HAC
values based on short-term exposure guidelines. Thus, the initial
screen usually involves comparing each discrete (i.e., short-term)
contaminant level with a HAC value based on a long-term exposure
guideline. What is the acute, intermediate or chronic long-term
exposure for a fetus and its critical ``windows of vulnerability''?
Health-Based Screening
Estimation of Long-Term Exposure Levels
Nearly all air samples collected for the measurement of VOCs,
metals, and other inorganic substances have come from four primary
sampling locations (1) (sites 0007, 0015, 0016, and 0017). Site 0007 is
approximately 1.2 miles northeast of Ash Grove and 1.6 miles northwest
of Holcim. Sites 0015, 0016, and 0017 are approximately 1.6 miles
south, 1.5 miles north, and 1.2 miles northwest of the TXI/Chaparral
facilities respectively (see Appendix C, Figure 2 and Appendix E,
Tables 1a & 1b). (2) Some Midlothian neighborhoods are located within
1-1.5 miles of one of the major industrial facilities but most are
farther away. (3) Since emission levels tend to drop off with distance
from the emission source, we expect the levels measured at the 4
primary sampling locations to be fairly representative of the upper
range of levels to which the majority of the residents of Midlothian
would be exposed. Of course individual exposure concentrations will
vary from day-to-day due to changes in emission levels, wind speed and
direction, and the movement of people around the city. (4)
Consequently, we have averaged the sample results from all monitoring
sites together to give the best approximation of the average
concentration to which Midlothian residents may have been exposed over
extended periods of time.
Response: It appears these sites were established in response to needs
other than monitoring public health impact.
Tayman Drive (Site 07) was the only monitor logically placed to
capture emissions from all industries and is the only monitoring site
that was in a prevailing wind pattern capable of capturing most
emissions from Holcim and Ashgrove. Unfortunately this data is 10 to 15
years old and is not reflective of current exposure. Industrial
activity has increased significantly since this data was collected and
tire derived fuel and other hazardous materials have been added to the
mix. Metals and inorganic compounds were not sampled here. The majority
of the data for metals was taken upwind from all the industries (site
0015, CAMS-94). Site 302 (almost directly west of TXI) also is not in
line with prevailing wind rose patterns. TSP monitoring (sites 0001 and
0012) for metals was very limited (six out of the last 27 years) and
none in the vicinity of Ashgrove and Holcim. TSP monitoring ended in
1998.
Site 015 is upwind of the town, schools, and the majority of the
population. Furthermore, it is upwind from all industrial activity. The
site was selected as a background monitor for DFW because of its upwind
location and is not in a position to capture the majority of the local
emissions; however, it could be useful in determining what blows in
from the Houston area. Metals and inorganics were measured here for
only three years and these measurements were based on
PM2.5. The major contribution that data from this
site gives to this study is a dilution of all constituents evaluated
and a distortion of true public health impact.
Site 016 is in a position to capture some emissions from TXI and
Chaparral Steel, but rarely Holcim and Ashgrove. Unfortunately, metals
and inorganic compounds were not sampled here.
CAMS-302 (Site 0017). Placed almost directly west and just slightly
north. This site is not in a prevailing wind pattern for any of the
industries. Metals speciation was from PM10--no TSP monitor.
The argument ``. . . we expect the levels measured at the four
primary sampling locations to be fairly representative of the upper
range of levels to which the majority of the residents of Midlothian
would be exposed'' could hold weight: 1) if data was more
representative of emissions from all industries (specifically Holcim
and Ashgrove) and at monitoring sites established based on prevailing
wind; 2) if all data was simultaneously collected to represent the same
level of industrial activity for a given period; and 3) if there were
not so many inconsistencies in the data (example: metal sampling).
Furthermore, readings captured at CAMS-94 (and possibly CAMS-302)
should be disregarded when the wind is blowing out of the south. These
readings do not capture community exposure and generally serve only to
dilute true impact.
``. . . Since emission levels tend to drop off with distance from
the emission . . ..'' This is not true of all emissions. Some
constituents can stay aloft and travel for great distances and when and
where they come down depends on many variables. For many constituents,
it depends on what size PM to which they attach. Take lead (or any
heavy metal) for example. Lead attached to the larger particulate
matter (greater than PM10) has a tendency to settle in
closer proximity (depending on wind speed) to the source while lead
attached to PM2.5 becomes aerosol and can stay
aloft indefinitely and travel long distances. If you were analyzing
data collected on a TSP monitor, this statement could to some degree
hold more weight. Unfortunately no TSP monitoring took place at the
sites listed above.
``. . . Of course individual exposure concentrations will vary from
day-to-day due to changes in emission levels, wind speed and direction,
and the movement of people around the city.'' While this is true, some
locations are more heavily exposed to total emissions for longer
periods of time than others. Locations located closer to Holcim and
Ashgrove realize a higher impact of total emissions. Unfortunately,
monitoring adequate to capture these exposures is severely limited and
missing for many constituents (example heavy metals). There could be
some logic in evaluating impact on communities within 1.5 miles of the
individual monitoring sites--but only for those constituents that were
adequately monitored and tend to settle close to the emission site.
There are too many variances (created by time lapses, increases in
production and TDF increases, lack of metal analysis, limited data
capturing emissions from industries on north side of Midlothian, etc.)
in monitoring sites to average across the board.
``. . . Consequently, we have averaged the sample results from all
monitoring sites together . . ..'' Since when do people get exposed to
``averages''? People are exposed to whatever is in the air at the time.
What is the average ``window of vulnerability'' for a fetus?
Evaluating Exposure to Chemical Mixtures
While risk assessments often focus on identifying risks from single
contaminant exposures, real-life situations such as the one in
Midlothian involve the simultaneous exposure to multiple contaminants.
Consequently, in addition to assessing the risks associated with
exposure to individual contaminants, we also evaluated aggregate
exposures from multiple contaminants for the Midlothian area, both for
non-carcinogenic and for carcinogenic effects.
Simultaneous exposures to multiple chemicals may have additive
effects (where the combined effect is equal to the sum of the effects
of each agent alone), synergistic effects (where the combined effect is
greater than the sum of the effects of each agent alone), or
antagonistic effects (in which one substance interferes with the
effects of another producing a less toxic effect), when compared to a
single chemical exposure alone. In general, aggregate exposures to
multiple chemicals at levels below their thresholds for minimal effects
would, at most, be expected to produce a simple additive effect.
Consequently, aggregate exposures to multiple chemicals were evaluated
assuming an additive effect. It was also assumed that all compounds
contributing to the exposure were elevated in unison and that people
were exposed to all the chemicals at the same time.
Response: ``Consequently, aggregate exposures were evaluated assuming
an additive effect''? How does this tie in to your explanation of
synergistic effects? Does ``Consequently . . .'' mean consequently
synergistic effects are not real? The bottom line is that total
aggregate effects were not really evaluated unless you have ``assumed''
synergistic effects and endocrine disruption activity are not possible.
Chemical Mixtures and Non-Carcinogenic Effects
To estimate the potential public health significance of
simultaneous exposures to multiple chemicals, we tabulated all of the
critical effects for each contaminant listed by the EPA on the
Integrated Risk Information System (IRIS) database which were the basis
for deriving the RfD or the RfC. We also tabulated all of the critical
effects listed by the ATSDR in their Toxicological Profile series which
were the basis for deriving their inhalation MRLs. The 95 percent UCL
of the estimated average daily exposure dose was divided by the
appropriate health-based value to calculate the 95 percent UCL on the
Hazard Quotient (HQ) for a particular critical effect (e.g., CNS
effects, developmental effects, liver toxicity, etc.). HQs from
multiple contaminants known to produce critical effects of a similar
nature or on the same organ system were summed to arrive at the Hazard
Index (HI) for each critical effect as a result of exposure to the
chemical mixture. Aggregate exposures with an HI less than 1.0 were
considered to be without appreciable risk for adverse health effects.
Aggregate exposures with an HI greater than 1.0 were subjected to
further analysis to determine the potential public health significance.
Response: How are synergistic effects and endocrine disrupting activity
factored into this formula?
Chemical Mixtures and Carcinogenic Effects
To estimate theoretical excess lifetime cancer risks associated
with simultaneous exposures to multiple carcinogens, we tabulated all
of the cancer critical effects for each contaminant listed by the EPA
on the IRIS database which were the basis for deriving the IUR or the
oral slope factor (if applicable). For each contaminant, the 95 percent
UCL on the estimated average daily exposure was multiplied by the IUR
to calculate the theoretical lifetime risk of developing certain types
of cancer (e.g., lung, liver, kidney, etc.), assuming a continuous, 70-
year exposure. Risks from exposures to multiple contaminants known to
produce the same type of cancer were summed to obtain an estimate of
the total excess risk of developing that cancer as a result of exposure
to the chemical mixture. Finally, all of the individual cancer risks
were summed to obtain a cumulative cancer risk estimate. Aggregate
exposures with a cumulative cancer risk estimate less than
1x10-4 were considered to be without appreciable
risk for adverse health effects. Aggregate exposures with a cumulative
cancer risk estimate greater than 1x10-4 were
subjected to further analysis to determine the potential public health
significance.
Response: How are synergistic effects and endocrine disrupting activity
factored into this formula? If you have not factored in these two
facets, do you believe you have scientifically evaluated aggregate
exposures?
Child Health Considerations
In communities faced with air, water, or food contamination, the
many physical differences between children and adults demand special
emphasis. Children could be at greater risk than are adults from
certain kinds of exposure to hazardous substances. Children play
outdoors and sometimes engage in hand-to-mouth behaviors that increase
their exposure potential. Children are shorter than are adults; this
means they breathe dust, soil, and vapors close to the ground. A
child's lower body weight and higher intake rate results in a greater
dose of hazardous substance per unit of body weight. If toxic exposure
levels are high enough during critical growth stages, the developing
body systems of children can sustain permanent damage. Finally,
children are dependent on adults for access to housing, for access to
medical care, and for risk identification. Thus adults need as much
information as possible to make informed decisions regarding their
children's health.
Health-based assessment comparison values such as the MRLs, RfDs,
and RfCs used in this health consultation are all based on the (1)
assumption that there is an identifiable exposure dose for individuals
including sensitive sub-populations (such as pregnant women, infants,
children, the elderly, or the immuno-suppressed) that is likely to be
without appreciable risk for non-cancer health effects, even if
exposure occurs for a lifetime. Each of these HAC values employs an
uncertainty factor designed to account for human variability or
sensitive sub-populations, including children. (2) With regard to CREG
values and potentially increased carcinogenic risks for children, only
one of the carcinogens observed in Midlothian air (vinyl chloride) is
listed by the EPA as having a mutagenic mode of action. Using the
recommended additional age-dependent adjustment factors of 10 for
exposures occurring between birth and 2.0 years, and three for
exposures occurring between the ages of 2.0 and 6.0 years, we would
anticipate a 31.3 percent higher lifetime risk than that calculated by
conventional methods.
(1) This should read: ``Though there is evidence to the
contrary that an identifiable exposure dose of many toxins
exists for individuals including sensitive sub-populations
(such as pregnant women, infants, children, the elderly, or the
immuno-suppressed) that is likely to be without appreciable
risk for non-cancer health effects, even if exposure occurs for
a lifetime, we proceed in our assumptions as if there were.''
Note: prior discussions regarding lead. ATSDR has consistently
flown in the face of science by condoning a blood-lead level of
10 mgL as an acceptable level of lead poisoning though science
has established (and CDC concurs) that it is not.
(2) The point to this statement is obscure and the information
is confusing. Are you saying that cancer is the only issue of
concern for children? A large number of the toxins in
Midlothian air are known fetotoxins, neurotoxins, endocrine
disrupters, teratogens. Mercury, lead, arsenic, benzene,
cadmium, chromium have all been associated with mutagenic
effects. Safe levels for the fetus for most of these chemicals
has not been determined.
Other
On page 29 under Results
Carbon tetrachloride was detected at quantifiable levels in 711
(7.46 percent) of the 952 ambient . . .. Did you mean 74.60 percent--
appears to be a typo in both places within this paragraph.
ADDENDUM To Prior Comments Submitted February 3, 2008
Midlothian Area Air Quality Part I:
Volatile Organ Compounds & Metals
December 11, 2007
Prepared by Sal and Grace Mier, Midlothian, Texas
As addendum to February 03, 2008 Comments
Date: March 09, 2008
Suggestions:
For reasons outlined in our prior comments, air monitoring data
collected in Midlothian by TCEQ cannot be scientifically justified as
adequate to determine public health implications. Therefore, it is
suggested that Under Section Results and Discussions (starting on page
22 up through 67) all ``Public Health Implications'' based on this air
monitoring data be removed.
Response to Petitioner and Community Health Concerns (starting on page
5): All responses reflecting an analysis based on TCEQ air monitoring
data collected in Midlothian should be revised to reflect adequate data
was not available to arrive at a scientific conclusion.
General Findings (page 8) should reflect that TCEQ air monitoring data
collected in Midlothian was inadequate to arrive at a scientific
conclusion of public health impact of toxic emissions in the air. All
conclusions using TCEQ air monitoring data as a basis should be
deleted.
Individual Contaminants--Non-Cancer Health Effects Evaluation (page 9):
This section should reflect that TCEQ air monitoring data provided
insufficient data to evaluate non-cancer health effects. All analyses
based on TCEQ data should be deleted.
Individual Contaminants--Cancer Health Effects Evaluation (page 9):
This section should reflect TCEQ air monitoring data collected in
Midlothian was inadequate to arrive at a scientific conclusion of
public health impact of toxins in the ambient air. All analysis based
on TCEQ air monitoring data should be deleted.
Aggregate Exposures--Non-Cancer Health Effects (page 9): This section
should reflect that due to absence of critical data such as dioxin/
furans, VOCs, heavy metals (especially mercury and lead), questions
regarding critical windows of vulnerability, questions regarding
endocrine disruptive activity and the overall inadequacy of the air
monitoring data, aggregate exposures and the impact on public health
could not be scientifically evaluated.
Aggregate Exposures--Cancer Health Effects (page 10): This section
should reflect that due to absence of critical data such as dioxin/
furans, heavy metals (especially mercury and lead), questions regarding
critical windows of vulnerability, questions regarding endocrine
disruptive activity and the overall inadequacy of the air monitoring
data, aggregate exposures and the impact on public health could not be
scientifically evaluated. (Note: Estimate on cancer risks considering
only chromium (VI) is understated.
Overall Conclusions (page 10): Basis for classification of an
``Indeterminate Public Health Hazard'' should be revised to reflect all
deficiencies that preclude a scientific public health evaluation.
Inadequacy of TCEQ air monitoring data for assessing public health
precludes such statements as, ``We found majority of risks associated
with exposure to chemicals analyzed in this health consultation as
low.'' All conclusions and inferences relating to public health based
on the TCEQ air monitoring data should be removed.
1. Paragraph 1. It should be reflected that the number of VOCs
and metals exceeding background levels could be significantly
higher if adequate air monitoring data were available.
2. Paragraph 2. ``. . . Under the aggregate exposure scenario,
total excess lifetime cancer risk for all cancers combined
could be interpreted as posing a public health hazard . . .''
This scenario is understated by inferring that this
interpretation is based on the assumption that all chromium
detected in the air is chromium (VI). A major omission is the
impact of the deadliest of all man-made toxins--dioxins/furans.
The statement regarding a possible public health hazard should
reflect this omission. This statement should also reflect an
assumption was made that all data reviewed adequately reflected
a complete picture of toxic exposure (which it does not) and
there are no synergistic effects of these aggregate exposures.
(Have other pathways for exposure such as dermal or ingestion
been factored in?)
3. Paragraph 3. The adequacy of the EPA NAAQS to capture true
public exposure and adequacy for evaluating public health
should be scientifically evaluated before proceeding.
4. Paragraph 4. ATSDR should request assistance of a reliable
independent scientist for help in evaluating the TCEQ
Midlothian air monitoring for adequacy of capturing public
impact and for adequacy in evaluating the public health of the
community. An assessment for the need for additional and
appropriate monitoring could also be recommended.
Recommendations (Page 11):
Please recommend that TCEQ establish a monitoring system that
captures a complete picture of toxic emissions from all sources and
data adequate for monitoring public health.
Actions Under Way (page 12):
Action to effectuate an adequate monitoring system in Midlothian
should be undertaken. DSHS should discuss with TCEQ a methodology for
establishing a monitoring system that captures emissions from all major
sources and produces data adequate for monitoring public health.
Conclusions (Starting on page 72):
All findings should reflect the inadequacy of TCEQ air monitoring
data to capture total emissions and the inadequacy for evaluating
public health. All findings based on this inadequate data should be
withdrawn.
Aggregate Exposures--Non-Cancer Health Effects (page 73)
The CNS/neurological effects are grossly understated. How were
dioxins factored in? How were synergistic effects factored in? Up-wind
readings for mercury give you for all intent and purpose zero data on
mercury. By the sheer nature of the cement industries and incineration
of hazardous waste and tire-derived fuel, you know that the emissions
of these toxins are significant. It is not becoming of an agency
charged with public health to make such a deficient statement. This
statement should be revised to reflect the deficiencies in the data
reviewed.
**********
Below are corrections to statements made in our original comments
submitted on February 3, 2008. It is requested that you substitute
statements as amended below. The change is highlighted in bold.
On page 5 in paragraph (3) the reference to the time benzene
exceeded the CREG, the sentence should read as follows:
At all three sites (0007, 0015, 0016) the CREG was exceeded 94
percent, 98 percent, 99 percent (respectively) of the time with spikes
up to 118, 512, 319 (respectively) times higher than the CREG.
On page 11 under response to item 3, the first sentence should
read:
Statements like ``. . . had one or more level above the most
conservative contaminant-specific cancer screening value . . .''
although technically true, sound so trivializing, especially when the
data shows that benzene levels exceeded this ``most conservative
screening value'' over 97 percent of the time.
On page 19 under paragraph in first paragraph (1) response,
sentence should read:
However VOC collection on Tayman Drive indicated that 94 percent of
the benzene emissions exceeded the CREG values and benzene emissions
spiked to an acute chronic inhalation RfC of 20.57 ppb in May 1995.
**********
During these last couple of years, there has been much speculation
in the community regarding the delay of this report. The initial
anticipated completion period of three months was stretched to six
months, and then went on indefinitely for over two years on an apparent
merry-go-round between TDSHS and ATDSR.
Speculation for the delay ranged from ``possible political
interference'' to ``a delay is a form of non-response--a method to keep
the community at bay for as long as possible.'' TDSHS' reason for delay
was, ``The data was so comprehensive that it would take a very long
time to complete the analyses.''
It was obvious to the community from the onset that based on the
positions of the air monitors, data collected by TCEQ would not be
adequate for assessing public health. It was our naive hope that
adequate data based on sound science was being collected. As it turned
out, this was not the case. This consultation was based on readily
available data that could be pulled into Access and/or Excel databases
along with the comparison data and easily manipulated to generate the
results provided in this report. Readily available references were
used. Prior TDSHS documents should have been easily accessible.
Community visits were completed in the first three months. Can you
provide some logic to the delay? Or was this delay just an effort to
keep the community pacified and at bay?
Final Comment:
We truly appreciate the fact that ATSDR/TDSHS acknowledged that a
finding less than an ``Indeterminate Public Health Hazard'' is not
appropriate. However, the basis for this finding omits the most glaring
and pertinent deficiencies--the lack of valid data to make an
appropriate health assessment of any kind. Premature assessments (based
on deficient air monitoring data) of a finding of ``no apparent health
hazard'' for many of the constituents evaluated in this consultation
are very disconcerting.
I refuse to be so cynical to imply that ATSDR/TDSHS are not
concerned about public health, because there are many professionals
working for these agencies who have demonstrated their commitment.
However there appears to be a pervasive institutionalized philosophy
and culture that does not allow public health issues to surface if they
will trump economic and industrial goals. Your agencies, professionals
and the communities to which you have a public health obligation
deserve better than this.
Addendum #10
NOT ``JUST STEAM''
A Review of ``Emissions Data from Midlothian Industry''
For the Texas Senate Natural Resources Committee,
September 9th, 2008
In the summer of 2008 Amanda Caldwell and Susan Waskey, two
University of North Texas Geography graduate students, did something no
one had previously done. They added up all the emission reports
submitted to State and Federal Government by the three cement plants
and adjacent steel mill in Midlothian. Their report, ``Midlothian
Industrial Plant Emission Data'' was the first to try to document the
cumulative impact from what is the largest concentration of smokestack
industries in North Texas.
Although there has been an operating cement plant in Midlothian
since 1960, emission data was only available from the state beginning
in 1990, and from the EPA beginning in 1988. The last available data
from both sources is currently 2006. Besides providing an idea of the
total pollution burden imposed by these facilities for the first time,
Caldwell and Waskey also spotlight the differences in reported volumes
of air pollution when industry submits emissions reports to the State
versus the Federal governments. The two databases reveal some
interesting contrasts in tracking 16 years of air pollution emissions
that call for closer examination.
Caldwell and Waskey's work definitively puts to rest the oft-
repeated unofficial explanation by the companies and their boosters
that that plant's emissions are ``just steam.'' In fact, pollution from
the smokestacks of these facilities is the largest industrial threat to
public health in North Texas, and has been for decades.
1. The Facilities
Texas Industries, Inc. (TXI) cement plant
One dry kiln
Four wet kilns
Fuel: coal, hazardous waste, permitted for tires
Holcim US Inc. cement plant
Two dry kilns
Fuel: coal, tires, oil filter fluff, petroleum coke, used oils
Ash Grove Texas L.P. cement plant
Three wet kilns
Fuel: coal and tires
Gerdau Ameristeel, (formally Chaparral Steel)
Electric Arc Furnace Steel Mill
2. The Emissions Reports
A) USEPA's Toxic Release Inventory (TRI)
Toxic Release Inventory reports are generated by industries as
required by the Emergency Planning and Community Right-to-Know Act
(EPCRA), enacted in 1986. According to the EPA,
``EPCRA's primary purpose is to inform communities and
citizens of chemical hazards in their areas. EPCRA Section 313
requires EPA and the states to annually collect data on
releases and transfers of certain toxic chemicals from
industrial facilities, and make the data available to the
public in the Toxic Release Inventory (TRI) . . . EPA compiles
the TRI data each year and makes it available through several
data access tools, including the TRI Explorer.'' (USEPA 2008)
The release data used in this project are self-reported by each
facility, and neither the quality of the data, nor the quantities
reported should be assumed to be precisely accurate.
Caution should be taken in interpreting trends from the TRl reports
as the list of ``reportable'' chemicals has changed over the years.
Since its inception in 1987, the list of toxic chemicals that must be
reported has doubled to more than 650, with most of the additions
occurring in 1995. Also, numerous changes have been made to the list,
including de-listing some chemicals and modifying reporting thresholds
of others.
B) Texas Commission on Environmental Quality's Annual Contaminant
Summary Reports
The second half of the data collection effort was focused on the
State of Texas' Contaminant Summary Report. Again, like the federal
data, 2006 is the latest reporting year for which data are available.
Reported data earlier than 1990 do not exist from the state, according
to a conversation with the Emissions Assessment Section Manager at
TCEQ. Data was also not collected in 1991 at the State level, for
reasons not readily known to the TCEQ manager.
The Contaminant Summary Report contains data detailed in three
sections: Criteria Emissions Total, Contaminant Summary Report, and
Hazardous Air Pollutants (RAPS) Summary Report. The Criteria Emissions
Total section lists data for seven ``Pollutant Classes,'' namely:
PM2.5--suspended particulate matter of a size 2.5
microns or less (requirement added in 2000),
PM10--suspended particulate matter of a size 10 microns or
less,
VOC--volatile organic compounds,
CO--carbon monoxide,
NOX--nitrous oxides,
SO2--sulfur dioxide, and
PB--lead.
These requirements originate from the National Ambient Air Quality
Standards (NAAQS), established by the USEPA under the direction of the
Clean Air Act, and annual reporting is further required under the Texas
Clean Air Act.
The Hazardous Air Pollutants (HAPS) Summary reports chemicals for
which both the federal and State Clean Air Act requires annual
reporting. Data from both the Criteria Emissions Total and HAPS Summary
Report were included in this report. The third section titled
``Contaminant Summary Report'' is a catch-all listing of chemicals
required by a mix of requirement, sources, including Criteria
Emissions, HAPS, permit, and other requirements, according to the TCEQ
manager Kevin Cauble. Chemicals unique to this listing are not included
in this project's analysis.
3. The Volume of Pollution
Between 1990 and 2006, the three cement plants and steel mill
reported to State and/or Federal Government that their facilities
released approximately one billion pounds--986,509,069--of harmful air
pollution into the North Texas skies, including:
10,000 pounds of Mercury
91,000 pounds of lead
Over seven million pounds of `` EPA-classified toxic'' air pollution
Approximately 35 million pounds of respirable Particulate Matter
Over 134 million pounds of global waning gases
Over 300 million pounds of smog-forming Nitrogen Oxide
Approximately 400 million pounds of acid rain causing Sulfur Dioxide
That's an average of over 61 million pounds of air pollution
released every year, 7000 pounds an hour, 117 pounds per minute, two
pounds per second over 16 years. And yet, the position of the Texas
Committee on Environmental Quality is that Midlothian has some of the
cleanest air in the state.
Because it's heavier than the gaseous pollution released by the
Midlothian plants, Particulate Matter contaminated with metals and
other combustion residues will usually fall out within 10 miles of the
source, with the heaviest concentrations in the areas most consistently
downwind of the cement plants, or in very close proximity of the plants
themselves.
A 10-mile radius around the Midlothian cement plants would include
portions of Arlington, Cedar Hill, DeSoto, Grand Prairie, Mansfield,
Midlothian, Red Oak, and Venus, and incorporate 314 square miles.
34,903,092 pounds of PM10, or soot, from all four
facilities is enough to deposit 111,156 pounds on each square mile in
that 10-mile radius over the last 16 years.
Almost all of the Lead and Mercury released by the cement plants is
emitted as Particulate Matter pollution. 91,000 pounds of lead is
enough to deposit 289 pounds of the poison on each square mile. 10,103
pounds of Mercury is enough for 32 pounds to be deposited on each
square mile in that same area.
334,816,276 pounds of Nitrogen Oxide is the equivalent smog-forming
pollution from the annual emissions of nine million automobiles.
402,516,432 pounds of Sulfur Dioxide is the equivalent to the SOX
released by 20 coal plants in a year.
4. Toxicity of Selected Pollutants
A) Particulate Matter, or soot, is toxic in its own right, more so
when other toxins are hitching a ride on its surface--almost all of the
Lead and Mercury released by the cement plants is emitted as
Particulate Matter pollution. Soot from engines, or industrial
processes like cement manufacturing is much smaller than the sand dust
or fire soot which evolution equipped human beings to expel. Because
it's smaller it remains deep in the lungs, doing damage.
In the last few years, PM pollution has been linked by scientists
to lung damage, asthma, heart attacks, strokes, blood clots, brain
cancer, genetic damage, and Parkinson's Disease. Toxicologists
specializing in PM pollution believe to be no ``safe'' level of
exposure to PM pollution.
B) Mercury does not decompose or exit the environment once it's
been released into the atmosphere. It is deposited back onto the
ground, where it persists in soil and water, and bio-accumulates in
fish and wildlife.
According to leading scientists, as little as 1/24th of an ounce of
Mercury can contaminate a 20-acre lake and all the fish in it. Using
this measuring stick, 10,000 pounds of Mercury is enough to contaminate
over 133,000,000 20-acre lakes. Joe Pool Lake is within five miles of
all the Midlothian cement plants and steel mill, and the closest plant
is within two miles of the Lake.
C) Lead and lead compounds can be highly toxic when eaten or
inhaled. Although lead is absorbed very slowly into the body, its rate
of excretion is even slower. With constant exposure, lead accumulates
gradually in the body. It is absorbed by the red blood cells and
circulated through the body where it becomes concentrated in soft
tissues, especially the liver and kidneys. Lead can cause lesions in
the central nervous system and apparently can damage the cells making
up the blood-brain barrier that protects the brain from many harmful
chemicals. Most of the leading scientists specializing in lead
poisoning believe there is no safe level of exposure to lead--that is
no level that is not capable of causing some neurological or
physiological effect.
D) According to the Agency of Toxic Substances and Disease
Registry, long-term exposure to Sulfur Dioxide
``can affect your health. Lung function changes were seen in
some workers exposed to low levels of sulfur dioxide for 20
years or more. However, these workers were also exposed to
other chemicals, so their health effects may not have been from
sulfur dioxide alone. Asthmatics have also been shown to be
sensitive to the respiratory effects of low concentrations of
sulfur dioxide.
Animal studies also show respiratory effects from breathing
sulfur dioxide. Animals exposed to high concentrations of
sulfur dioxide showed decreased respiration, inflammation of
the airways, and destruction of areas of the lung.
5. Specific Plants and Pollutants
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
A) TXI
TOTAL AIR POLLUTION 1990-2006: 336,979,556 pounds
TXI is the largest cement plant, and largest industrial facility
among the four examined in this analysis, so it's not surprising it
would lead in total pollution.
In general, the amount of TRI chemicals released to the environment
through the air by TXI spiked in the year 2000, to over 1.2 million
pounds.
This coincided with TXFs bringing the fifth cement kiln into
operation at their Midlothian plant. Subsequently, TRI releases
stabilized at a level lower than one million pounds after 2000, but at
a significantly higher rate than in the past (more than 480,000 lb/yr).
In 1999, reporter Steve Brown wrote in The Dallas Morning News that
TXI had promised that this $200 million expansion to add the 5th kiln
to their operation ``would not increase pollution,'' and it would
``have advanced pollution controls that would keep the project from
harming air quality'' (Brown 1999). The data from both the EPA Toxic
Release Inventory and the State Hazardous Air Pollutants reports show a
different outcome. Air releases from both reports are higher than prior
to 2000.
B) Holcim
TOTAL AIR POLLUTION 1990-2006: 307,966,836 pounds
Holcim's TRI releases and state emissions inventory consist mostly
of Toluene (404,288 lbs.), Benzene (232,109 lbs.), Sulfuric Acid
(172,145 lbs.) and unspeciated/mixed Xylenes (145,982 lbs.). Holcim has
also had lesser amounts of on-site landfill releases over the years.
Holcim's State air emissions (HAPS emissions consist mostly of
Toluene (508,429 lbs.), Benzene (329,279 lbs.), Xylenes (248,103 lbs.),
and Hydrochloric Acid (196,566 lbs.).
C) Ash Grove
TOTAL AIR POLLUTION 1990-2006: 263,141,444 pounds
Ash Grove's toxic air emissions consist mostly of sulfuric acid
(872,185 lbs) and hydrochloric acid (171,473 lbs). On-site landfill
releases are also of note , consisting mostly of Magnesium and
Magnesium Compounds (1,903,018 lbs.), and smaller amounts of Chromium
(34,464 lbs.) and Lead (8224 lbs.).
The State Air Emissions Inventory (HAPS) shows that most prevalent
toxic chemical released over the 17-year reporting period was Hydrogen
Chloride (334,655 lbs.) Ash Grove's state Criteria Emissions Releases
show that Sulfur Dioxide (SOX) and Nitrous Oxides (NOX) were the most
prevalent components of these emissions. Furthermore, there is a
discouraging upward trend in released amounts of Sulfur Dioxide during
the recent past.
What remarkable about Ash Grove's numbers are that they're so large
for the smallest cement plant. It has more SOX, NOX and PM10
than Holcim, which is twice its size.
D) Ameristeel
TOTAL AIR POLLUTION 1990-2006: 89,655,098 pounds
Most air releases were Zinc (352,076 lbs), Lead (47,238 lbs) or
Manganese (46,904 lbs). Chaparral's releases are primarily ``off-
site,'' with zinc releases over the 17-year period approaching 50
million pounds.
The State air emissions inventory (HAPS) consist mostly of
Manganese Dioxide (58,609 lbs.) or PM10-Manganese Dioxide
(72,583 lbs.), and Lead Oxide (50,337 lbs.) or PM10-Lead
Oxide (38,237 lbs.). The Nitrous Oxide (NOX) component of those
emissions seems to beholding steady at one million pounds per year.
6. These are Underestimates
The fact that there is absolutely no emissions data from either EPA
or the state for the first 30 years of industrial operations in
Midlothian--including the first four years of hazardous waste-burning
at two cement plants--means that the large numbers reported here for
the first time are inherently vast underestimates of the total
pollution burden produced by heavy industry in the town since 1960.
This is anything but a comprehensive review.
Even when records begin in 1990, there are large discrepancies in
the data reported to both the State and Federal governments. TRI and
State emissions data for several of the companies were not reported for
many of the years during the project time period:
Chaparral did not report TRI data in 1990.
Holcim did not report TRI data for the years 1990-1999.
Ash Grove did not report TRI data for the years 1990 and 1993-1995.
Holcim did not report Hazardous Air Pollutants data to the state
for the years 1990-1999.
It is unlikely that these facilities were not releasing anything
worthy of reporting to either the USEPA or State databases during these
years. Omissions such as these ensure that, even during the period when
records do exist, this analysis only gives a glimpse into the actual
pollution burden caused by the four facilities.
7. Contradictions in Data
A cursory examination of EPA air release data in Figure 56 (Total
Air Releases per Firm 1990-2006) and TCEQ air release data in Figure 60
(Total Hazardous Air Pollutants per Firm 1990-2006), show strikingly
different results. For this reporting period, the EPA data shows TXI to
be the firm with the largest amount of toxic chemicals released to the
air (5,287,384 lbs.), while the state's data show Holcim to be the
largest emitter of hazardous air pollutants (1,507,663 lbs).
According to the plants' TRI reports, there were almost 48,000
pounds of lead air pollution released by all four facilities over the
entire 16 years, versus the over 90,000 pounds of lead the same plants
reported sending up their stacks to the TCEQ and its predecessors
during the same period.
According to the plant's TRI reports, there were approximately 5000
pounds of Mercury air pollution released by all four facilities from
1990 to 2006 versus the approximately 10,000 pounds of Mercury air
pollution reported to the state over the same time.
Even within the same reporting system, the method used to calculate
or estimate reported quantities for various chemicals may have differed
from firm to firm and year to year, making comparisons or trend
analysis difficult. Take the case of Volatile Organic Compounds at the
cement plants that are literally across the street from each other.
When Holcim finally began reporting volumes for TRI in 2000, it
immediately cited large numbers for VOCs such as Toluene, Xylene, and
Benzene. It has been Holcim's position that these VOCs come from the
limestone itself and testing done over the last three years generally
supports this conclusion. On the other hand, neither TXI nor Ash Grove
have ever reported the large numbers of these VOCs that Holcim has,
despite mining and using the same Midlothian limestone. The result is
that even though Holcim did not report ANY emissions for nine of the 16
years covered in this analysis, it is the largest historical VOC
polluter in the study, with VOC totals that are at least five times
that of the next cement plant. Is Holcim's limestone that much
different than the other two plants, or are TXI and Ash Grove under-
reporting their emissions?
Some of these calculation differences could be investigated
further, as could the apparent reporting gaps (missing data) from some
of the firms. Also, the company-to-company differences in what chemical
substance get reported in which section of the annual report to the
state could be evaluated. Those chemicals from the state's Contaminant
Summary Report block that are not included in the HAPS or Criteria
Emissions blocks of data could also be scrutinized for inclusion in
this dataset.
Addendum #11
BIRTH DEFECT INVESTIGATION REPORT
Birth Defects Among Deliveries to Residents of
Midlothian, Venus, & Cedar Hill, Texas, 1997-2001
Prepared June 29, 2005 by Mary Ethen, Epidemiologist
Birth Defects Epidemiology and Surveillance Branch
Texas Department of State Health Services
BACKGROUND
A community member expressed concern over birth defects in
Midlothian (Ellis County), Venus (Johnson County), and Cedar Hill
(Ellis and Dallas Counties), Texas. The community member also expressed
concern about pollution from cement kilns in or near these three
communities and a steel mill in or near Venus, Texas.
METHODS
Case Definition
The areas of interest are south of Dallas and Fort Worth. The Texas
Birth Defects Registry began collecting information in this part of the
state with deliveries in January 1997, and the most recent delivery
year for which the registry has completed data collection is 2001.
Based on this information, a case was defined as an infant or fetus
. . .
with any of 48 specific birth defects, or with any
birth defect monitored by the registry;
born between January 1997 and December 2001;
born to a mother who resided in Midlothian, Venus, or
Cedar Hill at the time of delivery.
Each community was examined separately from the other two
communities.
Case Finding
The Texas Birth Defects Registry was searched to find cases meeting
the case definition. The mother's place of residence at the time of
delivery was based on information reported on the child's birth or
fetal death certificate, when available. If a birth or fetal death
certificate could not be found, the mother's place of residence at the
time of delivery was based on information in the Texas Birth Defects
Registry that had been abstracted from hospital medical records.
Occurrence Evaluation
Unadjusted Prevalence: Cases in the registry were used to calculate
prevalence rates per 10,000 live births for 48 specific birth defects
and for infants and fetuses with any birth defect monitored by the
registry. Calculations were done for the three communities separately.
The 95 percent confidence interval for each prevalence was calculated
based on the Poisson distribution. In order to determine if there was a
statistically significant elevation in the occurrence of birth defects,
the prevalence rates for the areas and time period of interest were
compared to the prevalence rates for all of Texas during January 1999
through December 2001. Prevalence rates were considered statistically
significantly different if their 95 percent confidence intervals did
not overlap.
Adjusted Prevalence: The occurrence of many types of birth defects is
known to vary between mothers of different age groups, mothers of
different racial/ethnic groups, and between male and female infants.
For each type of birth defect that was statistically significantly
elevated based on the unadjusted prevalence, we calculated prevalence
rates adjusted separately for age, race/ethnicity, and sex. Adjustment
accounts for any differences in the age, racial/ethnic, or sex
composition of populations being compared, in this case, differences
between the communities of interest during 1997-2001 and all of Texas
during 1999-2001.
Using the direct method of standardization, maternal age-specific
rates for the area of interest were standardized (adjusted) to the
maternal age distribution of all Texas resident live births during
1999-2001. The resulting adjusted rate is the hypothetical rate that
would have been observed in the area of interest if that area had the
same maternal age distribution as Texas overall in 1999-2001.
Similarly, maternal racial/ethnic-specific rates for the area of
interest were standardized to the maternal race/ethnic distribution of
Texas resident live births during 1999-2001, yielding the hypothetical
rate that would have been observed if the area of interest had the same
maternal race/ethnic distribution as Texas. Finally, adjustment for
infant sex was accomplished in the same manner.
The DIRST module of Computer Programs for Epidemiologists,\1\
version 4.0, was used to calculate directly standardized rates and
their associated 95 percent confidence intervals.
---------------------------------------------------------------------------
\1\ Abramson JH, Gahlinger PM. Computer Programs for
Epidemiologists: PEPI, version 4.0. !Salt Lake City, Utah: Sagebrush
Press, 2001.
Age-, Race-, and Sex-specific Prevalence: For the types of birth
defects that were statistically significantly elevated based on the
unadjusted prevalence and that remained statistically significant after
adjustment, we have shown prevalence by maternal age group, maternal
racial/ethnic group, and infant sex, plus 95 percent confidence
---------------------------------------------------------------------------
intervals based on the Poisson distribution.
Estimated Date of Conception: The estimated date of conception was
calculated and graphed for cases having the types of birth defects that
remained statistically significantly elevated after adjustment. If the
last menstrual period (LMP) date was available, the estimated date of
conception was calculated as the LMP date plus 14 days. If LMP date was
not available, the estimated date of conception was calculated as the
expected date of delivery minus 266 days.
Spot Map: For the types of birth defects that remained statistically
significant after adjustment, a spot map was made using the mother's
residence address at the time of delivery, as reported on the child's
birth or fetal death certificate. The map is not included in this
report to protect the privacy of the families.
RESULTS
Unadjusted Prevalence: We examined the occurrence of 48 types of birth
defects and any birth defect monitored by the registry among deliveries
during January 1997 through December 2001 to residents of Midlothian,
Venus, and Cedar Hill separately.
For Venus and for Cedar Hill during 1997-2001, none of the birth
defects examined was statistically significantly higher than the
statewide prevalence in 1999-2001. The prevalence of any monitored
birth defect also was not statistically significantly elevated in Venus
or Cedar Hill, compared to the entire state.
For Midlothian during 1997-2001, two categories of birth defects
were statistically significantly higher than the statewide prevalence
in 1999-2001.
The unadjusted prevalence of hypospadias or epispadias among
Midlothian resident deliveries during 1997-2001 was 102.39 cases per
10,000 live births (95 percent confidence interval 52.91-178.85) (Table
1), which was 3.5 times the prevalence for Texas in 1999-2001 (28.87
cases per 10,000 live births, 95 percent CI 27.86-29.88) and
statistically significant.
The unadjusted prevalence of any monitored birth defect among
Midlothian resident deliveries during 1997-2001 was 511.95 cases per
10,000 live births (95 percent CI 390.61-658.96) (Table 2). This was
1.5 times the prevalence for Texas in 1999-2001 (350.12 cases per
10,000 live births, 95 percent CI 346.59-353.65) and statistically
significant.
Adjusted Prevalence: Adjusted prevalences were calculated for
hypospadias or epispadias and for any monitored birth defect among
Midlothian resident deliveries during 1997-2001.
For hypospadias or epispadias (Table 1), adjusting for infant sex
had no impact on the prevalence, yielding a sex-adjusted prevalence of
102.75 cases per 10,000 live births, which was essentially unchanged
from the unadjusted prevalence of 102.39 cases per 10,000 live births.
Adjusting for maternal age group caused the prevalence of hypospadias
or epispadias to increase very slightly, from 102.39 unadjusted to
106.02 after adjustment. Adjusting for maternal race/ethnicity caused
the prevalence of hypospadias/epispadias to increase from 102.39
unadjusted to 119.86 after adjustment.
This means that the elevation observed in Midlothian during 1997-
2001 for hypospadias or epispadias cannot be attributed to differences
between Midlothian and Texas overall in the proportion of boys and
girls being born, or in the race/ethnic or age distribution of women
having children. The prevalence of hypospadias or epispadias remained
statistically significantly elevated in Midlothian after adjustment for
sex, maternal age, and maternal race/ethnicity.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
For any monitored birth defect (Table 2), adjusting for sex had no
impact on the prevalence. The sex-adjusted prevalence, 512.58 cases per
10,000 live births, was nearly the same as the unadjusted prevalence,
511.95. Likewise, adjusting for maternal age group had no impact on the
prevalence of any monitored defect (511.95 unadjusted compared to
513.71 after adjustment).
Adjusting for maternal race/ethnicity caused the prevalence of any
monitored birth defect to decrease from 511.95 per 10,000 unadjusted to
402.69 adjusted (95 percent CI 256.37-549.01) (Table 2). Further, the
adjusted prevalence was no longer statistically significantly elevated
compared to Texas in 1999-2001 (350.12; 95 percent CI 346.59-353.65).
This means that the elevation observed in Midlothian during 1997-
2001 for any monitored birth defect can be explained by differences
between Midlothian and Texas overall in the race/ethnic distribution of
women having children. In Midlothian, 83.2 percent of mothers who gave
birth in 1997-2001 were non-Hispanic White women, while in Texas during
1999-2001, only 39.2 percent of births were to non-Hispanic White
mothers. Further, in Texas overall during 1999-2001, the prevalence of
any monitored birth defect was statistically significantly higher among
non-Hispanic White mothers (374.16 per 10,000 live births; 95 percent
CI 368.33-380.00) than among African American mothers (339.69; 95
percent CI 329.34-350.04) or Hispanic mothers (340.34; 95 percent CI
335.21-345.48). Because most Midlothian mothers are non-Hispanic White
women, and because the prevalence of any monitored birth defect is
higher among mothers of this race/ethnic group, the unadjusted
prevalence of any monitored birth defect in Midlothian was higher than
the Texas prevalence, and it decreased after adjustment for race/
ethnicity.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Age-, Race-, and Sex-specific Prevalence: Since hypospadias or
epispadias was the only type of birth defect that was statistically
significantly elevated after adjustment, we took a closer look at it.
Table 3 shows the prevalence of hypospadias or epispadias by maternal
age group, maternal race/ethnicity, and infant sex among Midlothian
resident deliveries during 1997-2001. Data for Texas in 1999-2001 are
also presented for comparison.
The mothers of Midlothian children with hypospadias or epispadias
ranged in age from 17 to 37. The prevalence of hypospadias or
epispadias among mothers less than 20 years old was statistically
significantly higher in Midlothian than in Texas. For all other
maternal age groups, the Midlothian prevalences did not attain
statistical significance.
Midlothian mothers of `Other' race/ethnicity were significantly
more likely to have a child with hypospadias or epispadias than mothers
of `Other' race/ethnicity statewide. This was the only racial/ethnic
group that was statistically significantly higher than the state.
The prevalence of hypospadias or epispadias among male infants was
also statistically significantly higher in Midlothian than Texas.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Estimated Dates of Conception: The 12 Midlothian children born during
1997-2001 with hypospadias or epispadias were estimated to have been
conceived from September 1996 through April 2000. No more than one case
was conceived in any given month during this time period, nor was there
any other evidence of clustering in time (Figure 1).
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Spot map: The spot map of maternal residence address at time of
delivery for the 12 Midlothian children born during 1997-2001 with
hypospadias or epispadias did not show any strong evidence of
geographic clustering within Midlothian. Seven of the residences were
distributed within the current Midlothian city limits and five were
outside the city limits. The map is not included in this report to
protect the privacy of the families.
DISCUSSION
Using data in the Texas Birth Defects Registry, we examined the
occurrence of 48 specific birth defects and any defect monitored by the
registry among deliveries during 1997-2001 to residents of Midlothian,
Venus, and Cedar Hill, Texas. None of the birth defects examined were
statistically significantly elevated in Venus or Cedar Hill. Any
monitored birth defect and hypospadias or epispadias were elevated in
Midlothian during 1997-2001.
The prevalence of any monitored defect in Midlothian decreased and
was no longer statistically significantly elevated after adjusting for
maternal race/ethnicity. This indicates that the elevation observed in
Midlothian for any monitored birth defect can be attributed to
differences between Midlothian and Texas in the race/ethnic
distribution of women having children. If Midlothian had the same
maternal race/ethnic distribution as Texas, the prevalence of any
monitored birth defect in Midlothian would have been within the range
of what is expected.
Hypospadias or epispadias remained statistically significantly
elevated in Midlothian after adjustment for sex, race/ethnicity, and
age, meaning that this elevation cannot be explained by differences
between Midlothian and the state in the proportion of boys and girls
being born, or in the race/ethnic or age distribution of women having
children.
Hypospadias is a congenital defect in which the urinary meatus
(urinary outlet) is on the underside of the penis or on the perineum
(the area between the genitals and the anus). In epispadias, the
urinary meatus opens above (dorsal to) the normal position. The
corresponding defects in females are very rare.
All of the 12 Midlothian children had hypospadias, rather than
epispadias.
A spot map did not indicate geographic clustering within Midlothian
of the residences of the mothers of children with hypospadias, and a
graph of estimated conception dates did not indicate clustering in time
of conception.
We made 147 comparisons of community level birth defects data to
statewide data (48 birth defects plus any monitored defect, times three
communities). At the 95 percent level of significance, we would expect
five percent of the 147 comparisons, or seven comparisons, to have been
statistically significant due to chance. We found two that were
statistically significant, and one that remained significant after
adjustment for sex, maternal race/ethnicity, and maternal age.
Although hypospadias/epispadias was elevated in Midlothian, it does
not meet criteria to continue this investigation and thus further study
at this time is unlikely to yield useful results. To continue, our
protocol requires at least three cases with a documented biologically
plausible exposure that the cases have in common, or at least five
cases with an observed rate of more than 10 times the expected rate.
However, because of the elevation, the Texas Birth Defects Registry
will continue to monitor hypospadias. As more years of data become
available in the future, we will re-examine the prevalence of
hypospadias in the area.
CONCLUSIONS
Hypospadias or epispadias was elevated among Midlothian resident
deliveries during 1997-2001. We will re-examine the occurrence of
hypospadias or epispadias after subsequent delivery years are completed
in the Texas Birth Defects Registry.
For more information, contact Mary Ethen at the Birth Defects
Epidemiology and Surveillance Branch at 512-458-7111, ext. 2052, or e-
mail [email protected], or visit our web site at http://
www.dshs.state.tx.us/birthdefects/
Addendum #12
Summary of Investigation into the Occurrence of Cancer
Zip Codes 76065, 75104, and 76084,
Midlothian, Cedar Hill, and Venus
Ellis, Dallas, and Johnson County, Texas
1993-2002
May 19, 2005
Background:
Concern about a possible excess of cancer prompted the Texas Cancer
Registry (TCR) Branch of the Texas Department of State Health Services
(DSHS) to examine the occurrence of cancer in zip codes 76065, 75104,
76084, Midlothian, Cedar Hill, and Venus, Texas. Local residents were
concerned that benzene, 1, 3 butadiene, and radiation from the nearby
cement plants may be causing cancer among residents. Laryngeal cancer
has been associated with workers exposed to cement dust. Benzene has
shown an association with acute myeloid leukemia and non-Hodgkin's
lymphoma in the scientific literature, while radiation has been weakly
linked with several leukemia subtypes, non-Hodgkin's lymphoma, and
brain cancer. Exposure to 1, 3 butadiene has been associated with
leukemia. The TCR evaluated 1995-2002 incidence data and 1993-2002
mortality data for cancers of the female breast, prostate, lung and
bronchus, colon and rectum, male bladder, corpus and uterus, non-
Hodgkin's lymphoma, brain/CNS, larynx, selected leukemia subtypes, and
total childhood cancers. Incidence data are the best indicator of the
occurrence of cancer in an area because they show how many cancers were
diagnosed each year. Cancer mortality data are used as a supplemental
measure and are complete for the entire state through 2002. The rest of
this report examines the investigative methods the TCR used, the
results of the investigation, recommendations, and general information
on cancer risk factors.
Methodology:
According to the National Cancer Institute, a cancer cluster is a
greater than expected number of cancers among people who live or work
in the same area and who develop or die from the same cancer within a
short time of each other. The cancer cluster investigation is the
primary tool used by the TCR to investigate the possibility of excess
cancer in a community. The cancer cluster investigation cannot
determine that cancer was associated with or caused by environmental or
other risk factors. Instead, the cancer cluster investigation is
specifically intended to address the question ``Is there an excess of
cancer in the area or population of concern?''
The TCR follows guidelines recommended by the Centers for Disease
Control and Prevention for investigating cancer clusters\1\ and often
works with the DSHS Environmental and Injury Epidemiology and
Toxicology Branch, as well as other state and federal agencies. In
order to determine if an excess of cancer is occurring and if further
study is recommended, biologic and epidemiologic evidence are
considered. Such evidence may include documented exposures; the
toxicity of the exposures; plausible routes by which exposures can
reach people (ingesting, touching, breathing); the actual amount of
exposure to the people which can lead to absorption in the body; the
time from exposure to development of cancer; the statistical
significance of the findings; the magnitude of the effect observed;
risk factors; and the consistency of the findings over time. The
occurrence of rare cancers or unlikely cancers in certain age groups
may also indicate a cluster needing further study. Because excesses of
cancer may occur by chance alone, the role of chance is considered in
the statistical analysis.
---------------------------------------------------------------------------
\1\ Guidelines for Investigating Clusters of Health Events, Centers
for Disease Control and Prevention, MMWR 1990; 39 (RR-11): 1-16.
---------------------------------------------------------------------------
If further study is indicated, the TCR will determine the
feasibility of conducting further epidemiologic study. If the
epidemiologic study is feasible, the final step is to recommend and/or
perform an etiologic investigation to see if the cancer(s) can be
related to an exposure. Very few cancer cluster investigations in the
United States proceed to this stage.
To determine whether a statistically significant excess of cancer
existed in the geographic areas of concern, the number of observed
cases and deaths was compared to what would be ``expected'' based on
the state cancer rates. Calculating the expected number(s) of cancer
cases takes into consideration the race, sex, and ages of people who
are diagnosed or die from cancer. This is important because peoples'
race, sex, and age all impact cancer rates. If we are trying to
determine if there is more or less cancer in a community compared to
the rest of the state, we must make sure that the difference in cancer
rates is not simply due to one of these factors.
The attached Tables 1-6 present the number of observed cases and
deaths for males and females, the number of ``expected'' cases and
deaths, the standardized incidence ratio (SIR) or standardized
mortality ratio (SMR), and the corresponding 99 percent confidence
interval. The standardized incidence or mortality ratio (SIR, SMR) is
simply the number of observed cases or deaths compared to the number of
``expected'' cases or deaths. When the SIR or SMR of a selected cancer
is equal to 1.00, then the number of observed cases or deaths is equal
to the expected number of cases or deaths, based on the incidence or
mortality in the rest of the state. When the SIR or SMR is less than
1.00, fewer people developed or died of cancer than we would have
expected. Conversely, an SIR or SMR greater than 1.00 indicates that
more people developed or died of cancer than we would have expected. To
determine if an SIR or SMR greater than 1.00 or less than 1.00 is
statistically significant or outside the variation likely to be due to
chance, confidence intervals are also calculated.
A 99 percent confidence interval is used for statistical
significance and takes the likelihood that the result occurred by
chance into account. It also indicates the range in which we would
expect the SIR or SMR to fall 99 percent of the time. If the confidence
interval contains a range that includes 1.00, no statistically
significant excess of cancer is indicated. The confidence intervals are
particularly important when trying to interpret small numbers of cases.
If only one or two cases are expected for a particular cancer, then the
report of three or four observed cases will result in a very large SIR
or SMR. As long as the 99 percent confidence interval contains 1.00,
this indicates that the SIR or SMR is still within the range one might
expect and, therefore, not statistically significant.
Results:
The analysis of incidence data for zip codes 76065, 75104, and
76084, Midlothian, Cedar Hill, and Venus, Texas, from January 1, 1995-
December 31, 2002, and mortality data from January 1, 1993-December 31,
2002, found cancers of the breast, lung and bronchus, corpus and
uterus, brain/CNS, bladder, colorectal, non-Hodgkin's lymphoma,
selected leukemia subtypes, and total childhood cancers (0-19) to be
within normal ranges in both males and females. Prostate cancer
mortality was statistically significantly lower than expected in zip
code 76065 males while prostate cancer incidence was statistically
significantly lower than expected in zip code 76084 males. Analysis
summaries are presented in Tables 1-6.
Discussion:
Like other studies, this cancer cluster investigation had
limitations. The number of years of incidence data examined was limited
to eight years and did not include data for the most recent years. Ten
years of mortality data were examined as a supplemental measure. Also,
cancer incidence data are based on residence at the time of diagnosis
and mortality data the residence at the time of death. It is possible
that some residents who may have been exposed and developed cancer no
longer lived in the area at the time of diagnosis or death, so were not
included in the analyses. However, it is also possible that people may
have moved into the area and then developed or died from cancer because
of an exposure from a prior residential location or other factors.
These cases and deaths are included in the investigation.
Recommendations:
Based on the findings and the information discussed above, it is
not recommended at this time to further examine the cancers in zip
codes 76065, 75104, 76084, Midlothian, Cedar Hill, and Venus, Texas. As
new data or additional information become available, consideration will
be given to updating or re-evaluating this investigation.
Information on Cancer and Cancer Risk Factors:
Overall, the occurrence of cancer is common, with approximately two
out of every five persons alive today predicted to develop some type of
cancer in their lifetime.\2\ In Texas, as in the United States, cancer
is the second leading cause of death, exceeded only by heart disease.
Also, cancer is not one disease, but many different diseases. Different
types of cancer are generally thought to have different causes. If a
person develops cancer, it is probably not due to one factor but to a
combination of factors such as heredity; diet, tobacco use, and other
lifestyle factors; infectious agents; chemical exposures; and radiation
exposures. Although cancer may impact individuals of all ages, it
primarily is a disease of older persons with over one-half of cancer
cases and two-thirds of cancer deaths occurring in persons 65 and
older. Finally, it takes time for cancer to develop, more than 10 years
can go by between the exposure to a carcinogen and a diagnosis of
cancer.\3\
---------------------------------------------------------------------------
\2\ American Cancer Society website: http://www.cancer.org/docroot/
CRI/content/
CRI-2-4-1x-Who-ge
ts-cancer.asp?sitearea=. Accessed 04/15/05.
\3\ National Cancer Institute website: http://cis.nci.nih.gov/fact/
3--58.htm. Accessed 04/15/05.
---------------------------------------------------------------------------
The chances of a person developing cancer as a result of exposure
to an environmental contaminant are slight. Most experts agree that
exposure to pollution, occupational, and industrial hazards account for
fewer than 10 percent of cancer cases.\4\ According to Richard Doll and
Richard Peto, renowned epidemiologists at the University of Oxford,
pollution and occupational exposures are estimated to collectively
cause four to six percent of all cancer deaths.\5\ The Harvard Center
for Cancer Prevention estimates five percent of cancer deaths are due
to occupational factors, two percent to environmental pollution and two
percent to ionizing/ultraviolet radiation.\6\ Additionally much of the
evidence that pollutants and pesticide residues increase cancer risk is
presently considered quite weak and inconsistent. In contrast, the
National Cancer Institute estimates that lifestyle factors such as
tobacco use and diet cause 50 to 75 percent of cancer deaths.\7\ Eating
a healthy diet and refraining from tobacco are the best ways to prevent
many kinds of cancer. One-third of all cancer deaths in this country
could be prevented by eliminating the use of tobacco products.
Additionally, about 25 to 30 percent of the cases of several major
cancers are associated with obesity and physical inactivity.\8\
---------------------------------------------------------------------------
\4\ Cancer: What Causes It, What Doesn't. American Cancer Society
website: http://www.cancer.org/docroot/PUB/content/
PUB-1-1-Cancer-What-
Causes-It-What-Doesnt.asp
\5\ Doll R, Peto R. The Causes of Cancer. Oxford: Oxford University
Press, 1990.
\6\ Harvard Reports on Cancer Prevention. Harvard Center for Cancer
Prevention. Volume 1: Human Causes of Cancer. Harvard School of Public
Health website: http://www.hsph.harvard.edu/cancer/publications/
reports/vo11-summary.html
\7\ 2001 Cancer Progress Report. National Cancer Institute website:
http://progressreport.cancer.gov/doc
\8\ Cancer and the Environment. National Cancer Institute website:
http://www.cancer.gov/images/Documents/5d17e03e-b39f-4b40-a214-
e9e9099c4220/Cancer%20and%20the%20Environment.pdf
Known Risk Factors for Cancers Examined in This Investigation:
The following is a brief discussion summarized from the American
Cancer Society and the National Cancer Institute about cancer risk
factors for the specific cancers studied in this
investigation.\9\,\10\
---------------------------------------------------------------------------
\9\ American Cancer Society website. http://www.cancer.org.
Accessed 03/31/2005.
\10\ National Cancer Institute website: http://www.nci.nih.gov/.
Accessed 03/31/2005.
---------------------------------------------------------------------------
The occurrence of cancer may vary by race/ethnicity, gender, type
of cancer, geographic location, population group, and a variety of
other factors. Scientific studies have identified a number of factors
for various cancers that may increase an individual's risk of
developing a specific type of cancer. These factors are known as risk
factors. Some risk factors we can do nothing about, but many are a
matter of choice.
Prostate Cancer
Prostate cancer is the most common type of malignant cancer (other
than skin) diagnosed in men, affecting an estimated one in five
American men. Risk factors for prostate cancer include aging, a high
fat diet, physical inactivity, and a family history of prostate cancer.
African American men are at higher risk of acquiring prostate cancer
and dying from it. Prostate cancer is most common in North America and
northwestern Europe. It is less common in Asia, Africa, Central
America, and South America.
Breast Cancer
Simply being a woman is the main risk factor for developing breast
cancer. Breast cancer can affect men, but this disease is about 100
times more common among women than men. White women are slightly more
likely to develop breast cancer than are African-American women, but
African Americans are more likely to die of this cancer because they
are often diagnosed at an advanced stage when breast cancer is harder
to treat and cure. Other risk factors for breast cancer include aging,
presence of genetic markers such as the BRCA1 and BRCA2 genes, personal
and family history of breast cancer, previous breast biopsies, previous
breast irradiation, diethylstilbestrol therapy, oral contraceptive use,
not having children, hormone replacement therapy, alcohol, and obesity.
Currently, research does not show a link between breast cancer risk and
environmental pollutants such as the pesticide DDE (chemically related
to DDT) and PCBs (polychlorinated biphenyls).
Lung and Bronchus Cancer
The greatest single risk factor for lung cancer is smoking. The
American Caner Society estimates that 87 percent of lung cancer is due
to smoking. Several studies have shown that the lung cells of women
have a genetic predisposition to develop cancer when they are exposed
to tobacco smoke. Other risk factors include secondhand smoke, asbestos
exposure, radon exposure, carcinogenic agents in the workplace such as
arsenic or vinyl chloride, marijuana smoking, recurring inflammation of
the lungs, exposure to industrial grade talc, people with silicosis and
berylliosis, personal and family history of lung cancer, diet, and air
pollution.
Brain/CNS Cancer
The large majority of brain cancers are not associated with any
risk factors. Most brain cancers simply happen for no apparent reason.
A few risk factors associated with brain cancer are known and include
radiation treatment, occupational exposure to vinyl chloride, immune
system disorders, and family history of brain and spinal cord cancers.
Possible risk factors include exposure to aspartame (a sugar
substitute) and exposure to electromagnetic fields from cellular
telephones or high-tension wires.
Bladder Cancer
The greatest risk factor for bladder cancer is smoking. Smokers are
more than twice as likely to get bladder cancer as nonsmokers. Whites
are two times more likely to develop bladder cancer than are African
Americans. Other risk factors for bladder cancer include occupational
exposure to aromatic amines such as benzidine and beta-napthylamine,
aging, chronic bladder inflammation, personal history of urothelial
carcinomas, birth defects involving the bladder and umbilicus, high
doses of certain chemotherapy drugs, and use of the herb Aristocholia
Fangchi.
Colon and Rectum Cancer
Colorectal cancer is the second leading cause of cancer death in
both men and women. Researchers have identified several risk factors
that increase a person's chance of developing colorectal cancer: family
and personal history of colorectal cancer, hereditary conditions such
as familial adenomatous polyposis, personal history of intestinal
polyps and chronic inflammatory bowel disease, aging, a diet mostly
from animal sources, physical inactivity, obesity, smoking, and heavy
use of alcohol. People with diabetes have a 30 percent-40 percent
increased chance of developing colon cancer. Recent research has found
a genetic mutation leading to colorectal cancer in Jews of Eastern
European descent (Ashkenazi Jews).
Laryngeal Cancer
Risk factors for laryngeal and hypopharynx cancer include tobacco
use, alcohol abuse, poor nutrition, infection with human
papillomavirus, a weakened immune system, and occupational exposure.
Men who are aging and African Americans are more likely to be diagnosed
with this cancer.
Acute Lymphocytic Leukemia
Possible risk factors for ALL include the following: being male,
being white, being older than 70 years of age, past treatment with
chemotherapy or radiation therapy, exposure to atomic bomb radiation,
or having a certain genetic disorder such as Down syndrome.
Chronic Lymphocytic Leukemia
Possible risk factors for CLL include the following: being middle-
aged or older, male, or white; a family history of CLL or cancer of the
lymph system; having relatives who are Russian Jews or Eastern European
Jews; or having exposure to herbicides or insecticides including Agent
Orange, an herbicide used during the Vietnam War.
Acute Myeloid Leukemia
Possible risk factors for AML include the following: being male;
smoking, especially after age 60; having had treatment with
chemotherapy or radiation therapy in the past; having treatment for
childhood ALL in the past; being exposed to atomic bomb radiation or
the chemical benzene; or having a history of a blood disorder such as
myelodysplastic syndrome.
Chronic Myeloid Leukemia
Most people with CML have a gene mutation (change) called the
Philadelphia chromosome. The Philadelphia chromosome is not passed from
parent to child.
Non-Hodgkin's Lymphoma
Risk factors for non-Hodgkin's lymphoma include infection with
Helicobacter pylori, human immunodeficiency virus (HIV), human T-cell
leukemia/lymphoma virus (HTVL-1), or the Epstein-Barr virus and
malaria. Other possible risk factors include certain genetic diseases,
radiation exposure, immuno-suppressant drugs after organ
transplantation, benzene exposure, the drug Dilantin, exposure to
certain pesticides, a diet high in meats or fat, or certain
chemotherapy drugs.
For additional information about cancer, visit the ``Resources''
link on our web site at http://www.dshs.state.tx.us/tcr/.
Questions or comments regarding this investigation may be directed
to Ms. Brenda Mokry, Texas Cancer Registry, at 1-800-252-8059 or
brenda.mokry@ dshs.state.tx.us
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Biography for Salvador Mier
Sal Mier lives in Midlothian, Texas with his wife Grace.
Sal's 37-year career in public health started with the Centers for
Disease Control (CDC) in New Orleans, shortly after he graduated from
the University of New Mexico. This career took him to Puerto Rico,
Arkansas and New Mexico where he had a temporary assignment to the
Navajo Nation.
Sal worked for an interim period with the U.S. Public Health
Service, Health Resources and Services Administration, for a short
period. He returned to work with CDC where he ended his federal career
as Director, Division of Prevention Region VI, in Dallas, Texas.
After retiring from CDC, Sal was a private public health consultant
with a focus on U.S./Mexico Public Health issues, HIV and STDs.
Sal and his wife Grace have worked tirelessly these last five years
trying to get answers from what he refers to as ``our guardian
agencies'' about health issues that are surfacing in the community.
``Our only motivation is the health of our children, our grandchildren
and those yet to be born,'' he explains.
Chair Miller. Thank you, Mr. Mier.
Professor Parrish.
STATEMENT OF DR. RANDALL R. PARRISH, HEAD, NATURAL
ENVIRONMENTAL RESEARCH COUNCIL (NERC) ISOTOPE GEOSCIENCES
LABORATORY, BRITISH GEOLOGICAL SURVEY
Dr. Parrish. It is a privilege to be here and I thank you
for the opportunity. It is an interesting contrast to my day
job as research professor at University of Leicester and I run
a large environmental isotope analysis facility in the U.K. My
role here today is really just to provide you with my
perspective on the Colonie, New York, that is a suburb of
Albany, New York, health consultation as a result of my
conducting research there on depleted uranium pollution at the
site as part of a broader investigation of depleted uranium and
health issues.
What I want to do is really just emphasize some of the most
relevant and compelling facts and issues about the health
consultation. As illustrated on the side panels, depleted
uranium munitions and other uranium manufactured items were
made at the National Lead Industries plant in Colonie, New
York, from 1958 to 1984 when the plant was closed due to the
company's environmental negligence from release of excessive
radioactive uranium oxide aerosols on the surrounding
community, and the community can be seen to surround the
remediated plant. In about the mid-1980s the Federal Government
accepted responsibility for this site and up to 2006 has spent
approximately $200 million remediating the site. In response to
the community concerns expressed to the Army Corps of
Engineers, the ATSDR concluded a health consultation in 2004
and its fundamental conclusion was that in the active years of
emissions, these emissions endangered the local population and
workers' health by the risk of inhalation exposure to uranium
oxide. On this conclusion, there is general broad agreement.
With regards to the health consultation that ATSDR did at
the site, let me just mention a few specific outcomes. You will
recognize some themes here that are common to other health
consultations. The Agency decided not to conduct any new
research as part of its health consultation and did not pursue
any further environmental investigations or health surveillance
activities. It misunderstood or was unaware of the analytical
tools available at the time to identify the presence of
depleted uranium in urine bioassays via isotope analysis. It
concluded that the 20-year length of time from the 1984 closure
would make identification of any DU exposure, DU meaning
depleted uranium, impossible. It also concluded that it simply
wasn't feasible or possible to identify the cohort of workers
and residents with the highest exposure. It gave also
incomplete and in part unbalanced descriptions of the relative
health importance of the two exposure pathways, one being the
relatively benign ingestion pathway, that is, coming into
contact with contaminated soil, and the other being the more
insidious inhalation pathway which has higher health risks
associated with it. In short, the Agency appeared to dismiss
the viability of conducting any further health studies on the
exposed population.
Now, the difference in the Colonie situation with respect
to some other sites where health consultations have taken place
and probably the reason I am here is that our research group
has, so to speak, sort of picked up the pieces of the situation
following the health consultation and we have conducted some of
the work that ATSDR could and should have done. For example, we
determined the chemical form for some of the particulates and
showed that it was the least soluble of all forms of uranium
oxide. We also used a high-sensitivity method for uranium
isotope urine testing that we had previously developed in the
U.K., and we showed that depleted uranium could be identified
in the urine of exposed individuals and it can be quantified,
even more than 20 years after these people were exposed. We
extended substantially the existing 1980s vintage environmental
surveys and we worked in a collaborative fashion with the
community to identify a portion of the historically exposed
cohort. In short, we in part accomplished what ATSDR said was
not possible and we did this with very modest resources and
actually at no expense to the U.S. taxpayer. This brings this
whole issue into even sharper focus about the shortcomings of
the health consultation.
Sort of taking a step back, there is a larger perspective
about depleted uranium and health issues that relates to
broader issues such as Gulf War illness that affects veterans
and the continued use of depleted uranium munitions by the U.S.
military. ATSDR did not appear to recognize an opportunity at
Colonie to shed further light on these broader issues, the
opportunity being to study long-term health consequences, if
any, of exposure to inhaled depleted uranium oxides. The
exposure to DU has been an ongoing issue in the media and
government with respect to exposure of soldiers to this toxin
and its health consequences, and the issue does not have
sufficient study at present. A comprehensive study could have
added new knowledge to help resolve this issue and it is
therefore part of the government's duty of care to soldiers and
veterans who have unselfishly served the Nation.
Considering the acknowledged risks to health at Colonie
that arose partly that were obvious in the first place but also
confirmed by the health consultation, the lack of any resources
devoted to targeted health studies at Colonie when compared to
the $200 million spent on remediation is, if one is being
generous, grossly imbalanced, and if you are shedding it in the
worst light, you could say that this is somewhat immoral and
perverse.
Let me just conclude with a few general comments about
ATSDR and perhaps the way forward. The ATSDR remit sets quite a
high bar to reach, that is, basically effectively protecting
the health of the Nation. This is a complicated and potentially
very expensive challenge. The pattern of performance in recent
years as I have gathered simply from reading documents in the
past few weeks and learning more about this committee appears
to suggest that this standard is not being achieved. So it
seems to me there are two options. One is that we partly admit
that some of this high bar, this high standard of performance
may be unachievable, in which case, you know, it should be
redefined so that ATSDR can actually have realistic goals.
Alternatively, if the remit of ATSDR is a valid, you know,
public service imperative, then it seems to me you have to do
three things and they have to be coordinated and done
effectively together. The first is that the Agency has got to
have a strong vision, it has to have strong leadership and
especially needs commitment throughout the organization to its
mission and it has to basically embrace that ethos. The second
point is that the Agency needs to have the resources to pursue
its investigations to their logical and defensible conclusions
and be able to resist interference. Both of these two
recommendations, it seems to me, are essential to restore the
credibility of the Agency. The third thing that needs to be
done in concert with the rest is that the Agency needs to find
and implement a mechanism that effectively and defensibly
prioritizes its investigations and resources so that it
actually can deliver its remit. This external review prior to
release of documents could form a component of that. This third
one basically would allow the Agency to maintain credibility
once it establishes a renewed sort of presence for the future.
So that is the end of my statement. I will be glad to
answer questions later on. Thank you.
[The prepared statement of Dr. Parrish follows:]
Prepared Statement of Randall R. Parrish
Summary
National Lead Industries (NLI) contracted with the Department of
Energy and processed uranium at Colonie NY in the period 1958-84, but
in its latter years was environmentally negligent, badly polluting with
depleted uranium aerosols the surrounding site and community. The
amount of Depleted Uranium (DU) aerosol emissions were comparable to
the total respirable DU released in the entire 1991 Gulf War,
highlighting the significant pollution issue. In 2003-04, the ATSDR
conducted a relatively superficial examination of the health
consequences of the pollution of this site. The report lacked depth and
substance, failed to address community concerns with adequate
scientific data and explanation, it conducted no new research at the
site, and presented a confusing picture of the toxic hazards. It did
not draw upon the best science available. The site was remediated
(completion 2007) by the Army Corps of Engineers, costing more than
$190M. The ATSDR consultation significantly concluded that there was a
real and significant health risk to the public from depleted uranium
oxide emissions from the plant stack during its active years (1958-
1982), but it decided not to pursue any environmental surveying or
health surveillance activities for poorly articulated reasons. Planned
actions related to uranium were not done subsequent to the report's
publication. The liaison with the local community appeared to be
relatively poor, delivering little in the way of satisfactory
communication, and no perceived benefit. No new insight on the
situation was presented that was not already apparent and the nature of
uranium toxicology was not well balanced. In several respects it failed
to take advantage of the best science available to address the issues
at the site. It offered little in the way of comment on how to redress
the health concerns of the community. In most respects other than
providing information on toxins, it failed to deliver its remit for the
Colonie site.
My UK research group, beginning in 2004, investigated the nature of
the uranium aerosols, made isotope measurements that documented the
isotope characteristics of the source emissions, studied particle
dissolution in the natural environment--a parameter relevant to their
solubility, extended the survey of uranium pollution much more widely,
and studied the mobility of uranium in soils and plants, all in order
to gain a better understanding of the environmental pollution. We also
worked closely with the community to identify former workers and
residents who lived or worked in or near the plant for many years
during its operation, in order to gather oral history of events and
practices in the plant and to identify part of the exposed cohort for
potential health screening. TSDR evidently decided that this type of
approach was not possible or would not be a productive activity. It was
instead feasible and useful, and not particularly costly. We had
already developed a urine uranium isotope test that was capable of
detecting trace depleted uranium in urine. We then tested a small
cohort of residents and former workers and clearly showed that our
method was capable of identifying a substantial exposure to depleted
uranium aerosols more than 20 years after exposure. This clearly
offered a way forward to link health outcomes to exposures at Colonie,
something ATSDR in 2004 decided was not possible.
There is a breath-taking lack of environmental and community
justice in the Colonie situation. While the polluter, National Lead
Industries, was absolved two decades ago by the U.S. Government of
responsibility and while the Army Corps of Engineers spent nearly #200M
on site cleanup, no Federal Government monies have been spent on even a
modest-scope targeted health study to identify what if any health
outcomes have occurred for the exposed cohort of people who for years
lived near or worked in the site during its active years of uranium
pollution. The community has been left with no research, no credible
way forward, little or no redress, and a significant environmental
pollution legacy with a reasonable probability of some consequences to
health of those affected.
Much could have been learned about the environmental health issue
of aerosol depleted uranium emissions had ATSDR acted differently; this
could have informed U.S. Government policy as it pertains to Veterans'
Health related to DU munitions exposure in the battlefield (Gulf Wars I
and II) and potentially helped provide vital data to test any potential
connection between Gulf War Illness and depleted uranium exposure. It
would certainly have improved the medical knowledge database on the
inhalation hazard of respirable uranium oxide particles, a relatively
rare toxicological pathway which does not currently have benefit of any
systematic study of an exposed population, to my knowledge. The need
for additional research at the Colonie site is as acute now as it was
in 2003-04 when the ATSDR conducted its Health Consultation.
My remit--instructions from Congressional subcommittee
The Subcommittee has asked me to do two things: summarize my
investigations into the National Lead Industries (NLI) Colonie NY site
and critique the 2004 Colonie ATSDR report and suggest how to improve
its environmental health assessments in the future. My contribution
herein is largely concerned with the uranium issues at Colonie, not the
full menu of pollution-related toxins.
Background and current position; summary of expertise
I am Randall R. Parrish and occupy a joint position of Professor of
Isotope Geoscience, University of Leicester (UK) and Head of the UK
Natural Environment Research Council Isotope Geosciences Laboratory, a
national isotope research and analysis facility serving the UK
scientific, mainly the academic scientific community. I have occupied
this joint post since 1996. More details on my expertise, skills,
publications, research and so forth is contained in the CV and
biography provided as part of the requested testimony.
I conduct research in many areas of geo- and environmental science,
but have a particular expertise in analysis of uranium and lead
isotopes using high sensitivity mass spectrometry and am a recognized
authority in this area. I have published extensively using such
methods, mainly in geoscience in the field of geochronology--the
determination of the age of rocks and minerals using radioactive decay
of Uranium. Although most of my research has been and continues to be
in Earth science, since 2003 I have applied this expertise to
environmental health research on topics that relate to the issue of
depleted uranium (DU) pollution and health. Our work has had some
impact on how the UK government approaches its duty of care to the UK
soldiers that may have been exposed to depleted uranium munitions and
its environmental consequences. I developed a keen interest in this
problem because of the lack of thorough relevant studies, its novelty,
and the fact that it was and still is an issue in dire need of sound
scientific data to combat the huge amount of media and political noise
surrounding `depleted uranium' and its potential relationship to Gulf
War Illness.
The wider justification for study of the Colonie site
The overriding reason that I got involved in research at the
National Lead Industries Colonie NY site was to try to solve a long-
standing problem: how long does inhaled DU oxide reside in the human
body and what relationship, if any, does such an exposure have on human
health and how might it be quantified? In spite of notions to the
contrary, this problem has not been solved because no cohort of people
exposed by inhalation to this particular toxin has been adequately
studied. As it turns out the NLI Colonie NY site is virtually unique in
its relevance to this issue, quite apart from the intrinsic need to
address the environmental stewardship and potential health issues of
this highly polluted site. My role has been to provide the analytical
and environmental science to address this problem. I hope my testimony
will clarify your understanding of the problem and the perspective I
have on the 2004 Colonie ATSDR Health Consultation.
Some observations about the Colonie situation
The uranium pollution at Colonie originated at the
former National Lead Industries site; all agencies appear to
accept that there is no other credible source for the uranium
pollution there. From my knowledge base, I agree.
The uranium pollution is primarily composed of
depleted uranium oxide aerosol particles, which have a
distinctive isotope composition with some limited variability;
we have measured this extensively in our studies. My Ph.D.
student published an article on this just last week--it is
appended in these documents.
The uranium pollution at Colonie occurred as a result
of environmental negligence of National Lead Industries through
inadequate filtration and capture of combusted depleted uranium
metal waste.
The period of active pollution was 1958-1982 and
aerosol pollution ceased with plant closure, though re-
suspension of polluted soil undoubtedly occurred after plant
closure.
Our recent research has shown that household dust may
have unacceptably high levels of DU; this may be a risk to
health if disturbed--a potential health issue, and certainly a
perceived concern of the community at the present time.
ATSDR's 2004 principle conclusion of merit was that
the level of airborne radioactivity emitted from the plant
represented a distinct health risk during plant operation. The
ATSDR report's lack of recommendations concerning past risk to
health was a puzzling omission from the report and an obvious
source of frustration to the community.
The ATSDR 2004 report has an overemphasis on
ingestion exposure to DU by comparison with the acknowledged
more hazardous inhalation pathway, because the latter may lead
to long-term internal radiation whilst the former is likely to
be cleared quickly in the intestinal tract. This is all the
more important since our recent research has shown that the
uranium aerosol pollution at Colonie is very weakly soluble,
and contains a significant proportion of respirable particles.
This de-emphasis of the inhalation exposure pathway is a
significant weakness of the report.
In the assessment of health risks and exposures, what
is important is getting at an estimate of the cumulative
inhalation uranium exposure of workers and residents; this is
not simple. It needs to be appreciated that it is entirely
wrong to conclude that because urinary uranium levels are
relatively low now that there was/is no health issue. In this
`historic exposure situation' the comparison of current
excretion levels in relation to the overall population is a
flawed basis for health risk assessment.
The task of calculating a cumulative historic
inhalation uranium oxide dose is complex, but can be modelled
using existing, relatively well accepted biokinetic models
along with a range of solubilities of DU oxide particles, using
experimental data, and estimates of excretion of inhaled DU.
The U.S. Army Capstone (2004) report specifically investigated
this issue; the ATSDR report was apparently unaware of it and
in any case chose not to pursue this avenue of investigation. A
fairly thorough discussion of this topic was available in the
period 2000-2004 and for example is contained in the Royal
Society report on DU (2001). I have included an explanation of
this later in the written testimony explaining how current
excretion levels of DU can be used to calculate the much larger
quantities of inhaled uranium during an historic exposure.
The detection of depleted uranium as a component of
the urinary uranium excreted by affected people is a
challenging but feasible measurement; it was feasible in 2003-
04 (via for example the UK DUOB website) when ATSDR concluded
there was no method available, but it had yet to be published
in the refereed literature.
The quantity of inhalable DU oxide deposited in the
vicinity of the Colonie Plant is comparable to the total
aerosolized inhalable DU oxide produced in the entire 1991 Gulf
War conflict; in Colonie, >95 percent of this quantity was
deposited within 2km radius of the NLI plant; in the 1991 Gulf
conflict, the area of dispersion in Iraq-Kuwait was very much
larger and partly in sparsely inhabited areas along the Basra
Road. Thus the environmental pollution and health risk is
likely to have been much higher for Colonie residents than for
Gulf War veterans. This sobering perspective has never been
appreciated or recognized and is all the more unbalanced when
considering how funds have been spent on research into DU and
health.
No credible well-designed health assessment has been
funded or conducted at Colonie; yet, >$190M has been spent on
the NLI cleanup within its perimeter fence, not to mention
funding allocated to ATSDR for its Health Consultation and that
dedicated to other DU-Health research such as the Capstone
study of the U.S. Army. This whole funding situation appears
perverse, misdirected, and lacking a natural sense of balance
(one could say fairness & justice), in my opinion.
In my opinion the `zip code' based cancer occurrence
`studies' cited by the ATSDR Health Consultation and conducted
by NY State agencies were unlikely to accurately identify any
significant rise in illness that might have arisen from long-
term significant inhalation exposure to DU from the NLI plant
of a cohort of heavily exposed workers or residents. The
movement of people with time in and out of the area, the lack
of tracking of the most exposed few hundred individuals, and
the study of former workers unlikely to have lived nearby meant
that this type of study was doomed from the beginning of
delivering insight. Why ATSDR opted to not design a more
targeted study or to more intelligently discuss the
shortcomings of these NY State studies is baffling to me, and
no doubt a serious source of frustration to the community.
The studies that I and my team have conducted at
Colonie, both urinary testing (on a small scale) and
environmental surveying, have been modest in scale and cost,
and were entirely feasible at the time of the 2004 ATSDR
Consultation; the ATSDR paper made no recommendations to
undertake any such study.
Unfortunately the 2004 ATSDR Health Consultation
undertook no new research and seemed uninterested in such
follow-up work; while clearly recognizing the inherent health
risk of the plant, the paper concluded without recommending any
way of redressing the community concerns about uranium
pollution, whether well-founded or not. It is no wonder that
the report satisfied few.
I have solicited feedback about the 2004 report by
the Community Concerned about National Lead; their comments are
very critical of ATSDR. This is primarily because while the
health hazard was clearly admitted, no recommendations for new
research or health screening were made, for reasons that were
poorly articulated and justified. As a scientist, I too find a
puzzling lack of credible justification for the lack of action
arising from the report. The report has therefore made little
if any contribution to knowledge or public understanding of the
scientific and health issues of the Colonie site that were not
already available.
Our research at Colonie 2004-2009
With information from several sources, in 2004 I recognized the
unique situation of significant historic uranium aerosol inhalation
exposure of a large urban population in Colonie, a mixed industrial-
residential part of Albany NY. Its attributes of interest were:
(1) there was a great amount of uranium pollution;
(2) the nature of the pollution was primarily by aerosol
deposition of combusted uranium oxide particles;
(3) it took place over a long period of time but ceased more
than 25 years ago;
(4) many individuals who had lived through the active period
of aerosol deposition were still living in the area; and,
(5) it seemed certain that if individuals living there also
had aerosol-contaminated soil, then they would have inhaled the
toxin over a long period of time.
It thus appeared to be a well-controlled experiment where one had
an opportunity to address the health impacts of those exposed to
inhaled DU, and that such study might have a bearing on the larger
issue of inhaled DU and Veterans' Health. Though this latter problem
falls outside of the remit of ATSDR, I think it is important for
Members of the Committee to gain a perspective on how the Colonie
example could benefit and contribute to other scientific issues of
acute interest to the American Government, namely the health of Gulf
War(s) Veterans.
Chronological perspective on DU research and the Colonie site
To provide a better perspective, I will outline the pertinent
events leading up to the present that bear on my research at Colonie,
DU and Health, and the ATSDR consultation.
In chronological order, they are:
1958-1982: Colonie site uranium pollution;
1984; U.S. Government accepts responsibility of site
from the polluter, National Lead; DU munitions production
shifts to other U.S. plants.
1982-2007: Assessment of site and major remediation
by Army Corps of Engineers within the former National Lead
Industries site costing >$190M.
2001: publication of the WHO and Royal Society papers
on Depleted Uranium and Health, during a period when DU was a
major issue in the American, Canadian, and UK media.
2001: UK government established the Depleted Uranium
Oversight Board (DUOB) to oversee and undertake a voluntary
program of testing of veterans who may have been exposed to DU
through service primarily in the 1991 Gulf Conflict. The
minutes of this Board were available.
The DUOB undertook to establish a reliable urinary DU
exposure test that could potentially detect a milligram-sized
inhaled DU dose after 10 years had passed, in order to satisfy
the concerns of potentially exposed veterans. This test was
available as of late 2003. This was to be a much more sensitive
test than was available any where else in the world. The
program of testing took place between 2004 and 2006. To my
knowledge this capability currently exists only in the UK and
possibly Germany.
The NIGL laboratory of which I am Director was one
facility offering this test and it was engaged in the analysis
of many hundreds of urine samples during this period. I played
a key role in this development and testing.
The Final Report of the DUOB testing program
(published eventually in 2007) showed that no individual tested
in the program was DU-positive.
Because of the preponderance of DU-negative results,
even in 2004 part way through the program, I felt that there
were two explanations possible for these results:
(1) Some of the veterans were significantly exposed to
DU but the passage of time had ensured that residual DU
contamination was undetectable; thus health harm may
have occurred without a DU-positive test.
(2) The veterans with DU-negative test results were
not significantly exposed to DU.
Unfortunately there was no study available at the time to
quantify the residence time of inhaled DU oxide particles, and
both alternatives remained viable explanations of the data; the
debate in the UK concerning DU exposure and Health therefore
could not yet be fully resolved.
In the period around 2001-2004 unpublished
information became available from Iraqi medical officials of an
apparently progressive and significant rise in unusual cancers
and birth defects throughout the 1990s; this was not clearly
verified but Iraqi and some western medical officials
attributed this to DU exposure. This added some anecdotal
evidence that there might be a DU-Health connection even though
other reports were suggesting that the connection between DU
and Gulf War Illness was weak.
In 2004 I learned of the Colonie site; as noted
earlier in this testimony, it appeared to involve a significant
aerosol DU oxide pollution footprint in an urban area, with the
implication that it was likely that many people had a DU oxide
inhalation exposure; thus it to me seemed worth pursuing since
it offered a way to resolve the alternatives expressed above
about the interpretation of the DUOB DU-negative results.
With considerable anticipation of new insight, I read
the ATSDR 2004 report, and while pleased to read of its
conclusion that the uranium emissions during the plant's active
period was hazardous, I was quite disappointed with its lack of
new data/research and its lack of tangible actions and
recommendations for the future. To my knowledge no follow up
work was done by ATSDR related to uranium.
In 2004 I initiated a research project at Colonie,
aimed at providing (1) a modern environmental study to document
the nature and mobility in the environment of the DU oxide
aerosols and (2) urinary tests of potentially significantly
exposed individuals (former workers of the plant and residents
who had lived nearby for years) to determine whether any
urinary DU could be detected. A Ph.D. student (Nicholas Lloyd)
was given the environmentally-oriented project, while I
undertook the urinary testing. We cooperated in these studies
with colleagues at the University at Albany (Dr. David
Carpenter and Dr. John Arnason). Funding for this work was
provided by the British Geological Survey and the UK Natural
Environment Research Council.
In latest 2004 the analysis of the Colonie urine
samples showed that it was possible to detect DU in humans more
than 20-25 years following exposure (eventually published in
2008). This allowed one to favor one interpretation of the
DUOB-tested Gulf War veterans--that they had not acquired a
significant DU inhalation dose. We knew in latest 2004 that our
method of testing offered a way forward to identify and
potentially quantify the cumulative inhalation dose of DU for
the Colonie exposed population; this conclusion had very
important implications for any follow-on actions arising from
the 2004 ATSDR report.
Our environmental study data was progressively
completed in the period 2005-2008; it had several important
conclusions, namely:
(1) DU in soil profiles has very limited mobility,
indicating a lack of rapid dissolution of DU in the
natural environment;
(2) Particles of DU oxide aerosol could be located and
studied in contaminated soil, and in household dry
dusts, and after study (using a synchrotron X-ray
source), it was confirmed that UO2 was the
principle chemical component, a finding that is
expected in thoroughly combusted material; UO2
is the least soluble of any uranium oxide.
(3) UO2 particles form a minor component of
the man-made metal oxide aerosol particles contained in
soil; the bulk of the remainder mainly consists of lead
particles.
(4) Particles of UO2 within soil were found
to have suffered minor (generally <10 percent)
dissolution by being subject to natural weathering for
more than 25 years; this confirms that the combustion
product aerosol emissions from Colonie were relatively
insoluble.
(5) Samples of trees, plants, berries, etc., growing
on contaminated soil contain DU; this indicates that
some component of DU is soluble and taken up in plants.
(6) No sample of soil collected to date, including
those up to seven km (minus five miles) from the NLI
site, is free of DU; the pollution plume is much larger
than was originally thought.
(7) With our data, a calculation of the total mass of
DU emitted from the plant was made, the resultant
quantity being approximately 10 metric tons (give or
take a few). This is comparable to the total
aerosolized DU oxide produced by the Allied Forces in
the entire 1991 Gulf Conflict, demonstrating the
relative magnitude and concentration of DU in the
Colonie site.
2008: Publication of the Parrish et al. paper on the
Colonie site in Science of the Total Environment; this study
when combined with the efforts of the Community Concerned about
National Lead (CCNL), resulted in a renewed effort to obtain NY
State funding for a credible targeted follow-up health study of
affected residents/workers of the NLI site; this activity is
ongoing.
Critique of the ATSDR Health Consultation
Prior to making some criticism of the document, it is important to
note the strengths of the 2004 ATSDR Colonie Health Consultation,
namely:
It provided a good review and summary of the history
of the site and all previous investigations, and brought
together information from a variety of sources.
It used measurements of emissions of radioactivity
from the site available from environmental monitoring to
conclude that there was a significant health risk to those who
lived nearby during the period of active emissions.
It made an effort to have meetings with the community
to present its findings, take note of concerns before preparing
its final report.
It recommended two specific actions related to the
NLI plant, namely,
(1) ATSDR will work with local physicians and provide
information on taking patients' environmental exposure
histories. ATSDR will also make available resources
related to environmental exposure, including
contaminant-specific case studies and fact sheets.
(2) ATSDR is evaluating the feasibility of conducting
a study that would compare the mortality rates of
former NL workers to the mortality rates of the general
public. Former workers likely received the highest
exposures to depleted uranium from 1958 to 1984 during
operation of the facility. Currently, ATSDR is
determining whether relevant past worker records exist.
Unfortunately it also had many shortcomings. I will outline
what I feel are the most important problems rather than
undertake a detailed critique.
The study presents a skewed and narrow portrayal of
the potential hazards of DU in that it over-emphasized the
ingestion-related pathway and underplayed the inhalation
hazard. This may have been influenced by the lack of published
literature on health impacts to cohorts exposed to inhaled DU--
a situation arising because of the rarity of such incidents.
The report appears to have used the lack of literature to
downplay the importance of this problem instead of undertaking
a credible analysis of the inhalation hazard with available
data and models. This should have been done, but was not. The
analysis of the Royal Society (2001), WHO (2001) and Depleted
Uranium Oversight Boards (website 2001 onwards) had fairly
thorough treatment of this issue, but these sources of
information evidently failed to influence the report.
The discussion on pages 15-16 concerns the health
risks of exposure, pathways of exposure, and health survey
design analysis. It has undoubtedly left members of the public
confused because it contains inconsistencies, is partly wrong,
lacks detailed logic and explanation, and is sort of a shopping
list of assertions and conclusions without satisfactory
elaboration.
This section should have explained the inhalation hazard and
its consequences in detail, since this was the main exposure
pathway for the Colonie area (i.e., by breathing aerosols
during the plants operation). In my opinion, addressing the
health hazard of DU oxide inhalation exposure is the single
most important reason to have conducted this Health
Consultation. Therefore it should have noted the relative
magnitude of pollution of the site--one of the largest
concentrations of DU aerosol pollution in the world, if not the
largest. It should have explained that the consequences of
inhalation of respirable particles of DU oxide would lead to
long residence times in the lungs, on the order of years, with
consequent internal organ irradiation by alpha emitters and the
likely illness that a major dose of such radiation could have
led to. It should have sharply contrasted the differences
between the inhalation and ingestion pathways and their
implications of short (with ingestion) and long (with
inhalation) residence times in lungs. It should have mentioned
the consequences to subsequent urinary testing of these two
ingestion and inhalation scenarios. It could have and should
have summarized biokinetic models that are in theory capable of
modelling (i.e., predicting retrospectively) the magnitude of
cumulative inhalation dose if the time elapsed since exposure
was known and if the daily excretion of DU can be determined.
It should also have outlined generally the method of detection
(i.e., explained what bioassays methods were available,
especially the isotope tests) and their detection limits, to
explain to the public whether or not tests available at the
time were capable of detecting such residual DU in urine. It
should have acknowledged that a urinary measurement made more
than 20 years after exposure would be expected, even with very
large initial exposure, to be orders of magnitude lower in
concentration than it would have been initially. There is much
missing in this section; only ATSDR officials can provide the
rationale for such a superficial treatment of some of these
issues. The section appears to avoid dealing with the main
issue.
The statement on top of page 16 states that if DU had
been found in urinary tests, that such tests would be incapable
of indicating `where the DU came from.' This is largely wrong;
isotope analysis is a very powerful technique to establish
plausible links (or refute them) between sources and exposures.
This is all the more surprising since they discuss the NLI
plant as the only source of DU for the uranium pollution of the
site (on page 19). There is essentially a dismissal of the role
that isotope analysis of uranium could play in testing this
link. The report shows a lack of insight and understanding of
this whole area of measurement. This is all the more surprising
since analytical laboratories within CDC itself are conducting
research into such measurements of uranium in urine. Perhaps
there is a lack of joined up communication within CDC in this
regard. One could be forgiven for concluding that they just
were not interested in recommending any kind of urinary uranium
testing.
Pages 16-17 discuss the issue of existing health
surveys and the possibility of a new health assessment. I found
this an exceptional frustrating aspect of the study and the
single most disappointing part of the paper. Having concluded
already that there was a significant health risk from uranium
aerosols during the plant's emission history, they use these
two pages to first explain why the earlier zip code surveys of
NY State officials could not have worked in identifying any
possible excess of cancers arising from the plant. I would have
thought this would have prompted them to explain how a well-
designed health survey ought to be designed for this situation,
but they failed to do this. Instead, on page 17 the report
appears to signal a resignation that no possible survey could
be designed that might identify whether or not excess illness
might have arisen in the cohort of exposed individuals. This is
not a satisfactory outcome of a Health Consultation of this
type.
To provide a satisfactory basis for doing nothing, they
needed to explain why it would have been impossible to conduct
a survey to locate former workers at the plant and individuals
who lived in close proximity to the plant for many years. These
people could have been ranked in terms of potential exposure by
duration of exposure, and proximity to areas of very high
uranium in soil (as a proxy for the aerosol uranium
concentration).
Ironically the Concerned Citizens about National Lead group
was able to gather a lot of this sort of information and had
some of it at the time of the report's writing. In our work we
used their information effectively. In my time dealing with the
Colonie site, I have had conversations with residents of a
street adjacent the site in the heavily exposed pollution halo
who communicated an alarming number of health issues (mainly
cancers) and deaths in the past 25 years in houses in that
particular area. Precautionary instincts suggest this ought to
be investigated as a priority. No questions of this type were
asked by the Consultation. This to me seems a major oversight.
Part of the reason not to pursue further health
assessments appears to have been predicated on the perceived
inability to detect a low percentage of excess cancers that
might be attributed to the pollution in a much larger cohort
population (thousands of people). I fully agree that to use the
thousands of people in a current zip code as the `exposed
population' is a poor experimental design for a health
assessment of the Colonie situation. Such an approach stands no
chance of succeeding in being insightful for the Colonie
situation where only a relatively small number of individuals
(probably less than 1,000) was likely to have suffered a
significant inhalation dose. This is in essence the flaw with
the former NY State surveys. However, to do nothing and
recommend nothing in the face of this is not a satisfactory
option or outcome.
Instead, the report should have recommended conducting a
survey on the most exposed group of people; it should have
located the several hundred most heavily exposed individuals,
wherever they might now live, in addition to collecting death
statistics from cancer (for example) from those who formerly
lived near the site during its active years. This type of
systematic census work is both necessary and feasible. The
health issues with this targeted cohort could have been studied
to either (1) discover any alarming illness patterns) relative
to the general population, or (2) show that nothing was
identifiably anomalous. Had the survey identified excess
illnesses, then a campaign of appropriate-sensitivity uranium
isotope testing could have been commissioned to see whether DU
could be identified as part of the excreted uranium, in order
to provide quantitative data on possible past exposure to DU.
This is the sort of investigation that would have been a
satisfactory outcome to the ATSDR report; it needn't have been
hugely expensive or undertake the work.
The ATSDR authors were aware of inhalation exposure
computer models that could be used to make predictions on
exposure of an inhaled compound using particle grain size,
airborne concentration at the point of emission, density of
particles, and meteorological data. They could have made
assumptions about particle size and density and used existing
meteorological data to do this, but they did not. Give the
relative ease with which our own research was able to isolate
particles from contaminated soil or household dust, and study
their general size, shape and composition, the lack of interest
or awareness of this avenue of investigation represents a
significant oversight, and may indicate a lack of interest in
pursuing a credible, reasonably in-depth investigation into the
DU pollution.
On pages 30-31 in addressing direct concerns of the
community the report provides a misleading answer by failing to
mention the dangers of internal alpha radiation (in lungs in
inhalation exposure) after noting that airborne emissions were
the main hazard; the report obfuscates the issue here by
appealing to the benign nature of alpha radiation to skin,
which mixes up internal and external doses. This confusion was
entirely unnecessary.
On page 35 in addressing the 5th concern of the
community, the report explains the challenges in designing a
health survey and attributing any outcomes to NLI pollution. A
lot of the reason the report recommends that no health survey
would work is because the report concluded there was no means
of establishing a distinct exposure to DU. The authors would
have known that standard existing uranium bioassays and uranium
isotope urine tests had defined limits of detection that would
limit the ability of these tests to detect DU. They should have
realized that significant progress had been made on method
improvement and that further improvement in reducing detection
limits would be likely. They should have noted this in the
report and recommended that should methods become available
that could potentially quantify the past exposure via a urine
test, that this whole issue should have been revisited. They
should have recommended this be done.
On page 37-38 are the conclusive recommendations and
`planned actions' arising from the Consultation. No
recommendations are made with regards to DU exposure at all. In
the planned actions are mentioned the following two items:
1) ATSDR will work with local physicians and provide
information on taking patients' environmental exposure
histories. ATSDR will also make available resources
related to environmental exposure, including
contaminant-specific case studies and fact sheets.
2) ATSDR is evaluating the feasibility of conducting a
study that would compare the mortality rates of former
NL workers to the mortality rates of the general
public. Former workers likely received the highest
exposures to depleted uranium from 1958 to 1984 during
operation of the facility. Currently, ATSDR is
determining whether relevant past worker records exist.
I am not aware that there has been any progress on these two
`planned actions'; I have also checked with CCNL, the main community
group and they agree that no action on these was done following the
publication of the Consultation. This has increased the sense of
frustration by the community and is to say the least, puzzling. ATSDR
should comment on this lack of follow-up actions, if in fact this is
the case.
Scientific Recommendations to address environmental health issues at
NLI Colonie NY site
The ATSDR report has failed to resolve any of the outstanding
environmental health issues arising from NLI pollution at Colonie. A
sensible course of action for ATSDR for the future would be to embrace
the shortcomings of its report and take a new approach putting in place
a number of actions to make some substantial progress. For example,
Community consultation in light of this hearing and
recent research
Establish funding for limited health assessment study
Exposure screening of cohort with highest likelihood
of significant inhalation exposures--workers and residents,
perhaps several hundred individuals
Design and implement targeted health assessment of
cohort, including investigation of death statistics of those
likely to have had a relatively heavy exposure
Evaluate health data using precautionary ethos given
the small cohort size
Investigate further cleanup of indoor and outdoor
properties where resuspension of heavily contaminated dust
could be a problem.
Comments on the ATSDR mission/remit and its performance
The remit of ATSDR Health Consultations is articulated in the ATSDR
website is to ``serve the public by using the best science, taking
responsive public health actions, and providing trusted health
information to prevent harmful exposures and diseases related to toxic
substances''.
At Colonie, while noting the useful case history of the site and
especially its main conclusion that there existing a substantial health
risk from uranium emissions during the active years of the NLI plant,
the Agency in my opinion has failed to locate, present, and apply the
best science to Colonie, and when combined with the lack of any
identifiable responsive health actions arising from its investment of
resources, it is hard to conclude that in this case, it has come
anywhere near fulfilling its mission.
Recommendations to Congress concerning ATSDR
ATSDR's remit forms an important component of public health policy
and mitigation in the United States by undertaking prompt assessment
and recommending a course of action to mitigate toxic hazard risks and
derive new knowledge concerning unusual toxin situations. The work is
important and needs to be highly credible and to reflect the best
knowledge available anywhere.
The Colonie example shows that ATSDR needs to work considerably
harder in order deliver credible assessments and solutions commensurate
with its remit.
In cases like Colonie where it appears it had insufficient
experience with an unusual hazard (in this case the inhalation hazard
of uranium oxides) it needs to ensure that it taps into the best
knowledge available, not just the in house expertise. The Colonie
consultation could have been miles better if it had acquired an up to
date knowledge of concurrent activities taking place on this same
hazard in other government agencies (U.S. Army research on DU
inhalation; CDC uranium isotope measurement; National Academy of
Sciences reports on DU) and in other countries (UK DUOB screening
program, Royal Society biokinetic models of inhaled uranium exposure
and health risks for example). They appear to have failed to `leave no
reasonable stone unturned' in the Colonie study.
Governments (and certain industries) may fear what they might
uncover by doing a thorough study into a politically-charged issue like
depleted uranium. My view is that it is best to be transparent, face up
to the risks of doing the credible science where it appears justified
both fiscally and scientifically, do it well, and communicate clearly
the issues, risks and conclusions. I think it is likely that the
science will put some issues to bed instead of letting them fester
without resolution for years. The public deserve this transparency, and
responsible environmental stewardship dictates that we should
understand the environmental consequences of industrial processes (and
negligence) and assess risks properly in order to decide how best to
find credible solutions to these issues.
Other Supporting Documents
Summary of current community concerns
The following is a letter with concerns of the community submitted
to ATSDR arising from the Health Consultation. It is my impression that
most if not all of these concerns are still current because they were
not addressed in the report or in any follow-up actions. I have relied
on Anne Rabe of the Community Concerned with National Lead for this
input.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Other materials/research relevant to the Colonie site.
Illustrations of aspects of the Colonie site, urine
testing, particles emitted by the NLI plant, etc.
2003 DUOB extract--summary and annex on biokinetic
models
2006 Health Physics paper on the measurement of
uranium isotopes in urine
2008 Science of the Total Environment on the Colonie
site and urine tests there
2009 Journal of Atomic and Analytical Spectroscopy
paper on the Colonie uranium oxide particles and their isotope
composition.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Biography for Randall R. Parrish
American by birth (in 1952), the son of parents in the medical
business, I lived in the U.S. for all of my youth (Oklahoma, Colorado,
Arizona, Vermont). My geoscience career began at Middlebury College
(Vermont) during my BA degree studying Geology. I opted to undertake
graduate degrees in Canada at the University of British Columbia to
study with the late R.L. Armstrong, a most insightful geologist and
isotope geochemist. During the period 1974-83 I undertook field work
and research in the western Cordillera of Canada (British Columbia
mainly) where I combined field work in tectonics with laboratory and
theoretical work in the university environment, with a spell teaching
at a community college in southern British Columbia. I did my Ph.D.
thesis on the rise of the Coast Mountains of British Columbia, which
involved a lot of hard field work in remote places. I fortunately
escaped any dangerous incidents with bears, rivers, aircraft crashes
and so forth that are known in this profession. My first substantial
real job was at the Geological Survey of Canada in Ottawa where I was
employed from 1983-1996 extending my work that combined geochronology
(the dating of rocks and minerals to work out geological history) and
field and tectonic studies (in western Cordillera of Canada, much of
Canada's vast Precambrian Shield, Saskatchewan, NW Territories, Baffin
island, Northern Quebec, Ontario and Quebec, Yukon Territories, but
also other studies in the U.S., & Nepalese Himalaya). I also supervised
research at Carleton University Ottawa in geoscience. My work in Canada
is best known for the tectonic research in British Columbia and for the
innovations to mass spectrometry and geochronology methods that I and
my colleague the late J. Chris Roddick were largely responsible for,
including the synthesis of rare isotopes for geochronology (205Pb).
With the downturn in fiscal climate in Canada in the mid-1990s that
required major down-sizing of the public service, I managed change
there as Head of the Geochronology Research Facility, but subsequently
in 1996 moved to Britain to lead the Natural Environment Research
Council's Isotope Geoscience Laboratory, co-sited at the British
Geological Survey in Nottinghamshire in a cross appointment arrangement
through the University of Leicester, my main employer. This is still my
current position. In this capacity I have shouldered a range of
responsibilities including re-structuring of the facility, renewing its
scientific program and its liaison with the UK geoscience academic
community, raising funding for staff growth, program growth, and
instrumentation upgrading and expansion (we have 13 mass spectrometers
and equipment worth about 6M). Our facility is not a
research `empire' but a collaborative research facility that scientists
all over the UK can access--we therefore know how to cooperate and
collaborate effectively. Every five years we get put through a very
rigorous funding review; each time our performance has improved with
the facility now being very stable and well funded. I do a lot of Ph.D.
student training both in the field and laboratory environment as part
of our remit. My responsibilities expanded in the UK to include a
diversified research portfolio extending well beyond traditional
geology and geochronology to include heavy metal pollution, different
methods of geochronology, innovating methods of analysis in geoscience
using laser ablation ICP-MS techniques, climate change, provision of
solutions made to a very high calibration standard to worldwide
laboratories for inter-laboratory comparisons, and lately, applying my
analytical and scientific expertise to issues of depleted uranium and
health, and the screening of veterans for exposure. I applied my skills
to working out a method to detect DU in urine following an exposure
more than 20 years prior; this was a major improvement to prior
methods. Once I began the depleted uranium and health work, I have
tried to make good measurements the cornerstone of the science, let the
direction of the work be guided by advances and insights gained through
those results, and to follow the science of DU and health until I
become satisfied that I have done all that I could to provide insight.
This has put me on variable sides of the shifting political fence, with
the testimony of this hearing being an interesting collateral task.
I hold research grants in the UK to study a wide variety of
problems, mainly involving the evolution of the geology and landscape
in the eastern Himalaya, and in improved calibration of the geological
time scale through a joint NIGL-MIT-NSF project called EarthTime. My DU
research has been funded through piecemeal small grants and contracts,
and a funded Ph.D. studentship. I coordinate the thematic research
program of the Natural Environment Research Council concerned with
depleted uranium and will write a major review report on this topic
this year. Our largest contract in the DU business was that to measure
uranium isotopes in urine for the Depleted Uranium Oversight Board and
we played a part in that major government program funded by the
Ministry of Defense. That program was aimed towards the military's duty
of care to UK military veterans.
I have led our national facility and worked with its talented staff
to move the facility to considerable prominence as an environmental
science isotope facility of international stature where a number of
research areas are on par with the best world labs. These include the
DU work, high precision U-Pb geochronology, laser ablation in situ U-Pb
geochronology, multi-element isotope analysis in support of climate
research in the recent geological record, and silicon isotope analysis.
In the past five years, I have increasingly been involved with
grant proposal adjudication in the UK and elsewhere, editorial duties,
and undertaking strategic reviews of facilities, management and
operation of portions of large research centers within the UK,
including my host institution the British Geological Survey. I consider
myself a very good scientific leader and manager gained through
experience with colleagues during employment, and guided by common
sense. Unusually, I continue to maintain an active role in research and
innovative analytical duties; this has extended my period of
credibility as a scientist, thankfully!
Further information about our facility is available from http://
www.bgs.ac.uk/nigl/index.htm
Chair Miller. Thank you, Professor Parrish. Your use of the
phrase ``immoral and perverse'' made me feel better about
perhaps my opening statement being a bit harsh, and I do want
to thank you for coming a considerable distance to come to this
hearing today.
Dr. Parrish. It was my pleasure.
Chair Miller. We have been joined by the Ranking Member of
the Full Committee, Mr. Hall. Mr. Hall, do you have any
statement?
Mr. Hall. Chair Miller, thank you for having this hearing
and bringing these men before us here. I was particularly
interested in Sal Mier's testimony, his long-time service at
the Centers for Disease Control. I listened to him, and you are
welcome to come by my office, and I thank Dr. Broun. I
appreciate it. I don't have any questions because I don't know
what other questions you will have, but I will try to get back
here and listen to one of the other panels, but I thank you
very much.
Chair Miller. Thank you. You don't represent Midlothian, do
you?
Mr. Hall. No, but when the legislature is in session, you
never know where you are going to be.
Chair Miller. Mr. Hall covering all bets.
Mr. Camplin.
STATEMENT OF MR. JEFFREY C. CAMPLIN, PRESIDENT, CAMPLIN
ENVIRONMENTAL SERVICES, INC.
Mr. Camplin. Good morning. I would like to thank the
Subcommittee Members and staff for holding such an important
hearing on the lax behavior and misuse of science by ATSDR
leadership and staff. My name is Jeffery Camplin and I am
President of Camplin Environmental Services Inc., a safety and
environmental consulting firm based in Rosemont, Illinois. My
chosen research specialty is asbestos. I have been a volunteer
for the Illinois Dunesland Preservation Society since 2003
investigating why ATSDR purposely downplays the chronic
asbestos exposure of millions of Illinois citizens each year.
My story begins in 1993 when I brought my wife and three
kids to Illinois Beach State Park located on the Illinois Lake
Michigan shoreline north of Chicago. After building sandcastles
and burying each other in the sand, I heard my wife exclaim
``Look in the car. It is full of sand. It is in the kids' hair,
it is in their ears, it is in their shoes, it is everywhere.''
Sand eventually ended up in our laundry room as well. Little
did I know at the time that my wife along with millions of
other families should have been saying, ``Look at the asbestos
contamination from the beaches. It is in our car, it is on our
kids, it is in our home.''
I have been working for the last six years with Mr. Paul
Kakuris, President of the Illinois Dunesland Preservation
Society. Our research indicates that ATSDR has violated its
mission to serve the public by purposely not using valid
science, by not taking responsive public health actions and by
providing untrustworthy health information. Specifically, ATSDR
has become a complacent agency, choosing to produce outdated,
inferior work products when they know more-valid science
exists. When ATSDR's ethics and competence are challenged, a
great wall of arrogance and denial appears from their
leadership to strenuously fend off requests for accountability.
ATSDR also takes advantage of the public's gullibility to trust
an agency that is ethically bankrupt. The egotistical
leadership and complacent culture at this once great agency
needs a total overhaul. However, that is not enough.
We are here today to demand accountability for the harm
caused to public health by inexcusable and deliberate behavior
of ATSDR staff in downplaying elevated levels of toxic
microscopic asbestos along the entire Illinois Lake Michigan
shoreline. Evidence demonstrates that U.S. EPA and the State of
Illinois along with ATSDR bungled the cleanup of an asbestos
Superfund site at the south end of Illinois Beach State Park,
allowing trillions of asbestos fibers to be released from an
unfiltered pipe into Lake Michigan to this very day. Their
incompetence also allowed large areas of asbestos-contaminated
lake sediments to be dredged and dumped on and offshore at
heavily visited public beaches. Federal agencies and the State
of Illinois then generated rigged data to conclude the massive
asbestos contamination they created was not hazardous to the
millions of citizens who frequent these areas. Illinois is well
known for nurturing a culture of public officials with less
than honest and ethical behavior. Illinois citizens seized upon
the opportunity--I am sorry--Illinois officials seized upon the
opportunity presented by the complacent culture at ATSDR to
protect their unethically symbiotic agendas. They obtained
rubber-stamped approval of their intentionally flawed federal
and State reports.
In order to conceal the unethical behavior of their staff,
ATSDR will tell you the science is still developing while they
knowingly continue to use severely flawed and outdated asbestos
risk assessments. What they don't tell you is, the current
science completely discredits and invalidates all of their past
asbestos human health evaluations in Illinois as well as
hundreds of other sites throughout the Nation. ATSDR stubbornly
refuses to acknowledge this fact.
Just this week ATSDR arrogantly issued another health
consultation which intentionally fails to warn the public about
deadly microscopic amphibole minerals they found in beach sand
and air. Instead, ATSDR recklessly continues to invite families
to a shoreline chronically contaminated with asbestos, that is,
as long as they don't touch the visible pieces of debris during
their visit. Yet there is no recommendation to the public
regarding the microscopic asbestos that gets on our kids, gets
in our cars, gets in our homes and ultimately enters our lungs.
Maybe Dr. Frumkin can explain his staff's findings that
deceitfully concealed the hazard from the public.
Another example of ATSDR's indiscretion includes the review
of one of their beach asbestos results in 2006 that the EPA
identified as potentially harmful to health. ATSDR dismissed
the criticism by the U.S. EPA, stating the beaches were safe
anyway.
The fraudulent findings of ATSDR create a welcome
permission slip for the continuing dredging of toxic asbestos-
contaminated sand in Illinois. Spreading the contaminated
dredge material on the shoreline increases the risk of
mesothelioma cancer rates in Lake and Cook counties along Lake
Michigan that already have elevated mesothelioma rates when
compared to national averages. How high must the body count get
before ATSDR admits there is a problem?
In 2004, then-Illinois State Senator Barack Obama best
summed up our feelings when asked by a reporter about the
asbestos contamination along the Illinois shoreline. Our
current President said at the time, we can't have our kids
swimming in areas that might be contaminated with asbestos, and
then he stated they should consider shutting down the asbestos-
contaminated shoreline.
Precautionary protections are necessary to address the
continuing public health disaster and egregious violations of
public trust from getting any worse. The first step is for
ATSDR to acknowledge their past studies are flawed. Next, limit
the public's exposure to asbestos-laden shoreline beaches until
scientifically valid exposure assessments can be completed in
an open, inclusive and transparent manner. The final step is to
hold all parties liable for their actions. ATSDR officials Mark
Johnson, Jim Durant, John Wheeler and Howard Frumkin along with
State of Illinois and U.S. EPA officials must be held
accountable for their egregious and potentially criminal
behavior that resulted in millions of innocent families being
unwittingly exposed to deadly amphibole fibers.
On behalf of the Illinois Dunesland Preservation Society
and the citizens of Illinois, I want to thank you for this
hearing.
[The prepared statement of Mr. Camplin follows:]
Prepared Statement of Jeffery C. Camplin
Good morning. I would like to thank the Subcommittee Members and,
staff for holding such an important hearing on the lax behavior and
misuse of science by ATSDR/CDC leadership and staff. My name is Jeffery
Camplin, and I am President of Camplin Environmental Services, Inc., a
safety and environmental consulting firm based in Rosemont, Illinois.
My chosen research specialty is asbestos. I have been a volunteer for
the Illinois Dunesland Preservation Society since 2003, investigating
why ATSDR purposefully downplays the chronic asbestos exposures of
millions of Illinois citizens each year.
My story begins in 1993 when I brought my wife and three children
(two to three years old) to Illinois Beach State Park, located on the
Illinois Lake Michigan shoreline north of Chicago. After building sand
castles and burying each other in the sand I heard my wife exclaim,
``Look in the car, it's full of sand. It's in the kids' hair, in their
ears, and in their shoes . . . it's everywhere.'' Sand eventually ended
up in our laundry room as well. Little did I know at the time that my
wife, along with millions of other families, should have been saying,
``Look at the asbestos contamination from the beaches. It's in our car,
it's on our kids, and it's in our home.''
I have been working for the last six years with Mr. Paul Kakuris,
President of the Illinois Dunesland Preservation Society. Our research
indicates that ATSDR has violated its mission to serve the public by
purposefully not using valid science, by not taking responsive public
health actions, and by providing untrustworthy health information.
Specifically:
ATSDR has become a complacent agency, choosing to
produce outdated, inferior work products when they know that
more valid science exists.
When ATSDR's ethics and competence are challenged, a
great wall of arrogance and denials appears from their
leadership to strenuously fend off requests for accountability.
ATSDR also takes advantage of the public's
gullibility to trust in an Agency that is ethically bankrupt.
The egotistical leadership and complacent cultured this once great
agency needs a total overhaul. However, that is not enough: We are here
today to demand accountability for the harm caused to public health by
the inexcusable and deliberate behavior of ATSDR staff in downplaying
elevated levels of toxic microscopic asbestos along the entire Illinois
Lake Michigan shoreline.
Evidence demonstrates the USEPA and the State of Illinois, along
with ATSDR, bungled the cleanup of an asbestos Superfund site at the
south end of Illinois Beach State Park, allowing trillions of asbestos
fibers to be released from an unfiltered pipe into Lake Michigan to
this very day. Their incompetency also allowed large areas of asbestos-
contaminated lake sediments to be dredged and dumped on and off shore
at heavily visited public beaches. Federal agencies and the State of
Illinois then generated rigged data to conclude the massive asbestos-
contamination they created was not hazardous to the millions of
citizens who frequent these areas. Illinois is well known for nurturing
a culture of public officials with less than honest and ethical
behavior. Illinois officials seized upon the opportunity presented by
the complacent culture at ATSDR to protect their unethically symbiotic
agendas. They obtained ``rubber stamped'' approval of their
intentionally flawed federal and State reports.
In order to conceal the unethical behavior of their staff, ATSDR
will tell you that ``the science is still developing'' while they
knowingly continue to use severely flawed and outdated asbestos risk
assessment methods. What they don't tell you is that current science
completely discredits and invalidates ALL of their past asbestos human
health evaluations in Illinois and at hundreds of others sites
throughout the Nation. Yet, ATSDR stubbornly refuses to acknowledge
this fact.
Just this week, ATSDR has arrogantly issued another ``Health
Consultation'' which intentionally fails to warn the public about the
deadly microscopic amphibole mineral fibers they found in beach sand
and air. Instead, ATSDR's recklessly continues to invite families to a
shoreline chronically contaminated with asbestos . . . that is as long
as they don't touch the visible pieces of asbestos debris during their
visit. Yet there is no recommendation to the public regarding the
microscopic asbestos that get on our kids, get in our car, get in our
homes, and ultimately enters our lungs. Maybe Dr. Frumkin can explain
his staff's findings that deceitfully conceal this hazard from the
public.
Examples of other indiscretions by ATSDR include:
1. ATSDR generated beach asbestos exposure results in 2006
that the USEPA identified as potentially harmful to human
health. ATSDR dismissed the criticism by the USEPA along with
our ethics violation charges and published the report stating
the beaches were safe anyway.
2. In over a decade of testing, ATSDR has never performed or
reviewed any air sampling data that was obtained during the
hot, dry, dusty months of June through mid-August. They
intentionally test outside the beach season when the beaches
are damp and cooler.
3. ATSDR found no elevated risk to human health from the rare
but virulent asbestos fiber called tremolite found on Chicago's
Oak Street Beach. Tremolite asbestos-contamination has already
devastated the town of Libby, Montana with one of the highest
mesothelioma cancer rates in the Nation.
The fraudulent findings of ATSDR created a welcome permission slip
for the continued dredging of toxic asbestos contaminated sand in
Illinois. Spreading the contaminated dredge material on the shoreline
increases the risk of mesothelioma cancer rates in Lake and Cook
counties along Lake Michigan that are already elevated when compared to
the national average. How high must the body count get before ATSDR
admits there is a problem?
In 2004, then Illinois State Senator Barrack Obama best summed up
our feelings when asked by a reporter about the asbestos contamination
along the Illinois shoreline: Our current President said at the time,
``We can't have our kids swimming in areas that might be contaminated
with asbestos.'' He then stated they should consider shutting down the
asbestos contaminated shoreline.
Precautionary protections are necessary to address this continuing
public health disaster and egregious violation of the public trust from
getting any worse.
The first urgent step is for ATSDR to acknowledge
that their past studies are flawed.
Next, limit the public's exposure to the asbestos-
laden shoreline beaches until scientifically valid exposure
assessments can be completed in an open, inclusive, and
transparent manner.
The final step is to hold all parties liable for
their actions. ATSDR officials (Mark Johnson, Jim Durant, John
Wheeler, and Howard Frumkin), along with State of Illinois and
USEPA officials must be held accountable for their egregious
and potentially criminal behavior that has resulted in millions
of innocent families being unwittingly exposed to deadly
amphibole asbestos fibers.
On behalf of the Illinois Dunesland Preservation Society and the
citizens of Illinois, I want to thank you for this opportunity.
I will now address any questions you may have.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Biography for Jeffery C. Camplin
Since 1991, Jeff has been President of Camplin Environmental
Services, Inc. He is a Certified Safety Professional (CSP) and
Certified Professional Environmental Auditor (CPEA). He has been a
licensed asbestos professional in the State of Illinois since 1986.
Jeff is a nationally recognized safety and health expert who is an
accomplished author and public speaker. Jeff has been an instructor of
USEPA accredited asbestos abatement training courses for over 20 years.
In 2003, Mr. Camplin became a non-paid consultant for the Illinois
Dunesland Preservation Society involved with evaluating issues related
to the presence of statistically elevated levels of visible and
microscopic asbestos and other amphibole asbestos fibers present in
beach sand along the Illinois Lake Michigan shoreline. He determined
that asbestos public health assessments published by ATSDR in 2000 and
2006 were not based upon scientifically valid data. Mr. Camplin has
challenged several of these ATSDR studies without receiving credible
responses from the Agency.
Mr. Camplin has uncovered evidence of ATSDR staff rigging asbestos
studies by manipulating sampling protocol, analytical methods, and risk
models used in their studies. Examples of this rigging includes
sampling during and immediately after rain events, using larger pore
sized filter media in violation of standard protocols, and avoiding air
sample testing during the hot, dry, beach season of June through mid-
August. He also caught ATSDR staff on video violating ethical standards
by exposing the unprotected public to high levels of asbestos fibers
during ATSDR's activity-based asbestos testing on public beaches. These
findings not only discredit health evaluations performed at Illinois
Beach State Park and Oak Street Beach (Chicago), but also hundreds of
other asbestos health evaluations performed by ATSDR throughout the
United States using the same flawed and unscientifically sound
protocols.
Mr. Camplin has been interviewed by the USEPA's Inspector General's
Office who is currently completing a nearly two-year investigation into
the asbestos contamination issues along the Illinois Lake Michigan
shoreline. The investigation focuses on the manipulation and rigging of
studies by the State of Illinois, USEPA, and ATSDR to fraudulently
conclude that the statistically elevated levels of microscopic asbestos
fibers present in beach sand is safe for the public to disturb. He
seeks to have proper scientifically supported studies performed in the
future in an open, publicly inclusive, transparent manner, with
independent third party peer review. Mr. Camplin and the Illinois
Dunesland Preservation Society also seek to have those members of ATSDR
held accountable for their egregious ethical and professional conduct
violations during their manipulation of data in the creation of
scientifically unsound human health studies.
Chair Miller. My opening statement seems more and more
temperate.
Dr. Hoffman.
STATEMENT OF DR. RONALD HOFFMAN, ALBERT A. AND VERA G. LIST
PROFESSOR OF MEDICINE, MOUNT SINAI SCHOOL OF MEDICINE;
DIRECTOR, MYELOPROLIFERATIVE DISORDERS PROGRAM, TISCH CANCER
INSTITUTE, MOUNT SINAI MEDICAL CENTER
Dr. Hoffman. Thank you. For the last 30 years my research
and clinical practice have revolved around the investigation of
a group of chronic blood disorders termed myeloproliferative
disorders, which include polycythemia vera, essential
thrombocythemia and primary myelofibrosis. These are serious
disorders characterized by excessive production of red cells,
platelets and white blood cells and are associated with
excessive blood clotting, bleeding and eventual evolution to
acute leukemia.
In 2005, a mutation in an intracellular kinase termed JAK2
was found to be present in patients with myeloproliferative
disorders and was shown to play a role in the development of
this particular group of disorders. The mutation allows blood
cell production to occur in myeloproliferative disorders in the
absence of signals provided by hormones that normally control
blood cell production leading to the production of too many red
cells, white cells or platelets in patients with this disorder.
Most importantly for this discussion, the JAK2V617F mutation
has been shown to provide an almost foolproof means of
diagnosing patients with myeloproliferative neoplasms, since it
can be detected using molecular methods in over 95 percent of
patients with polycythemia vera. Since there are numerous other
causes of too many red cells or polycythemia other than this
form of blood cancer, physicians frequently had great
difficulty in making this diagnosis. With the advent of the
molecular test for JAK2V617F, the accuracy of definitively
diagnosing this disorder has been greatly elevated. Although
blood cells with JAK2V617F are occasionally observed in
patients with other kinds of blood cancers, it is rarely, if
ever, observed in normal people.
My first contact with the Agency for Toxic Substances and
Disease Registry began in the summer of 2006. Dr. Vince Seaman,
an epidemiologist and toxicologist at ATSDR, first called me to
ask me some questions about the nature of polycythemia vera and
about the possibility of environmental insults increasing the
incidence of this blood cancer. I was a bit skeptical about the
significance of this polycythemia vera cluster that Dr. Seaman
and his colleagues were then investigating in Carbon, Luzerne
and Schuylkill counts in eastern Pennsylvania in response to an
invitation made by the Pennsylvania Department of Public
Health. After a series of phone calls with Dr. Seaman, I gained
a greater degree of comfort with these investigations, that
this cluster was potentially important from a scientific point
of view and that it presented a possible public health danger
to the citizens of the State of Pennsylvania. In the past,
links between environmental exposures and clusters of
polycythemia vera have not been well documented. In my
discussions with Dr. Seaman, I emphasized the difficulty of
making the clinical diagnosis of polycythemia vera and that the
newly described molecular assay would provide a simple,
inexpensive means of making this diagnosis with certainty
merely by testing blood drawn from the study subjects. Dr.
Seaman agreed and we set out to create a means of obtaining
blood specimens for subjects who agreed to participate in the
study. We proceeded with the JAK2V61 testing due to my belief
that these studies were the state-of-the-art in 2009, although
there was initial pushback on the part of the Agency and I felt
that it was important to do this test to confirm the diagnosis
of polycythemia vera. By the end of 2007, these analyses had
been completed showing that about 53 percent of the subjects in
this study area fulfilled both clinical and molecular
diagnostic criteria of having this hematologic cancer. One
patient had diagnostic features of polycythemia as determined
by a committee of experts but did not have the JAK2 mutation.
The confirmed cases appeared to be clustered around numerous
EPA Superfund sites and sites of waste coal power plants in the
tri-county area. Remarkably, to me, at least, four of the
reported cases of polycythemia vera were located along Ben
Titus Road, a stretch of about 100 homes scattered along a two-
mile stretch. Each of these cases were confirmed to be
JAK2V617F positive and therefore to indeed have polycythemia
vera. Remarkably, the greatest number of cases of polycythemia
vera were in the Tamaqua area, a sparsely populated area not in
the area of greatest population near Wilkes-Barre.
With this data in hand, I and Dr. Seaman wrote an abstract
in August 2007 for consideration for presentation at the 2007
meeting of the American Society of Hematology to be held,
ironically, in Atlanta, Georgia, in December. Several
conference calls were held with numerous members of the ATSDR
staff who checked the data and went over the content of the
abstract word by word and agreed with the data and conclusions
of the abstract vocally during these numerous conversations.
The abstract----
Chair Miller. Dr. Hoffman, there is a five-minute
limitation. We are reasonably generous with it. Your whole
written statement will be part of the record. Could you
summarize in perhaps a paragraph?
Dr. Hoffman. Sure. The abstract eventually was accepted by
the Society in November of that year and it was accepted as an
oral presentation. I then went on to create this presentation
that was presented before the Society in December of 2007. A
representative of the Agency management team was to appear at
the presentation but at the last moment, although he was based
in Atlanta, he refused to attend or wasn't able to attend.
Several days prior to my presentation at Atlanta, the ATSDR
unbeknownst to me issued a press release stating that the
abstract presented results that were premature and
scientifically flawed. Medical colleagues in Hazleton called me
to inform me of this disclaimer because reports had appeared in
the local press. I was of course shocked and was incredulous
about the lack of forthrightness demonstrated to me by my
presumed collaborators at ATSDR. After my arrival in Atlanta I
was contacted on my cell phone on repeated occasions by
officials at ATSDR requesting that I either withdraw the
abstract entirely, state prior to my presentation that the
Agency disagreed with my conclusions or present an abridged
version of the data. I presented the abstract in its entirety
and it was well accepted by the audience at the American
Society of Hematology. In order to obtain further peer review,
we then went about upon Dr. Seaman's return from a trip to
Mozambique on ATSDR business to submit this publication to a
peer-review journal. Prior to that submission, the Agency
insisted of Dr. Seaman and myself to perform further geospatial
analyses which to a statistical point of view confirmed the
findings that were present in our abstract showing that there
was a higher incidence of polycythemia vera in this area and
that those cases were essentially around these areas of high
toxic exposure.
From my point of view, the mission of the Agency is to
generate and communicate credible scientific information about
the relationship between hazardous substances and adverse
events that affect human health and to promote responsive
public health actions. My experience was that in the case of
polycythemia vera in eastern Pennsylvania was that the ATSDR
did not accomplish this goal but only accomplished it
eventually with relentless prodding to complete the needed
investigations. My sense was that if the Agency was left to
themselves, they would have preferred to ignore the whole
problem. ATSDR seemed to be committed to a course of ignoring
and discrediting a mounting body of evidence which suggested
the presence of a cluster of polycythemia vera patients in this
tri-county area. With the full publication of our paper in
February of 2009, the Agency really I think greatly turned
around and began to become much more serious about these
investigations and hopefully in the future we will be able to
expand this area, which I think is of great interest. Thank you
for your time.
[The prepared statement of Dr. Hoffman follows:]
Prepared Statement of Ronald Hoffman
My name is Dr. Ronald Hoffman. I am the Albert A. and Vera G. List
Professor of Medicine at the Tisch Cancer Institute of the Mount Sinai
School of Medicine in New York, NY. At that institution I am Director
of the Myeloproliferative Disorders Program. For over 31 years I have
been a practicing clinical hematologist. Hematology is the study of the
diseases of the blood. In addition, I am a laboratory based scientist
who has investigated the stem cell origins of blood cancers. I am an
author of over 400 scientific papers and have served as the President
of both the International Society of Experimental Hematology and the
American Society of Hematology. I am the lead editor of the textbook
Hematology, Basic Principles and Practice, which is in its 5th edition
and is the leading textbook of hematology in the United States and
Europe. I have held prior faculty positions at Yale University School
of Medicine, Indiana University School of Medicine, Stanford University
School of Medicine and the University Of Illinois College Of Medicine.
For the last 30 years my research and clinical practice has
revolved around the investigation of a group of chronic blood cancers,
termed the myeloproliferative disorders with include polycythemia vera,
essential thrombocythemia and primary myelofibrosis. These disorders
are characterized by excessive production of red cells, platelets and
white blood cells. These disorders are frequently associated with
excessive blood clotting or bleeding and evolution to acute leukemia.
These disorders are now known to be blood cancers which originate at
the level of blood stem cells. In 2005 a mutation of an intracellular
kinase termed JAK2 was found to be present in patients with
myeloproliferative disorders. JAK2 is responsible for transmitting
signals to blood cell elements inducing them to produce greater numbers
of such cells in response to hormones that normally regulate blood cell
production. The JAK2 mutation was discovered by a group in France
headed by Dr. William Vainchenker. The mutation allows blood cell
production to occur in myeloproliferative disorder marrow cells in the
absence of the signals provided by the hormones that normally control
blood cell production, thereby leading to the production of too many
red cells, white cells or platelets in patients with these blood
cancers. This JAK2V627F mutation also been shown to provide an almost
fool proof means of diagnosing patients with myeloproliferative
neoplasms since it can be detected using molecular methods in over 95
percent of patients with polycythemia vera, and 50 percent of patients
with essential thrombocythemia and primary myelofibrosis. Previously,
polycythemia vera was diagnosed based upon a variety of costly
diagnostic tests as well as relatively nonspecific clinical signs and
symptoms. Since there are numerous other causes of too many red cells
or polycythemia other than this form of blood cancer, physicians
frequently had great difficulty in definitively making this diagnosis.
With the advent of the molecular test for JAK2V617F, the accuracy of
definitively diagnosing polycythemia vera has been greatly enhanced.
Although blood cells with the JAK2V617F are occasionally observed in
patients with other kinds of blood cancers it is rarely if ever
observed in normal people.
My first contact with the Agency for Toxic Substances and Disease
Registry (ATSDR) began in the summer in 2006. Dr. Vince Seaman, an
epidemiologist and toxicologist at ATSDR first called me to ask me some
questions about the nature of polycythemia vera and about the
possibility of environmental insults increasing in the incidence of
this blood cancer. I had never heard of the ATSDR and at that time had
not been previously acquainted with Dr. Seaman. I was a bit skeptical
about the significance of a cluster of polycythemia vera patients that
Dr. Seaman and his colleagues were then investigating in Carbon,
Luzerne and Schuylkill counties in Eastern Pennsylvania in response to
an invitation made by the Pennsylvania Department of Public Health.
After a series of phone calls with Dr. Seaman, I gained a greater
degree of comfort with these investigations and became concerned about
this high incidence of polycythemia vera in this area that had been
initially identified by the Pennsylvania Department of Public Health. I
thought that this cluster was potentially important from a scientific
point of view and that it presented a possible public health danger to
the citizens of Pennsylvania. In the past, links between environmental
toxic exposures and clusters of polycythemia vera had not been well
documented. In my discussions with Dr. Seaman I emphasized the
difficulty of making the clinical diagnosis of polycythemia vera and
that the newly described molecular assay for JAK2V167F would provide a
simple inexpensive means of making this diagnosis with certainty merely
by testing blood drawn from the study subjects. Dr. Seaman agreed and
we set about to create a means of obtaining blood specimens from the
subjects who agreed to participate in the study. Specimens were
collected in Tamaqua, shipped to my laboratory and analyzed for
JAK2V617F during the period from December 2006 through April 2007.
These specimens were shipped in a de-identified manner to my laboratory
and the assays were performed without knowledge of the patient source.
Initially I had asked that ATSDR to provide some support to cover the
expenses for the performance of these assays. To my surprise the Agency
administrators were unwilling to supply such funds and were actually
resistant to their performance. Their unwillingness to receive input
about the significance of the extraordinarily large numbers of patients
with this hematological cancer in this small area of Pennsylvania or to
consider the value of a molecular epidemiological tool to make their
task easier surprised me. Their lack of comfort in collaborating with
scientists outside their community or their area of expertise and to
readily incorporate new scientific advances into their research efforts
while investigating a possible cluster of blood cancer patterns seemed
odd, and closed minded in nature. I frequently felt that the members of
the Agency management team viewed that this molecular epidemiological
approach was overkill and unnecessary since they had already concluded
that the cluster was not significant or worthy of further
investigation. We proceeded with the JAK2V617F testing without the
support of the Agency due to my belief that these studies were the
state-of-the-art in 2009 and were required to confirm the diagnosis of
polycythemia vera The molecular testing for JAK2V617F was supported
with funds that I had received from the Myeloproliferative Disorders
Research Foundation for different purposes. The Foundation agreed to
this diversion of resources. Dr. Seaman and his team sent us fifty six
blood specimens which we evaluated for the JAK2V617F mutation. Over
half of these specimens were JAK2V617F positive and an additional five
patients from the area were shown to be JAK2V617F positive based upon
information present in their medical records; I also assisted ATSDR in
establishing a committee of medical experts to examine the medical
records of the participants in the study be certain that the clinical
characteristics of these individuals were consistent with a diagnosis
of polycythemia vera.
By the end of April 2007 these molecular analyses had been
completed showing that about 53 percent of the subjects in the study
area fulfilled both clinical and molecular diagnostic criteria of
having polycythemia vera. One patient had diagnostic features of
polycythemia vera as determined by our committee of experts but did not
have the JAK2V617F mutation The confirmed cases appeared to be
clustered around the EPA superfund sites and sites of waste coal power
plants in the tri-county area. Remarkably, four of the reported cases
of polycythemia vera were located along Ben Titus Road, a stretch of
about 100 homes scattered over a distance of mile; each of these cases
was confirmed as being JAK2V617F positive indicating that these
patients did indeed have polycythemia vera. Remarkably, the greatest
numbers of cases of polycythemia vera were in the Tamaqua area, a
sparsely populated area, not in the area of greatest population density
near Wilkes-Barre where the cancer registry data (which is based upon
diagnoses being made using clinical criteria) had indicated that the
greatest numbers of patients had lived. With this data in hand, I and
Dr. Seaman wrote an abstract in August 2007 for consideration for
presentation at the 2007 meeting of The American Society of Hematology
Meeting which was to be held in December 2007 in Atlanta, Georgia. Over
20,000 hematologists from around the world usually attend this meeting.
Several conference calls were held with numerous members of the ATSDR
staff who checked the data and went over the content of the abstract
word by word and agreed with the data and the conclusions of the
abstract vocally during these numerous conversations prior to its
submission. The abstract was then submitted for consideration for
presentation at the American Society of Hematology Meeting. Although
numerous ATSDR staff were aware of this submission and its content, Dr.
Seaman, without my knowledge, apparently did not have the abstract
formally cleared by the Agency. Dr. Seaman explained to me that he was
new at the Agency and was not fully aware of the clearance process for
documents of this type. This omission was surprising to me and appeared
to represent a technicality since so many of the ATSDR staff had gone
over the content of this abstract and had already agreed with its
content during our numerous phone conversations. In October of 2007 I
attended a community meeting dealing with this subject which was
organized by the ATSDR and the Pennsylvania Department of Health in
Hazelton, Pennsylvania. Prior to the meeting I had lunch with many of
the junior staff of ATSDR who had come to Hazelton. My collaborator at
the Agency, Dr. Vince Seaman was noticeably absent. Several weeks prior
to the meeting he had been sent to Mozambique for a mandatory training
period dealing with agency business. I felt that the timing of Dr.
Seaman's trip was odd and showed poor judgment on the part of the
Agency. Dr. Seaman had participated in the field of work that led to
the report and had the confidence and trust of the community. Many of
the community members saw Dr. Seaman as a so called ``straight
shooter.'' At the lunch many of the junior staff of the ATSDR bemoaned
Dr. Seaman's absence, but were energized by the findings that had
resulted from the collaboration between Dr. Seaman and my laboratory .
About 75-100 community members attended the meeting and there were a
series of presentations, some by the professionals in the community, by
ATSDR senior staff and by myself. The conclusions articulated by the
ATSDR spokesperson seemed at odds with the results summarized in our
abstract that had just been submitted to the American Society of
Hematology. The ATSDR claimed that groups of polycythemia vera cases
were scattered throughout the tri-county area in no predictable
pattern. They also emphasized that only half of the reported cases
actually had polycythemia vera based upon our molecular analyses but
failed to mention that even with this caveat in mind that the incidence
of polycythemia vera was still extraordinarily high in this region.
ATSDR appeared to minimize the importance of these findings and
concluded that it would be virtually impossible to identify the
inciting agent that might possibly have led to the polycythemia vera
cluster. The ATSDR spokesperson seemed to feel that this was a
fruitless effort and was not really worthy of further attention. I was
impressed by the anger of the community at the meeting, there sense of
futility and betrayal. At the meeting I mentioned to the audience that
we have submitted an abstract to the American Society of Hematology
about our findings and that the scientific community would assess the
validity of our conclusions. I attempted to inform them that if this
material was found scientifically meritorious that the scientific
community would demand further investigation of the problem. They
appeared skeptical. As I drove back to New York that evening with my
scientific colleague at Mount Sinai, Dr. Mingjiang Xu we talked about
the experiences of the day. We commented how we felt, that the ATSDR
had misinterpreted and prematurely drawn conclusions about the data
that we had participated in generating. We commented that many of the
ATSDR management were unwilling to think out of the box and how their
unwillingness to investigate the unknown or to address difficult
problems was the antithesis to the type of scientific investigation
that we were so familiar with in the biological and medical sciences.
Also we questioned if there was some outside constituency who ATSDR was
responding to that made them act like they just wanted this whole
matter to go away. Instead of viewing this as a challenging and
important scientific problem of possible importance, we felt that they
had concluded that it was not important or that it was futile to try to
further investigate its origins.. Their lack of familiarity with the
power of modern cellular and molecular biology and their unwillingness
to apply these tools in an innovative fashion to this problem was
surprising to me. I concluded that this type of nihilism was
antithetical to the performance of good science.
In the middle of November I was e-mailed by the American Society of
Hematology that our abstract had been accepted as an oral presentation.
Only 12 percent of the thousands of abstracts submitted to this meeting
receive a high enough grade to be presented at an oral session. I
immediately informed Vince Seaman of the acceptance. Vince was in
Mozambique on assignment but he and several other ATSDR staff members
helped me create the presentation and reviewed its content and
repeatedly altered the content until they approved it and the written
speech that I was to present at the meeting. There were repeated
attempts and requests on the part of ATSDR management to avoid showing
maps which might indicate a geographic relationship between the cases
of polycythemia vera and the known EPA super fund sites.
A representative of the Agency management team was to appear at the
presentation but at the last moment, although he was based in Atlanta,
he stated that it was not necessary and that he would not be attending.
Several days prior to my presentation at the Atlanta meeting the
ATSDR--unknownst to me--issued a press release stating that the
abstract presented results that were premature and scientifically
flawed. Medical colleagues in Hazelton called me and informed me about
this disclaimer by the Agency, reports of which had appeared in the
local press in Pennsylvania and asked me what I was going to do. I was
a bit shocked and was incredulous about the lack of forthrightness
demonstrated to me by my presumed scientific collaborators at ATSDR. I
told the physicians in Hazelton that I still believed that the data
were correct and that I intended to present the information and let the
scientific community evaluate its merit. I must tell you I felt
betrayed by the leadership of ATSDR since I had made great efforts to
get these leaders involved in the content of the abstract and obtain
their approval. After my arrival in Atlanta, I was contacted on my cell
phone on repeated occasions by officials of ATSDR requesting that I
either withdraw the abstract entirely, state prior to my presentation
that the Agency disagreed with my conclusions or present an abridged
version of the data. I was intimidated by these frequent calls by
government officials which created a great degree of stress and anxiety
for me. I was also outraged at this obvious attempt at intimidation. I
refused to alter the presentation and presented it in its entirety
although ATSDR continued to undermine its validity in the press. I felt
justified in these actions since numerous members of the Agency had
previously repeatedly approved the content of the abstract. The
presentation was well received and the scientific community accepted
the possibility that environmental contaminants might play a role in
the development of polycythemia vera in the patients in the Tamaqua
area.
After receiving this positive feedback from the members of the
American Society of Hematology, I realized that the only way that I
could further validate the data was for it to be published in a peer
reviewed journal so that once and for all this data would be in the
public domain and be open to further scientific input and criticism.
Upon Dr. Seaman's return from Mozambique we began writing this
manuscript. The senior leadership of the Agency continued to doubt
these conclusions and insisted that the Agency's biostatisticians
perform sophisticated geospatial analyses to further test the validity
of our findings. I strongly agreed with their scientific rigor not
wanting to be associated with incorrect information. This cluster
analysis was done using Satscan, a geospatial software tool developed
by the National Cancer Institute for the detection of cancer clusters.
The chance of the likelihood of the polycythemia vera cluster being a
random event based on the total number of cases in the tri-county area
was calculated by the Agency statisticians independently of my input or
that of Dr. Seaman. A single statistically significant cluster of
polycythemia vera patients (p<0.001) was identified near the geographic
center of the three counties. The incidence of polycythemia vera in the
cluster area was 4.3 times higher than that in the rest of the county.
The probability of one finding greater than 15 cases of polycythemia
vera in this area and 18 cases in the remainder of the tri-county area
was one in 220,000. The probability of the cluster being a random event
based on the total number of confirmed cases in the tri-county area was
1/2000. Several sources of hazardous materials were located in or near
the high rate area of polycythemia vera. Seven of the 16 waste coal
power plants in the United States are located in or within this area or
within a few miles of the area. Seven U.S. Environmental Protection
Agency super fund sites are contained within this area and another
possible cluster area that was identified. This manuscript was
completed and revised on numerous occasions with the participation of
members of the ATSDR and the Epidemiology Branch of the Pennsylvania
Department of Public Health. Numerous revisions were made on the
manuscript based upon the suggestions of the ATSDR and the Pennsylvania
Department of Public Health without compromising the validity of the
information presented. The manuscript was reviewed and revised word by
word during several teleconferences. This manuscript was accepted by
the peer reviewed journal, Cancer, Epidemiology, Biomarkers and
Prevention published in February 2009. During the submission process, a
number of minor changes were made in the manuscript to accommodate the
Journal's reviewers and specific publication format requirements. This
is a routine process and ATSDR did not require the final version of the
manuscript to be re-cleared. After the manuscript was published, the
chief epidemiologist at the Pennsylvania Department of Health, who had
actively participated in the word-by-word editing of the manuscript
even though he was not an author, became very upset when he found that
the manuscript had been altered. He made numerous calls to high-placed
officials at ATSDR in an effort to get them to discredit the
manuscript. The ATSDR management resisted these efforts as they
recognized that the manuscript contained factual, scientifically valid
information and there was no basis for the claims being made by the
Pennsylvania Department of Health.
I also participated in a round table discussion of expert
researchers convened by ATSDR and the Pennsylvania Department of Public
Health in Philadelphia later in 2008 to identify research priorities
about further investigating the extent of the cluster of cases of
polycythemia vera in the tri-county area and determining possible
factors that might have led to this cluster. The data that was
presented in the paper published in Cancer, Epidemiology, Biomarkers
and Prevention I believe is important and valid. I believe that it
provides information which justifies continued realistic concerns that
there is a relationship between a cluster of cases of polycythemia vera
and serious environmental exposures in the tri-county area. This
concern clearly merits careful, additional, detailed objective rigorous
scientific investigation to better define the magnitude of this problem
and what are the possible causes of such an event. This information is
of potential importance not only for the population of this tri-county
area but to all citizens of the United States because it provides a
possible link between the environment and blood cancers, an association
that has not to date been well documented.
ATSDR is the leading federal public health agency responsible for
determining human health effects associated with toxic exposures,
preventing continued exposures and mitigating associated human health
risks at the 1200 National Priorities hazard waste sites targeted for
cleanup by the U.S. Environmental Protection Agency. The mission of the
ATSDR is stated to be ``to generate and communicate credible scientific
information about the relationship between hazardous substances and
adverse human health effects and to promote responsive public health
actions.'' My experience was that in the case of the polycythemia vera
cluster in Eastern Pennsylvania that ATSDR accomplished this goal only
because of the relentless prodding to complete the needed
investigations due in part to the efforts of some of the talented staff
at the Agency working in collaboration with our group at the Mount
Sinai School of Medicine in New York and the continued input of the
physicians in the tri-county area and of course the residents of this
area. My sense was that if the Agency was left to themselves they would
have preferred to ignore the whole problem. ATSDR seemed committed to a
course of ignoring and discrediting a mounting body of evidence which
suggested the presence of a cluster of polycythemia vera patients in
the tri-county area. The Agency appeared to be overly responsive to
possible outside influences which compromised its ability to evaluate
the severity of this problem. Rather than questioning the validity of
this cancer cluster in a pro-active manner, their initial response was
to discount its significance and to express on numerous occasions the
futility in attempting to link the cluster of these cases of
polycythemia vera to any specific environmental toxins. This type of
work is obviously difficult and time consuming but appears to be the
core function of this agency. If the Agency is not willing to evaluate
such clusters in a pro-active and objective fashion and closely
interact with individuals with different and complementary areas of
expertise then the possibility of their accomplishing their stated
goals is very small. The scientific nihilism and lack of respect for
the integrity of scientific investigation initially displayed by
members of the Agency surely compromises the stated mission of this
agency. Their unwillingness to look objectively at the compelling data
generated by our investigations is puzzling and disturbing to me. The
Agency has many talented, skilled energetic professionals in its ranks
who have expressed to me frustration and concern about their being held
back from fully investigating the polycythemia vera cluster in
Pennsylvania. The reasons for these actions and their rationale remain
unclear. Most recently the Agency has become increasingly more
committed to more vigorously investigating the polycythemia vera
cluster and its causes. I congratulate them on this recent change in
policy. This behavior is much more appropriate and consistent with the
stated mission of the Agency and will likely to lead to a growth of a
valid body of information that will provide new insight into the
significance of the polycythemia vera cluster in Eastern Pennsylvania
and its possible causes. In addition these investigations will likely
provide new information about a possible link between blood cancers and
environmental toxins. Such information will hopefully be helpful in
decreasing in the future the incidence of such deadly cancers in areas
of such high risk for exposure to environmental toxins.
Biography for Ronald Hoffman
Dr. Ronald Hoffman is the Albert A. and Vera G. List Professor of
Medicine at the Mount Sinai School of Medicine, and Director of the
Myeloproliferative Disorders Program at the Tisch Cancer Institute,
Mount Sinai Medical Center. He is the principal investigator of the
Myeloproliferative Disorders Research Consortium, with an NCI funded
program project dealing with myeloproliferative disorders. His research
interests deal with stem cell biology and myeloproliferative disorders.
He is a former president of the American Society of Hematology and the
International Society of Experimental Hematology.
Discussion
Chair Miller. I want to thank all the witnesses for your
testimony and for appearing here today. We will now recognize
each Member present for five minutes of questioning. The Chair
now recognizes himself. I now recognize myself for five minutes
of questioning.
Explanations of ATSDR's Deficiencies
Dr. Hoffman, do you have an impression, an opinion of what
accounts for ATSDR's unwillingness to look at the data from the
cancer cluster that you looked at? Do you think it is the
leadership of ATSDR or do you think it is the culture of ATSDR?
Is there external pressure? Is there a reason that comes to
your mind to explain their reluctance to acknowledge or find
environmental exposure that may cause the cluster, the cancer
cluster?
Dr. Hoffman. Well, first of all, I want to state that I
think there is a number of very talented investigators there
and there is a very talented staff so there is a lot of good
folks there. My sense is that they felt that it was a futile
effort since there were so many environmental toxins in that
area to essentially develop a one-to-one relationship between a
particular environmental toxin and the development of
polycythemia vera. That led to a sense of futility. What was
articulated to me on numerous occasions was that even if we
found out that the incidence of polycythemia vera was greatest
in this area, what were we really going to do about it, could
we essentially define an additional--the known agent. That kind
of thinking or neolism, I would call it, is very foreign to me
because I am used to in a laboratory at least solving or trying
to attack very complex scientific problems, and I really
thought that that attitude was pervasive, this feeling that one
could not identify the toxic agent, and that led to, you know,
sort of snowballed into sort of talking away or speaking away
or downplaying the significance of this cluster. I think what
was also not perceived was the importance of the cluster. The
importance of the cluster really went beyond just this
particular area because it linked very conclusively, especially
with the sophisticated statistical analysis that I congratulate
them on performing which was very hard science showing that it
was highly unlikely that this was random. So what it really
shows is that blood cancers in general could be related to
environmental toxins. That is a very important question and
observation. The point is, is this a futile event? No, it is
not a futile event making this association because if we are
aware of this, then we can essentially define the cause of this
and hopefully develop chemopreventive agents to prevent
additional patients from getting these cancers. So I think they
were essentially frozen in time, and because of this sense of
futility and perhaps a sense of understanding the whole gamut
of hematologic malignancies, they didn't really appreciate the
importance of it.
Peer Review
Chair Miller. Dr. Hoffman, you congratulated ATSDR on their
statistical analysis and on the unlikely possibility that it
would be random.
Dr. Hoffman. Right.
Chair Miller. You have had your work peer reviewed. I
assume you are competent to do peer review. Have you looked at
enough of ATSDR's work to know how well it would fare in peer
review?
Dr. Hoffman. Mr. Miller, I am really not an epidemiologist.
I mean, I am a hematologist and a blood scientist. Prior to
this interaction which started on 2006, I had never heard of
this agency so I am really incapable of evaluating their other
work.
Chair Miller. Do you think that there would be a value in
requiring peer review for at least some of their assessments?
Dr. Hoffman. I felt from my perspective, I wanted my work
evaluated by outside reviewers. I wanted it evaluated and
presented at a scientific meeting where I could get feedback
from my peers. I also wanted it to go to a scientific journal
where people could show me that I was wrong because I was not
really interested in presenting or publishing incorrect data.
That is the way I was brought up scientifically. I think that
is a healthy way to act within any kind of investigative effort
if you are going to do real science.
More Explanation of Deficiencies
Chair Miller. Mr. Mier, you used to work for the CDC. You
never heard of ATSDR but you were inclined to assume that they
would do reliable work and that assumption you do not think
proved to be correct. What do you think is the reason for that?
What do you think happened? Why do you think they do not do the
job that you thought they would do?
Mr. Mier. You know, I don't know if it is just their
reluctance to go after an industry. I know that in Texas, at
least my feeling is that there is not much balance between the
need to prosper economically, to have jobs, and the need to
care for public health and the environment, and in our state my
biggest concern is with the State environmental agency and my
biggest concern was why ATSDR did not closer evaluate the data
that they were looking at upon which to make sweeping
generalizations about public health. To me, the air monitoring
system was so suspect. I am not a scientist, but based on other
scientists that I have dealt with have always told me that, and
there is so much tinkering that can be done with the various
aspects of the monitoring system. And why they would not--not
just ATSDR but the State public health agency with which they
have a cooperative agreement with in Texas, why they would not
look at the empirical evidence. I always felt that the best
monitors were the animals in our community, much better than
any mechanical device that we could have, but why they would
just not want to look at our animal issues as the potential for
a sentinel for human health.
Chair Miller. My time has expired, and I will try to be
reasonably indulgent with the other Members as a result.
Dr. Broun for five minutes.
Mr. Broun. Thank you, Chair Miller. I appreciate it.
Potential Fixes
We each have five minutes to ask questions so I am going to
ask a pretty broad question of each of you all and so if you
would, try to answer it within 30 seconds and we will go
forward. If you were a dictator, how would you fix ATSDR? What
would you do? I will start with Mr. Mier.
Mr. Mier. Boy, you know, to me it is a cultural thing.
Someone needs to go in there to let them know that----
Chair Miller. I am sorry, Mr. Mier, your mic is not on.
Mr. Mier. Oh, I am sorry. There is nothing wrong in going
after or looking at an illness closely when it might
potentially be related to an industry. I think there is a
tremendous reluctance to do that. I understand it is a very
complicated science but to run away from it and not look at
strong empirical evidence, to me I just can't understand that.
When I was dealing in my own humble way looking at viruses or
bacteria and the issues that I dealt with when I worked with
CDC, there was never any quarrel, but the dynamics changed
drastically when you point a finger at an industry.
Mr. Broun. Thank you, Mr. Mier. We need to fix it if there
is a problem, which obviously you all think there is a huge
problem there. We are trying to look to try to find out--this
is an investigation and oversight committee. We need to have
some--I would like to hear some suggestions of how to fix the
problem and not just wonder. So Professor, do you have any
suggestions of how we can fix this problem?
Dr. Parrish. I mean, I think big organizations have inertia
and if you want to change them, I think the first thing I would
do if I was dictating would be to--I would clarify what the
remit is, what is the mission of the Agency and what is its
relationship to other public health agencies and states, for
example. I know this because ATSDR bumps up against these other
things from time to time. So you need to clarify what your
boundaries are, and then I think once you have that mission
really clear, you have to recruit the leadership and the senior
management team to implement the vision for the Agency and make
sure they have the resources so they can actually pursue that
mission with vigor. That is what I would do.
Mr. Broun. Mr. Camplin.
Mr. Camplin. Two things. One, I would recommend that they
open up the process a little bit more on the very front end so
there is a little bit more agreement and buy-in along the whole
way as well as having that third party oversight, the peer
review oversight. We have requested that on numerous occasions
and it falls upon deaf ears. The other side of it is
accountability. There are policies and procedures in place that
they are supposed to be following and there doesn't seem to be
any kind of accountability and I know in our case at the
Illinois Beach State Park, we would love for this committee to
request the FBI to meet with myself along with Mr. Paul Kakuris
of the Illinois Dunesland Preservation Society so we can turn
over evidence of what we believe is criminal activity as well.
Mr. Broun. Doctor, I would love to talk to you about the
JAK2 mutation and all those things as a fellow physician, but
again, if you were dictator, what would you do to fix this? And
I certainly believe in peer review as a physician. We look at
those types of things. And I congratulate you on your research
in this--into these blood diseases.
Dr. Hoffman. Well, I guess I am a little bit more
optimistic about this culture. I think there are--again, I will
repeat, there are excellent people there. This is not a
deficiency in the talent of the staff. I think what they really
need to be is basically cut loose and be told to do good
science and unrestricted science. I think the submission of
work to peer review journals should be encouraged because once
that was accomplished and once the paper was accepted,
everything turned around, and in fact when the Pennsylvania
Department of Health when they finally saw our manuscript were
upset about some of the conclusions that were made. ATSDR to
their credit actually said that they weren't going to change or
deny anything because they had shown that it was correct and it
was peer reviewed. So from my perspective, going through this
over a couple of years with them, I think they need consultants
that have a lot of scientific information and can bring more to
the table and then they should be cut loose to essentially test
whether these things are scientifically valid. If not, their
resources will be depleted. They have to find out what is
really, really important and then they have to go after it as a
scientific mission.
Mr. Broun. Thank you all. Chair, I am about out of time and
I just--we are going to submit written questions for you all to
look at. I am sure that I look forward to your answers further.
Chair Miller. Thank you, Dr. Broun. In the last Congress,
Mr. Rohrabacher was a Member of the Committee so everyone
else's adherence to the five-minute rule looked pretty strict
by comparison but if everyone adheres to the five-minute rule,
I am going to have to change my own conduct.
Mr. Grayson. Oh, I am sorry. Ms. Dahlkemper is next.
Ms. Dahlkemper. Thank you, Mr. Chair.
Geographic Prevalence of Deficiencies
I believe one of the biggest roles of government is public
safety, and each of you are from a different area of the
country. I am from Pennsylvania where obviously Dr. Hoffman is
from, but you are all from different parts of the country and
we are seeing sort of a retelling of the story. Do any of you
have other areas where you have talked with colleagues kind of
dealing with this same type of issue in terms of the conduct of
ATSDR? It is open to any of you.
Dr. Parrish. I will just say, first of all, I don't because
I live in the United Kingdom so I will drop out of that.
Mr. Camplin. I will mention that at least on the asbestos
side of things, I have talked with many of the people over in
Libby, Montana, where there is currently an investigation going
on with W.R. Grace and their exposure to asbestos there, and
the persons I have talked to, they consider ATSDR and EPA more
of the dark side or the evil side than the actual polluters,
W.R. Grace themselves. They do not agree with their science and
they do not agree with the politics that are there as well.
Ms. Dahlkemper. Mr. Mier or Dr. Hoffman, have either one of
you had any talk with other colleagues in other areas of the
country who have had problems with this agency?
Mr. Mier. I talked to a few in Louisiana and other parts of
Texas but frankly, my wife and I have been--we are retired
grandparents and we have been so busy researching and
addressing this issue that I haven't spent a lot of time
talking to other people except that when I felt that we were
going to have the same people looking at it again in the same
old way and not getting an objective new look at it, that is
when I begged for help from scientists around the country that
were familiar with these issues and had them review our draft
consultation report.
Public Awareness
Ms. Dahlkemper. And my other question to all four of you, I
guess, is, the people in the communities where you are dealing
with, how much of this information has been put out to the
general public, what is the reaction. You know, Mr. Mier, you
still live in Midlothian. I mean----
Mr. Mier. I tell you, this is a very sensitive issue in our
community. When we are talking about potentially implicating
four industries with as many employees and family members as
are involved, it is a very sensitive issue and so they are very
defensive about pointing any fingers at any of the industries
so it is a very sensitive issue to discuss in our community
both at city government and even on the school board. So there
are very few of us that are actually working on it and
addressing it and we are looked at in a very different,
negative light, I think but a lot of people in the community,
unfortunately, and our only concern frankly is our
grandchildren and other children and children yet to be born in
our community and that is why are we looking at it. We are not
satisfied with the answers that we are getting and we think
that there may be some problems and we are not satisfied with
the way it has been looked at so far.
Ms. Dahlkemper. Thank you for your courage.
Chair Miller. Each of the witnesses and our Members can
make a point of taking the microphone. Although we can hear
you, there are others who are watching this on the Internet, et
cetera, and it is helpful for recording the hearing later.
Mr. Camplin. I would like to make one point about that.
Without a doubt, the public does give the Agency a lot of
credibility when they put any kind of report out and so there
is a doubt. When we challenge anything that they say, they tend
to get the benefit of the doubt and it isn't until we are able
to prove motive--because that is what they would say, why would
an agency like this, such a prominent agency, put out such
faulty reports. And when we explain the motives, then it
becomes very clear. But that is one of the problems in the
community is, they believe in these agencies. They believe in
what this agency at least used to stand for.
Ms. Dahlkemper. Yes?
Dr. Parrish. I mean, I could just say that in the situation
of Colonie, New York, the industry that did the polluting is
long gone, so it is a legacy issue, and I think generally the
health consultation done there added very little new knowledge.
It didn't seem--it caused a great deal of frustration in a way
because I think expectations were very high that this was going
to add new insight, provide solutions and so forth and it
basically did none of those things. And so, you know, on the
one hand I know there are a lot of people in that area in
government and industry that basically would like the whole
issue to sort of go away and be buried but on the other hand,
in particular the research that we did certainly served to
raise awareness of the issues and, you know, by undermining
part of the methodology that ATSDR used in their health
consultation, it has actually sort of in a certain portion of
the community provided a way forward, I think, for progress in
the future that was otherwise completely stalled.
Ms. Dahlkemper. Thank you.
Chair Miller. The gentlelady's time had only expired by a
little bit.
Mr. Bilbray.
Mr. Bilbray. Thank you, Mr. Chair.
Dr. Hoffman, I want to thank you for not just your
testimony but also highlighting again that coal-fired power
plants leave a legacy of destruction far beyond air pollution
and a sad state of affairs, if I may say it again, that while
we talk about the executive branch not doing enough oversight
here and not looking at this issue, at the same time the
legislative branch, this Congress is still buying coal-fired
electricity to power our lights overhead, and never pass up a
chance to take a cheap shot, so I want to put that out. You
know, clean coal is as logical as safe cigarettes, and thank
you for bringing up that there are other issues.
Asbestos
Mr. Camplin, your work with the asbestos problem here,
specifically this site, just for my own information, are we
talking short fiber, long fiber or is it a mixture of both at
this site that you were working with?
Mr. Camplin. It is not only a mixture of short and long
fibers but they are finding predominantly amphibole minerals,
which are much, much more toxic, and that is even more
disturbing because they put disclaimers in a lot of their
reports saying in fact that the risk modeling may significantly
underestimate these minerals that are there, so there is some
debate on what type of asbestos is toxic. However, what they
are finding on the beach there is no debate about it. It is the
most virulent, amphibole forms of the mineral.
Mr. Bilbray. Yes, in California ARB, we found there was a
distinct separation that has to be, you know, to really be
precise on this. Of course, at the same time we are talking
about that, our roads are paved with serpentine, which is all
asbestos and everybody that drives down a back road in the
Sierra Nevadas is being exposed.
Mr. Camplin. Well, it is the State mineral of California.
Mr. Bilbray. Yeah. Well, I guess it is appropriate with our
air quality. But traditionally with toxicology there are two
major measurements. One is level exposure and duration of
exposure, and though asbestos is different because certain
fibers, certain types can lodge in the lungs and maintain there
and continue to irritate and create the problem. Do you think
that the Agency might have been using like your instance the
short duration of exposure as a justification to reduce the
risk level from the toxicology point of view?
Mr. Camplin. It is even more obvious than that. If you were
going to test beach activities, I would ask maybe Dr. Frumkin
why his team has never reviewed data from June, July or early
August, which we would consider the beach season, and why
approximately 30 to 40 percent of the time that they do air
monitoring it happens to be either raining or it just did rain.
So that alone we think skews the data tremendously, and then
getting into their protocols themselves and the outdated risk
models they use, that just complicates things even further.
Mr. Bilbray. Okay. Well, coming from southern California,
my perception is it is always raining in your part of the
world.
Mr. Camplin. It is.
Mr. Bilbray. That is the challenge that we get over there.
You know, the Texas model I guess really kind of highlights
too the fact that when we get into these groups that somehow
when we try to get this agency to straighten out, we are
treating a symptom of a deeper problem, and that is, places
like Texas not having clean, inexpensive electricity so we can
stop drawing on these dirty, cheap sources that create the
problem. But I appreciate all your testimony.
Local Health Protection
Mr. Chair, my biggest concern is that when we talk about
public health protection as the gentlelady said and we say it
is government, I just would like to remind all of us as
somebody who comes from a background of being the Agency in the
neighborhood, the frontline of health protection is not those
of us in the Federal Government. We are the last line of
protection. The first line is the local community, the local
environmental health department, the local air district, and
one of the biggest things I want to do is make sure that the
Feds are there to support the local effort. We have seen with
Katrina what happens when the locals wait for the Feds to show
up, as opposed to what you saw in San Diego during our fires,
they kept saying FEMA did so well. It is only because the
locals didn't wait for FEMA to do it, FEMA came in and helped,
and one of the things I want to make sure is that when we
reform this approach that it is one of coming in and helping
the local community protect their own neighborhoods as opposed
to waiting for the Feds. Because the biggest shock I had when I
moved out of San Diego to Washington, D.C., is I look around
the environment in this community and the environmental health
around this community and let me assure you, I do not want my
neighborhoods to be controlled by the people who are taking
care of the environment in Washington, D.C., right now, and
that is one of those things that I think all of us should work
at empowering the local community to address these issues and
hopefully we can use this review as a way of doing more of
that.
I yield back, Mr. Chair.
Chair Miller. Thank you, Mr. Bilbray.
Mr. Grayson for five minutes.
Vieques, Puerto Rico
Mr. Grayson. Thank you, Mr. Chair. I appreciate the members
of this panel and what they have done to highlight the failures
of the ATSDR but I would like to talk about a different
circumstance that has come up that I think further underlines
the situation. That is the situation that I am talking about
regarding Vieques, which is an island off the coast of Puerto
Rico. Vieques is a beautiful place. Its economy is based on
fishing and tourism, and for 62 years it served as a military
testing ground for the Navy. And now it is the subject of a
great debate concerning the accuracy of ATSDR testing. The
military used among other weapons chemicals such as napalm,
Agent Orange and depleted uranium in and around the waters of
Vieques. In 2003 the Navy stopped that military testing and the
area has become a Superfund site because of the heavy presence
of metals and toxins in the area. It is being cleaned up but
there is a lot of chemical residue that remains. There are
dangerous levels of heavy metals and toxins that have shown up
in the crabs, in the fish, in the goats, in the wild horses
that roam the island and the vegetation and in the people who
live there. The health statistic in Vieques show the
consequences of those toxins compared to normal residents of
Puerto Rico. Residents of Vieques have a 269 percent increased
chance of cancer and a 73 percent increased chance of heart
disease and many other health problems. Infant mortality in
most of Puerto Rico is decreasing, but in Vieques it is
increasing and it has been increasing since 1980. And a 2001
study looking at the hair of the residents in Vieques showed
that 73 percent of these human beings were contaminated with
aluminum and 30 percent of the children under 10 years old
showed toxic levels of mercury.
One of my constituents, Rubin Ojeda, a former fisherman in
the area, told me almost every person that he knows in Vieques
has cancer or a family member who has cancer or other serious
illness. Rubin fished while the Navy dropped bombs around him
and he suffers from heart and respiratory disease as well as
deafness. His mother has anemia, high blood pressure and
diabetes. His uncle died of cancer and several of his fellow
fisherman have also died of cancer at young ages. In other
words, in Vieques, heavy metal poisons the land and the water
and the population carries that poison in its bloodstream and
there is no real debate about this anymore.
But somehow when this agency, ATSDR, tested the area, it
stated that the poisons in the fish and the crabs and the
vegetation somehow posed no threat or no danger to the
residents. This agency, which is supposed to protect our
children form poisons at Superfund sites, actually wrote that
it is safe to eat the seafood from the coastal waters and near-
shore lands and that residents have not been exposed to harmful
levels of chemicals resulting from Navy training activities.
These remarkable statements should not come as a surprise for
anybody who actually knows this agency. It is famous for
ignoring the dangers of formaldehyde in the trailers used by
Katrina victims, and for that the Agency was publicly chided by
its own chief toxicologist, who had been cut out of the loop
after raising concerns about the scientific basis for the
Agency's analysis.
In case after case documented in an excellent report put
together by the Science and Technology Oversight and
Investigations Subcommittee, this agency has trivialized health
concerns and failed to stop the ingestion of poison and the
spreading of cancer. In other words, Vieques is not an isolated
incident. There is a problem of leadership, structure and
agency culture, and from its inception in the early 1980s this
agency has fought with bureaucratic rivals, shortchanged
science and public health, and as a result it has let children
be poisoned, and this too should come to us as no surprise
because the Reagan Administration, which oversaw the creation
of this agency, never found an environmental protection that it
did not try to dismantle. Despite that origin, there are good
and conscientious employees within the Agency and I am hopeful
that we can work to restructure this agency so that its
leadership is committed to protecting the public from harm.
They should at the very least start with the acknowledgement
that its work in Vieques is flawed and it should start with a
commitment to reassess that site and take into account the
various independent studies which show elevated health risks in
the area.
You know, we try so hard as Members of Congress to improve
people's lives. When I look at what has happened in Vieques,
when I see all the health problems that Navy testing there has
caused and the health problems that have been perpetuated by
the failure of this agency to do anything about it, I am
reminded of the Hippocratic oath. Maybe the first thing we
should to do as Members of Congress is very simple. The first
thing that the government should try to do is very simple:
first, do no harm. Thank you.
Chair Miller. Thank you, Mr. Grayson.
Mr. Tonko is not a Member of this subcommittee. He is a
Member of the Full Committee, and as a courtesy the Chair is
happy to recognize Mr. Tonko for a round of questioning. He
does have a particular interest in this subject today.
Colonie, New York
Mr. Tonko. Thank you, Mr. Chair, for this very valuable
hearing, and to the panelists, thank you for being here. I
represent Colonie, New York, via the 21st Congressional
District in New York, and so my questions are directed towards
Professor Parrish.
Professor, so I can be perfectly clear on this issue, the
ATSDR people, did they test at all, did they use a certain
method or did they not test workers and residents?
Dr. Parrish. They did not test.
Mr. Tonko. So you were the only group that tested?
Dr. Parrish. That is correct.
Mr. Tonko. And when your system that you offered to ATSDR
was exchanged with their people information-wise----
Dr. Parrish. I have had no contact at all with ATSDR.
Mr. Tonko. None at all?
Dr. Parrish. None at all.
Mr. Tonko. So did they--do you know if anyone reviewed the
system you used?
Dr. Parrish. Well, our work first went through considerable
peer review in the U.K. to do with interlaboratory comparisons
and so forth and that work was published in 2006. The method
was developed in 2003 and it was applied to basically a very
large cohort of U.K. Gulf War veterans in the period 2004 to
2006. So we tested hundreds of U.K. veterans for depleted
uranium in their urine during that period of time. I mean, this
is the whole reason I started working in Colonie is to pursue
this topic that I got involved in in the U.K. as a result of
working with the government to test veterans of the first Gulf
War. And what we found in that particular situation is we
failed to find a single person who had had a DU positive
result. Everybody was normal. And this raised a really
important question. The question really was, were the veterans
of the 1991 conflict never exposed to DU in the battlefield or
were they actually exposed, did they acquire harm, for example,
but has it been too long a period of time since the testing in
order to detect the signature. So we needed--the reason we went
to Colonie was to follow this issue until it logically was
concluded, and the reason that Colonie is important is, there
is undoubtedly a very significant exposure to a lot of people
to the inhalation of depleted uranium oxides is arising because
of the manufacturing at the plant, so we knew there was an
exposed population, so we went there to try to find out, can we
see the signature in their urine? Even after 20 years, and the
answer was yes, we could.
Mr. Tonko. Now, my question to you also, were there any
opinions offered as to that method by professionals from ATSDR,
formal or informal, that were exchanged with you?
Dr. Parrish. No, because I have had no contact, none
whatsoever.
Mr. Tonko. So is there anything that we can do to go
forward with the town of Colonie? Should there be any concerns
or fears that the town residents--there are some theories that
as many as 2,000 homes, if not more, I hear many oftentimes
2,000 homes being in the area of the factory and of course the
factory workers, should they still have concerns about depleted
uranium?
Dr. Parrish. Well, let me first say that, you know, I am
not a medical doctor so don't misconstrue my opinions here, but
I suppose my general view is that the heaviest pollution took
place in the 1970s and affected probably in the neighborhood of
less than perhaps 1,000 people, and I am sort of drawing a line
around, you know, perhaps 600 to 800 meters around the plant,
but there were lots of houses and the residential area is
extensive. Sorry.
Mr. Tonko. No, I was just going to ask, has the Agency ever
contacted you to discuss your findings?
Dr. Parrish. No, they have not.
Mr. Tonko. Do you think they were aware of your findings?
Dr. Parrish. They are--I mean, I know that they--people
have told me that there has been some contact with ATSDR about
my paper but they have not contacted me.
Mr. Tonko. And should the Agency go back to the area?
Dr. Parrish. Well, I think somebody should go back. If the
Agency has got a different attitude, then they should go back
and redo some of the work, and some of the things they need to
do are to find the people who lived there and were most heavily
exposed, regardless of where they live now. They need to find
these people. Then they need to do basically a health kind of
census, what is the state of health and death results, for
example, in the area that is closest to the plant. If there is
something untoward going on in terms of that, then they could
institute a series of testing programs to find out whether
depleted uranium, for example, could be a correlated feature to
those health problems. So I think there is a way forward to do
this whole program there.
Mr. Tonko. Now, the Agency claims that, in quotes, it
``serves the public by using the best science.'' Have they
avoided the best science? Have they used the best science?
Dr. Parrish. Well, I think my words were, they either chose
not to or were unaware of the analysis tools at the time they
did their report in order to determine whether people had an
exposure. This was possible now. It certainly is possible now.
They concluded it wasn't possible----
Mr. Tonko. And if we use----
Dr. Parrish.--in their report.
Mr. Tonko. I am sorry. If we use your base number of 1,000
for round terms, is there an estimated cost that the Agency
should assume will be borne upon it?
Dr. Parrish. You know, I suppose--I have been asked
question and I would have thought that you could commit
something like perhaps $1 million or something, and with that
sort of money you could undertake a census to find the
individuals, look at their health and other death statistics as
well as conduct urinary tests for uranium isotope exposure on
perhaps several hundred people. You could certainly go some
distance to make progress towards the resolution of the issue.
Mr. Tonko. As I understand it, the Federal Government spent
nearly $200 million----
Dr. Parrish. That is correct, on the cleanup.
Mr. Tonko.--on the cleanup. Is that cleanup sufficient? Do
you have any sense professionally whether or not----
Dr. Parrish. I think--the Army Corps of Engineers did the
cleanup. I think they did a good job. What they did is
remediate the site so that it could then be turned over
eventually for some other purpose, but the primary health
danger that was at the site arose during the plant's original
operation in the 1960s and 1970s and early 1980s and so once
the plant stopped operating, the immediate health risk, as I
understand it, diminished considerably because emissions of
depleted uranium oxide particulates that were inhalable then
more or less ceased, and so the ongoing issues relate to sort
of secondary ingestion of contaminated soil or perhaps
resuspension of dust. But we have also found that there are
high levels of settled dust in attics and basements and houses
and so forth, and this may be an ongoing health issue. I don't
know.
Mr. Tonko. Just one quick final question, and I appreciate
your tolerance, Mr. Chair, but it is very important to this
community and to the district. There were allegations that the
company had bypassed smokestack filters.
Dr. Parrish. Yes.
Mr. Tonko. Do you have an opinion on that?
Dr. Parrish. I have been told this is a fact, and I have no
doubt that it is.
Mr. Tonko. Well, obviously it is an issue that still needs
to be----
Dr. Parrish. I think the--is it New York Department of
Environmental Conservation, I believe, they documented this at
the time in the late 1970s so there is no doubt that this has
taken place.
Mr. Tonko. Thank you, Professor.
Thank you, Mr. Chair.
Chair Miller. Thank you, Mr. Tonko. You were still well
short of Mr. Rohrabacher's territory.
Dr. Broun, if you would give me the indulgence of just one
last question, not a whole other round.
Animals as Sentinels of Human Health
Mr. Mier, Professor Parrish just discussed the willingness
of ATSDR to contact him and talk to him. Has ATSDR looked at
the animals that were in your film?
Mr. Mier. No, sir.
Chair Miller. Have you asked them to?
Mr. Mier. Yes, we have.
Chair Miller. And what did they say?
Mr. Mier. Initially the response was that it wasn't within
their mandated domain. Afterwards we were told that neither
ATSDR nor the Texas Department of State Health Services had the
expertise, and the latest communication was that the Texas
Department of Health has contacted a couple of researchers at
Texas A&M School of Veterinary Medicine who might be interested
in pursuing but that first of all they have to write a proposal
and then hopefully seek grant funds to do that.
Chair Miller. I am not sure that Mr. Mier is the best--Mr.
Mier is not a scientist. Perhaps Dr. Hoffman is the best to
direct this question to. Is there a value, a recognized value
in medical research that effects on animals are an indicator, a
sentinel for effects on humans?
Dr. Hoffman. In certain situations they are. There is not
necessarily 100 percent correlation between the effects on
small animals and humans, but I mean, you know, as was shown on
that film, I think it is of concern. I mean, I have no idea
what the incidence of similar abnormalities are in that area in
Texas but obviously that would be of more substantive data to
examine.
Chair Miller. It would get your attention?
Dr. Hoffman. Well, as it did in the area in Pennsylvania,
yes.
Chair Miller. Thank you to all the members of this panel
for your testimony, for coming here and for answering our
questions as well. We will now take a fairly short break before
the next panel. Thank you.
[Recess.]
Panel II:
Chair Miller. I would like to introduce our second panel.
Dr. Ronnie Wilson, in addition to being a former country music
disc jockey as he told me in the break, probably more pertinent
to this hearing was the Ombudsman as ATSDR from 1998 to 2005
and teaches now full time at Central Michigan University. Dr.
David Ozonoff is a Professor of Environmental Health at the
Boston University School of Public Health, and Dr. Henry S.
Cole is the President of Henry S. Cole & Associates, an
environmental consulting firm in Upper Marlboro and a former
senior scientist with U.S. EPA's Office of Air Quality Planning
and Standards. As I said earlier, it is the practice of the
Subcommittee to take testimony under oath. Do any of you have
any objection being sworn in, to swearing an oath? No? We also
provide that you may be represented by counsel. Do any of you
have counsel at today's hearings? All right. If you would now
all please stand and raise your right hand? Do you swear to
tell the truth and nothing but the truth? Let the record
reflect that all of the witnesses answered in the affirmative.
Mr. Wilson, you may begin.
STATEMENT OF DR. RONNIE D. WILSON, ASSOCIATE PROFESSOR, CENTRAL
MICHIGAN UNIVERSITY; FORMER OMBUDSMAN, AGENCY FOR TOXIC
SUBSTANCES AND DISEASE REGISTRY
Dr. Wilson. Thank you, Mr. Chair. Thank you for the
invitation to speak with your committee regarding ATSDR. I am
retired now from the government and the Army Reserves, and I am
an Associate Professor at Central Michigan University. I hold a
degree in journalism, a Juris Doctorate, and a Masters of
Science in Administration in Health Services.
I would like to acknowledge the quality science products
developed by the professionals within ATSDR who serve the
public well in developing toxicological profiles, health
education, health studies, emergency response, and public
health assessments. However, as my testimony will describe,
there are serious problems with and within the Agency.
After serving as the Regional Ombudsman and in enforcement
and public affairs role for 23 and a half years with EPA, I
became the ATSDR Ombudsman. I was selected to build a neutral
force to serve the public in their need to be heard.
In 1999, citizens in Tarpon Springs, Florida, asked me to
review whether an appropriate health assessment had been
conducted at the Stauffer Chemical Company site. The site had
been found to be a public health hazard. The company and
community were so hardened in their stance that there was no
way to find mutual grounds for an agreement. So after a year of
investigating, I published a 196-page report, gathering
evidence which the company, the state and ATSDR had never seen.
I found that the public health had not been properly studied,
and the use of asbestos in vast amounts had not been
considered.
After my report was issued, ATSDR moved quickly to review
the health of the community and the former workers, finding and
a spike of mesothelioma in women who had lived near the plant
and the workers who had likely had their health compromised.
This report is used to point out some issues within ATSDR.
ATSDR was a wonderful idea, a group of scientists who were
independent of EPA to look at the public health around
hazardous waste and other kinds of hazardous substance release
sites. However, the Agency was never fully staffed or funded
and was administratively tethered to the Centers for Disease
Control and Prevention, yoking two agencies with different
missions. The State's abilities to dictate the Agency's ability
to assess the heath of the public was detrimental.
I questioned the author of the original Stauffer Site
Public Health Assessment, a State employee, who produced the
report pursuant to a cooperative agreement. He drafted the
report to meet the requirements of the state being paid but
without looking at the details. He was busy on another site
with public and press interest.
In gathering materials for the Stauffer report, I asked the
state for information about former employees. Although the
public had been given the data, upon advice of the Florida
General Counsel, the state would not provide the data to me. I
asked if ATSDR had the authority to issue letters commanding
the production of information under section 104(e) of the
Superfund legislation. No one knew the answer. The CDC General
Counsel's office advised that the authority did exist and that
a presentation had been made in 1989 regarding the tool.
A 104(e) policy was drafted, went to the CDC General
Counsel for review and died because ATSDR was not an
enforcement agency. With no policy, the Agency remains
unprepared to command the production of data needed to properly
assess the public's health.
ATSDR is a dichotomy. In one world are the well-run
divisions of the public health, toxicology and education, and I
seldom ever heard a complaint about those. Then there was the
Division of Health Assessment and Consultation, or DHAC, the
largest portion of the Agency, a ``fiefdom'' managed with an
iron fist.
Talented, dedicated professionals in DHAC were not to
listen to the public and could not get products to completion.
DHAC leadership delayed the completion of Health Assessments
until they were worded exactly the way leadership felt things
should be, not the way they were. The Division's science
officer sought to develop new science to be applied by the
assessors, ignoring the established levels of the Division of
Toxicology and other science agencies.
One Division leader became concerned about this delay and
developed a spread sheet to analyze the days that it took to
get a completed public health assessment that was, on average,
well over 400 days.
DHAC employees also informed me of the large number of
health assessments that were developed at the beginning stages
of the Agency. The public's health at this large number of
sites was assessed by applying a basic template, documents
called interim or temporary assessments. Most of these
documents have never been revisited or simply received a
permanent cover.
DHAC Leadership presented a beautiful picture to the Agency
executives but the public revealed a different story. This
conflict led executives to the development of an Ombudsman
program, a mechanism to provide the public a voice and a
hearing.
The Stauffer report highlights an effective Ombudsman
program. The public then had a neutral person they could call
with their complaints. By the end of fiscal year 2005, the
public complaints to the Ombudsman had dropped as the Agency
had begun to actually include the citizens in that decision-
making process. However, this favorable report soon ended as
the program ceased to exist.
If Congress wishes to impact the health of persons living
near or at hazardous waste sites, reorganize ATSDR. My
suggestions simply are: legislate a merger for ATSDR and the
National Center for Environmental Health, or dictate the
separation of the two. Make the Agency independent of CDC.
Dictate the establishment of a permanent, independent Ombudsman
office for ATSDR and CDC. Restrict the use of cooperative
agreements with states to hire contractors and dictate the
recovery of the dollars spent for flawed reports.
This concludes my remarks, and I will be happy to answer
questions at the end of the session.
[The prepared statement of Dr. Wilson follows:]
Prepared Statement of Ronnie D. Wilson
Thank you for your invitation to speak with the Committee regarding
ATSDR.
I am retired from the government and the Army Reserves and I am an
Associate Professor for Central Michigan University. I hold a
Journalism degree, a Juris Doctorate, and a Masters of Science in
Administration in Health Services.
I acknowledge the quality science products developed by the
professionals within ATSDR who serve the public well in developing
toxicological profiles, health education, health studies, emergency
response, and public health assessments. However, as my testimony
describes, there are serious problems with, and within the Agency.
After serving as the Regional Ombudsman and in enforcement and
public affairs roles for 23.5 years with the Environmental Protection
Agency, I became the ATSDR Ombudsman. I was selected to build a neutral
force to serve the public in their need to be heard.
In 1999, citizens in Tarpon Springs, Florida, asked me to review
whether an appropriate health assessment had been conducted at the
Stauffer Chemical Company site. The assessment found the site to be a
public health hazard. The company and community were so hardened in
their stance that there was no way to find mutual grounds of agreement.
After a year of investigating, I published a 196-page report,
gathering evidence which the Company, the state and ATSDR had never
seen. I found that public health had not been properly studied, and the
use of asbestos in vast amounts had not been considered. After my
report was issued, ATSDR moved quickly to review the health of the
former workers and community, finding and a spike of mesothelioma in
women who lived near the plant and that worker health was likely
compromised.
The report is used to point out some of the many issues at ATSDR.
ATSDR was a wonderful idea, a group of scientists who were independent
of EPA to look at the public health around hazardous waste and other
kinds of hazardous substance release sites. However, the Agency was
never fully staffed or funded and was administratively tethered to the
Centers for Disease Control and Prevention, yoking two agencies with
very different missions.
The State's ability to dictate to the Agency was detrimental to the
assessment of public health.
I questioned the author of the original Stauffer Site Public Health
Assessment, a State employee, who produced the report pursuant to a
cooperative agreement. He drafted the report to meet the requirements
for the state to be paid, without looking into the details. He was busy
on another site with public and press interest.
In gathering materials for the Stauffer report, I asked the state
for information regarding former employees. Although the public had
provided me the data, upon advice of the Florida General Counsel, the
state would not. I asked if ATSDR had authority to issue letters
commanding production of information under section 104(e) of the
Superfund legislation. No one knew the answer. The CDC General
Counsel's office advised that the authority did exist and that a
presentation had been made in 1989 regarding the tool.
A 104(e) policy was drafted, went to the CDC General Counsel for
review and died because ``ATSDR is not an enforcement agency.'' With no
policy, the Agency remains unprepared to command the production of data
needed to properly assess the public's health.
ATSDR is a dichotomy. In one world is the well-run Divisions of
Health Studies, of Toxicology and Education, about which I seldom heard
citizen's complaints. Then there was the Division of Health Assessment
and Consultation, or DHAC, the largest portion of the Agency, a
`fiefdom,' managed with an iron fist. Talented, dedicated professionals
in DHAC were not to listen to the public and could not get products to
completion.
DHAC leadership delayed completion of Health Assessments until they
were worded the way leadership felt things ``should be,'' not as the
facts were. The Division's science officer sought to develop new
science to be applied by the assessors, ignoring established levels of
the Division of Toxicology and other science agencies. One Division
leader became concerned about this delay and developed a spread sheet
to analyze the number of days taken to complete a health assessment, an
average of more than 400 days.
DHAC employees informed me of the large number of Health
Assessments developed at the beginning stages of the Agency. The
Public's health at this large number of sites was assessed by the
application of basic template and documents called interim or temporary
assessments. Most temporary documents have never been revisited or
simply received a new, permanent cover.
DHAC Leadership presented a beautiful picture to the Agency
executives but the public revealed a different story. This conflict led
executives to develop an Ombudsman program as a mechanism to provide
the public a voice and a hearing.
The Stauffer report highlights an effective Ombudsman program. The
public had a neutral person to call to hear their complaints. By the
end of FY05, public complaints to the Ombudsman had dropped as the
Agency had begun to include the public in the decision-making process.
This favorable report soon ended as the program ceased to exist.
If Congress wishes to impact the health of persons living at or
near hazardous waste sites, reorganize ATSDR. My suggestions are:
Legislate a merger for ATSDR and the National Center
for Environmental Health, or dictate the separation of the two
entities.
Make the Agency independent of CDC.
Dictate the establishment of permanent, independent
Ombudsman offices for CDC and ATSDR, and
Restrict the use of cooperative agreements with
states as a tool to hire contractor and dictate the recovery of
funding not properly earned.
This concludes my remarks. Thank you for your time and
consideration of the public and the professionals at ATSDR. I would be
happy to answer your questions.
Biography for Ronnie D. Wilson
Dr. Ronnie Wilson has become a recognized expert in two fields that
impact health services administration. Due to his governmental and
legal experience, Dr. Wilson has become known for his ability to assist
others in how to avoid negligence or malpractice
Dr. Wilson has been on the staff at Central Michigan, teaching at
the graduate (Master's) level since September 1995. Central Michigan
University added Dr. Wilson to the full-time staff in 2005 after a
33.5-year career with the Federal Government.
While on loan from the Agency for Toxic Substances and Disease
Registry (ATSDR), Dr. Wilson served as the Executive Director of the
Delta Regional Authority, a federal/State partnership seeking to
improve the lives of 10 million people in eight states along the
Mississippi River.
Prior to working with the Delta Regional Authority, Dr. Wilson's
most recent position was Ombudsman for the federal agency that conducts
health studies around hazardous waste sites. In that role he spent more
than a year investigating a waste site in Florida and produced a 196-
page report to Congress and the head of the ATSDR. He was given an
award by the Florida Sierra Club for his effort to protect the public
health and the environment in Florida.
Dr. Wilson came to the ATSDR after more than 23 years with the
Environmental Protection Agency (EPA). At EPA he served in a variety of
roles, including that of Regional Ombudsman.
On a volunteer basis, Dr. Wilson served as the National Vice
President of the Spina Bifida Association of America for two years, as
a National Board member for five years.
As an Army Reserve officer, he is the holder of three Meritorious
Service Medals, and a Humanitarian Service Medal and he commanded an
Army History Detachment. He holds a BS degree in Journalism from
Arkansas State University, a Juris Doctorate from Woodrow Wilson
College of Law and a Master's of Science in Administration, Health
Services, from Central Michigan University.
Chair Miller. Thank you, Mr. Wilson. Dr. Ozonoff.
STATEMENT OF DR. DAVID OZONOFF, PROFESSOR OF ENVIRONMENTAL
HEALTH, BOSTON UNIVERSITY SCHOOL OF PUBLIC HEALTH
Dr. Ozonoff. Thank you, Chair Miller, Dr. Broun. My name is
David Ozonoff. I am a physician and Professor of Environmental
Health at Boston University School of Public Health, and by
trade over the last 30, 40 years, I am a cancer epidemiologist.
At Boston University I was the founding Chair of the department
that teaches and researches the effects of chemicals on health,
a department which I led for 26 years and where I continue to
work as a full professor directing a multi-million dollar
research program on health and the environmental effects of
chemicals, funded by NIH. I am therefore intimately familiar
with the underlying science which is beneath ATSDR's work, and
I know its formidable technical difficulty well.
In 1991, Congress asked the GAO to examine how well ATSDR
was performing those public health evaluations around Superfund
sites that were required by the 1986 SARA legislation, and I
was a member of the GAO expert panel whose judgments formed the
basis for the report's main findings. Those findings concluded
that ATSDR health assessments required more time and care and
better consideration of community health concerns, that there
should be independent peer review of the assessments, that the
contents of the assessments were redundant of EPA reports and
not useful to EPA or the community, and that the assessments
were incomplete and not reliable for indicating when follow-up
studies were needed.
Because of our relationship in the department, we worked
there for many years, decades in fact, with community groups
around the country, essentially one of the few if not the only
academic unit who did that. During that same period of the GAO
report, we were engaged by ATSDR via a cooperative agreement to
assist them in community involvement activities around several
federal facilities.
In the course of that work, we met frequently with
community members, both with and without ATSDR at community
sites. Our assistance was requested by ATSDR because of
persistent complaints. These are complaints that go back to the
very inception of the active work of the Agency in 1986, that
public health assessments were flawed, unhelpful, and/or
misleading. A common view was that somebody else had already
shot the arrow, and ATSDR was dutifully painting the target
around it.
To prepare for my appearance today and to get as objective
a view as I could, I made a number of calls to people both in
the environmental health professions and those connected in
communities with toxic problems to see what has changed since
that experience. The bottom line is this: not very much. The
health assessments are somewhat better on average than the
earliest years, but they remain extremely uneven. Some are
unsatisfactory. The Vieques example, mentioned earlier by Mr.
Grayson, is a notorious example whose reputation is now
rebounding around the environmental health community.
Recent ones that I have seen are incomplete. They give
insufficient weight to the most up-to-date human information,
and maybe because I am in epidemiology, I am sensitive about
this subject, but they do not pay sufficient attention to
epidemiology. And although the focus of the public health
assessment is rightfully on current potential exposures, the
reports often do a less-than-satisfactory job of characterizing
at least as well as they can past potential exposures. Reports
are difficult to read for community members, and they have a
one-size-fits-all format which doesn't convey the feeling that
the special concerns of the community have been heard or
understood.
And while ATSDR provides a short public comment period, the
health assessment documents desperately need independent peer
review from independent experts. At the very least the reports
have a tendency to miss the most current information or adopt
lowest common denominator judgments when evidence conflicts.
And in addition, there is insufficient breadth and depth of
technical expertise among the health assessors. These are a
handful of people at each site and with each health assessment
who are required to know sciences as disparate as hydrogeology,
meteorology, architecture, industrial hygiene, toxicology,
epidemiology, sociology, social psychology just to name a few.
And as good as some of them are and as truly dreadful as some
others are, this is almost an impossible task for one or a few
people responsible for drafting the average health assessment.
And not all health assessments are done by ATSDR staff. A
serious problem is that a number of states, in fact, almost
half of the states I believe, do ATSDR health assessments under
cooperative agreement, a practice which carries with it
substantial risk which we've seen, realized any number of
times, that State-based pressures are going to affect the
results.
I have made several concrete suggestions about what to do
in my written testimony as well as some more general
observations.
So to conclude, I would like to just answer a question that
you asked me via letter about my net opinion about whether
ATSDR is meeting its mission. In my own view and the view of
most community members I consulted, the routine work of ATSDR
remains deeply disappointing. I say remains because this is not
a new situation, as you have heard. And at the core of it is a
deep lost of trust from the communities that ATSDR is supposed
to serve. Despite this, I remain strongly of the view that it
is vitally important that there continue to be an agency whose
job it is to look at community chemical exposures from the
public health viewpoint. EPA is primarily a regulatory agency.
It is ATSDR's job to ensure that public health activities are
effective. To do this, it needs the support and trust of the
public to conduct studies and to recommend actions that are
focused solely on protecting public health. Public health has
the word public in it, and the public indeed should be the main
focus of ATSDR's activities.
In the context of the enormous problems that we face today
that are in the news every day, ATSDR's problems probably seem
minor, and in terms of cost, they are essentially trivial
compared to the sums that are being discussed daily. But for
the affected communities, they are far from trivial. In some
cases, they are matters of life, death, and certainly the
happiness of people in those communities.
In 30 or 40 years of observing this, one of the things that
I have seen is that chemical contamination doesn't just take
lives, as terrible as that is, and as a physician, that causes
me great pain to see. But in addition to that it also wrecks
lives, something that I have seen all too often. I would be
glad to answer questions after the panel has made their
statements. And I thank you for your interest in this urgent
matter.
[The prepared statement of Dr. Ozonoff follows:]
Prepared Statement of David Ozonoff
Chairman Miller, Member Broun and Members of the Subcommittee. My
name is David Ozonoff. I am a physician and Professor of Environmental
Health in the Department of Environmental Health at the Boston
University School of Public Health. I was the founding Chair of the
Department that teaches and researches the effects of chemicals on
health, a Department which I led for 26 years. I continue at Boston
University as a full Professor where I direct a multi-million dollar
research program on the health and environmental effects of chemicals,
funded by NIH.
By way of background, I received my undergraduate degree in
mathematics from the University of Wisconsin in 1962, my MD degree from
Cornell in 1967 and my Master of Public Health degree from Johns
Hopkins School of Hygiene and Public Health (now the Bloomberg School)
in 1968. I spent the first ten years of my career at MIT, where I
taught and did research, before moving to Boston University in 1977.
The Department I founded there had as its focus understanding the
health effects of chemicals on communities. We were then, and remain
today, 30 years later, one of the few academic units specializing in
this subject. Most investigations of community health effects are
carried out in the public sector by State and federal agencies, one of
which is ATSDR. In most of our research and technical assistance we
have worked closely with communities and while this helped me to see
the problem from their perspective, I am also intimately familiar with
the underlying science and its formidable technical difficulty. I know
quite well that judgments that appear straightforward on the surface
are anything but.
Difficult as such work may be, there have been persistent problems
with how ATSDR carries it out. In 1991 Congress asked the GAO to
examine how well ATSDR was performing the public health evaluations
around superfund sites required by the 1986 SARA legislation. Public
health assessments are meant to determine if hazardous waste sites were
causing harmful exposures to surrounding communities and, if so,
whether these exposures should be stopped or reduced. I was a member of
the GAO expert panel whose judgments formed the basis for the report's
main findings. The GAO concluded that ATSDR health assessments required
more time and care on the technical aspects and better consideration of
community health concerns; that there should be independent peer review
of the assessments; that the contents of the assessments were redundant
of EPA efforts and not useful to EPA or the community; and that the
assessments were incomplete and not reliable for indicating when
follow-up studies were needed. A number of recommendations were made,
including that Congress should check back later on progress. I see this
hearing as fulfilling that recommendation.
Because of our relationship and reputation working with
communities, in the 1990s we were engaged by ATSDR via a Cooperative
Agreement to assist them in community involvement activities around
several federal facilities. In the course of that work we met
frequently with community members at community sites. Dr. Cole, the
next panelist, helped us with some of that work. Our assistance was
requested because there continued to be persistent complaints from
communities that ATSDR's public health assessments were flawed,
unhelpful or misleading. A common view was that someone had already
shot the arrow and ATSDR was dutifully painting the target around it.
As a result of this background I have seen the problem from several
different perspectives, an experience which surely tempers my
judgments. I think I have a good feeling for what it is like to be in
ATSDR's shoes, always useful for fairness. I also have the advantage of
distance from the immediate fray. As my Department grew, my research
group expanded greatly and other problems began to claim my attention.
As a result I have spent considerably less time in recent years with
either the communities served by ATSDR or the Agency itself. I remain
close to many community activists and their leaders for whom ATSDR
represents, at the least, a serious problem. I have the greatest
respect for these residents and activists and for their dedication to
making their communities safer for themselves, their families and their
neighbors. The toll this takes on them is very large and their stories
are heart wrenching. I am not just a scientist but I am a spouse, a
father and a grandfather, and it takes little imagination for me to
identify with their concerns. I also know many of the principal players
from both the early days of ATSDR and the current leadership. To
prepare for my appearance today and to get as objective a view as I
could, I made a number of calls to people, both in the environmental
health profession and those connected to communities with toxics
problems, to see what has changed in recent years.
The bottom line is this: not very much. The health assessments are
better on average than in the early years but their quality remains
uneven and some are unsatisfactory. Some of the recent ones I have seen
are incomplete and do not give sufficient weight to the most up-to-date
human information, tending to de-emphasize epidemiology while spending
disproportionate time on toxicology and animal evidence. Often much of
the detail involves exposure analysis, a function of at least three
things: the experience and training of many of the health assessors is
more in the area of Earth science and engineering; site-specific detail
is available from parallel EPA efforts; and the lack of experience and
training that makes assessors more dependent on summary statements like
ATSDR toxicology profiles and fact sheets, a number of which are dated
or even obsolete. And although the focus of the public health
assessments is rightfully on current potential exposures, the reports
often do a less than satisfactory job characterizing (or addressing as
well as they can) past potential exposures. Finally, the reports are
difficult to read for community members and have a one-size-fits-all
feel which does not convey the feeling that the special concerns of the
community have been heard and understood.
While ATSDR provides a short public comment period on its reports,
the health assessment documents need independent peer review from
experts. At the very least the reports have a tendency to miss the most
current information or adopt lowest common denominator judgments when
evidence conflicts. In addition, there is insufficient breadth and
depth of technical expertise among the health assessors who are
required to know sciences as disparate as hydrogeology, meteorology,
architecture, industrial hygiene, toxicology, epidemiology, social
psychology and sociology, to name a few. As good as some of them are
(or as inadequate as are others), this is almost an impossible task for
the one or a few people responsible for drafting the average health
assessment. There also needs to be a full review of ATSDR Fact Sheets
used for public education for relevance to the concerns of communities
and their overall usefulness and appropriateness in specific
situations.
Not all health assessments are done by ATSDR staff. The Agency out-
sources the health assessment task to a number of states under
Cooperative Agreements. This practice is beneficial for building
capacity in cash strapped State health departments but carries with it
the risk that local pressures from the Governor's office or the
legislature will affect the result. ATSDR is not immune to these State-
based pressures but they are more distant and ATSDR has a greater
chance of independence. I have written about this problem in the past
and ask that our paper on the subject be appended to this testimony.
In summary, I would repeat and add to some of the recommendations
we made in 1991, including:
an effective arrangement for independent and timely
expert peer review of ATSDR health assessments, consultations
and studies.
an across the board review of the fact sheets and
recommendations ATSDR is giving to communities for relevancy to
their concerns. It is not uncommon for a community to be told
by ATSDR there is no hazard and then to be given advice they
should wash their hands and take off their shoes after being in
a contaminated outdoor environment.
an increase in the breadth of scientific talent
recruited by the Agency.
a re-evaluation of the practice of out-sourcing work
to State health departments. Perhaps regional style
consultation units, based at universities, would be useful.
Finally, you have specifically asked me to give my opinion about
whether ATSDR is meeting its mission. Let me try to answer the question
by giving you my own view and the view of most community members I
consulted. It is this. The routine work of ATSDR remains deeply
disappointing. ATSDR has acquired, partly on its own, partly for
reasons beyond its control, a reputation with communities it will have
a difficult time remedying. It is not alone in the government in being
a deep disappointment. But it is the disappointment we are here to talk
about today.
Disappointment is relative to what one expects. One way to think
about this is on the doctor-patient model. A patient with health
concerns or complaints expects a doctor to listen, to hear and
interpret beyond what's being said, and to be competent--or at least
competent enough so the patient will not be able to see obvious errors.
A patient also expects the doctor to be able to do things that make
them feel more comfortable if not to make them better. The most
damaging thing that can happen to the doctor--patient relationship is
loss of trust and faith by the patient. And that is what is at the core
of the problem with ATSDR. If a doctor doesn't meet basic expectations
the patient will look for another doctor. But there is no other
recourse when the patient is a neighborhood and the doctor is ATSDR.
This has produced a self-reinforcing feedback loop where ATSDR frankly
admits their reluctance to hold public meetings because of the abuse
they receive in these settings, opting instead for one-on-one
encounters. This is seen as a further withdrawal from the organized
community, which responds in kind, increasing the alienation.
This is a difficult situation. But I am strongly of the view that
it remains vitally important that there continue to be an agency whose
job it is to look at community chemical exposures from the public
health point of view. EPA is primarily an environmental regulatory
agency, not a public health agency. Public health has the word
``public'' in it, which implies looking at the situation from the
community's standpoint. ATSDR was supposed to step into the gap.
There is no simple technical or legislative fix for what ails
ATSDR. The problems are problems of leadership at virtually every
level. Presidents from Nixon to Obama have declared we must make an
effort to cure cancer in our lifetime. For those whose friends, family
and indeed themselves are in the cancer years, this appears to us an
important goal. But for my children and grandchildren's sake, I would
have also liked to hear that we will prevent cancer in our lifetime.
ATSDR depends upon advances in basic science to do its job and the
recent stimulus package recognized the importance of basic health
science to our economy and the terrible cost of dread disease in our
communities by injecting badly needed resources into the NIH.
Investment in science pays off in many multiples. But left out entirely
was money for the science of preventing cancer and other diseases
acquired in the environment and workplace. NIOSH got nothing, which
means it will get less again this year than last year. The NIH's
program for basic science underlying superfund, the Superfund Basic
Research Program, got nothing, which means it, too will shrink. CDC and
its Center for Environmental Health got nothing. CDC's only stimulus
money is for bricks and mortar projects. Bricks and mortar don't
prevent cancer. It is a wry adage in the public health community that
no Senator champions an agency because his wife didn't get breast
cancer or any Congressperson because her child was born healthy. Much
of essential public health and its importance remains invisible to the
public. Until this changes other things that need to change, like
ATSDR, won't.
I'm not talking about money here. The amount involved are almost
lost in the accounting noise among the sums we are talking of these
days. This is a question of leadership. The unglamorous parts of health
science, the parts that are true public health infrastructure and upon
which much else depends, like surveillance and vital records, things
ATSDR depends upon, have not had the necessary champions. I include
those in the private sector, like myself and in Congress but also the
Executive Branch. Indeed the Agency needs to signal to you in Congress
what must be done. ATSDR is a sister agency of CDC, but the CDC
administrator did not visibly, vocally or strenuously fight for it or
even her own agency, publicly. Whether she fought these battles
internally I don't know, but we needed visible and strong public
champions for public health and we didn't have them. We had a skilled
communicator but not a champion. Morale at CDC has dropped
precipitously. That's a leadership question. Similarly, ATSDR needs not
only the trust and confidence of the communities it is supposed to
serve, but its own leadership needs the trust and confidence of the
many dedicated professionals in the Agency itself. That's not a
question for legislation.
In the context of the enormous problems we face in the economy and
foreign policy, ATSDR's problems seem trivial, and in terms of cost
they are. But for the affected communities, they are far from trivial.
In some cases they are matters of life, death and happiness. If pressed
hard to name the single effect of living in a contaminated community I
see most consistently, it would be divorce. In a world where the
stresses on marriage are already large, the additional burden of
worrying about one's family and what might happen to them or coping
with what did happen to a child, is too much for too many. Chemical
contamination doesn't just take lives, as terrible as that is. It can
also wreck lives.
I thank you for your attention to this urgent matter, of which the
problems at ATSDR are real but only a part.
Biography for David Ozonoff
David Ozonoff received his Bachelor's degree in mathematics from
the University of Wisconsin in 1962 and his MD degree from Cornell
University Medical College in 1967. In 1968 he received an MPH degree
from Johns Hopkins School of Hygiene and Public Health. He then pursued
research work at MIT from 1968 to 1977, studying, among other things,
the psychophysical difficulties of radiologists when reading chest x-
rays. He and his colleagues also published one of the first two-
dimensional x-ray reconstructions (CAT scans) in the literature in
1969. He also served as a consultant to the World Health Organization,
assisting WHO in the preparation and writing of its contribution to the
first International Conference on the Environment which took place in
Stockholm in 1972. In 1975 he was a Macy Fellow in the History of
Medicine and the Biological Sciences at Harvard, and in 1976 a Mellon
Fellow in the History of Public Health at MIT.
In 1977 he moved to the Boston University School of Public Health
and in 1983 he became the founding Chair of the Department of
Environmental Health, a position he held until 2003 when he became
Chair Emeritus He is Professor of Public Health at Boston University
School of Public Health, and Professor of Sociomedical Sciences and
Community Medicine at Boston University School of Medicine. He directs
the Superfund Basic Research Program at Boston University, a $17
million dollar multi-project research effort. He is a Fellow of the
Johns Hopkins Society of Scholars and a Fellow of the Collegium
Ramazzini.
Dr. Ozonoff's research has centered on epidemiological studies of
populations exposed to toxic agents, especially the development of new
methods to investigate small exposed populations. He has studied
populations around Superfund sites in a number of places, most recently
case control and cohort studies in the Upper Cape region of
Massachusetts. Dr. Ozonoff frequently serves as advisor or consultant
to local, State and federal agencies on matters of health effects from
hazardous wastes and contaminated drinking water. He chaired the Water
Systems Security Committee of the National Research Council/National
Academies of Science and has served on several other NRC panels. He is
the author of numerous scientific articles and is on the editorial
boards of the Archives of Environmental Health and the American Journal
of Industrial Medicine and is co-Editor-in-Chief of Environmental
Health, an Open Access international journal.
Chair Miller. Thank you, Dr. Ozonoff. Dr. Cole, five
minutes.
STATEMENT OF DR. HENRY S. COLE, PRESIDENT, HENRY S. COLE &
ASSOCIATES, INC., UPPER MARLBORO, MARYLAND
Dr. Cole. Thank you, Chair Miller and Dr. Broun and Members
of the Subcommittee for this very important hearing. I am
President of Henry S. Cole & Associates, and it is an
environmental consulting firm which, among other things,
provides scientific support to numerous community organizations
on environmental issues.
I received my Ph.D. in meteorology at the University of
Wisconsin in 1969, was an Associate Professor of Environmental
Sciences at UW-Parkside during the 1970's, and my research into
air pollution meteorology led to my appointment to the
Wisconsin State Air Pollution Council. From 1977 to 1983 I was
senior scientist with U.S. EPA's Office of Air Quality Planning
and Standards where my work focused on predicting the impact of
source emissions on ambient air. I am giving you this
background because it qualifies me to talk about the particular
case that I am going to talk about which is Perma-Fix, a
facility that processes hazardous and industrial waste in
Dayton, Ohio.
Another thing is that ATSDR retained me as a consultant
from 1995 to 2003 to investigate the Agency's community
involvement practices and to work with the Agency's Community
and Tribal Advisory Committee. The purpose of that work was to
help them improve that program.
Since 2004, I have provided technical support to a Dayton,
Ohio, community organization affected by odors and emissions
from an industrial waste processing plant known as Perma-Fix.
For years, residents of surrounding low-income neighborhoods
complained of noxious odors. These complaints were confirmed by
the regional air pollution control agency which later issued a
notice of violations to Perma-Fix. Residents suspect that many
illnesses are related to the plant's emissions including
nosebleeds, respiratory disease, cardiac disorders, birth
defects, and many other symptoms.
In 2004, ATSDR responded to a community petition and agreed
to do a health consultation on this case. The consultation was
based on a monitoring study of chemicals in community air. The
consultation published in December 2008 found that none of the
chemicals tested were above levels of concern, and that
information on Perma-Fix's waste and processes did not reveal
an obvious source for the observed odors. I want to emphasize
those two findings.
As a scientist with experience in air pollution
meteorology, I found that the limited number of days sampled,
only six days sampled, is insufficient to give an accurate
representation of long- or short-term concentrations. The waste
process emissions and weather all vary from day to day,
requiring a far more robust sampling plan. In addition, the
consultation also failed to consider the additive effects of
pollutants and the fact that the area is non-attainment for
ozone and inhalable particulates. Moreover, ATSDR failed to
measure or obtain information on the plant's emission rates or
to conduct air quality monitoring.
It gets worse. In May 2006, the U.S. Government sued Perma-
Fix for its violations of the Clean Air Act. The complaint
identifies Perma-Fix as a major source of hazardous air
pollutions and cites numerous failures to control emission
sources. The resulting consent order included a stiff fine and
requirements to control emissions. The court docket contains
detailed information on the plant's emission sources, and ATSDR
officials declined to use this data readily available online
despite pleas from the community. They declined to use
government information, detailed information, on sources in
coming to its conclusion. I feel that that is unconscionable.
To find no obvious source for the odors, given that kind of
record, is absolutely unconscionable.
The Agency's sole recommendation asking Perma-Fix to
voluntarily control solvent releases could have been made back
in 2004 without doing a flawed and predictably inconclusive
monitoring study. It makes me so frustrated I can't get the
word out. Residents were so frustrated that in July 2007 they
petitioned the Agency once again, this time to halt all of its
work on Perma-Fix unless the Agency negotiated a protocol and
process acceptable to the community. They never did that.
Let me just say in concluding that I, too, poll communities
that I have worked with, and this agency has no trust. In fact,
if you look at the agencies that communicate with networks,
they advise communities to be very cautious about cooperating
with ATSDR because of these inconclusive studies, and many
groups feel that there is more harm done than good. The reason
for that is that if a conclusion is inconclusive, that quickly
gets translated to mean there is no problem. No evidence is
equated with no problem, and that is used as an excuse for
inaction. It may have even damaged the government's case. If
this health consultation had come out prior to the consent
degree in this case, it may have damaged the case. So one has
to wonder about an agency and whether they are fulfilling their
mission.
Finally, what has to be done? I think the proverb behind
you is very telling. It says, ``Where there is no vision, the
people perish,'' Proverbs 29:18. This agency has lost its
vision, especially in its dealings with communities, and I
think that the first thing that has to be done is to take a
close look at the leadership of the Agency and maybe what is
needed is a fresh start. Thank you.
[The prepared statement of Dr. Cole follows:]
Prepared Statement of Henry S. Cole
1.0 Introduction:
First, let me thank Chairman Miller, Ranking Member Broun and the
other Members of the Subcommittee for the opportunity to present my
views on the future of ATSDR.
By way of introduction, I am President of Henry S. Cole &
Associates, Incorporated, a Washington, DC area-based environmental
consulting company now in its 16th year. I received my Ph.D. in
atmospheric sciences at the University of Wisconsin in 1969. My career
in atmospheric and environmental sciences is approaching the 40-year
mark. During the 1970's, I served as an Associate Professor of
environmental Earth sciences at the University of Wisconsin-Parkside
and conducted a research project involving air pollution meteorology.
From 1977-1983, I then served as senior scientist with U.S. EPA's
Office of Air Quality Planning and Standards and Chief of the Modeling
Application Section. This section focused on the relationship between
sources, emissions, weather conditions and ambient concentrations. From
1983-1993, I served as Science Director of the Clean Water Fund.
My consulting firm, founded in 1993, has provided scientific
research and technical advice to support the efforts of dozens of
community-based organizations to improve the environmental health and
sustainability of their communities. A significant portion of my work
has been funded by community-based organizations that receive Superfund
Technical Assistant Grants (TAGs) from U.S. EPA. Other clients have
included neighborhood associations, State and national environmental
organizations and local governments. ATSDR conducted public health
assessments and consultations in a number of these communities. An
additional line of work is scientific support for companies with
technologies that are more sustainable than market standards.
From 1994 to 2003, I served as a consultant to the Agency for Toxic
Substances and Disease Registry (ATSDR) in order to help the Agency
improve its community involvement programs and practices. In this
capacity I provided advice to former Administrator Barry Johnson and
prepared a report based on case studies of numerous communities where
ATSDR provided health assessments or studies. Finally I served as an
advisor to the Agency's ``Community and Tribal Subcommittee.'' The
subcommittee included leaders of communities and tribes in which ATSDR
had worked. For additional details see attached CV and www.hcole-
environmental.com.
2.0 Is ATSDR Fulfilling It's Mission?
ATSDR describes it mission in the following way:
ATSDR's mission is to serve the public by using the best
science, taking responsive public health actions, and providing
trusted health information to prevent harmful exposures and
disease related exposures to toxic substances.
The Oversight Subcommittee has performed a great service by
examining ATSDR's handling of the FEMA trailers cased in which hundreds
of Katrina victims were exposed to formaldehyde. The Subcommittee
report demonstrates that ATSDR was negligent in the conduct of its
duty. In its efforts to play down the dangers, the Agency exercised a
callous disregard for both science and for the health of those exposed
in the trailers.
In my experience, however, the FEMA trailer case is not an isolated
case where the Agency has failed to live up to its mission.
Unfortunately, the Agency's performance in a substantial number of
communities has undermined its most valuable commodities, the ability
to provide ``trusted health information'' and the ability to ``prevent
harmful exposures'' and their effects.
I believe that the Agency has improved the overall quality of its
Public Health Assessments\1\ and community involvement programs since
the early 1990s.\2\ However, the Agency will have to make some
monumental changes in the conduct of science and in its relationship to
communities to warrant its continued use of tax payer dollars. Such
changes will require real leadership and a rededication to science and
public health even when the evidence requires expensive corrective
measures and opposition by federal agencies or by business. Moreover,
uncertainty is not an excuse to play down community concerns, but to
dig further and to err on the side of caution.
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\1\ Under cooperative agreements, Public Health Assessments are
often conducted by State Health Departments. I recently reviewed the
Ohio Department of Health/ATSDR assessment on the Armco-Hamilton Site
in Ohio (former steel mill and coke ovens along the Great Miami River).
In my judgment, this assessment did a reasonably good job in scoping
out the information existing and referred to U.S. Geological Survey
documents which described the vulnerability of groundwater to
contamination and the close down-gradient vicinity of the Hamilton
North municipal well field. The Health Assessment also recommended that
fish be tested for persistent, bio-accumulative contaminants such as
PCBs. See: Agency for Toxic Substances and Disease Registry (ATSDR),
Public Health Assessment for Armco-Hamilton Plant, 2005.
\2\ For example, ATSDR adopted a number of ideas from its community
and tribal advisory group, including the initiation of health-related
Technical Assistance Grants, which allow community organizations to
hire independent experts to serve as advisors pertaining to health
assessments and health studies.
3.0 ATSDR's Perma-Fix Health Consultation:
Today, I will focus on a very recent example, of an ATSDR Health
Consultation that has failed the Agency's mission--a consultation
dealing with a Dayton, Ohio community affected by a plant in their
midst that processes industrial and hazardous wastewaters, sludges and
oils. The company is Perma-Fix of Dayton (PFD).\3\ My association with
this case included technical consultation to the Dayton Legal Aid
Society in 2004 and pro-bono advice to community leaders.
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\3\ ATSDR, Health Consultation, Exposure Investigation Report,
Airborne Exposures to Select Volatile Organic Compounds, Perma-Fix Of
Dayton, Inc., Dec. 15, 2008.
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Let's imagine for the moment that you live in this community, know
as Drexel. Your homes and those of your neighbors are small. The
community has experienced economic stress for years--not just lately.
You have complained to various levels of government for years about the
frequent and sometimes overpowering odors that occur when Perma-Fix is
processing waste. These odors often make doing something out of doors
intolerable and when you get upset enough you call the Regional Air
Pollution Control Agency. Although RAPCA inspectors have confirmed the
validity and intensity of complaints for many, the problem continues
unabated. You also suspect that a high incidence of health problems has
something to do with emissions from this plant.\4\
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\4\ According to the Health Consultation, health-related concerns
include headaches, nausea, vomiting, nose bleeds, numbness in legs and
hands, heart, gastrointestinal and respiratory disorders, burning eyes,
sore throats, unexplained rashes, premature births, and birth defects.
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Then, in 2003, your neighborhood group hears about ATSDR, that it's
a government agency that can help environmentally stressed communities
with various studies. Agency officials respond to a call from the group
and your visit the community and appear to be friendly and sympathetic.
They tell you how to petition the Agency and with hopes high your
community group does so.
Now lets take a look at what actually happened.
ATSDR accepted the community petition and agreed to do a Health
Consultation in March 2004 based on an Exposure Investigation. The
purpose of the investigation was to determine whether volatile
emissions from Perma-Fix (PFD) were exposing residents to harmful
levels of any of 100 chemical species tested. To do this ATSDR
conducted an air monitoring program in the neighborhoods surrounding
the plant. The number of days utilized in the investigation was
extremely low; only six days during the 13-month period from June 2007-
June 2008.
More than four years after the petition, ATSDR published its Health
Consultation document just this past December (2008). The principal
findings of the Health Consultation on PFD are listed below:
Although the data only represent ambient air
concentrations during the time of sampling, none of the more
than 100 compounds analyzed were detected over health-based
values.
``The differences between the average concentrations
of volatile organic compounds (VOCs) for downwind and upwind
samples were not statistically significant. This lack of
difference may be due to the small sample size.''\5\
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\5\ ATSDR, Health Consultation, p. 13.
ATSDR's review of information on the wastes accepted
and the treatment processes used by PFD did not reveal an
---------------------------------------------------------------------------
obvious source for the observed odors in the neighborhood.
ATSDR's outdoor air sampling revealed one compound,
ethyl acetate--which has a low odor threshold and the
characteristic odor of fingernail polish remover--may be the
source of the reported solvent-like odors. That same odor was
observed by ATSDR staff while touring the PFD facility and was
most noticeable in the filter press room and testing
laboratory.
The sole recommendation found in the Health Consultation is as
follows:
``To reduce solvent-like odors, PFD should determine
if there is a source of ethyl acetate in their waste streams
and seek to eliminate or treat it if it is present.''
To understand why community members were frustrated and angry we
need to look not only at study's outcome (after four years) but also at
several inter- related problems including serious deficiencies in the
Agency's science, its failure to utilize critical information and its
flawed community involvement process.
3.1 Inadequacies in the Exposure Investigation's Monitoring Study
1. The number of sample days (six days over a 13-month period) was
woefully inadequate, especially if they are attempting to look at
health effects. Both emissions and weather conditions vary--thus a much
larger sample (days and locations) is needed to capture the worst
cases.\6\
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\6\ The document does not state whether or not the company was
notified as to the timing of testing in advance. Prior notification
would have allowed the company to take preventive actions (e.g., not
processing certain kinds of wastes) that are not normally employed.
2. The kind of monitoring study conducted by ATSDR should have been
supplemented with source testing and air quality modeling. ATSDR
officials acknowledged that it did not include source testing. Testing
stack and fugitive emissions could have given the Agency much better
---------------------------------------------------------------------------
information on the chemicals being emitted from the plant.
3. Air quality modeling can estimate the distribution of
concentrations from a source based on pollutant emission rates and
multi-year data sets on weather conditions. Although modeling has
limitations, the combination of monitoring and modeling provides better
information than either alone.
4. Although, the report addresses wind speed and direction, it does
not address the stability of the atmosphere (e.g., the presence or
absence of temperature inversions). The combination of stable
atmosphere with very slow wind speeds has the potential for worst case
conditions. It is not certain whether ATSDR's sampling included such
conditions. Moreover, as the Health Consultation acknowledges, the
sample collection length (from two to eleven hours) would not provide
information on peak concentrations of relatively short durations.
5. Samples were taken and analyzed on six different days. However, not
all of the contaminants were analyzed for each of the six days. Thus
the study may have failed to detect certain contaminants on some of the
days.
3.2 Problems with the Health Consultation Process
1. Despite repeated requests, the protocol was not provided to the
community for review and comment before the study was initiated. The
potential deficiencies could have been discussed in advance of the
study had a draft been provided in advance. This is a key requirement
for effective and respectful public involvement. The Health
Consultation does not include a response to citizen concerns and
recommendations.
2. ATSDR failed to incorporate substantial information pertaining
emissions including those of odors and hazardous air pollutants (HAPs)
that were available in various notices of government violations and
suits filed by a resident and regulatory agencies against Perma-Fix
(PFD). These include:
In 2002, the Regional Air Pollution Control Agency
(RAPCA) issued a Notice of Violation to Perma-Fix for the
company's failure to comply with RAPCA's previous orders
pertaining to odor and emissions controls from a number of
sources within the plant.
In 2005, U.S. EPA filed a ``Finding of Violation'' in
regard to PFD's failure to control a variety of hazardous air
pollution (HAP) emission sources regulated under the Clean Air
Act.
In May, 2006, the Justice Department in 2006, on
behalf of U.S. EPA joined the suit of a local resident for
injunctive relief and civil penalties against Perma-Fix for
similar violations. The complaint again cited numerous failures
to control emissions, e.g., the plant's bio-plant tanks and
wastewater treatment plant and other sources. In addition, the
company failed to keep records, conduct testing, or apply and
receive permits as required by regulations. (See attached copy
U.S. Justice Department complaint.)
In 2007, the parties to the 2006 suit entered into a
Consent Decree that imposed a civil penalty of $360,000 and
required PDF to (a) identify sources of emissions and odors (b)
measure emissions (c) prevent and control emissions and odors
and (d) obtain a Title V permit from U.S. EPA.
The filings associated with these complaints as well as a variety
of documents (e.g., reports by expert witnesses) were readily available
to the Agency online.\7\ The information contained in these sources
would have been extremely useful to ATSDR in its design of the
monitoring study and in generating a meaningful set of recommendations.
For example, one memorandum contained in the docket provides specific
information on waste streams and emission sources. I am also aware that
community leaders made numerous attempts to persuade ATSDR officials to
obtain and use this data. However, to my knowledge the Agency failed to
do so; moreover, the Health Consultation is mum on the Agency
violations, the federal and citizen litigation and the resulting
Consent Decree. (See Attached Documents)
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\7\ Documents on the case of Fisher and the United States versus
Perma-Fix of Dayton are available U.S. District Court, Southern
District of Ohio (Dayton), CIVIL DOCKET FOR CASE #: 3:04-cv-00418-MRM.
---------------------------------------------------------------------------
Residents were so frustrated with ATSDR's handling of the study,
that in July 2007 they petitioned the Agency once again--this time to
``halt all of its work regarding Perma-Fix until such time as it works
out an acceptable protocol and public involvement process with the
affected community.'' \8\ A copy of this letter is attached.
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\8\ Letter from Laura J. Rench to Howard Frumkin, Director National
Center for Environmental Health and ATSDR, July 25, 2007. (Attached)
---------------------------------------------------------------------------
In my judgment, it is unconscionable that the Agency failed to
include in its Consultation (2008) the list of uncontrolled emission
sources in the record and the extent which Perma-Fix was taking
meaningful steps to meet the requirements of the 2007 Consent Decree.
Instead, the Consultation's sole recommendation is of no real
consequence or utility. Moreover, it could have been made back in 2004
without expending funds for a predictably inconclusive monitoring
study. Most importantly, the tepid recommendation coupled with the
implied finding that there is ``no evidence for concern'' can be
readily translated to signify, ``no cause for concern.'' Had this
report been issued earlier, it might have been used to impede the
successful federal and citizen litigation against Perma-Fix and the
relief it provides.
Thus, it is not surprising that residents of Drexel have grown
frustrated and angry and have lost the trust they had in ATSDR. There
are many similar stories and word gets around. For example, the Center
for Health, Environment and Justice, an organization founded by
activist Lois Gibbs, has warned in its publications that communities
may opt to boycott ATSDR (and cooperating State health departments)
unless the Agency negotiates with the community in good faith regarding
study protocols and related issues of public concern.\9\
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\9\ Stephen Lester, Center for Health Environment & Justice,
Assessing Health Problems in Local Communities. Updated April 2007.
4.0 Recommendations:
What is needed to create the needed change at ATSDR? First, I would
propose that this subcommittee continue its valuable oversight of
ATSDR. Secondly, the Subcommittee should press ATSDR to adopt the
following policies submit legislation that would mandate the changes if
needed.
1. ATSDR should provide draft protocols for all exposure
investigations and health studies for public review and
comment. Upon the request of members of the public the Agency
should be required to subject protocols to independent review.
2. ATSDR should undertake the following measures with regard
to all community-related documents, including health
assessments, health studies, health consultations and exposure
investigations:
Provide drafts of the documents for public
review with a minimum 40-day comment period.
Upon request, subject the draft to peer
review by a group of experts free of ties with ATSDR or
facilities which are the subject of the investigation
of concern.
Upon request, the Agency should hold a public
meeting with regard to the draft document.
The final document should respond to all
community and peer review comments.
3. In formulating its findings and recommendations, ATSDR
should utilize all pertinent information including federal,
State and local agency enforcement actions and evidence
contained therein.
4. In any case where the Agency finds that it has insufficient
evidence to support a finding (e.g., health effects), it should
include clear language warning the public or business leaders
not to equate the absence of evidence signifies an absence of
effect or concern. ATSDR should monitor press coverage of all
of its community-based documents; where there are indications
of confusing statements or misinterpretations, ATSDR should
take immediate and public measures to correct such statements.
5.0 An integrated approach to community restoration and health.
Environmentally stressed communities approach ATSDR and other
health agencies because they have serious concerns and badly need help.
Low-income, minority and tribal communities often are impacted by a
multitude of environmental stresses: e.g., a waste management facility,
factory pollution, highly toxic diesel emissions, and unhealthful
levels of inhalable particulates and/or ground level ozone. Perhaps
there are sewerage related problems. There are other stresses as well--
such as unemployment, no access to health care, aging populations, lack
of adequate housing, etc. Health agency actions which focus on a single
source are poorly equipped to deal with this these situations.
Needs vary from one community to another; i.e., the local health
clinic may need expertise to deal with environmental exposures, perhaps
a local credit union or pension fund could invest in restoring homes to
livability, or perhaps the need is set up volunteers to visit the homes
of elderly neighbors on a continuing basis. Such efforts will require a
different vision and much greater coordination between programs and
agencies. However, there are examples of community-based approaches
which attempt to solve problems holistically. For example, in Trenton,
a non-profit organization, Isles, Inc. has set up programs to remove
lead from home environments and has trained residents to address these
problems and to restore dilapidated buildings. These programs have led
to employment and entrepreneurial opportunities. Trenton has the
potential to bring in up to $2.4 million for green collar jobs and
career development activities, many of them connected to restoration
and improved environmental health. See http://www.isles.org/
This program is by no means unique. In fact, President Obama's
economic stimulus package contains funding for community-based training
and employment in areas such as weatherization and renewable energy.
(See also, The Green Collar Economy by Van Jones and Ariane Conrad,
2008 for many examples of community-based initiatives aimed to bring
environmental health and economic progress to communities.)
I believe that public health agencies including ATSDR could play an
important role in fostering the kind of interagency and inter-
departmental coordination that is needed to bring a more holistic and
cost-effective approach to community health.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Biography for Henry S. Cole
Henry S. Cole, Ph.D., the President of Henry S. Cole & Associates,
is an environmental and atmospheric scientist with broad and in-depth
experience on issues involving air pollution, involving facility
emissions, air pollution meteorology and source receptor relationships.
His experience includes a wide range of pollutants and sources
including landfills, incinerators, power plants, cement kilns, and
industrial plants. Dr. Cole has a broad and interdisciplinary
background in environmental Earth sciences as well as atmospheric
sciences which enables him to provide scientific support and expert
opinion on the transport and fate of contaminants in the environment.
Dr. Cole is a professional member of the American Meteorological
Association and the American Chemical Society and has won awards from
the U.S. Environmental Protection Agency, Sierra Club, and Clean Water
Action.
Education
Cole earned his BS with high honors at Rutgers University College
of Agriculture (1965) with majors in soil science and meteorology. He
obtained his Ph.D. in meteorology at the University of Wisconsin in
1969 and received broad training in atmospheric sciences including
dynamics, thermodynamics, climatology, micrometeorology, and physical
meteorology.
Faculty Research and Teaching
As a faculty member of the University of Wisconsin-Parkside (1969-
1977) Cole conducted EPA-sponsored research on the air pollution
problems affecting the Chicago-Milwaukee L, Michigan shoreline
corridor. He co-authored some of the earliest and most referenced
journal articles on the impact and modeling of shoreline sources (e.g.,
power plants, urban emissions). (See Publications List). Cole taught a
variety of courses including meteorology, environmental Earth sciences,
and air pollution meteorology. He received tenure and promotion to
Associate Professor in 1976. During this period, Cole served as a
member of the Wisconsin State Air Pollution Control Council.
U.S. EPA Senior Scientist
During the period 1977-1983, Dr. Cole served as a senior scientist
in U.S. EPA's Office of Air Quality Planning and Standards (Monitoring,
Data and Analysis Division). In this capacity, Cole directed the
Modeling Application Section of the Source Receptor Analysis Branch.
This Section used point/stationary source, urban, and regional modeling
to develop emission limits and ambient air strategies as part of the
regulatory process. In position as Section Chief, Dr. Cole supervised
staff in their application of numerous point source, urban source, and
regional air quality models.
Clean Water Action
From 1983-1993, Cole served as Science Director of Clean Water Fund
Action, a national environmental public interest organization
headquartered in Washington, DC. Cole authored a number of studies on
EPA's Superfund program, the impacts of municipal waste incinerators
and on the Nation's mercury problem. During this period Cole frequently
provided testimony to Congressional committees on issues pertaining to
Superfund cleanups, mercury emissions, solid waste management policies,
and pollution prevention (e.g., alternatives to PCE-based dry
cleaning).
Discussion
Chair Miller. Thank you, Dr. Cole. Mr. Mier testified--you
all were all here for the earlier panel. Mr. Mier testified,
showed photographs of animals in his community in Midlothian,
Texas, and said ATSDR was not interested in seeing his animals
or the pictures of his animals. Dr. Hoffman said that obvious
apparent effects on animals would get his attention, and I
think if I had noticed that every tadpole near my house had two
heads, I would worry a little bit.
More Animals as Sentinels of Human Health
Dr. Ozonoff, what is the value or the reliability of
effects on animals in predicting as a sentinel or an indicator
of what effects there may be on human health?
Dr. Ozonoff. Well, there is a long tradition, actually, in
epidemiology of doing epidemiology on animals as well as doing
it on people. There are numerous studies in the literature, for
example, of trapping small rodents called voles and other small
animals around hazardous waste sites, net cropping them to see
what the health effects are. In Vietnam, Agent Orange was
looked at because--one reason it was looked at was because of
epidemiology on dogs, the canine dogs that were in Vietnam. The
canary in the coal mine is another classic example. These are
all warning flags. They don't give you the answer, but they are
like a big sign in the ground that says dig here.
Peer Review
Chair Miller. Dr. Ozonoff, you have said you were a part of
a panel some time ago that recommended that ATSDR health
assessments be subject to independent peer review. What has
ATSDR's response to that recommendation been?
Dr. Ozonoff. I can't give you a tally on how many of their
assessments are peer reviewed. My impression is very few, but
that some of them are often on the basis of controversy or
pressure. One of the things that we saw in the original GAO
panel was that the squeaky wheel got the grease and that health
assessments around very active community sites that made a lot
of noise were more detailed and got more attention than those
that didn't. In fact, some of them in the original batch of
800-some or 700-some under the initial mandate were just cut-
and-paste jobs of EPA memos, whereas if there was a community,
an active community group very concerned about what was going
on, they would get more attention.
Chair Miller. Dr. Wilson, you were nodding vigorously.
Dr. Wilson. I think that we have enough fingers and toes to
calculate the number of health assessments and consultations
that routinely are peer reviewed. I recommended in my Stauffer
report that a new health assessment be conducted and that it be
peer reviewed, and that was looked at as way out of proportion
for what could and should be done. I recommend that all of them
have the peer-review process. We are already spending well over
400 days. If we just speed up a little bit, we will have time
to do peer review within that 400 days and still get a better
quality product.
Information Access
Chair Miller. Dr. Wilson testified to the unwillingness of
ATSDR to push to get information, to get documents. What would
be the effect of the lack of those documents or what might be
the effect? Dr. Ozonoff, how important is it that they get the
information that might be available to other agencies or in the
private sector?
Dr. Ozonoff. Well, I think there is an interesting pattern
that emerges when you look at the health assessments. There is
a lot of emphasis on exposure pathways, analyzing exposure, and
to some extent toxicology, and a lot of that is a function of
the fact that those documents are easy to get. The EPA has got
a lot of exposure information, so that is available to them.
And a lot of ATSDR health assessors sit actually in EPA
regional offices so that there is not so much independence
between those two, and it is one reason that I think EPA
doesn't find the health assessments very useful because they
are redundant of documents that are with EPA.
When it comes to documents that are health related, I think
there is just not enough effort expended to get the
documentation both about community concerns--EPA often will be
very frank with both State agencies and communities in saying
that they don't want to have public meetings with communities
because of the abuse that they suffer when they are at public
meetings, so they meet on them one on one. This is a self-
fulfilling prophecy. This is the Agency withdrawing from the
community because of the community's response, the community
then seeing that the Agency is withdrawing, and it becomes a
self-reinforcing cycle. This is no way to get the kind of
information that we are talking about.
Difficulty With Epidemiology
Chair Miller. One more question, although the red light is
on. Dr. Ozonoff, your testimony was probably more critical than
my opening statement, although perhaps more elegantly put than
jackleg science. What is the effect on the health of human
beings from a pattern of inconclusive studies?
Dr. Ozonoff. You are asking me a question that I am very
conflicted about because I understand from my own work how
difficult it is to do these studies. One of the things that I
have said during my career that gets quoted most often
essentially started out as a joke, and like a lot of jokes
there is a grain of truth to it, which is that a definition of
a public health catastrophe is a health effect so powerful that
even an epidemiological study can detect it. Epidemiology, you
know, is not a very sensitive tool. It is a very blunt
instrument to try and figure out what is going on.
But I think that what Dr. Cole said is exactly right. The
contention that this is inconclusive or that we don't see
anything or that there doesn't appear to be something going on
is really interpreted as a statement that nothing is going on,
but the absence of evidence is evidence of absence. And that is
particularly harmful to these communities who then get no
follow-up.
So I don't know what we would find if we followed up on
these communities. That is part of the problem which is that it
remains invisible.
Chair Miller. Dr. Cole, you were raising your hand that you
wanted to chime in despite the fact----
Dr. Cole. Yeah, I do want to----
Chair Miller.--that the red light is on.
Dr. Cole.--chime in because there is a question of what you
do when there is scientific uncertainty, when there are a lot
of symptoms, when the data is sparse, when the resources don't
produce the evidence that you are really looking for, yet there
is a sense that there really is a problem. In those instances,
I believe that the public health model, and this is a public
health agency, is to err on the side of caution and to act
preventively. We don't have to wait, do we, until there are
corpses, until there are people and families that are
suffering?
Let me give you one very specific thing that could have
been done at Perma-Fix had there been a different mindset and
perhaps a slightly different mission at ATSDR. Had they looked
at all of the data, they would have found that there were a lot
of hazardous wastes coming into that facility, Perma-Fix, that
contained formaldehyde, a probable carcinogen, a very toxic,
hazardous air pollution. It is volatile. It escapes. Had they
done what I consider to be their job, they would have found
out, where are the sources? Where is that waste coming from
that contains all that formaldehyde? And then go to those
sources and find out what substitutions might be made or what
processes could be added to the facilities that generate that
waste that would reduce the amount of formaldehyde. That is
what prevention is, to take a look at the problem, not wait
until there is exact scientific evidence which, as Dr. Ozonoff
and others have said, is often difficult.
Also, we know that prevention oftentimes saves all kinds of
money. It is cost effective because there are many health
effects, both in the workplace and in the environment that
could be avoided, and that is a very good way to reduce health
care costs, to improve the health of communities, the
environmental health of communities, around this country.
Chair Miller. Thank you, Dr. Cole. There is a college
faculty joke that administrators don't like to have scientists
on their university panels because they know where they stand.
When the data changes, their opinions change. Dr. Broun.
Potential Fixes
Mr. Broun. Thank you, Chair. I'll also start off to ask you
all a question that I asked the first panel, and obviously you
all have pretty much answered that. If you were a dictator,
what would you do differently to fix the problem, but let me
ask Dr. Ozonoff, Doctor, if we could make a change to
accomplish the purposes of which ATSDR is supposed to be doing,
with what you are doing and other entities around the country
are doing and even State agencies as I think you mentioned in
your testimony are doing, if we enabled you or other entities,
governmental or private, to be able to do these studies,
wouldn't we be better off? Why? Why not? Just depending on how
you answer the question.
Dr. Ozonoff. I am a scientist, so I am always going to say
that research pays off and it is good to do research, and in
fact, that is exactly what I am going to say. It is very
difficult to know in advance what the benefit of any particular
area of basic science research is going to be, except that we
know that on average it pays off. At the risk of special
pleading, let me just make an observation that lots of money
was injected into the NIH and the recent stimulus package, but
not all of NIH got money. The research program that provides
the basic science for the Superfund program, underlying the
basic science that we are talking about, got zero. CDC, except
for bricks and mortar, got zero. NIOSH, which does the
equivalent thing in the workplace, got zero. And part of the
reason is is what Dr. Cole said. There is a vision here that is
missing, and it is just not missing at ATSDR. You know, there
is a wry adage among scientists, or at least cancer scientists,
which is that no Senator championed an agency because his wife
didn't get breast cancer or no Congresswoman championed an
agency because her children were born healthy. When public
health works, nothing happens, right? So therefore we don't
have champions.
I think we are seeing some of the results of that. Public
health agencies are not receiving the kind of moral support and
vision, and they are not being invested from the top down with
the kind of passion for public health that is required. That
would make a huge difference, and of course, I am a scientist.
I believe that research is important.
Mr. Broun. Well, could we do that in the private sector if
we just enable the private sector to do these things? Obviously
there are strong pressures as Dr. Cole, in his testimony,
talked about just from a liability perspective. Couldn't we do
this better in the private sector instead of having one central
governmental agency that is not undergoing peer review and not
undergoing the types of investigative work and really is not
charged or given the ability to do so, it seems to me?
Dr. Ozonoff. Well, I am in the private sector, and of
course our research is conducted in the private sector with
public monies, but I am very, as I said in my testimony, very
strongly of the opinion that public health has the word public
in it, that it is a public function, that it is a--it carries
out a common purpose, all right, and that common purpose is
very important. It needs to be supported. And ATSDR I think
fulfills a role that just has to be fulfilled. Somebody has to
be looking at these communities from the public health point of
view, and that is what ATSDR was tasked with.
Mr. Broun. Well, Dr. Cole, my time is about out so----
Dr. Cole. I think----
Mr. Broun.--but you will have to answer quickly, please.
Dr. Cole.--you touch on something important which you said,
can one agency carry out the mission? And remember, the mission
not only talks about science and determinations of cause and
effect, it also talks about prevention of harm. And I don't
think we can forget that, and if you look at these communities,
you will find that there are typically many, many health
hazards in those communities. Diesel trucks, other plants
besides the one that ATSDR or the landfill that they are
investigating. There are multiple environmental stresses,
particularly in so-called environmental justice communities,
low-income communities. And these communities not only have
many environmental stresses but economic stresses, nutritional
stresses, and many other stresses which complicate the health
effects. So the question is, what is the role of an agency like
ATSDR in those kinds of situations? And this gets to your point
that no one agency can do all of that. You know, there are
economic concerns, there are energy concerns such as the need
to weatherize homes and whatnot, there is lead in homes. Why
not train local people to be a part of the solution to many of
those problems? And there are examples of that. For example, in
Trenton, New Jersey, community members have been trained to
clean up the lead in people's homes. They get a job out of it.
That has led to broader restoration efforts. So what can an
agency like ATSDR do? Perhaps it can coordinate--go into a
community, work with a community, find out what the needs are
from the community, and then go to other agencies and the
private sector. Maybe there is a plant that would contribute to
taking care of something. Maybe they would clear a lot for a
public park. Everyone can be part of that solution, but you
can't slice and dice health. Health is a holistic concept. You
have to look at the community and all of the things that are
going on.
And I think the most unfortunate thing is the stove-piping
of government. You have EPA over here, you have the Commerce
Department here, you have ATSDR over here, CDC here, and really
it takes, to deal with a community, it takes a village as
someone said. Thanks for your forbearance there.
Mr. Broun. Thank you, Chair.
Chair Miller. Thank you, Dr. Broun. Dr. Ozonoff, do you
have an opinion on whether Dr. Broun is a real scientist?
Dr. Ozonoff. As a physician, yes, I do. Yes, he is a real
scientist.
Chair Miller. I want to thank this panel as well, and we
will take another quick break before our last panel. Thank you.
[Recess.]
Panel III:
Chair Miller. Our final witness is Dr. Howard Frumkin, the
Director of ATSDR and the National Center for Environmental
Health. Dr. Frumkin, you will have five minutes to provide a
spoken testimony, an oral testimony. Your full written
testimony will be included in the record.
Again, it is the practice of this committee to take
testimony under oath. Do you have any objection to taking an
oath?
Dr. Frumkin. No, sir.
Chair Miller. And you have a right to be represented by
counsel. Do you have counsel here today?
Dr. Frumkin. No.
Chair Miller. All right. If you would then stand and raise
your right hand? Do you swear to tell the truth and nothing but
the truth?
Dr. Frumkin. I do.
Chair Miller. Thank you, Dr. Frumkin. You may begin.
STATEMENT OF DR. HOWARD FRUMKIN, DIRECTOR, NATIONAL CENTER FOR
ENVIRONMENTAL HEALTH AND AGENCY FOR TOXIC SUBSTANCES AND
DISEASE REGISTRY (NCEH/ATSDR)
Dr. Frumkin. Chair Miller, Dr. Broun, Representative Broun,
good morning. I am a physician and epidemiologist with 27 years
of experience ranging from primary health care to research to
environmental health practice. I have a long and public record
to commitment to science, public health advocacy, and community
service.
As a scientist, I am deeply committed to using the best
science. As a public health advocate, I am passionate about
promoting health and protecting the public from hazards. As a
caregiver, I know that statistics are only proxies for real
people and that when I serve those people, they deserve all of
my skill, compassion, integrity, and courage, and as a public
servant, I am accountable for achieving these results.
I am proud of my agency, of our excellent staff, and of the
work we do in protecting public health. I testified before this
subcommittee almost a year ago at a hearing that focused on our
response to Hurricane Katrina, including our work specific to
formaldehyde in temporary housing units. I testified at that
time that in some respects we could and should have done
better. I also noted that there were key lessons to be learned.
During the past year, we have taken important steps to ensure
that our current and future work builds on those lessons, the
point to which I will return.
Committee staff prepared a lengthy report in advance of
today's hearing. I respectfully disagree with many of the
statements and conclusions in that report. I would welcome the
opportunity to provide a different perspective at an
appropriate time. In the meantime, in this brief oral
statement, I want to make just three points.
First, protecting the public from toxic exposures is
ATSDR's top priority, and we adhere scrupulously to good
science in doing so. We work at several hundred sites each
year. We identify public health hazards at a substantial
proportion of sites. We offer recommendations to protect the
public, and these recommendations have a strong track record of
implementation by appropriate authorities. In some cases, even
when exposures appear to be low, we recommend clean-up
activities, adopting the preventive approach that Dr. Cole just
described.
My written testimony includes examples of our successful
work including instances in which we exercised independence and
upheld scientific integrity despite considerable external
pressure. Protecting the public on the basis of good science is
ATSDR's top priority.
Second, we recognize challenges we face and limitations to
some of our work. Some of this is intrinsic to our mission.
While communities expect us to provide definitive answers about
the links between exposure and illnesses, even the best science
sometimes does not permit firm conclusions. An ailing patient
visiting a doctor expects a definite diagnosis, but even the
most thorough diagnostic workup cannot always yield an answer.
At other times, the data needed to assess the health effects of
an exposure simply have not been collected, as if a physician
had to attempt a diagnosis without blood test results. In still
other cases, we reach conclusions based on very sound science,
but members of the public differ with our conclusions. These
are all situations in which the communities we serve feel
distressed and disappointed, and so do we.
Another challenge is this. Our staff has declined from
about 500 in the early years of this decade to about 300 now.
The implications are obvious.
Let me acknowledge that we are not perfect. As strong and
science-based as our work is, there are things we could do
better. In this morning's testimony, we heard a number of very
sobering and disturbing perceptions. If we don't communicate
well, if we are not accountable to communities, if we don't use
available data fully, if we don't use the best possible
monitoring techniques, if we don't correct misrepresentations
of our work by other agencies or individuals, I don't believe
these things happen regularly or often, but if they do, shame
on us and we should do better.
I am firmly committed to representing opportunities for us
to do better and to continuously improving our performance.
This leads to my third point. We are working vigorously to
improve our work in four categories: overall mission, science
administration, organizational management, and specific
procedures.
With regard to overall mission, we are convening a national
conversation to examine not only ATSDR's approaches to
protecting public health, but how our work fits into the
broader universe of agencies and organizations. We believe that
some of our core practices now more than two decades old may be
ready for renovation, a perception that some of this morning's
witnesses echoed.
With regard to science administration, the Board of
Scientific Counselors, an independent expert body, conducted a
detailed review of our clearance and peer-review procedures at
my request. While the Board found our procedure to be generally
sound and effective, it identified several opportunities for
improvement which we are implementing. For example, we have
beefed up the staffing in our Office of Science, clarified
clearance requirements to our staff, and aligned one division
which had an independent peer-review process with the centrist
peer-review procedures.
With regard to organizational management, CDC brought in an
external firm, PriceWaterhouse, to review our center and to
compare it to others at CDC. The focus was on human resource
management. Overall, our center's management was comparable to
that across CDC, a bit better in some respects, a bit worse in
others. Several specific opportunities to improve emerged, and
we have launched a detailed and aggressive management
improvement initiative to address them. This includes
innovative approaches to hiring new talent, management
training, skill building in our staff, improved issues
tracking, and improved use of performance planning.
With regard to specific procedures, we continue to make
improvements, refining the language we use to communicate our
findings to the public, streamlining the updating of our
toxicologic profiles, replacing the software that tracks our
work at sites and more.
Mr. Chair, Dr. Broun, other Members of the Committee, on my
own behalf and on behalf of enormously dedicated, hard-working
staff, I affirm my commitment to good science, to good science
administration, and to public service. In this, I fully agree
with this committee. I am proud of the excellent work we do at
hundreds of sites nationally. I recognize that even excellent
work has room for improvement, and I pledge diligence in
identifying and acting on opportunities to improve. I
appreciate the constructive suggestions this Committee has
provided to date, and I look forward to collaborating with this
Committee as we move forward. Thank you.
[The prepared statement of Dr. Frumkin follows:]
Prepared Statement of Howard Frumkin
Good morning Chairman Miller and other distinguished Members of the
Subcommittee. Thank you for the opportunity to be here today. I am Dr.
Howard Frumkin, Director of the Agency for Toxic Substances and Disease
Registry (ATSDR) and the Centers for Disease Control and Prevention's
(CDC's) National Center for Environmental Health (NCEH).
I am a physician with 27 years of experience in environmental and
occupational medicine and epidemiology. I have been Director of NCEH/
ATSDR since September 2005. Previously, I served as Chairman of the
Department of Environmental and Occupational Health at Emory
University's Rollins School of Public Health and Professor of Medicine
at Emory Medical School.
I am committed to the goal of serving the public by protecting the
public's health, and bringing to bear the best science in doing so. As
a public servant, I am accountable for achieving this goal. I am very
proud of ATSDR's overall efforts to protect the public's health from
chemical exposures.
I testified before this committee on April 1, 2008, at a hearing
that focused on the work of ATSDR and NCEH in responding to Hurricane
Katrina, including our work specific to formaldehyde in temporary
housing trailers. I testified at that time that in some respects we
could and should have done better. I also noted that there were key
lessons to be learned. During the past year we have taken important
steps to ensure that our current and future work builds on those
lessons, which I will address later in this testimony.
Today's testimony will discuss more broadly ATSDR's scientific and
programmatic activities, and will focus on three areas.
First, I will provide background on ATSDR, including
examples of work the Agency has conducted at specific sites in
communities across the United States.
Next, I will discuss some of the challenges faced by
ATSDR.
Finally, I will share a vision for ATSDR as we look
toward the future, emphasizing our commitment to continuous
improvement in four categories: overall mission, science
administration, organizational management, and specific
procedures.
The ATSDR Story
ATSDR is the principal non-regulatory federal public health agency
responsible for addressing health effects associated with toxic
exposures. The Agency's mission is to serve the public by using the
best science, taking responsive public health actions, and providing
trustworthy health information to prevent harmful exposures and disease
related to exposures to toxic substances.
ATSDR was created by the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA) of 1980, more commonly known
as the Superfund law, and came into existence several years later.
CERCLA reflected Congressional and public concern with toxic chemicals,
particularly hazardous waste, in the aftermath of such environmental
disasters as Love Canal (New York) in the late 1970s.
ATSDR was charged with implementing the health-related provisions
of CERCLA. The language in CERCLA, and in the subsequent Superfund
Amendments and Reauthorization Act of 1986--or SARA--leaves room for
interpretation, but in general terms, it assigns ATSDR four
responsibilities, each of which is described in more detail below:
Protecting the public's health
Building the science base on toxic chemicals
Providing information on toxic chemicals to health
professionals and the public
Establishing and maintaining registries.
ATSDR has pursued each of these responsibilities during the nearly
quarter century since it came into being. Our work is very complex and
it has not always been perfect, as I acknowledged to this committee
last year, but overall I am proud of the wide range of achievements,
and proud that we have constantly sought to improve our performance.
Protecting the Public's Health
A core function of ATSDR is assessing potential health hazards
posed by hazardous waste sites and making recommendations for
protecting public health. This is a mandated function in the case of
Superfund sites, and discretionary in the case of other hazardous waste
sites. Our site-specific work is presented in one of several forms:
Public Health Assessments, Public Health Consultations, Exposure
Investigations, and Technical Assists.
A Public Health Assessment, or PHA, is generally conducted when
there are multiple contaminants and potential pathways of exposure. In
a PHA, ATSDR examines past, present, and future exposure scenarios to
evaluate whether people were, are, or may in the future be exposed to
hazardous substances and, if so, whether that exposure is harmful, or
potentially harmful, and in what ways. ATSDR scientists generally
analyze existing environmental and health data--provided by EPA, other
government agencies, businesses, and the public--and make
recommendations. In some instances ATSDR scientists conduct their own
health or exposure investigations. A Health Consultation is similar to
a Public Health Assessment in that it evaluates environmental data and
how people might be exposed, but focuses on a more specific health
question and uses a more limited data set. The purpose of an Exposure
Investigation is to fill environmental or biologic knowledge gaps with
information needed for our public health work. A Technical Assist is a
brief document that answers a specific, narrow question; because it
does not require extensive background research and data analysis, it is
generally completed more rapidly than the more detailed reports.
Recommendations for protecting health and preventing exposures are
regular components of these documents. ATSDR is not a regulatory
agency; our reports identify recommended actions that would be
appropriate for EPA or other authorities to undertake, but do not
compel these actions. Recommendations are directed to entities
responsible for characterizing or mitigating exposures, including State
and local government agencies. Our reports may also recommend that our
agency conduct further work such as health studies, or health
professional and community education. If there is an urgent health
threat, ATSDR can issue a public health advisory warning people of the
danger. ATSDR can also carry out health education or pilot studies of
health effects, full-scale epidemiological studies, exposure or disease
registries, disease and exposure surveillance activities, or research
on specific hazardous substances.
In addition, ATSDR can help protect the public from chemical
exposures in settings other than hazardous waste sites, circumstances
that are collectively referred to as ``releases.'' These releases may
range from chemical plant explosions to a spill of coal combustion
products. They can be those identified by government agencies or by
individuals within the community through the petition process.
ATSDR responds to emergencies involving the release of chemicals,
most often in collaboration with the Environmental Protection Agency.
ATSDR personnel provide real-time public health guidance following
acute releases of hazardous substances and health information to the
public (for example, helping determine when people can safely reoccupy
their homes and businesses after an evacuation).
Much of this public health protection work is carried out by State
health departments, with funding and technical support from ATSDR. Our
State cooperative agreement program functions in 29 states and one
tribal government. In many cases, ATSDR funding provides the only
support for these activities at the State level.
ATSDR's work in protecting public health has been highly
productive. The Agency issues between 300 and 400 Health Assessments
and Health Consultations, and provides more than 1,000 Technical
Assists, each year. During the period 1995-2006, 73 percent of our
recommendations were implemented by federal, State and local
authorities.
Over the nearly quarter century of our work, we have made important
contributions to the way community-based environmental public health is
practiced. The required knowledge and skill were hard-won; in the early
years growing pains were common, but over time ATSDR developed
considerable expertise in community-based work. Our staff is committed
to working closely with the communities we serve, to listening to and
respecting community concerns, and to incorporating community input
into our work plans. ATSDR's public communications recognize cultural,
ethnic, and linguistic diversity. The Agency has helped advance the
concept and practice of Environmental Justice, since many of the
communities we serve are poor and/or members of racial and ethnic
minorities.
ATSDR has a strong track record of sticking to the science and
advancing public health, even in sometimes controversial, highly
charged situations. Several examples are illustrative:
Montana: Vermiculite mined by the W.R. Grace Company in
Libby, Montana, was contaminated with tremolite asbestos. EPA and the
Montana Congressional delegation requested that ATSDR evaluate human
health concerns related to asbestos exposure in Libby. ATSDR has
conducted a number of activities in the community, including: a
screening program to identify people whose health may have been
impacted by exposure to asbestos (revealing that 18 percent of those
tested had abnormalities in the linings of their lungs, as compared to
between 0.2 and 2.3 percent of people without asbestos exposure); a
mortality review that compared asbestos-associated death rates for
residents of the Libby area with those in Montana and the United States
(finding that for the 20-year period examined, mortality from
asbestosis was approximately 40 times higher than the rest of Montana
and 60 times higher than the rest of the United States); and a
Tremolite Asbestos Registry, a listing of individuals with asbestos-
related disease or those at high risk of developing asbestos-related
disease because of exposure to asbestos. ATSDR continues to be actively
involved with the site and the community, joining recently with EPA to
establish the Libby Health Risk Initiative, a program to add to the
understanding of health effects of exposure to Libby amphibole.
Ohio: The Brush-Wellman company, in Ottawa County, Ohio, is
the major processor of beryllium in the United States. ATSDR completed
a Health Consultation in 2002, and found that emissions at the time did
not pose a risk. Past emissions were known to have exceeded applicable
standards, but available data were not sufficient to permit assessment
of the past hazard. Some local officials and the company strongly
objected to follow-up activity, but ATSDR offered clinical testing for
beryllium sensitization to local residents. All concerned individuals
were tested; of 18 participants, none tested positive. Based on that
finding, ATSDR did not recommend further testing. We followed up by
educating local health care providers to help them identify and test
for beryllium exposure and chronic beryllium disease.
Minnesota: Excel Dairy is a large dairy farm in Marshall
County, Minnesota. After neighbors complained of odors and respiratory
and other symptoms, ATSDR worked with the Minnesota Department of
Health (MDH) to sample for hydrogen sulfide (H2S) at nearby
homes. Data indicated that health based guidelines were frequently
exceeded, often for hours at a time. In 2008 ATSDR recommended that
Excel Dairy take immediate steps to protect health and safety,
especially of children, such as by applying permanent covers to the
manure lagoons. ATSDR also recommended that the Minnesota Pollution
Control Agency continue to monitor air emissions of hydrogen sulfide,
and that MDH work with local public health officials to provide people
living at the Dairy with appropriate information to protect their
health and safety. ATSDR also indicated that if measures to eliminate
exceedances of the state's standards for H2S were not
effective, the Agency would consider further exposure monitoring in
coordination with MDH. In 2008 ATSDR testified before a House
Subcommittee on this matter. EPA is collecting hydrogen sulfide
readings from the facility and will continue to conduct a follow-up
assessment.
New Jersey: The Kiddie Kollege Day Care Center in Franklin
Township, New Jersey, was housed in a former thermometer factory,
exposing children and staff to mercury. In 2007, ATSDR worked with New
Jersey health and environmental officials and staff at the nearby
Pediatric Environmental Health Specialty Unit, a university-based
effort funded partially by ATSDR, to assess the exposures. Initial
findings included elevated levels in 31 percent of children and 33
percent of adults tested, with follow-up testing after exposure had
stopped showing a reduction to low levels. New Jersey has since enacted
legislation establishing stringent criteria before building permits can
be issued for day care or educational institutions in environmentally
high risk sites. ATSDR was directed to prepare a report on children's
exposure to mercury, which was recently submitted to two Congressional
committees.
North Carolina: During the 1990s, residents of Randolph
County, North Carolina, complained of respiratory symptoms that they
associated with a nearby polyurethane foam manufacturing plant. ATSDR
worked with State authorities to conduct blood testing and air
monitoring. The findings prompted ATSDR to issue a public health
advisory on October 20, 1997, advising local, State, and federal
officials of potential adverse health impacts from hazardous air
emissions. Concern focused on toluene diisocyanate, a known trigger of
obstructive airway disorders. ATSDR also conducted an asthma
investigation of children residing within a mile radius and found an
elevated prevalence of this disease. During the last three years, ATSDR
and the State health department went on to conduct a more comprehensive
study of exposure and health in communities across North Carolina,
despite strong industry opposition. Current plans include education for
local physicians on the study results.
Ohio: City View Center, a shopping center in Cuyahoga County,
Ohio, was built on the site of a former landfill. In 2008, air monitors
detected explosive levels of methane and other combustible gases. Based
on the available information, ATSDR rapidly concluded that an urgent
public health hazard was present, and recommended that immediate action
be taken. ATSDR's finding provided the Ohio EPA, the Ohio Attorney
General, and the U.S. EPA with further grounds for compelling the
property owner to install an active vapor extraction system on the
landfill to reduce the migration of gases into the shopping center.
Building the Science Base on Toxic Chemicals
In crafting CERCLA, Congress assigned an applied research role to
ATSDR, which complements the biomedical research role of the National
Institute for Environmental Health Sciences (NIEHS). The Agency has
combined a program of original research with a longstanding commitment
to assembling and making widely available the results of research
across the scientific community.
ATSDR's applied research includes toxicologic research. In some
cases this research is conducted in-house; for example, ATSDR
scientists have developed innovative techniques of computational
toxicology to help rapidly assess hazards of chemical releases. In
other cases, ATSDR identifies critical toxicologic data needs and works
with other federal agencies, as well as State agencies, universities,
and volunteer organizations to fill those needs.
A key feature of ATSDR's scientific research is that it often grows
out of site-specific public health activities. For example, as
discussed earlier, ATSDR scientists have conducted a series of
epidemiological studies in Libby, Montana, to assess the health effects
of residents' long-term exposure to asbestos and related minerals.
Still other parts of ATSDR's research advance the science of
exposure assessment. For example, in evaluating the health effects of
past exposures to trichloroethylene in drinking water at Camp Lejeune,
North Carolina, ATSDR scientists confronted a challenge: how to
quantify people's past exposure to contaminants. Marines and their
families had consumed water over a period of years from a variety of
sources on the base that had varying levels of contamination. It became
necessary to reconstruct past exposures based on available records--a
complex process requiring historical analysis of contaminated drinking
water using innovative ground water modeling and statistical
techniques. ATSDR scientists developed and refined the necessary
techniques with input from panels of experts and peer reviewers.
ATSDR scientists have compiled data and called attention to the
problem of hydrogen sulfide exposure near construction and demolition
landfills, a result of the degradation of gypsum wallboard; and
described and quantified the problem of vapor intrusion, when volatile
chemical contaminants in groundwater enter basements.
In addition to original research, ATSDR assembles existing data on
toxic chemicals. ATSDR's Toxicological Profiles are thorough reviews of
available toxicological and epidemiologic information on specific
chemicals. They provide screening levels--called Minimal Risk Levels
(MRLs)--that ATSDR health assessors and other responders use to
identify contaminants and potential health effects that may be of
concern at hazardous waste sites. They are widely used references by
scientists and members of the public.
Providing Information on Toxic Chemicals to Health Professionals and
the Public
A third function of ATSDR is to provide health professional and
community education through direct service at the community level, and
through broader distribution of materials through the Internet and
other mechanisms. For example, ATSDR's ToxFAQs is a series of summaries
of information about hazardous substances. These are user-friendly
documents excerpted from Toxicological Profiles and Public Health
Statements. Each ToxFAQ serves as a quick and comprehensible guide,
with answers to the most frequently asked questions about exposure to
hazardous substances found around hazardous waste sites and the effects
of exposure on human health.
ATSDR also develops and provides medical education to assist health
professionals in diagnosing and treating conditions related to
hazardous exposures. An example of this work is ATSDR's Case Studies in
Environmental Medicine, a series of self-instructional modules that
increase clinicians' knowledge of hazardous substances in the
environment and aid in the evaluation of potentially exposed patients.
ATSDR has developed other products for the medical community, including
Grand Rounds in Environmental Medicine and Patient Education and Care
Instruction Sheets. In addition, ATSDR and EPA established and support
university-based Pediatric Environmental Health Specialty Units
(PEHSUs) to provide education and consultation for health
professionals, families and others about children's environmental
health.
Establishing and Maintaining Registries
The fourth function assigned to ATSDR is registries--confidential
databases designed to collect, analyze, and track information about
groups of people who share defined exposures or illnesses. ATSDR also
provides information to registrants about health services and other
services available to them through other sources. Below are examples of
registries in which ATSDR currently is actively involved:
Tremolite Asbestos Registry (TAR). This is a registry
of people exposed to tremolite asbestos originating in Libby,
Montana. The TAR includes contact, demographic, exposure, and
health outcome information for each registrant.
World Trade Center (WTC) Health Registry. ATSDR has
supported the New York City Health Department in developing the
World Trade Center Health Registry. The WTC Health Registry is
a comprehensive health survey of persons in the lower Manhattan
area of New York City who were most directly exposed to the
environmental effects of the events of 9/11/2001.
ATSDR Faces Challenges
While ATSDR has protected public health, advanced science, and
provided science-based information since its inception, the Agency
faces ongoing significant challenges. These are described below.
Science Cannot Answer All the Questions Posed at Sites
When communities are concerned about hazardous exposures, they want
clear, definitive answers, much as an ailing patient wants a clear,
definitive diagnosis. Communities often expect that an agency such as
ATSDR will arrive on the scene, rapidly assess the situation, and reach
unequivocal conclusions. Unfortunately, it is not always possible to
reach such conclusions. Among the reasons:
Accurate exposure data are often unavailable,
especially for past exposures. Without accurate exposure data,
it is impossible to correlate exposures with health outcomes.
Accurate health data are often unavailable. While
registries for certain diseases are sometimes available, such
as cancer and birth defects, statistical information is not
routinely collected for most health conditions. Without
accurate health data, well matched to exposure data by time and
place, it is impossible to correlate exposures with health
outcomes.
Some ailments, such as fatigue and headache, are
difficult to measure objectively, and therefore difficult to
characterize quantitatively.
Complete information on the toxic effects of many
chemicals is lacking, especially for such outcomes as
neurobehavioral, developmental, and reproductive function, and
especially following the types of long-term, low-dose exposures
which occur in many communities.
Toxicologic data usually refer to one chemical at a
time, but in real life, people frequently are exposed to
mixtures of chemicals. Scientific data on such mixed exposures
are scanty.
Many communities have relatively small populations,
which are difficult to study for reasons of statistical power.
It is for this reason that important health findings typically
emerge from large studies. The Framingham Heart Study enrolled
nearly 15,000 people over more than 50 years, and the National
Children's Study plans to follow 100,000 children from before
birth to age 21. In a community with a few hundred people, the
opportunities for robust research are far more limited.
In summary, definitive answers sometimes do not exist, due to the
inherent uncertainties of science, the limits of available data, the
limits of small-area epidemiology, and the lack of appropriate public
health tools.
Moreover, concerned citizens sometimes have honest disagreements
with the results of ATSDR assessments. While ATSDR scientists use
standardized methods to assure objective results, these sometimes yield
conclusions that are not expected by or acceptable to community
members. This is understandable. Community members, who are justifiably
concerned about unwarranted exposures from hazardous wastes, may reject
the concept of ``levels of risk'' when what they want is zero exposure.
For example, in some situations, even where a source of toxic chemicals
is identified, careful measurement may indicate that people absorb
little or none of the toxic chemical. Such findings can be unwelcome to
people who desire nothing less than complete elimination of the
contaminant. In some cases, ATSDR and counterpart State agencies have
repeated investigations several times, when negative conclusions were
challenged, only to replicate the original findings--and consequently
to face accusations of indifference or worse. Such situations are
difficult and frustrating, both for dedicated ATSDR staff and for
community residents who earnestly seek solutions to their problems.
Heavy Emphasis on Hazardous Waste Sites Relative to Other Exposure
Routes
In the early 1980s, following the national attention generated by
Love Canal, there was considerable focus on hazardous waste sites.
CERCLA (including its public health component, ATSDR) reflected this
focus. However, a variety of other sources, such as food, consumer
products, water, and air, are well recognized, and for many Americans
these, not hazardous waste sites, are the predominant pathways of
exposure to chemicals.
Workload Challenges
With tens of thousands of hazardous waste sites around the Nation,
and with countless other sources of chemical exposures, ATSDR faces a
potential workload that exceeds its current staffing level. Though
ATSDR's on-board FTE strength has fallen from 481 in FY 2002 to 306 in
FY 2008, without a reduction in workload during that period, we
continually strive to meet our mission through increased efficiencies
and productivity and the efforts of our dedicated staff.
Limited Research Capacity Relative to Extensive Data Needs
ATSDR has a specific challenge with regard to its research
capacity. ATSDR has carried out a limited program of targeted research,
and has worked to identify data gaps and compile research from
industry, academia, and other agencies. However, with the extensive
data needs related to toxic exposures, this remains an ongoing
challenge for the Agency.
Ongoing Efforts to Improve ATSDR
ATSDR is undertaking major efforts to improve its performance and
to meet the challenges outlined above. These efforts range broadly, and
can be described in four categories: review of the overall approach to
carrying out our mission, review of science administration processes,
review of management practices, and improvement of certain other
procedures.
Review of the Overall Approach to Carrying Out Our Mission
Careful consideration of ATSDR's mission has revealed important
challenges, as described above. After almost 25 years of operation with
a relatively unchanged portfolio, these challenges justify re-
examination of ATSDR's approach.
That re-examination is made more compelling by the many changes
that have occurred in chemical science and technology during the
quarter century of ATSDR's existence. Together these changes have
revolutionized the context within which ATSDR works to protect the
public from chemical hazards.
Analytic chemistry tools now permit measurement of
unprecedented low levels of chemical exposures.
Biomonitoring, the direct measurement of chemicals in
people's body fluids, has advanced tremendously, enabling
scientists to identify and quantify exposures.
The genetic revolution and the emergence of the
``omics'' (genomics, proteomics, metabolomics) offer the
potential to study gene-environment interactions, and to
understand exposures and health effects at an individual level.
Toxicologic advances such as computational and in
vitro methods offer enormous opportunities for insight into
chemical action, more rapidly and at less expense than ever
before.
Green chemistry represents an innovative approach
that seeks to design and produce environmentally safe
chemicals, avoiding the toxic effects on which ATSDR's work has
focused.
Together, these considerations make clear that a re-evaluation of
ATSDR's approach is timely and appropriate. Moreover, it is clear that
ATSDR's responsibility--protecting the public from toxic chemicals--
does not rest with ATSDR alone. Many other agencies share in this
responsibility, and many other stakeholders--industry, environmental
groups, community groups, professional associations--play essential
roles.
In fact, review of the Nation's efforts to protect the public from
chemical hazards over the last four decades--an effort that includes
ATSDR but extends well beyond--yields compelling conclusions. As a
nation we have achieved some notable successes, but we remain limited
in our ability to assemble needed data, draw consistent conclusions,
launch protective actions, and inform stakeholders. Various agencies
and organizations--governmental and non-governmental, regulatory and
non-regulatory--carry out public health functions related to chemical
exposures. These functions include exposure and health surveillance,
investigation of incidents and releases, emergency preparedness and
response, regulation, research, and education. But improvements can
always be made to increase coordination. Some key responsibilities are
not carried out adequately, while others are needlessly redundant.
ATSDR's mission and functions must be considered within this broader
context.
In recognition of these realities, ATSDR and its companion Center
at the CDC, the National Center for Environmental Health (NCEH), have
initiated the National Conversation on Public Health and Chemical
Exposures. This process will convene a wide range of stakeholders over
one to two years, including community groups, industry, environmental
groups, public health groups, and others. Early responses from various
stakeholder groups has been highly supportive. We expect this effort to
yield an action agenda for revitalizing the public health approach to
chemical exposures. Part of this agenda will be direction for ATSDR as
it moves into its second quarter century.
Review of Science Administration Processes
In 2008, this committee raised questions about the adequacy of
existing procedures for internal clearance and external peer review of
scientific documents at ATSDR. In response, NCEH/ATSDR asked the Board
of Scientific Counselors (BSC), an external expert group charged with
advising the Center on matters of science and science policy, to assess
these procedures and to suggest any needed improvements. The BSC's
overall conclusion was that the existing procedures generally function
well to achieve quality-assurance goals. The BSC report identified and
discussed several concerns and recommendations. A draft report was
presented at the November 2008 meeting of the BSC and the BSC approved
the final report in early March 2009. In the meantime, ATSDR has made
specific improvements. For example, an independent peer review process
maintained in one Division now is subject to additional oversight
consistent with Center-wide procedures; the staff of the NCEH/ATSDR
Office of Science has been enhanced through additional hiring, and
review procedures have been reiterated to supervisors to help assure
that all staff scientists are aware of them.
Review of Management Practices
In 2008, this committee also raised questions about management
practices at ATSDR. In response, CDC commissioned an independent review
of NCEH/ATSDR management practices. NCEH/ATSDR was compared to two
other CDC Centers and to data from government-wide management-practice
surveys, to permit conclusions about areas of particular need within
NCEH/ATSDR.
In general, NCEH/ATSDR management practices were found to be
comparable to those across CDC. Several opportunities for improvement
were identified. Examples include: increasing management awareness of,
engagement with, and accountability to the human capital strategy;
improving the use of existing human capital systems including human
resource data systems and processes, performance management, and
recruitment strategies; and improving the Agency capability to
constructively manage conflict and enable better program and scientific
results. In addition, NCEH/ATSDR leadership, in consultation with those
in supervisory positions at CDC's Coordinating Center for Environmental
Health and Injury Prevention (that NCEH/ATSDR is a part of), identified
other opportunities for management improvement. From these, NCEH/ATSDR
developed a broad plan for management improvement, and began
implementing that plan in late 2008. The plan has five areas of focus:
(1) unifying and revitalizing our mission; (2) human capital strategy;
(3) human capital practices; (4) employee relations; and (5) quality of
work life. Below are some examples of steps being taken to improve
management.
Initiated strategic planning in each Division, as a
step in engaging employees in efforts to achieve shared goals;
Promote training of managers in team-building,
leveraging diversity, complaint and conflict management,
alternate dispute resolution, and conduct and disciplinary
actions;
Adopted Issues Management Tracking software in the
NCEH/ATSDR Office of Policy, Planning, and Evaluation, to track
issues and provide a mechanism for senior management to triage
scientific issues to the appropriate office, and to maintain
oversight until project completion;
Initiated a system of job rotation within NCEH/ATSDR
to allow staff to move to different positions for short periods
(one to three months), to enhance staff skills, facilitate
collaboration and innovative partnering within these entities,
and improve morale;
Initiated several activities to attract new public
health professionals into entry-level positions, to ensure that
the needs of the future will be met.
Improvement of Specific Procedures
Finally, NCEH/ATSDR continues to make a wide range of changes in
specific procedures, in order to improve performance. Four examples,
each specific to ATSDR and each taken from the last year, are
illustrative.
The wording of Public Health Assessment conclusions:
ATSDR has for many years used five standard categories of
conclusions in its Public Health Assessments: ``Urgent Public
Health Hazard,'' ``Public Health Hazard,'' ``Indeterminate
Public Health Hazard,'' ``No Apparent Public Health Hazard,''
and ``No Public Health Hazard.'' Concerns were raised about
this terminology. In particular, the ``No Apparent Public
Health Hazard'' conclusion was seen by some communities as
invalidating their concerns--an understandable reaction, since
it was used in some cases of low but non-zero exposure, where a
finding of zero risk would be hard to support scientifically.
ATSDR reviewed these categories and developed a revised
classification that more clearly communicates risk. The new
conclusions replace telegraphic phrases with explanatory
language, featuring specific information relative to the
substance, the pathway, the time period, and the place. For
example:
``ATSDR concludes that touching, breathing, or
accidentally eating zinc found in soil and dust at the
XYZ site is not expected to harm people's health
because zinc levels in soil are below levels of health
concern.''
replaces
``This site posed no apparent public health
concern.''
Process for updating Toxicologic Profiles. Since its
inception ATSDR has produced Toxicologic Profiles by reviewing
the accumulated literature at a particular point in time,
culminating in publication of a monograph that promptly
commenced to go out of date. The Profile would be updated some
years later with a next edition, which would rather soon become
stale. ATSDR is replacing this ``book publication'' model with
a more contemporary model based on ongoing, web-based updates
of relevant sections as new material becomes available.
Improved data management: ATSDR requires a
sophisticated data management system to track its large number
of sites and activities. A custom-designed system, HazDat, was
used for this purpose for years, but became obsolete. In
response, ATSDR created Sequoia, a new database system, and
launched it in February 2008. Sequoia is a scientific and
administrative database developed to provide access to
information on the release of hazardous substances from
Superfund sites or from emergency events and to provide access
to information on the effects of hazardous substances on the
health of human populations. Sequoia assembles information on
site characteristics; site activities; site events;
contaminants found; contaminant media; basis for concentration
levels, such as maximum, mean, or other descriptor; exposure
pathways; impact on the population; ATSDR public health hazard
categorization; ATSDR recommendations; interventions to be
taken, as described in the public health action plan; and a
record of intervention effectiveness. Sequoia should enable
better tracking and attainment of performance measures, provide
data to support Healthy People objectives, and provide
accurate, comprehensive data to support the analysis and
identification of site-related trends and the identification of
appropriate public health interventions and studies.
Shift in product lines: The standard ATSDR product
over the years has been the Public Heath Assessment. These are
thoroughly researched documents, based on extensive data
reviews, and often require one to two years to complete--a
delay that was unacceptable to some communities. However,
community health concerns are often fairly specific. By using a
more targeted approach such as a Health Consultation, Exposure
Investigation, or Technical Assist to address those specific
concerns, we can respond more rapidly, address public concerns
more directly, and conserve scarce resources for instances when
a full Public Health Assessment is necessary to address more
complex exposure scenarios.
Conclusion
ATSDR is an agency with a relatively short history, but a history
that spans much of this nation's response to health concerns resulting
from hazardous environmental exposures.
Beginning with enactment of CERCLA legislation, ATSDR scientists
have worked to define a new domain of Environmental Public Health at
the community level, often working beyond the reach of the standard
tools of public health. Some challenges were apparent initially:
addressing questions for which there were no straightforward answers,
working in charged settings, and working across cultural and
institutional barriers. With time, other challenges have emerged:
integration across multiple chemical exposure pathways; the rapid
advance of science, leading to needed changes in Agency procedures; and
allocating resources effectively.
While there have been setbacks along the way, ATSDR has worked
diligently to address the needs and concerns of communities and the
people in those communities. Few federal agencies have a stronger track
record in working ``on the ground'' serving local communities. The
Agency has developed innovative tools and skill sets in carrying out
its mission. It has assembled a strong record of accomplishment--
protecting health near hazardous waste sites, advancing science, and
educating health professionals and the public.
Nevertheless I recognize the need for ongoing performance
evaluation and constant improvement. This committee has pointed out
several areas in which improvement may be needed. As described in this
testimony, ATSDR is taking aggressive action to improve in four key
domains: review of the overall approach to carrying out our mission,
review of science administration processes, review of management
practices, and improvement of specific procedures.
I am committed to ongoing improvement in every aspect of ATSDR's
work, enabling us to achieve the goals assigned by Congress and
deserved by the American public: protecting public health from
dangerous chemical exposures.
Biography for Howard Frumkin
Howard Frumkin is Director of the National Center for Environmental
Health at the U.S. Centers for Disease Control and Prevention, and the
Agency for Toxic Substances and Disease Registry (NCEH/ATSDR). NCEH/
ATSDR works to maintain and improve the health of the American people
by promoting a healthy environment and by preventing premature death
and avoidable illness and disability caused by toxic substances and
other environmental hazards.
Dr. Frumkin is an internist, environmental and occupational
medicine specialist, and epidemiologist. Before joining the CDC in
September, 2005, he was Professor and Chair of the Department of
Environmental and Occupational Health at Emory University's Rollins
School of Public Health and Professor of Medicine at Emory Medical
School. He founded and directed Emory's Environmental and Occupational
Medicine Consultation Clinic and the Southeast Pediatric Environmental
Health Specialty Unit.
Dr. Frumkin previously served on the Board of Directors of
Physicians for Social Responsibility (PSR), where he co-chaired the
Environment Committee; as president of the Association of Occupational
and Environmental Clinics (AOEC); as chair of the Science Board of the
American Public Health Association (APHA), and on the National
Toxicology Program Board of Scientific Counselors. As a member of EPA's
Children's Health Protection Advisory Committee, he chaired the Smart
Growth and Climate Change work groups. He currently serves on the
Institute of Medicine Roundtable on Environmental Health Sciences,
Research, and Medicine. In Georgia, he was a member of the state's
Hazardous Waste Management Authority, the Department of Agriculture
Pesticide Advisory Committee, and the Pollution Prevention Assistance
Division Partnership Program Advisory Committee, and is a graduate of
the Institute for Georgia Environmental Leadership. In Georgia's Clean
Air Campaign, he served on the Board and chaired the Health/Technical
Committee. He was named Environmental Professional of the Year by the
Georgia Environmental Council in 2004. His research interests include
public health aspects of urban sprawl and the built environment; air
pollution; metal and PCB toxicity; climate change; health benefits of
contact with nature; and environmental and occupational health policy,
especially regarding minority communities and developing nations. He is
the author or co-author of over 160 scientific journal articles and
chapters, and his books include Urban Sprawl and Public Health (Island
Press, 2004, co-authored with Larry Frank and Dick Jackson; named a Top
Ten Book of 2005 by Planetizen, the Planning and Development Network),
Emerging Illness and Society (Johns Hopkins Press, 2004, co-edited with
Randall Packard, Peter Brown, and Ruth Berkelman), Environmental
Health: From Global to Local (Jossey-Bass, 2005; winner of the
Association of American Publishers 2005 Award for Excellence in
Professional and Scholarly Publishing in Allied/Health Sciences), Safe
and Healthy School Environments (Oxford University Press, 2006, co-
edited with Leslie Rubin and Robert Geller), and Green Healthcare
Institutions: Health, Environment, Economics (National Academies Press,
2007, co-edited with Christine Coussens).
Dr. Frumkin received his A.B. from Brown University, his M.D. from
the University of Pennsylvania, his M.P.H. and Dr.P.H. from Harvard,
his Internal Medicine training at the Hospital of the University of
Pennsylvania and Cambridge Hospital, and his Occupational Medicine
training at Harvard. He is Board-certified in both Internal Medicine
and Occupational Medicine, and is a Fellow of the American College of
Physicians, the American College of Occupational and Environmental
Medicine, and Collegium Ramazzini.
Discussion
More on Animals as Sentinels of Human Health
Chair Miller. Thank you. Dr. Frumkin, you saw the
photographs in Mr. Mier's testimony, and his testimony was that
no one in Midlothian could get anyone at ATSDR to look at the
dogs. There were a Ms. Markwardt's dogs, and there were several
emails with ATSDR in which ATSDR on June 23 of this year, so
just a few weeks ago--January 23. I don't know what I said.
``Again, ATSDR is sympathetic to the plight of your animals but
studies involving animals, even the sentinels for human health
issues, are not activities engaged in or funded by our
agency.'' Before that, ATSDR had sent an email or someone at
ATSDR to Ms. Markwardt. ``ATSDR is sympathetic to the plight of
your animals. However, veterinarian animal issues are outside
of our mandated domain.'' Most recently, January 27, ATSDR
wrote Ms. Markwardt and again said it was beyond the expertise
or competence of the Agency and suggested that she talk to
someone at Texas A&M. No one at Texas A&M has contacted her
yet, and it is not clear they have the funding to pursue any
kind of study on the animals.
You have heard the testimony from others about the value of
animals as sentinels, as an indicator of something, some kind
of exposure that may affect us humans as well, and I am sure
you reviewed the report, our staff report, that shows several
instances in which ATSDR did look to effect on animals as an
indicator of effect on humans. Do you stand by those emails? Do
you stand by the refusal to look at the dogs in Midlothian or
other animals who have obvious health effects as not reliable
or beyond the duties of your agency?
Dr. Frumkin. Mr. Chair, I think this goes back to a point
that Dr. Ozonoff made. The range of expertise needed to serve
communities in a comprehensive way is enormous, ranging from
veterinary epidemiology to social science to meteorology and so
on. We just don't have the expertise on board to do good
veterinary epidemiology. Given that we have many more requests
to do studies than we have resources to do them, one of the
criteria we need to pay attention to is, do we have the
expertise and capacity to do it well? In a case like this where
it is a very, very heartbreaking situation, it certainly bears
further looking into. We just don't have what it takes to look
into it, and we believe we would serve the public better to be
sure that in this case the pet owner is connected with
competent veterinary epidemiologists than to try to take on
something that is outside our lane.
Chair Miller. But you wouldn't look at a dog to see if
maybe that might tell you something about the effect there
might be on humans?
Dr. Frumkin. It is a very worthwhile place to look.
Animals, when they become sick, can very well be sentinels for
environmental exposures. So I don't discount the importance of
looking in that direction.
Chair Miller. And you are familiar with the 1991 National
Academies Report, Animals as Sentinels of Environmental Health
Hazards?
Dr. Frumkin. Yes, as I just said, animals are very well-
recognized valuable sentinels, but a small agency just doesn't
have the capacity to do everything and that is a particular
line of inquiry that just is outside our skill set.
More on Peer Review
Chair Miller. Dr. Wilson, you hear the various suggestions
that ATSDR simply does not do peer review or infrequently does,
but Dr. Wilson said that there were fewer peer reviews of
ATSDR's health assessment than most people had fingers and
toes. Apparently Dr. Wilson is trying to protect the
possibility he can return to being a country music disc jockey
if need be. And everyone testified that ATSDR's default is not
to seek peer review. It is an extraordinary circumstance when
ATSDR does. Everyone seemed to think the default should be
getting peer review.
Why is it that ATSDR does not fairly routinely have your
health assessments, your methodology, your research, your
conclusions peer reviewed?
Dr. Frumkin. Let me differentiate between two kinds of
products. There are the scientific studies that we produce, and
there are the site-specific reports. On our scientific studies,
every one of them is externally peer reviewed. That is not only
a matter of good practice but it is legislatively required, as
I am sure your staff has alerted you.
On the site-specific activities, we are not required to get
peer review, and so we have an algorithm that we turn to. It
balances the need to get our products out quickly with the need
to do rigorous science. The peer review is very worthwhile in
terms of assuring the quality of science but does slow the
process down somewhat. And so there is discretion on the part
of our program managers to decide whether peer review is
needed. Our Office of Science is involved in that decision, and
when there is a site-specific report, that is either in the
realm of uncertain science or is liable to be controversial or
is in some other way appears to benefit from greater scrutiny,
we do submit that to peer review.
Chair Miller. The assessment by GAO panel, or the opinion
of the GAO panel that site-specific studies should routinely be
peer reviewed, you are familiar with that?
Dr. Frumkin. Yes, that was well before my time, but I am
familiar with it.
Chair Miller. Okay. And I assume that most people have 20
fingers and toes combined. Dr. Wilson's estimate that there
were fewer than 20 that had been peer reviewed, is that
correct?
Dr. Frumkin. I don't know what number of our products are
peer reviewed. I would have to get back to you on that.
Chair Miller. Well, in terms of the public feeling some
confidence in an ATSDR study, wouldn't peer review add to their
confidence?
Dr. Frumkin. I think peer review would be very helpful, and
we are very, very open to discussing a more comprehensive
program of peer review. We need to be mindful that we have to
balance the need to be expeditious in releasing our products
with the need to do the peer review. We heard the observation
earlier that our products take too long to get out the door,
and we have been very concerned about that and we have been
working hard to accelerate the production of our reports. And
so we would want to balance the two goods. But I think we are
very open to looking further into more extensive and regular
peer review.
Chair Miller. My time has expired. Dr. Broun.
Hindrances to ATSDR's Performance
Mr. Broun. Dr. Frumkin, you sat here through this whole
morning's testimony and heard all these charges against your
agency and some against you personally, and kind of going along
with what the Chair started out in the line of questioning, of
these charges against you, how would you answer those--I know
there have been a number of them but the most serious ones are
mismanagement and not being scientifically based or honest.
Would you please comment to that and since I just have five
minutes, I wanted to ask a second question. You can just
probably spend the next few minutes doing those and my time
will be up.
What are the greatest hindrances or stumbling blocks for
you and your agency to perform the mission that you have been
charged with?
Dr. Frumkin. Thank you, Dr. Broun. One challenge in
carrying out our mission is that it is intrinsically very
difficult mission. When communities expect us to come in and
have firm answers and when those answers are in many cases
elusive, either by their very nature or because the data we
need aren't available, then we end up disappointing communities
and our people are very disappointed in those situations as
well.
So it may be that the very model of work that we use, the
very kinds of services we deliver to communities need to be
rethought, and our national conversation aims to do that.
We don't have the depth of expertise and breadth of
expertise that an agency charged with our mission really ought
to have. We need to have expertise in everything from
meteorology to communication sciences to veterinary
epidemiology, and we don't have that. We are a very small
group, and in comparison to the thousands of hazardous waste
sites that are out there, the countless thousands of additional
chemical releases, our small agency really faces a huge
challenge quantitatively.
I don't think that we face the challenge of disloyalty to
science or unawareness of the best science or of lack of
dedication. I think we have a very dedicated and caring
workforce, but in the face of those challenges, the job is a
tough job.
More on Potential Fixes
Mr. Broun. What would you do in the way of trying to
overcome those stumbling blocks or hindrances to your being
able to perform what the communities expect?
Dr. Frumkin. Well, I think the steps that I described
earlier that we are now taking to improve our work very much
respond to that question. So at the very large level of looking
at our mission--there were some comments today about our work
plan. Should we delegate more work to the states or less work
to the states? Should we delegate more work to the private
sector or less? Those are fair questions to ask, and we are
asking questions at that large scale in our national
conversation.
We do need to be very attentive to good science
administration, and we need to look at issues like effective
peer review and clearance and be sure that we are doing as well
as we can. We have some suggestions already from this morning's
testimony about more extensive peer review, and that is the
kind of suggestion we need to take very seriously.
At the level of management within the Agency, we need very
good management. We need skilled management with human
resources issues and staff capacity building issues and so on
attended to. We are taking a lot of steps in that direction, so
I stand by what we are doing there. And then there are specific
procedures that we could do better, and we are working hard to
do better at them.
So I think that sort of thorough, open look, a willingness
to identify places where we could do better and then to take
advantage of those opportunities really is what we need to
have, and I am proud to say we have that.
Mr. Broun. Can the private sector handle the functions of
doing these studies and producing the scientific products that
are necessary?
Dr. Frumkin. In some cases we do do that. We have private
contractors who handle some of the preparation of our
toxicologic profiles. In some cases when we conduct
environmental sampling, we have private contractors who do
that. So a certain amount of sharing of this responsibility is
very appropriate.
I do believe that people expect their government to protect
their health, and so I am proud that we have a core government
role, and I think we ought to maintain that role, but I think
shared arrangements between the public and private sectors are
very, very practical and we have shown that they can work.
Mr. Broun. So the answer to that is the State and private
sector can perform these duties if we just enable them to do
so?
Dr. Frumkin. I think so.
Mr. Broun. Thank you very much. My time is out and I will
yield back, Mr. Chair.
Chair Miller. Thank you, Dr. Broun. Mr. Rothman has joined
us. Do you have questions, Mr. Rothman?
Mr. Rothman. I do indeed. Thank you, Mr. Chair.
Chair Miller. You have five minutes.
More on Vieques, Puerto Rico
Mr. Rothman. Thank you. Thank you, Doctor, for your
testimony. I would like to discuss with you an example of what
is a very disturbing conclusion that ATSDR has apparently
rendered with regards to the public health of the community of
Vieques, Puerto Rico. For over 60 years, roughly 200 days a
year the U.S. Navy used the eastern end of Vieques to practice
live ordinance training exercises. Numerous studies, both
academic and scientific, have confirmed that levels of heavy
metals, biotoxins, and carcinogens are sometimes up to 100,000
times higher than the safe levels in the local ecosystem, and
the island suffers a drastically higher cancer rate than the
rest of Puerto Rico.
I have got a lot of questions, Mr. Chair, which I will
submit for the record. As many as I can get in, though, in my
time I would be grateful to do.
In 2003 following four public health assessments, ATSDR
published a summary of the Agency's work that included such
observations that the residents of Vieques have not been
exposed to harmful levels of chemicals resulting from Navy
training exercises, that the bombing of the live impact area
has not affected the drinking water, that levels of chemicals
in Vieques' soil are not of public health concern, fish and
shellfish are safe to eat every day from Vieques, and other
conclusions that seem to be in conflict or contradiction to
other independent studies that have found evidence of potential
public health issues that ATSDR was unable to find.
Are you aware, Doctor, that the hair testing of the people
of Vieques, for example, provided to the U.S. Navy showed
extremely high levels of mercury disease, lead disease, cadmium
disease, arsenic disease, and aluminum disease? Doctor?
Dr. Frumkin. Mr. Rothman, are you referring to disease or
to the levels of exposure to those metals?
Mr. Rothman. Level of exposure to those metals. Let us
start there. If there is evidence of disease, I would like to
know if you found that as well.
Dr. Frumkin. I am not familiar in detail with all of the
data collected in Vieques over the years. Our agency's
involvement in Vieques predated my arrival at the Agency. I do
know that there has been sampling conducted by our people, and
a lot of sampling conducted by others and can't fully explain
the results or reconcile them.
Mr. Rothman. Would you feel comfortable raising your family
on Vieques today, Doctor?
Dr. Frumkin. I don't know enough about Vieques to be able
to answer that question.
Mr. Rothman. It is my understanding that the U.S. Navy has
not been asked by ATSDR to provide the kind of relevant
information that I think might clarify some of the conflict in
conclusions. Would you have any objection to requesting from
the Navy that kind of information?
Dr. Frumkin. No, sir. I am very happy to pledge to you
moving out of this hearing to take a fresh look at the Vieques
situation and to collect any data necessary to clarify the
health situation for the people there.
Mr. Rothman. That is very good news, Doctor. I understand
that you don't have enough information. You have committed to
getting more and being open to reexamining this whole issue
anew, is that a fair summary of your statement?
Dr. Frumkin. Yes, sir.
Mr. Rothman. Thank you very much, Doctor. No further
questions, Mr. Chair.
Chair Miller. Thank you. I do recognize myself for an
additional round of questions. Dr. Frumkin, when I finished
preparing my opening statement I felt bad. It is hard for a
southerner to be that harsh. We say bless his heart, he means
well, instead of the boy is just dumb as a fencepost. It is
hard for us to be that critical. But the last second two panels
made me feel much better about the tone of my opening
statement.
Changes in Response to Criticism
You have heard a lot of criticisms today, you know of the
GAO report that Dr. Ozonoff was part of, in 1992 there was a
study called Inconclusive by Design that makes many of the same
criticisms that we have heard today. I know that was before you
joined ATSDR, and certainly the problems with ATSDR predates
your joining the Agency, but can you identify anything that the
Agency did in response to the GAO study or the study
Inconclusive by Design that was scathing to respond to those
criticisms? Any change the Agency made?
Dr. Frumkin. Mr. Chair, what I can speak to is efforts over
the last three years, and that has been my time at the Agency.
We have recognized the need for a thorough look at the way we
do our business. We have recognized the need to do better in
many ways. Many of the criticisms that were leveled in those
reports 20 years ago are still leveled now, so we need to take
those seriously. That is exactly the motivator for this
national conversation that we are launching. It is meant to be
a multi-stakeholder effort, a very serious and probing effort,
to ask over the last 20 years of our work, what is going well,
what hasn't gone well, and what do we need to do to do much
better moving into the future.
Chair Miller. Not just still but within the last two hours
within this Committee room. You have said that there are
constraints of budget which I am sure is always true of any
Federal Government agency, and that is some of the reasons that
the science isn't better than it is or that it is not peer
reviewed, that you don't look at all the documents, you don't
go look at the dogs. But you have also heard all the testimony
today about the importance of a community being able to trust
ATSDR's assessment that if there is not something for them to
worry about, they need to be able to know that that ATSDR
assessment is something that they can rely upon. And you have
heard that communities can't rely upon that. Have you
considered whether it would be better to do fewer reports but
do them well? Get them peer reviewed, have something the
communities can rely upon but that an assessment that is not
reliable, is not credible, is worse than no assessment at all.
Dr. Frumkin. One of the very important possible solutions
for us is to take on fewer projects and to put more resources
and time into each project and do them in more depth, and I
think that is something we need to consider very seriously as
we move forward with our planning. It is also the case that
sometimes we do quite good work, very good work, but our
results are simply not welcome by the community which has other
expectations than what we can deliver, and that is not a matter
of malfeasance or inability on the part of our people. It is a
matter that some of the questions that communities very
understandably need to have answered just can't be answered.
And so we need to be very careful about acknowledging and when
we need to do better in order to win the trust of the community
when we simply need to communicate better and be more
accountable, even when we have unwelcome news to deliver.
Chair Miller. I yield back the balance of my time. Dr.
Broun, do you wish to have a second round of questions?
Mr. Broun. Mr. Chair, thank you. I have a number of
questions that I am going to submit to the witness, and I
appreciate your offer and I am glad to give you forbearance on
time, so we will work together I think very well.
Closing
Chair Miller. Mr. Rothman has left us. We are now at the
end of our hearing. Thank you, Dr. Frumkin. Under the rules of
the Committee, the record will remain open for two weeks for
additional statements from any Member. I think I neglected to
mention that one of the witnesses, Dr. Cole I think, had--we
will admit into the record letters that Dr. Cole made part of
his--appended to his testimony, and there can be submissions of
follow-up questions from the Committee for any witnesses. And
all witnesses are now excused, and the hearing is now
adjourned.
[Whereupon, at 12:56 p.m., the Subcommittee was adjourned.]
Appendix:
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Answers to Post-Hearing Questions
Answers to Post-Hearing Questions
Responses by Salvador Mier, Local Resident, Midlothian, Texas; Former
Director of Prevention, Centers for Disease Control
I thank you for the opportunity to respond to the following
questions and offer my perception.
As a prelude to my responses, I want to emphasize--public health
desperately needs the mission that gave birth to the ATSDR to be
carried out. This mission has never been truly respected or realized. A
culture of passive resistance by internal and external forces was
instituted at its inception to keep ATSDR from completing its mission.
This well-engrained culture of passive resistance is still very much
alive and pervasive today.
Although disgraceful, the FEMA trailer fiasco was no different than
the egregious 1991 ATSDR political move at reducing pollution control
and cleanup costs for industry by minimizing and denying the public
health hazard of dioxin. ATSDR denied the science then--and contrary to
scientific evidence--trivialized dioxin's proven and potential impact
on public health and attempted to get other agencies to jump on their
bandwagon. The same pattern of trivialization and denial is pervasive
in the majority of ATSDR public health assessments and consultations
and in their Toxicological Profiles upon which their findings are
based. The problems identified by this Subcommittee are only the tip of
the iceberg.
One only needs to track forward the culture instilled by Dr. Vernon
N. Houk, former Director, Center for Environmental Health, CDC. In so
doing it should be obvious that in order to evoke the critically needed
changes within ATSDR, all direct or indirect proteges of Dr. Houk
currently in leadership above and within ATSDR should be replaced--
starting with at a minimum the Director, Coordinating Center for
Environmental Health and Injury Prevention (CCEHIP), down through at a
minimum ATSDR Director, Deputy Director and Director, Division of
Health Assessments and Consultations. Merely tossing a new frog into
the swamp as Director is insufficient to bring about the desired
consequences.
Questions submitted by Representative Paul C. Broun
Q1. Can the private sector or State agencies perform some or all
functions of ATSDR? Would this be appropriate? What conflict of
interests could arise? How could you protect against this?
A1. Functions inherent to ATSDR's mission should be the responsibility
of a public agency--and the public rightfully expects this to be a
responsibility of a federal agency. A federal agency such as ATSDR is
(or should be) further removed from the internal State pressures that
impair and compromise a state's ability to make unbiased assessments.
Private and State agencies could perform some functions of ATSDR but
there are serious conflict of interest issues (especially for State
agencies) that compromise their ability to conduct fair and objective
assessments.
Possible Conflict of Interest--State Agencies
In a statement attached to my written testimony, Dr. Al Armendariz,
School of Engineering at Southern Methodist University (SMU) in Dallas,
Texas, made the following observations to which I concur.
``There is an obvious potential for a conflict of interest
when the ATSDR contracts with State regulatory agencies to
perform health assessments or to conduct follow-up
environmental sampling. [Example] In Texas, the TCEQ is the
State agency that grants permission to facilities in the form
of ``permits'' to emit pollutants to the atmosphere. In the
permit writing process, the State agency is making a legal
statement that a facility will not adversely impact public
health. There is a very obvious potential conflict of interest
when the same agency later goes into the community to do
follow-up sampling in response to an ATSDR investigation. A
State agency is essentially examining whether the facilities to
which it granted permission to emit pollutants at an earlier
date are now in fact causing an adverse public health impact.
If ATSDR is going to work with other organizations to conduct
assessments or do follow-up sampling, ATSDR should work with
independent third parties with no obvious conflict of interest,
such as State universities or schools of public health, a
Federal Government contractor, the American Lung Association,
etc.''
Possible Conflict of Interest Private Sector
Many universities, schools of public health and other health-based
organizations often depend on grants from private industries to fund
many of their research projects. The threat of losing a grant becomes
very real if an organization engages in activities that may not be
advantageous for a contributing entity and presents a conflict of
interest.
It is crucial to build in safeguards that prevent participation if
a potential for conflict of interest exists whether it be a State
government or an independent third party.
Problems With State Cooperative Agreements
The degree to which public health issues conflict with industrial
prosperity concerns varies greatly from state to state. As an example,
in Texas there is considerable political and industry influence (some
subliminal and some strongly overt) on the State environmental agency.
This tone of supporting industry at the cost of public health has been
clearly set by the State administration and is vigorously advocated and
promoted by industry lobbyists and generally has been supported by the
State legislature. It would be irresponsible to pretend this is an
exaggerated issue. It is a pervasive observation expressed by diverse
groups of stakeholders and should not be dismissed. In many states the
ability for State agencies to make an objective assessment of the
impact of toxic exposure on the communities' public health is greatly
compromised. This is why most communities turn to ATSDR--because it is
perceived to be more distant from local political pressures.
Currently, where there is a State cooperative agreement between
ATSDR and the state, ATSDR abdicates the investigative and decision-
making responsibility back to the state--the same institutions that
previously failed the community. This is a costly ``no value realized''
process--an egregious waste of taxpayer's money.
It would be naive to think that ATSDR can do all of the necessary
work independent of the state but ATSDR should assume greater
responsibility for many of the required tasks. Public Health
Assessments/Consultations performed under State Cooperative Agreements
should be severely limited--particularly when all avenues within the
state have already been exhausted and a community turns to ATSDR as the
last resort. Resources wasted under these cooperative agreements should
be re-channeled to improve ATSDR's methodologies used to identify
suspected environmental exposures to hazardous chemicals, conducting
their own assessments/consultation, improving quality control and
having their work peer reviewed by external experts.
Q2. To what extent do you attribute the ATSDR's problems to
leadership?
A2. See my opening statement. There appears to be an entrenched
institutionalized culture that has weakened ATSDR's commitment to
objectively temper and counter external pressures and has created
internal weaknesses that dissuade the Agency from fulfilling its
mission. Changes in this entrenched institutionalized leadership that
go deeper and higher than that of the Director's position are critical
if this culture is to change.
Q3. Do you believe ATSDR attempts to include revolutionary scientific
methods and techniques in their work?
a. If not, how would you propose they better integrate cutting
edge science?
b. Is there any risk to getting too far ahead of a technology
or method and coming to conclusions that are ultimately proven
unfounded?
c. How would you set up policies or procedures to
appropriately manage and unitize these innovations?
A3. I believe that there are internal barriers to and deficiencies in
easily accessible scientific data. This make it difficult for ATSDR
public health assessors to readily access and incorporate the evolving
science into their decision-making processes.
It appears ATSDR assessors are almost exclusively dependent on
summary statements and obsolete ATSDR toxicology profiles. Based on
language and references reflected in their findings, it appears ATSDR
assessors do not have access to evolving science or are not allowed to
work ``out of the box established by the ATSDR Toxicological
Profiles.'' Language in these Profiles appears to be the basis for most
arrived conclusions in the assessments/consultations.
In his written testimony to Congress Dr. Howard Frumkin states
``Since its inception ATSDR has produced Toxicologic Profiles by
reviewing the accumulated literature at a particular point in time [not
at the cutting edge], culminating in a publication of a monograph that
promptly commenced to go out of date. The Profile would be updated some
years later with a next edition, which would rather soon become
stale.''
Dr. Frumkin stated that ATSDR will be replacing the ``book
publication'' model of the Toxicological Profiles with a more
contemporary model based on ongoing, web-based updates of relevant
sections as new material becomes available. How cutting edge the
science will be depends on the time lapses between the availability of
the data and the update. ATSDR assessors should have immediate easy
access to all cutting edge scientific studies data bases and should be
mandated to incorporate the findings into their conclusions.
It appears extensive data needs for the Agency have not been met.
In his testimony, Dr. Frumkin acknowledges, ``ATSDR has a limited
research capacity relative to extensive data needs. Although ATSDR has
carried out a limited program of targeted research and has worked to
identify data gaps--with the extensive data needs related to toxic
exposures, this remains an ongoing challenge for the Agency.''
Keeping up with science appears to be a greater problem than
``getting ahead of science.'' Hence, the question, ``Is there any risk
to getting too far ahead of a technology or method and coming to
conclusions that are ultimately proven unfounded?'' is frustrating.
Let us pretend for a moment that ATSDR indeed accesses the cutting
edge science and this science presents validated information that warns
us of the need to incorporate measures to mitigate harm. What is the
greater risk--taking preventative measures or ignoring emerging
science? Protections that mitigate suspected risks can be relaxed if
further scientific findings emerge that more robustly support an
alternative explanation--but damage to human health cannot be
retroactively mitigated and many illnesses and death cannot be undone.
Resources dedicated to establishing a more proficient science data
base and a mandate to incorporate cutting edge science into the public
health assessments is critical.
Q4. How did your experiences with State and local health officials
differ from that of ATSDR?
a. Were they better or worse?
b. Do you believe there was enough coordination, too little,
or too much?
c. Did you view ATSDR's work as simply ``rubber-stamping'' the
state's work, or did they provide value?
A4. Shortly after ATSDR changed Midlothian's health assessment to a
consultation, ATSDR made it clear that they were abdicating all of
their responsibilities for making decisions back to the state. ATSDR
was to sign off on it. This basically made it clear that they would
simply be ``rubber-stamping'' the state's work.
We had very little interaction with ATSDR--unless we pursued it and
the bulk of the interaction was via e-mail communication. Up until
about six to seven months ago we had frequent communication (both via
telephone and e-mail) with several of the State public health agency
staff. We have had almost zero communication (either that we have
initiated or they have initiated) since. This July it will be four
years since we petitioned the ATSDR for a Public Health Assessment.
You ask, ``Was the state better or worse than ATSDR. For at least
20 years the community went to the State agencies asking them for a
health assessment because they were experiencing increasing public
health problems. The community found themselves on a merry-go-round.
The health department consistently told them that the environmental
agency says that the toxins to which they and their animals were
exposed was not supposed to make them sick so there was no point in
discussing or looking at their health issues.
In desperation for trusted health information, the community turned
to ATSDR. ATSDR catapulted them right back on the same merry-go-round.
The community ended up back in the same arena--receiving more of the
same. Was there a difference? No.
Q5. What was your impression of ATSDR's coordination with other
federal agencies like EPA?
A5. Since ATSDR was not actively involved with the process, there was
no opportunity to form an impression of ATSDR's coordination with other
federal agencies.
Q6. How does ATSDR's level of competence compare to other federal and
State entities charged with protecting public health?
a. Would you characterize the work ATSDR does as a specialized
niche?
b. Do any other agencies perform this same work?
c. Can you identify any areas of duplication?
A6. Would I characterize the work ATSDR does as a specialized niche?
Yes. ATSDR's Public Health Assessments/Consultations should be a
special niche--operating independent of external influences.
Assessing the impact of toxic exposure on public health is
dramatically different from most other public health challenges. First,
the science of environmental health is still evolving and the challenge
of attempting to associate environmental toxins to illness and disease
is apparently extremely difficult. Competency or lack of competency is
difficult to compare because ATSDR (and other agencies working in the
environmental health arena) appear to have a strong lack of will,
interest or courage to attempt to associate illness and disease that
might be associated to industrial toxins. Thus, in my opinion, it is
not so much competency that sets ATSDR and other similar agencies apart
from other public health entities but rather the mindset in approaching
the public health challenges is drastically different.
Efforts to link epidemiological data to toxic emissions from
industry evoke a drastically different set of dynamics and resistance
as compared to linking epidemiological data with a bacteria or virus as
sources. This is especially true when the emissions are from industries
that are active and remain an integral economic part of the community.
These are very real dynamics that science confronts in this arena and
are extremely difficult to deal with and cannot be dismissed. To
dismiss them is to be naive and irresponsible. ATSDR has a tendency to
trivialize and deny the existence of epidemiological data.
Agencies involved in assessing the public health impact of
industrial toxins must make more serious efforts to utilize
epidemiology. Although epidemiology is a common public health tool the
utilization of this instrument is almost non-existent in communities
impacted by industrial toxins. Time and time again we have been told by
both ATSDR and the State Public Health agency that epidemiology is too
expensive, too labor intensive and too difficult in the application to
environmental health issues.
``Do any other agencies perform the same work?'' Yes, some local
and State health departments have environmental health components that
can perform some of this work but the level of expertise and competency
varies significantly and with some it is questionable. Also, see
previous comments regarding potential conflict of interest.
Are there areas of duplication? This is a good question. There may
be some that involve ATSDR, the National Center for Environmental
Health (CDC and under the same Director) and the National Institute for
Environmental Health Sciences. This should be explored.
Q7. How does ATSDR compare with similar entities in other countries?
a. Do international public heal agencies have similar
problems?
b. What do you attribute this to?
A7. I have not studied similar entities outside the U.S. therefore do
not feel qualified to answer any part of this question.
However, note the testimony from Dr. Randall Parrish, University of
Leicester (UK). Using a readily available tool, Dr. Parrish was able to
pick up where ATSDR left off and identify depleted uranium in people
exposed at Colonie, NY. In this situation I attribute this more to lack
of will by ATSDR.
Q8. ATSDR does not do large-scale environmental sampling, and relics
upon the EPA and states to conduct this work.
Q8a. Do you believe ATSDR should also be doing this work?
A8a. ATSDR has the responsibility for scientifically evaluating the
adequacy, effectiveness and appropriateness of all data upon which they
will base their decisions--including environmental sampling and
monitoring (conducted by a State agency or other entity). This is an
important fist step in any analyses they perform. If based on science
and logic ATSDR deems there are gaps and flaws with the adequacy of
this data, then EPA, an EPA contractor or the private sector could
assume this responsibility. EPA is the logical federal agency for this
responsibility because of their expertise. I would assume that EPA also
has the budget capacity to consider undertaking some of these sampling
activities (since frankly this is part of their mission).
Although most State environmental agencies have this capacity they
are too often in a compromising and/or conflict of interest position
because they issue permits to industries and legally certify that those
industries will not adversely impact the public health of the
communities in which they operate. See prior statement regarding
potential conflict of interest.
Q8b. How would you suggest we pay for this work?
A8b. Adequate data necessary to arrive at a scientific conclusion is
not a luxury item and should not be considered optional. The primary
question should not be how the work should be financially supported but
rather how scientific conclusions can be made without it. We pay for
this work regardless of whether it is done by ATSDR or another entity.
The question should be, ``How can we get the most reliable data?''
ATSDR resources misdirected towards State Cooperative Agreements could
be redirected to pay for this work.
When determining cost you must also factor the increased cost of
health care that would ensue addressing illnesses that stem from our
failure to take adequate preventative measures to protect public
health.
Q8c. Would this be worth limiting the number of other studies,
assessments, or consultations the Agency initiated?
A8c. ATSDR has already instituted a ``shift in product lines''
downgrading to Health Consultations, Exposure Investigation, or
Technical Assists to as they put it--``respond more rapidly, and
address public concerns more directly--and conserve scarce resources to
address more complex exposure scenarios.'' Perhaps a closer look at
this shift in product lines is necessary to determine whether there was
a value added or lost. Take Midlothian, Texas as an example.
Midlothian, located within the DFW eight-hour Ozone Non-attainment
Area, is a complex scenario with the largest concentration of cement
kilns and one of the largest steel mills in the U.S. These processes
alone emit a large volume of chemical and heavy metal toxins. The
circumstances are further confounded because these cement kilns are
classified as waste recyclers permitted to burn refuse such as tires,
petroleum coke, asphalt roofing, etc. For 20 years the community has
been exposed to hazardous waste incineration--some even before trial
testing was completed. TXI currently is permitted to burn hazardous
waste in four outdated wet kilns not designed to burn hazardous waste.
These cement kilns are not required to meet the more stringent MACT
standards required for commercial hazardous waste incinerators. Animal
and human health issues have been surfacing for almost 20 years. This
is a complex scenario rife with aggregate toxic chemical exposures and
multiple confounding circumstances which logic would tell you would
demand a public health assessment.
Instead of performing a public health assessment ATSDR instituted
this ``shift in product lines'' and downgraded the assessment to a
``consultation.'' And as far as being able to ``respond more
rapidly,''--almost four years later it is still not finalized. And as
far as ``address public concerns more directly''--the document, and the
comments by the six scientists who reviewed the draft do not support
that the public's concerns were addressed.
The question to ask is, ``To what extent has this ``shift in
product lines'' already taken place--and has it improved the process
and conserved resources?''
Q9. Please describe the process that you (or your community) went
through in petitioning for ATSDR's help.
Q9a. Was your review ever downgraded to a health assessment or health
consultation?
Q9b. Were you consulted in this decision, or were you simply informed
by the Agency?
Q9c. Did you have any ability to appeal this decision?
A9a,b,c. The responses to these questions are all in my written and
oral testimony.
Q9d. How did this affect your overall impression of the services ATSDR
provided?
A9d. My impression was that Midlothian would not be getting a true
unbiased public health assessment that would withstand the scrutiny of
unbiased scientists. I knew that Midlothian's public health assessment
would not be subjected to an internal or external peer review.
Therefore out of desperation, I appealed to the science community for
help in reviewing the draft consultation published for public comment.
Six scientists responded. Their comments will give you insight and
answers to many of the questions you ask herein.
Q10. Please describe your level of communication with ATSDR.
a. Do you feel this was adequate?
b. What do you think they should have done differently?
A10. Once the ATSDR abdicated their responsibility for assessing
Midlothian's public health to the state, the bulk of our communication
was with the State agency staff. Basically, we feel ATSDR should have
retained the responsibility for making this assessment.
Q11. Do you believe ATSDR products accurately communicate agency
findings?
a. What are some of the problems you have identified in their
reports?
b. How can the Agency be more effective in communicating
risks?
A11. It is the weakness of and the omissions in their findings more so
than ATSDR's inability to accurately communicate these findings that
creates the problem. Communicating a concept or conclusion that does
not have a solid scientific basis and ignores ``community concerns''
will always remain difficult.
Dr. Frumkin's statement that communities expect that ATSDR reach
unequivocal conclusions does not accurately represent what communities
expect.
Giving reasons such as ``accurate exposure data are often
unavailable''--``accurate health data are often unavailable''--
``complete information on toxic effects of many chemicals is lacking,
especially for such outcomes as neurobehavioral, development,
reproductive function, and especially following the types of long-term,
low-dose exposures which occur in many communities''--``scientific data
on mixtures to chemicals is scanty,'' Dr. Frumkin further states,
``Unfortunately, it is not always possible to reach such [unequivocal]
conclusions.
Yet in an effort to force conclusions into neat little boxes
labeled ``No Apparent Public Health Hazard'' or ``Indeterminate Public
Health'' ATSDR reaches ``unequivocal'' conclusions--ignoring all
alleged unknowns as if the lack of data equated to no harm. Communities
expect trusted health information based on sound science. It is the
``monkey sees no evil'' game that ATSDR plays that communities find
frustrating. These unknowns should be acknowledged and be part of their
conclusions.
The proposed sample wording/rewording, ``ATSDR concludes that
touching, breathing, or accidentally eating zinc found in soil and dust
at the XYZ site is not expected to harm people's health because zinc
levels in soil are below levels of health concern,'' given in Dr.
Frumkin's testimony, as is just an example of an extension of
gobbledegook. This exampled phraseology is lacking explanatory
information that the public needs and to a large degree is
condescending and insults the community's intelligence. It is barren of
the scientific basis (expressed in layman's terms) upon which
conclusions are based that the public seeks and would just exacerbate
frustrations that currently exists.
Consider how lead is addressed as an example and suggested
clarification when less than a Public Health Hazard is issued.
Even though the preponderance of evidence shows that there is no
safe blood-lead level, ATSDR consistently uses--as a refuge to not
assess public health impact at lower levels--the statement (cut and
pasted from their Toxicological Profiles), ``CDC has determined that a
blood lead level at or above 10 micrograms per deciliter (mg/dL) in
children indicates excessive lead absorption and is grounds for
intervention''--essentially condoning 10 mg/dL blood-lead level as an
acceptable health risk.
If ATSDR continues to refuses to incorporate accumulated blood-lead
levels lower than 10 mg/dL as a health risk, at a minimum, communities
seeking trusted health information deserve this type of explanation:
All scientific research shows there is no known safe level of
lead.
Shortly after lead gets into your body, it travels in the
blood to the ``soft tissues'' and organs (such as the liver,
kidneys, lungs, brain, spleen, muscles, and heart). After
several weeks, most of the lead moves into your bones and
teeth. In adults, about 94 percent of the total amount of lead
in the body is contained in the bones and teeth. About 73
percent of the lead in children's bodies is stored in their
bones. Some of the lead can stay in your bones for decades;
however, some lead can leave your bones and re-enter your blood
and organs under certain circumstances (e.g., during pregnancy
and periods of breast feeding, after a bone is broken, and
during advancing age).
Lead (from mother's current exposures, and that leaching from
the mothers bones) interferes with neural development in
children and developing fetuses even at extremely low levels.
Even at very low levels, lead is associated with negative
outcomes in children, including impaired cognitive, motor,
behavioral, and physical abilities. Fetal lead exposure can
cause delay in the embryonic development of multiple organ
systems, including retardation of cognitive development in
early childhood.
Recent science associates very low blood-lead levels in adults
with cognitive deficiencies, increased deaths from heart
disease and stroke and miscarriages.
Deleterious human health effects at blood-lead levels 10 times
lower that 10 mg/dL have been observed. CDC recommends a blood-
lead level at 10 mg/dL as a point of intervention (not as an
acceptable level of poisoning or as an acceptable health risk)
because successful chelating treatments below this level have
not been identified; therefore, prevention of exposure is
essential. (Statements should be foot-noted with applicable
studies/references.)
Q12. Are you aware of ATSDR's recent efforts to improve its processes
and management?
a. Do you believe they will adequately address your concerns?
b. How would you improve tile Agency's processes and
management (or even culture)?
A12. I have read some of the Agency's proposed efforts. These efforts
to date have not been reflected in the quality of the end products--
Public Health Assessments/Consultations.
I have a major concern about the proposed ``National Conversation''
to determine the ``public health approach to chemical exposures.'' It
appears to be another form of ``passive resistance'' to proactively
addressing the issues that are before ATSDR. Just like public health
assessments and consultations are drawn out for years--keeping the
public silenced and at bay, thinking that their guardian agencies are
taking health-protective actions--this ``National Conversation'' will
serve as an infinite diversion--a refuge for inaction.
ATSDR already knows what they have to do and they have the science
to back needed action. Although it is good to keep dialogue open and
consistently seek improvement, ATSDR just simply needs to start
fulfilling its mission.
Agency processes and management practices are fairly simple to
correct and modify. Agency mindset and culture appear to be well
engrained and institutionalized over a long period. Effecting a change
in mindset and culture requires concerted proactive action.
Senior leaders who have maintained their positions in this current
environment are most culpable in setting the existing mindset and
culture. To effect desired changes within the Agency, they need to be
replaced. In my opinion, at a minimum, the Director, Coordinating
Center for Environmental Health and Injury Prevention (CDC), the
Director of ATSDR, the Deputy Director and the Director of the Division
of Health Assessments and Consultations must be replaced. There may be
a need to make other personnel changes in this agency but that would
require a review by an outside entity to determine this need.
The new CDC Director must clearly understand the ATSDR mission and
the desired mindset and culture necessary in order that ATSDR can carry
out its mission. This understanding is critical to assure that the
appropriate replacement staff is appointed and in turn, the new mindset
mandate is translated to the Agency staff.
Q13. How can ATSDR do a better job characterizing past exposures given
the complexity of the task? Do you have any specific recommendations?
A13. ATSDR needs to scientifically validate the merits of environmental
data available. If the system collecting data is suspect, then the data
produced are also suspect and should not be used as a basis for
ascertaining exposure either past or present.
ATSDR should review empirical evidence and determine whether this
empirical evidence could be related to exposure. Empirical evidence
such as birth defect and cancer clusters, animal and dog birth defects
and other health issues are sometimes much better monitors of exposure
than any mechanical devices. These are red flags that should warn that
something could be awry and further investigation is needed.
If cumulative body burden and past exposures are material to
predicted outcomes of current exposure assessments, ATSDR should not
proceed as if they are not material. Lack of data should not be
interpreted by ATSDR as an absence of a negative public health impact.
If past exposures are material to locating people that were in
harms way and needing possible additional medical attention or to
assess long-term effect on people in similar situations, then ATSDR
needs to ensure the best tools are used to assess these past exposures.
See Dr. Randall Parrish's testimony regarding ATSDR's failure to use
available tools to assess depleted uranium at Colonie, NY.
In some cases, ATSDR should consider implementing CDC's
biomonitoring activities to determine past exposure. This should be
given strong consideration in communities where the environmental
monitoring system is weak and thus the data generated cannot be used as
a basis to accurately characterize past exposure. This activity is
under the auspices of the National Center for Environmental Health at
CDC and is under the management of the ATSDR Director.
Q14. What roles should ATSDR play in exposure routes not associated
with hazardous waste (such as food, consumer products, water, and air)?
a. How should the Agency address these issues?
b. Would there be any overlap with other agencies?
c. What should the Agency do when there is a duplication of
effort?
d. Do you believe ATSDR's current mission is appropriate?
A14. ATSDR is the principal federal public health agency charged with
the responsibility of evaluating the human health effects of exposure
to hazardous substances in air, water, and soil and the food chain.
Other federal agencies already have responsibility for assuring the
safety, efficacy, and security of food, drugs and other consumer
products. Although their paths may sometimes cross, the roles and scope
of their activities are very different. ATSDR needs to do a better job
with its current responsibilities and not even contemplate the
expansion of their role.
Dr. Frumkin's expression in his testimony of concern about heavy
emphasis on hazardous waste sites is puzzling since this encompasses
the bulk of ATSDR's responsibilities. The statement, ``However, a
variety of other sources, such as food, consumer products, water, and
air are well recognized, and for many Americans these, not hazardous
waste sites, are the predominant pathways of exposure to chemicals,''
is worrisome. Determining whether the toxins/chemicals from the
hazardous waste sites are contaminating the food, water and air to is
within ATSDR's scope of responsibility. Furthermore for many Americans
living in, near or on hazardous waste sites--what impacts their health
is not an either or situation. Exposure to chemicals and toxins from
these hazardous waste sites is a confounding factor on top of the
normal body burden of toxins experienced by the many Americans.
ATSDR's current mission is extremely appropriate and critical to
the public health of this nation--it just needs to be carried out.
Continued failure to properly assess the impact from toxic
exposures or to be clear about potential health impacts will continue
to imperil the Nation's public health. It will be a signal to
industries and the environmental agencies that the edge has not yet
been reached and activities that produce further increases in toxic
emissions may be possible or that further preventative measures are not
necessary.
Those opposed to the success of ATSDR's mandated mission would
realize a great victory should ATSDR maintain the status quo or be
abolished.
Answers to Post-Hearing Questions
Responses by Randall R. Parrish, Head, Natural Environmental Research
Council (NERC) Isotope Geosciences Laboratory, British
Geological Survey
Answers to questions will refer to the question numbers 1 to 14;
several of the questions refer broadly to interactions witnesses have
had with ATSDR; in my particular situation these are not relevant since
I have never had any direct or indirect contact with ATSDR. ATSDR has
not contacted me with regards to my work at any time. I have not
attempted to contact ATSDR either. My contribution has mainly been in
evaluating the ATSDR Health Consultation done at Colonie, NY.
Questions submitted by Representative Paul C. Broun
Q1. Can the private sector or State agencies perform some or all of
the functions of ATSDR?
a. Could they do it better?
b. Would this be appropriate?
c. What conflict of interests could arise?
d. How could you protect against this?
A1. As I live in the UK I do not feel I have sufficient knowledge of
either State agencies or private sector organizations to address this
question.
Q2. To what extent do you attribute the ATSDR's problems to
leadership?
A2. I express my personal view here: I do feel this is in part a
leadership issue. In large organizations leadership sets the tone and
agenda. I listened to the response of the Director of ATSDR during
testimony and generally felt that his comments indicated to me that he
had failed to set a clear agenda of priorities for the Agency, and that
he was probably out of his depth, regardless of how good an academic
scientist he is or was in his previous role. Weak leadership has
undoubtedly contributed to the acute difficulties the Agency is in now.
Poor judgment near or at the top has led to some of the imprudent
actions--especially the formaldehyde issue.
Q3. Do you believe ATSDR attempts to include revolutionary scientific
methods and techniques in their work?
a. If not, how would you propose they better integrate cutting
edge science?
b. Is there any risk to getting too far ahead of a technology
or method and coming to conclusions that are ultimately proven
unfounded?
c. How would you set up policies or procedures to
appropriately manage and utilize these innovations?
A3. In my experience at Colonie, NY, there is little doubt that the
Agency failed to take account of and incorporate advances in methods of
toxic exposure detection. The Agency should ask the broad questions--
for example--what levels of exposure might have occurred and can these
be documented; can modeling be used to estimate better what inhalation
of toxic uranium oxide might have occurred? These types of questions
can be addressed. In my opinion the Agency need not have full expertise
within its own staff to answer all possible technological questions,
but they should have an outward-facing comprehensive knowledge of where
to find the experts and how to engage them as consultants, advisors, or
as analysts. If they embraced this type of ethos, they could retain the
capability of using the best methods and best science while not being
compelled to find this top notch expertise always within house. I
suspect the Agency has the worst of both worlds--neither the experts in
house nor the interest to seek outside expertise. This would lead to a
highly insular organization that would, over time, become more and more
inadequate given its remit. I do not have sufficient current knowledge
of the organization to comment much further except to say that what I
am suggesting is not rocket science--just pretty much down to Earth
common sense. If they want to get to the bottom of an issue, you need
to seek the best experts and use the most appropriate tools. I would
also say that if the Agency always requires the use of routine methods
that are common and well established, and if they require any method to
be formally accredited in a lab, then they will miss major
opportunities because the common methods may not be appropriate for
unusual requirements.
Q4. How did your experiences with State and local health officials
differ from that of ATSDR?
a. Were they better or worse?
b. Do you believe there was enough coordination, too little,
or too much?
c. Did you view ATSDR's work as simply ``rubber-stamping'' the
state's work, or did they provide value?
A4. I felt that the quality of the ATSDR health consultation at
Colonie, NY was fair at best, but to be fair, that of the NY agencies
were no better. Neither agency seemed to feel the need to do any proper
study of the situation. Both appeared to act not in a proactive
precautionary way, but almost entirely in a response to public
pressure. In neither case was protecting public health at the top of
the agenda. Neither agencies appeared to satisfy the concerns of the
public in any substantial way and this I consider to be a failure of
will.
Q5. What was your impression of ATSDR's coordination with other
federal agencies like EPA?
A5. No comment, not enough knowledge.
Q6. How does ATSDR's level of competence compare to other federal and
State entities charged with protecting public health?
a. Would you characterize the work ATSDR does as a specialized
niche?
b. Do any other agencies perform this same work?
c. Can you identify any areas of duplication?
A6. No comment, not enough knowledge.
Q7. How does ATSDR compare with similar entities in other countries?
a. Do international public health agencies have similar
problems?
b. What do you attribute this to?
A7. Hard to answer. In the UK we have the Health Protection Agency and
quite rigorous standards on brownfield or toxic substance sites and
there is a much stronger linkage between governmental levels dealing
with these sort of things, unlike the diffuse jurisdictions in the
U.S.; of course the UK is much smaller and the situation is different.
I get the impression that there is more proactive precautionary work
done in the UK than the U.S. given like for like situations. The U.S.
has a long history of companies with long standing links to the U.S.
military and U.S. DOE being allowed to pollute badly and get away with
it, at taxpayers' expense. In the UK there is a `polluter pays' default
policy, which requires costs to be borne primarily by those that do the
polluting. For example in the Colonie, NY area, the DOE-contracted
National Lead Industries did all the polluting and paid for none of the
cleanup, with the government willingly picking up the tab for the mess
($190M) and still with no agency seemingly interested in evaluating the
public health implications of it all. National Lead has had a habit of
abandoning sites and moving on. The ethos that allows this to continue
should be changed--this is long overdue but unfortunately an entrenched
pattern.
Q8. ATSDR does not do large scale environmental sampling, and relies
upon the EPA and states to conduct this work.
a. Do you believe ATSDR should also be doing this work?
b. How would you suggest we pay for this work?
c. Would this be worth limiting the number of other studies,
assessments, or consultations the Agency initiated?
A8. I think the most effective advice I could give ATSDR is to
prioritize its many projects and for those they commit to, to do them
well, rather than cover all of them poorly. This again, is just common
sense. They need to re-establish their credibility and they have to do
excellent and thorough work to achieve this. If their resources are
insufficient to do this at all sites, then they either need additional
resources, or need to do fewer of them. All of this is based on the
assumption that they also need to root out systemic problems within the
Agency that prevent them from being efficient and doing the best
science.
Q9. Please describe the process that you (or your community) went
through in petitioning for ATSDR's help.
a. Was your review ever downgraded to a health assessment or
health consultation?
b. Were you consulted in this decision, or were you simply
informed by the Agency?
c. Did you have any ability to appeal this decision?
d. How did this affect your overall impression of the services
ATSDR provided?
A9. See the preface; I have had no contact either way with the Agency--
they have not contacted me nor have I contacted them. They clearly had
something to gain from contacting me, but on the basis of their report,
I felt that it was sufficiently superficial and in part ill-informed
that I was unlikely to gain any new knowledge of the Colonie Site by
contacting them.
Q10. Please describe your level of communication with ATSDR.
a. Do you feel this was adequate?
b. What do you think they should have done differently?
A10. See the preface; I have had no contact either way with the
Agency--they have not contacted me nor have I contacted them. They
clearly had something to gain from contacting me, but on the basis of
their report, I felt that it was sufficiently superficial and in part
ill-informed that I was unlikely to gain any new knowledge of the
Colonie Site by contacting them.
Q11. Do you believe ATSDR products accurately communicate agency
findings?
a. What are some of the problems you have identified in their
reports?
b. How can the Agency be more effective in communicating
risks?
A11. I detailed what I felt were failings in the Colonie Health
Consultation in some detail in my original testimony, which is
available; I refer the Committee to this.
Q12. Are you aware of ATSDR's recent efforts to improve its processes
and management?
a. Do you believe they will adequately address your concerns?
b. How would you improve the Agency's processes and management
(or even culture)?
A12. No, I am not really aware of what if any progress has been made.
Little or none of this was evident during the Committee hearing of 12
March, nor was it convincingly made clear in the written testimony
materials. I would not be surprised if any `progress' was instead
relatively superficial. My personal opinion here is that the Agency is
unlikely to recover to an acceptable state without major leadership
change through the fabric of the whole senior leadership layer at
ATSDR, but again, I do not have detailed knowledge.
Q13. How can ATSDR do a better job characterizing past exposures given
complexity of the task?
a. Do you have any specific recommendations?
A13. This is a very important question and gets at the heart of the
public health issue of sites that have historic rather than active
pollution signatures. Many toxic substances produce health impacts many
years after exposure and it is therefore ESSENTIAL that the best and
most innovative methods be used to attempt to assess and detect such
exposures and try to quantify them, so that health outcomes might be
evaluated against the exposure data in order test linkages. The
Colonie, NY example is a perfect illustration of the need for ATSDR to
do better. If as occurred, the Agency assesses the current information
and concludes there was a major health risk, but then says it can do
nothing because it happened 20 years earlier, well that just isn't good
enough. Our group as you know come along right afterwards and did the
work that the ATSDR should have realized could be done. Neither ATSDR
nor the NY agencies seemed the least inclined to pursue the issue and
instead they appeared to fail to even appreciate that health
consequences may persist. In my opinion (as detailed in my written
testimony) they badly misunderstood many aspects of this problem and
largely missed the point--a demonstration of inadequate knowledge of
the science and issues. If they need to know what the past exposure
might have been, the Agency could commission the best labs (private or
public sector) to develop such tests when such tests (with their high
sensitivity requirements) are unavailable via routine methods. This is
what the UK did in order to satisfy Gulf War veterans who had
persistent concerns about exposure to depleted uranium munitions. If
the methods don't exist to detect a substance retained in the body from
an historic exposure, then talk to the experts and commission new
methods to be developed.
Q14. What role should ATSDR play in exposure routes not associated
with hazardous waste (such as food, consumer products, water, and air)
a. How should the Agency address these issues?
b. Would there be any overlap with other agencies?
c. What should the Agency do when there is duplication of
effort?
d. Do you believe ATSDR's current mission is appropriate?
A14. I do not have sufficient knowledge to answer this question.
Answers to Post-Hearing Questions
Responses by Jeffrey C. Camplin, President, Camplin Environmental
Services, Inc.
Questions submitted by Representative Paul C. Broun
Q1. Can the private sector or State agencies perform some or all of
the functions of ATSDR?
A1. A major problem with ATSDR research and studies is that private
sector and State agencies perform much of their work in an unsupervised
manner. I have identified many reports performed in the Chicago area
regarding asbestos where ATSDR has allowed State agencies to perform
incredibly faulty Public Health Assessments. ATSDR then ``rubber
stamps'' these reports without reviewing their accuracy. In another
case, ATSDR funded a study by the University of Illinois at Chicago
School of Public Health that also contained flaws. When I complained to
ATSDR about the poor quality of the study they funded I was told by
ATSDR leadership that it was not their report and they could not
require any changes. When I told them that all ATSDR funded studies
must follow their quality guidelines ATSDR stood silent. To summarize,
ATSDR needs to focus on ``accountability'' of their own staff and those
partners they delegate work to. Without accountability the flawed
studies will continue.
Q2. To what extent to you attribute the ATSDR's problems to
Leadership?
A2. Again, the leadership fails to hold their agency accountable for
their work products. When I challenged the flawed studies by State
agencies ``rubber stamped'' by ATSDR in Illinois, my challenges were
not addressed. I wrote specifically to ATSDR, CDC, and HHS leadership
and was responded to with form letters that ignored my challenges. In
one case I filed an ethics complaint against ATSDR staff that disturbed
asbestos contaminated sand during an exposure study while families were
on the beach. The ATSDR staff had personal protective equipment on
while they exposed families to asbestos fibers. I was told by ATSDR
leadership that their staff was ethical and only perform work in a
professional manner. Yet I had video and photos of the egregious
behavior that ATSDR refused to comment on. The leadership is arrogant
and complacent. ATSDR will continue to generate flawed work products as
long as the leadership is complacent and does not hold their staff or
partners accountable for their flawed work.
Q3. Do you believe ATSDR attempts to include revolutionary scientific
methods and techniques in their work?
A3. It is the exact opposite: ATSDR uses outdated, flawed, and
unscientifically modified methods to perform their work. All of their
asbestos studies contain numerous modifications and limitations which
skew and downplay the toxicological findings of their studies. All of
their asbestos pubic health assessments and consultations use a risk
model that they admit is inaccurate and outdated. Yet instead of using
more accurate risk models, ATSDR clings to the outdated model. ATSDR
simply adds disclaimers to their report that state the risk from
asbestos is significantly underestimated. This is unacceptable.
However, ATSDR leadership refuses to acknowledge the use of better
scientific methods. They won't even run a side by side comparison of
the outdated risk models to more current scientific methods and
techniques in their work. This is unacceptable and a major scientific
flaw in ATSDR studies.
Q4. How did your experience with State and local health officials
differ from that of ATSDR?
A4. State and local agency reports were definitely ``rubber stamped''
by ATSDR. This is a problem when State and local agencies also
participated in studies run by ATSDR staff. ATSDR, State, and local
agencies play off each other when their reports are challenged. ATSDR
will say that the state had control, while the state might say the
local agency actually made key decisions, while the local agencies
point the fingers back at the state and ATSDR. Draft documents and e-
mail are not subject to FOIA so it is impossible for the public to
determine who actually made any decisions on studies. ATSDR generally
fights all FOIA's. It would be helpful if this agency was more
transparent. Also, when State or local agencies will not respond to
FOIA's I generally requested the information from ATSDR. ATSDR would
state that they would not give me information from their files from
other agencies and that I would have to get any documents from those
agencies. Again, ATSDR promotes an atmosphere of secrecy to impede any
accountability of responsible parties; particularly of their own staff.
Q5. What was your impression of ATSDR's coordination with other
federal agencies like EPA?
A5. ATSDR and EPA play games with consultations and Public Health
Assessments. For instance, EPA performed an asbestos study at Illinois
Beach State Park in 2007. ATSDR helped them develop the study, they
were present at the site when the study was performed, and they even
participated in the study by disturbing beach sand and wearing air
monitoring equipment. ATSDR Region 5 staff did all of this. The same
staffer from ATSDR Region 5 also helped review the study. Then EPA
asked ATSDR to review the study as though it was the first time ATSDR
had seen the report. Region 5 ATSDR then asked the EPA's TRW asbestos
group to review their risk assessment. However, Region 5 ATSDR staffer
who participated in the testing and who was preparing the risk
assessment was also a member of the EPA's TRW asbestos group. In the
final risk assessment opinion the ATSDR Region 5 staffer documented the
process as though he had no involvement other than being the risk
assessor. In reality he had been involved in the entire process from
design to final report to peer review (of his own work). The EPA needed
a study that said the asbestos risks were low because of their
involvement with bungling an asbestos Superfund site that created the
contamination. ATSDR played along with EPA the entire way to make sure
the testing was rigged and the risk models were flawed. The ATSDR staff
also made sure he was involved in the peer review so his work product
would not be challenged. This is not transparency or ``independent''
peer review. This is rigging a study with the EPA to cover-up the
mistakes of their past flawed work product.
Q6. How does ATSDR's level of competence compare to other federal and
State entities charged with protecting public health?
A6. I believe that ATSDR has the potential to generate very competent
work. However, the leadership of ATSDR has developed a culture where
their work supports preconceived conclusions by rigging studies and the
data. ATSDR is very competent in arrogantly generating flawed work
products. They know that there are not too many others who have the
knowledge to challenge them. When someone does challenge them they
arrogantly hide behind the integrity of the Agency and their many
credentials. They cannot handle the truth. ATSDR leadership and staff
are very smart. Unfortunately they do not use their knowledge to
promote public health. They use their expertise to cover-up for errors
made by other agencies.
Q7. How does ATSDR compare with entities in other countries?
A7. I am working with the Italian government to write a paper on how
asbestos contaminated shorelines have been addressed by the U.S. vs.
Italy. The Italian government errs on the side of caution when risks
from asbestos are unknown. The Italian government was shocked to hear
how ATSDR was estimating risk from asbestos contamination along the
Illinois Lake Michigan shoreline. I have been asked by the Italian
government to participate on their scientific review panel when they
host the World Asbestos Conference later this year in Italy. Many other
nations will be presenting at this conference. Most countries look to
the U.S. for leadership on pubic health and toxicological studies.
However, they have become just as disappointed as I have been with the
quality of their work. ATSDR does not act in a precautionary manner
unlike most European countries. ATSDR is sliding backwards as the rest
of the world passes them by.
Q8. ATSDR does not do large scale environmental sampling and relies
upon the EPA and states to conduct this work. Do you believe ATSDR
should do this work?
A8. ATSDR actually did some asbestos testing in Illinois. I video taped
some of the testing where ATSDR staff from Region 5 and the Atlanta
office exposed the public during their testing. I filed an ethics
complaint against them. ATSDR concluded their work did not pose a risk
to human health. However, when they asked Region 5 EPA to provide
comments, EPA found ``extremely high exposures'' that ATSDR downplayed.
ATSDR published their flawed report anyway stating it was their report
and EPA had no jurisdiction. ATSDR should not be doing testing!
Yet there is also a problem with others doing the testing. ATSDR
generally takes the data from their ``partners'' study at face value.
There is no validity or accuracy checks done on the data. I have found
significant problems with data used by ATSDR in their studies. ATSDR
never. seems to review or reject ANY data. They just take the numbers
and plug them into their outdated risk models and conclude everything
is just fine. The solution is to hold ATSDR accountable for verifying
the integrity of data that they use in their studies. ATSDR must be the
Agency that independently verifies that data used in their risk
assessments is accurate. Right now they do not do this, at least with
asbestos studies.
Q9. Please describe the process that you (or your community) went
through in petitioning for ATSDR's help.
a. Was your review ever downgraded to a health assessment or
health consultation?
b. Were you consulted in this decision, or were you simply
informed by the Agency?
c. Did you have any ability to appeal this decision?
d. How did this affect your overall impression of the services
ATSDR provided?
A9. WE DID NOT PETITION FOR ATSDR's HELP. WE CHALLENGED THEIR FLAWED
DATA AND ASKED FOR BETTER STUDIES AND MORE ACCURATE RISK ASSESSMENTS.
ATSDR REFUSED TO ACKNOWLEDGE THEIR PAST ERRORS AND FLAWS IN THEIR
STUDIES. ATSDR CONTINUED TO GENERATE NEW TESTING FOR THE SOLE PURPOSE
OF COVERING UP THEIR FLAWED STUDIES, NOT TO IMPROVE UPON THEIR FLAWED
WORK.
Q10. Please describe your level of communication with ATSDR.
A10. I have challenged their flawed work through their information
quality guidelines to no avail. I also appealed their decisions without
having my concerns addressed in their responses. All I have ever asked
for is ANSWERS to the questions I posed to them about the quality of
their reports and studies. ATSDR (from the top down) ignores any
challenges and provides responses that avoid the actual challenge.
There should be an independent review of ATSDR's responses to
information quality challenges. Right now there is no accountability
for their non-responses to legitimate challenges and concerns.
Q11. Do you believe ATSDR products accurately communicate agency
findings?
A11. NO! ATSDR loads up their studies with all kinds of limitations and
qualifiers that significantly impact the accuracy of their findings.
Then ATSDR portrays their findings (with great confidence) that
everything is fine. Yet buried in the report are these significant
limitation and qualifiers that indicate how flawed the study actually
is. ATSDR needs to communicate just how unreliable their information
actually is. Better yet, they should just do more accurate testing.
ATSDR serves the polluter by generating ``gray area'' studies that
don't really say one way or the other if a hazard exists. This is
another way ATSDR performs studies that harm public health.
Q12. Are you aware of ATSDR's recent efforts to improve its processes
and management?
A12. There are no improvements. ATSDR already has good policies and
structure. The leadership is the problem. Since the leadership has not
changed I find it hard to believe anything has improved. What evidence
exists that anything has improved? I know in 1991 ATSDR said they were
going to improve and they didn't. Actions speak louder than words. What
has really changed and what is the evidence that has been verified by
an independent agency. I don't believe Dr. Frumkin's empty words that
things are changing. According to Dr. Frumkin's arrogant testimony
before the Subcommittee, ``I am proud of the excellent work we do at
hundreds of sites nationally. I recognize that even excellent work has
room for improvement'' (line 2229). I do not think that ATSDR was
ridiculed back in 1991 or by this subcommittee for improving upon their
``excellent'' work. ATSDR continually generates flawed work products
that harm public health. Major changes need to take place. Leadership
of ATSDR must be held accountable. If ATSDR leadership is not held
accountable, their complacency will continue.
Q13. How can ATSDR do a better job characterizing past exposures given
the complexity of the task?
A13. ATSDR needs to use accurate risk models. For asbestos, ATSDR
knowingly uses outdated risk models to calculate risk. ATSDR needs to
make great improvements with how they assess exposures to asbestos.
Q14. What role should ATSDR play in exposure routes not associated
with hazardous waste (such as food, consumer products, water, and air)?
A14. ATSDR needs to take a more holistic approach to public health
assessments. Most times they put blinders on and only look at risks
from the perspective of a certain hazardous waste in a certain
location. In reality, the public has multiple exposures from a variety
of sources. The risk from one specific site might not be enough to
declare a significant risk. However, when that risk is added to similar
risks in nearby areas or through other pathways the risk rises to a
level of concern.
Answers to Post-Hearing Questions
Responses by Ronnie D. Wilson, Associate Professor, Central Michigan
University; Former Ombudsman, Agency for Toxic Substances and
Disease Registry
Questions submitted by Representative Paul C. Broun
Q1. Prior to the establishment of ATSDR, how was public health
protected?
a. What role did academia play?
b. What role does academia play now?
c. What role does the private sector play?
d. How does this compare to now?
e. Has the role of protecting public health simply shifted
from the private sector to the public sector?
A1. Prior to the creation of ATSDR, little was known about the health
effects of toxic waste exposures. Some research had been conducted by
academia (often funded by or in conjunction with the private sector)
and some by EPA. There was a huge gap in knowledge and there was no
regulatory or legislative mandate to fill the void. Other than
academia, little work in the private sector has transpired to protect
public health from environmental exposures.
Although academia does play a role, ATSDR has provided funding and
oversight for much of the academic research. ATSDR has also conducted
important studies on the health effects of environmental exposures.
With no regulatory or legislative mandate, outside academia little
research has been conducted by the private sector.
Q2. To what extent do you attribute the ATSDR's problem to leadership?
A2. Many, both within and outside the Agency, feel that the present
leadership is a major portion of the problem with and within ATSDR. To
be fair however, conducting research in environmental health and
promoting public health is sometimes difficult and involves a high
degree of complexity. Mistakes can be made with the best intentions.
However, no matter the intent, mistakes have occurred and leadership
has known about ATSDR's deficiencies and has failed to take corrective
action.
Further, ATSDR leadership has become a poster child for micro-
management, even to the point of making determinations regarding the
exact words are to be used in health assessments, studies and
consultations. While ATSDR's leadership may be talented, they are not,
and will never be experts in everything, yet no matter what the issue
or the science involved, leadership can, and will, mandate their
opinion over that of those who are indeed experts--often with a bit of
world renown. A perfect example is the Katrina Trailers in which
management refused to recognize the dangers and sought to cover up the
issue and ultimately forced the removal of a senior scientist at great
expense to the taxpayers.
Q3. Can the private sector or State agencies perform some or all of
the functions of ATSDR?
a. Could they do it better?
b. Would this be appropriate?
c. What conflicts of interests could arise?
d. How could you protect against this?
A3. ATSDR partners with academia and State government to conduct
research and health assessments. Other than academia, the private
sector cannot, and will not do this work to protect public health. If
the private sector conducts research at all, they will do it to protect
their interests. ATSDR also does cutting edge research (e.g.,
groundwater contaminant fate and transport modeling as is being done at
Camp Lejeune; B-cell work in conjunction with the CDC National Center
for Environmental Health lab; polycythemia vera cluster investigation
in conjunction with academia and State government; and the Brick Twp,
NJ Autism Cluster investigation, started in 1998 by ATSDR in
conjunction with CDC's Developmental Disabilities division, which
provided the first, clinical estimate of autism prevalence in a U.S.
community since the late 1980s and established that autism was sharply
increasing.
The key problem with ATSDR is the poor quality of many of the
health assessments and health consults. This could be changed by
requiring independent peer review and by encouraging ATSDR to involve
the community at the planning and scoping stage of the health
assessment/consult as well as the conduction of the health assessment/
consult.
ATSDR has helped build capacity of State governments. Funding by
ATSDR to several states in the late 1980s was crucial in establishing
birth defect registries in these states as well as crucial to the use
of these registries to investigate the health effects of environmental
exposures. ATSDR funded the Woburn study of childhood leukemia that was
conducted by the MADPH. ATSDR funded, provided oversight, and conducted
the water and air modeling for the Dover Twp/Toms River, NJ childhood
cancer study that was conducted by the NJDOH.
ATSDR is a leader in epidemiological research on the health effects
of exposures to toxic waste chemical contaminants in drinking water,
having either conducted or funded the major studies in this field
(e.g., four NJ studies, Woburn, Camp Lejeune, Tucson). ATSDR also
funded studies in two states that first documented that exposures to
disinfection byproducts (e.g., Trihalomethanes) in drinking water was
associated with adverse birth outcomes (low birth weight and specific
birth defects).
Q4. Are community complaints about the work of ATSDR new?
A4. Community concerns were the basis for enactment of CERCLA.
Therefore, from the beginning of ATSDR, communities have rightfully
looked to ``their agency'' to solve health concerns. However, such
concerns have often strained at the limits of environmental science.
Working more closely with communities will help, but will not solve all
the communities concerns.
Q4a. Why does this seem to be a perennial problem?
A4a. Although ATSDR is second only to CDC's STD/HIV in the involvement
of communities in its activities, this is not saying much because,
other than STD/HIV, the rest of CDC has a poor record on this as well!
It is a problem because ATSDR still is not fully committed to involving
communities at the ground floor of the planning and scoping of its
activities and the conduction of its activities. There are some
exceptions, such as the CAPs that have been formed at a few sites.
ATSDR needs to create a mechanism for full community involvement at
each site. Community involvement should be from the moment a site is
discovered (or where a hazardous condition becomes know) until the site
clean-up is complete. This may require a community action group or it
may be handled in a simpler fashion. But some mechanism should be
mandated, established, and employed.
The issue continues to arise because of a form of ``ivory tower
syndrome,'' in which the staff, most often in an assessment or
consultation role, does not seek community input because, ``. . . we
are the scientist, what do they know.'' In such instances, the failure
to include the community not only generates resistance but also serves
to restrict the information flow from the community and to the
community.
Q5. Do you believe ATSDR products accurately communicate agency
findings?
a. What are some of the problems you have identified in their
reports?
b. How can the Agency be more effective in communicating
risks?
A5. Toxicological profiles and health assessments are often not reader-
friendly. The health assessments often answer questions that are not of
interest to the community and fail to address adequately questions that
are of interest. There is too much ``boiler-plate'' material that is
unnecessary. Public health assessments (PHAs) need to be tailored to
the particular site and the concerns at that site. In addition, PHAs
are uneven in their quality. As for risk communication, holding large
``availability sessions'' and public meetings is not usually the best
way to communicate risks! (See answer to #4 on the need for community
participation mechanisms).
Profiles, by law, must present the most up-to-date toxicological
information. According to some scientific journals, they are the most
often cited toxicological resources. ATSDR has provided a public health
statement in the front of each toxicological profile that is intended
to be understandable to the lay audience, e.g., community groups. More
recently, the profiles have added material that is intended to be
helpful to a medical readership. However, if the documents are not
meeting the specific needs of an audience, perhaps the Agency could use
focus or other similar groups as a sounding board for improvement of
the final products.
ATSDR should work closely with the concerned community members
(e.g., the activists), State and local health agencies and health
providers to ensure better health communications. ATSDR must seek to
make sure the questions of concern are addressed, to establish trust,
to be fully transparent, to obtain community buy-in to the approach
being undertaken, to make sure the community understands the
limitations of the agreed-upon approach, and to establish the best way
to communicate the information/risks.
PHAs would possess far greater value if mid-level to lower-upper
level management was not so concerned with political correctness and
``softening'' the information. Certain words, like ``carcinogenic''
cannot be used because the public might become ``alarmed.'' Yet, the
community is asking for the accurate information.
Q6. Are you aware of ATSDR's recent efforts to improve its processes
and management?
a. Do you believe they will adequately address your concerns?
b. How would you improve the Agency's processes and management
(or even culture)?
A6. I see no evidence of any improvement. The initial planning for the
so-called ``conversation'' developed with hardly any staff input. So
staff feel the new process is designed protect (shield) our leadership
from Congressional attacks.
Morale is at an all time low throughout CDC as well as ATSDR,
primarily because leadership does not respect staff and does not seek
staff input at the ground floor of the planning stage of new
initiatives or reorganization, etc. ATSDR and National Center for
Environmental Health (NCEH) staff are not collaborating as they
should--a failure of the leadership. There is too much concern about
``turf'' within and between ATSDR and NCEH, and there is insufficient
commitment to community involvement at ATSDR and NCEH.
Either the existing leadership needs to seriously address these
problems or they need to be replaced with leadership that will address
these problems. Likewise, Congress should mandate a formal merger, or
separation, of ATSDR and NCEH, so the staff and the public will have an
understanding of to whom they need to speak and who is responsible for
assigned functions.
Q7. What was your impression of ATSDR's coordination with other
federal agencies like EPA?
A7. It is my experience that ATSDR often does try hard to coordinate
and work with other agencies but gets little response and cooperation
from these agencies. However, one could also assume that some of the
failure of other agencies to be cooperative is in part the self
infliction of wounds. I have hear high level officials from four
Regions of the EPA indicate that while ATSDR could do good work, they
took so long to do so that others ways of dealing with problems without
including ATSDR had become the norm.
Q8. How does ATSDR's level of confidence compare to other federal and
State entities charged with protecting public health?
A8. I am not sufficiently versed in all the efforts of other agencies,
but in general both federal and State entities have been hamstrung by
lack of funding/staff and the policies. However, I have never seen
confidence or talent as a problem at ATSDR. Rather, I have seen
restrictions on the staff by management to ``word smith'' documents
(assessments and consultation) to avoid ``alarmist'' issues is more the
problem.
Q9. How does ATSDR compare with similar entities in other countries?
a. Do international public health agencies have similar
problems?
b. What do you attribute this?
A9. I have no knowledge of any agency in any other country that is
similar to ATSDR.
Internationally, the Agency is respected, often by countries that
have no such public health entity. Having products from ATSDR, like
toxicological profiles, serves to assist other countries.
Q10. ATSDR does not do large scale environmental sampling, and relies
upon the EP and states to conduct this work.
a. Do you believe ATSDR should do this work?
b. How would you suggest we pay for the work?
c. Would this be worth limiting the number of other studies,
assessments or consultation the Agency initiated?
A10. Large scale sampling probably should continue to be performed by
EPA and the states, although it would be helpful to involve ATSDR at
the ground floor of the planning, scoping and conduction of sampling at
each site. ATSDR should work more closely with other federal agencies/
groups, e.g., the U.S.G.S., in order to gather current environmental
data.
Sampling should be paid for by the polluters, and most often times
is paid via the cost recovery efforts of EPA.
During the early days of ATSDR's existence, there was a serious
problem with the number of health assessments that the Agency was
required to perform in a short period of time. This is no longer a
major problem. Instead, the major problems for the PHAs and consults
are unevenness and lack of consistency across the PHAs/consults,
failure to address the concerns of the community, and poor scientific
quality. Much of this could be resolved by requiring peer review of
PHAs and health consults.
Additionally, the ATSDR Board of Scientific Counselors should
monitor the quality of PHAs and set up a task force (within ATSDR or
independent of ATSDR) to deliberate and develop a consensus concerning
the risks of specific, controversial hazardous substances (e.g., TCE,
PCE, dioxin, PCBs, perchlorate, and emerging threats) that would guide
ATSDR's health assessments Finally, full community participation is
vital to the success of ATSDR's work.
Q11. Do you believe ATSDR attempts to include revolutionary methods
and techniques in their work?
a. If not, how would you propose they better integrate cutting
edge science?
b. Is there any risk to getting too far ahead of a technology
or method and coming to conclusions that are ultimately proven
unfounded?
c. How would you set up policies or procedures to
appropriately manage and utilize these innovations?
A11. ATSDR is at the forefront in historical exposure reconstruction
modeling for drinking water. In its effort at Camp Lejeune (working
with expert researchers at GA Tech and expert consultants), it is
breaking new ground in the modeling of the historical groundwater
migration of contaminants in order to provide the epidemiological
studies at the base with monthly estimates of contamination levels at
the tap decades before testing of the tap water quality were performed
(i.e., actual testing for contamination did not begin until 1982 but
the water modeling effort was able to provide scientifically sound
estimates of contaminant levels back to the beginning of the water
plant's operation in the early 1950s).
No other epidemiological study of drinking water contamination has
conducted such an extensive, and cutting-edge, modeling effort. ATSDR
also is in the forefront of disease cluster investigation methods,
e.g., its use of molecular testing to confirm polycythemia vera cases
in PA, its use of clinical testing to confirm autism cases at Brick
Township, and its use of water modeling and air modeling at Toms River.
ATSDR's use of immune function tests in communities in proximity to
several toxic waste sites identified a pattern of blood cells in
certain individuals that resembled a pattern seen in chronic
lymphocytic leukemia although these individuals did not have leukemia.
This was the first time this phenomenon was observed. In collaboration
with the NCEH lab, ATSDR conducted the first of its kind study to
follow-up these individuals with this pattern of blood cells and found
that these individuals were at increased risk of eventually having
leukemia and that this pattern of blood cells was associated with
living in proximity to hazardous waste sites.
ATSDR also provided funding and oversight to academic researchers
who conducted research focusing on the health effects of exposures to
PCBs in the Great Lakes region and at Anniston AL.
ATSDR has state-of-the-art GIS technology and an expert staff on
GIS mapping and analysis methods.
ATSDR does attempt to include novel, innovative methods in its
research. In addition, the protocols of all ATSDR epidemiological
studies must undergo peer review and IRB review before the study is
conducted. After the study is conducted, the report of the findings
(either a journal article draft or a draft report) must undergo peer
review as well as agency clearance. Even with these reviews, it is
possible for the quality of the study to be substandard scientifically.
Therefore, the Board of Scientific Counselors should set up a task
force that monitors the quality of the epidemiological research at
ATSDR. These review mechanisms should ensure that the findings and
conclusions are not ``unfounded.''
Q12. How can ATSDR do a better job characterizing past experiences
given the complexity of the task?
a. Do you have any specific recommendations?
A12. Historical exposure reconstruction is the best way to do this, but
it is expensive, time-consuming, and cannot be done at most sites
because of lack of sufficient data. But often the problem is that the
public health assessment (PHA) is not focused enough on past exposures.
Of course, it is understandable and appropriate for a PHA to focus on
present exposures if they are occurring. But a strong commitment to
evaluate, as best one can, past exposures is needed as well. Often,
this is one of the major concerns a community has. The PHA should go
the extra mile to uncover any information that would help it to
characterize past exposures.
Q13. What role should ATSDR play in exposure routes not associated
with hazardous waste (such as food, consumer products, water and air)?
a. How should the Agency address these issues?
b. Would there be any overlap with other agencies?
c. What should the Agency do when these is duplication of
effort?
d. Do you believe ATSDR's current mission is appropriate?
A13. ATSDR's current mission is appropriate. If there are gaps (e.g.,
disinfection byproducts in drinking water, other exposures not related
to toxic waste substances), then ATSDR should work with NCEH to make
sure these gaps are filled. ATSDR should conduct epidemiological
research on the health effects of exposures to disinfection byproducts
and other non-microbial contaminants (CDC focuses on microbial
contaminants) in drinking water, and become the leader in this
research, but the Agency has not moved strongly in this direction.
ATSDR may require more staff and resources, it does have the expertise
for water and air modeling and it has access to the NCEH lab.
Any overlap with EPA could be resolved (e.g., by collaboration!),
but in most instances there really is not overlap with EPA (or any
other agency) in the research effort. ATSDR really does fill an
important gap in the research on the health effects of environmental
exposures.
Answers to Post-Hearing Questions
Responses by Henry S. Cole, President, Henry S. Cole & Associates,
Inc., Upper Marlboro, Maryland
This report is written in response to a series of questions by
Congressman Broun and is based on my experience with ATSDR and a number
of affected to communities where ATSDR provided health assessments or
consultations. It is also based on my experience in dozens of
communities impacted by hazardous waste sites, power plants, factory
pollution, etc., where State regulatory agencies were involved. I have
not answered several questions, e.g., those involving past exposure
methodologies, and cutting edge technologies. Please use other sources
of information for these issues.
Questions submitted by Representative Paul C. Broun
Q1. Big picture: Does ATSDR contribute to the health of
environmentally stressed communities?
A1. In working with environmentally stressed communities, ATSDR has
focused largely on determining whether a particular source(s) have the
potential to expose and adversely affect the health of residents. This
function is clearly embedded in the Agency's mission statement:
ATSDR's mission is to serve the public by using the best
science, taking responsive public health actions, and providing
trusted health information to prevent harmful exposures and
disease related exposures to toxic substances.
However, this statement also requires ATSDR to take ``responsive
public health actions'' and to provide information in a way that would
actually prevent harmful exposures and improve community health. In my
judgment, ATSDR's efforts toward these objectives are lacking.
The communities in greatest need of help are most often impacted by
a multitude of environmental stresses: e.g., a waste management
facility, factory pollution, highly toxic diesel emissions, and
unhealthful levels of inhalable particulates and/or ground level ozone.
Perhaps there are sewerage related problems. There are other stresses
as well--such as unemployment, no access to health care, aging
populations, lack of adequate housing, etc. Although there is clearly a
need to study the health impacts of various sources and chemicals,
studies alone will not bring real help to communities.
A holistic approach
Needs vary from one community to another; i.e., the local health
clinic may need expertise to deal with environmental exposures, perhaps
a local credit union or pension fund could invest in restoring homes to
livability, or perhaps the need is set up volunteers to visit the homes
of elderly neighbors on a continuing basis. Such efforts will require a
different vision and much greater coordination between programs and
agencies. However, there are examples of community-based approaches
which attempt to solve problems holistically. For example, in Trenton,
a non-profit organization, Isles, Inc. has set up programs to remove
lead from home environments and has trained residents to address these
problems and to restore dilapidated buildings. These programs have led
to employment and entrepreneurial opportunities. Trenton has the
potential to bring in up to $2.4 million for green collar jobs and
career development activities, many of them connected to restoration
and improved environmental health. See http://www.isles.org/
This program is by no means unique. In fact, President Obama's
economic stimulus package contains funding for community-based training
and employment in areas such as weatherization and renewable energy.
(See also, The Green Collar Economy by Van Jones and Ariane Conrad,
2008 for many examples of community-based initiatives aimed to bring
environmental health and economic progress to communities.)
Multi-Agency Approach
Of course, no one agency is equipped to deliver the multi-faceted
assistance that many environmentally stressed communities need for
improved health. Given that the Administration is looking for ways to
make government funding work more effectively, Congress and the
Administration should consider creating an agency in the Department of
Health and Human Services with a broader mission than ATSDR. The new
agency would focus on the problems and needs of environmentally
stressed communities. This agency would work closely with communities
and local governments to assess and meet the broad needs of public
health. ATSDR would be replaced by (or ``morphed'' into) a branch that
provides scientific assistance to the new agency. The new agency would
marshal the resources of a broad range of government entities including
EPA, the National Institutes of Environmental Health, Housing and Urban
Affairs, the Department of Agriculture, Commerce Department, etc., to
deliver the most needed targeted services (e.g., medical, nutritional,
community restoration, educational) etc. The Agency would also attempt
to work with local authorities and industries to seek creative
solutions (e.g., a program to retrofit truck fleets with particulate
filters and catalytic converters to curb highly toxic diesel fumes).
Q2. The role of the private sector.
A2. A number of Congressman Broun's questions focus on the potential
role of the private sector in protecting public health. I have
separated private sector into several components:
Regarding industries (e.g., manufacturing, energy,
agribusiness, pharmaceuticals, etc.)--in general they have
failed to protect public health (communities and workers)
without strong regulation and enforcement by government. A good
example is mountain top mining (MTM)--coal companies blast the
tops of mountains to get at coal and dump the overburden into
the headwaters of streams. The Bush Administration removed
regulatory obstacles to MTM despite extensive damage to
ecosystems and communities in Appalachia.
Industrial research institutes that address
environmental health, in my judgment, often tilt their
scientific findings to protect the financial interests of their
corporate members. For example, research funded by the
chlorinated plastic industry attempts to downplay the dangers
associated with the life cycle impacts of vinyl plastics. One
exception is the insurance industry, especially those that
insure health and environmental damages. Such insurers have a
stake in preventing illness and environmental problems such as
toxic spills and climate change (potential for increased
frequency and intensity of storms and related damage).
Private research institutes and institutes of higher
education have brought about an enormous increase in our
understanding of the relationship between toxic chemicals and
health effects.
The work of consulting firms often depends on the
interests of the client. For example, consulting firms working
for potentially responsible parties at Superfund sites may
conduct field studies and risk assessments that understate the
extent of the problem requiring remediation. As a result
clients have lower cleanup costs. However, this is not to say
that all consulting firms do biased research; to the contrary
many firms have produced excellent studies for government, non-
governmental organizations, etc.
Q3. The role of State agencies.
A3. In my experiences, State regulatory agencies and State departments
of health have been weak in their protection of community health. In
some cases this has to do with insufficient resources. For example,
such agencies rely on the regulated industries for information (e.g.,
stack testing). In other cases there is an extremely close relationship
between agency officials and corporate officials. In many cases,
economics, combined with political influence, trumps environmental
health. For example, in the Ohio EPA has permitted an energy company to
build a large coke oven battery in Middletown, OH despite the impacts
on the local airshed (already a non-compliance zone with regard to
ozone and PM2.5); this facility will be located about 0.7 miles upwind
of an elementary school.
Q4. ATSDR's Leadership Problem.
A4. ATSDR's mission statement is as follows:
ATSDR's mission is to serve the public by using the best
science, taking responsive public health actions, and providing
trusted health information to prevent harmful exposures and
disease related exposures to toxic substances.
The Agency's conduct with regard to formaldehyde exposure in FEMA
trailers alone requires that the Agency's top leadership be replaced.
There were at least three serious problems: (1) bad science (2) failure
to protect the health of families living in the trailers and (3)
communicating reassurance rather than accurate information on risk to
trailer occupants. The Oversight Subcommittee report (date)
demonstrates that the behavior of top ATSDR officials, including its
Administrator, not only failed to carry out the Agency's mission but
destroyed its credibility beyond repair.
In addition, the Agency under current leadership lacks both the
vision and creativity that is needed to restore the health of
environmentally stressed communities.
Q5. Community Complaints.
A5. As I have stated in my testimony, a large number of communities are
frustrated and angered by ATSDR's work in their communities. For
example, a national organization with a large grassroots following has
warned in its publications that communities may opt to boycott ATSDR
(and cooperating State health departments) unless the Agency negotiates
with the community in good faith regarding study protocols and related
issues of public concern.\1\
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\1\ Stephen Lester, Center for Health Environment & Justice,
Assessing Health Problems in Local Communities. Updated April 2007.
---------------------------------------------------------------------------
Witness statements at the March 12, 2009 hearing provide further
evidence that the problems at ATSDR are widespread. Secondly, two
Congressmen testified at the hearing about the problems with the
Agency's investigations of the naval bombing range in Vieques, Puerto
Rico. These problems described include: studies that are shallow and
predictably inconclusive from the start, flawed methodologies, over
reliance on company or federal agency data (e.g., DOD, DOE), failure to
use all available sources of information, failure to effectively
involve communities in the design of studies, and a failure to obtain
peer review, especially in controversial cases. Finally, ATSDR's
response to uncertainty is too often to find an ``inconclusive hazard''
without recommendations for further study or preventive measures.
Rather than err on the side of precaution, ATSDR often issues ``no
evidence'' findings that are quickly translated by sources and
enforcement agencies to mean ``no problem.'' While there are dedicated
scientists and other professionals at ATSDR, the prevailing leadership
has failed to take advantage of a large store of expertise and desire
to help communities. Moreover, the Agency has done little to provide
actual relief from or prevention of harm in environmentally stressed
communities.
Risk communication:
The quality of risk communication depends upon several factors: (1)
the quality of information used as inputs to the assessments (2) the
inclusion of all applicable exposure pathways and routes (3) the
confidence that community members have in those conducting the
assessment and reporting the findings. One way to ensure that all of
these conditions are met is to involve the community and their
technical advisors from the outset. Programs that give community
organizations access to environmental and public health scientists
should be expanded. Independent peer review should be provided when
concerned parties request on.
Trends: are the complaints new?
Current efforts: The complaints outlined above are certainly not
new. The Agency got off to a very bad start by conducting a large
number of congressionally-mandated health assessments at sites on the
Superfund National Priorities List (NPL). These were cursory reports
based on EPA and industry data. Residents had little or no opportunity
to provide input or comments. Residents in many ``Superfund
Communities'' felt that the reports understated their impact and need
for protection. Spurred by widespread and growing criticism in the late
1980's and early 90's then Administrator Dr. Barry Johnson sponsored a
series of large meetings that included grassroots organizations and
ATSDR staff. These meetings led to the formation of an ongoing
Community and Tribal Committee and a Community Involvement Branch (CIB)
at the Agency. CIB has formed ongoing community advisory panels (CAPs)
to obtain input and promote dialogue between officials and residents;
up-front and continued work of CAPs have helped to improve the
responsiveness of ATSDR to community concerns and the Agency's trust
level. In addition, Dr. Johnson directed the Agency to take decisive
action at a number of sites. I believe that these efforts paid off in
terms of what ATSDR was able to deliver and its trust among affected
communities. In my judgment the Agency has lost focus following Dr.
Johnson's retirement (1998). Dr. Henry Falk had good intentions but
lacked the strong leadership skills needed to guide an Agency with a
difficult mission.
As stated above, the Agency has suffered irreparable harm under Dr.
Frumkin. His recent efforts to establish a national dialogue are simply
``too little and too late'' to make the kind of changes that are
needed.
Q6. ATSDR Products.
A6. One critical problem with risk communication in ATSDR products is
that the Agency fails to effectively involve communities in the design
of studies and in the wording of reports. In my written testimony
(March 12, 2009), I stated that community members should (and their
experts) be given an effective opportunities to provide input on
protocols for all investigations and on drafts of all reports
(including health consultations) before they are finalized. Community
advisory panels that work with ATSDR over extended periods have been
effective in a number of cases; these help to build confidence in the
final ATSDR product.
Moreover, ATSDR products are almost never peer reviewed. ATSDR
should provide a peer review process whenever interested parties (e.g.,
community members) request one. Affected communities often have a
legitimate need for concern and help; community members are likely to
be highly suspicious where ATSDR comes up with ``no-evidence or no-
impact'' finding--unless they have been involved from the outset in a
meaningful way that develops a strong level of trust.
Q7. ATSDR coordination with other agencies.
A7. ATSDR works very closely with U.S. EPA's Superfund Office. The
coordination takes place largely at the regional level, with ATSDR
regional officials often headquartered in EPA regional offices. ATSDR
also uses data generated by EPA or by parties liable for cleanups
including industries in the private sector and federal facilities
(especially Department of Defense and Department of Energy facilities).
In my judgment, ATSDR often allows these agencies to control the flow
of information, the extent of testing, and even the outcome of studies.
Federal agencies including EPA, DOD, and DOE must often address issues
involving cost. For example, given the absence of the Superfund
feedstock tax, EPA has little money to fund cleanups; thus they are
dependent on the industries liable for the cleanup to conduct the
remedial work. Negotiations do not always center on protection of
health and environment, but on the costs to the company and the agreed
upon cleanup may be less than protective of health and the environment.
ATSDR officials who work in close coordination with EPA officials may
in some cases be unwilling to ``rock the boat.'' I would recommend that
agencies conducting health studies be given greater resources to obtain
their own data and greater independence from EPA and potentially liable
parties including federal facilities. Potentially responsible parties
(PRPs) should reimburse health-based agencies for the costs of
investigations.
ATSDR also has cooperative agreements with State Departments of
Health (DOHs). The DOHs often conduct public health assessments under
cooperative agreement for ATSDR. The DOHs operate under similar
restraints with regard to obtaining information.
Answers to Post-Hearing Questions
Responses by Howard Frumkin, Director, National Center for
Environmental Health and Agency for Toxic Substances and
Disease Registry (NCEH/ATSDR)
Questions submitted by Representative Paul C. Broun
Q1. Please explain the difference between a Health Assessment, a
Health Consultation, an Exposure Investigation, and a Technical Assist.
A1. A public health assessment is defined as a comprehensive site
evaluation of data and information on the release of hazardous
substances into the environment in order to assess any past, current,
or future impact on public health, develop health advisories or other
recommendations, and identify studies or actions needed to evaluate and
mitigate or prevent human health effects (42 Code of Federal
Regulations, Part 90, published in 55 Federal Register 5136, February
13, 1990).
A public health consultation is a response to a specific public
health issue or question which requires the analysis of site-specific
data, health outcome data or chemical-specific data. A public health
consultation can also serve as a written record of a verbal response
provided when immediate public health input is needed. Often site-
specific data is provided to ATSDR as it becomes available and in order
to provide timely input on public health issues ATSDR will develop
multiple public health consultations. Public health consultations are
therefore more limited in the range of issues addressed. For instance,
a public health consultation often includes the review and analysis of
information on a single pathway of exposure whereas a public health
assessment includes the review and analysis of multiple pathways of
exposure.
Public health assessments differ from public health consultations
in that they may consider all pathways at a site, and are released for
public comment and include a response to comments.
In an exposure investigation, ATSDR collects and analyzes site-
specific information and biological tests (when appropriate) to
determine whether people have been exposed to hazardous substances.
Exposure investigations support a site evaluation by conducting
targeted sampling to evaluate exposures within a community. ATSDR
documents the findings and analysis of its exposure investigations in
the public health consultation format.
A technical assist is a response to external requests for
environmental public health technical and/or educational information.
Such requests may be received via phone calls, letters, and/or e-mails
from external requestors. In general, the technical assist will be used
by the requestor to make a more informed decision. Unlike other ATSDR
documents, technical assists do not include a public health hazard
category. If a data or information package is submitted for evaluation
or a public health hazard category will be determined, a public health
consultation or public health assessment is the appropriate format to
document the analysis and decision process.
Q1a. How does ATSDR determine which products to provide?
A1a. A preliminary assessment is made of the exposure pathways, the
environmental media data, and community concerns to decide what product
or products would provide the most appropriate and timely public health
response. In most cases ATSDR will coordinate with the person
requesting our services to discuss the request and the products and
services that are most likely to meet their needs.
Q1b. Does ATSDR consult with the petitioner when it chooses which
product to provide?
A1b. When ATSDR receives a petition, a team of environmental
scientists, physicians, toxicologists, and other staff members
evaluates all site information and decides whether ATSDR will perform a
Public Health Assessment or if some other action--such as a Public
Health Advisory, Health Consultation, or community environmental health
education--would better meet the community's needs, or if no ATSDR
involvement is needed. As noted above, in most cases ATSDR coordinates
with the petitioner to discuss the request. Petitioners are informed in
writing of ATSDR's decision and the reasons for it. Throughout the
Public Health Assessment process, ATSDR is in regular communication
with the petitioner and the community.
Q1c. Does the petitioner have any recourse to appeal ATSDR's decision?
A1c. The petitioner may request a change in the type of ATSDR product
at any time. However, as a practical matter, few ever do as the ATSDR
proposed product is tailored to produce the most timely and relevant
public health response. Public health assessments are designed for more
complex sites to address multiple human exposure pathways and many
contaminated media whereas health consultations focus on a single human
exposure pathway and media.
Q2. Approximately what percentage of work done by ATSDR is self-
initiated, mandated by law, or the result of an outside petition?
A2. Very little of ATSDR's work at sites is strictly self-initiated.
Approximately 35-45 percent of our current work results from citizen
petitions and National Priorities List (NPL)-mandated work. The
majority of the remaining work comes from federal and State agencies,
primarily requests from EPA and State environmental agencies.
Q2a. How many petitions for assistance does ATSDR receive in a year?
A2a. ATSDR has received more than 750 petitions since the Agency first
began accepting them in 1987. The average number of petitions each year
is approximately 35. (ATSDR received 34 petitions in 2008.)
Q2b. What percentage of petitions are you able to actually assist on?
A2b. While all petition requests are carefully reviewed, approximately
60 percent have been accepted resulting in the development of a Public
Health Assessment or Health Consultation.
Q2c. How do you prioritize such petitions?
A2c. Petition requests are prioritized using available data based on
the likely severity of the environmental and physical hazards, an
understanding of the potential pathways of exposure and the affected
population, the availability of data needed to carry out an assessment,
and evidence or suggestions of adverse health outcomes in the
community.
Q3. What options does ATSDR have if sampling data is limited for a
particular review?
A3. ATSDR routinely deals with incomplete exposure information. ATSDR's
ability to draw public health conclusions is sometimes limited by the
quantity and/or quality of the exposure information. It is critical
that the exposure information used to evaluate the risk for adverse
health effects be complete and accurate. Often situations exist in
which either no--or insufficient--data are available or we cannot
answer the questions posed by the community due to limitations in
science, even when data are available. However, we do have options for
responding to situations in which there is limited sampling data, as we
discuss below.
If exposure data are limited, we can
search for and retrieve existing data (ATSDR has
pioneered methods, and is very experienced at this task),
measure past exposures using new and innovative
methods (however, even when we can measure levels in the
environment, it is difficult to know if people have actually
been exposed),
model past exposures,
use biomonitoring techniques (such as those developed
by the National Center for Environmental Health laboratory)
when appropriate,
report that there are limitations when we cannot
quantify exposures and say so, communicating well, or
recommend that needed sampling be done by agencies
such as EPA and State agencies that are equipped to perform the
sampling.
If health outcome data are limited, we can
use existing health outcome databases (although the
United States does not systematically collect data on many
health outcomes, such as asthma, neurodevelopmental disorders,
or immune function disorders) or
collect data by performing epidemiological studies
(such studies are expensive and time-consuming, and therefore
only rarely feasible).
Q3a. Is caveating the limitations in the report your only option?
A3a. No. We have many options, as described above.
In addition, ATSDR works closely with CDC's National Center for
Environmental Health Environmental Public Health Tracking Program. The
Tracking Program brings together data on environmental hazards,
exposure to environmental hazards, and health effects potentially
related to exposure to environmental hazards.
As a final note, we need to emphasize that caveats are important.
The public needs to know if data is missing and how that may limit what
we can do.
Q3b. How challenging is this in terms of communicating results?
A3b. This creates frustration for some members of the public, who
expect definitive answers. For example, at Colonie, New York, we
considered an epidemiologic study of workers exposed to metals. We
requested health data for the former workers but were not able to
obtain the data. This important and missing piece of information,
combined with the lack of environmental data for the years of peak
activity at the plant, left a research gap for investigators and
frustrated members of the community.
However, we do have options for responding to situations in which
there is limited sampling data, as we discussed above.
Q3c. How do you propose ATSDR address this issue?
A3c. We address the issue of not having enough data by using the best
available data, recommending how data gaps can be filled, and
communicating the limitations of that data to the communities we serve.
ATSDR is striving to expand the use of state-of-the-art exposure
assessment strategies, and also to combine the use of sampling and
modeling results. For example, to accurately estimate park visitor
exposures to asbestos at the Illinois Beach State Park site, ATSDR
employed activity-based-sampling and used the most current methods for
asbestos analysis, developed by the International Organization for
Standardization.
We also recognize that we must redouble our effort to be clear
about the limitations of the data and to work with communities from the
beginning of the public health assessment process, and throughout the
process, to ensure that--to the extent possible--expectations are
realistic. ATSDR has launched initiatives so that concerned citizens
better understand the complex nature of environmental exposures and
will be able to make informed decisions about the exposure to toxic
substances and their health.
Q4. In the case of formaldehyde levels in FEMA trailers, EPA conducted
sampling after limited consultation with ATSDR. That sampling was
deemed to be insufficient to characterize long-term exposure. How does
the Agency now ensure that it receives appropriate samples to
adequately characterize exposure and risk?
A4. In the case of the initial work with the FEMA trailer data, ATSDR's
role was as a technical assist that primarily involved reviewing EPA
sampling data.
In its initial review, ATSDR staff did not consider the
implications of chronic exposures. That has been corrected. We
corrected the Health Consultation and published a revised document
providing background information on exposure to formaldehyde and health
effects (including those of long-term exposure), and clarifying the
limitations of the data analysis.
Following the initial assessment, and recognizing that the ATSDR
health consultation was not designed to reflect actual conditions of
those living in trailers, CDC's National Center for Environmental
Health undertook--and is continuing to conduct--extensive activities to
assess health risks related to temporary housing units used after
Hurricane Katrina. These activities include: a structural study to
analyze emissions from individual components of trailers and mobiles
homes used as temporary housing, and a study of occupied housing to
evaluate levels of formaldehyde under actual living conditions. This
effort led to recommendations regarding the use of the trailers as
temporary housing and resulted in FEMA removing people from units with
unsafe levels of formaldehyde. NCEH also is undertaking a comprehensive
long-term study of children's health related to Hurricane Katrina.
Recognizing that this is a broader problem, NCEH and ATSDR convened a
group of agencies to address broadly the health challenges of
manufactured structures. The results of this effort are expected during
the coming year.
ATSDR routinely confers with other agencies on sampling
methodology. Recent examples include the coal fly ash spill in
Tennessee and concerns over the use of Chinese drywall in homes. ATSDR
brings unique value by adding public health expertise to EPA's sampling
expertise, allowing the methods to consider the ways that people are
actually exposed.
Q5. How can ATSDR do a better job characterizing past exposures given
the complexity of the task? Do you have any specific recommendations?
A5. Reconstructing past exposures is a core challenge in the
environmental health field. ATSDR routinely deals with incomplete
exposure information. ATSDR has several options for investigating
exposures and potential health effects.
We can search for and retrieve existing data. ATSDR scientists are
skilled at locating data sources and obtaining available data.
ATSDR is utilizing new ways to measure past exposures. Using
innovative methods, ATSDR scientists are able to measure levels of
environmental contaminants in ways previously unavailable; however,
even when we can measure levels in the environment, it is often
difficult to know if people have actually been exposed.
ATSDR also has developed methods to model past exposures. The
Agency uses exposure-dose reconstruction as an approach that
incorporates computational models and other approximation techniques to
estimate cumulative amounts of hazardous substances internalized by
individuals presumed to be or who are actually at risk from contact
with substances associated with hazardous waste sites. For example,
ATSDR developed techniques for modeling complex water distribution
systems to investigate past exposures to TCE and PCE at Camp Lejeune in
North Carolina. ATSDR's water modeling activities support the Agency's
current epidemiologic study of childhood birth defects and cancer
possibly related to past exposure to contaminated drinking water at the
base. We are also exploring the use of modeling in conjunction with
sampling data.
In addition, we are increasingly using biomonitoring techniques to
measure the level of contaminants that are actually in people's bodies.
However, this is only appropriate for past exposures when the chemical
persists in the body. Some are quickly metabolized or expelled and,
therefore, do not yield usable biomonitoring results.
Advancing science in the three areas discussed above--1) measuring
past exposures, 2) modeling, and 3) biomonitoring--would further
improve the characterization of past exposures.
Q6. How does ATSDR decide when to partner with State health
departments?
A6. ATSDR works closely with State and local health departments
whenever possible. In more than half the states, this work is carried
out through our cooperative agreement program using federal funds.
Funding is based on a competitive process to ensure states are
qualified to conduct this work. In all the states, we provide technical
assistance as requested by the states.
Q6a. Do these partnerships end up providing states with additional
resources from the Federal Government?
A6a. Yes. The cooperative agreement program allows states to build
capacity in environmental health. Even though resources are limited, in
many cases the only capacity within the state to deal with health
impacts of hazardous waste sites comes from money ATSDR provides.
Q6b. Is this an appropriate function of the Federal Government, or
should states be funding work with their own resources?
A6b. There is a role for both the Federal Government and the State
governments in environmental health. How these roles are balanced is a
policy decision.
The Comprehensive Environmental Response, Compensation and
Liability Act (CERCLA), as amended by the Superfund Amendments and
Reauthorization Act (SARA), provides that ``The activities of the
Administrator of ATSDR described in this subsection and section 9611
(c)(4) of this title shall be carried out by the Administrator of
ATSDR, either directly or through cooperative agreements with States
(or political subdivisions thereof) which the Administrator of ATSDR
determines are capable of carrying out such activities. Such activities
shall include provision of consultations on health information, the
conduct of health assessments, including those required under section
3019(b) of the Solid Waste Disposal Act [42 U.S.C. 6939a (b)], health
studies, registries, and health surveillance.'' See 42 U.S.C.
9604(i)(15).
Q6c. How does ATSDR ensure that conflicts of interest do not arise, or
that ATSDR's work is simply seen as a ``rubber stamp?''
A6c. In general, conflicts do not arise in our work activities with
State health departments. Our goal is mutual--we want to provide the
best public health information for the communities potentially impacted
by a toxic exposure. ATSDR interacts with State Health Departments on a
routine basis, in the context of technical assistance; and ATSDR has a
more formalized process, the State Cooperative Agreement Program. There
is an inherent sensitivity in working collaboratively with our State
Partners. The states are closer to their community concerns. On the
other hand, federal agencies can provide additional resources or
certain types of specialized expertise. ATSDR prides itself on strong
working relationships with State Health Departments. In rare cases-say,
when the state owns the site of concern--there may be an appearance of
or the potential for a conflict of interest, however, ATSDR minimizes
any potential impact and ensures that these sites are addressed with
the best public health approach available. In all cases, ATSDR insists
that good science be used in all products produced by the state with
our support. Protecting public health is our first priority.
ATSDR routinely receives requests from State Health Departments for
technical assistance. For example, when a coal burning power plant had
an accidental release of fly ash in a Tennessee community, the
Tennessee Health Department immediately requested ATSDR technical
assistance in responding to community health concerns. In providing
technical assistance ATSDR provides independent review based on its
expertise and experience, and does not simply ``rubber-stamp''
conclusions or products. In this circumstance, the Tennessee Health
Department prepared a fact sheet to distribute to the local community
members to provide information on their health and this fly ash
release. ATSDR reviewed the fact sheet and noted that the statement
related to health concerns was too reassuring to the community, since
it did not consider the longer-term exposure to the fly ash in the
sediment. The Tennessee Health Department agreed with ATSDR to change
the fact sheet language. The revised fact sheet in now on their web
site and being used for all additional public health meetings.
Q7. How has the Agency evolved in terms of the services it provides?
A7. Initially, most of ATSDR's work was mandated at Superfund sites,
listed on EPA's National Priorities List. Over the years, the amount of
that work has declined, as fewer Superfund sites have been proposed.
Technical requests from other agencies and from State and local health
departments have emerged as an increasing force for ATSDR's
environmental health response work. The role of ATSDR is an important
one and despite the modest resources (approximately $74 million), we
make positive contributions to health and safety in many communities.
Q7a. Has the number of health assessment and consultation petitions
increased recently?
A7a. Petitions have remained relatively stable through the years,
averaging approximately 35 per year. From 1987-2007, ATSDR received
more than 750 petitions. Approximately 60 percent of these were
accepted and addressed by ATSDR and its cooperative agreement partners.
Q7b. Has the Agency begun to investigate additional pathways of
exposure?
A7b. Although Love Canal and other hazardous waste sites were the focus
when CERCLA was enacted and ATSDR created, ATSDR authority under CERCLA
is not limited to hazardous waste sites--it extends to hazardous
substance ``releases.'' This can include multiple ways people are
exposed to chemicals. Examples of the breadth of ATSDR's work include
our emergency response program and our work with air releases from
power plants and industrial facilities, such as those at the Mirant and
Rubbertown sites.
Enormous progress has been made in addressing threats from
hazardous waste sites. In addition, emerging science has provided
greater insights into how people are exposed to chemicals and what
chemicals are in people's bodies. It is clear that many human exposures
to chemicals are not from waste sites. As a result, we recognize the
importance of investigating sources and pathways of exposure beyond
hazardous waste sites.
In evaluating the health impacts of chemical exposures from a
broader range of sources, we are cognizant of the possibility of
duplication of effort with other agencies. This is part of the
motivation for our National Conversation on Public Health and Chemical
Exposures. Over a year into planning, this process involves a broad
cross-section of stakeholders, including environmental groups,
communities, professional groups, public health groups, industry, and
other agencies, to assess our work to date, in the broader context of
cross-government efforts to address chemical hazards and to make
recommendations for involvement. These may involve substantial changes
in how ATSDR does its work. This effort will identify gaps in, and
emerging priorities for, the public health approach to chemical
exposures and identify solutions that strengthen public health.
Q7c. How has this impacted the Agency?
A7c. ATSDR has done limited work with exposures to hazardous substances
not related to hazardous waste sites, such as naturally-occurring
asbestos, air emissions from power plants and industrial facilities,
and uranium in water. The National Conversation on Public Health and
Chemical exposures will help inform development of approaches to
addressing potential health impacts of other sources and pathways of
exposure.
Q7d. How has the Agency adapted its communications strategy to meet
these changes?
A7d. We have and will continue to communicate effectively with the
communities we serve. Through openness, cultural competency, and
careful needs assessment, we actively engage communities through our
site work. Our Community Involvement Branch includes communication
specialists, health educators, and other professionals with extensive
experience in this area. These professionals, like others at the
Agency, stay abreast of developments in the field and incorporate them
into our work.
Q8. The ability to determine causation is complex and analysis of
health risk levels vary based on numerous factors.
A8. Communities often expect that an agency such as ATSDR will arrive
on the scene, rapidly assess the situation, and reach unequivocal
conclusions. Unfortunately, it is not always possible to reach such
conclusions. Definitive answers sometimes do not exist, due to the
inherent uncertainties of science. Available data--both environmental
and health outcome data--are often limited. Small area epidemiology
lacks the statistical power to draw definitive conclusions. Finally,
the public health field often lacks the appropriate tools to allow us
to establish causation.
Despite limitations, ATSDR has identified a public health hazard in
approximately 30 percent of cases. In approximately 40 percent of
cases, available data suggest little or no risk, and, in approximately
30 percent of cases, available data do not permit a conclusion. In
addition, our documents include specific recommendations and follow-up
actions to be taken by agencies with appropriate jurisdiction. More
than 70 percent of these are implemented.
It is possible to draw certain negative conclusions with
confidence. For example, with sufficient information we may positively
conclude that contamination from an identified source is not reaching a
community. However, positive conclusions are harder to reach. For
example, even when we identify a complete pathway and document
exposure, we cannot always establish a causal link between the exposure
and disease in the community. In many cases, it is impossible to draw
firm conclusions.
Q8a. How does the Agency communicate the limitation of their products
and findings?
A8a. ATSDR communicates these limits both in person and in writing. For
example, Community Involvement and Health Education Specialists,
through public meetings, public availability/poster sessions and other
community meeting formats, communicate with stakeholders throughout the
process. Through early and ongoing communication, ATSDR provides
information on public health implications, risk, and limitations of our
work in qualitative terms. The information includes how we will be:
reviewing environmental data (to include
environmental or health data limitations and data gaps),
gathering community concerns,
identifying ways people might come in contact with
chemicals,
determining if people are being exposed,
determining how that exposure might affect public
health,
providing conclusions and recommendations,
preparing a public health action plan, and
communicating community involvement activities.
In summary, we want communities to know what to expect, including
the difficulty in coming up with a causal link between exposure and
disease. For example, we communicate ``risks'' instead of ``cause.''
In addition, ATSDR has recently revised its public health hazard
conclusion categories to more clearly describe, using plain language,
the potential risks from eating, touching and breathing unsafe
chemicals. Our revised hazard conclusion categories will be placed at
the front our documents so that the community is immediately aware of
our public health messages and other issues about the site.
Q8b. To what extent do you attribute criticism of agency products to
poor communication?
A8b. We attempt to minimize the potential for poor communication.
Communicating information is fundamental to ATSDR's Public Health
Assessment process, and we work very hard at it. ATSDR has extensive
experience and great expertise in communicating with the public.
However, we recognize that there are always opportunities to do better.
Sometimes, however, community members, who are justifiably
concerned about exposures to hazardous substances, may reject the
concept of ``levels of risk'' when what they want is zero exposure.
Despite our early and active engagement with communities and our
scientific attempts to address their concerns, there will always be
expectations which we cannot meet. In the case of Illinois Beach State
Park, several individuals remain convinced that dangerous exposures are
occurring, despite four rounds of extensive air sampling over the last
decade using highly reliable methods that reached the opposite
conclusion. In stressful situations, research shows that many people
have difficulty processing information and give greater weight to
negative information. By pulling from this research, we can better
guide our communication efforts.
Q8c. Do you have any suggestions on how to better communicate the
limitations?
A8c. As I said in my testimony, even excellent people and organizations
can always improve. ATSDR is continuing to take steps to improve our
ability to communicate complex scientific information to communities,
including:
Continue fine-tuning our community involvement
process; focusing our site teams on the skills needed to
effectively interact with communities, including preparing and
presenting information to stakeholders, and including them in
the decision-making processes.
Continue initiating contact before the health
assessment process begins and listen to community concerns,
obtain critical information, and assess needs, and increasing
our on-site community-level environmental health literacy
education efforts.
Continue incorporating community outreach activities
as a standard component of the ATSDR Public Health Assessment
and Health Studies activities.
Continue developing and incorporating community
health education activities along with our community outreach
activities.
Implement the new language and format of our public
health hazard conclusion categories so that our health messages
are clearer and easier to understand.
Continue to use PHCs, LPHCs, and TAs to respond to
stakeholder environmental health concerns in a timely manner.
Our goal is to include the community in the public health
activities at the beginning and during the health assessment to ensure
they are provided current, ongoing, and relevant information throughout
the process and have the opportunity to provide input.
Q9. Do you believe ATSDR attempts to include revolutionary scientific
methods and techniques in their work?
A9. ATSDR pays close attention to emerging scientific methods, and uses
them when appropriate. We recognize the need to balance the use of new
methods with the use of validated and widely accepted techniques. For
example, when we investigated polycythemia vera (PV) in Pennsylvania,
as public health scientists, we knew that most cluster investigations
do not identify environmental causes, and are cautious and deliberate
about such investigations. ATSDR focused initially on verifying and
quantifying the excess cases of disease, sought outside hematologic
expertise, and remained open minded about a possible environmental
etiology. The hematology expert had identified a genetic mutation
called JAK2 found to occur in most PV patients. This revolutionary
discovery has now led scientists to search for the cause of the JAK2
mutation in hopes that this knowledge will help them find the cause of
PV. Using this genetic marker, ATSDR scientists confirmed 38 cases of
PV. ATSDR will further evaluate the spatial distribution of cases and
review available environmental data. ATSDR plans to conduct further
scientific research to determine the cause of the PV.
Ultimately, the decision of when to use new methods is a scientific
judgment and a decision best made in consultation with a broad range of
scientific experts. Through expert panels and peer review, ATSDR
engages independent scientists and scientists from other agencies and
institutions in its decision-making process.
When ATSDR develops new methods, we report those methods through
peer-reviewed, scientific journals.
Q9a. How can the Agency better integrate cutting-edge science?
A9a. The methods ATSDR uses to integrate new technologies with existing
science work very well. For example, we have re-trained scientists to
apply new methods. We have a dedicated GIS unit and a dose
reconstruction lab. ATSDR scientists have developed innovative
techniques of computational toxicology to help rapidly assess hazards
of chemical releases. ATSDR also provides training to State and local
partners to assist them in incorporating new methods into their health
assessment work.
In addition, ATSDR scientists continuously monitor scientific
literature and attend professional meetings to increase their awareness
of new techniques and how to apply them to their work at sites. We use
peer review to ensure that these methods are the best available for
assessing exposures and protecting public health.
ATSDR's external Board of Scientific Counselors evaluated our site
assessment and our peer review procedures. While providing us with a
number of constructive recommendations, their report highlights the
soundness of our approach in incorporating both public and expert
scientific input.
ATSDR also works closely with NIH and other science-based agencies
and organizations to keep abreast of new and innovative technologies,
methods, and techniques.
Q9b. Is there any risk to getting too far ahead of a technology or
method and coming to conclusions that are ultimately proven to be
unfounded?
A9b. There is a risk to getting too far ahead of a technology or
method. However, we do not shy away from using cutting-edge science.
Before cutting-edge techniques or methods are applied to a public
health problem, those approaches are peer-reviewed as are the developed
products (be they Public Health Assessments, health studies,
toxicological profiles, etc.). Our primary objective is to protect
public health and we maintain that objective throughout the health
assessment process.
Q9c. How would you set up policies or procedures to appropriately
manage and utilize these innovations?
A9c. The decision to use new methods requires scientific judgment.
These decisions are best made in consultation with scientific experts,
both internally and externally. Through the use of expert panels and
peer reviews, ATSDR calls upon the expertise of independent scientists
and scientists from other agencies to inform our decision-making
process.
When ATSDR develops new methods, we report those methods through
peer-reviewed, scientific journals.
We clearly identify limitations in methods, data analyses, and
conclusions in our products, as is standard in scientific documents. We
have peer review policies and procedures in place to triage documents
when new or controversial science is applied. Additionally, our Board
of Scientific Counselors has reviewed clearance procedures and receives
programmatic reviews and updates and provides guidance on our
scientific approaches and programs.
Q10. How does ATSDR compare with similar entities in other countries?
A10. Most countries do not have any agency similar to ATSDR, nor do
they have programs as comprehensive as those administered by the
Environmental Protection Agency (EPA) to regulate and remediate
chemical releases. Each year ATSDR receives requests from the
governments of other countries to send their scientists, physicians,
epidemiologists, and engineers to Atlanta for special training on
conducting public health assessments. For example, the French
government does not have an agency comparable to ATSDR;, they have
sought ATSDR staff to teach in French public health agencies, and have
sent public health scientists to train with ATSDR. In addition, the Pan
American Health Organization (PAHO) has translated our public health
assessment manual into Spanish for use by public health officials in
Latin America.
Q10a. Do international public health agencies have similar problems?
A10a. The World Health Organization (WHO) has limited capabilities in
the core areas of ATSDR's work. Addressing health issues related to
environmental exposures to hazardous substances often is left to the
independent countries to address. The Basel Convention addressed the
trans-boundary shipment of hazardous waste, but did not include any
health-related discussion.
ATSDR is seen as the world leader in addressing public health
concerns related to exposures to hazardous waste.
Q10b. What do you attribute this to?
A10b. Even though hazardous wastes have been a concern for many years,
the investment of resources to address public health issues resulting
from these exposures has been limited. More investment must be made to
improve the science and the methods that public health officials use to
evaluate exposures and to educate and assist communities with
environmental health concerns.
Q11. ATSDR does not do large scale environmental sampling, and relies
upon the EPA and states to conduct this work.
Q11a. Do you believe ATSDR should also be doing this work?
A11a. Many times, environmental data already exist, based on regulatory
requirements. However, to answer important exposure questions, ATSDR
scientists often need data that do not exist. These are needed to fill
gaps between existing sets of data or to provide site-specific
information related to exposures and health.
In limited cases, ATSDR does conduct environmental or biological
sampling, although these efforts can be tremendously expensive and
time-consuming. ATSDR can only conduct a few large-scale sampling
projects each year. This leaves ATSDR with the difficult trade-off
between conducting more extensive sampling at fewer sites, and
responding to concerns at a greater number of sites.
To make the best use of limited resources, ATSDR generally works in
partnership with other agencies when large scale environmental sampling
is needed. These agencies often have the regulatory authority to
conduct environmental monitoring and sampling, as well as the technical
expertise and resources. As noted earlier, ATSDR often is called on to
provide technical assistance in development of sampling plans to ensure
sampling is conducted in a way that maximizes the usefulness of data
for assessing exposures. And, ATSDR often assists in evaluating data,
applying its expertise in the health effects of potential exposures.
There are also creative solutions to this dilemma. For example,
environmental sampling is useful, but, in some cases, it can be
replaced by biomonitoring. In the case of 1,4 Dioxane, ATSDR used
existing NCEH biomonitoring data to determine that there were no
detectable levels in the people sampled. This was an economical
solution that allowed us to use our resources to respond to other
exposures.
Q11b. How would you suggest we pay for this work?
A11b. ATSDR does not have the resources to conduct large-scale
research--either to develop environmental or biological sampling data
to assess exposures or to investigate the toxicological properties of a
hazardous substance. The Agency identifies data needs, seeks out
existing data to fill those needs, and works in partnership with other
agencies, at the federal, State, and local levels, as well as with
academic institutions and private entities, to develop data to meet
needs where sufficient data do not currently exist.
Q11c. Would this be worth limiting the number of other studies,
assessments, or consultations the Agency initiated?
A11c. Limiting the number of sites in order to free up resources to
conduct original sampling would diminish ATSDR's capacity for
responding to community concerns and frustrate communities seeking
answers to important health concerns. Already ATSDR does only a small
number of health studies, which are far more resource intensive than
other approaches.
Sites under consideration for Public Health Assessments, Health
Consultations, Exposure Investigations and Technical Assists come to
ATSDR through the Superfund process, from direct requests from other
federal agencies (EPA, DOE, DOD, etc.), and from requests from
concerned community members. ATSDR reviews each site and prioritizes
according to need and available resources; however, we strongly believe
that it is important to remain responsive to communities, to work with
them to address health concerns, and to engage at sites as needed.
Q12. What role should ATSDR play in exposure routes not associated
with hazardous wastes (such as food, consumer products, water, and
air)?
a. How does the Agency intend to address these issues?
b. Is there any overlap with other agencies?
c. What does the Agency do when there is duplication of
effort?
A12. ATSDR helps protect the public from exposures to hazardous
substances from releases at hazardous waste sites and at a variety of
other settings. These releases may range from chemical plant explosions
to a spill of coal combustion products. They can be those identified by
government agencies or by individuals within the community through the
petition process.
A series of environmental laws in the 1970s and 1980s defined the
U.S. approach to chemical exposure risks. A mosaic of agencies and
organizations, governmental and nongovernmental, regulatory and non-
regulatory, carry out various public health functions. As a result,
some key responsibilities may not be carried out adequately, and others
may be redundant. ATSDR's mission and functions must be considered
within this broader context.
In recognition of these realities, ATSDR and its companion Center
at the CDC, the National Center for Environmental Health (NCEH), have
initiated the National Conversation on Public Health and Chemical
Exposures. This process is designed to identify gaps in, and emerging
priorities for, the public health approach to chemical exposures and
identify science-based solutions that strengthen public health. This
will build on ATSDR's strong working relationships with a broad range
of stakeholders, and further help us to use resources responsibly,
avoid redundancy, and eliminate gaps in public health coverage.
Public health functions related to chemical exposures include
exposure and health surveillance, investigation of incidents and
releases, emergency preparedness and response, regulation, research,
and education. When our efforts overlap, we work closely with other
agencies by sharing data and expertise to recognize and mitigate
community exposures and protect public health. For example, ATSDR
responds to emergencies involving the release of chemicals, most often
in collaboration with the Environmental Protection Agency. ATSDR
personnel provide real-time public health guidance following acute
releases of hazardous substances and health information to the public
(for example, helping determine when people can safely reoccupy their
homes and businesses after an evacuation).
ATSDR also works with other partner agencies to provide advice and
guidance on topics such as exposure routes, toxicology, data sampling,
data collection, epidemiology, and data analysis. We collaborate with
the Food and Drug Administration and U.S. Department of Agriculture on
issues pertaining to food, with the Environmental Protection Agency and
U.S. Geological Survey on air and water concerns, and with the Consumer
Product Safety Commission when product safety is in question. We may
evaluate data collected by these other agencies for health
implications, while our partner agencies may examine other aspects,
such as environmental or regulatory implications.
Q13. How does ATSDR's level of competence compare to other federal and
State entities charged with protecting public health?
A13. ATSDR is a non-regulatory environmental public health agency. We
are community-oriented, working to respond to local concerns. We
operate by bridging the work of other agencies, and between federal
agencies and states. We are a specialized agency, and, in the areas in
which we specialize, we are very good.
However, we are a small agency, lacking the depth and breadth in
some areas that would enable us to more fully fulfill our mission. With
only 300 employees, we lack adequate capacity in certain important
fields, such as veterinary epidemiology, industrial hygiene, and air
quality modeling. To address these challenges, we work closely with
other federal and State agencies. To help devise a long-term solution,
we have initiated our National Conversation to identify gaps in, and
emerging priorities for, the public health approach to chemical
exposures, and to identify science-based solutions that strengthen
public health.
Q13a. Would you characterize the work ATSDR does as a specialized
niche?
A13a. Several agencies (including NIH's National Institute of
Environmental Health Sciences and EPA, in addition to ATSDR) share
responsibility for assessing the human health effects from exposure to
environmental contaminants. ATSDR does have a specialized niche in
assessing exposures to hazardous waste. CERCLA specifically established
ATSDR for this purpose. ATSDR has pioneered the public availability
session and remains an authority on public interaction with communities
potentially impacted by hazardous waste sites. ATSDR is a world leader
in providing toxicological profiles of specific toxic substances.
ATSDR's toxicological profiles are frequently used and held in very
high regard, domestically as well as internationally.
Q13b. Do any other agencies perform this same work?
A13b. ATSDR's work complements that of NIEHS, EPA, the National
Toxicology Program (NTP), NIOSH, OSHA, FDA, and Consumer Product Safety
Commission (CPSC). These agencies, along with other agencies and
organizations, governmental and non-governmental, regulatory and
nonregulatory, carry out various public health functions related to
chemical exposures. These functions include exposure and health
surveillance, investigation of incidents and releases, emergency
preparedness and response, research, and education. NCEH/ATSDR plays a
significant role in carrying out several of these key public health
functions.
Q14. In your testimony, you describe one of the problems ATSDR faces
is the difficulty ATSDR sometimes faces when a community refuses to
believe your conclusions. Specifically, you mention that ATSDR and
counterpart site agencies have had to repeat investigations several
times at the same location which end up yielding the same conclusions
as the original investigation. This does not seem like the most
efficient use of resources. What can be done to ensure that communities
who have genuine problems have access to the resources ATSDR can
provide?
A14. ATSDR does, from time to time, revisit a site. In some instances
this may be considered inefficient, but we consider it to be prudent,
as our work is a mixture of community service and the best science. If
new data are available, new scientific methods emerge, or community
concerns persist, this may justify returning to conduct additional work
at a site.
For example, in the case of Illinois Beach State Park, continuing
questions illustrated a need for additional information. New sampling
techniques provided a greater level of confidence in the results. Even
there, a small number of community members were not convinced. However,
through the cooperation with other federal and State agencies, we
provided the community with scientifically rigorous health guidance. On
the other hand, after careful review of new research related to the
Colonie, New York, site, since the hazard has long ago been removed,
among other reasons, ATSDR concluded that a community study would be
unlikely to have scientific yield or public health benefit.
Q15. In your written statement, you mention the challenges related to
the research capacity at ATSDR. Given the workload and the statutory
authorities given to ATSDR, would you consider research to be a primary
goal for this organization? Would it not make more sense that you
identify gaps in scientific knowledge through your public health
assessments and leave it to another, more-equipped agency or
organization to undertake the research required to fill those holes?
A15. ATSDR is charged under CERCLA with expanding the knowledge base
about health effects from exposure to hazardous substances.
Research on the human health effects of environmental exposure to
hazardous substances is conducted by a number of federal agencies,
including the NIEHS, NCEH, EPA, and ATSDR. ATSDR carries out its
research responsibilities through a number of mechanisms. The Agency
takes steps to initiate needed research. For example, ATSDR identifies
important data gaps and takes steps to fill those gaps, such as through
petitions to the National Toxicology Program to conduct research on
particular exposures (i.e., naturally occurring asbestos). ATSDR also
funds a longstanding program through the Association of Minority Health
Professions Schools (AMHPS) to conduct needed research, while
supporting the training of minority professionals in toxicology.
ATSDR has a distinct role in applied public health research,
arising from the Agency's site-specific work. Examples of ATSDR's work
in applied public health research include the development of innovative
modeling techniques at Camp Lejeune in North Carolina, investigation of
community exposures to TDI (toluene diisocyanate) in North Carolina,
research on a possible environmental component of polycythemia vera in
Pennsylvania, and research into beryllium disease in community settings
in Ohio.
This research flows from our field work. We definitely have a
research role, but we need to be strategic. In some cases, it is better
for us to leave research to others; in other cases, it is important
that ATSDR do the research, based on the unique expertise and
experience of its workforce.
Questions submitted by Representative Steve Rothman
Q1. ATSDR seems to say to the people of Vieques Island, ``Nevermind.
Nothing to worry about here.''
A1. This is not an accurate characterization of ATSDR's approach to the
people of Vieques. Over the last decade ATSDR's work in Vieques has
been extensive, careful, and responsive. This work included:
A series of Public Health Assessments (PHAs) to
investigate environmental contamination on the island and
possible pathways by which people might be exposed to those
contaminants.
Training and materials for health care providers and
educators so that accurate environmental health information was
available to the community.
Extensive consultation with the community, before,
during, and after its investigations, to hear public concerns
and to incorporate them into its work.
ATSDR's work on the island included four PHAs, each investigating a
different potential pathway of exposure to dangerous chemicals:
groundwater and drinking water (2001), soil (2003), fish and shellfish
(2003), and air (2003). In addition, we convened two expert panels, one
to evaluate the accuracy and reliability of hair testing, and one to
assess environmental risk factors for heart disease.
Throughout the course of our work in Vieques, we encouraged
community participation, provided educational material, and held
meetings to explain both our findings and the methods used to reach our
conclusions. We solicited public comments on each of our Public Health
Assessments and addressed those comments in our final documents. We met
with members of the community, both individually and in public forums,
to discuss the findings. We worked through health care providers and
educators on the island to make educational material available to
residents. This is a record of Agency action that reflects sincere
concern for, and accountability to, the people we serve.
ATSDR continues to be dedicated to the health of the people of
Vieques. We have committed to re-engaging in Vieques, to assessing new
or persistent health concerns, to analyzing any new data, and to
reassessing our conclusions as appropriate.
Q1a. Why is it that independent scientists can find troubling evidence
of potential public health issues that ATSDR is unable to find?
A1a. ATSDR is not aware of any published peer-reviewed scientific
studies that have documented human exposure to hazardous chemicals on
Vieques at levels of health concern.
There is evidence of environmental contamination on Vieques. We are
aware of some credible, though unpublished, measurements of chemicals
in grass, in non-edible plant species near the live impact area (LIA)
at the eastern end of the island, and in non-edible animals, as well as
studies of how plants may take up metals. These data suggest that some
plants near the LIA and some non-edible marine species contain
contaminants--results that correspond to ATSDR's own findings. However,
this contamination was some miles from where people live on the island.
Moreover, detailed assessment did not identify specific pathways--say,
eating, drinking, or breathing--by which people might absorb these
contaminants. At the time of our assessments, neither the food people
were eating, nor the water they were drinking, nor the air they were
breathing, nor the soil they were touching, contained contaminants at
levels associated with health problems. Even if contaminants are
present in the environment, if they do not reach people's bodies, then
human health effects are not expected.
The Environmental Protection Agency (EPA), National Oceanic and
Atmospheric Administration (NOAA) and others continue to characterize
the nature and extent of the contamination associated with past
Department of Defense (DOD) activities on the island. Based on this
work, we are currently considering whether new data warrant additional
activities to assess potential exposures that might impact the health
of the people of Vieques.
Q2. Are you aware of the scientific studies done on the island of
Vieques questioning the ATSDR's public health assessments?
A2. Through media reports, we are aware of several studies of
environmental contamination and health on Vieques. ATSDR has requested
the environmental studies for review, but was informed that they had
not been published and were unavailable. ATSDR also followed up on
reports of a study of cancer mortality on Vieques; however, this report
has also not yet been published. ATSDR is assessing the quality and
availability of cancer registry data in Puerto Rico, including
Vieques--previously unsatisfactory but now said to be much improved--to
determine if the registry can be used to study cancer rates on Vieques.
Q3. Are you aware of the hair testing of the people of Vieques
themselves, provided to the U.S. Navy, showing extremely high levels of
mercury, lead, cadmium, arsenic and aluminum?
A3. ATSDR is aware of the human hair analysis, which indicated elevated
levels of mercury (and antimony in one individual). Hair analysis is a
controversial method in environmental health, and one that can be
subject to variability and inaccuracy. To assess the Vieques findings,
ATSDR convened an independent expert panel to evaluate the science of
hair analysis. This is an example of ATSDR's willingness to carefully
evaluate whether emerging or novel scientific methods might assist in
our assessments. In this case the expert panel concluded that the hair
analysis was likely to be unreliable. ATSDR offered to follow up with a
broader, biological exposure investigation, of which human hair
analysis would be a part, in addition to other specimens; however, the
community opted not to participate at that time.
ATSDR was also made aware of results of animal hair testing from
the Puerto Rico Department of Agriculture in cooperation with the
Farmers Association of Puerto Rico. These groups concluded that
agricultural products from Vieques were suitable for consumption and
did not contain toxic levels of these contaminants.
Q4. How do you evaluate the public health exposures of dangerous
contaminants at specific sites?
A4. We assess whether chemicals released into the environment are
reaching people by empirically evaluating the specific pathways that
might operate: eating, drinking, touching, or inhaling the chemicals.
If there is a ``completed pathway''--evidence that chemicals are
reaching people--we then determine quantitatively whether the exposure
levels are associated with adverse health effects, by turning to
toxicological, epidemiological, and medical studies in the literature.
Q4a. How do you know what to test for?
A4a. Two main sources guided our sampling efforts: in-house expertise
related to chemicals present in explosive residue; and Department of
Defense (DOD) data regarding the composition of the bombs. The
Environmental Protection Agency (EPA) has an oversight role in working
with DOD to determine adequate characterization of the nature and
extent of contaminants. In addition to reviewing sampling data from
other agencies, ATSDR sampled for bomb-related metals and explosive
residues.
Q4b. Did the U.S. Navy provide ATSDR with a list of all the chemicals
used at its Roosevelt Roads Naval Station on Vieques or found in its
munitions which have leached chemicals onto the island and into the sea
as a result of ordnance exercises at the Vieques Naval Training Range
for over 69 years?
A4b. Yes, the Navy provided ATSDR with a list of chemicals found in its
munitions; however, we cannot know with certainty whether the list of
chemicals provided by the Navy was complete.
Q4c. Did the U.S. Navy provide information to ATSDR about the amount
of depleted uranium, or napalm or Agent Orange or dioxins or other
potentially toxic chemicals it used on Vieques?
A4c. The Navy provided ATSDR with this information. The information the
Navy provided indicated that:
Two Marine aircraft fired 263 rounds of ammunition
armed with depleted uranium (DU) penetrator projectiles on the
LIA in February 1999.
The Nuclear Regulatory Commission (NRC) conducted an
environmental survey on Vieques in June 2000.
More than 70 percent of the DU rounds have been
located and the locations have been marked.
NRC reported that a recent survey found no additional
depleted uranium.
Q4d. Wouldn't you agree that the party who is in the best position to
know exactly what toxics and chemicals were used on Vieques is the U.S.
Navy? If so, did ATSDR ever demand the kind of relevant information
I've mentioned here, so that the people of Vieques and those of us who
are concerned about their health might know what they have really been
facing in terms of harmful exposure to all these toxic chemicals?
A4d. The Navy has extensive information on environmental contaminants
in Vieques, and ATSDR must rely on the Navy data in its assessments.
This not unusual; we often have to rely on data from others. In the
case of Vieques, ATSDR asked for and received data from the Navy. ATSDR
has also received information from NRC on depleted uranium, from the
U.S. Fish and Wildlife Service (FWS) and NOAA on aquatic life, and from
EPA on various environmental media.
Q5. Do you stand by your agency's assessment that Vieques is a
perfectly safe environment?
A5. No ATSDR document says that the environmental is perfectly safe.
However, each of our Public Health Assessments on specific pathways is
based on solid analysis and we stand by these documents. According to
the data we have reviewed, as long as people do not enter restricted
areas, including the LIA and nearby waters, they are safe from
contaminant exposure and from the physical injury risk associated with
unexploded ordnance.
Q6. Would you feel comfortable raising your family in a similar
environment?
A6. The data we have reviewed have revealed nothing that would prevent
me from raising my family on Vieques. However, I would keep my family
out of the restricted, unremediated areas in the LIA.
Q7. What do you think ATSDR could have done differently to improve the
public health assessments performed on Vieques?
A7. Vieques is one of ATSDR's most comprehensive investigations. It
included four Public Health Assessments, in addition to other work. The
Vieques investigation included assessments of the air pathway, soil
pathway, water pathway, seafood pathway, hazards associated with
vibrations, and numerous review panels to evaluate unpublished data
collected by others. ATSDR provided numerous health education,
physician education, and school-based environmental health education
resources and training to help the community gain the knowledge to
identify hazards, protect themselves from the hazards, and notify
authorities about the hazards.
EPA and other agencies are engaged in an environmental clean up and
additional sampling, and ATSDR remains available to review their data
as necessary.
As discussed above, ATSDR's focus was on assessing exposures rather
than health outcomes. Some may suggest that we should have done a
health outcome study during our work on Vieques. Typically, ATSDR does
not investigate health outcomes unless exposures are documented. This
is to focus ATSDR's limited resources in communities where exposures
are found.
ATSDR was--and is--interested in learning more about health
statistics on Vieques, especially if there is strong local support for
such an inquiry. At the time of our work on Vieques, cancer registry
data were not considered adequate to support rigorous analysis. Since
ATSDR's work, the Puerto Rico cancer registry has made significant
progress. We may consider using these data to address the concern about
the cancer rate on Vieques.