[House Hearing, 110 Congress]
[From the U.S. Government Printing Office]
THE EPA'S IRIS PROGRAM
=======================================================================
HEARINGS
BEFORE THE
SUBCOMMITTEE ON INVESTIGATIONS AND
OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
MAY 21, 2008
and
JUNE 12, 2008
__________
Serial No. 110-104
and
Serial No. 110-108
__________
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
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COMMITTEE ON SCIENCE AND TECHNOLOGY
HON. BART GORDON, Tennessee, Chairman
JERRY F. COSTELLO, Illinois RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas F. JAMES SENSENBRENNER JR.,
LYNN C. WOOLSEY, California Wisconsin
MARK UDALL, Colorado LAMAR S. SMITH, Texas
DAVID WU, Oregon DANA ROHRABACHER, California
BRIAN BAIRD, Washington ROSCOE G. BARTLETT, Maryland
BRAD MILLER, North Carolina VERNON J. EHLERS, Michigan
DANIEL LIPINSKI, Illinois FRANK D. LUCAS, Oklahoma
NICK LAMPSON, Texas JUDY BIGGERT, Illinois
GABRIELLE GIFFORDS, Arizona W. TODD AKIN, Missouri
JERRY MCNERNEY, California JO BONNER, Alabama
LAURA RICHARDSON, California TOM FEENEY, Florida
PAUL KANJORSKI, Pennsylvania RANDY NEUGEBAUER, Texas
DARLENE HOOLEY, Oregon BOB INGLIS, South Carolina
STEVEN R. ROTHMAN, New Jersey DAVID G. REICHERT, Washington
JIM MATHESON, Utah MICHAEL T. MCCAUL, Texas
MIKE ROSS, Arkansas MARIO DIAZ-BALART, Florida
BEN CHANDLER, Kentucky PHIL GINGREY, Georgia
RUSS CARNAHAN, Missouri BRIAN P. BILBRAY, California
CHARLIE MELANCON, Louisiana ADRIAN SMITH, Nebraska
BARON P. HILL, Indiana PAUL C. BROUN, Georgia
HARRY E. MITCHELL, Arizona
CHARLES A. WILSON, Ohio
------
Subcommittee on Investigations and Oversight
HON. BRAD MILLER, North Carolina, Chairman
JERRY F. COSTELLO, Illinois F. JAMES SENSENBRENNER JR.,
EDDIE BERNICE JOHNSON, Texas Wisconsin
DARLENE HOOLEY, Oregon DANA ROHRABACHER, California
STEVEN R. ROTHMAN, New Jersey DAVID G. REICHERT, Washington
BRIAN BAIRD, Washington PAUL C. BROUN, Georgia
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
BART FORSYTH Republican Counsel
TOM HAMMOND Republican Professional Staff Member
STACEY STEEP Research Assistant
C O N T E N T S
EPA's Restructured IRIS System: Have Polluters and Politics Overwhelmed
Science?
May 21, 2008
Page
Witness List..................................................... 2
Hearing Charter.................................................. 3
Opening Statements
Statement by Representative Brad Miller, Chairman, Subcommittee
on Investigations and Oversight, Committee on Science and
Technology, U.S. House of Representatives...................... 10
Written Statement............................................ 11
Prepared Statement by Representative F. James Sensenbrenner Jr.,
Ranking Minority Member, Subcommittee on Investigations and
Oversight, Committee on Science and Technology, U.S. House of
Representatives................................................ 13
Prepared Statement by Representative Jerry F. Costello, Member,
Subcommittee on Investigations and Oversight, Committee on
Science and Technology, U.S. House of Representatives.......... 13
Prepared Statement by Representative Eddie Bernice Johnson,
Member, Subcommittee on Investigations and Oversight, Committee
on Science and Technology, U.S. House of Representatives....... 14
Statement by Representative David G. Reichert, Member,
Subcommittee on Investigations and Oversight, Committee on
Science and Technology, U.S. House of Representatives.......... 12
Panel I:
Mr. John B. Stephenson, Director, Natural Resources and
Environment, Government Accountability Office
Oral Statement............................................... 15
Written Statement............................................ 16
Biography.................................................... 35
Discussion
The Revised IRIS Process....................................... 36
Did OMB Review EPA's GAO Exit Conference Comments?............. 37
The IRIS Process............................................... 42
Delayed Risk Assessments....................................... 42
Comparing Risk Assessments: EPA vs. FDA........................ 44
Risk Assessment vs. Risk Management............................ 46
GAO Recommendations............................................ 48
More on Risk Assessment vs. Risk Management.................... 50
Panel II:
Dr. George M. Gray, Assistant Administrator for Research and
Development, U.S. Environmental Protection Agency
Oral Statement............................................... 52
Written Statement............................................ 54
Biography.................................................... 57
Ms. Susan E. Dudley, Administrator, Office of Information and
Regulatory Affairs (OIRA), Office of Management and Budget
Oral Statement............................................... 58
Written Statement............................................ 59
Biography.................................................... 62
Discussion
More on EPA's GAO Exit Conference Comments..................... 63
OMB's Role in Risk Assessments................................. 64
More on the IRIS Process....................................... 64
How Transparent Is the New IRIS Process?....................... 68
Timelines for IRIS Assessments................................. 73
Appendix: Additional Material for the Record
DOD Interests in Emerging Contaminants by Tom Morehouse, Program
Advisor, Emerging Contaminants, Office of Deputy Under
Secretary of Defense (Installations & Environment), October 26,
2006........................................................... 80
Memorandum to George Gray, Assistant Administrator, ORD, from
Marcus Peacock, Deputy Administrator, United States
Environmental Protection Agency, dated April 10, 2008.......... 101
EPA's Integrated Risk Information System, Assessment Development
Procedures..................................................... 103
Toxic Communities: How EPA's IRIS Program Fails the Public
June 12, 2008
Page
Witness List..................................................... 116
Hearing Charter.................................................. 117
Opening Statements
Statement by Representative Brad Miller, Chairman, Subcommittee
on Investigations and Oversight, Committee on Science and
Technology, U.S. House of Representatives...................... 122
Written Statement............................................ 123
Statement by Representative F. James Sensenbrenner Jr., Ranking
Minority Member, Subcommittee on Investigations and Oversight,
Committee on Science and Technology, U.S. House of
Representatives................................................ 124
Written Statement............................................ 125
Prepared Statement by Representative Eddie Bernice Johnson,
Member, Subcommittee on Investigations and Oversight, Committee
on Science and Technology, U.S. House of Representatives....... 128
Witnesses:
Mr. Jerome M. Ensminger, Master Sergeant, U.S. Marine Corps
(Ret.)
Oral Statement............................................... 129
Written Statement............................................ 132
Mr. Lenny Siegel, Executive Director, The Center for Public
Environmental Oversight (CPEO)
Oral Statement............................................... 165
Written Statement............................................ 167
Biography.................................................... 188
Dr. Linda E. Greer, Director, Health Program, Natural Resources
Defense Council
Oral Statement............................................... 189
Written Statement............................................ 191
Biography.................................................... 199
Discussion
Deliberative, Interagency Decision-making...................... 199
OIRA's Role in the IRIS Process................................ 201
The IRIS Process............................................... 201
Tracking Citizen Exposure to TCE............................... 203
Science Policy................................................. 203
Assessing Cumulative Exposures................................. 205
The Agency for Toxic Substances and Disease Registry (ATSDR)... 206
The European REACH Program..................................... 209
Appendix: Additional Material for the Record
Statement by David G. Hoel, Medical University of South Carolina,
Charleston..................................................... 212
EPA'S RESTRUCTURED IRIS SYSTEM: HAVE POLLUTERS AND POLITICS OVERWHELMED
SCIENCE?
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WEDNESDAY, MAY 21, 2008
House of Representatives,
Subcommittee on Investigations and Oversight,
Committee on Science and Technology,
Washington, DC.
The Subcommittee met, pursuant to call, at 11:10 a.m., in
Room 2318 of the Rayburn House Office Building, Hon. Brad
Miller [Chairman of the Subcommittee] presiding.
hearing charter
SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
EPA's Restructured IRIS System:
Have Polluters and Politics
Overwhelmed Science?
wednesday, may 21, 2008
11:00 a.m.-1:00 p.m.
2318 rayburn house office building
The Subcommittee on Investigations and Oversight will hold the
first of two hearings on the Integrated Risk Information System (IRIS)
at the Environmental Protection Agency (EPA).
We have three excellent witnesses who can place the role of IRIS in
perspective as well as address questions regarding the Bush
Administration's evolving system to draft and review IRIS entries:
Mr. John Stephenson, Director, Natural Resources and Environment,
Government Accountability Office.
Dr. George Gray, Assistant Administrator for Research and Development,
United States Environmental Protection Agency.
Ms. Susan Dudley, Administrator, Office of Information and Regulatory
Affairs, Office of Management and Budget.
What Is IRIS and Why Does It Matter?
IRIS was established in the 1980s to provide a single source of
information on the risks associated with exposure to chemicals. The
IRIS database provides a hazard identification and dose-response
analysis, scientific information that when combined with estimates of
exposure allow regulatory agencies to produce a risk assessment.
Historically, entries to the database were the result of extensive in-
house development by the science staff at EPA, peer review processes
with experts from outside the agency, and opportunities for public
input and comment. To the degree interagency communications occurred,
they were managed by EPA (See Figure 1).
While not a regulatory product itself, IRIS is designed to help
regulators set priorities about what to regulate and inform regulators
about what level of exposure workers or communities can absorb safely.
A long-recognized principle in the U.S. approach to regulation has been
the distinction between risk assessment--the characterization of what
science tells us regarding a particular hazard--and risk management, or
what you want to do about the hazard (including choosing to do
nothing). Science can point to where regulation may be needed, but
science may not be the sole consideration in setting a regulatory
standard or approach. IRIS is designed to be a risk assessment tool.
Government officials in federal agencies, in State and county
governments and even in foreign countries, have come to rely upon IRIS
for the most reliable, most comprehensive statements on what science
tells us about the risk associated with a particular chemical.
A long-standing challenge for the IRIS database is meeting the
requests for information on the many chemicals that are manufactured
and utilized in global commerce, and updating information on chemicals
that have been previously evaluated. IRIS is loosing ground to the
torrent of new chemicals introduced to the marketplace. Approximately
700 new chemicals enter commerce each year. Those new chemicals are
added to the over 80,000 currently reported under the Toxic Substances
Control Act (TSCA) as being in the market. In addition, about one half
of the assessments on approximately 480 chemicals currently in the
database need to be updated according to EPA staff estimates. To keep
IRIS relevant would require aggressive moves to speed the production
and approval of entries. Congress has actually increased funding for
IRIS staff in recent years in an effort to address this severe backlog
(this committee supported increased funding in Chairman Boehlert's FY
2007 Views and Estimates Report to the Committee on the Budget--see
Figure 2 for a representation of the IRIS budget).
IRIS Slows to a Crawl
Instead of seeing IRIS entries spike with funding and personnel
increases, additions and updates to IRIS have slowed to a crawl (Figure
3). Only four IRIS listings have been finalized in the past two years.
In comparison, the State of Minnesota requested new or updated
assessments of 52 chemicals of concern in the 2006 solicitation for the
2007 Program.\1\
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\1\ Submission by the Minnesota Department of Health to the
Integrated Risk Information System (IRIS); Request for Chemical
Substance Nominations for the 2007 Program. Docket ID No. EPA-HQ-ORD-
2006-0950.
This outcome appears to be tied to the intervention of OMB in the
IRIS review and approval process. Beginning in 2004, OMB established a
formal system of interagency review (Figure 5). This system, ostensibly
designed to improve the quality of IRIS entries, appears to have all
but stopped IRIS entries. On April 10 of this year, EPA announced a new
IRIS review and approval system that is even more elaborate than its
predecessors (Figure 4).
It appears that any IRIS listing that is the least bit
controversial will take six years or more to be completed. The
interagency process allows agencies with a direct conflict of interest
multiple opportunities to influence the development and content of IRIS
assessments all within a process that lacks any transparency for
Congress or the public. The Department of Defense, the Department of
Energy and NASA all are responsible for pollution on the federal lands
they manage and for the health and safety of the personnel that manage
their facilities and operations. Rocket fuel, jet fuel, solvents,
munitions, nuclear waste all contain hazardous materials that can
become pollutants contaminating aquifers and air, and exposing workers
and families to real harm.
IRIS Entries Become a Political Science
EPA leadership has agreed to OMB establishing a review that gives
polluting agencies lengthy, unmonitored opportunities to try to
convince OMB that the risks of a particular substance should not be set
at a particular level. It is hard to understand what special science
expertise these other agencies bring to the table such that OMB needs
to set up an interagency review to discuss science.
Remember that the development of IRIS assessments and, the risk
assessment process generally, is supposed to be separate from the risk
management process. There you would expect interested parties,
including other federal agencies, to discuss how to manage risks by
weighing costs and benefits in a search for the best option given a
particular configuration of risk and need. IRIS is supposed to be
solely about what science says regarding health and environmental risk
associated with the listed chemicals. With 7000 scientists, and
mandated by law and appropriation to be the Nation's lead agency on
environmental science, EPA really has no peers when it comes to
understanding the science at stake in IRIS listings.
The process established on April 10 allowing agencies to discuss a
particular IRIS listing is closed to the public. Because that work
represents pre-deliberative discussions, any materials from that
process are not subject to the Freedom of Information Act. Because
these processes are managed by OMB, it will be very difficult for
Congress to learn of what is happening due to OMB's consistent
assertions that all of their work should be shielded from Congress and
the public. Whether the proposals that come out of this lengthy,
secretive process are based solely on science, or whether other
considerations held sway, would be very hard for anyone to ever prove.
IRIS is withering. It is loosing its relevance due to the sweep of
time, new science and new substances as well as its own inability to
refresh its data. The process put in place on April 10 appears
guaranteed not to improve this situation, but to make it worse. But
even if the process was somehow producing more entries, more quickly,
the integrity of the process is itself in question and that alone will
undermine the utility of the IRIS database. If policy-makers and the
public believe the science has been cooked to meet a polluter's agenda,
then they will not have confidence in the science. It is a simple
problem and one that the April 10 revision puts at center stage.
The Subcommittee hopes to explore these issues with witnesses on
Wednesday morning.
The Minnesota Department of Health Submission to the Integrated Risk
Information System (IRIS); Request for Chemical Substance Nominations
for 2007 Program (Docket ID No. EPA-HQ-ORD-2006-0950)
The Health Risk Assessment staff at the Minnesota Department of
Health wish to nominate a list of chemicals to be included in the
Integrated Risk Information System (IRIS); Request for Chemical
Substance Nomination for 2007 Program. These chemicals are of concern
to the Minnesota Department of Health because they are among
contaminants found in Minnesota groundwater. In Minnesota, health-based
values are derived for such contaminants. When conducting risk
assessments, the Minnesota Department of Health has relied upon the
IRIS summaries as a resource for the development of these health
protective values. Therefore, it is our hope that you take our
nominated chemicals in consideration. By obtaining IRIS summaries of
these chemicals it will result in a more thorough and accurate risk
assessment process.
1,2,3--Trichloropropane
1--Methylnaphtalene
1--Methylphenol
2,2--Dichloropropane
2,3,4,5--Tetrachlorophenol
2,3,5,6--Tetrachloroterephthalic acid
2,6--dinitrotoluene
2,6--diethylaniline (Alchlor degradate)
2--Nitrophenol
3,5--Dichlorophenol
4--Isopropyl toluene
Acetochlor ESA
Acetochlor OA
Alachlor ESA (degradate of Alachlor)
Alachlor OA (degradate of Alachlor)
Aluminum
Deaminated diketomethribuzin (degradate of Metribuzin)
Deaminated metribuzin (degradate of Metribuzin)
Deethylatrazine (degradate of Atrazine and Propazine)
Deisopropylatrazine (degradate of Atrazine, Cyanazine and Simazine)
Diallate
Diazion
Dichlorofluoromethane
Diketometribuzin (degradate of Metribuzin)
Dimethenamid
Dimethenamid ESA (degradate of Demethenamid)
Dimethenamid OXA (degradate of Dimethenamid)
Ethafluralin
Hydroxyatrazine
Iron
Isopropyl ether
Isoxaflutole
Lithium
Metolachlor ESA
Metsulfuron-methyl (Ally)
Monomethyl tetrachloroterephthalic acid
n-Butylbenzene
Nicosulfuron
n-Propylbenzene
Primisulfuron-methyl (Beacon)
Radionuclides (all)
Sec-Butylbenzene
Sodium
Thifensulfuron methyl
Tin
Total petroleum hydrocarbons
Tribenuron-methyl
Triclopyr
Trinitro-phenylmethylnitramine
Triphenyltin hydroxide
Vanadium
In addition, the Minnesota Department of Health currently needs and
uses reference concentrations and reference doses for less than chronic
periods of exposure to assess risks from a variety of exposure
scenarios. These scenarios include less than chronic exposures that
commonly occur at contaminated sites resulting in the need for less
than chronic toxicity values to assess current risks. The EPA 2002 ``A
review of the reference dose and reference concentration processes''
has guided much of the practice of the Department in this area.
The Department has found that health effects that result from less
than chronic periods of exposure, when combined with high drinking
water exposures associated with specific life stages (e.g., childhood),
result in drinking water values that are lower and therefore more
appropriate as drinking water standards for the general population than
the value calculated using a chronic reference dose and lifetime
average dose. As a result, the Department is very interested in recent
efforts by IRIS to develop less than lifetime reference values, and
urges the EPA to continue to develop and publish these analyses. The
Department also urges the EPA to consider the potential that effects
observed in chronic studies result from early exposures rather than
continuous exposure. To the extent that studies are available; the
Department urges the EPA to present acute, short-term, longer-term, and
chronic evaluations (recommendations for critical studies for each and
resulting reference doses) for each chemical that undergoes review in
the future.
Chairman Miller. Good morning. This hearing will now come
to order.
More than 80,000 chemicals are now in use, and another 700
new chemicals enter the marketplace each year. Americans need
an efficient system to evaluate the risk to public health and
the environment of chemicals on a regular basis and to have
ready access to that information. That is the mission of the
Integrated Risk Information System, or IRIS, but IRIS now has
evaluations of only about 480 chemicals.
In recent years, IRIS's assessments have not been the open
discussions among scientists we associate with scientific peer
review but have become a secretive process managed by OMB.
OMB's mission does not include scientific analysis, nor does
OMB appear to have the expertise to perform such work. As a
result of OMB's control of IRIS evaluation procedures, however,
four chemicals have been listed by IRIS in the last two fiscal
years. EPA scientists produced 15 or so assessments in each of
those years, but the assessments disappeared into an abyss of
elaborate, endless reviews, mostly behind closed doors. A
weighing of the need for assessments against the productivity
under IRIS appears to show that the system is fundamentally
broken and in desperate need of reform.
Instead, EPA and OMB appear intent upon choking
productivity under IRIS further still and depriving the
assessments of what credibility they have left. Just last
month, EPA unveiled its new process for developing and
reviewing IRIS assessments. The solution offered by EPA and OMB
is to take an already-broken system and to make it more
convoluted, more secretive, and more suspect.
The new system establishes an interagency process that
gives polluting agencies even more opportunity than they had
before to slow walk the IRIS process to avoid the consequences
of their own conduct. With the new process announced April 10,
we may view two new entries a year as the golden era of IRIS
assessments. As GAO will testify this morning, it is highly
likely that no new chemical entry that is the least bit
controversial will ever come out of this system in less than
six years and probably more like eight years.
If the goal of the IRIS review process is to produce new
IRIS entries, this system, designed by OMB and dutifully
blessed by EPA's leadership, would be judged an abysmal
failure. However, if the goal is to avoid new IRIS entries, or
at least troublesome, inconvenient entries, this new system
should perform beautifully. It effectively kills IRIS without
honestly acknowledging that intent.
How does it kill IRIS?
Any new entry or revision that will make it into IRIS will
be of very dubious reliability. Any entries that make it into
IRIS will emerge from a largely secretive process that allows
polluters to urge EPA to shift its science so that it is
acceptable to the polluting agencies. The public will never
have confidence that EPA stood firm on scientific principle or
fought off the combined forces of OMB, the Department of
Defense, the Department of Energy, or any other agencies that
may have a desire to avoid cleaning up their practices or their
messes. If the science appears to have been reworked behind
closed doors to protect the interests of polluters, at the
instance of polluters, who can believe the science?
The Office of Information and Regulatory Affairs, OIRA, at
OMB say that they are just managing an interagency process.
That is a fiction. EPA is the agency that Congress directed in
statute to do environmental science and charged with protecting
public health and the environment. EPA is given billions of
dollars a year in tax funds to carry out that research and
regulatory work.
There is no need for the secretive interagency process that
OMB is requiring. The Department of Defense and National
Aeronautics and Space Administration, the Department of Energy
have entirely different missions and entirely different areas
of expertise. Their interest in IRIS is that of an agency using
the very chemicals that are being evaluated, not of a
scientific agency making decisions based upon science. OMB is
using that interagency process to undermine IRIS's integrity
and take it away from EPA's control.
EPA says that this really is their process, honest. They
control it and are happy with it, but it is headed by political
appointees. Dr. Gray is a political appointee. His testimony
has been vetted and approved by OMB. EPA's official response
even to the GAO report we will hear today was vetted and
approved by OMB. And no IRIS entry can go forward without OMB
approval.
The Oversight and Government Reform Committee this week,
just yesterday, held a hearing and issued a report that
demonstrates the degree to which the White House has controlled
the opinions of the EPA scientists on regulatory matters. With
IRIS, we see that even in the realm of science, before policy
should have a role, before economic consideration should have a
role, EPA appears to follow the dictates of OMB. Thousands of
career scientists must answer to political appointees without
scientific expertise not about how to manage risk, whether risk
management measures are justified by the economic costs, but
about what risks chemicals pose to public health and to the
environment in the first place, a question in which political
considerations should have no role.
Whatever your personal views of motive or intent by the
EPA, the political leadership of the EPA, or by OMB, I hope
almost everyone would agree that two new entries a year when
700 chemicals are entering the marketplace every year, is just
not acceptable. I look forward to GAO's testimony today for
offering advice to Congress on how to make IRIS relevant again
and responsive to the needs of the American public again and
not just to agencies that are using chemicals and do not want
to be disturbed, do not want to be inconvenienced, and their
friends at OIRA.
[The prepared statement of Chairman Miller follows:]
Prepared Statement of Chairman Brad Miller
More than 80,000 chemicals are now in use, and another 700 new
chemicals enter the marketplace each year. Americans need an efficient
system to evaluate the risk to public health and the environment of
chemicals on a regular basis and have ready access to that information.
That is the mission of the Integrated Risk Information System, or IRIS,
but IRIS now has evaluations of only about 480 chemicals.
In recent years, IRIS' assessments have not been the open
discussions among scientists we associate with scientific peer review,
but has become a secretive process managed by OMB. OMB's mission does
not include scientific analysis, nor does OMB appear be have the
expertise to perform such work. As a result of OMB's control of IRIS
evaluation procedures, four chemicals have been listed on IRIS in the
last two fiscal years. EPA scientists produced 15 or so assessments in
each of these years, but the assessments disappeared into an elaborate,
endless series of reviews, mostly behind closed doors. A weighing of
the need for assessments against the productivity under IRIS, appears
to show that the system is fundamentally broken and cries out for
reform.
Instead, EPA and OMB appear intent upon choking productivity under
IRIS further still, and depriving the assessments of their remaining
credibility. Just last month, EPA unveiled its new process for
developing and reviewing IRIS assessments. The solution offered by EPA
and OMB is to take a broken system and to make it more convoluted,
secretive and suspect.
The new system establishes an interagency process that gives
polluting agencies even more opportunity than they had before to slow
walk the IRIS process to avoid the consequences of their own conduct.
With the new process announced April 10, we may view two new entries a
year as the golden era of IRIS assessments. As GAO will testify, it is
highly likely that no new chemical entry that is the least bit
controversial will ever come out of this system in less than six years,
and probably eight years.
If the goal of the IRIS review process was to produce new IRIS
entries, this system--designed at OMB and dutifully blessed by EPA's
leadership--would be judged an abysmal failure. However, if the goal is
to avoid new IRIS entries, or at least troublesome entries, then this
new system should perform beautifully. It effectively kills IRIS
without honestly acknowledging that purpose.
How does it kill IRIS?
Any new entries or revisions that make it into IRIS will be of
dubious reliability. Any entries that make it into IRIS will emerge
from a largely secretive process that allows polluters to urge EPA to
shift its science so that it is acceptable to the polluting agencies.
The public will never have confidence that EPA stood firm on scientific
principle, and fought off the combined forces of OMB, the Department of
Defense, the Department of Energy or any other agencies that may have a
desire to avoid cleaning up their practices or their messes. If the
science appears to have been reworked behind closed doors to protect
the interests of polluters, who can believe the science?
The Office of Information and Regulatory Affairs at OMB say that
they are just managing an interagency process. That is a fiction. EPA
is the agency that Congress directed in statute to do environmental
science and charged with protecting public health and the environment.
EPA is given billions of dollars to carry out that research and
regulatory work.
There is no need for the secret interagency process that OMB is
mandating. The Department of Defense, the National Aeronautics and
Space Administration and the Department of Energy have entirely
different missions and entirely different areas of expertise. Their
interest in IRIS is that of a polluter, not of a science agency. OMB is
using this interagency process to subvert the IRIS process and take it
away from EPA's control.
EPA will say this is really their process--honest--they control it
and are happy with it. Dr. Gray is a political appointee of the
Administration. His testimony has been vetted and approved by OMB.
EPA's official response to the GAO report we will hear about today was
vetted and approved by OMB. And no IRIS entry can go forward without
OMB approval.
The Oversight and Government Reform Committee this week held a
hearing and issued a report that demonstrates the degree to which the
White House has controlled the ``opinions'' of EPA on regulatory
matters. With IRIS, we see that even in the realm of science, EPA
appears to follow the dictates of OMB. Thousands of career scientists
must answer to political appointees without scientific expertise not
about how to manage risk, whether risk management measures are
justified by the costs, but about what risks chemicals pose to public
health and to the environment, a question in which political
considerations should play no part.
Whatever your personal views of motive or intent of EPA or OMB, I
think almost everyone would agree that just two new entries a year is
simply not acceptable. I look forward to GAO's testimony today for
offering advice to Congress on how to make IRIS relevant and responsive
to the needs of the American public and not just a handful of polluters
and their friends at OIRA.
Chairman Miller. At this time I would like to recognize Mr.
Reichert of Washington who is sitting in for Mr. Sensenbrenner
of Wisconsin.
Mr. Reichert. Thank you, Mr. Chairman. I ask unanimous
consent to submit a statement from Ranking Member Sensenbrenner
and a memo from the EPA into the Committee records.
Chairman Miller. Without objection.
Mr. Reichert. I yield back.
[The prepared statement of Mr. Sensenbrenner follows:]
Prepared Statement of Representative F. James Sensenbrenner Jr.
The Integrated Risk Information System (IRIS) process was
originally developed for a specific task. Different offices throughout
the Environmental Protection Agency (EPA) were relying on different
assessments of the health effects of chronic exposure to toxic
chemicals. IRIS was intended to establish a uniform database within
EPA.
Over time, however, IRIS became an authoritative resource on
chemical toxicity. Other agencies, states, the international community,
and industries increasingly began to rely on IRIS, and the assessments
took on increased importance. These outside groups have sought to
impact a process that was not initially designed to handle external
pressures. The result has been an IRIS process that has effectively
broken down.
The Government Accountability Office (GAO) recently issued a
scathing condemnation of the current state of the IRIS program. The
report's title, Low Productivity and New Interagency Review Process
Limit the Usefulness and Credibility of EPA's Integrated Risk
Information System, accurately sums up GAO's findings. But IRIS' actual
production numbers are worse. EPA currently has a backlog of 70 ongoing
assessments and has managed to complete only two assessments in each of
the last two years. At the current pace, it will take 35 years for EPA
to finish its current backlog.
EPA has attempted to develop a uniform process for IRIS
assessments. The agency argues that it can expedite the IRIS process by
involving other agencies earlier in the process. While preventing last
minute delays is an important reform, the ability of other agencies to
extend the timeframe of assessments should be sharply limited. Data
gaps in risk assessments will always exist as better science is always
developing. EPA needs to limit the timeframe of assessments to prevent
other agencies from indefinitely delaying the process.
EPA must balance its need to complete assessments with the rights
of interested parties to comment. The best way to achieve this balance
would be to give more notice of its assessments. EPA already publishes
an annual agenda of the chemical it intends to assess in the Federal
Register. If EPA moves the date of that publication forward, providing
more notice, interested parties will have a longer period to comment on
what they deem to be insufficiencies in the scientific record. During
this comment period, EPA can focus on its backlog. Because it offered a
comment period, EPA can then fairly limit the ability of outside
parties to delay assessments once they are underway. The result would
be a more efficient process that preserves taxpayers' money and
promotes public health.
I urge EPA to consider these proposals, because IRIS must be fixed.
In April, this subcommittee held a hearing on formaldehyde levels in
trailers provided to the victims of Hurricane Katrina. In that hearing,
we investigated how the Agency for Toxic Substances and Disease
Registry struggled to identify the proper ``level of concern'' for
long-term exposure to formaldehyde. EPA determined its formaldehyde
assessment was outdated in 1997, but eleven years later, that
assessment is still incomplete. These hurricane victims are the real
world result of EPA's bureaucratic failures.
[The prepared statement of Mr. Costello follows:]
Prepared Statement of Representative Jerry F. Costello
Mr. Chairman, I appreciate the Subcommittee's attention to this
important matter. The role of the Environmental Protection Agency's
(EPA) IRIS program cannot be understated. Created in the 1980s, the
program is a primary resource for information on the risks associated
to exposure of chemicals. Government officials, State and local
governments and many scientists have come to rely on the comprehensive
analysis completed by the IRIS program.
However, the rate at which information requests have been processed
over the years is troubling. Recent revisions to the program have
received conflicting reviews as to whether these steps will increase
productivity or continue to slow the process further. A March 2008 GAO
report concluded that the IRIS database is at serious risk of becoming
incomplete because EPA has not been able to routinely complete timely,
credible assessments or decrease its backlog of 70 ongoing assessments.
That a total of four assessments were completed over the course of
fiscal years 2006 and 2007 is unacceptable.
I look forward to hearing our witnesses' testimony today and
working with my colleagues on the Committee to improve and increase
efficiency within this important program. Thank you, Mr. Chairman, I
yield back.
[The prepared statement of Ms. Johnson follows:]
Prepared Statement of Representative Eddie Bernice Johnson
Thank you, Mr. Chairman. The mission of the Environmental
Protection Agency is to protect both environmental quality and human
health through effective regulations and other policy implementation.
What is confounding to me, regarding the Integrated Risk
Information System, is why only four IRIS listings have been finalized
in the past two years.
After all, approximately 700 new chemicals enter commerce each
year. There are more than 80,000 chemicals reported under the Toxic
Substances Control Act as being in the market.
It seems implausible to me that only four chemicals should be
investigated to completion and published in the IRIS database at E.P.A.
The Government Accountability Office report, published in March
2008, concluded that, ``the IRIS database is at serious risk of
becoming obsolete because E.P.A. has not been able to routinely
complete timely, credible assessments or decrease its backlog of 70
ongoing assessments.''
The statement of George M. Gray, Ph.D., who is Assistant
Administrator for Research and Development at E.P.A., explains that
IRIS began as ``an internal E.P.A. resource.''
Even if that explanation is true, then why would E.P.A. compile
only four IRIS listings in the past two years?
It makes me question what E.P.A. is doing, when it comes to
chemical toxicity and public health.
Dr. Gray's statement also says that the risk assessment process
``consists of both `science' and `science policy' components.''
It goes on to say that, ``although there are some instances at
E.P.A. where `pure science' is involved, . . . much of the work done at
E.P.A. . . . involves both science and science policy. . . .Due to the
uncertainty in IRIS assessments, judgments and choices must be made
about the most appropriate assumptions . . . to use in deriving
toxicity data.''
Mr. Chairman, I chafe at this testimony.
These statements insult the scientific community that publishes
data on these matters. They also insult the talented scientists who are
working at E.P.A., who are perfectly capable of interpreting peer-
reviewed literature and making public health decisions.
This subcommittee has concerns that the IRIS system has become
politicized, when it should be based solely on scientific facts
regarding health and environmental risk associated with the listed
chemicals.
Although I understand that E.P.A. is making moves to re-evaluate
the IRIS System, there are only so many patches that may be placed on a
sinking ship.
For me, what is truly sinking is the feeling I get when I consider
the good scientists who have dedicated their entire careers to
environmental safety at E.P.A. I suspect that those who remain must be
frustrated at this gross politicization of science and wide scale
destruction of our environment.
Mr. Chairman, you will know that I have a near-perfect voting
record with environmental groups, and I will be swift to act, should I
see a way to rectify the situation.
Thank you, and I yield back the remainder of my time.
Panel I:
Chairman Miller. It is now my pleasure to introduce our
witnesses today. Mr. John Stephenson is the Director of Natural
Resources and Environment Division at the Government
Accountability Office, which just released a report on IRIS's
new interagency review process. Mr. Stephenson, you will have
five minutes for your spoken testimony. Your written testimony
will be included in the record for the hearing. When you
complete your testimony, we will begin with questions, and each
Member will have five minutes to question you. It is a practice
of the Subcommittee to take testimony under oath. Do you object
to swearing an oath?
Mr. Stephenson. No.
Chairman Miller. Please stand and raise your right hand. Do
you swear to tell the truth and nothing but the truth?
Mr. Stephenson. I do.
Chairman Miller. Mr. Stephenson, the Committee also
provides that you may be represented by counsel. Are you
represented by counsel at today's hearings?
Mr. Stephenson. I am not.
Chairman Miller. Then Mr. Stephenson, please begin.
TESTIMONY OF MR. JOHN B. STEPHENSON, DIRECTOR, NATURAL
RESOURCES AND ENVIRONMENT, GOVERNMENT ACCOUNTABILITY OFFICE
Mr. Stephenson. Thank you, Mr. Chairman, and other Members
of the Committee. I am here today to discuss our recently
issued report on IRIS, a database that contains the scientific
position on health effects of exposure to more than 540 toxic
chemicals. IRIS is a critical component of EPA's capacity to
support scientifically sound environmental decisions, policies,
and regulations. Our March 2008 report concluded that the IRIS
database is at serious risk of becoming obsolete because EPA
has not been able to complete timely, credible assessments or
decrease its back-load of 70 ongoing assessments. In summary,
we found that EPA efforts to improve IRIS since 2000 have been
thwarted by a combination of factors including OMB interagency
reviews, EPA decisions to delay assessments to wait for new
research or additional uncertainty analysis, and the
compounding effect of continuous delays.
The two new OMB interagency reviews involve other federal
agencies in a manner that limits the credibility of IRIS
assessment and hinders EPA's ability to manage them. In
addition, OMB is inserting itself into the decision-making
process by, for example, requiring EPA to terminate five
assessments EPA's own office of theirs said that it needed to
implement the Clean Air Act. The effect of all of these changes
to what should be a scientific process is that chemicals remain
in the assessment phase indefinitely, and few assessments are
ever finalized. Indeed, EPA staff have prepared over 32 draft
assessments of toxic chemicals in the past two years, yet only
four have been finalized.
Our report includes eight specific recommendations for
streamlining the IRIS program, improving the transparency and
credibility of the assessments, and ensuring that EPA has the
requisite independence to achieve its goals, recommendations
that EPA in February agreed to consider before finalizing the
IRIS process. However, EPA released its final IRIS process on
April 10th as you mentioned, and instead of seeking public
comment, as OMB promised in responding to our report, made it
effective immediately. To say that we are disappointed is a
gross understatement. The new IRIS process is not responsive to
our recommendations and is in many respects worse than the
draft we reviewed. For example, the draft process would have
made comments from other federal agencies part of the public
record. However, the new process expressly defined such
comments as deliberative, excluding them from the public
record. EPA's position that the IRIS process is transparent
because final assessments must undergo public and external peer
review is ludicrous. Transparency at a late stage after OMB and
other federal agencies have had multiple opportunities to
influence the content of the assessment without any disclosure
of their input does not compensate for its absence earlier.
In addition, the estimated timeframes under the new process
will likely perpetuate the cycle of delays and exacerbate the
problems we identified in our report and sought to address with
our recommendations, all of which were aimed at preserving the
viability of this critical database which is integral to EPA's
mission of protecting the public health from exposure to toxic
chemicals. Instead of significantly streamlining IRIS, EPA has
institutionalized an assessment process from the outset that
will take 6 to 8 years to complete.
We all understand that science regarding the toxicity of a
given chemical is never perfect, but at some point EPA must
complete assessments so that it can take the next step of
exploring what regulatory options are appropriate for
protecting human health. My testimony includes several examples
of dangerous chemicals that are stuck in the endless loop of
assessment and reassessment. I would like to summarize just one
very quickly.
In 1998, EPA initiated a toxic risk assessment of
trichloroethylene, a degreasing agent used widely by the
Department of Defense and others. Numerous studies have linked
TCE to cancer and birth defects over the last decade. EPA
completed a draft risk assessment in 2001 which was then peer
reviewed by the science advisory board and released for public
comment. During the comment process, questions were raised
about the assessment by DOD and others that led to a request
for the National Academies of Science to review it in 2004. In
2006, the Academies concluded that the weight of evidence of
cancer from TCE had actually strengthened since EPA's 2001
assessment. Nevertheless, after more than 10 years, TCE is back
at the draft development stage, and the public continues to be
exposed to this dangerous chemical. EPA estimates that its
final assessment will not be completed until 2010. In
frustration, five Senators, spurred by the TCE contamination in
the drinking water at Camp Lejeune, North Carolina, introduced
a bill last year that would require EPA to complete its risk
assessment and issue a drinking water standard within 18
months.
Mr. Chairman, IRIS is a critical process that is clearly
broken and needs to be fixed. We believe that the Congress
should consider directing EPA to suspend implementation of its
new process and develop one that is transparent and otherwise
responsive to our recommendations. If EPA is unable or
unwilling to take the steps necessary to improve this critical
program, we believe that other approaches including legislative
action may be needed.
That concludes my comments, and I will be happy to take
questions.
[The prepared statement of Mr. Stephenson follows:]
Prepared Statement of John B. Stephenson
Mr. Chairman and Members of the Subcommittee:
I am pleased to be here today to discuss issues associated with the
Environmental Protection Agency's (EPA) Integrated Risk Information
System (IRIS)--one of the most significant tools that EPA has developed
to effectively support its mission of protecting people and the
environment from harmful chemical exposures. IRIS contains EPA's
scientific position on the potential human health effects that may
result from exposure to more than 540 chemicals in the environment and
is a critical component of EPA's capacity to support scientifically
sound risk management decisions, policies, and regulations. IRIS is
also relied upon by State and local environmental programs and some
international regulatory bodies for managing their environmental
protection programs. As shown in Figure 1, the toxicity assessments in
the IRIS database fulfill the first two critical steps of the four-step
risk assessment process--providing hazard identification and
quantitative dose-response assessments. IRIS information can then be
used with the results of exposure assessments (typically conducted by
EPA's program or regional offices) to provide an overall
characterization of the public health risks for a given chemical in a
given situation. The development of health risk assessments is thus
directly dependent on the development of toxicity assessments such as
those developed in the IRIS program.
Under the National Academies' risk assessment and risk management
paradigm, policy considerations are relevant in the risk management
phase, which occurs after the risk assessment phase.\1\ With risk
assessment information, decision-makers can make informed risk
management decisions on how to protect public health, reflecting other
important data and considerations, such as the costs and benefits of
mitigating identified risks, the technological feasibility of managing
risks, and the concerns of various stakeholders. Examples of risk
management decisions include deciding how much of a chemical a company
may discharge into a river, determining the extent to which a hazardous
waste site must be cleaned up, and setting allowable levels of
contamination in drinking water.
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\1\ The National Academies comprises four organizations: the
National Academy of Sciences, the National Academy of Engineering, the
Institute of Medicine, and the National Research Council.
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Thus, although IRIS assessments are not regulatory in nature, the
quantitative IRIS values may influence many risk management decisions
and serve as a basis for regulatory consideration. However, EPA's
productivity in finalizing IRIS assessments is poor, and EPA has a
significant backlog of incomplete IRIS assessments and a growing number
of outdated assessments. Importantly, EPA has not been able to complete
assessments of key chemicals of concern to public health, including
dioxin, formaldehyde, trichloroethylene (TCE), naphthalene, and
tetrachloroethylene (perc) (see Appendix I).
In this context, my testimony today discusses (1) highlights of our
March 2008 report, Chemical Assessments: Low Productivity and New
Interagency Review Process Limit the Usefulness and Credibility of
EPA's Integrated Risk Information System\2\ and (2) key aspects of
EPA's revised IRIS assessment process, released on April 10, 2008. For
our March 2008 report, we examined the outcome of steps EPA has taken
to ensure that IRIS contains current, credible chemical risk
information; to address the backlog of ongoing assessments; and to
respond to new requirements from the Office of Management and Budget
(OMB). We also examined the potential effects of planned changes to the
IRIS assessment process on EPA's ability to ensure that IRIS provides
current, credible risk information. In conducting our work, we obtained
and analyzed information on EPA's productivity and the resources
provided to the program for fiscal years 2000 through 2007, user needs,
and EPA's assessment completion goals. We also interviewed EPA's
National Center for Environmental Assessment officials who manage the
IRIS assessment program; officials from other EPA program offices and
federal science and health agencies involved in the IRIS assessment
process; and officials from the Department of Defense, the Department
of Energy (DOE), the National Aeronautics and Space Administration
(NASA), and OMB. For this testimony, we supplemented our report with a
review of the IRIS assessment process that EPA released on April 10,
2008. We conducted this work from May 7 to May 21, 2008, in accordance
with generally accepted government auditing standards. Those standards
require that we plan and perform the audit to obtain sufficient,
appropriate evidence to provide a reasonable basis for our findings and
conclusions based on our audit objectives. We believe that the evidence
obtained provides a reasonable basis for our findings and conclusions
based on our audit objectives.
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\2\ GAO-08-440 (Washington, D.C.: Mar. 7, 2008).
Background
IRIS was created in 1985 to help EPA develop consensus opinions
within the agency about the health effects of chronic exposure to
chemicals. Its importance has increased over time as EPA program
offices and the states have increasingly relied on IRIS information in
making environmental protection decisions. Currently, the IRIS database
contains assessments of more than 540 chemicals. According to EPA,
national and international users access the IRIS database approximately
nine million times a year. EPA's Assistant Administrator for the Office
of Research and Development has described IRIS as the premier national
and international source for qualitative and quantitative chemical risk
information; other federal agencies have noted that IRIS data are
widely accepted by all levels of government across the country for
application of public health policy, providing benefits such as
uniform, standardized methods for toxicology testing and risk
assessment, as well as uniform toxicity values. Similarly, a private-
sector risk assessment expert has stated that the IRIS database has
become the most important source of regulatory toxicity values for use
across EPA's programs and is also widely used across State programs and
internationally.
Historically and currently, the focus of IRIS toxicity assessments
has been on the potential health effects of long-term (chronic)
exposure to chemicals. According to OMB, EPA is the only federal agency
that develops qualitative and quantitative assessments of both cancer
and non-cancer risks of exposure to chemicals, and EPA does so largely
under the IRIS program. Other federal agencies develop quantitative
estimates of non-cancer effects or qualitative cancer assessments of
exposure to chemicals in the environment. While these latter
assessments provide information on the effects of long-term exposures
to chemicals, they provide only qualitative assessments of cancer risks
(known human carcinogen, likely human carcinogen, etc.) and not
quantitative estimates of cancer potency, which are required to conduct
quantitative risk assessments.
EPA's IRIS assessment process has undergone a number of formal and
informal changes during the past several years. While the process used
to develop IRIS chemical assessments includes numerous individual steps
or activities, major assessment steps include (1) a review of the
scientific literature; (2) preparation of a draft IRIS assessment; (3)
internal EPA reviews of draft assessments; (4) two OMB/interagency
reviews, managed by OMB, that provide input from OMB as well as from
other federal agencies, including those that may be affected by the
IRIS assessments if they lead to regulatory or other actions; (5) an
independent peer review conducted by a panel of experts; and (6) the
completion of a final assessment that is posted to the IRIS web site.
Unlike many other EPA programs that have statutory requirements,
including specific time frames for completing mandated tasks, the IRIS
program is not subject to statutory requirements or timeframes. In
contrast, the Department of Human Health and Services' Agency for Toxic
Substances and Disease Registry (ATSDR), which develops quantitative
estimates of the non-cancer effects of exposures to chemicals in the
environment, is statutorily required to complete its assessments within
certain timeframes.
Findings and Recommendations from Our March 2008 Report on the
Productivity and Credibility of EPA's Integrated
Risk Information System
The IRIS database is at serious risk of becoming obsolete because
the agency has not been able to routinely complete timely, credible
assessments or decrease a backlog of 70 ongoing assessments.
Specifically, although EPA has taken important steps to improve the
IRIS program and productivity since 2000 and has developed a number of
draft assessments for external review, its efforts to finalize the
assessments have been thwarted by a combination of factors including
the imposition of external requirements, the growing complexity and
scope of risk assessments, and certain EPA management decisions. In
addition, the changes to the IRIS assessment process that EPA was
considering at the time of our review would have added to the already
unacceptable level of delays in completing IRIS assessments and further
limited the credibility of the assessments.
EPA's Efforts to Improve the IRIS Assessment Program Have Not Produced
the Desired Results
EPA has taken a number of steps to help ensure that IRIS contains
current, credible chemical risk information; to address its backlog of
ongoing assessments; and to respond to new OMB requirements. However,
to date, these changes--including increasing funding, centralizing
staff conducting assessments, and revising the assessment process--have
not enabled EPA to routinely complete credible IRIS assessments or
decrease the backlog. That is, although EPA sent 32 draft assessments
for external review in fiscal years 2006 and 2007, the agency finalized
only four IRIS assessments during this time (see Fig. 2).
Several key factors have contributed to EPA's inability to achieve
a level of productivity that is needed to sustain the IRIS program and
database: new OMB-required reviews of IRIS assessments by OMB and other
federal agencies; the growing complexity and scope of risk assessments;
certain EPA management decisions and issues, including delaying
completion of some assessments to await new research or to develop
enhanced analyses of uncertainty in the assessments; and the
compounding effect of delays. Regarding the last factor, even a single
delay in the assessment process can lead to the need to essentially
repeat the assessment process to take into account changes in science
and methodologies.
A variety of delays have impacted the majority of the 70
assessments being conducted as of December 2007--48 had been in process
for more than five years, and 12 of those for more than nine years.
These time frames are problematic because of the substantial rework
such cases often require to take into account changing science and
methodologies before they can be completed. For example, EPA's
assessment of the cancer risks stemming from exposure to naphthalene--a
chemical used in jet fuel and in the production of widely used
commercial products such as moth balls, dyes, insecticides, and
plasticizers--was nearing completion in 2006. However, prior to
finalizing this assessment, which had been ongoing for over four years,
EPA decided that the existing non-cancer assessment had become outdated
and essentially restarted the assessment to include both cancer and
non-cancer effects. As a result, six years after the naphthalene
assessment began, it is now back at the drafting stage. The assessment
now will need to reflect relevant research completed since the draft
underwent initial external peer review in 2004, and it will have to
undergo all of the IRIS assessment steps again, including the
additional internal and external reviews that are now required (see
Appendix I).
Further, because EPA staff time continues to be dedicated to
completing assessments in the backlog, EPA's ability to both keep the
more than 540 existing assessments up to date and initiate new
assessments is limited. Importantly, EPA program offices and State and
local entities have requested assessments of hundreds of chemicals not
yet in IRIS, and EPA data as of 2003 indicated that the assessments of
287 chemicals in the database may be outdated--that is, new information
could change the risk estimates currently in IRIS or enable EPA to
develop additional risk estimates for chemicals in the database (for
example, developing a cancer potency estimate for assessments with only
non-cancer estimates). In addition, because EPA's 2003 data are now
more than four years old, it is likely that more assessments may be
outdated now.
The consequences of not having current, credible IRIS information
can be significant. EPA's inability to complete its assessment of
formaldehyde, which the agency initiated in 1997 to update information
already in IRIS on the chemical, has had a significant impact on EPA's
air toxics program. Although in 2003 and 2004, the National Cancer
Institute and the National Institute of Occupational Safety and Health
(NIOSH) had released updates to major epidemiological studies of
industrial workers that showed a relationship between formaldehyde and
certain cancers, including leukemia, EPA did not move forward to
finalize an IRIS assessment incorporating these important data.
Instead, EPA opted to await the results of another update to the
National Cancer Institute study. While this additional research was
originally estimated to take, at most, 18 months to complete, at the
time of our report (more than three years later) the update was not
complete. In the absence of this information, EPA's Office of Air and
Radiation decided to use risk information developed by an industry-
funded organization--the CIIT Centers for Health Research--for a
national emissions standard. This decision was a factor in EPA
exempting certain facilities with formaldehyde emissions from the
national emissions standard. The CIIT risk estimate indicates a potency
about 2,400 times lower than the estimate in IRIS that was being re-
evaluated and that did not yet consider the 2003 and 2004 National
Cancer Institute and NIOSH epidemiological studies. According to an EPA
official, an IRIS cancer risk factor based on the 2003 and 2004
National Cancer Institute and NIOSH studies would likely be close to
the current IRIS assessment, which EPA has been reevaluating since
1997. The discrepancy between these two risk estimates raises concerns
about whether the public health is adequately protected in the absence
of current IRIS information. For example, in 1999, EPA published a
national assessment that provided information about the types and
amounts of air toxics to which people are exposed. The assessment,
which also used the CIIT risk estimate for formaldehyde, concluded, for
example, that formaldehyde did not contribute significantly to the
overall cancer risk in the State of New Jersey. However, in carrying
out its own risk assessment on formaldehyde, the New Jersey Department
of Environmental Protection opted to use the risk information that is
currently in IRIS (dating back to 1991) and found that the contribution
from formaldehyde to overall cancer risk in New Jersey is quite
significant, second only to diesel particulate matter. (Appendix I
provides additional information on EPA's IRIS assessment for
formaldehyde.)
One of the factors that has contributed to EPA's inability to
complete assessments in a timely manner--the new OMB-directed OMB/
interagency review process--also limits the credibility of the
assessments because it lacks transparency. Specifically, neither the
comments nor the changes EPA makes to the scientific IRIS assessments
in response to the comments made by OMB and other federal agencies,
including those whose workload and resource levels could be affected by
the assessments, are disclosed. In addition, the OMB/interagency
reviews have hindered EPA's ability to independently manage its IRIS
assessments. For example, without communicating its rationale for doing
so, OMB directed EPA to terminate five IRIS assessments that for the
first time addressed acute, rather than chronic exposure--even though
EPA initiated this type of assessment to help it implement the Clean
Air Act.
The Expansion of Agencies' Roles in IRIS Assessments That EPA Was
Considering at the Time of Our Review Would Have Caused Further
Delays and Limited the Assessments' Credibility
For our March 2008 report, we reviewed the additional assessment
process changes EPA was planning and concluded that they would likely
exacerbate delays in completing IRIS assessments and further affect
their credibility. Specifically, despite the OMB/interagency review
process that OMB required EPA to incorporate into the IRIS assessment
process in 2005, certain federal agencies continued to believe they
should have greater and more formal roles in EPA's development of IRIS
assessments. Consequently, EPA had been working for several years to
establish a formal IRIS assessment process that would further expand
the role of federal agencies in the process--including agencies such as
DOD, which could be affected by the outcome of IRIS assessments. For
example, some of these agencies and their contractors could face
increased cleanup costs and other legal liabilities if EPA issued an
IRIS assessment for a chemical that resulted in a decision to regulate
the chemical to protect the public. In addition, the agencies could be
required to, for example, redesign systems and processes to eliminate
hazardous materials; develop material substitutes; and improve personal
protective clothing, equipment, and procedures. Under the changes that
EPA was planning at the time of our review, these potentially affected
agencies would have the opportunity to be involved, or provide some
form of input, at almost every step of EPA's IRIS assessment process.
Most significantly, the changes would have provided federal agencies,
including those facing potential regulatory liability, with several
opportunities during the IRIS assessment process to subject particular
chemicals of interest to additional process steps. These additional
process steps, which would have lengthened assessment times
considerably, include:
giving federal agencies and the public 45 days to
identify additional information on a chemical for EPA's
consideration in its assessment or to correct any errors on an
additional assessment draft that would provide qualitative
information;\3\
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\3\ This represents an additional review of a new draft product and
comment period that had not existed previously. As shown in Appendix
II, the assessment process EPA used at the time of our review included
publishing its annual IRIS assessment agenda in the Federal Register
and soliciting relevant scientific information from the public.
giving potentially affected federal agencies 30 days
to review the public comments EPA received and initiate a
meeting with EPA if they want to discuss a particular set of
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comments;
allowing potentially affected federal agencies to
have assessments suspended for up to 18 months to fill a data
gap or eliminate an uncertainty factor that EPA plans to use in
its assessment; and
allowing other federal agencies to weigh in on (1)
the level of independent peer review that would be sought (that
is, whether the peer reviews would be conducted by EPA Science
Advisory Board panels, National Academies' panels, or panels
organized by an EPA contractor); (2) the areas of scientific
expertise needed on the panel; and (3) the scope of the peer
reviews and the specific issues they would address.
EPA estimated that assessments that undergo these additional
process steps would take up to six years to complete. While it is
important to ensure that assessments consider the best science, EPA has
acknowledged that waiting for new data can result in substantial harm
to human health, safety, and the environment. Further, although
coordination with other federal agencies about IRIS assessments could
enhance their quality,\4\ increasing the role of agencies that may be
affected by IRIS assessments in the process itself reduces the
credibility of the assessments if that expanded role is not
transparent. In this regard, while EPA's proposed changes would have
allowed for including federal agencies' comments in the public record,
the implementation of this proposal was delayed for a year, in part,
because of OMB's view that agencies' comments about IRIS assessments
represent internal executive branch communications that may not be made
public--a view that is inconsistent with the principle of sound
science, which relies on, among other things, transparency. (Appendix
II and III provide flow charts of the IRIS process that was in place at
the time of our review and EPA's draft proposed process being
considered at the time of our review, respectively).
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\4\ We recommended in our 2006 report on human health risk
assessment that EPA consistently involve stakeholders as appropriate to
the risk assessment. We made this recommendation in the context of
improving the overall quality, consistency, and transparency of risk
assessments. GAO, Human Health Risk Assessment: EPA Has Taken Steps to
Strengthen Its Process, but Improvements Needed in Planning, Data
Development, and Training, GAO-06-595 (Washington, D.C.: May 31, 2006).
Recommendations Made in Our March 2008 Report
To address the productivity and credibility issues we identified,
we recommended that the EPA Administrator require the Office of
Research and Development to re-evaluate its draft proposed changes to
the IRIS assessment process in light of the issues raised in our report
and ensure that any revised process, among other things, clearly
defines and documents an IRIS assessment process that will enable the
agency to develop the timely chemical risk information it needs to
effectively conduct its mission. One of our recommendations--that EPA
provide at least two years' notice of IRIS assessments that are
planned--would, among other things, provide an efficient alternative to
suspending assessments while waiting for new research because
interested parties would have the opportunity to conduct research
before assessments are started.
In addition, we recommended that the EPA Administrator take steps
to better ensure that EPA has the ability to develop transparent,
credible IRIS assessments--an ability that relies in large part on
EPA's independence in conducting these important assessments. Actions
that are key to this ability include ensuring that EPA can (1)
determine the types of assessments it needs to support EPA programs and
(2) define the appropriate role of external federal agencies in EPA's
IRIS assessment process, and (3) manage an interagency review process
in a manner that enhances the quality, transparency, timeliness, and
credibility of IRIS assessments. In its February 21, 2008, letter
providing comments on our draft report, EPA said it would consider each
of our recommendations in light of the new IRIS process the agency was
developing.
Key Aspects of the Revised IRIS Assessment Process Implemented in April
2008 Which Is Not Responsive to GAO's
Recommendations
On April 10, 2008, EPA issued a revised IRIS assessment process,
effective immediately. Overall, EPA's revised process is not responsive
to the recommendations made in our March 2008 report--it is largely the
same as the draft proposed process we evaluated in our March 2008
report (see Appendix III and IV). Moreover, changes EPA did incorporate
into the final process are likely to further exacerbate the
productivity and credibility issues we identified in our report.
We recommended that EPA ensure that, among other things, any
revised process clearly defines and documents a streamlined IRIS
assessment process that can be conducted within time frames that
minimize the need for wasteful rework.
As discussed in our report, when assessments take longer than two
years, they can become subject to substantial delays stemming from the
need to redo key analyses to take into account changing science and
assessment methodologies. However, EPA's revised process
institutionalizes a process that the agency estimates will take up to
six years to complete. Further, the estimated time frames do not factor
in the time for peer reviews conducted by the National Academies, which
can take two years to plan and complete.\5\ EPA typically uses reviews
by the National Academies for highly controversial chemicals or complex
assessments. Therefore, assessments of key chemicals of concern to
public health that are reviewed by the National Academies are likely to
take at least eight years to complete. These time frames must also be
considered in light of OMB's view that health assessment values in IRIS
are out of date if they are more than 10 years old and if new
scientific information exists that could change the health assessment
values. Thus, EPA's new process institutionalizes time frames that
could essentially require the agency to start assessment updates as
soon as two years after assessments are finalized in order to keep the
IRIS database current. Such time frames are not consistent with our
recommendation that EPA develop, clearly define, and document a
streamlined IRIS process that can be conducted within time frames that
minimize the need for wasteful rework. Further, the agency would need a
significant increase in resources to support such an assessment cycle.
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\5\ It is not clear whether the time frames exclude reviews
conducted by EPA's Science Advisory Board, which can also add
considerably more time than the most basic level of peer review used by
the IRIS program--panels organized by an EPA contractor.
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In addition, EPA had previously emphasized that, in suspending
assessments to allow agencies to fill in data gaps, it would allow no
more than 18 months to complete the studies and have them peer
reviewed. However, under the new process, EPA states that it generally
will allow no more than 18 months to complete the studies and have them
peer reviewed. As we concluded in our report, we believe the ability to
suspend assessments for up to 18 months would add to the already
unacceptable level of delays in completing IRIS assessments. Further,
we and several agency officials with whom we spoke believe that the
time needed to plan, conduct, and complete research that would address
significant data gaps, and have it peer reviewed, would likely exceed
18 months. Therefore, the less rigid time frame EPA included in its new
process could result in additional delays.
Finally, the new process expands the scope of one of the additional
steps that initially was to apply only to chemicals of particular
interest to federal agencies.\6\ Specifically, under the draft process
we reviewed, EPA would have provided an additional review and comment
opportunity for federal agencies and the public for what EPA officials
said would be a small group of chemicals. However, under EPA's new
process, this additional step has been added to the assessment process
for all chemicals and, therefore, will add time to the already lengthy
assessments of all chemicals.
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\6\ The new IRIS assessment process refers to such chemicals as
``mission critical.'' The process defines a mission-critical chemical
as one that ``is an integral component to the successful and safe
conduct of an agency's mission in any or all phases of its
operations.'' According to the process, ``impacts on the use of
mission-critical chemicals include cessation or degradation of the
conduct of the mission and/or unacceptable resource constraints.''
We also recommended that the EPA Administrator take steps to
better ensure that EPA has the ability to develop transparent, credible
IRIS assessments--an ability that relies in large part on EPA's
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independence in conducting these important assessments.
Contrary to our recommendation, EPA has formalized a revised IRIS
process that is selectively, rather than fully, transparent, limiting
the credibility of the assessments. Specifically, while the draft
process we reviewed provided that comments on IRIS assessments from OMB
and other federal agencies would be part of the public record, under
the recently implemented process, comments from federal agencies are
expressly defined as ``deliberative'' and will not be included in the
public record.\7\ Given the importance and sensitivity of IRIS
assessments, we believe it is critical that input from all parties,
particularly agencies that may be affected by the outcome of IRIS
assessments, be publicly available. However, under EPA's new process,
input from some IRIS assessment reviewers--representatives of federal
agencies, including those facing potential regulatory liability, and
private stakeholders associated with these agencies--will continue to
receive less public scrutiny than comments from all others.
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\7\ Making these comments public would have been a change from the
OMB/interagency review process that has been in place since 2004.
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In commenting on a draft of our March 2008 report, and in a recent
congressional hearing, EPA's Assistant Administrator, Office of
Research and Development, stated that the IRIS process is transparent
because all final IRIS assessments must undergo public and external
peer review. However, as we stated in our report, the presence of
transparency at a later stage of IRIS assessment development does not
explain or excuse its absence earlier. Under the new process, neither
peer reviewers nor the public are privy to the changes EPA makes in
response to the comments OMB and other federal agencies provide to EPA
at several stages in the assessment process--changes to draft
assessments or to the questions EPA poses to the peer review panels.
Importantly, the first IRIS assessment draft that is released to peer
reviewers and to the public includes the undisclosed input from federal
agencies potentially subject to regulation and therefore with an
interest in minimizing the impacts of IRIS assessments on their budgets
and operations.
In addition, EPA's revised process does not provide EPA with
sufficient independence in developing IRIS assessments to ensure they
are credible and transparent. We made several recommendations aimed at
restoring EPA's independence. For example, we recommended that the EPA
Administrator ensure that EPA has the ability to, among other things,
define the appropriate role of external federal agencies in the IRIS
assessment process and determine when interagency issues have been
appropriately addressed. However, under the newly implemented IRIS
assessment process, OMB continues to inform EPA when EPA has adequately
addressed OMB's and interagency comments. This determination must be
made both before EPA can provide draft assessments to external peer
reviewers and to the public and before EPA can finalize and post
assessments on the IRIS database. While EPA officials state that
ultimately IRIS assessments reflect EPA decisions, the new process does
not support this assertion given the clearances EPA needs to receive
from OMB to move forward at key stages. In fact, we believe the new
IRIS assessment process may elevate the goal of reaching interagency
agreement above achieving IRIS program objectives. Further, as
discussed above, because the negotiations over OMB/interagency comments
are not disclosed, whether EPA is entirely responsible for the content
of information on IRIS is open to question.
In our report, we also emphasized the importance of ensuring that
IRIS assessments be based solely on science issues and not policy
concerns. However, under the new IRIS assessment process, EPA has
further introduced policy considerations into the IRIS assessment
process. That is, the newly implemented IRIS assessment process
broadens EPA's characterization of IRIS assessments from ``the agency's
scientific positions on human health effects that may result from
exposure to environmental contaminants'' to ``the agency's science and
science policy positions'' on such effects. EPA's new, broader
characterization of IRIS raises concerns about the agency's stated
intent to ensure that scientific assessments are appropriately based on
the best available science and that they are not inappropriately
impacted by policy issues and considerations. For example, in
discussing science and science policy at a recent Senate hearing, EPA's
Assistant Administrator of Research and Development described science
policy considerations as including decisions about filling knowledge
gaps (e.g., whether and to what extent to use default assumptions) and
assessing weight-of-the-evidence approaches to make scientific
inferences or assumptions. We believe that these are scientific
decisions that should reflect the best judgment of EPA scientists who
are evaluating the data, using the detailed risk assessment guidance
the agency has developed for such purposes. We have concerns about the
manner and extent to which other federal agencies, including those that
may be affected by the outcome of assessments, are involved in these
decisions as well as the lack of transparency of their input. As we
highlighted earlier, under the National Academies' risk assessment and
risk management paradigm, policy considerations are relevant in the
risk management phase--which occurs after the risk assessment phase
that encompasses IRIS assessments. The National Academies recently
addressed this issue as follows: ``The committee believes that risk
assessors and risk managers should talk with each other; that is, a
`conceptual distinction' does not mean establishing a wall between risk
assessors and risk managers. Indeed they should have constant
interaction. However, the dialogue should not bias or otherwise color
the risk assessment conducted, and the activities should remain
distinct; that is, risk assessors should not be performing risk
management activities.'' \8\
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\8\ National Academies, Scientific Review of the Proposed Risk
Assessment Bulletin from the Office of Management and Budget Committee
to Review the OMB Risk Assessment Bulletin (2007).
Concluding Observations
The new IRIS assessment process that EPA implemented in April 2008
will not allow the agency to routinely and timely complete credible
assessments. In fact, it will exacerbate the problems we identified in
our March 2008 report and sought to address with our recommendations--
all of which were aimed at preserving the viability of this critical
database, which is integral to EPA's mission of protecting the public
and the environment from exposure to toxic chemicals. Specifically,
under the new process, assessment time frames will be significantly
lengthened, and the lack of transparency will further limit the
credibility of the assessments because input from OMB and other
agencies at all stages of the IRIS assessment process is now expressly
defined as deliberative and therefore not subject to public disclosure.
The position of the Assistant Administrator, Office of Research and
Development, that the IRIS process is transparent because all final
IRIS assessments must undergo public and external peer review is
unconvincing. Transparency at a later stage of the IRIS assessment
process--after OMB and other federal agencies have had multiple
opportunities to influence the content of the assessment without any
disclosure of their input--does not compensate for its absence earlier.
We continue to believe that to effectively maintain IRIS EPA must
streamline its lengthy assessment process and adopt transparency
practices that provide assurance that IRIS assessments are
appropriately based on the best available science and that they are not
inappropriately biased by policy issues and considerations. As
discussed in our April 29, 2008, testimony before the Senate
Environment and Public Works Committee, we believe that the Congress
should consider requiring EPA to suspend implementation of its new IRIS
assessment process and develop a streamlined process that is
transparent and otherwise responsive to our recommendations aimed at
improving the timeliness and credibility of IRIS assessments.\9\ For
example, suspending assessments to obtain additional research is
inefficient; alternatively, with longer-term planning, EPA could
provide agencies and the public with more advance notice of
assessments, enabling them to complete relevant research before IRIS
assessments are started.
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\9\ GA0, Toxic Chemicals: EPA's New Assessment Process Will
Increase Challenges EPA Faces in Evaluating and Regulating Chemicals,
GAO-08-743T (Washington, D.C.: April 29, 2008).
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In addition, as discussed in our April 2008 testimony, the Congress
should consider requiring EPA to obtain and be responsive to input from
the Congress and the public before finalizing a revised IRIS assessment
process. We note that while EPA and OMB initially had planned for EPA
to release a draft revised IRIS assessment process to the public, hold
a public meeting to discuss EPA's proposed changes, and seek and
incorporate public input before finalizing the process, EPA released
its new assessment process without obtaining public input and made it
effective immediately. This was inconsistent with assertions made in
OMB's letter commenting on our draft report, which emphasized that EPA
had not completed the development of the IRIS assessment process and
stated: ``Indeed, the process will not be complete until EPA circulates
its draft to the public for comments and then releases a final product
that is responsive to those comments.''
Finally, if EPA is not able to take the steps we have recommended
to effectively maintain this critical program, other approaches,
including statutory requirements, may need to be explored.
Mr. Chairman, this concludes my prepared statement. I would be
happy to respond to any questions that you or other Members of the
Subcommittee may have at this time.
Contacts and Acknowledgments
Contact points for our Congressional Relations and Public Affairs
Offices may be found on the last page of this statement. Contributors
to this testimony include Christine Fishkin (Assistant Director), Laura
Gatz, Richard P. Johnson, and Nancy Crothers.
Appendix I:
Examples of Key IRIS Assessments That Have Been Delayed
Some key IRIS assessments have been in progress for a number of
years, in part because of delays stemming from one or more of the key
factors we identified that have hindered EPA's productivity.\10\
Examples include the following:
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\10\ The factors we identified that have hindered EPA's efforts to
improve productivity are the OMB/interagency review process managed by
OMB, the growing complexity and scope of risk assessments, certain
management decisions and issues regarding the IRIS program,
congressional action that has delayed some assessments with potentially
significant economic effects, and the compounding effect of delays.
Naphthalene. EPA started the IRIS assessment of cancer risks stemming
from the inhalation of naphthalene in 2002. Naphthalene is used in jet
fuel and in the production of widely used commercial products such as
moth balls, dyes, insecticides, and plasticizers. According to a
presentation delivered at the 2007 annual meeting of the Society for
Risk Analysis by an Army Corps of Engineers toxicologist,\11\ ``The
changing naphthalene regulatory environment includes a draft EPA risk
assessment that if/when finalized, will change naphthalene's status
from `possible' to `likely' human carcinogen.'' \12\ Thus, according to
this presentation, one potential impact of this IRIS assessment on DOD
is that DOD would need to provide many employees exposed to naphthalene
with equipment measuring their exposure to the chemical. In addition,
because many military bases are contaminated with naphthalene, a
component of jet fuel (approximately one percent to three percent) used
by all DOD services, DOD could face extensive cleanup costs. By 2004,
two years after starting the assessment, EPA had drafted a chemical
assessment that had completed internal peer reviews and was about to be
sent to an external peer review committee. Once it returned from
external review, the next step, at that time, would have been a formal
review by EPA's IRIS Agency Review Committee. If approved, the
assessment would have been completed and released. However, in part
because of concerns raised by DOD, OMB asked to review the assessment
and conducted an interagency review of the draft. In their 2004 reviews
of the draft IRIS assessment, both OMB and DOD raised a number of
concerns about the assessment and suggested to EPA that it be suspended
until additional research could be completed to address what they
considered to be significant uncertainties associated with the
assessment. Although all of the issues raised by OMB and DOD were not
resolved, EPA continued with its assessment by submitting the draft for
external peer review, which was completed in September 2004.\13\
However, according to EPA, OMB continued to object to the draft IRIS
assessment and directed EPA to convene an additional expert review
panel on genotoxicity to obtain recommendations about short-term tests
that OMB thought could be done quickly.\14\ According to EPA, this
added six months to the process, and the panel, which met in April
2005, concluded that the research that OMB was proposing could not be
conducted in the short-term. Nonetheless, EPA officials said that the
second expert panel review did not eliminate OMB's concerns regarding
the assessment, which they described as reaching a stalemate. In
September 2006, EPA decided, however, to proceed with developing the
assessment. By this time, the naphthalene assessment had been in
progress for over four years; EPA decided that the IRIS non-cancer
assessment, issued in 1998, was outdated and needed to be revisited.
Thus, EPA expanded the IRIS naphthalene assessment to include both non-
cancer and cancer assessments. As a result, six years after the
naphthalene assessment began, it is now back at the drafting stage. The
assessment now will need to reflect relevant research completed since
the draft underwent initial external peer review in 2004, and it will
have to undergo all of the IRIS assessment steps again, including
additional internal and external reviews that are now required. This
series of delays has limited EPA's ability to conduct its mission. For
example, the Office of Air and Radiation has identified the naphthalene
assessment as one of its highest-priority needs for its air toxics
program. In addition, the Office of Solid Waste and Emergency Response
considers the naphthalene assessment a high priority for the Superfund
program--naphthalene has been found in at least 654 of Superfund's
current or former National Priorities List sites.\15\ Although EPA
currently estimates that it will complete the assessment in 2009,
meeting this revised estimate will be challenging, given all of the
steps that are yet to be completed and the extensive external scrutiny
to which it will continue to be subjected.
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\11\ Presentations at the Society for Risk Analysis meeting reflect
the views of the authors and ``do not necessarily reflect the views of
any other organization or agency.''
\12\ Using its 1996 Proposed Guidelines for Carcinogen Risk
Assessment, EPA concluded in the 1998 IRIS assessment of naphthalene
that its human carcinogenic potential could not be determined at that
time, but noted that there was suggestive evidence of potential human
carcinogenicity. (EPA also noted that under its 1986 cancer guidelines,
EPA classified naphthalene as a possible human carcinogen.)
Subsequently, in 2002, the International Agency for Research on Cancer
(IARC), part of the World Health Organization, concluded that
naphthalene is possibly carcinogenic to humans; in 2004, the Department
of Human Health and Services' National Toxicology Program concluded
that naphthalene can reasonably be anticipated to be a human
carcinogen. EPA's current assessment will be subject to the agency's
2005 cancer guidelines.
\13\ According to DOD, EPA did not specifically ask the peer
reviewers to address some of the technical questions DOD had raised and
wanted the peer review to address.
\14\ Genotoxic substances are a type of carcinogen, specifically
those capable of causing genetic mutation and of contributing to the
development of tumors. This includes both certain chemical compounds
and certain types of radiation.
\15\ The National Priorities List is EPA's list of seriously
contaminated sites.
Royal Demolition Explosive. This chemical, also called RDX or
hexahydro-1,3,5-trinitrotriazine, is a highly powerful explosive used
by the U.S. military in thousands of munitions. Currently classified by
EPA as a possible human carcinogen, this chemical is known to leach
from soil to groundwater. Royal Demolition Explosive can cause seizures
in humans and animals when large amounts are inhaled or ingested, but
the effects of long-term, low-level exposure on the nervous system are
unknown. As is the case with naphthalene, the IRIS assessment could
potentially require DOD to undertake a number of actions, including
steps to protect its employees from the effects of this chemical and to
clean up many contaminated sites. Although EPA started an IRIS
assessment of Royal Demolition Explosive in 2000, it has made minimal
progress on the assessment because EPA agreed to a request by DOD to
wait for the results of DOD-sponsored research on this chemical. In
2007, EPA began to actively work on this assessment, although some of
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the DOD-sponsored research is still outstanding.
Formaldehyde. EPA began an IRIS assessment of formaldehyde in 1997
because the existing assessment was determined to be outdated.\16\
Formaldehyde is a colorless, flammable, strong-smelling gas used to
manufacture building materials, such as pressed wood products, and used
in many household products, including paper, pharmaceuticals, and
leather goods. While EPA currently classifies formaldehyde as a
probable human carcinogen, the International Agency for Research on
Cancer (IARC), part of the World Health Organization, classifies
formaldehyde as a known human carcinogen. Since 1986, studies of
industrial of workers have suggested that formaldehyde exposure is
associated with nasopharyngeal cancer, and possibly with leukemia. For
example, in 2003 and 2004, the National Cancer Institute (NCI) and the
National Institute of Occupational Safety and Health (NIOSH) released
epidemiological studies following up on earlier studies tracking about
26,000 and 11,000 industrial workers, respectively, exposed to
formaldehyde; the updates showed exposure to formaldehyde might also
cause leukemia in humans, in addition to the cancer types previously
identified. According to NCI officials, the key findings in their
follow-up study were an increase in leukemia deaths and, more
significantly, an exposure/response relationship between formaldehyde
and leukemia--as exposure increased, the incidence of leukemia also
rose. As with the earlier study, NCI found more cases of a rare form of
cancer, nasopharyngeal cancer, than would usually be expected. The
studies from NCI and NIOSH were published in 2003 and 2004,\17\ around
the time that EPA was still drafting its IRIS assessment. In November
2004, the Chairman of the Senate Environment and Public Works Committee
requested that EPA delay completion of its IRIS assessment until an
update to the just-released NCI study could be conducted, indicating
that the effort would take, at most, 18 months. EPA agreed to wait--and
more than three years later, the NCI update is not yet complete. As of
December 2007, NCI estimates that the study will be completed in two
stages, one in mid-2008 and the second one later that year. An NCI
official said that the additional leukemia deaths identified in the
update provide ``greater power'' to detect associations between
exposure to formaldehyde and cancer. EPA's inability to complete the
IRIS assessment it started more than 10 years ago in a timely manner
has had a significant impact on EPA's air toxics program. Specifically,
when EPA promulgated a national emissions standard for hazardous air
pollutants covering facilities in the plywood and composite wood
industries in 2004, EPA's Office of Air and Radiation took the unusual
step of not using the existing IRIS estimate but rather decided to use
a cancer risk estimate developed by an industry-funded organization,
the CIIT Centers for Health Research (formerly, the Chemical Industry
Institute of Toxicology) that had been used by the Canadian health
protection agency. The IRIS cancer risk factor had been subject to
criticism because it was last revised in 1991 and was based on data
from the 1980s. In its final rule, EPA stated that ``the dose-response
value in IRIS is based on a 1987 study, and no longer represents the
best available science in the peer-reviewed literature.'' The CIIT
quantitative cancer risk estimate that EPA used in its health risk
assessment in the plywood and composite wood national emissions
standard indicates a potency about 2,400 times lower than the estimate
in IRIS that was being re-evaluated and that did not yet consider the
2003 and 2004 NCI and NIOSH epidemiological studies. According to an
EPA official, an IRIS cancer risk factor based on the 2003 and 2004 NCI
and NIOSH studies would likely be close to the current IRIS assessment,
which EPA has been attempting to update since 1997. The decision to use
the CIIT assessment in the plywood national emissions standard was
controversial, and officials in EPA's National Center for Environmental
Assessment said the center identified numerous problems with the CIIT
estimate. Nonetheless, the Office of Air and Radiation used the CIIT
value, and that decision was a factor in EPA exempting certain
facilities with formaldehyde emissions from the national emissions
standard. In June 2007, a federal appellate court struck down the rule,
holding that EPA's decision to exempt certain facilities that EPA
asserted presented a low health risk exceeded the agency's authority
under the Clean Air Act.\18\ Further, the continued delays of the IRIS
assessment of formaldehyde--currently estimated to be completed in 2010
but after almost 11 years still in the draft development stage--will
impact the quality of other EPA regulatory actions, including other air
toxics rules and requirements.
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\16\ The cancer portion of the formaldehyde assessment was
originally issued in 1989 and updated in 1991; the non-cancer
assessment was added in 1990.
\17\ NCI published the results of its study in two publications.
The first study, published in November 2003, focused on the association
between formaldehyde exposure and leukemia. M. Hauptmann, J.H. Lubin,
P.A. Stewart, R.B. Hayes, A. Blair, ``Mortality from
Lymphohematopoietic Malignancies among Workers in Formaldehyde
Industries,'' Journal of the National Cancer Institute (2003). The
second study, published in June 2004, evaluated the association between
formaldehyde exposure and other cancers--including nasopharyngeal
cancer. M. Hauptmann, J.H. Lubin, P.A. Stewart, R.B. Hayes, A. Blair,
``Mortality from Solid Cancers among Workers in Formaldehyde
Industries,'' American Journal of Epidemiology (2004). The results of
the NIOSH study were described in one publication, dated March 2004,
which assessed mortality from all causes and all cancers. L.E.
Pinkerton, M.J. Hein, L.T. Stayner, ``Mortality among a Cohort of
Garment Workers Exposed to Formaldehyde: an Update,'' Occupational and
Environmental Medicine (2004).
\18\ Natural Resources Defense Council v. E.P.A., 489 F.3d 1364,
1372-73 (D.C. Cir, 2007). The court did not specifically address EPA's
reliance on the CIIT study, holding instead that the Clean Air Act
prohibited establishment of the exemptions at issue.
Trichloroethylene. Also known as TCE, this chemical is a solvent widely
used as a degreasing agent in industrial and manufacturing settings; it
is a common environmental contaminant in air, soil, surface water, and
groundwater. TCE has been linked to cancer, including childhood cancer,
and other significant health hazards, such as birth defects. TCE is the
most frequently reported organic contaminant in groundwater, and
contaminated drinking water has been found at Camp Lejeune, a large
Marine Corps base in North Carolina. TCE has also been found at
Superfund sites and at many industrial and government facilities,
including aircraft and spacecraft manufacturing operations. In 1995,
the International Agency for Research on Cancer classified TCE as a
probable human carcinogen, and in 2000, the Department of Health and
Human Services' National Toxicology Program concluded that it is
reasonably anticipated to be a human carcinogen. Because of questions
raised by peer reviewers about the IRIS cancer assessment for TCE, EPA
withdrew it from IRIS in 1989 but did not initiate a new TCE cancer
assessment until 1998. In 2001, EPA issued a draft IRIS assessment for
TCE that proposed a range of toxicity values indicating a higher
potency than in the prior IRIS values and characterizing TCE as
``highly likely to produce cancer in humans.'' The draft assessment,
which became controversial, was peer reviewed by EPA's Scientific
Advisory Board and released for public comment. A number of scientific
issues were raised during the course of these reviews, including how
EPA had applied emerging risk assessment methods--such as assessing
cumulative effects (of TCE and its metabolites) and using a
physiologically based pharmacokinetic model--and the uncertainty
associated with the new methods themselves.\19\ To help address these
issues, EPA, DOD, DOE, and NASA sponsored a National Academies review
to provide guidance. The National Academies report, which was issued in
2006, concluded that the weight of evidence of cancer and other health
risks from TCE exposure had strengthened since 2001 and recommended
that the risk assessment be finalized with currently available data so
that risk management decisions could be made expeditiously. The report
specifically noted that while some additional information would allow
for more precise estimates of risk, this information was not necessary
for developing a credible risk assessment. Nonetheless, 10 years after
EPA started its IRIS assessment, the TCE assessment is back at the
draft development stage. EPA estimates this assessment will be
finalized in 2010. More in line with the National Academies'
recommendation to act expeditiously, five senators introduced a bill in
August 2007 that, among other things, would require EPA to both
establish IRIS values for TCE and issue final drinking water standards
for this contaminant within 18 months.
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\19\ Physiologically based pharmacokinetic models are a class of
dosimetry models that are useful for predicting internal doses to
target organs. With the appropriate data, these models can be used to
extrapolate across species and exposure scenarios and address various
sources of uncertainty in risk assessments.
Tetrachloroethylene. EPA started an IRIS assessment of
tetrachloroethylene--also called perchloroethylene or ``perc''--in
1998. Tetrachloroethylene is a manufactured chemical widely used for
dry cleaning of fabrics, metal degreasing, and making some consumer
products and other chemicals. Tetrachloroethylene is a widespread
groundwater contaminant, and the Department of Health and Human
Services' National Toxicology Program has determined that it is
reasonably anticipated to be a carcinogen. The IRIS database currently
contains a 1988 non-cancer assessment based on oral exposure that will
be updated in the ongoing assessment. Importantly, the ongoing
assessment will also provide a non-cancer inhalation risk and a cancer
assessment. The IRIS agency review of the draft assessment was
completed in February 2005, the draft assessment was sent to OMB for
OMB/interagency review in September 2005, and the OMB/interagency
review was completed in March 2006. EPA had determined to have the next
step, external peer review, conducted by the National Academies--the
peer review choice reserved for chemical assessments that are
particularly significant or controversial. EPA contracted with the
National Academies for a review by an expert panel, and the review was
scheduled to start in June 2006 and be completed in 15 months. However,
as of December 2007, the draft assessment had not yet been provided to
the National Academies. After verbally agreeing with both the non-
cancer and cancer assessments following briefings on the assessments,
the Assistant Administrator, Office of Research and Development,
subsequently requested that additional uncertainty analyses--including
some quantitative analyses--be conducted and included in the assessment
before the draft was released to the National Academies for peer
review. As discussed in our March 2008 report on IRIS (GAO-08-440),
quantitative uncertainty analysis is a risk assessment tool that is
currently being developed, and although the agency is working on
developing policies and procedures for uncertainty analysis, such
guidance currently does not exist. The draft tetrachloroethylene
assessment has been delayed since early 2006 as EPA staff have gone
back and forth with the Assistant Administrator trying to reach
agreement on key issues such as whether a linear or nonlinear model is
most appropriate for the cancer assessment and how uncertainty should
be qualitatively and quantitatively characterized. EPA officials and
staff noted that some of the most experienced staff are being used for
these efforts, limiting their ability to work on other IRIS
assessments. In addition, the significant delay has impacted the
planned National Academies peer review because the current contract,
which has already been extended once, cannot be extended beyond
December 2008. The peer review was initially estimated to take 15
months. As a result, a new contract and the appointment of another
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panel may be required.
Dioxin. The dioxin assessment is an example of an IRIS assessment that
has been, and will likely continue to be, a political as well as a
scientific issue. Often the byproducts of combustion and other
industrial processes, complex mixtures of dioxins enter the food chain
and human diet through emissions into the air that settle on soil,
plants, and water. EPA's initial dioxin assessment, published in 1985,
focused on the dioxin TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin)
because animal studies in the 1970s showed it to be the most potent
cancer-causing chemical studied to date. Several years later, EPA
decided to conduct a reassessment of dioxin because of major advances
that had occurred in the scientific understanding of dioxin toxicity
and significant new studies on dioxins' potential adverse health
effects. Initially started in 1991, this assessment has involved
repeated literature searches and peer reviews. For example, a draft of
the updated assessment was reviewed by a scientific peer review panel
in 1995, and three panels reviewed key segments of later versions of
the draft in 1997 and 2000. In 2002, EPA officials said that the
assessment would conclude that dioxin may adversely affect human health
at lower exposure levels than had previously been thought and that most
exposure to dioxins occurs from eating such American dietary staples as
meats, fish, and dairy products, which contain minute traces of
dioxins. These foods contain dioxins because animals eat plants and
commercial feed and drink water contaminated with dioxins, which then
accumulate in animals' fatty tissue. It is clear that EPA's dioxin risk
assessment could have a potentially significant impact on consumers and
on the food and agriculture industries. As EPA moved closer to
finalizing the assessment, in 2003 the agency was directed in a
congressional appropriations conference committee report to not issue
the assessment until it had been reviewed by the National Academies.
The National Academies provided EPA with a report in July 2006. In
developing a response to the report, which the agency is currently
doing, EPA must include new studies and risk assessment approaches that
did not exist when the assessment was drafted. EPA officials said the
assessment will be subject to the IRIS review process once its response
to the National Academies' report is drafted. As of 2008, EPA has been
developing the dioxin assessment, which has potentially significant
health implications for all Americans, for 17 years.
Biography for John B. Stephenson
John Stephenson has been the Director of Environmental Protection
Issues within GAO's Natural Resources and Environment team since
October 2000. He began his GAO career with the Dayton Field Office
(formerly Cincinnati Regional Office) where he focused primarily on
acquisition management, defense capabilities, and information
technology issues. In 1987, he transferred to Headquarters as an
Assistant Director in the Accounting and Information Management
Division (the forerunner of the IT, SI, and FMA teams). In that
capacity he directed numerous projects, assisted in several
testimonies, and issued over 100 reports on information technology
issues. From April 1998-February 2000, he was detailed to the Senate
Special Committee on the Year 2000 Technology Problem where he was the
Deputy Staff Director. In that capacity, he ran the day-to-day
operations of the Committee including establishing strategy and
agendas, managing the staff, overseeing investigations, conducting over
35 hearings, and representing the Chairman (Senator Bennett, R-UT) and
the Vice Chairman (Senator Dodd, D-CT) in a variety of forums. He was
appointed to GAO's Executive Candidate Program in June 1999. From
March-October 2000, he worked in the Office of the Comptroller General
and directed GAO's mission support reorganization and realignment
project for the Chief Mission Support Officer. John holds a BS degree
in Industrial Management from Purdue University, an MBA from Xavier
University, and is a graduate of the Harvard Kennedy School of
Government's Senior Executive Fellows program.
Discussion
The Revised IRIS Process
Chairman Miller. Thank you. At this point, we will have our
first round of questions. The Chair now recognizes himself for
five minutes.
I would like to ask Mr. Whittaker to display a chart,
Figure 1, if you would, please.
Chairman Miller. Mr. Stephenson, displayed there is I
believe an EPA-prepared chart that describes the IRIS process
that existed before 2004. Is that--before OMB made helpful
changes, helpful suggestions, about what the process should be
instead. Is that correct?
Mr. Stephenson. That looks like a reasonable
representation. We have a little bit different one in our
testimony but----
Chairman Miller. Okay. Now, if Mr. Whittaker could then
display Figure 3.
Chairman Miller. All right. Is that the current process?
That also is an EPA-prepared document to show their process.
Mr. Stephenson. Yes. That looks like some of the new steps
that have been inserted in the new process.
Chairman Miller. Okay. It will be the testimony of the
later witnesses today that that process is the streamlined
version of the earlier process and that we should not believe
our own lying eyes that this really is more streamlined than
the previous process. Is it your testimony or your belief that
it is in fact a more complicated, convoluted process, not a
streamlined process?
Mr. Stephenson. It appears to be more complicated, but if
you put the individual timeframes associated with each of those
steps, we didn't invent the six to eight years, it is based on
adding up the amount of time that could be taken for each of
those steps and two years additional for any chemical that is
deemed mission critical.
Chairman Miller. But just if our eyes tell us that this
looks a lot more complicated, our eyes did not lie?
Mr. Stephenson. Not in our opinion.
Did OMB Review EPA's GAO Exit Conference Comments?
Chairman Miller. All right. Thank you. Mr. Stephenson, one
of your findings was that the EPA needed to be more independent
and that the lack of independence was undermining the
credibility of IRIS assessments. Is it your typical procedure
to show proposed findings to the agency that you have been
examining?
Mr. Stephenson. Yes, there is a two-step process. Whenever
GAO completes a review, we hold what we call an exit conference
with the affected agency, usually at the program level; and it
is really a fact check, if you will, to make sure that we have
characterized the facts correctly. We did that and then when we
go back and consider those comments, and we publish a draft
report which we then pass by the agency for official review. In
this case, we passed the final report by both EPA and OMB since
both were affected.
Chairman Miller. And what was the result of that review?
Mr. Stephenson. Well, the first process is not considered
official agency comments because it isn't blessed all the way
up the chain. Nevertheless, it represents the views of the
program office people who run IRIS, and in that case they felt
like the interagency review process that was being levied on
them was indeed adding time to the process. And not only that,
they felt like they could not move forward without an OMB
blessing at several points along the way when they had
adequately responded to concerns of the other agencies and OMB.
So in that sense, this science agency that, as you
mentioned, is set up in statute to be a science agency was kind
of, in our view, being obstructed by other agencies that don't
have that as their primary mission.
Chairman Miller. And in their own view based on what they
said to you.
Mr. Stephenson. Yes. I mean, OMB will tell you that EPA
owns the IRIS process, but it depends upon which part of OMB
you talk to. The management agenda part of OMB says that EPA
loses control of the process when they send a draft assessment
to OMB, yet the OIRA part of OMB will tell you that EPA still
owns the process, and they are only serving to coordinate the
federal family of comments.
Chairman Miller. Have they stuck with that initial response
to the GAO's facts?
Mr. Stephenson. They asked that we not consider the exit
conference comments of the program office officials and instead
consider the official agency comments which no longer
considered the interagency process as obstructive or taking
additional time, rather that the real thing that took time was
the complexity of IRIS assessments.
Chairman Miller. Okay. So OMB told them that they were in
fact independent? They misapprehended the facts when they said
that they were not independent, OMB advised them that they
were, and now it is their view that they are?
Mr. Stephenson. They are the decision-makers according to
OMB.
Chairman Miller. My time is almost expired, but I have two
documents that have been provided to the Minority which I
believe are the initial response of the staff of IRIS, and then
the official response. And I now enter both of these into the
record.
[The information follows:]
Chairman Miller. My time is now expired. Mr. Reichert for
five minutes.
The IRIS Process
Mr. Reichert. Thank you, Mr. Chairman. Thank you for being
here with us this morning, sir. I have a question about
balancing priorities. How do you balance the competing
priorities of timeliness and thoroughness?
Mr. Stephenson. In science, that is always an issue. As I
said in my statement, the science is never going to be
absolutely certain on a given chemical, but in the judgment of
the scientific community, they have to decide when protecting
human health should be undertaken. You have to get into a cycle
of risk assessments that takes about two to four years. To have
it take 10 years, you will never finish anything. Chemicals
should be reassessed after 10 years, so it is obvious that you
won't make any progress at two per year. You need more like 50
a year.
Mr. Reichert. But to follow up on that, until this new
process was released, were there any schedules imposed at any
point in this process?
Mr. Stephenson. That was part of the problem. There were no
schedules imposed. So now there is a schedule imposed on that
complex flow chart you just saw, and if you add all those up,
the minimum you can complete an assessment in is six years. In
other words, that is an unacceptable schedule.
Mr. Reichert. Mr. Chairman, I will yield back.
Chairman Miller. Thank you. Mr. Baird for five minutes.
Delayed Risk Assessments
Mr. Baird. Have you got any insights into what the costs of
the current situation is in terms of the relatively slow pace
and some bias of information?
Mr. Stephenson. Well, I mean, if you don't have a credible
risk assessment, you can't move from the risk assessment
process to the risk management process. The risk management
process is where you start determining what regulatory options
are appropriate. So the cost and lack of protection to human
health, I don't know how you would measure that, but it has got
to be enormous if you are not getting these risk assessments
completed in time. Now, you know, they can use other sources of
science. They don't have to use IRIS, and they have in some
cases done that. Nevertheless, IRIS was put in place to
streamline the scientific process so that we get on with the
business of determining which regulatory options were
appropriate for a given chemical.
Mr. Baird. You know, I have witnessed a pattern in the
past. I spent a fair bit of time doing research on the area of
risk analysis, and a rhetorical pattern which is, well, of
course we need to protect the public, but we must make that
protection based on the best available science. And if the
corollary is that you make interventions to slow down or
obstruct or obfuscate the best available science, you then
allow the prior argument to occur. Is there any of that going
on where people are saying, well, we can't regulate because we
don't have the information but then obstructing the access to
the information?
Mr. Stephenson. I mean, we are not trying to say that there
is intentional obstruction going on. We didn't try to find
that. But that is why we do believe transparency in the entire
process is so critical. It removes the perception of a conflict
of interest. We encourage DOD and DOE and any agency to provide
comments on risk assessments, but it should be in the sunlight,
it should be available to the scientific community for
scrutiny, the same as any other comments from any other
organization is.
Mr. Baird. What recourse exists? If you are a scientist
working for an agency, and you have in your best scientific
judgment made a case in a certain direction, and it heads to
another entity and comes back in some way different than what
you had put forward, what options exist right now?
Mr. Stephenson. Well, I mean, that is why independence of
EPA is so important. They have to own the process. You have to
hope that the credibility of the science will rule and that
they will consider legitimate comments appropriately and
address those kinds of concerns appropriately. But to keep all
that from public view is not a good thing.
Mr. Baird. Yeah, that is my question. So do we believe it
has happened that someone has put forward a report that went to
a different entity, let us say OMB, the scientific judgment in
the initial report is in some way altered, influenced,
undermined, blocked, and then it comes back and is disseminated
in a fashion different than the initial input?
Mr. Stephenson. I don't know that, but OMB, DOD, anybody
can challenge the assumptions within the assessment, the
uncertainty analysis, exposure characteristics. And so they can
ask for additional research if they think there are gaps in the
research which can take up to two years. There is a certain
amount of ad hocness to the whole process that is secretive
right now, and you just can't tell what is going on. And to say
again that there is transparency in the final assessment does
not excuse its absence early in the process when you need to
see what is going on with these decisions.
Mr. Baird. Right. And let me ask this question. If someone
were to ask for--in the IRIS process, if someone says, okay, so
this is our best available science at the present moment
regarding risk of exposure at certain levels----
Mr. Stephenson. Right.
Mr. Baird.--we don't ever expect to have the final answer
on all these chemicals. What IRIS I thought was to get the best
available evidence out there.
Mr. Stephenson. That is what we are suggesting, that you
should take available research, do the best assessment you can,
put it into the database, and the intention is to revisit it at
least every 10 years or when new science becomes available. So
it should be a moving database that is the repository for the
best available science on any chemical.
Mr. Baird. If that is the case then, requests for
additional information that are delaying should not necessarily
delay publication of a position, they should be included as a
corollary opinion or a statement, an explicit statement; but
here is a question that is unresolved, but you don't
necessarily delay moving forward with the information, right?
Mr. Stephenson. But all of that rationale for moving
forward or considering that science later and the next
reassessment of that chemical should be open to the science
community for scrutiny.
Mr. Baird. Right. Right. I think that is right. But I think
there is a difference between saying we are not going to move
forward with something----
Mr. Stephenson. Right.
Mr. Baird.--until we get the additional information versus
move forward with what you have got with the caveat explicitly
stated that while we put this forward, there are these
additional questions. What you are saying right now is that the
additional questions can block moving forward.
Mr. Stephenson. Exactly. If you wait until the science is
perfect, you will never regulate, you will never complete a
toxicity assessment. So it is always a judgment call, and it is
only the first step to deciding whether you need to regulate or
not. It doesn't mean anything. It is just the best available
science on that chemical at the time.
Mr. Baird. Thank you.
Chairman Miller. Thank you, Mr. Baird. Mr. Rohrabacher for
five minutes.
Comparing Risk Assessments: EPA vs. FDA
Mr. Rohrabacher. I have been trying to put into perspective
the discussions on this particular issue compared to some of
the other issues that we face. You seem to be telling us we
need to speed up assessments in the process. Certainly I
wouldn't disagree with the concept about transparency and
openness. In terms of speed, now let me note that in other
areas where we have people taking the----
Chairman Miller. Mr. Rohrabacher, it is very hard to hear
you. Your mic----
Mr. Rohrabacher. Excuse me. I will get a little--have to
lean down a little closer. The assessment time that, for
example, that the FDA takes in approving a new drug or
approving a new medical process that could be sold on the
market, would you think that we should be speeding up those
type of assessments?
Mr. Stephenson. Well, I think they should all be made
efficient. This is entirely different. This is toxic chemicals.
They are not things that you consume, not things that you eat.
Mr. Rohrabacher. Well, but----
Mr. Stephenson. And we----
Mr. Rohrabacher. Actually it is something you consume.
Mr. Stephenson. Well, IRIS----
Mr. Rohrabacher. Something that will affect people's health
and it will affect in a big way whether or not certain people
live or die, and frankly with the FDA approval, we have the
same situation. There are people who wait for years and are
told, oh, boy, the FDA has approved this and it is going to
save 100,000 people a year but it has taken them 10 years to
get it on the market, and it hasn't changed a bit in 10 years.
And so we have to assume that 100,000 people a year have been
negatively affected by not having it available to them. So why
is there a dichotomy then between speeding up the assessment
now but not wanting to speed up the FDA assessments?
Mr. Stephenson. Let me just say that IRIS, you don't start
from scratch in researching the chemical. It is based on a body
of research that is already available. So you are not starting
from ground zero. It is not a new drug that has been
introduced, it is not consumed. You may be exposed to it in a
variety of ways, airborne ways. You are not ingesting it like a
food product or a drug. So the standards are completely
different. Speeding up to me means you start with the available
assignments right now and you create a system where you can
complete the synopsis of a summary of that scientific
information on a given chemical in about two years. Then you
are going to revisit it as new research becomes available. But
if you never finish the risk assessment in the first place,
then EPA can't move to the next step of determining what is
appropriate in terms of regulating or not a given chemical.
This is the first step to regulating or deciding what you need
to regulate a dangerous chemical. This is deciding how
dangerous it is. It is based on existing research, not new
research necessarily.
Mr. Rohrabacher. Well, I think in both situations you have
people's lives at stake or at least their health at stake. And
it seems to me that there is a sort of predetermined reaction
with certain people that some are trying to basically protect
the public to the point that the public is sometimes damaged by
that and sometimes it is not. Sometimes you can be overly
protected and find that the person who is trying to actually
end up helping you is doing something that prevents you from
improving your situation.
Mr. Stephenson. In your example, you are denying a drug
that may save lives in the future. In my example, you are not
moving forward with regulations on a chemical that may protect
human health until you wait for the science to be perfect. It
is a judgment call in both cases. You are absolutely right. But
we are suggesting that if you wait until the science is
perfect, then there is many more years of a potentially
dangerous chemical that could affect public health.
Mr. Rohrabacher. As could public health be affected by
people who take too long in assessing something that could have
a dramatic impact on cancer or some other malady.
Thank you very much. I appreciate your testimony.
Risk Assessment vs. Risk Management
Chairman Miller. Thank you. Mr. Stephenson, if I could get
Mr. Whittaker again to put up the streamlined process, Figure
3.
While it is coming up, Mr. Stephenson, quickly, explain
again in a sentence or two the difference between risk
assessment and risk management.
Mr. Stephenson. Risk assessment is when you are really
synthesizing the best available research on a given chemical to
determine the toxicity of that chemical.
Chairman Miller. What danger does this chemical pose.
Mr. Stephenson. What danger does it potentially pose.
Chairman Miller. What is risk management?
Mr. Stephenson. Risk management is when you take that
information and you decide how serious it is, how many people
are affected, what regulatory options might be available, what
would be the cost benefit of instituting those regulations, and
it is a whole separate process that starts after the risk
assessment is complete.
Chairman Miller. Mr. Rohrabacher talked about some people--
I thought he was probably calling my name--who thought we
should be doing, you know, a good deal more to protect people
from risk. Is that not risk management rather than risk
assessment?
Mr. Stephenson. It is.
Chairman Miller. Okay. So this is simply trying to decide
what danger to the public health and to the environment a
chemical may pose.
Mr. Stephenson. And until you know that you don't know
what----
Chairman Miller. You don't know what to do about it.
Mr. Stephenson. Right.
Chairman Miller. Or whether you need to do anything about
it.
Mr. Stephenson. That is right.
Chairman Miller. Or how to proceed with any kind of risk or
cost benefit analysis, is that correct? Okay. Now, you talked
about transparency. Again, looking at Figure 3, and I assume
that you have got it before you which may be easier on your
neck to look down, but could you kind of walk through the
various steps where there is no public participation, there is
no transparency?
Mr. Stephenson. I don't have it in front of me
unfortunately but----
Chairman Miller. Can you turn so you can see it?
Mr. Stephenson. Where there is no public participation is
when EPA is starting its draft assessment process and other
agencies can comment on the approach and on what things should
be considered on, if they have research they can bring it
forward. With glasses on I can't see that.
Chairman Miller. This is the Science Committee, and the
Science and Technology Committee doesn't mean that we are all
adept at technology.
Mr. Stephenson. Well, I think it is probably, it is hard to
tell. I mean, this is a very confusing process, but in general,
it is the part where they look at the draft assessment,
determine if additional research is needed, what default
assumptions might be appropriate, what toxicity assessments
might be appropriate.
Chairman Miller. And the agencies that are using the
chemical presumably would have a chance to comment at that
point?
Mr. Stephenson. Exactly. Like I say, I disagree with this
in your risk assessment. You may need to do this additional
research or you need to consider that.
Chairman Miller. We are using again the example of TCE. Is
it your impression that the DOD's toxicologist would be
participating or someone else or do you know?
Mr. Stephenson. I don't know.
Chairman Miller. Just someone at Department of Defense
would presumably be participating. How about TCE manufacturers?
Mr. Stephenson. I don't know.
Chairman Miller. You don't know if they would be given an
opportunity to comment privately or publicly? Well, we know
they could comment publicly.
Mr. Stephenson. TCE is a degreaser that is widely used in
motor pools and in gas stations across the country. It is used
everywhere.
Chairman Miller. If the Department of Defense's point is,
we really need to use this or our stuff isn't going to work
right, that is really more risk management than risk
assessment?
Mr. Stephenson. It is. If they have concerns about the cost
of cleaning up TCE based on a given standard, that is all risk
management decisions.
Chairman Miller. And if they are saying this TCE is just
not going to hurt you, it doesn't pose any kind of
environmental risk, it doesn't pose any kind of health risk,
that is risk assessment.
Mr. Stephenson. Exactly.
Chairman Miller. Okay. And wouldn't you expect scientists
to be involved in risk assessment?
Mr. Stephenson. That is our assertion.
Chairman Miller. Is there any reason that if their
toxicologists are participating in this it wouldn't be an open,
transparent process, it wouldn't be peer reviewed, it wouldn't
be an open, transparent discussion, argument, disputation,
asserting facts in public for them to be questioned by other
scientists, other peers, expert in the field? Is there any
reason that kind of debate should be private?
Mr. Stephenson. We can't imagine a scientific concern that
shouldn't be made public.
Chairman Miller. All right. And what expertise in science
does OMB have?
Mr. Stephenson. I don't know.
Chairman Miller. Is that part of their mission to your
knowledge?
Mr. Stephenson. There is no ``s'' in OMB so I don't know.
Chairman Miller. There is no public health, there is no
environment, it is all management and budget. Okay. Mr. Baird,
four or five minutes.
GAO Recommendations
Mr. Baird. Mr. Stephenson, if there would be an ``s'' it
would be OMBS.
Mr. Stephenson. You said that, I didn't.
Chairman Miller. That is the line of questioning I was
pursuing earlier. Can you talk a little bit about what it would
take to change the current situation. Is this something we need
to deal with statutorily or do we need to just say to those who
would meddle inappropriately, knock it off or what do we do?
Mr. Stephenson. Again, we had eight specific
recommendations that EPA said it would consider in our report,
and it did not. Other than loosely assigning some timeframes to
this cumbersome process, I can't imagine what recommendations
they did consider. So that is why we suggest in our testimony--
you have got to remember that the report was written before
this new process was unveiled on April the 10th. Our report was
in March. And so we were frankly very surprised when this
process came out, and we mentioned there may be a need for
legislation. Certainly we would recommend stopping this
process, but there may be--if EPA is unable to make the changes
we suggest in our report, then legislative action may be needed
to establish timeframes and establish a process for them. That
is not the desired approach, but I am not sure what else can be
done.
Mr. Baird. And you don't seem to have seen much evidence
that they are going to follow these recommendations?
Mr. Stephenson. To the contrary. I think this process is
worse than the draft we reviewed because of the transparency
issue, because of the many bites at the apple that agencies
with a conflict of interest like DOD have that is now secretive
and not public. And all this is new from the draft proposal.
But we are encouraging agencies to participate in the process
early, it just should be done in the sunlight and with better
planning and advanced notice of when you are going to do
assessment. There is no reason why this process can't be
shortened and still be very, very credible.
Mr. Baird. Have any cogent arguments been made or what are
the arguments that are made for keeping the shades drawn and
not letting the sunlight in?
Mr. Stephenson. The only thing that came up was the quality
of the assessments. If you take 10 years, the quality doesn't
make much difference because it is obsolete the day it is
finished. So there have been no good arguments that I can see
why this process can't be streamlined and improved, and it is
so, so critical to the protection of human health that we just
have to get it fixed.
Mr. Baird. In science there are some occasions where things
are confidential, identity of peer reviewers and peer review. I
think it is actually an error to do that myself. But certainly
the data are supposed to be made available.
Mr. Stephenson. The data, the assumptions, the process----
Mr. Baird. Methodology.
Mr. Stephenson.--the methodology. Everything should be
totally open. How are you going to assure that the best science
is considered and is in there if it is not an open process?
Mr. Baird. This is admittedly a little bit extreme but
under the current situation, risk analysis, risk assessment
could be sent up. Somebody with OMB or some other agency could
say, yes, but you haven't studied this impact in the strain of
Norwegian rats R24A6. You haven't done this with R24A2, and we
won't let you go forward until you do R24A6 and just sort of
throw that out there, whether or not it is relevant but
nevertheless results in a significant delay. Is that----
Mr. Stephenson. It could happen. I mean, we have no
evidence of that, but if it is not open to scrutiny by the
scientific community, things like that could happen. It could
be continually be assessed. If it is continually assessed, it
is never regulated.
Mr. Baird. But if it were made available, then people would
have transparency and say possibly, thank goodness for this
agency doing their job. It turns out that the assessment had
not looked at something important, and then the people who
asked that more be looked at were doing a good job and a good
public service. Or conversely, the publicity or the
transparency could lead some to say they are asking tangential,
ridiculous, and unjustified questions which are not
scientifically defensible. It could go either way, right?
Mr. Stephenson. Exactly. Very well said.
Mr. Baird. Thank you. I would yield back.
Chairman Miller. Mr. Rohrabacher for five minutes.
More on Risk Assessment vs. Risk Management
Mr. Rohrabacher. Yes, I am not sure if I agree with the
Chairman on his emphasis of differentiating risk management
from risk assessment. Obviously, we live in a real world. What
we have to do is make sure the activities that are being
conducted relate to exactly what the impacts will be and not
just state theoretical standard not associated with the way
things happen in our lives. Is it possible for the OMB to come
in earlier? Scientists, I have a great deal of respect for
scientists, but I also know that sometimes scientists become
too focused and do not fully appreciate the magnitude of what
they are doing to other people and other things outside of the
laboratory. And sometimes perhaps--and I am a journalist by
profession, by the way. So I realize that I do not know this
much about anything but I do know this much about that much.
And sometimes it helps science authorities to have their
perspective come in and talk to them about putting their
science in perspective, rather than having it be a purely
scientific laboratory endeavor, does it not?
Mr. Stephenson. Well, yes, but I mean the toxicity of a
chemical is the toxicity of a chemical. It is not subject to
the implications of whatever that assessment shows. That is
risk management. That is when you decide whether it needs to be
regulated or not.
Mr. Rohrabacher. But there are certain----
Mr. Stephenson. Is it a big risk?
Mr. Rohrabacher. Yeah, but there are certain areas that--
for example, if a certain chemical is needed to complete a
mission that is important for the security or safety or even
health of the public, that should be taken into consideration
in terms of the risks that people take in order to achieve that
other goal.
Mr. Stephenson. Under either risk management phase. That is
when cost becomes an option. Toxicity should have no bearing on
the cost of that toxicity assessment.
Mr. Rohrabacher. But the importance of that should not be
part of a determinant factor by those scientists at all?
Mr. Stephenson. I mean, we are not suggesting that----
Mr. Rohrabacher. That should----
Mr. Stephenson. We are not suggesting that the EPA
scientists go into a vacuum in a closed room and do their
analysis. We are suggesting that everybody should have an
opportunity to comment on that. We just think that all the
comments should be treated openly, that the whole science
community----
Mr. Rohrabacher. There is no question about whatever
communication happens, and I would certainly look into that,
within government, people should be held accountable and it
should be transparent. I mean I certainly am not suggesting
that. I am suggesting that maybe what you are suggesting is
that it be a lack of communication.
Mr. Stephenson. No. No. The cost of cleaning up a given
chemical--let us use TCE again. Let us say that it is
determined and it has been by the National Academy and EPA and
everybody else who has looked at it to be a very toxic chemical
that likely causes cancer. Now we should move to the risk
management phase and decide--that is when we decide, okay, DOD
uses a lot of this stuff and if we set the cleanup standard at
this level, it is going to cost them hundreds of millions of
dollars to clean it up. That is a risk management decision.
Those factors, those cost benefit analysis of the regulation--
--
Mr. Rohrabacher. Or let me put----
Mr. Stephenson.--are appropriate but not in the scientific
phase.
Mr. Rohrabacher. Let me put it in a different way. You have
got a chemical that is an important part of a process that is
used to save lives rather than just put things at risk. Maybe
there is a chemical that is needed in the process of a certain
kind of food that is necessary to prevent starvation or to take
care of certain types of diseases in Africa or such. Yeah, we
need to know that that is important----
Mr. Stephenson. I agree.
Mr. Rohrabacher.--that if there is going to be no way to
control the mosquitoes in Africa if this decision goes the
wrong way.
Mr. Stephenson. I agree, and those decisions are made all
the time. When you consider how expensive it would be for the
regulated community to impose a regulation, all those are fair
game and appropriate discussions, but they are part of the risk
management phase, not the scientifically based risk assessment
phase of a chemical.
Mr. Rohrabacher. I am thinking that what we are talking
about is--again, you are much more an expert. That is why you
are testifying and I am listening. But it just seems to me that
we have--the process isn't as defined as all of these boxes
that we have seen and that people realize that within a period
of time perhaps more science examination can come into the
process rather than in the first box it could also come in the
last box unless we have a totally closed system. Does that make
sense?
Mr. Stephenson. Yeah, and we are not suggesting a closed
system. We are suggesting that it is appropriate for all
commenters to comment on a scientific risk assessment.
Mr. Rohrabacher. I am certainly not in favor of anything
that would hinder transparency or making people accountable.
Mr. Stephenson. Nor are we.
Mr. Rohrabacher. Thank you very much.
Chairman Miller. That was the last round of questions. I
would, just to summarize, if I understand correctly your
testimony in response to Mr. Rohrabacher's question, you see no
virtue in consciously not knowing and not consciously not
learning the potential risk to public health or to the
environment of a chemical?
Mr. Stephenson. None whatsoever.
Chairman Miller. Okay. Thank you very much. If we will now
have a short break, and the next set of witnesses, the next
panel.
[Recess.]
Chairman Miller. Welcome back. We do have a couple of
housekeeping matters that I neglected earlier. One is I now ask
unanimous consent that all Members have two weeks to enter
statements for the record. Without objection.
I also ask unanimous consent to enter materials in the
record. All the materials have been shared with the Minority
already. Again, without objection.
Panel II:
I would now like introduce our second panel. Dr. George
Gray is the Assistant Administrator for Research and
Development of the United States Environmental Protection
Agency. Ms. Susan Dudley is the Administrator for the Office of
Information and Regulatory Affairs of the Office of Management
and Budget, OIRA. As our witnesses should know, taking
testimony is limited to five minutes after which the Members of
the Committee will have five minutes to ask questions in at
least one round and perhaps a series of rounds. It is the
practice of the Subcommittee to take testimony under oath. Do
either of you have any objections to being sworn in? The
Committee also provides that you may be represented by counsel.
Are either of you represented by counsel today? You are not?
Okay. If you would please stand and raise your right hand? Do
you swear to tell the truth and nothing but the truth? Let the
record reflect that both the witnesses answered yes that they
do so swear.
At this point, we will now open our first--I am sorry. Dr.
Gray, you may begin.
STATEMENT OF DR. GEORGE M. GRAY, ASSISTANT ADMINISTRATOR FOR
RESEARCH AND DEVELOPMENT, U.S. ENVIRONMENTAL PROTECTION AGENCY
Dr. Gray. Thank you, Chairman Miller, Members of the
Committee. Thank you for the opportunity to appear before this
subcommittee to discuss EPA's highly regarded IRIS, Integrated
Risk Information System. As you know, IRIS is a repository of
information on potential adverse effects of long-term exposure
to over 540 potential environmental contaminants.
The IRIS program began in the mid-1980s. At that time, it
was clear that the toxicity values that were being used and
developed by EPA were not internally consistent across the
Agency, even when based on the same data. That was due to
different assumptions, different science, different choices of
defaults. IRIS was therefore formed as an internal database in
response to the critical need to have Agency-wide toxicity
values in one place.
Word quickly spread about the existence of IRIS, and State
and local, public health and environmental agencies as well as
the regulated community asked us to make it publicly available.
So in the late 1980's IRIS was made available to the public. I
have actually been interested in and using IRIS for many years
as part of my research and my teaching at the Harvard School of
Public Health. I have had a very longstanding interest in IRIS.
Now the IRIS website gets more than 20,000 hits a day with
inquiries coming from over 100 countries. The IRIS assessments
contain only part of the information that is needed to
characterize public health risks of chemical substances in
support of risk management decisions.
It is important to understand not only how risk assessment
differs from risk management but also to recognize that risk
assessments, including our IRIS assessments, include both
science and science policy components. This is often a source
of confusion.
Now like all living processes, the IRIS process has evolved
over time. For example, efforts have been made to enhance our
peer review process and to address the longstanding issue of
the timeliness of our IRIS reviews. Because it began as an
internal EPA resource, the agenda for developing IRIS
assessments first focused on those chemical assessments that
were needed for EPA. But now each year EPA develops an annual
agenda for the IRIS program and announces the new assessments
under review in the Federal Register. In recent years the IRIS
program has also sought nominations for IRIS chemical reviews
from the public and from other federal agencies.
Some of these recent changes in the IRIS process include:
development of our IRIS track web system so people can see the
status of a chemical; new opportunities for the public and
other agencies to review and comment on IRIS assessments; and
enhanced independent external peer review of our draft IRIS
assessments.
In 2005, a formal process for documenting all the existing
steps in the IRIS process, including formalizing some of these
and some new recent changes to the process, was initiated. And
on April 10, 2008, this revised IRIS process was announced by
EPA.
The release of this is noteworthy because this is the first
time that the IRIS process has been transparently documented
and made available to the public. The new IRIS process has been
designed to provide greater transparency, objectivity, balance,
rigor, and predictability in our IRIS assessments. For example,
improvements in the IRIS process helped define critical and
appropriate roles for public and interagency comments and for
interactions that promote greater communication, sharing
information, between all interested parties in EPA. Yearly
involvement of various stakeholders is consistent with
recommendations we received from our own science advisory board
and from the GAO. Remember that along with the increased
opportunities for public and other agency involvement, all
draft IRIS toxicological reviews will ultimately undergo
independent external peer review, and all final decisions on
IRIS content remain with EPA.
It is worth noting that the revised IRIS process also meets
many of the recommendations of the recently-issued 2008 GAO
report. Specifically, we believe that the new process clearly
defines and documents a streamlined IRIS process, it defines
the critical and appropriate roles for the public and other
agencies, and importantly, it sets time limits for all parties
including EPA. So though the revised process is expected to
improve the timeliness of IRIS assessments, it is important to
recognize that many assessments today are more complex than
ever, and some assessments will take longer than others to
complete.
For example, recent NAS and Science Advisory Board
reviewers have recommended EPA do a better job of incorporating
quantitative uncertainty analysis in IRIS assessments.
Right now, EPA needs time to implement and evaluate this
new process, recognizing that additional changes to the process
may be needed in the future because it really is intended to be
a living database and a living process.
So thank you, Chairman Miller and Members of the
Subcommittee for the opportunity to describe the scope, the
purpose, and the future of EPA's IRIS program. I look forward
to answering any questions you may have.
[The prepared statement of Dr. Gray follows:]
Prepared Statement of George M. Gray
Good morning, Chairman Miller and Members of the Committee. My name
is Dr. George Gray, and I am the Assistant Administrator for Research
and Development (ORD) at the U.S. Environmental Protection Agency
(EPA). I also serve as the Agency's Science Advisor. Thank you for this
opportunity to appear before the Subcommittee to discuss EPA's highly
regarded Integrated Risk Information System (IRIS), which is managed by
EPA's National Center for Environmental Assessment (NCEA) within ORD.
As you may know, IRIS is a repository of human health risk
information on the potential adverse effects of long-term, or chronic,
exposure to over 540 potential environmental contaminants. The risk
information in IRIS can include quantitative risk estimates for both
non-cancer and cancer effects, as well as a detailed narrative that
accompanies the risk estimates. The narratives, or qualitative risk
information, include a full discussion of the peer reviewed scientific
literature used in the assessment, the EPA confidence in the IRIS risk
estimates, and an explanation of the judgments (including application
of default approaches and uncertainty factors) that the Agency must
make in the face of inadequate data.
A significant part of EPA's efforts to fulfill its mission to
protect public health and the environment is to regulate, when
necessary, the release of contaminants into the Nation's air, water,
and soil. As first outlined by the National Academy of Sciences (NAS)
in its seminal 1983 report (``Risk Assessment in the Federal
Government: Managing the Process,'' National Academies Press,
ISBN:0309033497, commonly called the ``Red Book''), there are two
distinct steps that should be used in the Federal Government to assess
and manage risks. These steps are called risk assessment and risk
management. Risk assessment, as defined by the NAS, is ``the
characterization of the potential adverse health effects of human
exposures to environmental hazards'' (p. 18). Risk assessments can
entail either quantitative or qualitative expressions of risk, and
should include characterization of the uncertainties inherent in the
process of inferring risk. The risk assessment process has four
components: hazard identification, dose-response evaluation, exposure
assessment, and risk characterization. Risk management is defined by
the NAS as ``the process of evaluating alternative regulatory options
and selecting among them'' (p. 18). A risk assessment may serve as one
of the bases of risk management.
IRIS assessments fall into the first step (risk assessment);
however they only include information on hazard identification and
dose-response evaluation. Combined with exposure information,
government and private entities use IRIS to help characterize the
public health risks of chemical substances and thereby support risk
management decisions. Thus, it is important to note that an IRIS health
assessment is not a complete risk assessment. It provides part of the
foundation for EPA's decision-making and regulatory processes. In
addition, risk managers consider other important factors in a risk
management decision such as exposures, statutory and legal
considerations, social considerations, public health considerations,
economic factors, and political considerations.
It is important to recognize that although risk assessment is
distinct from risk management, the risk assessment process consists of
both ``science'' and ``science policy'' components. That is, although
there are some instances at EPA where ``pure science'' is involved
(e.g., conducting bench or lab research on animals in toxicity
studies), much of the work done at EPA (including IRIS assessments)
involves both science and science policy. For example, due to the
uncertainty in IRIS assessments, judgments and choices must be made
about the most appropriate assumptions, data sets, health endpoints,
models, etc. to use in deriving toxicity values. These are science
policy choices because the science is not precise enough to provide
definitive answers. For this reason, guidance documents such as EPA's
``Guidelines for Carcinogen Risk Assessment'' were developed and
approved through the Agency's Science Policy Council to inform the many
choices in the risk assessment process. This is an important
distinction that is often overlooked or confused by the public, yet the
NAS Red Book (1983) recognized and commented on this issue in the very
first chapter and its section on ``Scientific and Policy Judgments in
Risk Assessment'' (p. 28).
The IRIS program began in the mid-1980s. At that time, it was clear
that the toxicity values that were being developed by EPA were not
internally consistent across the Agency. For example, EPA's Program
Offices were publishing toxicity values for a particular chemical in
their rule-makings and in other policy documents that were based on the
same set of available scientific data--but these values could be orders
of magnitude different and based on different human health endpoints or
default uncertainty factors. This example illustrates how important it
is to acknowledge where the science stops and science policy begins, as
credible scientists can (and often do) reach different conclusions
based on their interpretation of the science or make different choices
when confronted with several scientifically plausible options. IRIS was
therefore formed in response to a critical need to have Agency-wide
toxicity values in one place--including accompanying narratives
detailing the supporting studies, key assumptions and choices, and text
on confidence--that were developed through reviews by Agency health
scientists.
IRIS was originally intended to be an internal system that provided
EPA risk assessors and managers with an EPA consensus position on the
potential human health hazard and dose-response information for
environmental contaminants of interest to Agency programs and regions.
Word spread quickly about the existence of IRIS and many asked to make
it a publicly available system. State and local public health and
environmental agencies, as well as the regulated community, requested
access to the IRIS information. Therefore, in the late 1980's, IRIS
access was made available to the public. EPA was pleased to share this
information resource with a large, external user community. IRIS first
became available on a dial-up service and later through the National
Library of Medicine's TOXNET family of information resources, and then
on the Internet. The IRIS web site is accessed over 20,000 times per
day with inquiries coming from well over 100 other countries.
The IRIS process has evolved over time including in areas such as
setting the annual IRIS agenda, level of independent external peer
review, and opportunities for public and other federal agency review
and comments. Because IRIS began as an internal EPA resource, the
agenda for developing IRIS assessments focused on those chemical
assessments of interest to EPA's program offices and regions. It was an
informal process where only Agency needs were addressed. Now each year,
EPA develops an annual agenda for the IRIS program and announces new
assessments under review in the Federal Register. EPA uses five general
criteria to determine which new chemicals to assess: (1) potential
public health impact; (2) EPA statutory, regulatory, or program/
regional-specific implementation needs; (3) availability of new
scientific information or methodology that might significantly change
the current IRIS information; (4) interest to other governmental
agencies or the public; and (5) availability of other scientific
assessment documents that could serve as a basis for an IRIS
assessment.
In recent years, the IRIS Program has also sought nominations for
IRIS chemical reviews from the public and other federal agencies. The
list of new or updated assessments chosen for potential development is
published in the Federal Register (FR) as part of the IRIS annual
agenda. The Agency is also working to improve the prioritization
process to more appropriately capture relative priorities of individual
chemical assessments under development. For each of the assessments
added to the IRIS agenda, an initial literature search is conducted. As
literature searches are completed, the results are posted on the IRIS
web site (www.epa.gov/iris) and the public and other agencies are
invited to review the literature search results and submit additional
information to EPA. Other recent changes to the IRIS process include
creation of a chemical assessment tracking system (IRISTrack) on the
IRIS web site to inform the public and stakeholders of the status of
the IRIS assessments that are underway, new opportunities for the
public and other agencies to review and comment on the qualitative and
draft IRIS assessments (including the ability to participate in
``listening sessions'' held during the public comment period), and
enhanced independent external peer reviews of draft IRIS assessments.
The IRIS program has also experienced an expansion of scientific staff
and a significantly increased budget over the last few years. For
example, based on the enacted FY 2003 resources, EPA has since nearly
tripled the number of IRIS staff and have quadrupled the IRIS budget
through the FY 2009 request to 37.0 FTE and $9.4 million, respectively.
In 2005, a formal process for documenting all of the existing steps
in the IRIS process, including formalizing recent changes to the
process, was initiated, and on April 10, 2008, the revised IRIS process
was announced by EPA. The public release of the revised IRIS process is
especially noteworthy because the IRIS process has never before been
transparently documented and made available to the public.
Consequently, the IRIS process had often been viewed as a ``black box''
both within and outside of the Agency, as it was unclear what steps
comprised the process, what the timing was for each step, or where
opportunities existed for internal and external Agency involvement. The
new IRIS process has been designed to provide greater transparency,
objectivity, balance, rigor and predictability in IRIS assessments.
Specifically, improvements to the IRIS process help define critical and
appropriate roles for public and interagency comments and interactions,
and promote greater communication and sharing of information between
all interested parties and EPA. The outcome of these improvements are
expected to result in a more predictable, streamlined, and transparent
process for conducting IRIS assessments, which will ultimately lead to
assessments that are of the highest quality and rigor.
Delays in the completion of IRIS assessments have been a long-
standing problem at EPA. For example, prior IRIS assessments took an
average of five years to complete, and EPA has been working on some
assessments for a decade or longer. The revised process was designed to
help address these delays, in part, by allowing for input from various
stakeholders (e.g., EPA program and regional offices, other agencies,
scientific organizations, NGOs, and the public) early in the process
and providing clear descriptions and timeframes for each step. The
early involvement of various stakeholders is consistent with
recommendations from EPA's Science Advisory Board (SAB) as well as a
prior report by the General Accounting Office (GAO). For example, in a
September 26, 2000, letter from EPA's SAB to Administrator Carol
Browner, it was noted that ``critical data'' were often missing from
IRIS risk assessment discussions and it was suggested that one way to
enhance the quality of toxicologic evaluations was to ``make the IRIS
process open to public stakeholder review in a more formal manner.'' A
2006 report by GAO (GAO-06-595) entitled ``Human Health Risk
Assessment: EPA Has Taken Steps to Strengthen Its Process but
Improvements Needed in Planning, Data Development, and Training'' also
noted that ``. . . several experts said that increased involvement with
a broad range of stakeholders early in the planning process would help
identify alternative methods and models and obtain stakeholder
concurrence with the agency's approach.'' The new process therefore
allows the EPA access to a wide range of scientific data, expertise,
and knowledge that can be used to produce timely and high quality IRIS
assessments. However, it should be noted that all draft IRIS
assessments are peer reviewed by outside experts, and all final
decisions on IRIS content remain with EPA.
It is important to recognize that many of the assessments today are
more complex than ever before. For example, some chemicals have
extensive toxicity testing data that must be reviewed and analyzed, new
data are now available for assessing the mode of action of many
chemicals, and more sophisticated statistical and modeling techniques
(e.g., physiologically-based pharmacokinetic or PBPK models) are now
available for evaluating intra-species and inter-species differences.
Recent peer reviews of IRIS assessments by the NAS and EPA's SAB have
also recommended that EPA do a better job of incorporating quantitative
uncertainty analyses into IRIS assessments. The timelines in the new
IRIS process balance the need for careful consideration of science and
science policy in assessments with the Agency's need for information.
An important aspect of the revised process includes ``mission
critical'' chemicals that will be determined by a sponsoring agency
together with EPA. A ``mission critical'' chemical is one that is an
integral component to the successful and safe conduct of an agency's
mission in any or all phases of its operations. Impacts on use of
mission critical chemicals include cessation or degradation of the
conduct of the mission and/or unacceptable resource constraints.
Agencies must identify to ORD those chemicals on the IRIS Program
Annual Agenda that they determine meet this definition, and generate a
detailed report documenting what types of new research will address
significant data gaps and whether such research can be conducted within
the allotted time frame (but it is ultimately up to EPA to agree to
allow new research to be conducted). Although we do not anticipate that
many chemicals will receive this designation each year or that
additional studies will be requested for all mission critical
chemicals, any such new studies will help fill important data gaps to
ensure assessments of the highest quality.
Independent external peer reviews are also a hallmark of EPA's
commitment to ensuring we have high-quality science that has been
vetted by a panel of outside experts. Consistent with past practices,
the revised process specifies that all draft IRIS Toxicological Reviews
will undergo independent external peer review. Most reviews will be
conducted by external peer review panels at public meetings, although a
small number of complex or high profile chemicals may undergo more in-
depth SAB or NAS peer reviews. As part of the revised IRIS process,
external peer reviewers will also for the first time have an
opportunity to review the revised IRIS Toxicological Review and comment
on ORD's responses to the peer reviewers and public comments. This is
an important step that is consistent with other peer review practices,
such as publishing in the peer-reviewed literature, to ensure that peer
reviewer comments are adequately addressed or sufficient rationale is
provided for not addressing such comments.
It is noteworthy that the revised IRIS process meets many of the
recommendations of the recently issued 2008 GAO report entitled ``Toxic
Chemicals: EPA's New Assessment Process Will Increase Challenges EPA
Faces in Evaluating and Regulating Chemicals'' (GAO-08-743T).
Specifically, the revised process (1) clearly defines and documents a
streamlined IRIS assessment process; (2) sets time limits for all
parties, including OMB and other federal agencies, to provide comments
to EPA on draft IRIS assessments; (3) defines the appropriate role of
external federal agencies in EPA's IRIS assessment process; and (4)
determines the types of IRIS assessments to conduct on the basis of the
needs of EPA's program offices and other users. The GAO (2008) report
also lacks an appropriate characterization of several key issues. For
example, the GAO report erroneously suggests that only pure science is
involved in the risk assessment process. In reality, all risk
assessments (including IRIS assessments) have always included a mix of
science and science policy, as acknowledged in the NAS (1983) Red Book.
The GAO report also mischaracterizes the interagency review process at
EPA. Specifically, to ensure that scientists and policy-makers are able
to have full and frank discussions without being concerned about how
these discussions may be viewed or misrepresented, all internal EPA
comments and interagency comments and disposition documents on draft
IRIS assessments are considered ``deliberative'' and do not become a
part of the public record. This is not a new or unique process, as this
protection is the same as that afforded any other policy-making setting
at EPA (and other federal agencies follow similar processes).
Additionally, once EPA comes to a conclusion and releases its external
review draft, there is a transparent public comment and external peer
review process. The GAO report also incorrectly suggests that EPA will
not have the final say on the content of IRIS assessments under the
revised process. However, despite increased opportunities for public
and other agency involvement, the revised process makes it clear that
all final decisions on content will remain within EPA.
EPA now needs time to implement and evaluate the new process,
recognizing that additional changes to the process may be needed in the
future (i.e., it is intended to be a ``living'' document). Because the
revised process attempts to streamline and set specific time frames for
each step, it is expected to reduce the amount of time to complete
future IRIS assessments.
Thank you, Chairman Miller and Members of the Subcommittee for this
opportunity to describe the scope, the purpose and the future of EPA's
IRIS program. I look forward to answering any questions you may have.
Biography for George M. Gray
On November 1, 2005, Dr. Gray was sworn in to serve as the
Assistant Administrator for the Office of Research and Development,
which is the 1,900-person, $600 million science and technology arm of
the Environmental Protection Agency. Dr. Gray was appointed to this
position by President George W. Bush and confirmed--by unanimous
consent--by the U.S. Senate.
Prior to joining EPA, Dr. Gray was Executive Director of the
Harvard Center for Risk Analysis and a Lecturer in Risk Analysis at the
Harvard School of Public Health (HSPH). In 16 years at HSPH, his
research focused on scientific bases of human health risk assessment
and its application to risk policy with a focus on tradeoffs in risk
management. Dr. Gray taught toxicology and risk assessment to both
graduate students and participants in the School's Continuing
Professional Education program.
Dr. Gray holds a B.S. degree in biology from the University of
Michigan, and M.S. and Ph.D. degrees in toxicology from the University
of Rochester. He and his wife, Ann, and their two children make their
home in McLean, Virginia.
Chairman Miller. Thank you, Dr. Gray. Ms. Dudley for five
minutes.
STATEMENT OF MS. SUSAN E. DUDLEY, ADMINISTRATOR, OFFICE OF
INFORMATION AND REGULATORY AFFAIRS (OIRA), OFFICE OF MANAGEMENT
AND BUDGET
Ms. Dudley. Thank you, Chairman Miller and distinguished
Members of the Committee. As administrator of the Office of
Information and Regulatory Affairs, or OIRA, I am pleased to be
here today to talk with you about OIRA's role in ensuring that
the highest quality of information, including scientific
information, is used and disseminated by federal agencies.
OIRA was created as part of the Office of Management and
Budget by the Paperwork Reduction Act of 1980. Staffed almost
exclusively by career civil servants, OIRA has served
Administrations, both Democratic and Republican, for decades by
providing centralized oversight and interagency coordination of
federal information, as well as regulatory and statistical
policy.
In recognition of the increasing importance of science-
based regulation at federal agencies, OIRA's staffing has
evolved over the last 8 years to include scientific and
engineering expertise to accompany a well-established team of
economists, statisticians, lawyers, and information policy
specialists. This more diversified pool of expertise enables us
to engage with federal experts throughout the government on
issues relevant to policy development.
Since the fall of 2005, OMB has coordinated interagency
review of the Environmental Protection Agency's IRIS. IRIS is
an important online database containing science and science
policy information on chronic human health effects. It supports
risk-based decision-making not only by EPA but by other federal
agencies, State and local environmental programs, international
regulatory bodies, academia, industry and others.
Interagency coordination allows EPA to take advantage of
the broad scientific expertise that exists throughout the
government. The science in IRIS assessments is growing more and
more complex, and vigorous discussion among a diverse set of
governmental experts helps EPA ensure that the IRIS assessments
reflect the consensus on the best science and science policy
judgments. OMB has continually supported changes that will
improve the quality and efficiency of the IRIS program.
Since 2000, OMB has supported funding increases of over 450
percent, and IRIS's program budget has increased from $1.7
million in fiscal year 2000 to $9.6 million in fiscal year
2007. Despite this increased funding, concerns remain with the
pace of development of IRIS assessments. EPA observes that
assessments take an average of five years to complete, with
some taking as long as 10 years. In response to concerns both
with delays in implementing IRIS assessments and lack of
transparency in the IRIS process, EPA has recently revised the
process to clarify the role of the public and interagency
reviewers and promote greater communication and sharing of
information between all interested parties and EPA. The new
process is expected to reduce the time to complete an IRIS
assessment from the historical average of over five years down
to three to four and one-half years. EPA expects these changes
will result in a more predictable, streamlined, and transparent
process for conducting IRIS assessments, which will ultimately
lead to assessments that are of the highest quality and rigor.
So in conclusion, let me reiterate a few key points. EPA's
IRIS database is a highly regarded database of potential
chronic effects of environmental contaminants on human health.
It is widely used within EPA, by other federal, State, and
local agencies and elsewhere to support policies to protect
human health. It includes science policies as well as pure
science, quantitative risk estimates, and qualitative
narratives. Scientists at other federal agencies and the public
have an appropriate role in the development of IRIS
assessments. EPA's recent clarifications to the process for
developing IRIS assessments should improve both the quality and
efficiency of assessments by engaging the public as well as
experts within and outside the government earlier in the
process and providing streamlined opportunity for review and
comment.
I have a few seconds left on my clock. I would like to
correct a misimpression that may have been left from the last
panel. OMB did not review EPA's response to the GAO report as
was suggested.
Thank you.
[The prepared statement of Ms. Dudley follows:]
Prepared Statement of Susan E. Dudley
Chairman Miller, Ranking Member Sensenbrenner, and distinguished
Members of the Committee, thank you for inviting me to testify at
today's hearing about the Environmental Protection Agency's Integrated
Risk Information System (IRIS) database policy.
As the Administrator of the Office of Information and Regulatory
Affairs (OIRA), I am pleased to be here today to talk with you about
OIRA's role in ensuring that the highest quality of information,
including scientific information, is used and disseminated by federal
agencies.
OIRA was created as part of the Office of Management and Budget
(OMB) by the Paperwork Reduction Act of 1980. Staffed almost
exclusively by career civil servants, OIRA has served Administrations,
both Democratic and Republican, for decades by providing centralized
oversight and interagency coordination of federal information, as well
as regulatory and statistical policy.
Over the last 27 years, OIRA's interagency coordination role has
been an integral part of government accountability--a non-partisan tool
for understanding the likely effects of government policy. In
recognition of the increasing importance of science-based regulation at
federal agencies, OIRA's staffing has evolved over the last eight years
to include scientific and engineering expertise to accompany a well
established team of economists, statisticians, and information
technology specialists. This more diversified pool of expertise enables
us to engage with experts throughout the Federal Government on issues
relevant to policy development.
EPA's Updated IRIS Process
The Environmental Protection Agency (EPA)'s Integrated Risk
Information System (IRIS) is an online database prepared and maintained
by the EPA's National Center for Environmental Assessment (NCEA) within
the Office of Research and Development (ORD). IRIS contains science and
science policy information on chronic human health effects.\1\ The
hazard identification and dose-response assessment information in IRIS
can be used in combination with exposure information to characterize
the public health risks of a given substance in a given situation.
These risk characterizations can form the basis for risk-based
decision-making, regulatory activities, and other risk management
decisions designed to characterize and protect public health. The IRIS
database supports risk-based decision-making not only by EPA, but by
other federal agencies, State and local environmental programs,
international regulatory bodies, academia, industry, and others.
According to EPA, national and international users access the IRIS
database approximately nine million times a year.\2\
---------------------------------------------------------------------------
\1\ See EPA, ``Revised IRIS Process Q&A's,'' (EPA Q&A) question 1,
available at http://oaspub.epa.gov/eims/
eimscomm.getfile?p-download-id=472643
\2\ See U.S. Government Accountability Office, Report to Chairman,
Committee on Environment and Public Works, U.S. Senate, ``Chemical
Assessments: Low Productivity and New Interagency Review Process Limit
the Usefulness and Credibility of EPA's Integrated Risk Information
System,'' (March 2008), p. 6.
---------------------------------------------------------------------------
OMB recognizes the importance of IRIS assessments for making sound,
science-based decisions across the government, throughout the country,
and internationally as well. OMB has continually supported changes that
will improve the quality and efficiency of the IRIS program.
Since 2000, OMB has supported funding increases for the IRIS
program of over 450 percent; as evidenced in the President's annual
budgets, the funding requested has increased from $1.7 million in FY
2000 to $9.6 million in FY 2007.\3\
---------------------------------------------------------------------------
\3\ Id. at 14.
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Despite these funding increases, concerns remain with the pace of
development of IRIS assessments. EPA observes that prior assessments
took an average of five years to complete, with some taking as long as
10 years.\4\ In response to concerns both with delays in completion of
IRIS assessments, and lack of transparency in the IRIS process, EPA has
recently revised the process to provide greater transparency,
objectivity, balance, rigor and predictability in IRIS assessments. The
revised process clarifies the role of the public and interagency
reviewers, and promotes greater communication and sharing of
information between all interested parties and EPA. EPA expects these
changes to result in a more predictable, streamlined, and transparent
process for conducting IRIS assessments, which will ultimately lead to
assessments that are of the highest quality and rigor.\5\
---------------------------------------------------------------------------
\4\ See EPA Q&A, supra note 1, at question 13.
\5\ Memorandum from EPA Deputy Administrator Marcus Peacock to EPA
Assistant Administrator George Gray (Peacock Memo), ``Implementation of
Revised IRIS Process,'' (April 10, 2008), available at http://
oaspub.epa.gov/eims/
eimscomm.getfile?p-download-id=472651
---------------------------------------------------------------------------
The nomination process for chemicals to be included in IRIS is
transparent and open. ORD initiates the process through a Federal
Register notice which invites nominations from the public and at the
same time reaches out to the EPA Program and Regional Offices and other
agencies for their nominations. After receiving the nominations and
discussing them with other agencies and EPA Program and Regional
Offices, EPA determines its IRIS agenda for the coming year, and
publishes that in the Federal Register. EPA's determination is based on
its published selection criteria, as well as its available work force
and areas of expertise.
EPA then begins the process of developing chemical health
assessments that ultimately are posted to the IRIS database.\6\ This
assessment process consists of 13 steps:
---------------------------------------------------------------------------
\6\ Id.
---------------------------------------------------------------------------
1. A scientific literature search for each chemical;
2. A Federal Register notice seeking scientific information
on selected chemical substances;
3. EPA development of draft qualitative IRIS health
assessment;
4. Review of the draft qualitative assessment within EPA, by
other agencies, and by the public, announced in the Federal
Register;
5. EPA review of public and agency comments;
6. EPA evaluation of interagency interest in closing data
gaps for mission critical chemicals;\7\
---------------------------------------------------------------------------
\7\ EPA defines a ``mission critical chemical'' as one that is an
integral component to the successful and safe conduct of an Agency's
mission in any or all phases of its operation. Id. at n. 1.
7. Design and implementation of new studies for mission
---------------------------------------------------------------------------
critical chemicals, if needed;
8. EPA completion of its draft IRIS review, including
quantitative values;
9. EPA initiation of interagency review (and revision of
draft assessment documents as appropriate);
10. EPA initiation of independent external peer review and
release of the draft IRIS assessment to the public;
11. EPA revision to the IRIS assessment and development of an
IRIS summary based on expert review and public comment;
12. EPA initiation of final intra-agency and interagency
review; and
13. EPA completion of the IRIS assessment and IRIS summary and
posting of completed IRIS assessments on to the database.
OMB Role in the IRIS Process
Since the fall of 2005, OMB has coordinated review of IRIS
assessments (steps 9 and 12 in the new process). Interagency
coordination allows EPA to take advantage of the broad scientific
expertise that exists throughout the government. The science in IRIS
assessments is growing more and more complex, and vigorous discussion
that involves a diverse set of governmental experts helps EPA ensure
that the IRIS assessments represent the consensus opinions of the
government's leading scientists. In addition, risk assessment involves
science policy judgments which help to shape the risk assessment
process. As many accepted `default' positions are based on scientific
consensus opinions, a frank and broad discussion among interagency
experts helps to inform EPA's choices.\8\ The agencies involved in any
interagency review process will vary depending on the chemical in
question, agencies' expertise, and agencies' interest in it. The
interagency group may consist of representatives from the following
offices and departments:
---------------------------------------------------------------------------
\8\ See EPA, Office of the Science Advisor, Staff Paper, ``Risk
Assessment Principles and Practices,'' (March 2004), available at
http://www.epa.gov/OSA/pdfs/ratf-final.pdf. Sections 2.1.3 and 4.1.2
discuss the science policy used in risk assessment and in determining
default assumptions.
---------------------------------------------------------------------------
Office of Management and Budget (OMB),
Office of Science and Technology Policy (OSTP),
Council on Environmental Quality,
Department of Health and Human Services (HHS)
[including representation from the Agency for Toxic Substances
and Disease Registry (ATSDR), Centers for Disease Control and
Prevention (CDC), National Institutes of Health (NIH), National
Institute for Environmental Health Sciences (NIEHS), National
Institute for Occupational Safety and Health (NIOSH) and Food
and Drug Administration (FDA)],
Department of Defense (DOD),
Department of the Interior (DOI),
Department of Labor (DOL),
National Air and Space Administration (NASA),
Department of Energy (DOE),
Department of Transportation (DOT),
Department of Agriculture (USDA), and
the Consumer Product Safety Commission (CPSC).
In step 9 noted above, EPA provides OMB the draft health assessment
and the draft charge to the external peer reviewers. OMB distributes
these draft documents to the others in the interagency group for review
and comment. EPA then revises the draft health assessment and charge,
as appropriate, to respond to the interagency comments. After
completing interagency review, EPA publishes the draft assessment in
the Federal Register for public comment and begins independent peer
review. After revising the IRIS assessment based on peer review and
public comment, EPA again shares the assessment with OMB and other
federal agencies (step 12 listed above).
Under EPA's revised system, OMB will continue to coordinate
interagency review to help assure timely responses from agencies within
designated review periods. For step 9, interagency review comments are
due within 30 to 60 days, depending on the complexity of draft
assessment documents.\9\ EPA will respond, as appropriate, in 15-30
days.\10\ At step 12, interagency and intra-agency review comments are
provided to ORD within 30 days\11\ and ORD addresses any remaining
issues within 15 days.\12\ In addition, the EPA web page allows the
public to track the progress of each chemical as it moves through the
IRIS assessment process.\13\
---------------------------------------------------------------------------
\9\ See Peacock Memo, supra note 5, at step 9(C)(a).
\10\ Id. at step 9(E).
\11\ Id. at step 12(D)(a).
\12\ Id. at step 12(E).
\13\ See www.epa.gov/iris
---------------------------------------------------------------------------
OMB supports the new EPA IRIS process and EPA's efforts to provide
greater transparency, and opportunities for the public to share
information and comment on EPA's assessment. For example, the public
has an opportunity to comment on EPA's initial literature review and to
present additional information on a chemical. The public can also
comment on the draft qualitative assessment and participate in an EPA-
sponsored ``listening session.'' This ``listening session'' will allow
for broad public participation earlier in the assessment process. The
new process also defines appropriate roles for the public and
interagency interactions with ORD and also allows the interagency
group, as well as the EPA Program and Regional Offices, in addition to
the public, opportunities to share information and comment on EPA's
draft assessments.\14\ All of these steps will also help to ensure the
high quality of IRIS assessments. OMB also believes that the new
process will increase efficiencies in the IRIS program. EPA estimates
that the new process will reduce the time to complete an IRIS
assessment from the historical average of over five years to three to
four and one-half years, with perhaps an additional one to two and one-
half years for the smaller number of mission critical chemicals.\15\
Thus this revised process not only allows for earlier public and agency
involvement, but also streamlines the process such that EPA will be
able to release IRIS assessments in a more timely manner.
---------------------------------------------------------------------------
\14\ See EPA Q&A, supra note 4, at questions 6 and 12.
\15\ Id. at question 13.
Conclusion
Thank you for the opportunity to testify in today's hearing. EPA's
IRIS database is highly regarded and widely used. EPA's recent
clarifications to the process for developing IRIS assessments should
improve both the quality and efficiency of the assessments by engaging
the public as well as experts within and outside the government earlier
in the process and providing streamlined opportunity for review. I
would be happy to answer any questions you may have.
Biography for Susan E. Dudley
Susan Dudley was nominated by the President on July 31, 2006, and
appointed on April 4, 2007, to serve as the Administrator of the Office
of Information and Regulatory Affairs (OIRA) of the Office of
Management and Budget.
Prior to her service at OIRA, from 1998 through January 2007, Ms.
Dudley served at the non-profit Mercatus Center at George Mason
University, where she directed the Regulatory Studies Program from 2003
to 2006. As an Adjunct professor at the George Mason University School
of Law from 2002 to 2006, she designed and taught courses on
regulations and led regulatory clinics.
Earlier in her career, Ms. Dudley served as a career civil servant,
working as a policy analyst at the Environmental Protection Agency
(1984-1985), an economist at OIRA (1985-1989), and an economist advisor
to the Commodity Futures Trading Commission (1989-1991). From 1991
until 1998, she was a consultant to government and private clients at
Economists Incorporated.
Ms. Dudley has authored more than 25 scholarly publications on
regulatory matters ranging from e-rule-making, to electricity, health
care, the environment, and occupational safety. Before joining the
Administration, she served on the boards of the Association of Private
Enterprise Education and the International Foundation for Research in
Experimental Economics, which was founded by Nobel Prize winning
economist Vernon Smith. She has also served as a citizen member of
several committees and boards in the Commonwealth of Virginia,
including the Virginia Environmental Education Advisory Committee
(2000-2002), the Administrative Law Advisory Committee (2000-2003), and
the Virginia Waste Management Board (1996-2001).
Ms. Dudley holds a Master of Science degree from the Sloan School
of Management at the Massachusetts Institute of Technology (1981) and a
Bachelor of Science degree (summa cum laude) in Resource Economics from
the University of Massachusetts, Amherst (1977). She lives in Virginia
with her husband and two sons.
Discussion
Chairman Miller. Thank you, Ms. Dudley. There are only
three witnesses today. Mr. Stephenson, would you mind rejoining
the panel so you might be able to respond to questions that
were directed to all of us because your testimony has been very
different from the testimony of that we have heard from others
today.
Mr. Stephenson. Yes, it has.
Chairman Miller. Again, if Mr. Whittaker could put up
Figure 1.
Mr. Rohrabacher. Mr. Chairman, I might note that we didn't
have these witnesses available to comment on his testimony----
Chairman Miller. Well, they certainly----
Mr. Rohrabacher.--to have the time when he was testifying.
It seems to be not quite a balanced decision on your part.
More on EPA's GAO Exit Conference Comments
Chairman Miller. Dr. Gray, do you have anything to say in
response to anything Mr. Stephenson said?
Dr. Gray. There are areas where I think there is some
misperceptions in some of Mr. Stephenson's testimony.
Chairman Miller. Perhaps we can elaborate on those as we go
along. Ms. Dudley? Okay, could you----
Ms. Dudley. Yes, I do, too.
Chairman Miller. Can you just tell me the topics quickly
and perhaps we can try to hit those as we ask questions, Mr.
Rohrabacher and I.
Ms. Dudley. I don't have notes on all the topics. One was
the notion that OMB reviewed EPA's response to the GAO report,
which is not true. OMB did not review that.
Chairman Miller. You have already said that that was simply
not true.
Ms. Dudley. Just the----
Chairman Miller. Is there anything that you want to
elaborate besides that it is not true?
Ms. Dudley. Yeah, the suggestion that OMB doesn't have
scientific expertise. You know, Mr. Stephenson's response was
that there is no ``s'' in OMB but there is no ``s'' in GAO,
either.
Chairman Miller. Okay.
Mr. Stephenson. Or EPA.
Ms. Dudley. That is right. So I don't think whether there
is an ``s'' in the title of an agency qualifies.
Mr. Stephenson. Well, I didn't mean that literally.
OMB's Role in Risk Assessments
Chairman Miller. Well, we haven't really begun our line--
well, I guess I will now recognize myself for five minutes.
Following that, Ms. Dudley, do you think it is part of the role
of OMB or allow it to review scientific assessments prepared by
other agencies of government?
Ms. Dudley. OMB serves a coordinating function. We
coordinate interagency review of various things, so OMB's role
I think is a legitimate role. We have scientists that engage
other scientists throughout the Federal Government in reviewing
IRIS assessments.
Chairman Miller. Well, I understand that there is one
toxicologist that works for OIRA, is that correct?
Ms. Dudley. You know, I am not sure exactly their
credentials. We have toxicologists, risk assessors,
statisticians.
Chairman Miller. Well, they are remarkably productive,
because they respond point by point in great detail at great
length to the assessments that come up from the scientific
agencies of government. Is that all done in-house or are there
others who are invited to participate in OIRA's work or OMB's
work?
Ms. Dudley. No, it is certainly an interagency effort. So
OMB doesn't provide the--we don't do the analysis, we
coordinate it with other agencies. So we take advantage of the
expertise throughout the Federal Government. So at the----
Chairman Miller. Do you take advantage of expertise outside
of the Federal Government?
Ms. Dudley. No, as a rule, OIRA does not do that. Our role
is coordinating within the government.
More on the IRIS Process
Chairman Miller. Okay. If we could turn back our attention
to Figure 1. This is the IRIS process that existed before OMB,
OIRA, made helpful suggestions to make sure, to try to make
this a more productive transparent system, is that correct?
Ms. Dudley. I have to defer to Dr. Gray on that.
Dr. Gray. The first thing I would have to say is that these
diagrams, I don't necessarily--I am not able to endorse these
because I was not involved in preparing them. In fact, I will
say----
Chairman Miller. Actually it says--these are not diagrams
prepared by critics of OMB----
Dr. Gray. No.
Chairman Miller.--or EPA to belittle or make a mockery of
the complexity of the process. These are actually EPA
documents.
Dr. Gray. Yes, they are. And the only reason I am unable to
completely verify things is that the process that we use in
IRIS prior to April 10th was never written down and made
publicly available.
Chairman Miller. Okay. But if we could now look at Figure
3.
Ms. Dudley. May I ask, do you have hard copies of those? It
is hard for us to see them on the screens.
Chairman Miller. Okay. Is your need now satisfied? Okay.
This is the streamlined version, the streamlined transparent
version of the earlier, slow, opaque process, is that correct?
Dr. Gray. This is----
Chairman Miller. This is what is recently adopted.
Dr. Gray. This is our process, yes, that is how to find
many of those enhancements that I had mentioned that have been
going on in the IRIS process for many years. They are designed
to enhance the transparency and the timeliness of the process
and in fact putting timelines on this, which are not on this
diagram I notice, is very helpful in that it reminds both EPA
of its responsibilities and the others who are involved in the
responsibilities. It also indicates all of the various places
where the EPA, its regions and program offices, the public,
non-governmental organizations, anyone in the scientific
community, and other agencies can come together to provide
input to our process.
Chairman Miller. That is a yes. Let me ask the same
question that I asked of Mr. Stephenson to clarify or to
summarize his testimony response to Mr. Rohrabacher's
questions. Do either of you see a virtue in consciously not
knowing and consciously not learning the environmental or
public health risk posed by a chemical? That is a yes or no
answer.
Ms. Dudley. No.
Dr. Gray. Not at all. Not at all.
Chairman Miller. None. And the purpose of IRIS is that, to
assess what the risk is.
Dr. Gray. IRIS is an input to the risk assessment process.
It is not a complete risk assessment.
Chairman Miller. Okay. But it is not risk management?
Dr. Gray. That is correct.
Chairman Miller. Ms. Dudley, it is not risk management,
correct?
Ms. Dudley. IRIS is not risk management. It is a component
of the risk----
Chairman Miller. If there is a later decision about what to
do about it, if a chemical poses a risk but the IRIS decision,
the IRIS listing is the best available science at the time of
what risk a chemical poses, isn't that right?
Ms. Dudley. It is science and science policy because
science doesn't give you the full answer, so there are policy
judgments involved.
Chairman Miller. Well, the policy is what scientific
assumptions to make if the data is incomplete.
Ms. Dudley. That is correct. It deals with uncertainty.
Chairman Miller. It is still science. A policy might be, do
we really need to use TCE, even if it is toxic, because our
machines, our Bradley fighting vehicles, work better, and it is
important that our Bradley fighting vehicles work better. That
is policy, right?
Dr. Gray. Sir, could I make a statement? I know----
Chairman Miller. That is risk management.
Dr. Gray. That is management. Risk policy--I notice there
is a copy of the NAS Red Book next to you. Chapter 1, the very
first thing after defining terminology says science and policy
and risk assessment. That is the kind of policy we are talking
about.
Chairman Miller. All right. Well, my time is expired. There
will be other opportunities. Mr. Rohrabacher for five minutes.
Mr. Rohrabacher. Thank you very much, Mr. Chairman. So, Dr.
Gray, you were mentioning these charts that have been shown a
number of times in this hearing. So you are suggesting that the
chart that has been given to us during this hearing is not an
officially approved chart from your agency?
Dr. Gray. I am just saying that I was not involved in
drafting them, and it is--there are questions about defining
the previous versions of the process simply because they were
not written down in the same way as we have now done.
Mr. Rohrabacher. I am not quite understanding the answer,
whether that was--it seems that you are saying that this chart
then was developed by somebody in your agency, that it was not
officially entitled to have the final word on what the flow
chart would----
Dr. Gray. No, I don't think that is quite it. It is my
understanding that those were put together in an effort for our
staff to come up here and brief the Committee, and we use those
to brief some other committees. What I am saying is I didn't--I
was not involved in putting those together. The only one of
those that I can say accurately, to the best of my knowledge,
completely and accurately reflects the way things are done is
the last one that does reflect the new process that we have
released.
Mr. Rohrabacher. So the complicated flow chart that we see
does not reflect or does reflect----
Dr. Gray. It does reflect the process as it is currently
defined.
Mr. Rohrabacher. And what is your disagreement then with
the Chairman on the flow chart? I was not quite understanding
why----
Dr. Gray. Oh, simply----
Mr. Rohrabacher.--you brought up that point.
Dr. Gray. Well, because it is very difficult I think to
accurately compare these because in the past this process has
not been written down as explicitly and transparently as it is
now so that knowing exactly what the process was in each of
those steps is a little harder.
Mr. Rohrabacher. So, the other flow chart, the original one
that has been presented to us as the formerly streamlined
process now has been made more complicated actually does not
reflect the complication of what it was before?
Dr. Gray. Well, to me, complication is not what this is
about. This is about making sure we are doing the right
science. Those processes that we were looking at in, I believe
it was Chart 1 and maybe Chart 2, are the ones that have us in
the place today where we have assessments that are taking over
10 years to do. That is not what I want, that is not what EPA
needs. The new process is designed with timelines and
milestones to help us move that process along, and actually
though it may look more complicated, I believe it is both more
streamlined and will be more efficient.
Mr. Rohrabacher. Okay. So what you are suggesting then is
that because something looks more complicated, it doesn't
necessarily mean that it is more time consuming and
complicated?
Dr. Gray. No, I would--that is exactly true.
Mr. Rohrabacher. Well, I think that is a disagreement you
have with our Chairman, but I will follow through on that.
Dr. Gray. Thank you.
Mr. Rohrabacher. I think that sometimes, yes, I really
understand that you sometimes cannot believe your eyes. Thank
you.
Chairman Miller. Well, as I said in the opening that we
should--apparently it is you testimony that we should not
believe our lying eyes, that the flow chart that was prepared
by IRIS staff--I am advised by our Committee staff that all the
charts were prepared by IRIS committee staff and prepared to
our staff as part of our preparation for this hearing. Isn't
that correct?
Dr. Gray. I believe that is what I said.
Chairman Miller. You may not have done it, but it was IRIS
staff that prepared the charts that describe the process as it
has existed along the way before 2004, before OMB and OIRA
began making helpful suggestions about how it might be
different, how it existed from 2004 to April 2008 and how it
exists since April 10, 2008, isn't that right?
Dr. Gray. That is correct.
How Transparent Is the New IRIS Process?
Chairman Miller. All right. There has been discussion of
transparency. Well, it is not really possible to describe how
many steps there are because there are so many kind of sub-
numbers. But say for instance looking at 2F, Step 2F, federal
agencies identify mission critical chemicals. Is that step
transparent? Does the public know what the agencies have had to
say about what chemicals are mission critical?
Dr. Gray. The designation mission critical is something we
expect to happen very, very infrequently. When it does, it
happens in consultation with and with the agreement of the EPA.
If that in fact is something that is--if that designation is
made and agreed to by the Agency, it would be certainly made
known publicly.
Chairman Miller. The final decision or the viewpoints that
went into the decision?
Dr. Gray. The decision that this has been chosen to be
mission critical and that the Agency had agreed that in fact
there were specific areas of research that could be conducted
in a short amount of time that would provide additional
information to improve the----
Chairman Miller. How about Step 8B, internal Agency review
of draft assessment?
Dr. Gray. It has always been the practice that our
discussions that we have within our Agency where I can tell you
there is rarely scientific agreement, those are always kept
deliberative within the Agency.
Chairman Miller. So if it was a chemical that was being
used by the Department of Defense, the Department of Defense--
that would be the step at which, or a step at which the
Department of Defense would say whatever they had to say about
TCE being on the IRIS list? Now, whether it should be on the
list of chemicals that we know something about the risk--what
we know about the risk, is that right?
Dr. Gray. I am sorry, could you--I wasn't sure what your
question was.
Chairman Miller. 8B. Internal agency review. Is that all
your agency or is that----
Dr. Gray. Yeah, no, that is EPA. As I said, our remarks in
EPA have always been kept deliberative, if it is something
that--and are not released publicly.
Chairman Miller. All right. How about nine? OMB interagency
review of draft assessment and peer review charge? Is that
public?
Dr. Gray. No, that is interagency.
Chairman Miller. Okay. And what would happen at that step?
Dr. Gray. This is when the Office of Management and Budget
would coordinate a review of the document by other federal
agencies. Comments would come in to EPA, they would be combined
with our comments that we had from within our agency and would
be considered in ultimately revising the document that would
then go very importantly to step 10A, external peer review, so
that any scientific choices, any scientific decisions that are
made in that document have to pass independent external peer
review.
Chairman Miller. Well, who would be commenting at that
point? Would the Department of Defense--if you are talking
about a chemical used by the Department of Defense, would the
Department of Defense, would that be where they would have
something to say?
Dr. Gray. This process opens up the ability for comment
much more broadly for the----
Chairman Miller. Was that a yes?
Dr. Gray.--for the agencies, for the public, and other
interested parties.
Chairman Miller. I am talking about nine, interagency
review of draft assessment peer. Is that where the Department
of Defense would have something to say?
Dr. Gray. It is my understanding, and I don't know how OMB
does the formal process for reviewing these, but this would go
out to all of the federal agencies to have an opportunity to
comment.
Chairman Miller. And that would be----
Dr. Gray. And as the GAO has recognized--we often get very
useful comments back from that interagency process.
Chairman Miller. Okay. And that is public or private?
Dr. Gray. Those are deliberative, within the executive
branch.
Chairman Miller. That means it is not public.
Dr. Gray. That is correct.
Chairman Miller. Okay. Now, if this is all about what risk
a chemical poses, not what to do about it, what risk it poses,
isn't that entirely a scientific decision?
Dr. Gray. No----
Chairman Miller. Are toxicologists at DOD commenting? Who
are you getting from DOD?
Dr. Gray. I don't know who all of the commenters are, but
again, as GAO has recognized, EPA says those comments that come
in are useful. But again, they can be comments on science and
on the science policy decisions and choices that are made----
Chairman Miller. Which is also science. Which is also
science.
Dr. Gray. No, we have----
Chairman Miller. Of course it is.
Dr. Gray. We have a separate process in our Agency for
example for dealing with science policy. We develop guidelines
for those choices. They are vetted through our Science Policy
Council.
Chairman Miller. What would be the----
Dr. Gray. We keep these two things separate.
Chairman Miller. What would be the purpose of having this
be a deliberative process, rather than open, transparent,
having everyone who had anything to say, say it right out loud
in front of God and everybody? So everybody else who has
expertise can comment on what they had to say, whether their
factual assumptions are correct, whether their analysis is
correct or flawed, whatever. Isn't that the whole nature of
peer review? Isn't scientific analysis open? Ms. Dudley?
Ms. Dudley. Mind if I comment on that? I think the purpose
is that healthy skepticism and frank discussions or candid
discussions among scientists throughout the government actually
makes for better results. And let me just read to you from the
National Academies--they frequently ask questions.
``Deliberative portions of meetings''--and this is the National
Academy of Sciences--``deliberative portions of meetings are
closed to allow the discussions and consensus process to
proceed frankly and without public posturing so that Committee
Members are free to change their positions in the face of
evidence or argument.'' That is the same nature, the same
reason as Dr. Gray said the discussions among EPA scientists
who don't always agree, the discussions among interagency
scientists. Providing that opportunity for candid, frank
discussion is valuable.
Chairman Miller. Mr. Stephenson, do you have anything to
say on this point?
Mr. Stephenson. Well, any time you want to question a risk
assessment, whether it is what Dr. Gray is referring to as
science policy or not, I still see no problem with the
toxicologist at DOD suggesting that you don't have a good
enough uncertainty analysis. Why can't that be made public, the
basis for that statement? It is not to say that individual
scientists within DOD statements would be available, but at
least the DOD position on that particular risk assessment or
why they are concerned with the science would be publicly
available. I can't understand the scenario in which
deliberative--if it encourages more frank and open
conversations with the federal family, why doesn't it encourage
more frank and open conversations with other public commenters?
I mean, the logic defies me.
Chairman Miller. I now recognize myself for another--well,
do you wish, Dr. Gray, before I recognize myself for another
five minutes, do you wish to comment on what Mr. Stephenson had
to say?
Dr. Gray. I did want to say that I think it is important
for these discussions to take place. One of the new
enhancements in the IRIS process that is here is something that
we call listening sessions in which we open up and invite
scientists from the public, from industry, from environmental
organizations to all come in and to have a discussion about the
science of a particular assessment at two different points here
to make sure that we are hearing a wide range of views and we
are getting that kind of input. We think that is very
important.
Chairman Miller. Now I recognize myself for five more
minutes. Is there any stage at which a TCE manufacturer would
have a say? Would a TCE manufacturer be able to talk to OMB?
Would a TCE manufacturer fit in any of these boxes? Would
someone outside a Federal Government agency have any chance to
comment other than the public comment?
Dr. Gray. Can I say right here, this goes back to my
previous point of these listening sessions. Previously, there
are contacts that come from various affected parties. It may be
an industry or a manufacturer or use----
Chairman Miller. Right. You have to have public comment.
Dr. Gray. No.
Chairman Miller. That is not public, that is private.
Dr. Gray. Now in the new process, that will be happening in
these open public listening sessions.
Chairman Miller. Okay. Is there an opportunity for a
manufacturer other than a public open listening sessions to
have a say? Do they fit in any of these boxes or do they talk
to OMB, to OIRA?
Dr. Gray. I cannot speak for that. In our case, the
intention now is to have these listening sessions which are
open, publicly available as the----
Chairman Miller. Right.
Dr. Gray.--way that anyone who wants to bring----
Chairman Miller. Any chance----
Dr. Gray.--information brings it in.
Chairman Miller. Any chance to do it in a deliberative way,
not a public way, but deliberative way?
Dr. Gray. No.
Chairman Miller. Okay.
Mr. Stephenson. Mr. Chairman----
Chairman Miller. Ms. Dudley, is there any opportunity for
deliberative----
Ms. Dudley. No, not to my knowledge.
Chairman Miller. OMB doesn't talk to manufacturers or no--
--
Ms. Dudley. We talk to other federal scientists. Our role
is coordinating scientific dialogue between scientists within
the Federal Government.
Mr. Stephenson. Mr. Chairman, could I add a comment here?
Chairman Miller. Mr. Stephenson.
Mr. Stephenson. In the course of doing our work and having
discussions with DOD, DOE, and NASA, none of them really had
objections to their comments on the scientific risk assessment
being made public. So I am not sure where this need for
deliberation comes from.
Chairman Miller. All right. I am sorry, Dr. Gray and Ms.
Dudley, you are both testifying that there is no step in this
whole process, there is no procedure by which a private party,
not a government agency, a private party can participate
formally or informally in a deliberative way, not in a public
way, but privately? Ms. Dudley, is that correct?
Ms. Dudley. I am not familiar with the entire process. I
know that the two steps that OMB manages--interagency review--
that is not an opportunity for people outside the government to
weigh in.
Chairman Miller. Okay. Now, both the EPA and OMB have
recently asserted in Congressional testimony and refused to
answer questions based upon the deliberative process privilege,
that internal government discussions are not subject to--I
don't agree with it, I am stating that--the assertion the
privilege that EPA and OMB has asserted. Do you contend that if
there were private conversations with those outside of
government that they would be subject to any privilege?
Ms. Dudley. I am not a lawyer. I know that our process is
that in our regulatory review as well as the IRIS review, we do
not talk to people outside the government. In our regulatory
review, we operate under Executive Order 12866, and under that
when we have a regulation under review, if we are to meet with
people outside the government, we post that on our website, we
post the attendees to that meeting and we also invite the
agency.
There is a balance to be struck, and I understand where you
are going. There is a balance to be struck between a
deliberative process to allow for that frank and candid
discussion and also for the public's need for transparency and
need to know. And I think we try to strike that balance. In the
IRIS process, it is through this new procedure, and in the
regulatory process it is through our transparent posting of
meetings with people outside the government.
Chairman Miller. Dr. Gray, the head of your agency asserted
that privilege yesterday and refused to answer a direct
question in another committee.
Ms. Dudley. Actually, if I could just quickly correct that.
I was sitting next to him, and he did not assert that
privilege.
Chairman Miller. I am sorry. He didn't actually say those
words, he just said he wasn't going to answer. So do you
intend, assert that I-don't-feel-like-telling-you privilege?
Ms. Dudley. Only the President can assert Executive
Privilege, and to my knowledge he has not done that in the
issue of the testimony yesterday nor today.
Chairman Miller. Do you have any idea of the nature of the
privilege upon which the head of the EPA was lying in refusing
to answer direct questions in a committee?
Ms. Dudley. Are we discussing yesterday or on IRIS?
Chairman Miller. Well, I am trying to figure out which one
of these is going to be available to a Congressional oversight
committee.
Ms. Dudley. On this issue, actually, Dr. Gray is probably
better to answer. But after the assessments have gone through
interagency review, they are available for public peer review,
and all the information on which those assessments rely is
available for scientists outside the government or the general
public outside the government to evaluate.
Chairman Miller. Okay. Dr. Gray, did you have an answer to
that question?
Dr. Gray. I would agree completely with what Ms. Dudley has
just said. No, there is--here the only things--there is a
deliberative process with the discussions that we have within
the EPA and the discussions that we have with the other federal
agencies. When the ultimate decisions are made, the choices,
the data, the endpoints in an IRIS assessment, those are put
forth in a transparent way and go out for independent, external
peer review to make sure that the science choices, the science
assumptions, the data choices we have made are scientifically
appropriate.
Chairman Miller. Dr. Gray, Mr. Stephenson said a minute ago
that--he listed three agencies, NASA and who else?
Mr. Stephenson. DOE and DOD.
Chairman Miller. They say they don't mind commenting right
out loud in front of God and everybody. They don't need for it
to be privileged or private, deliberative. They are willing to
say what they have to say publicly. Are there agencies that
have objected to having their comments be public?
Dr. Gray. The deliberative steps here were decisions that
were taken by the EPA to make these steps deliberative as they
have been in the past and as is done with other kinds of
reviews that we have.
Ms. Dudley. Excuse me sir, do you mind if I comment on
that?
Chairman Miller. Sure.
Ms. Dudley. Any agency that wants to make that information
public certainly can do that during the comment period. So
there is nothing in this process that would bar them from
making that information public.
Timelines for IRIS Assessments
Chairman Miller. I understand this has only been in effect
since April 10, 2008, and it is designed to streamline the
process so that it would be more productive and that more
chemicals will be assessed. We won't still be waiting 11 years
after formaldehyde was submitted for re-evaluation, and
formaldehyde is--we have had another Subcommittee hearing on
formaldehyde. It would have been nice to have for the EPA and
FEMA and for the Centers for Disease Control to have a picture
of formaldehyde's likely toxicity, likely risk, based on the
current science. But it still hasn't happened. When are we
going to know that this is actually producing more assessments?
Four in the last two years does not seem like the changes made
in 2004 resulted in a leap in productivity. When are we doing
to know if this is now going to fix whatever errors there are?
Mr. Stephenson thinks that it will not but it will make it
worse. When are we going to decide who is correct?
Dr. Gray. Well, I would say that we agree, that there are
real issues with the development of IRIS assessments and their
timeliness. These delays have been a longstanding issue, and it
is very clear the fact that we have a significant number that
have taken 10 years or more, that a lot of the delays predate
any changes in this process. Our goal is to have a process that
will increase the rigor and the timeliness with these timelines
that will provide strict milestones for EPA and for the other
parties in this entire process to move this along. I think what
we need now is time to implement this process, to evaluate it.
It is intended to be a living document, recognizing it may need
future revisions, but I think that the process that we have
been using certainly hasn't gotten us to the place we want to
be.
Chairman Miller. Ms. Dudley.
Ms. Dudley. You know, I wasn't involved in developing the
new IRIS process, but the fact that it has timelines for every
step along the way, including interagency comment and EPA
response to that, I think will both streamline the process and
improve the quality and rigor of the resulting assessments.
Chairman Miller. What are the consequences of not meeting
the timelines?
Ms. Dudley. I don't know that there are any consequences.
Dr. Gray. No, but these are intended as part of a
management system that we are implementing so that people know
on our side how we expect them to do their work and when we
expect them to do their work when we deal with the other
agencies how things go. For example, one of the things that is
commonly done is to suggest to an agency, if we don't hear from
you in some amount of time, we assume you have no comments.
Those sorts of things may well be the way in which this would
work to help make sure that things keep to the timelines.
Chairman Miller. Mr. Stephenson, when do you have a sense
of how well this is working?
Mr. Stephenson. If you look at the timeframes that are
missing from your chart with this system, we already know that
it is not going to work.
Chairman Miller. And how is that?
Mr. Stephenson. All we did was add up the timeframes which,
as you just heard, may or may not have consequences. We added
them up through this flow chart, and they total six years. And
if it is a mission critical system, the DOD commenter or
whomever, has the ability to ask for additional research, which
can take up to 18 more months. It is already broken.
Dr. Gray. I would like to suggest that in fact this process
I believe can help us get done in less time than our current
five and one-half year per assessment average; if you add up
the timelines and remove those small fraction of chemicals that
might be considered mission critical, this is something that
will take less time than our current process and will be more
responsive, more rigorous, and more transparent.
Mr. Stephenson. We are not thrilled with the current
process.
Chairman Miller. Are there no milestones at all in the
current process, in the previous process?
Dr. Gray. There are none that are written down and publicly
available.
Chairman Miller. Okay.
Mr. Stephenson. That is the improvement. It is no longer ad
hoc. Now you know what the process is.
Ms. Dudley. Sir, I actually have a chart that I don't
know--did you get this just before the hearing? I am sorry that
we don't have it so that you can put it up.
Chairman Miller. I haven't seen it but perhaps the staff
has.
Ms. Dudley. What it does is it takes a look--EPA has data
on the number of IRIS assessments completed going back to 1997.
The GAO reports--I am not sure what day it starts, but it
doesn't go back as far as we have data. And that suggests that
there are increases--that you see increases and decreases in
the assessments but that on average in the last three years of
the previous administration, there were four assessments per
year, whereas the average between 2000 and 2007 has been 4.6.
So I think we all agree that the process, that it is too slow
and we need to speed that up, but I think it is not fair to
characterize the previous way as the golden age and the future
as a slowing of the process.
Mr. Stephenson. I agree with that.
Chairman Miller. I am advised by our staff that we do have
this but we got it 15 minutes before the hearing. So there has
not exactly been an ample opportunity to look at it closely.
That is the end of the hearing today. Thank you all for
appearing. We did have an earlier hearing on the issue of
formaldehyde in trailers provided by FEMA. And an effort began
in 1997 to update the listing for formaldehyde. The equivalent
agencies through the EPA and other developed countries list
formaldehyde as a known carcinogen. It is still listed as a
suspected carcinogen, and since 1997, there has not been a
completed revision of formaldehyde's risk to the public, risk
to health, risk to the environment. There were hundreds and
thousands of people who were living in trailers provided by
FEMA that used particle board made with formaldehyde with high
levels of formaldehyde in the air inside the trailers, with
families who were displaced by Katrina and by Rita breathing
that air every day. It would have been nice to have a current
assessment of the health consequences for formaldehyde that
FEMA could have relied upon, that the Centers for Disease
Control could have relied upon, and that the Agency for Toxic
Substances and Disease Registry, ATSDR, could have relied upon
instead of saying, well, just open the windows and doors. If in
fact formaldehyde is a substantially greater health risk than
the now more than decade old assessment, that is a current
science. There is no virtue--and I agree with all of the
witnesses today--there is no virtue in not knowing. There is no
virtue in not finding out. This is not a process about--ours is
not intended to be health or risk management. It is not what to
do about the fact that there is a risk, it is what is the risk?
And there is no virtue in not knowing. But it is hard to look
at EPA's performance and not conclude that we are not doing a
sufficient job in determining which of the 80,000 chemicals
present a hazard and what the hazard is.
So I thank all of you for appearing today, and we will
pursue this further. Thank you. The hearing is adjourned.
[Whereupon, at 12:50 p.m., the Subcommittee was adjourned.]
Appendix:
----------
Additional Material for the Record
TOXIC COMMUNITIES: HOW EPA'S IRIS PROGRAM FAILS THE PUBLIC
----------
THURSDAY, JUNE 12, 2008
House of Representatives,
Subcommittee on Investigations and Oversight,
Committee on Science and Technology,
Washington, DC.
The Subcommittee met, pursuant to call, at 10:00 a.m., in
Room 2318 of the Rayburn House Office Building, Hon. Brad
Miller [Chairman of the Subcommittee] presiding.
hearing charter
SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
Toxic Communities: How EPA's IRIS Program
Fails the Public
thursday, june 12, 2008
10:00 a.m.-12:00 p.m.
2318 rayburn house office building
The Subcommittee on Investigations and Oversight will hold the
second hearing on the Integrated Risk Information System (IRIS) at the
Environmental Protection Agency (EPA).
On May 21, 2008, the Subcommittee heard the Government
Accountability Office's (GAO) evaluation of the Administration's new
process for reviewing and approving chemical assessments for inclusion
in the IRIS database. In their March 2008 review of EPA's IRIS program
GAO found that the IRIS database was at serious risk of becoming
obsolete because the Agency has not been able to complete credible
assessments in a timely manner or to reduce the backlog of 70
assessments that were in the development, review or approval
process.\1\ In their subsequent examination of the process implemented
by the Administration on April 10, 2008, GAO testified that the recent
assessment process changes arid the other process changes being
implemented by EPA were likely to increase the time needed to finalize
IRIS assessments and to further reduce the credibility of IRIS
assessments.\2\
---------------------------------------------------------------------------
\1\ U.S. Government Accountability Office (GAO). 2008. Chemical
Assessments Low Productivity and New Interagency Process Limit the
Usefulness of EPA's Integrated Risk Information System. GAO-08-440.
\2\ U.S. Government Accountability Office (GAO). 2008. Chemical
Assessments EPA's New Assessment Process Will Further Limit the
Productivity and Credibility of Its Integrated Risk Information System.
Testimony before the Subcommittee on Investigations and Oversight,
Committee on Science and Technology, House of Representatives.
---------------------------------------------------------------------------
The witnesses will address the role of IRIS assessments in the
regulatory process for implementing environmental statutes administered
by EPA and by State, territorial, and tribal governments and the
consequences of extended delay in the IRIS assessment process for
public health. They will also address questions regarding the Bush
Administration's evolving system to draft and review IRIS entries.
Witnesses include:
Mr. Jerome Ensminger, Master Sergeant U.S. Marine
Corps (ret.)
Mr. Lenny Seigel, Center for Public Environmental
Oversight
Dr. Linda Greer, Senior Scientist, Natural Resources
Defense Council
Dr. David G. Hoel, Professor, Medical University of
South Carolina
What Is the Role of an IRIS Assessment in the Regulatory Process?
Federal and State governments adopt environmental and public health
laws to protect natural resources and the public. EPA, State,
territorial, anal tribal governments implement environmental statutes
through the issuance of regulations that set standards for air and
water quality and for clean-up of contaminated areas. Regulations also
set deadlines for achieving the standards. At the federal level, EPA
administers environmental statutes to protect public health and the
environment, to establish criteria for the handling and disposal of
hazardous materials, and that govern the clean-up of contaminated land
and water. The preparation of a regulation requires assembling a wide
variety of information to define risk and justify the risk management
approach mandated by the regulation. In addition to the information and
procedural requirements imposed by individual statutes, there are
general statutes governing the issuance of regulations by federal
agencies that also impose procedural and information requirements
(e.g., Administrative Procedures Act, Paperwork Reduction Act, Unfunded
Mandates Reform Act) and there are Executive Orders and guidance from
the Office of Management and Budget (OMB) that also require procedures
and analyses to be done in support of a regulation.
Two of the most commonly required analyses are risk assessments and
cost-benefit analyses. While not a regulatory product itself, IRIS is
designed to help regulators set priorities about what to regulate and
inform regulators on a safe exposure level for workers or communities.
An IRIS assessment provides a hazard identification and dose-response
analysis, scientific information that when combined with estimates of
exposure allow regulatory agencies to produce a risk assessment. Delay
in the production of the IRIS assessment translates into delay in
implementation of environmental statutes and in establishment of
standards to protect public health.
While some State governments have environmental programs that
independently establish standards (e.g., California), many State
governments and virtually all territorial and tribal governments rely
upon the Federal Government to develop and evaluate the scientific
information that will determine safe levels of exposure and allow
regulatory agencies to set standards for air and water quality to
protect public health and the environment. For example, in response to
EPA's solicitation to set priorities for developing IRIS assessments,
the State of Minnesota submitted a list of 52 chemicals of concern.\3\
---------------------------------------------------------------------------
\3\ Submission by the Minnesota Department of Health to the
Integrated Risk Information System (IRIS); Request for Chemical
Substance Nominations for the 2007 Program. Docket ID No. EPA-HQ-ORD-
2006-0950.
The Case of Trichloroethylene: How Long Does a Controversial IRIS
Assessment Take to Complete?
In its March 2008 report on EPA's IRIS program GAO examined six
specific IRIS assessments that are in process.\4\ One of the six
assessments was of trichloroethylene or TCE. GAO's report provided the
following timeline for the development of a cancer assessment of TCE
for inclusion in the IRIS database: EPA developed a cancer assessment
of TCE for inclusion in the IRIS database, but withdrew it in response
to peer reviewers' comments in 1989. EPA initiated a new TCE cancer
assessment in 1998 and issued a new draft assessment in 2001. This
draft and its findings were controversial. It was reviewed by EPA's
Science Advisory Board and released for public comment. The National
Academy of Sciences (NAS) was asked to review the draft and to resolve
issues raised in the SAB review and through the public comment process
about methods EPA used to assess the risk of TCE. In 2006, the NAS
panel released their report. The panel stated:
---------------------------------------------------------------------------
\4\ U.S. Government Accountability Office (GAO). 2008. Chemical
Assessments Low Productivity and New Interagency Process Limit the
Usefulness of EPA's Integrated Risk Information System. GAO-08-440.
The committee found that the evidence on carcinogenic risk and
other health hazards from exposure to trichloroethylene has
strengthened since 2001. Hundreds of waste sites in the United
States are contaminated with trichloroethylene, and it is well
documented that individuals in many communities are exposed to
the chemical, with associated health risks. Thus, the committee
recommends that federal agencies finalize their risk assessment
with currently available data so that risk management decisions
can be made expeditiously.\5\
---------------------------------------------------------------------------
\5\ National Research Council. 2006. Assessing the Human Health
Risks of Trichloroethylene: Key Scientific Issues. The National Academy
Press. Washington, DC. p. 2.
Despite this direction from the NAS to move forward, EPA has not
yet released its assessment of TCE. According to GAO, the assessment is
back at the draft development stage and will not be finalized until
---------------------------------------------------------------------------
2010.
What Are the Consequences for Public Health When IRIS Assessments Are
Delayed?
TCE is a solvent that has been in commerce since the 1920s. TCE is
a degreasing agent and has been widely used in manufacturing and
industrial settings. It is one of the most commonly identified
contaminants at sites included on EPA's National Priority List (NPL)
under the Superfund program. It is a found in air, water, and soils. A
number of different cancers, reproductive and developmental problems,
neurotoxic effects, and auto-immune disease have all been associated
with exposures to TCE.
Since TCE is a contaminant of air, water, and soils its clean-up is
determined through various statutes administered by EPA including: the
Safe Drinking Water Act, the Clean Air Act, and the Comprehensive
Environmental Response, Compensation, and Liability Act (CERCLA) or
Superfund. Under each of these statutes, EPA has the authority to set
maximum contaminant levels that define safe drinking water, set air
quality standards that define clean air, and that set standards for
clean-up of contaminated soil and water at Superfund sites. These
standards cannot be strengthened, until EPA has completed the IRIS
assessment, a risk assessment, and other supporting studies and
information requirements (e.g., cost-benefit analysis, regulatory
impact analyses, etc.) needed to support a regulation. Many people
believe the TCE standards currently in place are inadequate to protect
human health especially that of children and other sensitive sub-
populations.
The Subcommittee will hear from two witnesses whose family or
communities have experienced serious health impacts that are associated
with exposure to TCE. One of the sites listed on the Superfund NPL is
Camp Lejeune, the Marine Corps base in North Carolina. The drinking
water source for the base is contaminated with TCE and
tetrachloroethylene (PCE or perc): The Marine Corps closed contaminated
drinking water wells in 1985, and the site was listed in 1989. The
Agency for Toxic Substances and Disease Registry estimated that up to
one million people were exposed to these toxic contaminants before the
contaminated wells were closed in 1985.
The community of Mountain View, California has several TCE clean-up
sites. Several of the contaminated sites are located on federal lands
including the Orion Park Military Housing Area (U.S. Army). These areas
are still undergoing clean-up and remediation and residents of the area
are still exposed to TCE through a process known as vapor intrusion.
Mr. Ensminger and Mr. Seigel will discuss the experiences of their
family and community, respectively and why they believe EPA's IRIS
program needs reform.
Attachment
The Minnesota Department of Health Submission to the Integrated Risk
Information System (IRIS); Request for Chemical Substance Nominations
for 2007 Program
(Docket ID No. EPA-HQ-ORD-2006-0950)
The Health Risk Assessment staff at the Minnesota Department of
Health wish to nominate a list of chemicals to be included in the
Integrated Risk Information System (IRIS); Request for Chemical
Substance Nomination for 2007 Program. These chemicals are of concern
to the Minnesota Department of Health because they are among
contaminants found in Minnesota groundwater. In Minnesota, health based
values are derived for such contaminants. When conducting risk.
assessments, the Minnesota Department of Health has relied upon the
IRIS summaries as a resource for the development of these health
protective values. Therefore, it is our hope that you take our
nominated chemicals in consideration. By obtaining IRIS summaries of
these chemicals it will result in a more thorough and accurate risk
assessment process.
1,2,3--Trichloropropane
1-Methylnaphtalene
1-Methylphenol
2,2--Dichloropropane
2,3,4,5--Tetrachlorophenol
2,3,5,6-Tetrachloroterephthalic acid
2,6-dinitrotoluene
2,6-diethylaniline (Alchlor degradate)
2-Nitrophenol
3,5-Dichlorophenol
4-Isopropyltoluene
Acetochlor ESA
Acetochlor OA
Alachlor ESA (degradate of Alachlor)
Alachlor OA (degradate of Alachlor)
Aluminum
Deaminated diketomethribuzin (degradate of Metribuzin)
Deaminated metribuzin (degradate of Metribuzin)
Deethylatrazine (degradate of Atrazine and Propazine)
Deisopropylatrazine (degradate of Atrazine, Cyanazine and Simazine)
Diallate
Diazion
Dichlorofluoromethane
Diketometribuzin (degradate of metribuzin)
Dimethenamid
Dimethenamid ESA (degradate of Demethenamid)
Dimethenamid OXA (degradate of Dimethenamid)
Ethafluralin
Hydroxyatrazine
Iron
Isopropyl ether
Isoxaflutole
Lithium
Metolachlor ESA
Metolachlor ESA
Metsulfuron-methyl (Ally)
Monomethyl tetrachloroterephthalic acid
n-Butylbenzene
Nicosulfuron
n-Propylbenzene
Primisulfuron-methyl (Beacon)
Radionuclides (all)
Sec-Butylbenzene
Sodium
Thifensulfuron methyl
Tin
Total petroleum hydrocarbons
Tribenuron-methyl
Triclopyr
Trinitro-phenylmethylnitramine
Triphenyltin hydroxide
Vanadium
In addition, the Minnesota Department of Health currently needs and
uses reference concentrations and reference doses for less than chronic
periods of exposure to assess risks from a variety of exposure
scenarios. These scenarios include less than chronic exposures that
commonly occur at contaminated sites resulting in the need for less
than chronic toxicity values to assess current risks. The EPA 2002 ``A
review of the reference dose and reference concentration processes''
has guided much of the practice of the Department in this area.
The Department has found that health effects that result from less
than chronic periods of exposure, when combined with high drinking
water exposures associated with specific life stages (e.g., childhood),
result in drinking water values that are lower and therefore more
appropriate as drinking water standards for the general population than
the value calculated using a chronic reference dose and lifetime
average dose. As a result, the Department is very interested in recent
efforts by IRIS to develop less than lifetime reference values, and
urges the EPA to continue to develop and publish these analyses. The
Department also urges the EPA to consider the potential that effects
observed in chronic studies result from early exposures rather than
continuous exposure. To the extent that studies are available, the
Department urges the EPA to present acute, short-term, longer-term, and
chronic evaluations (recommendations for critical studies for each and
resulting reference doses) for each chemical that undergoes review in
the future.
Chairman Miller. The hearing will come to order. Good
morning, and welcome to our second hearing on EPA's Integrated
Risk Assessment System, IRIS.
The glacial pace at which EPA is completing assessments of
chemicals has real consequences for public health, and tragic
consequences for human beings and their families. Completion of
an IRIS assessment is just the first step in the process of
protecting people from dangerous exposures to toxic chemicals.
With an IRIS assessment in place, it is easier to deal with the
clean-up of chemical contamination of the air or water, to
adopt safer practices in the workplace, and to consider steps
to regulate toxic substances that can harm our children and our
communities.
The Government Accountability Office's recent report on
IRIS concluded that EPA's process for initiating and completing
IRIS assessments resulted in proposals that are now in
preparation for more than five years, with some assessments
taking more than a decade. The new process that EPA and OMB
instituted just in April will add additional years to our
assessments, according to the GAO conclusions.
The years of study and discussion regarding IRIS
assessments comes on top of a regulatory process that is
burdened with time-consuming steps for complete risk
assessment, cost benefit analysis, and internal and external
reviews, all as laid out in Executive Orders and in statute.
Even after a regulation is finalized, it can be challenged in
court and sent back to the Agency for revision. When finally
established, a new regulation usually includes some time, often
many years, for the affected parties to transition away from
the practices that are being regulated.
During this entire process, exposures continue, toxic
substances remain unregulated or under-regulated in commerce,
and contamination is not cleaned up, or not cleaned up to a
level that we think is actually safe.
Today, we will hear from people who have lived and are
living with those consequences. These people will describe what
their families and communities have endured for years,
situations that no one would wish to endure for a day.
While the failures of the IRIS database are not responsible
for these experiences, the gaps in IRIS and the improper
intrusion of politics into database entries have likely
contributed to the situations that these people and their
communities have had to deal with. When State and local
authorities get poor information or no information regarding
the health hazards of a particular pollutant, their response to
pollution in a community is likely to be confused and
confusing. When citizens can't turn to IRIS for information--
and the database gets 20,000 web hits a year--then it is hard
for them to know what they are fighting in terms of clean-ups
and health risks.
The worst thing about these families' experiences is that
they are likely to be repeated because exposures that led to
the chemical that led to the problems continue. TCE was
discovered in the early 1900s and has been on the market and
widely used since the 1920s as a degreaser. Discovery of its
toxic properties eliminated its use as an analgesic in the
1930s, and by the 1970s, evidence in animal experiments showed
that it might cause cancer. It is one of the most frequently
occurring contaminants in Superfund sites, and it is present in
air, drinking water, and soils.
EPA has been working on a revised TCE assessment since
1989. Two years ago, following interventions by NASA, the
Department of Energy, the Department of Defense, and OMB, the
National Academy reviewed EPA's draft IRIS assessment and the
science available on TCE, and said that ``evidence on
carcinogenic risk and other health hazards from exposure to TCE
has strengthened since 2001. Priority should be given to
finalizing the risk assessment so that risk management
decisions can be made expeditiously.''
Expeditious is not a word that describes this situation.
GAO estimates that EPA will not complete their TCE assessment
until 2010. That is 21 years from the start date. If they
completed their assessment in 2010, we will still be years away
from real regulatory action. People have been exposed to a
known toxic substance for decades for a generation while their
government has engaged in one study after another. Have we
become so obsessed with getting the science exactly right that
we have lost sight of our real goal, protecting public health?
Or is getting the science exactly right a pretext for
obstruction of any real protection of the public.
This system defies common sense. It is broken. It is
condemning people to future health problems.
I now yield to my distinguished colleague, the Ranking
Member of the Subcommittee, Mr. Sensenbrenner, for an opening
statement.
[The prepared statement of Chairman Miller follows:]
Prepared Statement of Chairman Brad Miller
Good morning and welcome to our second hearing on EPA's Integrated
Risk Assessment System (IRIS).
The glacial pace at which EPA is completing assessments of
chemicals has real consequences for public health and tragic
consequences for individuals and their families.
Completion of an IRIS assessment is just the first step in the
process protecting people from dangerous exposures to toxic chemicals.
With an IRIS assessment in place, it is easier to deal with the clean-
up of chemical contamination of the air or water, to adopt safer
practices in the workplace and to consider steps to regulate toxic
substances that can harm our children and our communities.
The Government Accountability Office's recent report on IRIS
concluded that EPA's process for initiating and completing IRIS
assessments resulted in proposals that are in preparation for more than
five years, with some assessments taking more than a decade. The new
process that EPA and OMB instituted just this past April will add
additional years to IRIS assessments.
The years of added study and discussion regarding IRIS assessments
come on top of a regulatory process that is burdened with very time
consuming steps for a complete risk assessment, cost-benefit analyses,
and internal and external reviews as laid down in Executive Orders and
statute. Even after a regulation is finalized, it can be challenged in
court and sent back to the Agency for revision. When finally
established a new regulation usually includes some time, often many
years, for the affected parties to ``transition'' away from the
practices that are being regulated.
During this entire process, exposures continue, toxic substances
remain unregulated or under-regulated in commerce, and contamination is
not cleaned up or not cleaned up to a level that we think is actually
safe.
Today we will hear from people who have lived, and ore living with,
these consequences. These people will describe what their families and
communities have endured for years--situations that no one would wish
to experience for even one day.
While the failures of the IRIS database are not responsible for
these experiences, the gaps in IRIS, and the improper intrusion of
politics into database entries have likely contributed to the
situations that these people and their communities have had to deal
with. When State and local authorities get poor information, or no
information, from IRIS regarding the health hazards of a particular
pollutant, their response to pollution in a community is likely to be
confused and confusing. When citizens can't turn to IRIS for
information--and the database gets 20,000 web hits a year--then it is
hard for them to know what they are fighting for in terms of clean-ups
and health risks.
The worst thing about these families' experiences is that they are
likely to be repeated because exposures to the chemical that led to
their problems continue. Trichloroethylene or TCE was discovered in the
early 1900s and has been on the market and widely used since the 1920s
as a degreaser. Discovery of its toxic properties eliminated its use as
an analgesic in the 1930s and by the 1970s evidence in animal
experiments indicated it might cause cancer. It is one of the most
frequently occurring contaminants in Superfund sites and it is present
in air, drinking water, and soils.
EPA has been working on a revised TCE assessment since 1989. Two
years ago, following interventions by NASA, the Department of Energy,
the Department of Defense and OMB, the National Academy reviewed EPA's
draft IRIS assessment and the science available on TCE and said that:
``evidence on carcinogenic risk and other health hazards from exposure
to trichloroethylene has strengthened since 2001 . . .. Priority should
be given to finalizing the risk assessment so that risk management
decisions can be made expeditiously.''
Expeditiously? Expeditious is not a word that describes this
situation. GAO estimates that EPA will not complete their TCE
assessment until 2010--that's twenty-one years from their original
start date.
If they complete the assessment in 2010, we will still be years
away from regulatory action. People will have been exposed to a known
toxic substance for decades, for a generation, while the government
engages in study after study. Have we become so obsessed with getting
the science right that we have lost sight of our real goal protecting
public health? Or, is getting the science right a pretext for
obstruction?
This system defies common sense. It is broken, and it is condemning
people to future health problems.
I now yield to my distinguished colleague, the Ranking Member of
the Subcommittee, Representative Sensenbrenner for an opening
statement.
Mr. Sensenbrenner. Thank you very much, Mr. Chairman.
Before making my statement, let me say that Dr. David Hoel, who
is the Minority witness at today's hearing, got stuck in the
Atlanta airport last night because of bad weather. We kind of
know about that the last couple of weeks in Wisconsin where I
come from. I would like to ask unanimous consent that Dr.
Hoel's testimony be placed in the record, and that he be
instructed to respond to certain written questions by Members
of the Committee and their staff, and that the responses to
those questions also be placed into the record.
Chairman Miller. Without objection, that is so ordered.
[The statement of Mr. Hoel appears in Appendix: Additional
Material for the Record.]
Mr. Sensenbrenner. Mr. Chairman, the Integrated Risk
Information System, IRIS, process was originally developed for
a specific task. Different offices throughout the EPA were
relying on different assessments of the health effects of
chronic exposure to toxic chemicals. IRIS was intended to
establish a uniform database within the EPA.
However, over time, IRIS has become an authoritative
resource on chemical toxicity. Other agencies, states, the
international community, and the industries have been becoming
increasingly reliant on IRIS and the assessments took on
increased importance. These outside groups have sought to
impact a process that was not initially designed to handle
external pressures. The result has been an IRIS process that
has effectively broken down.
The GAO recently issued a scathing condemnation of the
current state of the IRIS program. The report is titled ``Low
Productivity and New Interagency Review Process Limit the
Usefulness and Credibility of EPA's Integrated Risk Information
System.'' Now, that is a mouthful, but I think it says where we
are at now. In my opinion, it accurately sums up the GAO's
findings. But IRIS' actual production numbers are even worse.
EPA currently has a backlog of 70 ongoing assessments, and has
managed to complete only two assessments in each of the last
two years. Talk about a snail's pace. At the current pace, it
will take 35 years for the EPA to finish its current backlog,
and that is assuming it takes on no further tasks.
The EPA has attempted to develop uniform process for IRIS
assessments. The Agency argues that it can expedite the IRIS
process by involving other agencies earlier in the process.
While preventing last-minute delays is an important reform, the
ability of other agencies to extend the timeframe of
assessments should be sharply limited. Data gaps in risk
assessments will always exist as better science is always
developing. EPA needs to limit the timeframe of assessments to
prevent other agencies from indefinitely delaying the process.
EPA must also balance its need to complete assessments with
the rights of interested parties to comment. The best way to
achieve this balance would be to give more notice of its
assessments. The EPA already publishes an annual agenda of the
chemical it intends to assess in the Federal Register. If the
EPA moves the date of that publication forward, thus providing
more notice, the interested parties will have a longer period
to comment on what they deem to be insufficiencies in the
scientific record. During this comment period, EPA can focus on
its backlog. Because it offered a comment period, EPA can then
fairly limit the ability of outside parties to delay
assessments once they are underway. The result would be a more
efficient process that preserves taxpayers' money and promotes
public health. In my opinion, that is a win-win.
I urge the EPA to consider these proposals, because IRIS
must be fixed. In April, this subcommittee held a hearing on
formaldehyde levels in trailers provided to the victims of
Hurricane Katrina. In that hearing, we investigated how the
Agency for Toxic Substances and Disease Registry struggled to
identify the proper level of concern for long-term exposure to
formaldehyde. EPA determined its formaldehyde assessment was
outdated in 1997, but 11 years later, the assessment is still
incomplete. These hurricane victims are the real world result
of EPA's bureaucratic failures.
I yield back the balance of my time.
[The prepared statement of Mr. Sensenbrenner follows:]
Prepared Statement of Representative F. James Sensenbrenner Jr.
The Integrated Risk Information System (IRIS) process was
originally developed for a specific task. Different offices throughout
the Environmental Protection Agency (EPA) were relying on different
assessments of the health effects of chronic exposure to toxic
chemicals. IRIS was intended to establish a uniform database within
EPA.
Over time, however, IRIS became an authoritative resource on
chemical toxicity. Other agencies, states, the international community,
and industries increasingly began to rely on IRIS, and the assessments
took on increased importance. These outside groups have sought to
impact a process that was not initially designed to handle external
pressures. The result has been an IRIS process that has effectively
broken down.
The Government Accountability Office (GAO) recently issued a
scathing condemnation of the current state of the IRIS program. The
report's title, Low Productivity and New Interagency Review Process
Limit the Usefulness and Credibility of EPA's Integrated Risk
Information System, accurately sums up GAO's findings. But IRIS' actual
production numbers are worse. EPA currently has a backlog of 70 ongoing
assessments and has managed to complete only two assessments in each of
the last two years. At the current pace, it will take 35 years for EPA
to finish its current backlog.
EPA has attempted to develop a uniform process for IRIS
assessments. The agency argues that it can expedite the IRIS process by
involving other agencies earlier in the process. While preventing last
minute delays is an important reform, the ability of other agencies to
extend the timeframe of assessments should be sharply limited. Data
gaps in risk assessments will always exist as better science is always
developing. EPA needs to limit the timeframe of assessments to prevent
other agencies from indefinitely delaying the process.
EPA must balance its need to complete assessments with the rights
of interested parties to comment. The best way to achieve this balance
would be to give more notice of its assessments. EPA already publishes
an annual agenda of the chemical it intends to assess in the Federal
Register. If EPA moves the date of that publication forward, providing
more notice, interested parties will have a longer period to comment on
what they deem to be insufficiencies in the scientific record. During
this comment period, EPA can focus on its backlog. Because it offered a
comment period, EPA can then fairly limit the ability of outside
parties to delay assessments once they are underway. The result would
be a more efficient process that preserves taxpayers' money and
promotes public health.
I urge EPA to consider these proposals, because IRIS must be fixed.
In April, this subcommittee held a hearing on formaldehyde levels in
trailers provided to the victims of Hurricane Katrina. In that hearing,
we investigated how the Agency for Toxic Substances and Disease
Registry struggled to identify the proper ``level of concern'' for
long-term exposure to formaldehyde. EPA determined its formaldehyde
assessment was outdated in 1997, but eleven years later, that
assessment is still incomplete. These hurricane victims are the real
world result of EPA's bureaucratic failures.
Chairman Miller. Thank you, Mr. Sensenbrenner. Mr.
Sensenbrenner spoke of the backlog and said that there was no
further work for EPA to do, and an IRIS list that would take 35
years. Since 600 new chemicals enter the marketplace a year, it
is reasonable to assume that there will be more for EPA to do.
I ask unanimous consent to enter documents for the record
that had been provided to the minority. Without objection, it
is so ordered.
[The information follows:]
Chairman Miller. I also ask unanimous consent that any
additional statements submitted by Members be included in the
record. Without objection, so ordered.
[The prepared statement of Ms. Johnson follows:]
Prepared Statement of Representative Eddie Bernice Johnson
Thank you, Mr. Chairman. This is the second hearing in one month on
the Integrated Risk Information System within the Environmental
Protection Agency.
This system is intended to protect both environmental quality and
human health through effective regulations and other policy
implementation.
However, today's witnesses will make clear that environmental
contamination has impacted their lives in the most severe ways.
It is my hope that this subcommittee can learn what influence the
current Administration has had on IRIS, and how IRIS' functions have
changed since the commencement of the current Administration.
Some of the problems with that process were the subject of this
subcommittee's hearing two weeks ago.
Oversights as glaring and irresponsible have major consequences.
Today, we will hear true stories from Americans whose lives are
forever changed as a result of needless, reckless pollution.
It is our duty to hear them, and to work out policies to prevent
tragedies of this nature from ever occurring.
This subcommittee is aware that within the IRIS system, only four
chemical listings have been finalized in the past two years.
While approximately 700 new chemicals enter commerce each year, and
more than 80,000 chemicals reported under the Toxic Substances Control
Act, it is beyond my comprehension that the E.P.A. is taking no action
to inform the public on the health risks of no more than four
chemicals.
This subcommittee seeks to closely evaluate the work--or lack
thereof--of the E.P.A. when it comes to chemical toxicity and public
health.
My condolences go to Ms. Holt-Orsted and Mr. Ensminger, who have
seen loss of life as a result of environmental contamination.
My own constituents, in Dallas, have struggled with lead
contamination in the past, and they continue to deal with long-term
health effects.
This issue of the politicization of science--particularly
environmental protection--is of gravest concern to me.
Congress is right to provide vigorous oversight in situations where
the Federal Government may be guilty of failing its citizens in such an
egregious manner.
Thank you, Mr. Chairman. I yield back the balance of my time.
Chairman Miller. And now, it is my pleasure to introduce
our witnesses today. The first is a North Carolinian--at least,
an adopted North Carolinian, Mr. Jerome Ensminger, retired
Master Sergeant with United States Marine Corps. Second, Mr.
Lenny Siegel, Executive Director of the Center for Public
Environmental Oversight; and Dr. Linda Greer is the Director of
the Natural Resources Defense Council's Health Program.
You will have five minutes for your spoken testimony, and
your written testimony will be included in the record for the
hearing. When you have completed your testimony, we will begin
with questions. Each Member will have five minutes to question
the panel.
It is the practice of the Subcommittee to take testimony
under oath. Do any of you have any objection to being sworn in?
The Committee also provides that you may be represented by
counsel. Are you represented by counsel at today's hearing?
If you now would please stand and raise your right hand? Do
you swear to tell the truth and nothing but the truth? All of
the witnesses have responded in the affirmative.
Mr. Ensminger, you may begin.
STATEMENT OF MR. JEROME M. ENSMINGER, MASTER SERGEANT, U.S.
MARINE CORPS (RET.)
Master Sergeant Ensminger. Good morning. My name is Jerry
Ensminger, and I served my country faithfully for more than 24
years in the United States Marine Corp. I would like to thank
the Chairman, the Committee Members, and their staff for all of
the hard work that went into making these hearing possible. I
must say that since 3 January 2007, I have been heartened and
inspired by the oversight activities by this Congress. You have
been taking on the important issues that matter to the majority
of our citizens, not just the issues that reflect the benefit
of special-interest groups and big business. I am appearing
here today as a tragic example of the consequences of a system
that ignores our environment and the inevitable health effects
that result from it.
Marine Corp Base Camp Lejeune, North Carolina is quite
possibly one of, if not the worst, water-contamination
incidents in modern world history. The Agency for Toxic
Substances and Disease Registry, or ATSDR, estimates that
between 750,000 and one million people were potentially exposed
to horrendous levels of toxins through their drinking water
while stationed at Camp Lejeune. My daughter Janey was
conceived while her mother and I lived in one of the base-
family housing areas where the drinking water was affected by
the contamination at the base. Just like our other children,
Janey was born seemingly normal. That is until she was
diagnosed with Acute Lymphocytic Leukemia, ALL, at the age of
six.
In 1997, the ATSDR proposed a childhood leukemia and non-
Hodgkin's lymphoma study for Camp Lejeune children who had been
exposed to volatile organic chemicals, or VOCs, cleaning
solvents, in utero, while their parents lived at the base,
between the years of 1968 through 1985. The protocol and
proposal for this study outlines that the expected occurrences
of the target illnesses in a cohort of 10,000 to 12,000 births
for that time period would be 7.2 cases. The ATSDR has
confirmed 14 cases of leukemia and two cases of non-Hodgkin's
lymphoma. This more than 100-percent increase in the incidence
of these childhood cancers.
Mr. Chairman, let me lay out some of the facts and figures
relating to the Camp Lejeune water-contamination situation. The
documented levels of contaminants in the finished drinking
water, at the tap, were some 280 times higher than what is
considered safe for these very same chemicals. The Navy Bureau
of Medicine and Surgery issued strict regulations in their
BUMED instructions 6240.3(b), in 1963, governing potable water-
distribution systems on Naval Shore Facilities. Included in
these regulations were preemptive measures to ensure that
existing and future water supplies were not contaminated by
extraneous sources. The Camp Lejeune family-area water-supply
wells were located on the virtual property line, down gradient,
and directly across the street from potential civilian
contamination sources, gasoline stations, auto-repair
facilities, dry-cleaning establishments, and known septic
systems.
In 1971, the Naval Facilities Engineering Command from
Norfolk, Virginia, came to Camp Lejeune and selected multiple
sites for new drinking-water supply wells. One of these new
wells was HP-651, which began producing well water for the Camp
Lejeune Point Water Distribution Plan in January of 1972. The
site which had been selected by the Navy engineers for the
placement of HP-651 was at the back corner of the base disposal
yard, the junk yard. The disposal yard had been in operation
for decades by the time they selected for a water-supply well.
In February of 1985, HP-651 tested positive for some 26,000
parts-per-billion of volatile organic chemicals. There is
little doubt that this water-supply well was contaminated
immediately upon or shortly after its construction.
The irony of all of this is the fact that many of the human
exposures that took place at Camp Lejeune would have been
avoided, had Navy and Marine Corp officials followed their own
regulations. The most audacious and blasphemous truth to this
entire water-contamination incident at Camp Lejeune is the fact
that Navy and Marine Corp officials knew of the existence of
this contamination in their drinking water for five years
before they took any action to rectify the problem. Navy and
Marine Corp officials were knowingly poisoning their own
people. That is correct. All of this was known and taking place
behind the scenes at the very same time that my daughter,
Janey, was suffering through her fight with leukemia, and they
said absolutely nothing.
Not only did they say nothing, they went as far as to
return two of the three contaminated wells for the Tarawa
Terrace Housing Area back online for two more years. They had
the opportunity of tapping into the local community water
lines, which were located just a few feet from the property
line. Instead, Navy and Marine Corp officials opted against
this idea because they did not want to owe the local government
any reciprocating favors.
Since the ATSDR entered the gates of Camp Lejeune to
execute their Congressionally mandated mission, representatives
of the Department of the Navy have done all they could to
obstruct their efforts. I can make this statement with
confidence, because I possess the documentation to back it up.
As recently as the week before last, DOD and Department of the
Navy officials were threatening to thwart the ATSDR initiatives
at Camp Lejeune by withholding the funding.
I spoke earlier about my daughter Janey. My daughter
Janey--and I do not know if anybody else in this room ever had
a child that was diagnosed with a catastrophic illness, but I
can assure you, when Janey was diagnosed, and they told me that
she had leukemia, it took me to my very knees, in the hallway
at the Naval hospital at Camp Lejeune. And my forehead went
down on the deck, and I broke out in a sweat, and I could not
move. Janey went through hell, and all of us that loved her
went through hell with her. A six-year-old child, naturally,
they have had their normal inoculations; but a child with
leukemia is poked and prodded. You just cannot believe what
they go through. I held my daughter in the treatment rooms when
they took needles and broke through her hip to extract bone
marrow to test, and she screamed in my ear, ``Daddy, Daddy do
not let them hurt me.'' And the only response that I could give
her was, ``Janey, the only reason I am letting them hurt you is
because they have to hurt you. They are trying to help you.''
When she got hit with chemotherapy, I would make it a few
miles down the road, and she would get so sick, I would have to
stop, and pull over, and hold her and rub her back while she
threw her guts up, wishing that I could take that off of my
child and put it on myself, but God would not do it.
Throughout Janey's treatment, when she was allowed to go
back to school, her treatments made her look like a freak. She
lost her hair. She gained more than 30 pounds at a time when
she was on steroids. Her schoolmates would pick on her and call
her Cabbage Patch Kid. She would come home from school crying.
I do not know how many times I had to take Janey in the
evenings and just go out to the beach and walk to try to make
sense out of what was happening to her.
At Duke University Medical Center where Janey died, and
where Janey was receiving a lot of her treatments, in the
pediatric ward, the majority of the rooms up there have soft
walls. They fold. There's two rooms at the corners, directly
across from the nurses' station that have two solid walls. They
are referred to by the parents as the dying rooms, and the
closer your child comes to dying, the closer you are to those
two rooms. When you get moved into one of them, you know you
are next. It is like watching mortar rounds walking towards
your bunker.
Nights in the hospital, I spend countless nights in a cot
that folded down from the wall. And you lay in that hospital
all hours of the night, listening to the kids that they got in
the treatment rooms screaming bloody murder. I never cried in
front of Janey the whole time she was being treated, which was
nearly two-and-a-half years. That morning, that day, I started
crying, and she looked up at me, and she had pneumonia, and she
could hardly talk. And she looked at me, and she said, ``Stop
it.'' And I said, ``Stop what?'' And she said, ``Stop crying,
Daddy.'' She said, ``I love you.'' And I said, ``Janey, I know
that.'' I said, ``I love you.'' And she said, ``I know.'' Those
were the last words my daughter spoke to me. She went into a
coma. Thirty-five minutes later, she was dead.
Janey is dead now. Nothing is going to bring her back. But
there were people who were exposed at Camp Lejeune, adults, the
siblings of these in utero children, that are just now reaching
the latency period for their exposures. They are, right now,
developing cancers, adult leukemia, non-Hodgkin's lymphomas,
male breast cancers--six cases of it that we found--renal
failures. Those people need help. We do not need any more
delays from DOD and the Department of the Navy and the United
States Marine Corp.
It is a known fact that the United States Department of
Defense is our nation's largest polluter. It is beyond my
comprehension why an entity with that type of reputation and
who has a vested interest in seeing little to no environmental
oversight would be included in the scientific process. Not only
are they obstructing science, they are also jeopardizing the
public health for millions of people all around the world. It
is quite obvious by their activities to thwart science that
they have something to fear. What they fear is that past
negligence and the liability that comes along with it. There is
little wonder why DOD has been seeking immunities from
environmental regulations for the last seven years running, and
yet this Administration and past Congresses have allowed DOD's
tentacles to infiltrate the realm of science.
We all need to just back off a little bit and allow science
to speak for itself and let the chips fall where they may.
Thank you, Mr. Chairman.
[The prepared statement of Mr. Ensminger follows:]
Prepared Statement of Jerome M. Ensminger
Good morning, my name is Jerry Ensminger and I served my country
faithfully for more than 24 years in the United States Marine Corps. I
would like to thank the Chairman, the Committee Members and their
staffs for all of the hard work that went into making these hearings
possible. I must say that since 3 January 2007, I have been heartened
and inspired by the oversight activities of this Congress. You have
been taking on the important issues that matter to the majority of our
citizens, not just the issues that affect/benefit special interest
groups and big business!
I am appearing here today as a tragic example of the consequences
of a system that ignores our environment and the inevitable health
effects that result from it. Marine Corps Base, Camp Lejeune, North
Carolina is quite possibly one of, if not the worst drinking water
contamination incidents in modern world history! The Agency for Toxic
Substances and Disease Registry (ATSDR) estimates that between 750,000
and 1,000,000 people were potentially exposed to horrendous levels of
toxins through their drinking water while stationed at Camp Lejeune.
My daughter Janey was conceived while her mother and I lived in one
of the base family housing areas where the drinking water was affected
by the contamination at the base. Just like our other children, Janey
was born seemingly normal, that is until she was diagnosed with Acute
Lymphosytic Leukemia (A.L.L.) at the age of six. In 1997, the ATSDR
proposed a childhood leukemia/non-Hodgkins lymphoma study for Camp
Lejeune children who had been exposed to Volatile Organic Chemicals
(V.O.C.'s, cleaning solvents!) in utero while their parents lived at
the base between the years of 1968-1985. (Note: The start date of this
study was based upon the beginning date for the computerization of
birth records in North Carolina, not on potential exposure.) The
protocol/proposal for this study outlined that the expected occurrences
of the targeted illnesses in a cohort of 10,000-12,000 births for that
time period would be 7.2 cases. The ATSDR has confirmed 14 cases of
leukemia and two cases of non-Hodgkins lymphoma, this is more than a
100 percent increase in the incidence of these childhood cancers!
Mr. Chairman, let me layout some of the facts and figures relating
to the Camp Lejeune water contamination situation. The documented
levels of contaminates in the finished drinking water (at the tap) were
some 280 times higher than what is currently considered safe for these
very same chemicals! The Navy Bureau of Medicine and Surgery issued
strict regulations (BUMED INST 6240.3B [CLW 0144]) in 1963 governing
potable water distribution systems on Naval Shore Facilities. Included
in these regulations were preemptive measures to ensure that existing
and future water supplies were not contaminated by extraneous sources.
The Camp Lejeune, Tarawa Terrace family housing area water supply
wells were located on the virtual property line, down gradient, and
directly across the street from multiple potential civilian
contamination sources! (Gasoline stations, auto repair facilities, dry
cleaning establishments, and known septic systems.) In 1971, the Naval
Facilities Engineering Command from Norfolk, Va. came to Camp Lejeune
and selected multiple sites for the construction of new drinking water
supply wells for the base.
One of these new wells was HP-651, which began producing raw water
for the Camp Lejeune Hadnot Point water distribution plant in January
of 1972. The site which had been selected by the Navy engineers for the
placement of HP-651 was at the back corner of the base disposal yard!
(junk yard!) The disposal yard had been in operation for decades by the
time this site was selected for a drinking water supply well. In
February 1985, HP-651 tested positive for some 26,000 ppb of Volatile
Organic Chemicals (CLW 5260)! There is little doubt that this water
supply well was contaminated immediately upon, or very shortly after
its construction! (Note: The ATSDR's on-going water modeling for the
Camp Lejeune, Hadnot Point and Holcomb Blvd. water systems will verify
this fact once it is completed.) The irony of all this is the fact that
many of the human exposures that took place at Camp Lejeune would have
been avoided had Navy and Marine Corps officials followed their own
regulations!
The most audacious and blasphemous truth in this entire water
contamination incident at Camp Lejeune is the fact that Navy and Marine
Corps officials knew of the existence of this contamination in the
drinking water for five years before they took any action to rectify
the problem (CLW 0430-0432, 0436, 0438, 0441, 0443, 0592, 0593)! (Navy
and Marine Corps officials were knowingly poisoning their own people!)
That is correct, all of this was known and taking place behind the
scenes at the very same time that my daughter Janey was suffering
through her fight with leukemia and they said absolutely nothing! Not
only did they say nothing, they went as far as to return two of the
three known contaminated wells for the Tarawa Terrace housing area back
on-line for two more years! They had the option of tapping into the
local community water lines which were located just a few feet from the
property line. Instead, Navy and Marine Corps officials opted against
this idea because they didn't want to owe any reciprocating favors to
the local community government! (CLW 1129-1131)
Since the ATSDR entered the gates of Camp Lejeune to execute their
Congressionally-mandated mission, representatives of the Department of
the Navy (DON) have done all they could to obstruct their efforts. I
can make this statement with confidence because I possess the
documentation to back it up! As recently as the week before last, DOD
and DON officials were threatening to thwart the ATSDR's initiatives at
Camp Lejeune by withholding funding! (CLW 2407, 0000, 0000 (A), 2995,
2999, 3243, 3307, 4925, 4926)
It is a known fact that the United States Department of Defense is
our nation's largest polluter. It is beyond my comprehension why an
entity with that type of reputation and who has a vested interest in
seeing little to no environmental oversight would be included in the
scientific process. Not only are they (DOD) obstructing science, they
are also jeopardizing the public health for millions of people all
around the world. It is quite obvious by their activities to thwart
science that they have something to fear. What they fear is their past
negligence and the liability that comes along with it! There is little
wonder why the DOD has been seeking immunities from environmental
regulations for the last seven years and yet this administration and
past Congress' have allowed their (DOD's) tentacles to infiltrate the
realm of science. We all need to allow science to speak for itself and
let the chips fall where they may!
Chairman. Miller. Mr. Ensminger, I know that Mr.
Sensenbrenner joins me in extending our condolences for the
loss of your daughter and all that you and your family have
gone through.
Mr. Siegel.
STATEMENT OF MR. LENNY SIEGEL, EXECUTIVE DIRECTOR, THE CENTER
FOR PUBLIC ENVIRONMENTAL OVERSIGHT (CPEO)
Mr. Siegel. Good morning. I am from the town of Mountain
View, California. We have about seven or eight Superfund sites
and numerous other contamination sites. I work with communities
all over the country. I visit communities, folks from Camp
Lejeune, and lots of places, and I hear lots of stories like
Jerry's.
The Environmental Protection Agency's integrated risk
information system is the foundation of most of the federal,
State, and tribal risk-management decisions that determine the
safety of the air that we breathe, the water we drink and the
soil under our feet. Quantitative judgments embedded in IRIS
may read like a foreign language or quantum physics to most
Americans. People do not understand it. But those judgments
affect our health, our environment, and our property.
Unfortunately, over the past several years, the White House
and federal agencies that are among the world's greatest
polluters, Department of Energy, Department of Defense, and
NASA, have essentially hijacked EPA's authority to conduct
human health-risk assessments. EPA's announcement in April of
the new process for IRIS simply institutionalizes an approach
that has been used, at least for perchlorate and
trichloroethylene. This is an approach that unnecessarily puts
Americans at risk. In lay terms, the fox is now managing the
hen house.
In my prepared testimony, I tell the story of
trichloroethylene. I could tell perchlorate because I have
worked on that as well. Federal agencies have delayed and
perhaps prevented, in the long run, the establishment of more
protective health standards for TCE. The process they use for
that is apparently the precedent for the new IRIS process that
EPA announced in April.
In 2001, EPA issued a draft human health-risk assessment
for TCE. Though its Science Advisory Board generally endorsed
the study, EPA, under pressure from the White House and federal
polluting agencies, withdrew its 2001 findings, and it turned
the issue of TCE toxicity over to what was called the
interagency working group, and that working group sent it to
the National Academy of Sciences for re-review.
In early 2003, January 2003, EPA scientists came to my
community of Mountain View to discuss the migration of TCE
vapors into homes and businesses at, at least, four
contamination sites. One of them was not Superfund. The others
were Superfund. Over 400 people attended that meeting. The
picture is up there.
EPA told us that, based on the 2001 risk assessment, that
TCE was five to 65 times as toxic as previously believed. I
learned about a year later from a friend in the Navy that that
provisional risk assessment would never be implemented, that
the EPA was going to withdraw it and go through the process I
just mentioned.
They weakened the standards, and those weakened standards
have led to less protection for the people in my community and
communities throughout the country, even though, as Chairman
Miller read, the Academy of Science's review committee found
that the evidence that TCE caused cancer was even stronger than
EPA believed in 2001. Still, EPA has really done almost nothing
to move forward to establish new standards for TCE.
The key point of my testimony is that these numbers in IRIS
actually make a difference in people's lives and their health
and what happens to their property. This is a picture of my
friend Jane's house, about a half-mile from my house.
She lives across the street from the birthplace of the
semiconductor industry, and they originally thought that the
plume boundary from TCE was in the middle of the street in
front her house. It turns out the plume goes under her house,
because when they tested her son's bedroom, they found 0.8
micrograms per cubic meter of TCE in the air. According to the
initial standard that the EPA science brought based on the 2001
health-risk assessment, that was almost two orders of magnitude
higher than what the standard should be, what was considered a
legally safe cancer risk. With the standard that was in place
before the 2001 health-risk assessment, he was considered safe,
so it made it a difference.
Now, fortunately, and it is really not fortunate at all,
but the measurements in the basement of the house were higher,
and so they installed a fan to ventilate the house and lower
the contamination. After age 11, her son's exposures went down
because we did something about it. We do not know whether he
will get sick as a result. Jane does know that she is going to
have a lot of trouble selling her house because it has the
mitigation system there.
This is a picture of where Shirley lived in Bayport,
Minnesota.
She had contamination in her private drinking water supply,
between the five parts per billion, which is the longstanding
standard for TCE in drinking water, and one which is where
everybody expected the number to go if the 2001 human health-
risk assessment had been implemented. Her nephew wrote me.
Because the rule was for this Superfund site in Bayport,
Minnesota is that people who had contamination above five would
have treatment systems on their private wells. She did not get
it, and she died of cancer a couple of years ago. And her son
asked me, you know, why is it that she did not get the
protection? I cannot say. I am not a scientist, and I am not
sure scientists can tell you she got sick because of that
exposure or to what degree it added to the risk she faced,
because we drink this stuff, breathe this stuff all over the
place. But I do know that that number made a difference as to
whether her water was treated for the trichloroethylene that
she was drinking and was showering in and was being exposed to.
The numbers also make a difference to these polluting
agencies. We found on the Web an Air Force presentation a few
years back, around the time that this was all happening, that
figured out that it would cost the Department of Defense $5
billion extra to clean up TCE if the standard went from five
parts per billion to one part per billion for drinking water. I
do not know if that is really true. There are reasons why it
might not have been as high, but it might have been higher. The
point is that the Defense Department's interest in this is
primarily one that they are a responsible party, rather than
their mission is to protect human health and the environment.
So the people that I work with, the people who are
impacted, the people who are breathing and drinking the
contamination of these sites are calling on EPA to withdraw the
revision that it made in the IRIS process in April because they
are basically institutionalizing something that has been
putting people at risk already.
And we have come up with three principles that we think the
IRIS process should involve. The IRIS process is not the entire
process, but it is the foundation of it. First, all
stakeholders, including the affected public, private polluters,
federal polluting agencies, including the Defense Department,
should have the same access to the decision-making process for
the assessment of hazardous substances. This notion of a
deliberative process in which the federal polluters meet
privately with EPA to design the studies is unacceptable.
Secondly, federally funded risk-relevant research should be
managed by agencies that do not have conflicts of interest.
What happened with perchlorate is that the Defense Department
sponsored some research and did not like the results, so they
sponsored more research to disprove it. I'm much more
comfortable when the Centers for Disease Control does studies
because they are not encumbered by the conflict of interest.
The third one, the entire process of assessing hazardous
substances should be carried out in the sunshine, with
oversight by the public, the press, and by Congress. I'm not a
toxicologist or an epidemiologist. I assume that Members of
this committee are not, the same, as well. We are not in a
position to determine whether it should be 1, 5, or 50 for TCE,
but we are calling upon you.
This is the people who are living and breathing this stuff.
We are calling upon you to ensure that we have a fair, open,
and timely process to evaluate not only the chemicals that we
are discussing today, but the many more than impact our lives.
Thank you.
[The prepared statement of Mr. Siegel follows:]
Prepared Statement of Lenny Siegel
Getting the Fox out of the Henhouse: Restoring the Integrity of EPA's
Process for Determining the Toxicity of Industrial and Military
Chemicals
Executive Summary
The Environmental Protection Agency's Integrated Risk Information
System (IRIS) is the foundation of most of the federal, State, and
tribal risk management decisions that determine the safety of the air
we breathe, the water we drink, and soil under our feet. The
quantitative judgments embedded in IRIS may read like a foreign
language or quantum physics to most Americans, but they affect our
health, our environment, and our property.
Unfortunately, over the past several years, the White House and
federal agencies that are among the world's greatest polluters have
hijacked EPA's authority to conduct human health risk assessments.
EPA's April announcement of a new IRIS process simply institutionalizes
an approach--used for perchlorate and trichloroethylene (TCE)--that
unnecessarily puts Americans at risk. In lay terms, the fox is now
managing the henhouse.
In my prepared testimony I tell the story of trichloroethylene.
Federal agencies have delayed and perhaps prevented the establishment
of more protective health standards for TCE, following a pattern that
appears to be a precedent for the new IRIS process. In 2001 EPA issued
a Draft Human Health Risk Assessment for TCE. Though its Science
Advisory Board generally endorsed that study, EPA--under pressure from
the White House and federal polluting agencies--withdrew the 2001
findings. It turned the issue of TCE toxicity over to the Interagency
Working Group and sent it to the National Academies of Sciences for re-
review. Meanwhile, EPA scientists significantly weakened the standards
they were using to guide vapor intrusion investigations in my community
of Mountain View, California. Though in July 2006 the Academies of
Sciences told EPA and the other agencies to move quickly to promulgate
a TCE standard, EPA has done little.
EPA risk findings make a difference. It's the difference between
response and inaction in the bedroom of Jane's son in Mountain View,
California. It's the difference between water treatment and inaction in
Shirley's former home in Bayport, Minnesota. According to an Air Force
scientist, it's a difference of $5 billion in the cost of groundwater
treatment at 1400 Defense Department sites.
People impacted by TCE, perchlorate, and other toxic substances
have called upon EPA to withdraw its recent IRIS changes and instead
create a process based upon the three following principles:
1. All stakeholders, including the affected public, private
polluters, and federal polluting agencies, should have the same
access to the decision-making process for the assessment of
hazardous substances.
2. Federally funded risk-relevant research should be managed
by agencies that do not have conflicts of interest--that is,
agencies that will incur significant costs or encumbrances
associated with more protective health and environmental
standards should not control these research activities.
3. The entire process of assessing hazardous substances should
be carried out in the sunshine, with oversight by the public,
the press, and by Congress.
The TCE Risk Assessment
The Environmental Protection Agency's Integrated Risk Information
System (IRIS) is the foundation of most of the federal, State, and
tribal risk management decisions that determine the safety of the air
we breathe, the water we drink, and soil under our feet. The
quantitative judgments embedded in IRIS may read like a foreign
language or quantum physics to most Americans, but they affect our
health, our environment, and our property.
Unfortunately, over the past several years, the White House and
federal agencies that are among the world's greatest polluters have
hijacked EPA's authority to conduct human health risk assessments.
EPA's April announcement of a new IRIS process simply institutionalizes
an approach that unnecessarily puts Americans at risk. In lay terms,
the fox is now managing the henhouse.
Today I am going to tell the story of trichloroethylene (TCE), the
once-universal solvent that is one of the most common contaminants at
both federal and private hazardous waste sites across the country.
Federal agencies have delayed and perhaps prevented the establishment
of more protective health standards for TCE, following a pattern that
appears to be a precedent for the new IRIS process.
In August 2001 EPA issued a Draft Human Health Risk Assessment for
Trichloroethylene. In considering the impact of the compound on young
children, as well as cumulative exposures, it found that TCE was much
more toxic than previously believed. In December 2002, EPA's Science
Advisory Board peer review praised the ``ground-breaking'' assessment,
finding:
The Board advises the Agency to move ahead to revise and
complete this important assessment. The assessment addresses a
chemical, trichloroethylene (TCE), significant for being a
nearly ubiquitous environmental contaminant in both air and
water, being a common contaminant at Superfund sites, and
because it is ``listed'' in many federal statutes and
regulations. The draft assessment is also important because it
sets new precedents for risk assessment at EPA. We believe the
draft assessment is a good starting point for completing the
risk assessment of TCE. The Panel commends the Agency for its
effort and advises it to proceed to revise and finalize the
draft assessment as quickly as it can address the advice
provided in this report.
Meanwhile, in November 2002, EPA issued tables along with its Draft
Vapor Intrusion Guidance. Vapor intrusion is the migration of volatile
compounds such as TCE from the subsurface into homes, schools, offices,
and other structures. Those tables included target indoor air, soil
gas, and groundwater concentrations for TCE based upon the 2001 draft
Risk Assessment. That Draft Vapor Intrusion Guidance remains in limbo;
EPA has no plans to finalize it.
In January 2003, EPA scientists convened a public meeting in my
community of Mountain View, California to discuss the emerging pathway
of vapor intrusion at a number of local TCE cleanup sites. Over 400
people attended. EPA scientists explained that TCE was now considered
five to 65 times as toxic as previously believed, and they introduced a
screening level for TCE in indoor air, .017 micrograms per cubic meter
(mg/m3), corresponding to a one-in-a-million (``ten to the
minus six'') excess lifetime cancer risk. In fact, most EPA regions
adopted that number as a provisional goal.
EPA and the Mountain View responsible parties (polluters),
including the Navy and NASA, continued their vapor intrusion
investigations. Testing, using the provisional screening level, showed
that most of the homes at an award-winning new housing development were
safe after all. However, despite the Navy's misinterpretation of site
data, we were eventually able to show that military families were being
exposed to unsafe levels of intruding TCE vapors in the Army-run Orion
Park Military Housing Area, formerly part of Moffett (Field) Naval Air
Station.
In March 2004 I attended an EPA-sponsored workshop on vapor
intrusion in San Diego. I was surprised to hear there, from a Navy
friend, that I shouldn't worry about the vapor levels in Mountain View.
EPA--the Navy had been assured--was going to withdraw the 2001 draft
Risk Assessment. And indeed, that's what happened.
Back home in Mountain View, EPA adopted an interim action level of
1.0 mg/m3 for TCE in indoor air. EPA explained the status of
the health standard in its June 2004 Draft First Five-Year Review
Report for the Middlefield-Ellis-Whisman (MEW) Superfund Study Area,
Mountain View, California:
EPA's ORD [Office of Research and Development] and OSWER
[Office of Solid Waste and Emergency Response] have requested
additional external peer review of the draft TCE Health Risk
Assessment by the National Academy of Sciences. Consequently,
review of the toxicity value for TCE may continue for a number
of years. In the interim, because of the uncertainties
associated with the draft TCE Health Risk Assessment, EPA
Region 9 is considering both the draft TCE Health Risk
Assessment toxicity values, as well as the California TCE
toxicity value (similar to EPA's previously listed TCE toxicity
value from 1987), in evaluating potential health risks from
exposure, and in making protectiveness determinations.
That October a high EPA official told U.S. Today that the agency
was ``not forced to go to the National Academy of Sciences.'' I told
the same reporter that EPA's action was like ``voluntarily'' jumping
off the railroad tracks as a speeding train approached.
The National Academies Review
EPA actually moved the TCE issue to the same Interagency Working
Group that weakened EPA's drinking water guideline for perchlorate--an
essential component of solid rocket fuel--from an expected 1 ppb to
24.5 ppb. I actually learned that EPA, the White House, NASA, and the
Departments of Energy and Defense were following the perchlorate game
plan for TCE over dinner at a perchlorate meeting in Las Vegas in
September 2004. Making conversation with a gentleman sitting across the
table, I found that he too had an interest in TCE. In fact, as a
Department of Energy--not EPA--official, he was awarding the study
contract to the National Academies of Sciences for its TCE review, just
as he had done with perchlorate.
I had been at one of the Academy meetings about perchlorate, and I
knew what a juggernaut of federal agencies and their contractors had
weighed in calling for weaker perchlorate standards. So I encouraged
people from TCE-impacted communities to attend Academy TCE Committee
meetings and testify, and I was impressed by their response. For
example, in March 2005 a carload of people from Endicott, New York took
the day off work and drove down to DC on their own dime, and then drove
back the same day, only to be caught in a Pennsylvania blizzard. In
June, West Coast activists attended and spoke at the TCE Committee
meeting in Irvine, California, displaying the photos of workers who
died following exposure to TCE at the View-master plant in Beaverton,
Oregon. People from impacted communities did not pretend to have
toxicological or epidemiological expertise. They simple reported that
they and their neighbors of family members had been exposed to TCE.
Many had contracted serious illnesses. And they wanted the experts on
the Committee to think about them, not just the well-funded testimony
of polluters, when it continued its deliberations.
It was at the first Academy TCE Committee meeting that the
Interagency Working Group went public--at least about TCE. A White
House official introduced a panel that not only included an EPA
official, but also representatives of three federal polluting agencies:
NASA, the Department of Energy, and the Department of Defense. What I
had known for some time was finally out in the open: Federal agencies
whose primary concern about TCE was the hundreds, maybe thousands of
sites for which they were responsible for cleanup, were overseeing the
government's efforts to update the health risk data that would be
incorporated into IRIS. That is, the foxes had been given the keys to
the henhouse.
In July 2006 the Academy TCE committee issued its report. It was
long and complicated, and it provided detailed advice on how to conduct
additional studies. But its overall conclusion was clear:
The committee found that the evidence on carcinogenic risk and
other health hazards from exposure to trichloroethylene has
strengthened since 2001. Hundreds of waste sites in the United
States are contaminated with trichloroethylene, and it is well
documented that individuals in many communities are exposed to
the chemical, with associated health risks. Thus, the committee
recommends that federal agencies finalize their risk assessment
with currently available data so that risk management decisions
can be made expeditiously.
So what did EPA and the Interagency Working Group do? While in
early 2005 they spent only a month implementing Academy recommendations
for a weaker perchlorate standard, they moved slowly on TCE, even in
the face of the strong Academy recommendation. They moved so slowly
that one year later Senator Clinton, Senator Dole, and three other
Senators introduced legislation designed to accelerate the development
of new risk data and to create an interim vapor intrusion standard for
TCE. Still EPA stalled, and EPA officials told Congress that the
necessarily slow process could actually lead to a less protective
standard.
Finally, in April 2008 EPA announced its new IRIS process,
essentially institutionalizing the informal process that it had applied
to TCE, as well as perchlorate. Activists from throughout the country
responded by sending the attached ``Grassroots Letter'' to EPA, calling
EPA's action ``an attempt to cement a privileged position for federal
polluting agencies, in which they would have recurring, generally
secret (`deliberative') input into EPA's findings.'' Ironically, one
key provision in the new process will not apply to TCE because it
cannot be a ``mission-critical chemical substance.'' In general,
federal agencies no longer use TCE, though some contractors apparently
do.
It Makes a Difference
The risk data for TCE is not just an abstract principle. It makes a
difference in the real world.
My neighbor, Jane, in Mountain View, California lives across
Whisman Avenue from the birthplace of the American commercial
semiconductor area, now known as the Middlefield-Ellis-Whisman (MEW)
Superfund Study Area. Historically, official maps showed her home just
outside the five parts per billion (ppb) contour line that defined the
edge of the regional TCE groundwater plume. In March 2004, she finally
got EPA and the MEW Responsible Parties to test the air in her house.
They found that TCE from the MEW plume was intruding into her home. TCE
levels in her 11-year-old (at the time) son's bedroom was .8 mg/
m3, above the screening level EPA had originally presented
to the community, but below the interim action level. Only because
levels in her basement were about 4 mg/m3, above that action
level, did EPA and the companies install a ventilation system.
In Bayport, Minnesota, Shirley lived down gradient of a
metal-plating shop that released enough TCE to place much of the town
on the Superfund National Priorities List (NPL). Shirley's private
drinking water well tested TCE at 2.5 ppb in 1988. In 1999, just before
she moved, her well tested at 4 ppb of TCE. In 2002, she was diagnosed
with cancer. In 2005 she died. Her family wants to know, ``If Shirley's
well never got over 4 ppb of TCE, and she died of cancer, why is the
minimum for installing wellhead treatment systems 5 ppb?'' I have no
way of knowing whether the TCE in Shirley's well was a primary cause of
her illness. The point is that the risk management decision is a
function of the Maximum Contaminant Level (MCL), which in turn is based
upon IRIS data.
In April 2003, an Air Force scientist estimated that if EPA
were to lower the MCL for TCE to 1 ppb (from 5 ppb), it would cost the
Defense Department an additional $5 billion in current dollars to
address groundwater contamination alone at its estimated 1400 TCE
sites. I'm not convinced by the Air Force calculations, but it's clear
that Defense environmental officials believed that the adoption and
implementation of standards based upon EPA's 2001 draft Human Health
Risk Assessment would be very costly.
Three Principles
Neither I nor the people with whom I work, people who have been
exposed to significant levels of TCE and other toxic compounds, have
the expertise to determine exactly what is safe. We count upon our
government, directed by you, our elected officials, to establish a
fair, open process to develop risk data. We ask you to direct EPA to
reverse its recent IRIS pronouncements and instead to create a new
process based upon the following three principles from the ``Grassroots
Letter.''
1. All stakeholders, including the affected public, private
polluters, and federal polluting agencies, should have the same
access to the decision-making process for the assessment of
hazardous substances.
2. Federally funded risk-relevant research should be managed
by agencies that do not have conflicts of interest--that is,
agencies that will incur significant costs or encumbrances
associated with more protective health and environmental
standards should not control these research activities.
3. The entire process of assessing hazardous substances should
be carried out in the sunshine, with oversight by the public,
the press, and by Congress.
To protect our health and the health of future generations,
Congress must guarantee the integrity of the IRIS process.
Grassroots Letter Attachment
Biography for Lenny Siegel
Education:
Valedictorian, Culver City High School, Culver City, California, 1966
Stanford University (Physics), 1966-1969
Employment:
Pacific Studies Center, Mountain View, Director, 1970-present
Center for Public Environmental Oversight (CPEO), Executive Director,
July, 1994-present
Teaching Experience:
UCLA Department of Urban Planning, Guest Professor, Spring, 1995 and
Winter, 1997
UC-Berkeley Extension, Guest Lecturer, ``Strategies for Site
Remediation: A Case Studies Approach,'' Winter, 1995, 1996, and
1997; Fall, 1998
Council of Energy Resource Tribes, Guest Lecturer, ``Mitigation of
Environmental Impacts to Indian Lands due to Department of
Defense Activities,'' Summer, 1994 and 1995
Award:
U.S. Environmental Protection Agency, Region 9, Environmental
Achievement Award, November, 2001
Sample Publications:
``Independent Review of the Draft Site Management Plan for the Mott
Haven Schools Complex Bronx, New York,'' March, 2008; ``Community
Perspectives on VOC Response at Department of Defense Installations,''
September, 2007; ``Independent Review of the Cleanup of the Mott Haven
Schools Complex, Bronx, New York,'' January, 2007; ``Homes, Schools,
and Parks: Where, When, and How to Build on Contaminated Sites,''
December, 2006; ``Gulf Coast Reconstruction: The Biggest `Brownfield,'
'' October, 2005: ``A Stakeholder's Guide to `All Appropriate
Inquiries,' '' August, 2005.
``Vapor Intrusion: The New Frontier of Toxic Cleanup,'' (BNA,
September, 2004); Stakeholders' Guide to Munitions Response (Spring,
2004); Stakeholders' Guide to Federal Facilities Cleanup (Summer,
1997); Military Contamination and Cleanup Atlas for the United States--
1995 (September, 1995); Covering The Map: A Survey of Military
Pollution in the United States (May, 1993); Citizens' Guide to Military
Base Clean-Up and Conversion (September, 1993). He is also a
contributor to Community Risk Profiles: A Tool to Improve Environment
and Community Health (Rockefeller University, April, 1995). For
additional publications, see http://www.cpeo.org/pubs/pub.html
Consulting Experience
Council of Energy Resource Tribes
Kaho'olawe Island Reserve Commission
Military Toxics Project
New York Lawyers for the Public Interest
Physicians for Social Responsibility-Los Angeles Office
RAND Corporation
Rockefeller University Program on the Human Environment
Silicon Valley Toxics Coalition
Committees (italicized are current):
Air Combat Command Project on Streamlined Oversight, External Review
Group
ASTM/ISR Brownfields Steering Committee
California Base Closure Environmental Advisory Group
California Brownfields Reuse Advisory Group (Co-Chair)
California CLEAN Loan Committee
California Site Mitigation Update advisory group
California Superfund Working Group
Clean Sites Independent Review of Program Performance, Defense
Environmental Restoration Program, Blue Ribbon Review Panel
Community Environmental Health Assessment Project Steering Committee,
National Association of City and County Health Officials
Compliance Assistance Advisory Committee (U.S. EPA)
Defense Science Board Task Force on Unexploded Ordnance Clearance
Operations
Department of Toxic Substances Control (California) External Advisory
Group
Federal Facilities Environmental Restoration Dialogue Committee
Interstate Technology & Regulatory Council Perchlorate Work Team
Interstate Technology & Regulatory Council Vapor Intrusion Work Team
Moffett Naval Air Station Restoration Advisory Board
National Environmental Justice Advisory Council Subcommittee on Waste
and Facility Siting
National Environmental Justice Advisory Council Federal Facilities
Working Group
National Policy Dialogue on Military Munitions
National Research Council Committee on ACWA Secondary Wastes
National Research Council Committee on Army Non-Stockpile Chemical
Demilitarization Program (three iterations)
National Research Council Committee on Environmental Remediation at
Naval Facilities (two iterations)
Northeast Mountain View Advisory Council (Board member)
Peer Review Panel for the VOC Historical Case Initiative
Range Rule Partnering Team
Range Rule Risk Methodology Partnering Team
Western Region Hazardous Substance Research Center Outreach Advisory
Committee
Chairman Miller. Thank you, Mr. Siegel. Not only am I not a
toxicologist, I could not pronounce the chemical.
Dr. Greer.
STATEMENT OF DR. LINDA E. GREER, DIRECTOR, HEALTH PROGRAM,
NATURAL RESOURCES DEFENSE COUNCIL
Dr. Greer. Good morning, and thanks for the opportunity to
testify. I am a toxicologist. I direct the health program at
the Natural Resources Defense Council, where I have been for 15
years, and I have watched the EPA's evaluation of toxic
chemicals for many years, both in my capacity as the director
of the health program at NRDC, as a member of the executive
committee of EPA's Science Advisory Board, where I served for
six years, and on many committees at the National Academy of
Sciences, including, most recently, the Committee on Emerging
Issues in Toxic Chemicals. I commend you, Mr. Miller, for your
interest in the IRIS review process, and more specifically, in
your concern in the Committee's concern about the recent
changes that have been made to this program.
IRIS is, as you have said, as cornerstone program at EPA,
which provides the scientific information necessary to develop
our nation's air and drinking-water standards as well as
hazardous-waste clean-up levels. The changes that are the
subject of today's hearing are yet another escalation of the
Administration's war on science and public health that has gone
on for nearly eight years. It's a record of political
interference with the work of government scientists across a
range of environmental issues, including global warming or even
endangered species, has been well established. Things are no
better in the case of analyzing and regulating toxic chemicals
that pose a risk to health. In this area, the Administration
has attempted and in some cases succeeded in blocking,
weakening, and delaying health standards for a very long list
of pollutants, including arsenic, mercury, lead, benzene,
perchlorate, formaldehyde, particulates and ozone, and of
course, trichloroethylene. In addition, the Administration has
weakened the public's right to know about the release of toxic
chemicals into their community.
Thus, the recent changes to the IRIS program that are the
subject of today's hearing are properly viewed as one part of a
much broader agenda to sacrifice public health protections and
limit public understanding of the risk of toxic chemicals in a
manner that benefits a host of polluting industries and federal
agencies.
For many years, IRIS assessments were developed by EPA
scientists. Drafts were released simultaneously for public
comment and external independent peer review. OMB and
government agencies, such as DOD or DOE, who sometimes had a
stake in the outcome of the evaluation because of their
obligation to address contamination at their facilities, had an
opportunity to review and comment on the draft when it was
released for public comment. These procedures allowed EPA
scientific experts to create and own the assessment and kept
influence by government agencies with polluter profiles to a
minimum. The new process established by the White House turns
this process on its head. It invites interference by OMB and
other agencies, both at the onset of the process, in the
middle, and at the bitter end--a license-to-kill, so to speak--
if the process did not end as they wished.
Importantly, these newly introduced intervention points are
considered deliberative, and hence shielded from public view,
forcing EPA to respond to concern behind closed doors, and
alarmingly the new opportunities are not limited to data
critiques. One particularly misguided new feature offers
agencies outside of EPA up to two years to undertake their own
additional studies of ``mission critical'' chemicals,
suspending EPA's evaluation of these contaminants for a very
substantial period of time while they take advantage of this
opportunity to delay a potential day of reckoning.
Although current EPA leadership argues that the new process
was developed in order to provide ``greater transparency,
objectivity, balance, rigor, and predictability'' to the IRIS
assessment, we would characterize these changes quite
differently. In our view, the new process is designed precisely
to give the polluting agencies more access, more opportunity
for delay, and more influence to what has historically been an
objective scientific evaluation process and to allow these
opportunities to occur behind closed doors, hiding the exercise
of that influence from public view.
In fact, if one's intention was to design a new system that
would deliver greater influence to government agencies with
pollution problems over EPA rules, it would be hard to think of
a system that would be better than this one. The claim that the
new process will result in a more balanced and objective result
simply does not pass the laugh test.
Before closing, I would like to turn briefly to the issue
of timeliness, which as we have seen from our other witnesses,
is a real problem in the IRIS program. The IRIS program has
always struggled to keep pace with EPA's regulatory needs and
many environmental contaminants lacking IRIS assessments are
quite important to public health, TCE, for one, perchlorate for
another. There is no IRIS risk assessments for nearly one-third
of the 189 hazardous air pollutants, for example. Furthermore,
even where important chemicals are in the IRIS database, the
risk assessments available for many of these chemicals are
outdated. The average assessment on IRIS is over 13 years old
with the oldest having not been significantly revised since the
mid-1980's, and, as has been mentioned, these problems greatly
exacerbate the already long period of time required for EPA
standard-setting procedures, up to a decade in some cases, and
have been the focus of criticism for some time.
Clearly, constructive reform of the IRIS program is needed
and constructive reform would focus on increasing resources
available to undertake IRIS reviews as well as policy changes
that would streamline the difficult decision-making inherent in
the process. The new procedures run completely counter to these
goals and will only exacerbate the backlog. Properly
implemented, the EPA IRIS program provides a crucial scientific
service to the public, and I emphasize speed is important but
scientific integrity is paramount. These changes hit IRIS on
both fronts in a terrible way, slowing the process further and
compromising its content. We request that the Science Committee
and the Subcommittee work with other House colleagues to ensure
that the new IRIS process is overturned or withdrawn and that
you require IRIS health assessments to be reviewed in an open
process without inappropriate political interference. Thank you
very much for this opportunity to testify.
[The prepared statement of Dr. Greer follows:]
Prepared Statement of Linda E. Greer
Good morning and thank you for this opportunity to testify on the
failure of the EPA IRIS program to serve the needs of the public.
My name is Linda Greer, and I direct the Health Program at the
Natural Resources Defense Council, where I have worked for more than
fifteen years. I have a Master's degree in public health and a Ph.D.,
in environmental toxicology. I have watch-dogged EPA's evaluation of
toxic chemical hazards and risks for many years, both in my capacity as
the Health Program Director at NRDC and as a member of the Executive
Committee of EPA's Science Advisory Board, where I served for six
years. I have also served on many committees of the National Academy of
Sciences, including most recently the Committee on Emerging Issues in
toxic chemicals and served on the NAS Board on Life Sciences from 2001-
2004. The Natural Resources Defense Council (NRDC) is a national,
nonprofit organization of scientists, lawyers and environmental
specialists dedicated to protecting public health and the environment.
Founded in 1970, NRDC has 1.2 million members and online activists,
served from offices in New York, Washington, Chicago, Los Angeles, San
Francisco and Beijing.
NRDC's Health program focuses on toxic chemical pollutants in air,
water, food, and shelter. Over the years, we have focused our
particular attention on the ``biggest pollutants'' in these media, the
ones disproportionately responsible for the biggest threats to human
health. This has led to successful efforts to substantially reduce
diesel air emissions from trucks and buses, for example, and to take a
number of dangerous and outdated pesticides off the market. There are
more than 70,000 chemicals in commerce, but some are much more toxic
than others, and we can make great progress in environmental health
protection if eve focus on the chemicals pollutants that pose the
greatest threat to human and ecological health.
We commend the Science and Technology Committee and this
subcommittee for its interest in the EPA Integrated Risk Information
System (IRIS) chemical review process and its oversight of recent
changes made by EPA and the Bush Administration. These changes are yet
another escalation of the Administration's war on science and public
health that has gone on for nearly eight years. Its record of political
interference with the work of government scientists across a range of
environmental issues including global warming and endangered species
has been well-established. Things are no better in the case of
analyzing and regulating toxic chemicals that pose a risk to public
health. In this area, the Administration has attempted (and in some
instances succeeded) to block, weaken, or delay health standards for a
long list of dangerous pollutants including arsenic, mercury, lead,
benzene, perchlorate, formaldehyde, particulates and ozone. In
addition, the Administration has weakened the public's right to know
about the release of toxic chemicals into their communities.
Thus, the recent changes to the IRIS process that are the subject
of today's hearing should properly be viewed as one part of a much
broader agenda to sacrifice public health protections and limit public
understanding of the risk of toxic chemicals, in a manner that benefits
a host of polluting industries and federal agencies. Indeed, by
attempting to weaken the IRIS process, the Administration has zeroed in
on one of the earliest and most fundamental steps in the process of
protecting public health, that in which EPA's scientists identify the
health risks posed by exposure to certain chemicals. The Committee's
hearings should preface Congressional action to reverse the recent
changes to the IRIS process and ensure the integrity and effectiveness
of the program is restored.
The importance of the IRIS database
The IRIS database is a publicly available database which contains
EPA's evaluation of potential human health effects from exposure to
more than 540 chemicals, including highly hazardous chemicals such as
vinyl chloride, butadiene, benzene, lead, mercury, and asbestos.\1\
While these evaluations are not regulations per se, they are used by
both State and federal regulators and by the international community
for a range of environmental health regulation and management purposes.
For example, the information can be used in combination with exposure
data to set cleanup levels at hazardous waste sites, or to set exposure
standards for air, water, soil, and food. Thus, the accuracy,
credibility, and timeliness of IRIS assessments have real world
consequences for human health.
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\1\ Integrated Risk Information System (IRIS) http://cfpub.epa.gov/
ncea/iris/index.cfm
---------------------------------------------------------------------------
The global importance of this database cannot be overstated. For
example, in May, 2008 alone, the IRIS website received almost 25,000
requests (an average of over 800 per day), from over 2,000 separate
computer sources and from over 60 different countries.\2\
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\2\ IRIS (Integrated Risk Information System). Web Statistics for
iriswebp. Washington, DC: U.S. Environmental Protection Agency.
Available: http://www.epa.gov/reports/objects/iriswebp/iriswebp/
iriswebp
IRIS conducts scientific assessments, not policy documents
Risk assessments involve the integration of hazard identification,
dose-response assessment, and exposure assessment to estimate the
probability (likelihood) of harm. Rather than conducting entire risk
assessments, the IRIS program is limited to conducting hazard
identification and assessing dose-response relationships for
environmental chemicals; EPA factors in exposure scenarios and risks
under its regulatory programs.
Hazard identification, the first step in a risk analysis,
determines whether or not the substance of concern is likely to have
adverse health effects. This step requires a thorough review of
relevant toxicologic data and may include human epidemiology, whole
animal studies, non-animal data, and field data. The result is a
scientific determination of whether or not a substance causes adverse
health outcomes such as cancer, neurological disease, birth defects, or
death. Since reliable human data is often not available, hazard
evaluations generally rely heavily on identifying whether the substance
is toxic in animals or other test systems.
The dose-response assessment follows hazard identification and is
designed to identify safe levels of exposure for chemicals that pose
harm. This assessment consists of scientifically characterizing the
relationship between the amount of exposure (dose) and the incidence of
an adverse health endpoint. Methodologies for dose-response assessment
often differ between cancer and non-cancer effects and between acute
and chronic exposure scenarios. They are often scientifically
controversial, because they must extrapolate from high experimental
doses to more typical ambient exposure levels.
Ideally, epidemiological data would be available that clearly
illuminate the hazards and the dose-response relationships for
chemicals of concern in human populations. Unfortunately, this is
nearly never the case. Most chemicals lack key studies of effects in
humans as well as studies of effects in animals at ambient levels. As a
result, IRIS assessors are called upon to make informed judgments
regarding the relevance of the animal data to humans, and to select the
most appropriate extrapolation method. Further, the IRIS assessments
require independent expert judgment to decide whether various safety
factors should be applied to assessment data to ensure public health
protection. For example. EPA often decides to include margins of safety
to protect vulnerable populations, relevant genetic variations,
vulnerable life stages, disease states, concomitant exposure to complex
mixtures, and other relevant factors that may influence the probability
of an effect caused by exposure to the substance of concern.
Importantly, decisions made in the IRIS program are informed by
various EPA guidance documents that are publicly-available and
publicly-documented, and have been publicly-vetted. Reliance on these
important guidance documents is crucial to ensure that evaluations are
consistent across substances and as objective as possible.
The new process established by the White House turns this process
on its head: it invites the injection of non-scientific considerations
into the IRIS assessments, and further, it shields from public scrutiny
the input from other parts of the government with a potential financial
or political interest in the outcome of a particular assessment. When
political appointees, perhaps acting on behalf of regulated industries,
and polluting agencies are able to interfere in a non-transparent and
inappropriate manner, the whole process is severely compromised.
Summary of the new process
The new 2008 IRIS process introduces three new opportunities for
OMB and other non-health agencies to weigh in on EPA's health
assessments, where previously there was only one. Importantly,
interagency comments and OMB comments for all three of the new
intervention points are shielded from public view: the first two bites
at the apple, and the last one. Thus, whereas the pre-2004 IRIS process
provided the agencies and OMB with the draft assessment at the same
time as it was provided to the public, the new process injects
polluting agencies such as DOD and DOE into the assessment process at
an earlier stage, and forces the IRIS staff to address the interests of
the agencies and OMB, whether they are consistent with health-
protective policies or not. These exchanges take place out of the
public eye. Following this negotiation, the draft review is publicly
noticed. But then there is a final intervention point provided to OMB
and the other agencies that require that the IRIS staff to resolve any
outstanding concerns by OMB and the other agencies, including polluting
agencies, before the assessment can be finalized. While the 2008
process boils down to `death by a thousand cuts,' this ability to have
the last word--and to axe an assessment at the bitter end--may be the
deepest cut of all.
The U.S. Government Accountability Office (GAO) recently released
its review of the new process, in a report entitled: Low Productivity
and New Interagency Review Process Limit the Usefulness and Credibility
of EPA's Integrated Risk Information System.\3\ This report provided a
detailed and highly critical assessment of the failures of the IRIS
program to meet its deadlines and requirements, blaming in large part
the interference by polluting agencies and political appointees. The
GAO report predicts that the new process will produce IRIS assessments
that lack credibility, and will worsen what is already a critical
backlog of new and updated assessments. NRDC agrees with the GAO
evaluation, whose many findings validate our years of work to right
this cornerstone program for public health protection.
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\3\ United States Government Accountability Office. Low
Productivity and New Interagency Review Process Limit the Usefulness
and Credibility of EPA's Integrated Risk Information System. Report to
the Chairman, Committee on Environment and Public Works, U.S. Senate.
Report No. GAO-08-440; March 2008. Available at http://www.gao.gov/
new.items/d08440.pdf
A summary of the report is also available online at: Toxic Chemicals:
EPA's New Assessment Process Will Increase Challenges EPA Faces in
Evaluating and Regulating Chemicals, GAO-08-743T, April 29, 2008.
Summary at http://www.gao.gov/docsearch/abstract.php?rptno=GAO-08-743T
For many years, IRIS assessments were developed by EPA scientists.
Drafts were released simultaneously for public comment and external
(independent expert) peer review. OMB and government agencies such as
DOD or DOE, who sometimes had a stake in the outcome of the evaluation
because of their obligations to address contamination at federal
facilities, had an opportunity to review and comment on the draft when
it was released for public review and comment.
The new IRIS process introduces significant new steps that are both
time-consuming and undermine the objectivity and transparency necessary
for credible and valid assessments (see Table 1). Significant aspects
of the new process are as follows:
1. In the 2008 process, IRIS staff is now required to develop
a qualitative draft assessment, prior to the quantitative
assessment, which must undergo both public and interagency
review. This qualitative draft serves as a summary of the
scientific literature that the staff intends to rely on to
supports its assessment. Although this procedure sounds benign,
it seriously compromises the timeliness and transparency of the
IRIS program. First, it allows other government agencies to
delay an assessment far nearly two years to do additional
research on any chemicals that an agency deems to be ``mission
critical,'' thereby significantly stalling the start of the
formal IRIS evaluation. Even more alarming, the comments and
submissions of the other agencies to the qualitative draft are
considered `deliberative' which, if unchallenged or upheld by
the courts, would shield the comments from public scrutiny.
2. In the new 2008 process, agencies outside of EPA are
invited to designate chemicals as `mission critical' and to
intervene in the IRIS assessment of these chemicals. Mission
critical chemicals are defined as those that are, ``an integral
component to the successful and safe conduct of an Agency's
mission in any or all phases of its operations. Impacts on use
of mission critical chemicals include cessation car degradation
of the conduct of the mission and/or unacceptable resource
constraints.'' [emphasis added] In other words, ``mission
critical'' chemicals includes not only those that are vital and
have no viable substitute, but also those where the potential
cost to an agency of cleaning up a pollution mess it (or its
contractors) have created is ``unacceptable'' or where
potential future limitations on use (such as stricter exposure
standards) are deemed too expensive by the agency. These are
exactly the kinds of policy considerations that should not be
allowed to intrude on the IRIS assessment process.
3. Following the quantitative draft, the IRIS staff develops
the draft quantitative assessment (the Toxicological Review).
This is subjected to public and interagency review, followed by
external (independent expert) peer review. The important
difference is that prior to 2004, this represented the first
and simultaneous opportunity for both the public and the other
agencies to comment, with all comments publicly accessible. By
contrast, with the 2008 process this is now the second public
comment. opportunity, and the third OMB/interagency
intervention point, but the first where the OMB/interagency
comments would be publicly accessible.
4. Finally, before the IRIS assessment can be finalized and
publicly released, the 2008 process requires OMB and
interagency approval. The pre-2004 process had only required
internal agency review. This 2008 process invites the fourth
and final opportunity for OMB/interagency interference with the
evaluation. Although the new process says that EPA has the
power to make the final decision, it is clear that the other
agencies and OMB will have significant access and influence
over the final editing choices.
Although current EPA leadership argues that the new process was
developed in order to provide ``greater transparency, objectivity,
balance, rigor and predictability'' \4\ to the IRIS assessments, we
strongly disagree. In fact, the administration's claims are Orwellian.
This new process is designed precisely to give the polluting agencies
more access and more influence to what has historically been an
objective scientific evaluation process--and to add at least two or
more years to the review of mission critical chemicals.
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\4\ Revised IRIS Process Question & Answers (pdf). http://
cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=190045
EPA announces improvements to IRIS process. EPA press release, 04/10/
2008.
http://yosemite.epa.gov/opa/admpress.nsf/
03dd877d6f1726c28525735900404443/
1365469639099e6585257427005bb22a!OpenDocument
To put it plainly, in this new proposal, the Administration is
attempting to provide those agencies with the most at stake in the
degree of protection established for a particular chemical multiple
opportunities to weigh-in and influence the outcome of EPA's decisions,
while hiding the exercise of that influence from the public. The
Administration's claim that, for example, providing the Department of
Defense multiple opportunities to weaken or delay setting a health
standard for TCE--a chemical for which DOD is responsible of widespread
contamination of drinking water--completely outside of public view,
will result in a more balanced and objective result, doesn't pass the
laugh test.
The EPA leadership further claims that the outcome of the new
process is expected to `streamline' the IRIS process and make it more
`transparent.' Again, we strongly disagree. The new process allows
public review at only one stage, which is review of the qualitative
draft. All other evaluation steps occur behind closed doors, shielded
from accountability to the public or other more objective, outside
scientific experts.
It is indicative of the Administration's disregard for public input
on its changes to the IRIS process, and its eagerness to put them in
place, that OMB admonished GAO for being so critical of a draft
proposal, and assured the GAO that ``[i]ndeed, the process will not be
complete until EPA circulates its draft to the public for comments and
then releases a final product that is responsive to those comments.''
Assurances notwithstanding, some six weeks later the Administration
finalized this deeply flawed proposal without any opportunity for
public review or comment. This short-circuiting of the public comment
process does not square with the principles of public right-to-know, or
EPA's lip service in support of an open and transparent process.
Backlog at IRIS: Timeliness is already a terrible problem that cannot
bear to be compounded by further delay
In the U.S., there are about 8,000 chemicals in commerce deemed
``economically significant'' (i.e., produced or imported at a rate
greater than 10,000 pounds per site annually). Unfortunately, only
about 550 chemicals in total have been evaluated in the IRIS program.
Even when compared just to the universe of chemicals regulated by EPA,
IRIS is obviously failing to adequately serve the public's needs. For
instance, the EPA is responsible for regulating the emissions of 188
hazardous air pollutants (HAPs) under the Clean Air Act, but only 129
of them appear in the IRIS database. In other words, in almost 20 years
since. IRIS was created, the EPA has been unable to complete
Toxicological Reviews for nearly one-third of these dangerous
pollutants.
Furthermore, even when important chemicals are in the IRIS
database, the risk assessments available for many of these chemicals
are outdated: the average assessment on IRIS is over 13 years old, with
the oldest having not been significantly revised since the mid-1980s.
Considerable new evidence of toxicity has emerged for many of these
chemicals since their last assessment, which renders tile conclusions
potentially obsolete and limits their usefulness and credibility with
regulatory agencies.
According to the IRIS website, the program has finalized only
thirteen assessments since 2004. As GAO notes ``[t]he IRIS database is
at serious risk of becoming obsolete because EPA has not been able to
routinely complete timely, credible assessments or decrease its backlog
of 70 ongoing assessments.'' \5\
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\5\ Toxic Chemicals: EPA's New Assessment Process Will Increase
Challenges EPA Faces in Evaluating and Regulating Chemicals, GAO-08-
743T, April 29, 2008. Summary at http://www.gao.gov/docsearch/
abstract.php?rptno=GAO-08-743T
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Consider for example Trichloroethylene (TCE), a solvent used as a
degreasing agent. TCE is one of the roost common contaminants of
Superfund sites across the Nation, primarily from military uses, and is
linked to cancer, including childhood cancer, and birth defects.\6\ The
IRIS draft was initiated a decade ago, in 1998. In 2001, EPA concluded
that TCE was ``highly likely'' to cause cancer and specifically noted
the added health risks when exposures took place during childhood.
Finalization of that assessment has been held up after repeated
objections from military contractors and the Department of Defense.
Finally it was reviewed by the National Academies, which issued their
report in July 2006, finding that the data linking TCE with cancer was
even stronger than EPA IRIS staff had determined, and recommending that
the IRIS assessment be finalized as soon as possible. Nonetheless, the
Defense Department continued to insist that it not be finalized until
more data was available, and today the assessment has still not been
finalized.
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\6\ ATSDR ToxFAQs for trichloroethylene. http://www.atsdr.cdc.gov/
tfacts19.html
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Clearly, constructive reform for the IRIS program would focus on
increasing resources available to undertake IRIS reviews as well as
policy changes that would streamline the difficult decision-making
inherent in the process. The new procedures run completely counter to
these goals and will only exacerbate this backlog.
Delays to IRIS assessments result in continued unsafe exposures to
humans and wildlife
Setting a health assessment standard under IRIS is only the first
step in a long regulatory process. For example, for the EPA to
establish a national drinking water standard, the Agency would
typically reach out to stakeholders for input and perhaps even convene
a Federal Advisory Committee, which could take over a year.
Additionally, the docket for a proposed rule could remain open for at
least a few months to collect comments from the public. Depending on
the extent of the comments received, the Agency could again take up to
a year or more to address and respond to those comments. In the end, it
could take the Agency years, even decades, to finalize a drinking water
regulation.
As new or updated IRIS assessments continue to languish, or get
weakened to satisfy the demands of OMB and federal agencies including
the Department of Defense and Department of Energy, the process of
setting health standards becomes unspeakably prolonged. And the public
continues to suffer due to lack of adequate public health protections.
For example. the Administration has successfully blocked a much
needed update of the IRIS assessment for formaldehyde. An updated
assessment reflecting recent science that shows greater health hazards
posed by formaldehyde could ultimately be the basis of establishing
stricter emissions or exposure limits from building materials and other
sources. Meanwhile, people living in temporary trailers provided by
FEMA after Hurricane Katrina have complained of a host of illnesses
they believe are related to the high levels of formaldehyde which they
have been exposed to in those trailers.
Similarly, delay in IRIS has contributed to an inexcusable failure
to develop a national health-protective standard for perchlorate, a
component of rocket fuel and other explosives, in drinking water.
Scientific evidence is overwhelming that exposure to perchlorate, an
iodine uptake inhibitor in the thyroid gland, can cause significant
development problems for developing infants. Subtle alterations of
thyroid hormones during pregnancy--even within the normal range--have
been associated with decreased intellectual and learning capacity in
childhood.
Approximately 350 public water systems serving over 41 million have
reported perchlorate detections.\7\ The source of the contamination at
many of these sites is defense and aerospace facilities and military
installations.\8\ The Defense Department mounted a years-long battle,
and elicited White House support, against IRIS draft assessments in
1998 and in 2002 that had determined that even low doses of perchlorate
may be harmful to early development of the human brain.\9\ The final
IRIS assessment was not completed until 2005. Due to the year's long
delay in assessing and quantifying the harm posed by perchlorate in the
IRIS program, the public remains years away from a national drinking
water standard that will protect their health.
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\7\ U.S. EPA Unregulated Contaminant Monitoring Rule (UCMR)
database, January 2005 data release, and data collected by State
agencies in Arizona, California. Texas, and Massachusetts.
\8\ Wall Street Journal online. Inside Pentagon's Fight to Limit
Regulation of Military Pollutant. Peter Waldman. December 29, 2005.
\9\ Wall Street Journal online. Inside Pentagon's Fight to Limit
Regulation of Military Pollutant. Peter Waldman. December 29, 2005.
Objectivity and transparency of IRIS review is paramount
IRIS assessments must be shielded from political interference and
be open to public scrutiny to ensure their scientific rigor and
adherence to public health protective policies.
Under the new IRIS process, polluting federal agencies are provided
excessive and redundant opportunities to intervene in the development
of the IRIS assessments, shielded from scrutiny by the scientific
community and the public. This is indefensible. The IRIS assessments
and the comments provided by federal agencies, academics, industry,
public interest groups, the general public, and others regarding drafts
are supposed to be about science. The Administration has no reason for
insisting upon secrecy other than to shield injection of politics and
policy into the scientific debate, and avoid public airing of
scientific arguments that won't stand up to public scrutiny.
Political appointees in the EPA undermine EPA's mandate to protect
human health and the environment
The Director of the IRIS program, George Gray, is clearly
subverting the mission of the EPA in the development of the new IRIS
process, essentially carrying out the mission of the OMB instead. Gray,
who is EPA Assistant Administrator for the Office of Research and
Development, was previously the Director of the Harvard Center for Risk
Analysis, a seemingly prestigious academic center but one quite
notorious for its extensive support from with corporate money and its
tendency to promote industry perspectives in environmental health
policy deliberations. With Gray holding direct management power over
the IRIS program, the Administration has ensured that EPA resistance to
the agenda of undermining public health protections will be minimal,
and, more often, will be aided by its political appointee.
A documented example of Gray's role in blocking the work of his own
IRIS staff is the case of the Toxicological Review of
tetrachloroethylene also known as perchloroethylene (perc), a dry
cleaning and degreasing chemical and widespread groundwater
contaminant. The IRIS assessment was initiated in 1998. In 2006 Risk
Policy Report revealed that George Gray was insisting that his staff
re-analyze the cancer risks of the chemical to try to fit the data to a
model that would have assumed (without scientific evidence) that low
doses were safe, whereas the staff's careful review of all available
data did not support this assumption.\10\ In addition, Gray's directive
contradicts EPA's established, peer-reviewed cancer guidelines. Had the
IRIS staff complied with Gray's directive, it would have resulted in a
less-protective assessment. This assessment has still not been
updated.\11\
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\10\ Clean Air Report via InsideEPA.com. Staff rebuff ORD Chief's
bid for new risk study for key solvent. Inside Washington Publishers.
Vol. 17, No. 20. October 5, 2006. Originally reported in Risk Policy
Report, September 26, 2006, p. 1.
\11\ On January 25, 2007, the California Air Resources Board
ordered the phase-out of the use of perchloroethylene, from dry
cleaning, with a complete ban by 2023. See details in news release at:
http://www.arb.ca.gov/newsrel/nr012607b.htm
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In short, the political appointee currently in charge of the IRIS
program, and defending the Administration's new reforms to Congress and
the public, has blocked an updated assessment of a chemical polluting
groundwater across the Nation, and is insisting EPA scientists use
unsupported and unprotective assumptions in a model intended to
downplay the potential harm posed to the public by the chemical.
According to NRDC discussions with IRIS staff, additional instances
of interference by George Gray to delay or weaken assessments include:
blocking IRIS from posting acute (less than 24 hour)
risk values.\12\ Acute risk values are relevant to communities
that are exposed to chemicals by burst releases of toxics
(smokestacks, etc.) that may not exceed short-term (days-weeks)
or long-term (months-years) regulatory standards, but may still
pose a hazard to acutely exposed individuals.
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\12\ EPA Eyes Expanded Risk Database Used in Toxic Regulation,
Clean-ups. ``The managers of an EPA chemical risk database are
considering adding short-term and acute exposure categories on several
chemicals to gauge the resources needed to add the broader risk data to
the system.'' January 27, 2003. Inside Washington Publishers.
blocking IRIS from posting summaries of its
assessments online, arguing that the summaries give a naive
public and regulators inaccurate impressions, contribute to
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misunderstandings, and are misused.
blocking the IRIS staff recommendations to apply a
10-fold safety factor to site-specific assessments where
children may be exposed to ethylene oxide, a potent human
carcinogen with evidence that exposures during early life
significantly increase the risk of developing cancer. Use of
such a safety factor under precisely these conditions is
specifically recommended in the EPA Supplemental Cancer
Guidelines on Children's Exposure.
These examples should be alarming to any Member of Congress, and
any member of the public, who cares about ensuring that the best
science is used by EPA to determine the risks posed by dangerous
chemicals and who cares about fully informing the public about the
risks posed by exposure to toxic chemicals. It also illustrates why
NRDC and other environmental and public health groups, as well as the
GAO, are so concerned about the changes to the IRIS process that will
allow more of the decision-making to take place behind closed doors,
where political appointees can make demands on career employees,
without having to defend the merits of their scientific arguments (or
the injection of policy and political preferences in a scientific
process) before the public.
Conclusion
Properly implemented, the EPA IRIS program provides a critical
scientific service to the public. Like other vital EPA programs, it
must be preserved and protected so that EPA's scientists can conduct
their work without political interference. The EPA's authority to
determine the risks posed by hazardous chemicals should not be
sacrificed to the desire of other federal agencies' or industry
interests in avoiding clean-up costs or requirements for additional
controls on emissions and exposures.
We request that the Science Committee work with other House
colleagues to ensure that the new IRIS process is overturned or
withdrawn and require IRIS health assessments to be reviewed in an open
process, without inappropriate political interference.
There are hundreds of potentially dangerous chemicals that are
either already in the IRIS database but need to be updated, or that
have not yet been added. Without an open, credible, effective, science-
based, fully-funded program to develop these assessments without
political interference from the White House or other federal agencies,
EPA will continue to fall further behind in a fundamental program that
serves as the foundation for fulfilling its mission: protecting the
environment and public health.
Thank you for the opportunity to testify today.
Biography for Linda E. Greer
Linda E. Greer joined the Natural Resources Defense Council (NRDC)
in 1990 as a Senior Scientist specializing in public health issues,
especially toxic chemicals and hazardous waste. She now is the Director
of the Environment and Health Program. Linda is currently focusing on
the scientific controversies in determining toxicity of chemicals in
regulation and on mercury pollution. Prior initiatives have most
notably included pollution prevention opportunities at large chemical
manufacturing facilities, where she directed a large and successful
collaborative project to reduce toxic wastes and releases with the Dow
Chemical Company. Linda has been appointed to the Board of Life
Sciences for the National Academy of Sciences as well as the U.S. EPA
Science Advisory Board Executive Committee, and she serves several
other technical and policy advisory groups.
Dr. Greer teaches an intensive summer course, ``Scientific
Fundamentals of Risk Assessment'' for law students and practicing
lawyers, which she has done for ten years, and she has taught a
graduate-level class to scientists in toxic chemical impact and
regulation.
She received her Ph.D. in Environmental Toxicology from the
University of Maryland in 1989, M.S.P.H. in Environmental Sciences and
Engineering from UNC-Chapel Hill, and B.S. in Biology from Tufts
University.
Dr. Greer is the author of over a dozen technical and policy
articles on environmental matters, and has frequently testified before
Congress.
Discussion
Deliberative, Interagency Decision-making
Chairman Miller. Thank you, Dr. Greer.
At this point we will have our first round of questions,
and the Chair now recognizes himself for five minutes. Mr.
Ensminger, as you know, as other witnesses have testified, the
current IRIS process allows repeated interagency,
intragovernmental discussions about the health risk
assessments. Those discussions, to use the word that Dr. Greer
quoted, are deliberative. You would probably call those secret.
The doors are closed. We are not entirely sure what happens in
there. But your testimony made it pretty clear that you do not
believe that your former employer, the Department of Defense,
talks about public health or expresses concern for public
health. They are more concerned about potential clean-up costs,
Mr. Siegel said perhaps as much as $5 billion. What they are
not doing is talking about the public good. I have always
thought that democracy dies behind closed doors. To use Justice
Brandeis's phrase, sunlight is the best disinfectant and the
electric light the most efficient policeman, but last week in
our hearings, Susan Dudley, the head of OIRA, the Office of
Information and Regulatory Affairs at OMB, the office within
OMB that supervises this interagency, intragovernmental
process, extolled the virtues of closed-door meetings. She said
that it encouraged candor, that people could say exactly what
was on their mind and not worry about the consequences of it
because they knew that what they had to say would go no further
and therefore they could say exactly what they thought and that
the process was better as a result. Do you have any thoughts on
her view of the virtues of closed-door meetings and a
deliberative process to decide?
Master Sergeant Ensminger. Mr. Chairman, it is my opinion
that if somebody has to go behind closed doors to say
something, they have something to hide, and why else wouldn't
they want to say it out in the open. If you can't say it out in
front of everybody, maybe you better keep your mouth shut.
Chairman Miller. Right out in front of God and everybody,
as we would say in North Carolina.
Mr. Siegel, do you have a----
Mr. Siegel. I have a slightly different perspective. I have
served on a number of National Academy of Science's committees
dealing with various contaminations at Department of Defense
facilities, and those meetings, they exclude DOD and we have a
number of scientists talking frankly, and that works because I
am in the room, because they have a representative of the
public interest in the room to make sure that it is not just a
few people trying to pull the wool over everybody else's eyes.
There are stages and various processes where, you know, private
discussions may make sense but not if a major interest group is
excluded.
Chairman Miller. And I am sorry, who would you include as a
major interest group?
Mr. Siegel. Well, I am basically there representing the
impacted public from the sites.
Chairman Miller. You are considering yourself or the public
as an interest group?
Mr. Siegel. Yeah, and I strongly believe that my presence
affects what other people in the room say because, you know,
not that I am going to run to the press and leak something but
they have to treat things differently when they know that there
is somebody who is asking real questions.
Chairman Miller. You think perhaps the candor that Susan
Dudley thought was a virtue of being able to say whatever you
thought was actually not such a virtue and----
Mr. Siegel. I mean, this is almost like a brainstorming
session where people are saying I think this but I am not
really sure, and so in the privacy of that environment, people
will say things they aren't sure of and then say oh, I see, you
are right, and they aren't quoted in the press and the thing
isn't taken too far, but that only works if it is open to other
people with other interests, and that is a scientific
discussion. That is not a political discussion.
Chairman Miller. Dr. Greer.
Dr. Greer. Well, I think the important principle here is
transparency and accountability of the decision-making process,
and what we have seen through the IRIS experiences is that
behind closed doors, arguments are made, data is hidden, and
the decision that comes out in the end is not transparent and
is not accountable, so although there may be a minor role for
informal conversations to try to get your act together, the
general principle for all EPA rule-making is one of
transparency and accountability to the public and to all
affected parties, and that is what we lose with these closed-
door deliberations, which are decision-making deliberations.
OIRA's Role in the IRIS Process
Chairman Miller. The current interagency process, the IRIS
listing process, the one--actually the one that preceded the
one that was adopted in April seemed to have the OIRA, OMB
really in control because it was interagency and now it seems
to be more clearly in control in a process that statutes seem
to contemplate the EPA would run. Do you think the EPA is
capable of conducting an interagency discussion on its own or
they need OMB standing over their shoulder or actually being
the ones themselves to decide, Dr. Greer?
Dr. Greer. Well, EPA is absolutely capable of doing that. I
mean, this is really at the core of scientific deliberation.
They have guidance documents on principles of how to make these
decisions and they have decades of experience in making these
decisions. I would contrast that against any of the scientific
experts in any of these agencies who are really in a much less
expertise, less experience and this is really EPA's arena.
Chairman Miller. Mr. Siegel.
Mr. Siegel. I think that not only does EPA have the
capacity but I think that the other agencies--there are a lot
of good people at the Department of Defense who are trying to
do good science too and they are capable of communicating with
EPA and EPA is capable of communicating back, and the OIRA
involvement to me smacks of a political involvement, that you
have people who are involved not primarily because of their
scientific expertise but because of their political
obligations.
The IRIS Process
Chairman Miller. My time is expired, but Mr. Sensenbrenner
is not here so I will recognize myself for a second round of
questions.
Mr. Whittaker, I think you are the audiovisual guy. There
were two charts in the hearing last week. Chart 3, that is--
actually could I see Chart 1 first? All right. That chart based
on Susan Dudley's testimony last week is the very complicated
process. That is actually prepared by the EPA and it is the
flow chart to show the IRIS process, which she--before 2004,
and then there was an interim one and then Chart 3, Mr.
Whittaker, that is the chart that she said streamlined the IRIS
process. Mr. Siegel, does that--is it your impression like
GAO's that that actually will further complicate, not
streamline it? It does not look just to my own lying eyes to be
a simplification of the earlier chart.
Mr. Siegel. As I said, you know, there are a lot of good
people at EPA and career people I talk to, you know, are very
concerned about this sort of thing, and I tease them. I say it
takes the EPA 30 days to put in a light bulb, and basically you
have that not just with IRIS but with a large number of
processes, things just drag on and on while people are already
exposed. It is one thing if there is a delay and nobody is
being exposed but you basically have people like Shirley, like
Janey Ensminger, people who are being exposed while this is
being--this process goes on. So again, things that take a long
time that are complicated are okay if people are safe, but if
you don't know that they are safe, you need to act quickly, and
when we have tried to accelerate some of these studies like on
perchlorate, they say, we can't possibly do it by such and such
a date. Well, I guess that is because they don't really care
about the exposures that are going on. That is all I can think
of.
Chairman Miller. Mr. Ensminger, you appear to want to
comment.
Master Sergeant Ensminger. I had a researcher make the
comment to me the other day exactly about OMB overruling the
EPA. I believe the OMB has one toxicologist on their staff.
Chairman Miller. I asked Susan Dudley that last week and I
did not get a clear answer.
Master Sergeant Ensminger. They have one toxicologist on
their staff who overruled the thousands that work at EPA. Boy,
isn't that something?
Chairman Miller. Well, again, what you just said is
consistent with what I had heard. When I asked Susan Dudley
that, the head of OIRA, I did not seem to get a clear answer
and she said that they had access to other expertise that they
employed.
Master Sergeant Ensminger. And Mr. Siegel made a comment a
while ago about the DOD had good researchers on their staff as
well. Why are we duplicating these efforts? Why is DOD
authorized to use taxpayers' money to do research on these
chemicals when we are already funding somebody else to do it,
the EPA? I mean, this is ludicrous. Is it the Department of
Defense or is it the Department of Legal Defense?
Chairman Miller. When Susan Dudley testified last week, I
asked her if in any of these old mini blocks, I haven't
actually counted how many blocks there are, other than the
public comment section periods, whether there was an
opportunity for anyone in the private sector to be part of
deliberative discussions and obviously public comment is not a
deliberative discussion or secretive, as I am sure you would
say, and I would too, and she said no, that actually all the
participation by the private sector would be through public
comment. There was no opportunity for them to have any say, any
opportunity to influence an IRIS decision, an IRIS assessment,
not TCE manufacturers, not any private sector companies that
might face clean-up costs, no opportunity except during public
comment. Mr. Siegel, is that consistent with your own
observations of the process?
Mr. Siegel. It is my understanding that through the
perchlorate study group, and you may have the documents, that
the contractors for these federal polluting agencies have a
direct line to the Defense Department, NASA participants
because these agencies end up in many cases paying for the
clean-up of the contractor obligations. I mean, it is little
known, when Congress looked at this over 10 years ago, that
companies like Lockheed and Aerojet charged the costs of their
clean-up off as overhead on their government contracts and the
people in the Defense Department who are in charge of dealing
with it, know it so they are very open to input from these
companies when they go to EPA. I don't know that the companies
are actually in the room in the meetings with EPA, but their
information is.
Chairman Miller. Dr. Greer.
Dr. Greer. Yes, that is right. I was going to say the same
thing, that the perchlorate study group is a great example of
how that is really not the case, that what Susan Dudley was
talking about, there is plenty of precedent for that not being
true. You know, in this case, that was a group set up by the
military. They were present in the so-called interagency
deliberations, and Aerojet was actually the chair of the
deliberations in many of the meeting notes that NRDC has. So
they were running the deliberation, let alone not present.
Chairman Miller. Dr. Greer, if there were not this
streamlined process, interagency IRIS process, could federal
agencies still weigh in on an IRIS assessment and how would
they go about that?
Dr. Greer. Well, you know, federal agencies have always had
an opportunity to comment and weigh in on these assessments.
That has been the case all the time. They have weighed in
during the public comment period but not in secret and, you
know, not with a license to kill. That is the big difference
between what we are looking at today and the normal procedures.
We certainly would not object to having these agencies weigh in
with the public, you know, on the record, so to speak.
Mr. Siegel. You know, one of the things that I wonder is
what these agencies, polluting agencies say in private versus
what they are actually saying in public, that we have no way of
knowing that.
Tracking Citizen Exposure to TCE
Chairman Miller. Mr. Ensminger, obviously a lot of folks
have lived on Camp Lejeune. The military is transient by
nature. I grew up in Fayetteville. As you pointed out when we
talked yesterday, I know you have less than warm feelings for
Fayetteville since you see it as an Army town. I know that
people are on and off of military bases, their families are on
and off military bases all the time, and keeping track of all
the people who have been exposed is no small task. How is the
government doing in identifying the people who have been
exposed and trying to see what health outcomes they have had,
whether they have had health consequences that are consistent
with the TCE exposure risk?
Master Sergeant Ensminger. To answer your question, Mr.
Chairman, to date, to date, there have been no studies done on
any population groups at Camp Lejeune other than the in utero
population. In other words, the siblings of those in utero
children, their parents, the men and women who were stationed
at Camp Lejeune, the Marines and sailors, and the civilian
employees that work aboard the base, to date, no studies have
been done on them. Trying to get the Department of Defense,
Department of the Navy and the United States Marine Corps to
execute a notification process, actually had to go to the
extreme of getting an amendment to the Defense Authorization
bill through the Senate last year to force them to live up to
their own motto, which is semper fidelis, always faithful.
Science Policy
Chairman Miller. When Dr. Gray of the EPA, the official who
seems to be in charge of IRIS, and Ms. Dudley from OMB, from
OIRA appeared last week, they, particularly Dr. Gray, used the
phrase that IRIS includes both science and science policy. I
pushed him some on exactly what he meant by science policy and
I think most people would think that science policy was just
part of science. Occam's razor, for instance, appears to be
science policy rather than strictly science. Dr. Greer, can you
give us some idea of what elements of a policy might be in an
IRIS listing?
Dr. Greer. Yes. So, you know, there is a mixture of science
and some decisions that I would call policy decisions in an
IRIS assessment. For example, deciding whether the data has
enough certainty to negate the need for a safety factor or
deciding whether or not a certain study shows that there really
is disproportionate vulnerability in a certain type of
population. I think the key thing here though to focus on is
that those policy decisions are best made by relying on
existing EPA guidance documents because the key here is
consistency. The key here is consistency and how you make those
decisions so that you get objective, clear and health-
protective decisions, and those guidance documents are publicly
vetted, publicly commented on and open, and so what I get
worried about in this distinction between science and policy is
that we lose the plot here, that the plot here is how to make
consistent decisions that err on the side of protecting public
health and that is not about individual analysts or even the
boss, George Gray, inserting his own personal opinion on how he
thinks something ought to go. That is about following the rules
of the road that EPA has in those longstanding documents.
Mr. Siegel. May I add something?
Chairman Miller. Mr. Siegel.
Mr. Siegel. One of the innovative things in the TCE human
health risk assessment, the draft for 2001, is that it
incorporated cumulative exposures because as you are exposed to
other similar chemicals to TCE or even alcohol can enhance the
impact of the exposure and the scientists who led that study
explained it to me with an analogy of taxes. If you make zero
dollars a year and then all of a sudden you make $5,000 more,
your taxes don't really go up. You barely pay any taxes anyhow.
But if you start out at $100,000 and you go to $105,000, your
taxes might go up a couple thousand dollars, and the same is
true with the body. If you already have a load of exposure to
chemicals that affect the kidney or affect the liver or various
parts of the body and it goes up, it has an impact. The 2001
human health risk assessment incorporated that. That is a
policy decision. Some people argue the other side and say no,
we should address that at the risk management stage when we
decide whether or not to treat the well, to treat the air,
something like that. That is a viable argument. It is a policy
debate. Unfortunately, I don't know of any place where that
cumulative exposure is addressed at the risk management stage.
So I think I would go with the 2001 health risk assessment and
say yes, we should do it in the risk assessment phase and that
should be part of IRIS. But that is a policy decision that
affects how the science comes out.
Chairman Miller. Mr. Ensminger, you seem to want to answer
this.
Master Sergeant Ensminger. No, I wanted to go back to that
thing about the studies. Now, there are some feasibility
studies that have been proposed by ATSDR for some of these
other population groups. The protocols have just been written
for them. They are in the peer review process now and approval
process but like I said in my testimony, just the week before
last, the Department of Defense and Department of the Navy were
balking at $1.6 million and ATSDR is estimating that next
year's feasibility studies and their water modeling at Camp
Lejeune is going to come somewhere close to $12 million. I can
just hear them now, that, you know, they are doing everything
they can to kill the Camp Lejeune efforts and they are going to
use every excuse in this world to make that possible, but I
will be here fighting them.
Assessing Cumulative Exposures
Chairman Miller. Mr. Ensminger, I want to come back to you
in just a second on your experience with ATSDR, which has also
gotten the Subcommittee's attention. But Mr. Siegel and I think
Dr. Greer, Mr. Ensminger has obviously done a good deal of
research and it is obvious what his motivation is from having
heard his testimony, that the typical expectation for a
population the size of the children who were exposed in utero
would have been 7.2 cases, and ATSDR has now confirmed 14 to
this point of childhood leukemia, two cases of non-Hodgkin's
lymphoma. That is more than twice what would be expected, but
Mr. Siegel, your discussion of the cumulative effect, is that--
is it likely that that baseline does include a fair number of
folks whose leukemia is a result of environmental exposures?
Did that question make sense?
Mr. Siegel. Yes. I mean, basically it is very difficult to
show, unless you have a specific disease like mesothelioma--I
can't pronounce that one.
Chairman Miller. We have Dr. Greer here to pronounce
everything for us.
Mr. Siegel. There are some specific diseases that have
fingerprints. Most diseases are not caused by a single exposure
to a single chemical and so it is very difficult to show that
the particular--even in Janey's case, it is difficult to show
that that particular exposure caused the disease but we know
that if we know something about the exposures, that it was
probably a very major percentage of the cause, not just--you
know, but if there were other exposures, that would have also
increased it, and the problem--we have a problem, a burden of
proof in this country, and I will give you an example. A man I
met in Kentucky earlier this year where he was one of the key
subjects in a study by the University of Kentucky which showed
that there is a relationship between TCE and Parkinsonism, and
he was obviously very sick and the woman who was with him
wasn't exposed as much and she wasn't quite as sick and they
used this for this very well, you know, regarded published
scientific study, and that is great, you know, that they can
show that there is--that TCE is a factor in Parkinsonism. They
told me that the doctor who did the study on him, that included
him, would not certify for his purpose of workers' compensation
that he was sick because of that exposure and so with all the
studying that is going on and a lot of scientists are, you
know, getting awards and degrees and all kinds of stuff for
doing it, but the problem I have is that the studies go on and
they don't end up helping people and that is something that
needs to be addressed.
Chairman Miller. Dr. Greer, I guess my question was, is
there reason to think that the baseline is not actually a clean
baseline that assumes no environment exposures but may in fact
the baseline be the result of, in some part, to some extent of
environmental exposures?
Dr. Greer. Yeah, I mean to some extent, you know what they
try to do is compare against a control population that looks
the same about everything except the exposure of concern, but I
will tell you that an environmental epi study that shows twice
as high as expected is very alarming. I mean, two times as high
is a high rate for an environmental epi study, and the reason
for that is because unlike laboratory animals that you control
every single thing that they are exposed to, people are exposed
to a lot of things. People smoke and people have other
diseases, et cetera, et cetera. So when you are comparing a
disease caused by an environmental exposure with a baseline of
disease, it is sort of muddy and you have a hard time seeing
trends. Two times is high for an environmental study and would
certainly be a red flag for most environmental epidemiologists
as, you know, something that looks like a real concern.
The Agency for Toxic Substances and Disease Registry (ATSDR)
Chairman Miller. Mr. Ensminger, you mentioned ATSDR is
involved in this. ATSDR is an agency of the Federal Government
I had never heard of a year ago. The Agency for Toxic
Substances and Disease Registry is part of the CDC, the Centers
for Disease Control. They were involved in the FEMA trailers,
the, I guess, hundreds of thousands of people who were living
in trailers provided by FEMA as a result of being victims of
Katrina, being displaced by Katrina and Rita. Mr. Sensenbrenner
mentioned that in his opening remarks, that we had had a
hearing on FEMA trailers and formaldehyde exposure. The
formaldehyde was used in those trailers as a very cheap
building material, an adhesive that held together particleboard
that was used for walls and flooring and cabinets and that
since 1997 the IRIS assessment process has had before them a
reassessment of formaldehyde that EPA has yet to act upon. With
a fairly active effort to influence the process by the
industry, our impression of ATSDR was that they were entirely
too eager to please FEMA. FEMA asked ATSDR for a health
assessment. It obviously would not have done them a lot of good
to go to IRIS to find out what the effect of formaldehyde was,
and ATSDR provided a health assessment that they knew was not
appropriate to the circumstances because they were trying to
please FEMA, give FEMA what they wanted. What has been your own
impression of ATSDR from your dealing with them?
Master Sergeant Ensminger. Well, specifically--and ATSDR is
many, many different departments, several different
departments. Their largest department is the Department of
Health Assessments and Consultations. For lack of a better
term, the public health assessment for Camp Lejeune is a piece
of crap, okay.
Chairman Miller. Could you put that in lay terms?
Master Sergeant Ensminger. They--and there are so many
errors in that public health assessment, and every one of those
errors have been pointed out to those people. And they
absolutely refused to pull that health assessment down and
correct it.
Last year, there was a hearing held specifically about Camp
Lejeune, and we almost had to beat them into submission just to
get them to put a disclaimer up at the beginning of that public
health assessment so people weren't looking at that thing and
relying on the erroneous information that they have on their
website.
Now, public health assessments and consultations with
ATSDR, when we discussed this yesterday with some of your
staff, ATSDR was given an exception when they were created back
in the early '80s to bypass the peer review process because of
the backlog in Superfund sites that they needed to do
assessments on. So Congress gave them a pass on the peer review
process for public health assessments. That backlog is done.
There is no backlog for Superfund sites anymore. ATSDR needs to
be held to the same standard as everybody else and those public
health assessments need to go through a peer review process.
And I will guarantee you, if this is instituted, you will see a
much better product coming out of ATSDR than you see now.
Matter of fact, I would make the--I would bet you that
there are a lot of people working at ATSDR who are so used to
pulling out their little tray in their desk that got all their
little standard quotes that they can just slip in there and
nobody ever questions. I bet you if you make them go through
the peer review process you will see a lot of people that work
at ATSDR that won't be working there later.
Chairman Miller. Mr. Siegel or Dr. Greer, do you have any
experience with ATSDR?
Mr. Siegel. Well, you know, when I visit a community that
has just found out about contamination in their water there,
everybody wants a health study. Often that means bringing in
ATSDR. But ATSDR's batting average is very low. They almost
never find, with their methodology, with the burden of proof,
that people are sick as a result of environmental exposures.
I would ask them, you know, how many times out of all the
health assessments that you have done, have you found that
there is a direct link between the exposure and disease? And
the problem is, to me, with their methodology, and their
methodology may be good for some purposes, but not for the
purpose that they have been assigned, you know, to help guide
risk management decisions at these sites.
Unless you believe that people really don't get sick as a
result of exposures to these chemicals, and there are people
who believe that, in which case, ATSDR's batting average is
very good. But almost--friends of mine wrote a report,
``Inconclusive by Design,'' 20 years ago about ATSDR, and the
same is true today.
Chairman Miller. Dr. Greer, anything?
Dr. Greer. Well, as I said in my oral statement, you know,
the changes to the IRIS program that we were talking about are
just part of what we regard as the Administration's war on
science and public health protection, and I think ATSDR is
another--is an area which shows the influence of the
Administration on some of their deliberations.
It is true, actually, that ATSDR is sometimes inconclusive
by design. What we urge them strongly to do is if they are
going into a community where they know that it is a small
community and statistics will not allow them to ever find
something significant, because there just are not enough people
to study, that they should say that it is scientifically not
possible to do a study, rather than going in and doing a study
and saying we didn't find anything statistically significant,
which sounds like there is nothing wrong here.
So they really need to develop a bright line threshold that
they make an evaluation at the outset to say is there enough
people or enough type of disease here that we could actually
study this scientifically, or this doesn't lend itself to a
scientific study and we need to make a decision to move
forward, erring on the side of protecting human health, to do
it without the study. And that is what we have urged upon them
many times without success.
Chairman Miller. Mr. Ensminger.
Master Sergeant Ensminger. Also, the researchers at ATSDR--
now, I am going to take their side for a minute here, which is
unusual, but ATSDR's researchers, when they go to a DOD site
specifically, all the information gathering for their health
assessment--DOD Superfund sites are placed on an honor system.
They are on an honor system. These people are the keepers of
all the records on that--for that base, and these researchers
are literally thrown to these wolves when they go to these
bases and have to rely on these people. These people withhold--
I mean, I have got letters that I provided with my testimony
back in 1994 where ATSDR was complaining that the people at
Camp Lejeune weren't providing them with the documents they
needed to do their required mission. And when they did provide
them with data, there was no supporting documentation to back
up what they were giving them.
I mean, how can you place a polluter on an honor system?
They have already shown they don't have any honor, and they
have proven it time and time again in the Camp Lejeune
situation, dragging their feet, putting up road blocks,
stalling, giving incorrect data. And I have documented
situations at Camp Lejeune where they knowingly provided
incorrect data to ATSDR, which skewed one of their studies, and
never corrected. They relied on us to correct it.
Chairman Miller. We are getting short on time, and Mr.
Siegel?
Mr. Siegel. This is a systemic problem. ATSDR does not do
studies. They take data that is provided to them by the
polluter, sometimes by the regulator which really doesn't do
its own studies, and they do an assessment. But they do not
generate any new data. They don't go out and do sampling, they
don't go out and interview people like a university study would
do. They just take the existing data and make a judgment based
upon it, which in my experience--that is what I have seen.
Somebody may know more about it, but that is generally the way
they operate when they are asked to conduct a public health
assessment.
The European REACH Program
Chairman Miller. This probably needs to be a final
question, but this morning when I rolled out of bed and walked
down to the corner to get the Washington Post thinking of
today's hearing, there was an article on the front page on a
decision by the European Union that has been adamantly opposed
by the Bush Administration and the chemical industry that would
take a fundamentally different approach to regulating chemicals
that may be toxic.
What we have been talking about today is just the very
initial stages of a regulatory process before cost benefit
analysis, for instance, is supposed to be taken into effect.
Just assessing which chemicals have what toxic effect, and in
this case, we can see that two assessments are coming out when
600 new chemicals enter the marketplace a year. TCE, which
appears to cause a great deal of damage, has taken 20 years,
formaldehyde, 11 years and counting.
This hearing has been about how to fix that IRIS assessment
process, but Mr. Siegel, Dr. Greer, do you think maybe our
fundamental approach should be different? EU, by the way, is
500 million people in developed economies. We are 300 million
people in a developed economy. It is hard to imagine that
industry will simply stop producing goods from the European
market, which is significantly two-thirds, again, the size of
our economy.
Mr. Siegel.
Mr. Siegel. The short answer is yes. I mean, I have
actually been to a Defense Department-sponsored meeting with
their contractors where the European approach, the REACH
program has been presented. And very clearly, with the Defense
contractors, they are already finding that they are changing
their practices, phasing out certain uses of chemicals like
chromium, because of their need to market globally. American
companies are at a competitive disadvantage if they do not
recognize this new approach. But unless, you know, the American
Defense Department adjusts its specifications, which would
actually require the use of toxic substances, it will be
limited.
But this is definitely--you know, it is being heard, it is
being felt, and it would be so easy for the U.S.--I mean, the
implementing would be hard, would take a while, but it would be
so easy, so helpful to put the burden of proof on the people
who are using these toxic substances, rather than on the people
who are the victims, that there is a problem.
Chairman Miller. Dr. Greer.
Dr. Greer. Well, you know, we Americans really like to
think of ourselves as number one, and at the head of the pack
globally on so many things, but I have to tell you that Europe
is far ahead of us on these issues of public health protection
and environmental contaminants. And the REACH program really
has a tremendous amount of promise. I mean, it sort of takes--
you know, here a chemical is innocent until proven guilty, and
you see how long it takes to get proven one way or the other.
Under their new system, a chemical is going to be guilty until
proven innocent; that is, data is going to be required before a
chemical can get on the market so that we don't get this big
bad backlog. And of course, the incentive will be to get that
information forward, because they want to put it on the market.
So it is a really smart idea. I think because we are in
such a global economy, we may be the accidental beneficiaries
of a lot of that work because when global companies need to
make certain products, the European standards are going to be
higher than the American standards, and they probably will
benefit from that. But you know, we have had our feet in cement
shoes for almost a decade now on these toxic chemical issues,
and we have got our work cut out for us to get back to where
some of these colleagues in the other developed countries have
really been on this scientifically.
Chairman Miller. It seems unlikely they will produce two
versions of their product----
Dr. Greer. Exactly.
Chairman Miller.--so the safe European version and the
toxic American version.
Mr. Ensminger, do you have any thoughts on it? You don't
have to have any thoughts on this, you have had thoughts on a
lot of things.
Master Sergeant Ensminger. I do. Well, basically the
European Union is concerned about their people. It makes you
wonder what our government is concerned about. Is it people or
money?
Chairman Miller. That is a pretty good valedictory
statement from the witnesses.
I want to thank all of you for appearing today for this
hearing. Under the rules of the Committee--the Subcommittee,
the record will be open for an additional two weeks for any
Member to submit additional statements and any additional
questions that could go to you for written response.
The hearing is now adjourned. Thank you.
[Whereupon, at 11:28 a.m., the Subcommittee was adjourned.]
Appendix:
----------
Additional Material for the Record
Statement of David G. Hoel
Medical University of South Carolina
Charleston, South Carolina
Discussion of EPA's IRIS and the Health Effects of Trichloroethylene
I am a University Distinguished Professor in the Department of
Biostatistics, Bioinformatics and Epidemiology at the Medical
University of South Carolina in Charleston. Prior to joining the
University, I was employed for over twenty years at the National
Institute of Environmental Health Sciences of the National Institutes
of Health.
There I was Director of the Division of Risk Assessment, and served
for a time as Acting Scientific Director of the Intramural Research
Program. I was a member of the Environmental Protection Agency's
scientific panels for perchlorate and for trichloroethylene (TCE). I
was a peer reviewer of the National Research Council's report on TCE.
The opinions I state today are my own.
I will comment on the general process used by EPA (e.g., IRIS) for
calculating permissible dose levels of environmental carcinogens with a
focus on the example of TCE. I will conclude with a few
recommendations.
EPA 2001 TCE Report
The EPA 2001 TCE risk assessment had a number of shortcomings that
were pointed out by individual scientists and EPA's Scientific Advisory
Board's TCE Advisory Panel. Although there were several health
endpoints under consideration, cancer is the predominant outcome used
for exposure standard setting. This is due in part to the target of one
in a million lifetime cancer risk, and the assumption of a linear no
threshold dose-response for carcinogens. It should be noted that the
NRC report discussed this assumption and the need to validate it. The
usual method for estimating cancer risk was applied to TCE. Basically,
a few selected epidemiological studies and a few high dose rodent
studies were individually fit to a linear dose response function in
order to estimate the dose which would correspond to a lifetime risk of
one in a million. Figure 1 is a reproduction of a graph of the results
of this process taken from the EPA draft report, with Table 1 giving
the numbers used in Figure 1.
First there is a question of the selection of epidemiological
studies used for this process.
EPA used three studies: Henschler (1995) kidney cancers among
workers in a German cardboard factory, Anttila (1995) Finnish workers
who were monitored for TSE (kidney, liver and NHL) and an ecological
study of drinking water in New Jersey (NHL).
The data from animal studies was also treated in a manner similar
to human studies. Using kidney cancer as the primary example, EPA gave
three dose estimates. They were derived from the rat study, the German
worker study and the Finnish worker study. EPA calculated the dose
estimates to be (see Table 1).
This represents a range in estimated dose by a factor of almost
10,000, suggesting that the process is so variable as to be
meaningless. It should be noted that the most extreme result produced
by EPA was from the Finnish study, which was not statistically
significant, and the workers had fewer kidney tumors than were
expected. It is not clear why this study was included in the analysis.
Multiple studies are often quantitatively combined using meta
analysis or joint data analysis techniques. A meta-analysis was carried
out by EPA (Wartenberg et al., 2000), but not used in the calculating
cancer risk. The specific TCE application has been criticized in the
scientific literature and most recently by the NRC 2006 report. If done
correctly, with consideration of exposure, as has been done with
radiation and cancer (e.g., Lubin and Boice, 1997), one could avoid
using selected studies and their less stable risk estimates. Further
Bayesian statistical methods can adjust for exposure uncertainties
which vary among studies. The NRC report gives very detailed
recommendations concerning the meta analysis process.
I feel that without a considerably more sophisticated analysis,
which does not selectively choose individual studies and treat them
independently, the low-exposure cancer risk estimates in EPA 2001 are
unreliable and should not be used to set environmental standards.
NRC 2006 TCE Report
The NRC (2006) report on TCE recommended that low dose cancer risk
estimates be based on rodent bioassays and human data be used as
validation of the rodent studies. This is a reasonable approach, which
I support. The human epidemiological data is thought to be preferable
but the very large uncertainty of exposures plus the confounding of
other chemical exposures, as well as lifestyle issues, greatly
decreases the value of the data for quantitative risk estimation.
Basic toxicological research focuses on a compound's mode of action
(MOA); that is, how it and its metabolites affect the carcinogenesis
process. Also, the use of physiologically based pharmacokinetic models
(PBPK) to evaluate the relationship between routes of exposure and the
formation of reactive metabolites of interest is critical to
quantitative risk estimation. This information, although discussed, was
not incorporated into the EPA cancer risk models. This PBPK model
information, along with MOA understanding, is key to evaluating the
validity of the predictability of rodent cancer effects to man. The NRC
report discusses these important issues and makes specific research
recommendations for improved TCE risk estimation.
An issue of increasing concern is the variability in response by
various susceptible human subgroups. This is frequently discussed but
rarely employed in evaluating the degree of sensitivity in subgroups.
These subgroups include age, medical conditions and genetic
variability. For example, Bronley-Delancey et al. (2007) measured the
variability of TCE metabolism by genetic subgroups by using human
hepatocytes. This basic type of human data provides guidance on
possible adjustments of environmental exposure levels for genetic
subgroups in the population.
All of this is important applied science which is essential to
quality risk estimation, but it suffers from two problems.
First, the risk assessors are not integrating enough scientific
information into their actual cancer risk estimates. There are modern
statistical methods for accomplishing this. The ongoing effort in
radiation carcinogenesis is one area where re-analysis is performed as
new, better methods are developed, and it is a good example of
scientific responsiveness to innovation.
The second issue is that there are no longer effective government
programs directed at solving these issues through academic research.
This work is too applied for NIH (i.e., NIH's toxicology grant study
section no longer exists) and other agencies are not focused on these
issues. Considering the cost of inappropriate risk estimates, in either
dollars or health effects, this seems foolish from a societal
viewpoint.
Finally, EPA's IRIS process involves both risk estimation and risk
management. EPA should consider using outside scientific experts to
carry-out the risk estimation. This is done successfully by WHO's IARC
for qualitative risk assessment of chemical carcinogens and by the NRC
for quantitative risk estimation of various radiation types. Through
the use of independent scientific experts and a rigorous peer review
process these risk estimates are considered authoritative. Some 30
years ago EPA had the NRC develop quantitative cancer risk estimates
for chemical contaminants in drinking water. The Agency could then use
exposure levels and the NRC risk estimates to establish standards based
upon risks and benefits.
Conclusions and Recommendations
EPA must develop cancer risk estimates for TCE using
an integrated approach following the advice of the SAB Panel
and the NRC Committee. Further, it should focus on the best
estimate of risk, including an estimated uncertainty. EPA
should also seriously consider the NRC's recommendation of
developing the risk estimates based upon the animal and
laboratory studies and using the human studies as validation of
their risk models.
While developing risk estimates, EPA should consider
obtaining quality outside scientific advice before and during
the process, instead of waiting until the document is
completed. EPA should consider having risk assessment, but not
risk management, for the more important chemicals carried out
by a committee of outside experts. The National Academies' NRC
is well suited for this purpose.
EPA and other governmental agencies should sponsor
extramurally the development and refinement of risk assessment
methodology in general. Also, they should support key
laboratory and human studies directed at specific problems
associated with any major chemical problem, such as TCE.
Greater attention must be given to potentially
sensitive subgroups and to adverse health outcomes other than
cancer.
References
Bronley-Delancey, A. et al. Env Health Persp 114: 1237-42, (2006).
Hoel, D. in The Scientific Basis of Trichloroethylene Risk Assessment,
ISBN 0-9657650-0-8, (2004).
Lubin, J.H. and Boice, Jr., J.D. JNCI 89: 49-57, (1997).
National Research Council, Assessing the Human Health Risks of
Trichloroethylene: Key Scientific Issues. The National
Academies Press, (2006).
Wartenberg, D. et al. Env Health Persp 108 (Suppl 2): 161-176.
Biography for David G. Hoel
Education:
1961--A.B. (Mathematics and Statistics) with highest honors, University
of California at Berkeley
1966--Ph.D. (Statistics) University of North Carolina at Chapel Hill
1966-1967--U.S. Public Health Service Postdoctoral Traineeship in
Preventative Medicine, Stanford University
Brief Chronology of Employment:
1997-date--Distinguished University Professor, Medical University of
South Carolina, Charleston, South Carolina
2000-date--Clinical Professor, Department of Radiology, University of
South Carolina, School of Medicine, Columbia, South Carolina
1993-1997--Professor and Chairman, Department of Biometry and
Epidemiology and Associate Director for Epidemiology, Hollings
Cancer Center, Medical University of South Carolina,
Charleston, South Carolina
1981-1993--Director, Division of Biometry and Risk Assessment, National
Institute of Environmental Health Sciences, Research Triangle
Park, North Carolina
1990-1991--Acting Director, National Institute of Environmental Health
Sciences and also the National Toxicology Program, Research
Triangle Park, North Carolina
1984-1986--Associate Director, Radiation Effects Research Foundation,
Hiroshima, Japan
1979-1980--Visiting Scientist, Epidemiology Department, Radiation
Effects Research Foundation, Hiroshima, Japan
1977-1979--Acting Scientific Director, National Institute of
Environmental Health Sciences, Research Triangle Park, North
Carolina
1973-1981--Chief, Biometry Branch, National Institute of Environmental
Health Sciences, Research Triangle Park, North Carolina
1970-1973--Mathematical Statistician, National Institute of
Environmental Health Sciences, Research Triangle Park, North
Carolina
1970-date--Adjunct Professor, Department of Biostatistics, University
of North Carolina, Chapel Hill
1968-1970--Statistician, Oak Ridge National Laboratory, Oak Ridge,
Tennessee
1967-1968--Senior Mathematician, Westinghouse Research Laboratories,
Pittsburgh, Pennsylvania
Honors and Other Scientific Recognition:
Fellow, American Statistical Association, 1974
NIH Director's Award, 1977
Mortimer Spiegelman Gold Medal Award, American Public Health
Association, 1977
Public Health Service Superior Service Award, 1980
Senior Executive Service Award, 1983, 1987-1991
Citation Classic, Institute for Scientific Information (Hoel et al.
``Estimation of risks of irreversible delayed toxicity'' J.
Toxicol. Env. Health 1:133-51, 1975).
Member, Council of Fellows, Collegium Ramazzini, 1987
Member, Institute of Medicine, National Academy of Sciences, 1988
Council Member, National Council on Radiation Protection and
Measurements (NCRP), 1992-1998 and 1999-2005
Westinghouse Distinguished Scientist, 1993-2004
Ramazzini 1994 Award Recipient for ``Contributions to scientific
knowledge on the oncogenic effects of nuclear radiation''
Fellow, American Association for the Advancement of Science, 1997
National Associate, National Academy of Sciences and National Research
Council, 2001
Editorial--Books:
Methods for Estimating Risk of Chemical Injury: Human and Nonhuman
Biota and Ecosystems, SCOPE /SGOMSEC 2, Proceedings of Workshop
on Quantitative Estimation of Risk to Human Health from
Chemicals, Rome, Italy, 1982 (co-editor with VB Vouk, GC Butler
and DB Pekall).
Banbury Report 19: Risk Quantitation and Regulatory Policy, Proceedings
of the Banbury Conference on Risk Quantitation and Regulatory
Policy, (co-editor with R Merrill and F Perera). Cold Spring
Harbor Laboratory, 1985.
Statistical Methods in Cancer Epidemiology, Proceedings of a Conference
of the U.S.-Japan Cooperative Cancer Research Program, 1985
(co-editor with W Blot and T Hirayama).
Environmental and Occupational Health Sciences: A Series, Member,
Editorial Advisory Board, 1986-date.
Trends in Cancer Mortality in Industrial Countries, (co-editor with D
Davis), New York Academy of Sciences, 1990.
Biostatistics in Cancer Risk Assessment, (co-editor with T Yanagawa),
Scientist, Inc., Tokyo, 1991.
2-Amino-N6-hydroxyadenine: A collaborative study on the
genetic toxicology of 2-amino-N6-hydroxyadenine,
(co-editor with FJ de Serres), Mutation Research, Vol. 253,
1991.
International Case Studies in Risk Assessment and Management, (co-
editor with L Mohr and W Nixon), The Medical University of
South Carolina Press, 1998.
Multimedia Modeling and Risk Assessment, (co-editor with J Regens and C
Travis), The Medical University of South Carolina Press 1999.
Extrapolation of Radiation-Induced Cancer Risks from Non-human
Experimental Systems to Human, (Chairman) Members include B
Carnes, R Dedrick, RJM Fry, D Grahn, W Griffith, P Groer, RJ
Preston) National Council on Radiation Protection and
Measurements, NCRP Report No. 150, 2005.
Editorial--Journals:
Associate Editor, Journal of Statistical Computation and Simulation,
1972-1978
Associate Editor, Journal of the American Statistical Association,
1973-1979
Member, Editorial Board of the Journal of Toxicology and Environmental
Health, 1975-1979
Member, Editorial Board of Communications in Statistics, Part B--
Simulation and Computation, 1977-1979
Member, Editorial Board of the Journal of Environmental Pathology and
Toxicology, 1979-1980
Member, Editorial Board of Fundamental and Applied Toxicology, 1981-
1986
Member, Editorial Board of Environmental Health Perspectives, 1973-2000
Member, Editorial Advisory Board of Journal of Statistical Computation
and Simulation, 1978-date
Member, Editorial Board of the IMA Journal of Mathematics Applied in
Medicine and Biology, 1983-1988
Section Editor, Journal of Environmental Pathology, Toxicology and
Oncology, 1986-date
Contributing Editor, American Journal of Industrial Medicine, 1987-date
Associate Editor, Environmental Research, 1987-date
Member, Editorial Board of Risk Analysis, 1987-1990
Associate Editor, Journal of Communications in Statistics, 1987-date
Associate Editor, Biological Monitoring: An International Journal,
1988-1990
Member, International Advisory Board, Journal of Environmental
Statistics, 1992-1995
Section Editor, Encyclopaedia of Biostatistics, 1996-1997
Editorial Board, Environmental and Ecological Statistics, 2004-
Societies:
American Statistical Association
Biometric Society
Society for Risk Analysis
Collegium Ramazzini
American Association for the Advancement of Science
Radiation Research Society
Health Physics Society
Society for Epidemiological Research
Society Appointments:
Member, Regional Committee of the Biometric Society (ENAR), 1973-1975,
1978-1980
Biometrics Section Representative on the Council of the American
Statistical Association, 1975-1976
Secretary, Biometrics Section, American Statistical Association, 1979
Representative of the Institute of Mathematical Statistics to the
Biology Section of the AAAS, 1978-1981
Program Chairman, Biometric Society Spring Meetings, 1977
Member, Council of the Society for Risk Analysis, 1982-1985
Member/Chairman, American Statistical Association Awards Committee,
1991-1993
National Academy of Sciences Committees:
Member, Subcommittee on Margin of Safety and Extrapolation of the Safe
Drinking Water Committee, 1976-1977
Member, Panel on Low Molecular Weight Halogenated Hydrocarbons of the
Coordinating Committee for Scientific and Technical Assessments
of Environmental Pollutants, 1976-1977
Chairman, Risk Assessment Subcommittee, Safe Drinking Water Committee,
1978-1979
Member, Committee on Chemical Environmental Mutagens, 1980-1983
Member, Board on Toxicology and Environmental Health Hazards, 1982-1985
Member, Committee on the Biological Effects of Ionizing Radiation (BEIR
V), 1986-1989
Member, Committee to Provide Interim Oversight of the DOE Nuclear
Weapons Complex, 1988-1990
Member, Committee on Environmental Epidemiology, 1990-1992
Member, Committee on Epidemiology and Veterans Follow-up Studies, 1990-
Member, Committee on Applied and Theoretical Statistics, 1991-1994
Member, Committee on The Health Effects of Mustard Gas and Lewisite,
1991-1992
Chairman, Committee to Study the Mortality of Military Personnel
Present at Atmospheric Tests of Nuclear Weapons, 1993-1994
Member, National Toxicology Program's Science Advisory Board 1994-1996
Chairman, Committee on the Assessment of Wartime Exposure to Herbicides
in Vietnam, 1996-2002
Member, Committee to Review the Health Effects in Vietnam Veterans of
Exposure to Herbicides, 1997-2003
Chairman, Board of the Medical Follow-up Agency, 1996-2001
Member, Commission on Life Sciences, 1999-2000
Advisor, Division on Earth and Life Studies (DELS), 2001-
Chairman, Medical Follow-up Agency, Patterns of Illness and Care before
Deployment to the Persian Gulf War, 2001-2003
Member, Defense Threat Reduction Agency (DTRA), Committee to Review the
Dose Reconstruction Program, 2002-2003
Member, National Research Council, National Academy of Sciences,
Committee on California Agriculture Research Priorities--
Pierce's Disease, 2003-2004
World Health Organization and Other International Activities:
Member, International Agency for Research on Cancer Working Group on
the Evaluation of the Carcinogenic Risk of Chemicals to Man,
1977, 1981, 1982
Consultant, Subcommittee of International Commission for Protection
against Environmental Mutagens and Carcinogens (ICPEMC)
October, 1977-1982
Member, Environmental Mutagenesis and Carcinogenesis Panel, U.S.-Japan
Cooperative Medical Science Program, NCI; 1987-1992
Member, Advisory Committee on The Radiation Protection of the Public
from Radioactive Residues in Kazakhstan, International Atomic
Energy Agency United Nations, 2003-2005
U.S. Government Advisory Committees:
Member, International Agency for Research on Cancer Working Group on
the Use of Mechanistic Data to Evaluate the Carcinogenicity of
Chemicals to Humans, 1991
Ex-officio member, Administrator's Pesticide Policy Advisory Committee,
EPA, 1976
Chairman, Subcommittee on Estimation of Risks of Irreversible, Delayed
Toxicity of the DHEW Committee to Coordinate Toxicology and
Related Programs, 1975
Advisor, Carcinogen Assessment Group, EPA, 1977
Member, Scientific Advisory Board of the National Center for
Toxicological Research, 1977-1980
Member, Ad Hoc Working Group to Develop Radioepidemiological Tables,
NIH, 1984-1985
Member, Work Group on Health Effects Risks of the EPA Science Advisory
Board's Committee on Research Strategies, 1987-1988
Chairman, Research Needs Subcommittee of the Committee to Coordinate
the Environment and Related Programs, U.S. Public Health
Service, 1990-1991
Member, Office of Technology Assessment Advisory Panel on Aging Nuclear
Power Plants: Life Attainment, License Renewal, and
Decommissioning. Congress of the United States, 1992
Member, EPA's FIFRA (pesticide) Science Advisory Panel, 1993-
Member, Interagency Staff Group for Development of OSTP Carcinogen
Document, Office of Science and Technology Policy, 1983-1984
(Report: Chemical Carcinogens: A Review of Science and Its
Associated Principles, Environmental Health Perspectives, Vol.
67, pp 201-282, 1986.)
Member, EPA's Science Advisory Board's Radiation Advisory Committee,
1993-1995
Member, DOD's Breast Cancer Research Program Integration Panel, 1995-
1996
Panel Member, NIH Consensus Development Conference on Breast Cancer
Screening in Women Ages 40-49, 1997
Member, FDA, Transmissible Spongiform Encephalopathies Advisory
Committee, 1997-2000
Consultant, FDA's Center for Biologics Evaluation and Research (CBER),
2004-2008
Chairman, EPA's Expert Panel Review of Benzene Risk Assessment, 1997
Consultant, EPA's Science Advisory Board's Radiation Advisory
Committee, 1996-
Member, EPA's Science Advisory Board's Environmental Health Committee,
1997-2004
Member, U.S. Consumer Product Safety Commission's Chronic Hazard
Advisory Panel (CHAP), 1999-
Member, EPA's Science Advisory Board's Environmental Health Committee,
TCE Health Risk Assessment: Synthesis and Characterization
Review Panel, 2002
Member, EPA's Expert Panel Review of Perchlorate, 2002
Member, EPA's Expert Panel Review of Asbestos, 2003
Member, EPA's Expert Panel Review, Supplemental Guidance for Assessing
Cancer Susceptibility from early-life Exposure to Carcinogens''
(SGACS), 2003
Chairman, Committee to Study the Extrapolation of Radiation Risks from
Animals to Humans, National Council on Radiation Protection and
Measurements (NCRP), 1991-2005
Member, Scientific Advisory Committee of the Electric Power Research
Institute's (EPRI) Environmental Risk Analysis Program, 1994-
1995
Member, Scientific Committee 89 (non-ionizing radiation), National
Council on Radiation Protection and Measurements (NCRP), 1994-
1995
Member, Scientific Advisory Board, Environmental Health Foundation
(EHF), 1994-1998
Member, Health Effects Institute (HEI) Diesel Epidemiology Project,
1998-1999
International Conferences Organized:
``Methods for Estimating Risk of Chemical Injury: Human and Non-Human
Biota and Ecosystems'' in Rome, Italy, July 12-16, 1982 (with
G. Butler, D. Peakall, and N. Nelson)
``Conference on Risk Assessment and Statistical Methods'' in Kyoto,
Japan, August 30-31, 1984 (with A. Kudo and K. Wakimoto)
``The Third Japan-U.S. Conference on Biostatistics in the Study of
Human Cancer'' in Hiroshima, Japan, November 11-13, 1988 (with
K. Aoki and T. Yanagawa)
``Trends in Cancer Mortality in Industrial Countries'' in Carpi, Italy,
October 21-22, 1989 (with D. Davis, J. Fox, and A. Lopez)
``International Biostatistics Conference in the Study of Toxicology''
in Tokyo, Japan, May 23-25, 1992 (with A. Sakuma and T.
Yanagawa)
``The Fourth Japan-U.S. Biostatistics Conference in the Study of Human
Cancer'' in Tokyo, Japan, November 9-11, 1992 (with R. Miller,
H. Sugano, and T. Yanagawa)
``The Role of Environmental Factors in Breast Cancer: Collaborative
Workshop'' in Washington, DC, December 6-8, 1992 (with D.
Davis)
``International Conference in Immunogenetic Risk Assessment in Human
Disease'' (MUSC) in Charleston, March 6-8, 1994 (with J.
Pandey)
``The International Forum on Risk Assessment and Risk Management''
(MUSC) in Charleston, March 5-7, 1996 (with L. Mohr and W.
Nixon)
Congressional Testimony:
Senate Committee on Appropriations: Subcommittee on Labor, Health and
Human Services, Education, and Related Agencies (Sen. Harkin)--
March 14, 1991
House Committee on Appropriations: Subcommittee on Labor, Health and
Human Services, Education, and Related Agencies (Cong.
Natcher)--April 16, 1991
House Committee on Energy and Commerce: Subcommittee on Oversight and
Investigations (Cong. Dingell)--May 8, 1991
Senate Committee on Appropriations: Subcommittee on Labor, Health and
Human Services, Education, and Related Agencies (Sen.
Specter)--February 5, 1997
Senate Committee on Environment and Public Safety (Sen. Boxer)--May 6,
2008
Bibliography:
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of an r-simplex. American Mathematical Monthly 74:819-820,
1967.
Hoel DG: Sequential testing of sample size. Technometrics 10:331-341,
1968.
Hoel DG: Closed sequential tests of an exponential parameter.
Biometrika 55:387-391, 1968.
Hoel DG and Mazumdar M: An extension of Paulson's selection procedure.
Annals of Mathematical Statistics 39:2067-2074, 1968.
Hoel DG: Discussion of engineering analysis of experimental data by
Robert P. Benedict. ASME Trans. 91:130, 1969.
Hoel DG and Mazumdar M: A class of sequential tests for an exponential
parameter. Journal of American Statistical Association 64:1549-
1559, 1969.
Crump KS and Hoel DG: Some applications of renewal theory on the whole
line. Journal of Applied Probabilty 7:734-746, 1970.
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Hoel DG: On the Monotonicity of the OC of an SPRT. Annals of
Mathematical Statistics 41:310-314, 1970.
Hoel DG: A simple two-compartmental model applicable to enzyme
regulation. Journal of Biological Chemistry 245:5811-5812,
1970.
Hoel DG: Some modifications and applications of Wald's OC formula.
Annals of the Institute of Statistical Mathematics 22:65-75,
1970.
Kastenbaum MA, Hoel DG and Bowman KO: Sample size requirements: One-way
analysis of variance. Biometrika 57:421-430, 1970.
Kastenbaum MA, Hoel DG and Bowman KO: Sample size requirements:
Randomized block designs. Biometrika 57:573-577, 1970.
Hoel DG: A method for the construction of sequential selection
procedures. Annals of Mathematical Statistics 42:630-642, 1971.
Hoel DG and Mitchell TJ: The simulation, fitting, and testing of a
stochastic cellular proliferation model. Biometrics 27:191-199,
1971.
Hoel DG and Sobel M: Comparisons of sequential procedures for selecting
the best binomial population. Proceedings of the Sixth Berkeley
Symposium on Probability and Statistics 4:53-69, 1971.
Hoel DG: A representation of mortality data by competing risks.
Biometrics 28:475-488, 1972.
Hoel DG: An inverse stopping rule for play-the-winner sampling. Journal
of American Statistical Association 67:148-151, 1972.
Hoel DG, Sobel M and Weiss GH: A two-stage procedure for choosing the
better of two binomial populations. Biometrika 59:317-322,
1972.
Hoel DG and Walburg Jr. HE: Statistical analysis of survival
experiments. Journal of the National Cancer Institute 49:361-
372, 1972.
Hook GER, Bend JR, Hoel DG, Fouts JR and Gram,TE: Preparation of lung
microsomes and a comparison of the distribution of enzymes
between subcellular fractions of rabbit lung and liver. Journal
of the Pharmocology Experimental Therapeutics 182:474-490,
1972.
Beauchamp JJ and Hoel DG: Some investigations and simulation studies of
canonical analysis. J. Stat. Comput. Simul. 2:197-209, 1973.
Hoel DG and Crump KS: Estimating the generation time distribution of an
age-dependent branching process. Biometrics 30:125-135, 1973.
Patel KM and Hoel DG: A generalized Jonckheere K-sample test against
ordered alternatives when observations are subject to arbitrary
right censorship. Communication in Statistics 2:373-380, 1973.
Patel KM and Hoel DG: A nonparametric test for interaction in factorial
experiments. Journal of American Statistical Association
68:615-620, 1973.
Chand N and Hoel DG: A comparison of models for determining safe levels
of environmental agents. In Proschan F and Serfling RJ (Eds.):
Reliability and Biometry. Philadelphia, SIAM, 1974, pp. 681-
700.
Crump KS and Hoel DG: Mathematical models for estimating mutation rates
in cell populations. Biometrika 61:237-252, 1974.
Haseman JK and Hoel DG: Tables of Gehan's generalized Wilcoxon test
with fixed point censoring. Journal of Statistics Comput.
Simul. 3:117-135, 1974.
Hoel DG: Some statistical aspects of experiments for determining the
teratogenic effects of chemicals. In Pratt J (Ed.): Statistical
and Mathematical Aspects of Pollution Problems. New York Marcel
Dekker, Inc., 1974, pp. 375-381.
Hoel DG: Statistical models for estimating carcinogenic risks from
animal data. In Proceedings of the Fifth Annual Conference on
Environmental Toxicology. AMRL-TR-74-125 Washington, D.C., GPO,
1974, pp. 285-291.
Hoel DG and Weiss GH: A comparison of methods for choosing the better
of two negative exponential lifetime distributions. In
Proschan, F. and Serfling, R.J. (Eds.): Reliability and
Biometry. Philadelphia, SIAM, 1974, pp. 619-636.
Chase GR and Hoel DG: Serial dilutions: Error effects and optimal
designs. Biometrika 62:329-334, 1975.
Hoel DG: Human risk assessment based on laboratory animal studies. In
Second Joint U.S./USSR Symposium on the Comprehensive Analysis
of the Environment. U.S. Environmental Protection Agency,
Washington, D.C., 1975, pp. 22-24.
Hoel DG, Gaylor DW, Kirschstein RL, Saffiotti U and Schneiderman MA:
Estimation of risks of irreversible, delayed toxicity. Journal
of Toxicology Environmental Health 1:133-151, 1975.
Hoel DG, Sobel M and Weiss GH: A survey of adaptive sampling for
clinical trials. In Elashoff RM (Ed.): Perspectives in
Biometrics. New York, Academic Press, 1975, pp. 29-61.
Hoel DG, Sobel M and Weiss GH: Comparisons of sampling methods for
choosing the best binomial population with delayed
observations. J. Stat. Comput. Simul. 3:299-313, 1975.
Hoel DG and Weiss GH: A clinical trial design with a fixed maximum
number of failures. Communication in Statistics 4:429-436,
1975.
Simon R, Weiss GH and Hoel DG: Sequential analysis of binomial clinical
trials. Biometrika 62:195-200, 1975.
Crump KS, Hoel DG, Langley CH and Peto R: Fundamental carcinogenic
processes and their implications for low dose risk assessment.
Cancer Research 36:2973-2979, 1976.
Hoel DG: Statistical extrapolation methods for estimating risks from
animal data. Annals of New York Academy Sciences 271:418-420,
1976.
Hoel DG, Weiss GH and Simon R: Sequential tests for composite
hypotheses with two binomial populations. Royal Statistical
Society 38:302-308, 1976.
Guess HA and Hoel DG: The effect of dose on cancer latency period.
Journal of Environmental Toxicology 1:279-286, 1977.
Hoel DG: Some problems in low dose extrapolation. In Hiatt HH, Watson
JD and Winsten JA (Eds.): Origins of Human Cancer, Vol. 4, Book
C. Cold Spring Harbor, NY, Cold Spring Harbor Laboratory, 1977,
pp. 1391-1396.
Hoel DG and Weiss GH: Properties of noise emitted by vehicular queues.
Transportation Research 11:39-44, 1977.
Simon R, Hoel DG and Weiss GH: The use of covariate information in the
sequential analysis of dichotomous response experiments.
Communication in Statistics (A-Theory and Methods) 6:777-788,
1977.
Haseman JK and Hoel DG: Statistical design of toxicity assays: Role of
genetic structure of test animal population. Journal of
Toxicology Environmental Health 5:89-101, 1979.
Hogan MD, Chi P, Hoel DG and Mitchell TJ: Association between
chloroform levels in finished drinking water supplies and
various site-specific cancer mortality rates. Journal of
Environmental Pathology and Toxicology 2:873-887, 1979.
Hoel DG: Animal experimentation and its relevance to man. Proceedings
from U.S.-Japan Conference on Biostatistics in the Study of
Human Cancer, May 1978. Environmental Health Perspective 32:25-
30, 1979.
Hoel DG: Low-dose and species-to-species extrapolation for chemically
induced carcinogenesis. In McElheny VK and Abrahamson S (Eds):
Banbury Report 1: Assessing Chemical Mutagens: The Risk to
Humans. Cold Spring Harbor, NY, Cold Spring Harbor Laboratory,
1979, pp. 135-145.
Hoel DG: Sequential methods in genetic risk assessment. Genetics 92:
s195-s198, 1979.
Hoel DG: Statistical approaches to toxicological data. Proceedings, 5th
Symposium on Statistics and the Environment, NAS. Environmental
Health Perspective 32:267-271, 1979.
Schoenfelder CA and Hoel DG: Properties of the Neyman-Scott
carcinogenesis model at low dose rates. Mathematical
Biosciences 45:227-246, 1979.
Anderson AW, Hoel DG and Kaplan NL: A general scheme for the
incorporation of pharmacokinetics in low dose risk estimation
for chemical carcinogenesis: Example--vinyl chloride.
Toxicology Applied Pharmacology 55:154-161, 1980.
Hoel DG: Incorporation of background in dose-response models.
Proceedings, Symposium on Extrapolation of Laboratory Toxicity
Data to Man: Factors Influencing the Dose-Toxic Response
Relationship, April 1979. Federation Proceedings 39:73-75,
1980.
Yanagimoto T and Hoel DG: Comparisons of models for estimation of safe
doses using measures of the heaviness of tail of a
distribution. Annals of the Institute of Statistical
Mathematics, Part B, 32:465-480, 1980.
Yanagimoto T and Hoel DG: Measures of the heaviness of tail of
estimation of safe doses. In Matusita K (Ed.): Recent
Developments in Statistical Inference and Data Analysis. New
York, North Holland Publishing Company, 1980, pp. 347-357.
Gaylor DW and Hoel DG: Statistical analysis of carcinogenesis data from
chronic animal studies. In Sontag JM (Ed.): Carcinogens in
Industry and Environment. New York, Marcel Dekker, 1981, pp.
97-111.
Haseman JK, Hoel DG and Jennrich RI: Some practical problems arising
from the use of the gamma multi-hit model for risk estimation.
Journal of Toxicology Environmental Health 8:379-386, 1981.
Hogan MD and Hoel DG: Estimated cancer risk associated with
occupational asbestos exposure. Risk Analysis l:67-76, 1981.
Hoel DG: Carcinogenic Risk. Risk Analysis l:63-64, 1981.
Hoel DG: Extrapolation models of animal toxicity data to man. In Hoch
RJ (Ed.): Conference Proceedings: Environmental Risk
Assessment: How New Regulations Will Affect the Utility
Industry. Palo Alto, Calif., Electric Power Research Institute,
1981, pp. 4-95 to 4-103.
Hoel DG: Statistical issues in toxicology. Selected Papers, Society for
Industrial & Applied Mathematics. Environmetrics 81:248-257,
1981.
Hoel DG and Crump KS: Waterbourne Carcinogens: A Scientist's View. In
Crandell R and Lave L (Ed.): The Scientific Basis of Health in
Safety Regulations. The Brookings Institute, 173-195, 1981.
Hoel DG: Extrapolation of laboratory data to human health effects.
Environmental Science Research 25:521-526, 1982.
Hoel DG: Statistical measures of risk. Drug Metabolic Reviews 13:829-
838, 1982.
Hogan MD and Hoel DG: Extrapolation to man. In Hayes AW (Ed.):
Principles and Methods of Toxicology. New York, Raven Press,
1982, pp. 711-731.
Kato H, Brown CC, Hoel DG and Schull WJ: Studies of the mortality of A-
Bomb survivors. Report 7. Mortality, 1950-1978: Part II.
Mortality from causes other than cancer and mortality in early
entrants. Radiation Research 91:243-264, 1982.
Brown KG and Hoel DG: Modeling time-to-tumor data: Analysis of the ED01
Study. Fundamental Applied Toxicology 3:458-469, 1983.
Brown KG and Hoel DG: Multistage prediction of cancer in serially dosed
animals with application to the ED01 study. Fundamental Applied
Toxicology 3:470-477, 1983.
Hoel DG: Conditional two sample tests with historical controls. In Sen
PK (Ed.): Contributions to Statistics: Essays in Honour of
Norman L. Johnson. Amsterdam, North Holland Publishing Company,
1983, pp. 229-236.
Hoel DG, Kaplan N and Anderson MW: Implication of nonlinear kinetics on
risk estimation in carcinogenesis. Science 219:1032-1037, 1983.
Hoel DG, Wakabayashi T and Pike MC: Secular trends in the distributions
of the breast cancer risk factors--menarche, first birth,
menopause, and weight--in Hiroshima and Nagasaki, Japan.
American Journal of Epidemiology 118:78-89, 1983.
Pike MC, Krailo MD, Henderson BE, Casagrande JT and Hoel DG: `Hormonal'
risk factors, `breast tissue age' and the age-incidence of
breast cancer. Nature 303:767-770, 1983.
Portier C and Hoel DG: Optimal bioassay design under the Armitage-Doll
multistage model. Journal of Toxicology Environmental Health
12:1-19, 1983.
Portier C and Hoel DG: Low-dose rate extrapolation using the multistage
model. Biometrics 39:897-906, 1983.
Poon AH and Hoel DG: Nonparametric estimation of the survival function
when cause of death is uncertain. Biometrics 40:1151-1158,
1984.
Portier C and Hoel DG: Design of animal carcinogenicity studies for
goodness-of-fit to multistage models. Fundamental Applied
Toxicology 4:949-959, 1984.
Portier C and Hoel DG: Type 1 error of trend tests in proportions and
the design of cancer screens. Communication in Statistics (A-
Theory and Methods) 13:1-16, 1984.
Portier CJ, Hoel DG and Van Ryzin J: Statistical analysis of the
carcinogenesis bioassay data relating to the risks from
exposure to 2,3,7,8-tetrachlorodibenzo-p-dioxin. In Lowrance WW
(Ed.): Public Health Risks of the Dioxins. New York,
Rockefeller University, 1984, pp. 99-119.
Hoel DG: Epidemiology and the inference of cancer mechanisms. National
Cancer Institute Monograph 67:199-203, 1985.
Hoel DG: Mathematical dose-response models and their application to
risk estimation. In Vouk VB, Butler GC, Hoel DG and Pekall DB
(Eds.): Methods for Estimating Risk of Chemical Injury: Human
and Nonhuman Biota and Ecosystems, Scope 1985/SGOMSEC 2. New
York, J. Wiley and Sons, 1985, pp. 347-359.
Hoel DG and Jennrich RI: Life table analysis with small numbers of
cases: An example--multiple myeloma in Hiroshima and Nagasaki.
Journal of Statistics Comput. Simul. 20:311-322, 1985.
Bernstein L, Gold LS, Ames BN, Pike MC and Hoel DG: Some tautologous
aspects of the comparison of carcinogenic potency in rats and
mice. Fundamental Applied Toxicology 5:79-86, 1985.
Hoel DG: The impact of occupational exposure patterns on quantitative
risk estimation. In Hoel DG, Merrill RA and Perera FP (Eds.):
Risk Quantitation and Regulatory Policy, Banbury Report 19,
1984. Cold Spring Harbor, NY, Cold Spring Harbor Laboratory,
1985, pp. 105-118.
Hoel DG: Dose-response in radiation carcinogenesis: Animal studies. In
Castellani A (Ed.): Epidemiology and Quantitation of
Environmental Risk in Humans from Radiation and Other Agents:
Potential and Limitations. London, Plenum Press, pp. 93-103,
1985.
Hoel DG and Preston DL: Dose-response in radiation carcinogenesis:
Human studies. In Castellani A (Ed.): Epidemiology and
Quantitation of Environmental Risk in Humans from Radiation and
Other Agents: Potential and Limitations. London, Plenum Press,
pp. 105-122, 1985.
Yanagawa T and Hoel DG: Use of historical controls for animal
experiments. Environmental Health Perspective 63:217-224, 1985.
Hoel DG: The incorporation of pharmacokinetics in low-dose risk
estimation. In Clayton D, Krewski D and Munro I (Eds.):
Toxicological Risk Assessment (Volume I). Boca Raton, Fla., CRC
Press, 1985, pp. 205-214.
Bernstein L, Gold LS, Ames BN, Pike MC and Hoel DG: Toxicity and
carcinogenic potency. Risk Analysis 5:263-264, 1985.
Gold LS, Bernstein L, Kaldor J, Backman G and Hoel DG: An empirical
comparison of methods used to estimate carcinogenic potency in
long-term animal bioassays: Lifetable vs. summary incidence
data. Fundamental Applied Toxicology 6:263-269, 1986.
Brown KG and Hoel DG: Statistical modeling of animal bioassay data with
variable dosing regimens: Example--vinyl chloride. Risk
Analysis 6:155-166, 1986.
Hoel DG and Yanagawa T: Incorporating historical controls in testing
for a trend in proportions. Journal of American Statistical
Association 81:1095-1099, 1986.
Portier CJ, Hedges JC and Hoel DG: Age-specific models of mortality and
tumor onset for historical control animals in the National
Toxicology Program's carcinogenicity experiments. Cancer
Research 46:4372-4378, 1986.
Hogan M and Hoel DG: Utilizing scientific data in assessing human
cancer risk associated with chemical exposure. In Report:
Chemical Carcinogens: A Review of the Science and Its
Associated Principles by U.S. Intergency Staff Group on
Carcinogens, Environmental Health Perspectives, Vol. 67, pp.
253-258, 1986.
Hoel DG: Statistical aspects of chemical mixtures. In Vouk VB, Butler
GC, Upton AC, Parke DV and Asher SC (Eds.): Methods for
Assessing the Effects of Mixtures of Chemicals, SGOMSEC3. New
York, J. Wiley & Sons Limited, 1987, pp. 369-377.
Hoel DG and Landrigan PJ: Comprehensive evaluation of human data. In
Tardiff RG and Rodricks JV (Eds.): Toxic Substances and Human
Risk, Principles of Data Interpretation. New York, Plenum
Press, 1987, pp. 121-129.
Portier CJ and Hoel DG: Issues concerning the estimation of the TD50.
Risk Analysis 7:437-447, 1987.
Kaplan N, Hoel DG, Portier CJ and Hogan MD: An evaluation of the safety
factor approach in risk assessment. In Pratt RM, McLachlan JA
and Markert CL (Eds.): Developmental Toxicology: Mechanisms and
Risk, Banbury Report 26. Cold Spring Harbor, NY, Cold Spring
Harbor Laboratory, 1987, pp. 335-346.
Hoel DG: Radiation risk estimation models. Environmental Health
Perspective 75:105-107, 1987.
Weinberg CR, Brown KG and Hoel DG: Altitude, radiation, and mortality
from cancer and heart disease. Radiation Research 112:381-390,
1987.
Hoel DG: Cancer risk models for ionizing radiation. Environmental
Health Perspective 76:121-124, 1987.
Hoel DG, Haseman JK, Hogan MD, Huff JE and McConnell EE. The impact of
toxicity on carcinogenicity studies: Implications for risk
assessment. Carcinogenesis 9:2045-2052, 1988.
Pedersen LG, Darden TA, Deerfield DW, Anderson MW and Hoel DG: A
theoretical study of the effect of methylation or ethylation at
06-guanine on the structure and energy of DNA double strands.
Carcinogenesis 9:1553-1562, 1988.
Piegorsch WW and Hoel DG: Exploring relationships between mutagenic and
carcinogenic potencies. Mutation Research 196:161-175, 1988.
Bailer AJ and Hoel DG: Metabolite-based internal doses used in a risk
assessment of benzene. Environmental Health Perspective 82:177-
184, 1989.
Bailer AJ and Hoel DG: Benzene risk assessments: Review and update. In
Mehlman MA (Ed.): Benzene: Occupational and Environmental
Hazards Scientific Update (Vol. 16, Advances in Modern
Environmental Toxicology). Princeton, NJ, Princeton Scientific
Publishing Co., Inc., 1989, 131-140. and Cell Biology and
Toxicology 5(3):287-295, 1989.
Yanagawa T, Hoel DG and Brooks G: A conservative use of historical data
for a trend test in proportions. Journal of Japan Statistical
Society 19(1):83-94, 1989.
Hoel DG and Dinse GE: Using Mortality Data to Estimate Radiation
Effects on Breast Cancer Incidence. Environmental Health
Perspective 87:123-129, 1990.
Portier CJ, Hoel DG, Kaplan NL and Koop A: Biologically Based Models
for Risk Assessment. In Vannio H, Sora M, and McMichael AJ
(Eds.): Complex Mixtures and Cancer Risk. Lyon, France,
International Agency for Research on Cancer Scientific
Publications, 1990, No. 104.
Hoel DG: An Overview of the Probable Consequences of Prolonged
Inhibition of Gastric Acid Secretion. In Elder J (Ed.):
Profound Gastric Acid Suppression: Long-Term Safety Risk?
Research and Clinical Forums 12(1):169-176, 1990.
Davis DL, Hoel DG, Fox J and Lopez A: International Trends in Cancer
Mortality in the France, West Germany, Italy, Japan, England
and Wales, and the USA. Lancet 336:474-481, 1990.
Davis DL, Hoel DG, Fox J and Lopez A: International Trends in Cancer in
France, West Germany, Italy, Japan, England and Wales, and the
United States. Annals of the New York Academy of Sciences
609:5-48, 1990.
Hoel DG: Assumptions of the HERP Index. Risk Analysis 10:623-624, 1990.
Ellett WH, Hoel DG and Cooper RD: BEIR V Estimates of Excess Cancer
Mortality. Conference Proceedings: Statistics of Human Exposure
to Ionizing Radiation Workshop. Oxford, England, 1990 Radiation
Protection Dosimetry 36:309-314, 1991.
Hoel DG: A Balanced Approach to Risk Assessment. In Tsuchiya K, Lee SD,
Grant LD and Mehlman MA (Eds.): Conference Proceedings:
Toxicology and Industrial Health, Vol. 7, Number 5/6, IXth UOEH
International Symposium and First Pan Pacific Cooperative
Symposium. Kitakyushu, Japan, 1991, pp. 305-311.
deSerres FJ and Hoel DG: Collaborative Study on the Genetic Toxicology
of 2-Amino-N6-Hydroxadenine (AHA): An Exercise in Genetic Risk
Assessment. Mutation Research 253:1-3, 1991.
Swenberg JA, Hoel DG and Magee PN: Mechanistic and Statistical Insight
into the Large Carcinogenesis Bioassays on DEN and DMN. Cancer
Research 51:6409-6414, 1991.
Davis DL, Ahlbom A, Hoel DG and Percy C: Is Brain Cancer Mortality
Increasing in Industrial Countries? American Journal of
Industrial Medicine 19:421-431, 1991.
Hoel DG, Davis DL, Miller AB, Sondik EJ and Swerdlow AJ: Trends in
Cancer Mortality in 15 Industrial Countries 1969-1986. Journal
of the National Cancer Institute 84:313-320, 1992.
Huff J and Hoel DG: Perspective and Overview of the Concepts and Value
of Hazard Identification as the Initial Phase of Risk
Assessment for Cancer and Human Health. Scandinavian Journal of
Work Environmental Health 18(1):83-89, 1992.
Piegorsch WW, Carr GJ, Portier CJ and Hoel DG: Concordance of
Carcinogenic Response between Rodent Species: Potency
Dependence and Potential Underestimation. Risk Analysis 12:115-
121, 1992.
Hoel DG: Multistage Models of Carcinogenesis and Their Implications for
Dose-Response Models and Risk Projections. Conference
Proceedings: International Conference on Radiation Effects and
Protection. Mito, Japan, March 18-20, pp 123-126, 1992.
Shimizu Y, Kato H, Schull WJ and Hoel DG: Studies of the Mortality of
A-Bomb Survivors. Mortality, 1950-8: Part 3. Non-cancer
mortality in the years 1950-85 based on the recently revised
doses (DS86). Radiation Research 130:249-266, 1992.
Dinse GE and Hoel DG: Exploring Time Trends in Cancer Incidence. Cancer
Causes and Control 3:409-417 1992.
Davis DL and Hoel DG: Figuring Out Cancer. International Journal of
Health Services 22(3):447-453, 1992.
Davis DL, Blair A, and Hoel DG: Agricultural Exposures and Cancer
Trends in Developed Countries. Environmental Health Perspective
100:39-44, 1992.
Fung VA, Huff JE, Weisburger EK and Hoel DG. Predictive Strategies for
Selecting 379 NCI/NTP Chemicals Evaluated for Carcinogenic
Potential: Scientific and Public Health Impact. Fundamentals
and Applied Toxicology 20:413-436, 1993.
Portier C, Clark G, Edler L, Greenlee W, Hoel D, Tritscher A and Lucier
G: Ligand/Receptor Binding for 2,3,7,8-TCDD: Implication for
Risk Assessment. Fundamentals and Applied Toxicology 12:48-56,
1993.
Hoel DG, Carter R, Ron E and Mabuchi K: The Influence of Death
Certificate Errors on Cancer Mortality Trends. Journal of the
National Cancer Institute 85:1063-1068, 1993.
Hoel DG: Questions about Radiation and Risk Estimates that Remain After
BEIR-V. Radiation Research 136:137-139, 1993.
Davis DL, Bradlow HL, Wolff M, Woodruff T, and Hoel DG, Anton-Culver H:
Medical Hypothesis: Xeno-estrogens as Preventable Causes of
Breast Cancer. Environmental Health Perspectives 101:372-377,
1993.
Yanagawa T and Hoel DG: Incorporating Geographic Distribution into the
Expected Number of Deaths in a Comparative Study. Statistical
Science and Data Analysis, Matsusita K et al., Eds. 25-32,
1993.
Hoel DG and Portier CJ: Nonlinearity of Carcinogenesis Dose.
Environmental Health Perspective 102:109-113, 1994.
Davis DL, Dinse GE, and Hoel DG: Decreasing Cardiovascular Disease and
Increasing Cancer Among Whites in the United States from 1973
to 1987. JAMA 271:431-437, 1994.
Mori H, Nakamura T, Mine M, Kondo H, Okumura Y, and Hoel DG: Early
Mortality of Atomic Bomb Survivors based on House
Reconstruction Survey. International Journal of Radiation
Biology 65: No. 2, 267-275, 1994.
Hoel DG: Ionizing Radiation and Cancer Prevention. Environmental Health
Perspective 103 (Suppl 8):241-243, 1995.
Daniel DM, Lackland DT, Baron LF, Nixon DW, Garr DR, Gross AJ, O'Brien
and Hoel DG. Comparison of White and African-American Barriers
to Mammography: A Need for a Barrier-Specific Approach to Care.
Cancer Prevention International 2:3-21, 1995.
Gordis L, Berry DA, Chu SY, Fajardo LL, Hoel DG, Laufman LR,
Rufenbarger CA, Scott, JR, Sullivan DC, Wasson JH, Westhoff CL
and Zern RT. National Institutes of Health Consensus
Development Conference Statement: Breast Cancer Screening for
Women Ages 40-49, January 21-23, 1997. (Special Article)
Journal of National Cancer Institute 89(14):1015-1026, 1997.
Radivoyevitch T, Hoel DG, Hahnfeldt PJ, Rydberg B and Sachs RK. Recent
Pulsed Fields Gel Electrophoresis Data Suggest Two Types of
DSBs [4409-R]. Radiation Research 149:52-58, 1998.
Radivoyevitch T, Hoel DG, Chen AM, Sachs RK. Double-Strand Break
Misrejoining After X-Irradiation: Relating Moderate to Very
High Doses by a Markov Model [4437-R]. Radiation Research
149:59-67, 1998.
Nietert P, Sutherland SE, Silver RM, Pandey JP, Knapp R, Hoel DG and
Dosemeci, M. Is Occupational Organic Solvent Exposure a Risk
Factor for Scleroderma? Arthritis and Rheumatism 41:1111-1118,
1998.
Radivoyevitch T, Hoel, DG, Hahnfeldt, Sachs RK. Size Distribution of
Misrejoining DNA Fragments in Irradiation Cells. Mathematical
Biosciences 149:107-136, 1998.
Hoel DG and Li P. Threshold Models in Radiation Carcinogenesis. Health
Physics 75(3):241-250, 1998.
Nicholas JS, Lackland DT, Dosemeci M, Mohr L, Dunbar JB, Grosche B and
Hoel DG. Mortality among United States Commercial Pilots and
Navigators. Journal of Occupational and Environmental Medicine
40:980-985, 1998.
Nicholas JS, Lackland DT, Butler GC, Mohr LC, Dunbar JB, Kaune WT,
Grosche B and Hoel DG. Cosmic Radiation and Magnetic Field
Exposure to Airline Flight Crews. American Journal of
Industrial Medicine 34:574-580, 1998.
Dinse GE, Umbach DM, Sasco AJ, Hoel DG and Davis DL. Unexplained
Increase in Cancer Incidence in the United States from 1975 to
1994: Possible Sentinel Health Indicators? Annual Review of
Public Health Vol. 20, 1999.
Grosche B, Lackland D, Mohr L, Dunbar J, Nicholas J, Burkart W and Hoel
D. Leukemia in the vicinity of two Tritium releasing nuclear
facilities: a comparison of the Kruemmel Site, Germany, and the
Savannah River Site, South Carolina, USA. Journal of
Radiological Protection 19:243-252, 1999.
Radivoyevitch T and Hoel, DG. Modeling the Low-LET Dose-Response of
BCR-ABL Formation: Predicting Stem Cell Numbers from A-bomb
Data. Mathematical Biosciences 162:85-101, 1999.
Radivoyevitch T and Hoel D. Biologically-Based Risk Estimation for
Radiation-Induced Chronic Myeloid Leukemia. Radiation &
Environmental Biophysics 39(3):153-159, 2000.
Nicholas JS, Butler GC, Lackland DT, Hood WC, Hoel DG and Mohr LC.
Flight deck magnetic fields in Commercial Aircraft. American
Journal of Industrial Medicine 38(5):548-554, 2000.
Nicholas JS, Butler GC, Lackland DT, Tessier GS, Mohr LC and Hoel DG.
Health among commercial airline pilots. Aviation, Space, and
Environmental Medicine 72(9);821-826, 2001.
Tessier GS, Lam C, Nakamura T and Hoel DG, Two-Stage Cancer Models
Applied to Gamma and Neutron Exposed Mice. European J. of
Oncology 6(3):297-301, 2001.
Schubauer-Berigan MK, Frey GD, Baron L andHoel DG. Mammography Dose in
Relation to Body Mass Index, Race, and Menopausal Status.
Radiation Protection Dosimetry 98(4):425-432, 2002.
McGreevy KM, Baron LF and Hoel DG. Clinical Breast Examination
Practices Among Women Undergoing Screening Mammography.
Radiology 224(2):555-559, 2002.
Schubauer-Berigan MK, Baron L, Frey GD and Hoel DG. Breast Dose
Variability in a Biracial Population Undergoing Screening
Mammography. Radiation Protection Dosimetry 98(4):417-424,
2002.
Baker GS and Hoel DG. Corrections in the Atomic bomb Data to Examine
Low Dose Risk. Health Physics 85(6):709-720, 2003.
Carnes BA, Grahn D, Hoel D. Mortality of Atomic Bomb Survivors
Predicted from Laboratory Animals. Radiation Research, 160:159-
167, 2003.
Nicholas J, Butler G, Davis S, Bryant E, Hoel D and Mohr L. Stable
Chromosome Aberrations and Ionizing Radiation in Airline
Pilots. Aviation, Space and Environmental Medicine 74:953-956,
2003.
Nakamura T and Hoel DG. Comparing Risks between Radiation and Dioxin
Exposure Based on Two-Stage Model. Environmetrics 14:203-211,
2003.
Creasman WT, Hoel DG and DiSaia PJ. WHI: Now that the Dust has settled.
A Commentary. American Journal of Obstetrics and Gynecology
189:621-626, 2003.
Heath, Jr. CW, Bond PD, Hoel DG and Meinhold CB. Residential Radon
Exposure and Lung Cancer Risk: Commentary on Cohen's County-
based Study. Health Physics 87(7):647-655, 2004.
McGreevy KM, Hoel B, Lipsitz SR, Bissada, NK and Hoel DG. Racial and
Anthropometric Differences in Insulin-Like Growth Factor I
(IGF-I) and Insulin-Like Growth Factor Binding Protein-3
(IGFBP-3) Levels. Urology 2004 (in press).
McGreevy KM, Hoel B, Lipsitz SR and Hoel DG. Impact of Nutrients on
Insulin-like Growth Factor-I, Insulin-like Growth Factor
Binding Protein-3 and their Ratio in Black and White Males.
Public Health Nutrition, 2004 (accepted).
Hoel, DG, Carnes B. Cancer Dose-Response Analysis of the Radium Dial
Workers. Proceedings from the HEIR 2004 9th International
Conference on Health Effects of Incorporated Radionuclides--
Emphasis on Radium, Thorium, Uranium and their Daughter
Products. GSF-National Research Center, Neuherberg, Germany,
November 29-December 1, 2004. 2005 (in press)