[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
FIXING EPA'S BROKEN INTEGRATED
RISK INFORMATION SYSTEM
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON INVESTIGATIONS AND
OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
FIRST SESSION
__________
JUNE 11, 2009
__________
Serial No. 111-33
__________
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
48-753 WASHINGTON : 2009
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COMMITTEE ON SCIENCE AND TECHNOLOGY
HON. BART GORDON, Tennessee, Chair
JERRY F. COSTELLO, Illinois RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas F. JAMES SENSENBRENNER JR.,
LYNN C. WOOLSEY, California Wisconsin
DAVID WU, Oregon LAMAR S. SMITH, Texas
BRIAN BAIRD, Washington DANA ROHRABACHER, California
BRAD MILLER, North Carolina ROSCOE G. BARTLETT, Maryland
DANIEL LIPINSKI, Illinois VERNON J. EHLERS, Michigan
GABRIELLE GIFFORDS, Arizona FRANK D. LUCAS, Oklahoma
DONNA F. EDWARDS, Maryland JUDY BIGGERT, Illinois
MARCIA L. FUDGE, Ohio W. TODD AKIN, Missouri
BEN R. LUJAN, New Mexico RANDY NEUGEBAUER, Texas
PAUL D. TONKO, New York BOB INGLIS, South Carolina
PARKER GRIFFITH, Alabama MICHAEL T. MCCAUL, Texas
STEVEN R. ROTHMAN, New Jersey MARIO DIAZ-BALART, Florida
JIM MATHESON, Utah BRIAN P. BILBRAY, California
LINCOLN DAVIS, Tennessee ADRIAN SMITH, Nebraska
BEN CHANDLER, Kentucky PAUL C. BROUN, Georgia
RUSS CARNAHAN, Missouri PETE OLSON, Texas
BARON P. HILL, Indiana
HARRY E. MITCHELL, Arizona
CHARLES A. WILSON, Ohio
KATHLEEN DAHLKEMPER, Pennsylvania
ALAN GRAYSON, Florida
SUZANNE M. KOSMAS, Florida
GARY C. PETERS, Michigan
VACANCY
------
Subcommittee on Investigations and Oversight
HON. BRAD MILLER, North Carolina, Chair
STEVEN R. ROTHMAN, New Jersey PAUL C. BROUN, Georgia
LINCOLN DAVIS, Tennessee BRIAN P. BILBRAY, California
CHARLES A. WILSON, Ohio VACANCY
KATHY DAHLKEMPER, Pennsylvania
ALAN GRAYSON, Florida
BART GORDON, Tennessee RALPH M. HALL, Texas
DAN PEARSON Subcommittee Staff Director
EDITH HOLLEMAN Subcommittee Counsel
JAMES PAUL Democratic Professional Staff Member
DOUGLAS S. PASTERNAK Democratic Professional Staff Member
KEN JACOBSON Democratic Professional Staff Member
TOM HAMMOND Republican Professional Staff Member
JANE WISE Research Assistant
C O N T E N T S
June 11, 2009
Page
Witness List..................................................... 2
Hearing Charter.................................................. 3
Opening Statements
Statement by Representative Brad Miller, Chair, Subcommittee on
Investigations and Oversight, Committee on Science and
Technology, U.S. House of Representatives...................... 7
Written Statement............................................ 14
Statement by Representative Paul C. Broun, Ranking Minority
Member, Subcommittee on Investigations and Oversight, Committee
on Science and Technology, U.S. House of Representatives....... 15
Written Statement............................................ 17
Witnesses:
Dr. Kevin Teichman, Deputy Assistant Administrator for Science,
Office of Research and Development (ORD), U.S. Environmental
Protection Agency (EPA)
Oral Statement............................................... 26
Written Statement............................................ 28
Biography.................................................... 29
Mr. John B. Stephenson, Director, Natural Resources and
Environment, U.S. Government Accountability Office
Oral Statement............................................... 30
Written Statement............................................ 31
Biography.................................................... 36
Discussion
Ensuring EPA's Program Control................................. 37
The Effect of an IRIS Listing.................................. 38
How IRIS Assessments Are Used.................................. 38
Transparency Process........................................... 39
Program Schedule and Productivity.............................. 41
Potential Improvements......................................... 42
Deliberative Process........................................... 42
The GAO High-Risk List......................................... 43
Royal Demolition Explosive..................................... 43
Assessment Timeliness.......................................... 44
Peer Reviews................................................... 45
Fairness and Time Constraints.................................. 47
More on the Transparency Process............................... 47
Closing........................................................ 48
Appendix 1: Answers to Post-Hearing Questions
Dr. Kevin Teichman, Deputy Assistant Administrator for Science,
Office of Research and Development (ORD), U.S. Environmental
Protection Agency (EPA)........................................ 52
Appendix 2: Additional Material for the Record
Nipping IRIS in the Bud: Suppression of Environmental Science by
the Bush Administration's Office of Management and Budget,
Staff Report by the Majority Staff of the Subcommittee on
Investigations and Oversight, June 11, 2009.................... 56
The IRIS Information Roadblock: How Gaps in EPA's Main
Toxicological Database Weaken Environmental Protection, Center
for Progressive Reform White Paper #904, June 2009............. 125
FIXING EPA'S BROKEN INTEGRATED RISK INFORMATION SYSTEM
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THURSDAY, JUNE 11, 2009
House of Representatives,
Subcommittee on Investigations and Oversight,
Committee on Science and Technology,
Washington, DC.
The Subcommittee met, pursuant to call, at 1:11 p.m., in
Room 2318 of the Rayburn House Office Building, Hon. Brad
Miller [Chair of the Subcommittee] presiding.
hearing charter
SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
COMMITTEE ON SCIENCE AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
Fixing EPA's Broken Integrated
Risk Information System
thursday, june 11, 2009
1:00 p.m.-3:00 p.m.
2318 rayburn house office building
Purpose
On Thursday, June 11, 2009, the Subcommittee on Investigations and
Oversight of the House Committee on Science and Technology will hold a
hearing entitled ``Fixing EPA's Broken Integrated Risk Information
System.'' We will receive testimony from two witnesses at this hearing:
Mr. John Stephenson, Director, Natural Resources and Environment, U.S.
Government Accountability Office, and Dr. Kevin Teichman, the Deputy
Assistant Administrator for Science, Office of Research and
Development, the Environmental Protection Agency. They will testify
about the new Integrated Risk Information System (IRIS) process
announced by EPA Administrator Lisa Jackson on May 21, 2009.
Background
By the end of the Bush Administration, the Environmental Protection
Agency's (EPA) IRIS process was broken. What began two decades ago as
an initiative at EPA to establish a reliable database on what science
said about the risks of particular chemicals devolved by the end of the
Bush Administration into a tortured round of interagency bickering,
mediated by the Office of Information and Regulatory Affairs (OIRA). As
a result of the IRIS process breaking down, public health offices
across the country and around the world, as well as concerned citizens,
were left without the reliable, expanding, up-to-date database of
chemical risks that they had come to count on.\1\
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\1\ The Subcommittee has carried out extensive work on OIRA's role
in relationship to IRIS. In 2008, the Subcommittee held two hearings on
this subject. The first of these hearings was on May 21, 2008, when the
Subcommittee took testimony from Dr. George Gray, the then-Assistant
Administrator for Research and Development at EPA, and Ms. Susan
Dudley, the then-Administrator of the Office of Information and
Regulatory Affairs (OIRA) at the Office of Management and Budget.
Additionally, Mr. John Stephenson of GAO testified on findings
regarding the lack of productivity in the IRIS process. In the second
hearing, on June 12, 2008, the Subcommittee received testimony from Mr.
Jerry Ensminger (U.S.M.C., retired), Mr. Lenny Seigel (Executive
Director, Center for Public Environmental Oversight), and Dr. Linda
Greer (Director of the Health Program at the Natural Resources Defense
Council). On June 11, 2008 Chair Miller sent a document request to OMB
asking for all materials relating to OIRA's involvement in the proposed
IRIS entry for trichloroethylene (TCE). In response, the Committee
received a few boxes of materials. The great majority of those
materials were either peer reviewed articles, articles done by EPA
staff, or research reports done under contract to industry or polluting
agencies. Subcommittee staff were obliged to visit OMB's office to
review thousands of pages of documents and take notes because the
office refused to provide copies. A clear picture of OIRA's almost
daily involvement on TCE emerged from that review. However, OIRA
refused to provide access to most documents regarding interagency
communications or internal communications surrounding TCE. Because the
110th Congress was drawing to a close, it was not practical to push for
a subpoena for these records. We were never shown any document that
could have been construed as having Executive Privilege attached to it.
OIRA's entire approach appeared to amount to little more than
obstruction of the work of the Subcommittee; in a sense, OIRA did to
the Subcommittee's investigation what they have perfected in terms of
slow-rolling IRIS proposals.
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A chemical's entry in the IRIS database is nothing more than a
science-based assessment of risks associated with a particular
chemical. IRIS entries are produced in the Office of Research and
Development (ORD) of EPA, and those entries are not an expression of
regulatory intent or advice. The entries are not even all that is
required of a complete risk assessment as defined in the seminal
National Academies of Science report, Risk Assessment in the Federal
Government: Managing the Process (1983).\2\ And risk assessment is a
long step away from a regulatory effort, which is described in the
terminology of the panel as ``risk management.'' However, the absence
of IRIS entries for widely used, toxic chemicals leaves State and local
regulators, first responders, and citizens without crucial information
that can guide their response to an emergency or an emerging health or
environmental threat.
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\2\ In that 1983 report, ``Risk Assessment in the Federal
Government: Managing the Process,'' the National Research Council panel
identified four components of a complete risk assessment: hazard
identification, dose-response evaluation, exposure assessment, and risk
characterization. IRIS reflects science that addresses the first two
conditions. In discussing the difference between risk assessment and
risk management, the Academy panel wrote: ``Risk assessment is the use
of the factual base to define the health effects of exposure of
individuals or populations to hazardous materials and situations. Risk
management is the process of weighing policy alternatives and selecting
the most appropriate regulatory action, integrating the results of risk
assessment with engineering data and with social, economic and
political concerns to reach a decision.'' See the discussion on page 3
of the 1983 report.
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OIRA has been involved in the IRIS process since the closing years
of the Clinton Administration. Initially OIRA was pulled into the
process to facilitate interagency discussions about particular
chemicals proposed for IRIS listings. Agencies that had a record of
pollution with certain chemicals were concerned that new IRIS standards
would trigger the long march to new regulations and the end result
would be that the polluting agencies would have to change their
practices and clean up legacy wastes. Those who polluted saw that
disputing what scientific research had found about the risks of a
particular chemical could become the first line of defense against the
distant possibility of regulation.\3\ By the late 1990s, OIRA was
playing a role as facilitator for contentious interagency discussions
for some particular proposed IRIS listings.\4\
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\3\ This effort by polluters, or those who fear regulation of
whatever stripe, of pushing the struggle back to what the science says
about a particular risk rather than arguing over how to structure a
regulation has been described as ``paralysis by analysis.'' Science
lends itself to endless study because there is never an absolute, final
answer to any question, but always another layer of research that could
add to the body of accumulated knowledge. If those who want to avoid
regulation can shift the terms of discussion from the risk management
end of the spectrum to the science and what uncertainties remain, a
regulatory struggle need never begin. For analysis of how this process
has unfolded among regulated industries, see David Michaels, Doubt Is
Their Product: How Industry's Assault on Science Threatens Your Health,
Oxford University Press, New York, 2008.
\4\ The Subcommittee was also able to review records from 1998 when
OIRA first began to push into the interagency struggles over
characterizing risks to former marines and their families from TCE and
other chemicals at Camp LeJeune. At that time, OIRA's interest was more
in the costs of the studies and making sure the then-proposed survey
study met OIRA quality standards. OIRA reviews all survey instruments
as part of its authority under the Paperwork Reduction Act of 1980.
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Suppressing IRIS entries essentially shuts down the flow of
coherent, reliable information about what chemicals pose what kinds of
risks. Testimony received by the Subcommittee at the second day of
hearings on this subject in 2008 emphasized the important role of IRIS
as a public health and safety resource. That hearing, entitled ``Toxic
Communities: How EPA's IRIS Program Fails the Public,'' took testimony
from U.S.M.C. (retired) Master Sergeant Jerry Ensminger, the Executive
Director of the Center for Public Environmental Oversight, Mr. Lenny
Siegel, and Dr. Linda E. Greer, Director for Health Programs at the
Natural Resources Defense Council. Mr. Ensminger was particularly
compelling in making a case for why polluting agencies such as DOD
should not be allowed privileged access to discussions about the
science of potential pollutants.
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 . . .
and yet this Administration and past Congresses have allowed
DOD's tentacles to infiltrate the realm of science.\5\
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\5\ ``Toxic Communities: How EPA's IRIS Program Fails the Public,''
Hearing before the Subcommittee on Investigations and Oversight,
Committee on Science and Technology, June 12, 2008, p. 132.
Mr. Ensminger was stationed at Camp LeJeune. His daughter, Janey,
died of acute lymposytic leukemia. Water at the Camp was contaminated
with trichloroethylene (TCE) and perchlorate (perc) and these
chemicals, as well as other volatile organic compounds in the water
system at the Camp, may have caused Janey's condition. DOD has been
working for many years to block new IRIS standards on TCE and perc.
During the Bush Administration, OIRA's involvement changed in scope
and kind from what it had been in the Clinton Administration. John
Graham, the first Director of OIRA in the Bush Administration, brought
in technical specialists--including toxicologists--to tend to science-
based discussions of proposed environmental regulations, guidance and
IRIS entries. Graham also oversaw a complete overhaul--some might
describe it as an endless evolution--of the review and approval process
for IRIS proposals.
IRIS Process Reforms Past and Present
On April 10, 2008, EPA announced a new IRIS review process for
future entries into the IRIS database. In testimony before the
Subcommittee, the then Assistant Administrator for Research and
Development at EPA, Dr. George Gray, described this new process as
``streamlined.'' Comparing the process as it existed before 2004 and
the process announced on April 10, 2008, it is hard to understand in
what sense the process could be described as ``streamlined'' (see
Attachments 1 and 2). The fruits of this new process were exactly four
new IRIS entries in the years since that process was announced
(actually, they had gone through as a single proposal as they were four
variants on one chemical compound so this could be counted as ``one''
new entry and not distort the record). In the two years prior to
announcing this new process, EPA had been allowed to post four new
entries (two each year).
GAO issued a very strong report concerning mismanagement of the
IRIS program in a March, 2008 report (``Chemical Assessments: Low
Productivity and New Interagency Review Process Limit the Usefulness
and Credibility of EPA's Integrated Risk Information System,'' GAO-08-
440). In addition, GAO added the IRIS program to its ``High Risk''
report in January of 2009--placing additional pressure on EPA and the
new Administration to take steps to fix this broken process.
On May 21, EPA Administrator Lisa Jackson announced a new IRIS
process that appears to be much improved over the system she inherited
(see Attachment 3). It imposes transparency on interagency comments
concerning proposed IRIS entries; it eliminates the ability of
polluting agencies (such as the Department of Energy, NASA, or the
Department of Defense) to further drag out assessments by declaring
particular chemicals as ``mission critical''; it puts EPA solidly in
charge of the entire process with a timeline for each step in the
process.
All of these steps away from an OIRA-dominated system are positive.
However, questions still remain about how this process will perform in
actual practice.
1. Control: Will EPA really have the muscle to stand up to
pressure from more powerful agencies that have historically
obstructed IRIS entries as a way of strangling potential
regulation? Will EPA be able to withstand pressure from offices
inside the White House should those offices mobilize to block
or significantly redo a proposed IRIS listing? EPA faired badly
during the prior Administration in struggles over science and
regulation. Some of those problems reflected the political
preferences of the Bush Administration, but some of those
problems reflect the ingrained institutional interests of other
agencies who do not want to be regulated and White House
offices that want to have a great measure of control over what
EPA (among many agencies) can and cannot do. Institutional
interests do not change with elections, and EPA will still face
some pressure on that front. The Chair's position has been that
EPA scientists should be in charge of EPA science products.
2. What role will OIRA play? This is really a more specific
observation related to control, but the new plan announced by
Administrator Jackson is ambiguous about what White House
offices will be involved in reviews of EPA IRIS proposals.
Because discussion of proposed listings is supposed to be
limited solely to ``science'' matters, it is hard to imagine
any White House office actually having the time or resources to
appropriately weigh in on science matters--even the Office of
Science and Technology Policy. There is no office in the White
House that does ``science'' per se. OIRA is really designed to
weigh in on the ``risk management'' side of the regulatory
equation, not the ``risk assessment'' or science side which
comes well before any regulatory proposal is even contemplated.
No office in the White House is more influential with agencies
than is the Office of Management and Budget (OMB) precisely
because OMB controls every agency's budget request. OIRA is
housed at OMB and that location gives them a very powerful
voice, when they raise it, in the work of the line agencies. Is
it appropriate to let OIRA play any role at all in science
matters?
3. Productivity: While the newly announced process does
eliminate some steps in the IRIS approval process, it remains
to be seen whether it will allow for a substantial increase in
IRIS entries being finalized by EPA. With 700 new chemicals
entering the marketplace each year, and a backlog of needed
updates and new entries, the bare minimum standard for success
of IRIS is probably 20 entries a year--which is what the new
process promises to deliver.
The Subcommittee will pursue these matters, and others, during the
hearing. If IRIS is unable to function effectively, public health and
safety will ultimately suffer. Getting this program right is a high
priority for the Subcommittee and the country. The Subcommittee Chair
expects to send a request letter to the Government Accountability
Office to have them continue to monitor the new IRIS process.
Chair Miller. Good afternoon. The hearing will now come to
order. Welcome to today's hearing entitled ``Fixing EPA's
Broken Integrated Risk Information System.''
A little more than a year ago Susan Dudley, then the head
of the Office of Information Regulatory Affairs at OMB, OIRA,
and Dr. George Gray, then the head of the Office of Research
and Development at EPA, testified before this subcommittee. The
hearing was to examine the stunning lack of productivity in a--
in new and revised risk assessments for chemicals in the EPA's
Integrated Risk Information System, IRIS.
Dudley and Gray testified that the productivity was a
complicated approval process for assessments which this
flowchart produced by EPA, Mr. Whittaker, illustrated. This is
the complicated process that they needed to fix.
So they testified that they had solved the problem by
developing a streamlined approval process which this flowchart,
also produced by EPA, illustrates.
Again, Mr. Whittaker, if you could show the complicated
system, chart one, okay, and then the simplified system, chart
two.
Gray's and Dudley's testimony reminded me of a famous
quotation from Marx--not Karl, Chico. ``Well, who are you going
to believe? Me or your own eyes?'' Gray's and Dudley's
testimony strained credulity in other ways. Dudley explicitly
denied in her testimony that OIRA, the office that she headed,
ever challenged scientific assessments by EPA scientists.
Scientific assessment of a toxic effect of chemical exposure
would not even remotely be OIRA's job. Our staff today released
a report on IRIS that shows that OIRA did just that on several
occasions, enough to conclude that intruding on scientific
assessments was routine for OIRA. Dudley testified that the
streamlined process, that was chart two, for approving IRIS
listings was entirely EPA's handiwork. Our staff's report shows
that the process was a result of a multi-year, interagency
process that was driven by OIRA, not by EPA.
OIRA's conduct in requiring a perpetual paralysis in
approval procedures and intruding on the independence of EPA's
scientists appears to have been intended to keep IRIS from
doing its job and to keep us all in the dark about the public
health consequences of chemical exposures. It certainly had
that effect. While 70 chemicals were in some stage of review by
EPA, EPA averages three new and revised IRIS entries a year.
The new EPA Administrator, Lisa Jackson, announced a new
process on May 21, 2009. This chart illustrates the new
process.
If we are to believe our own eyes, the new process is
substantially streamlined.
Just as important, discussions between Federal Government
agencies about IRIS listings will be transparent. There is no
excuse for keeping interagency discussions secret from Congress
and from the American people. We are entitled--I am speaking as
a Member of Congress and as one of the American people, we are
entitled to know the potential health effects of chemical
exposures even if various government agencies find the
chemicals very useful.
And no agency can trigger an even more tortured approval
process by declaring that a chemical is ``mission critical.''
Under strict rules of grammar the word ``perpetual'' is like
the word ``naked'' or ``nude.'' Neither allows for degrees, but
the IRIS approval process devised by Dudley's OIRA was
perpetual for all chemicals and more perpetual for ``mission
critical'' chemicals.
We are interested in hearing today about EPA's new
procedures, and there should be little doubt that the
procedures are an improvement, but we need to see how the
procedures work in practice to know whether the procedures are
enough of an improvement. The institutional interests and
ambitions of federal agencies survive presidential transitions.
There will still be agencies that want to use chemicals without
annoying restrictions and may try to avoid risk management
issues by obstructing the risk assessment of an IRIS listing.
And it is human nature to forsake power reluctantly, even the
unwholesome, even sinister power that OIRA exercised over EPA's
scientific assessments.
The American people need and deserve credible,
scientifically-sound assessments of the health effects of
chemical exposures. That means EPA must be in charge, not OIRA.
The Subcommittee will continue to work to follow the work
of IRIS, and I have written the GAO to ask that they closely
monitor the new IRIS process as well. And I have now included
both our staff report on IRIS as well as a new report from the
Center for Progressive Reform with my statement for the record.
[See Appendix: Additional Material for the Record.]
I now recognize my distinguished colleague, Dr. Broun, for
his opening statement.
[The prepared statement of Chair Miller follows:]
Prepared Statement of Chair Brad Miller
A little more than a year ago, Susan Dudley, then the head of the
Office of Information and Regulatory Affairs in OMB, and Dr. George
Gray, then the head of the Office of Research and Development at EPA,
testified before this subcommittee.
The hearing was to examine the stunning lack of productivity in new
and revised risk assessments for chemicals in the EPA's Integrated Risk
Information System (IRIS).
Dudley and Gray testified that the productivity problem was a
complicated approval process for assessments, which this flow chart
produced by EPA illustrated.
But Gray and Dudley said they had solved the problem by developing
a streamlined approval process, which this flow chart, also produced by
EPA, illustrated.
Gray's and Dudley's testimony reminded me of a famous quotation
from Marx--not Karl, but Chico: ``Well, who you gonna believe, me or
your own eyes?''
Gray's and Dudley's testimony strained credulity in other ways.
Dudley explicitly denied in her testimony that OIRA, the office
that she headed, ever challenged scientific assessments by EPA's
scientists. Scientific assessment of the toxic effect of chemical
exposure would not even remotely be OIRA's job. Our staff today
released a report on IRIS that shows that OIRA did just that on several
occasions, enough to conclude that intruding on scientific assessments
was routine for OIRA. Dudley testified that the ``streamlined'' process
for approving IRIS listings was entirely EPA's handiwork. Our staff's
report shows that the process was the result of a multi-year,
interagency process driven by OIRA, not EPA.
OIRA's conduct in requiring a perpetual paralysis in approval
procedures and intruding on the independence of EPA's scientists
appears to have been intended to keep IRIS from doing its job, and to
keep us all in the dark about the public health consequences of
chemical exposures. It certainly had that effect. While 70 chemicals
were in some stage of review by EPA, EPA averaged three new and revised
IRIS entries a year.
The new EPA Administrator, Lisa Jackson, announced a new process on
May 21, 2009. This chart illustrates the new process. If we are to
believe our own eyes, the new process is substantially streamlined.
Just as important, discussions between Federal Government agencies
about IRIS listings will be transparent. There is no excuse for keeping
interagency discussions secret from Congress and the American people.
We are entitled to know the potential health effects of chemical
exposures, even if various government agencies find the chemicals very
useful.
And no agency can trigger an even more tortured approval process by
declaring that a chemical is ``mission critical.'' Under strict rules
of grammar, the word ``perpetual'' is like the word ``naked'': neither
allows for degrees. But the IRIS approval process devised by Dudley's
OIRA was perpetual for all chemicals, and more perpetual for mission
critical chemicals.
We are interested in hearing today about EPA's new procedures, and
there should be little doubt that the procedures are an improvement.
But we will need to see how the procedures work in practice to know
whether the procedures are enough of an improvement. The institutional
interests and ambitions of federal agencies survive presidential
transitions. There will still be agencies that want to use chemicals
without annoying restrictions, and may try to avoid risk management
issues by obstructing the risk assessment of an IRIS listing. And it is
human nature to forsake power reluctantly, even the unwholesome, even
sinister power that OIRA exercised over EPA's scientific assessments.
The American people need and deserve credible, scientifically sound
assessments of the health effect of chemical exposures. That means the
EPA must be in charge, not OIRA.
This subcommittee will continue to follow the work of IRIS, and I
have written the GAO to ask that they closely monitor the new IRIS
process as well.
Mr. Broun. Thank you, Mr. Chair.
The Integrated Risk Information System (IRIS) process was
originally developed in the mid 1980's for a specific task.
Different offices throughout the EPA were relying on different
assessments of the health effects of exposure to chemicals.
IRIS was intended to establish a uniform database within
EPA to--that represented a consensus determination. Over time,
however, IRIS became an authoritative resource on chemical
toxicity. As a credit to the agency's diligence, other
agencies, states, and the international community and
industries increasingly began to rely on IRIS, and 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.
As we learned from GAO last year, EPA had a backlog of 70
ongoing assessments and managed to complete only two
assessments in each of the last two years. Even when EPA
managed to produce assessments, the National Academy of
Sciences has roundly criticized their work. The competing
priorities of issuing assessments in a timely manner and
producing assessments that are scientifically credible are
central to the problems we face today.
The completely unsatisfactory timeframes for these
assessments are the results of several factors. Reviews are
becoming more complex as attention increases for high-profile
chemicals. EPA management and program decisions are delaying
completion. Outside stakeholder reviews are becoming more
detailed, and Congressional action is becoming more prevalent.
All of these delays have compounded effects and create a
domino effect on schedules as Mr. Stephenson pointed out in
previous testimony. Until recently the IRIS process was an
opaque process that had no schedule deadlines and limited
outside review. While the previous Administration's proposed
process wasn't perfect, it was the first time that the process
was formalized, thoroughly examined, and given strict
timelines. If nothing else, the previous Administration
recognized the untenable nature of the existing IRIS process
and presented a proposal to fix the problem.
While the previous process wasn't perfect, neither is this
new process. Previous processes required EPA to develop a
consensus assessment, the original purpose of the IRIS process.
The newly-proposed process does not require each EPA office to
concur on assessments but rather to simply consult.
Furthermore, these internal agency consultations are not
required to be available to the public, which ultimately limits
transparency. EPA's failure to develop consistent assessments
raises the questions of how authoritative and useful IRIS will
be in the future.
One of the assessed arguments for the new proposal is its
new streamlined process. As I mentioned earlier, the natural
tension between fairness and timeliness begs the question of
whether a streamlined process will ultimately sacrifice
scientific credibility, especially considering recent negative
reviews from the National Academy of Sciences. In order to
streamline the process, the new Administration has cut out
quality control measures such as visibility and the
adjudication of peer review comments, the requirement for a
qualitative assessment review, the public review of that
qualitative assessment, the evaluation of agency interest in
closing data gaps for mission-critical chemicals, design and
implementation of new studies for mission-critical chemicals,
and the development of short-term research projects that may
aid in filling data gaps.
More importantly, this new streamlined process uses a bit
of slight of hand to take the scientific literature review and
data culling periods off the schedule entirely. This work will
still be done, but EPA doesn't account for this time in its
schedule, allowing them to create the appearance of a speedier
process.
One of the largest criticisms of the previous proposal was
the role played by the White House and more importantly OMB and
Office of Regulatory Information and Affairs. Despite these
previous criticisms, the new process states that White House
offices will continue to be involved in the interagency
consultation process.
Apparently this was only a concern when it was politically
fashionable. If anyone had a problem with the previous
Administration's meddling, you can probably expect more of the
same since OIRA is staffed almost exclusively by career civil
servants.
Somebody tried to dismiss this concern by noting that EPA
is not ultimately responsible for the process but they always
had final authority. Even under the previous process it could
be claimed that even with that previous authority, EPA was
still subordinate to the influence of OMB.
Similarly, one could argue that EPA will truly have final
authority under the new process, but ultimately the EPA
Administrator still works for the President. The only
difference is that now maybe the Administrator also works for
the new environment czar, Carol Browner. We aren't really sure
about this since she is removed from any type of Congressional
oversight, transparency or accountability.
I hope that science's rightful place doesn't turn out to be
behind the cloak of deliberative process and executive
communication.
Despite concerns about White House meddling, OMB has
provided useful input into EPA assessments according to GAO's
2008 report. While OMB should certainly not use this review
process to obstruct or prevent assessments, EPA also shouldn't
be afraid to address valid scientific inquiries.
Additionally, OMB plays an important role in shepherding
the interagency process. Without OMB taking the lead in this
process, it remains to be seen if EPA will have enough clout to
force or compel other agencies to comply with its timelines and
directions.
This also raises another question relating to who will
ultimately be the adjudicator of conflicts, an arbiter of
scientific disputes. In an ideal world neither the White House
nor EPA would be involved in this as it is truly a discussion
meant for the scientific community.
Unfortunately, in the real world there needs to be a
bureaucratic referee. Is EPA truly an unbiased partner when
they are the agency that drafts the assessments? What incentive
does EPA have to incorporate peer review as comments that may
contradict their opinions? Are we setting up a system when EPA
will be responsible for monitoring its own work?
Even if EPA is unbiased or the Office of Research and
Development's staff tasks to conduct these assessment experts
on every chemical are aware of all the science? If the answer
is no, then aren't we essentially making pure but poorly
informed assessments? If none of these questions matter because
assessments go through peer review, why would it matter if
other agencies, industry or the White House, were involved
since the final product will be peer reviewed?
As you can tell, I remain very skeptical of the new
process, but I do see some commendable aspects. New
transparency measures for the interagency review process are
promising, even though they don't extend into internal
communication between EPA line offices, which could prove to be
just as informative and important.
Despite this potential bright spot, several other questions
remain.
With that, Mr. Chair, I am attaching a letter from
Toxicology Excellence for Risk Assessment to my statement that
I will enter in the record, and I appreciate your indulgence
and look forward to the witnesses' testimony.
[The prepared statement of Mr. Broun follows:]
Prepared Statement of Representative Paul C. Broun
The Integrated Risk Information System (IRIS) process was
originally developed in the mid-1980's for a specific task. Different
offices throughout the Environmental Protection Agency (EPA) were
relying on different assessments of the health effects of exposure to
chemicals. IRIS was intended to establish a uniform database within EPA
that represented consensus determinations.
Over time, however, IRIS became an authoritative resource on
chemical toxicity. As a credit to the agency's diligence, 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.
As we learned from GAO last year, EPA had a backlog of 70 ongoing
assessments and managed to complete only two assessments in each of the
last two years. Even when EPA managed to produce assessments, the
National Academy of Sciences has roundly criticized their work. The
competing priorities of issuing assessments in a timely manner and
producing assessments that are scientifically credible are central to
the problems we face today.
The completely unsatisfactory timeframes for these assessments are
the result of several factors. Reviews are becoming more complex as
attention increases for high profile chemicals, EPA management and
program decisions are delaying completion, outside stakeholder reviews
are becoming more detailed, and Congressional action is becoming more
prevalent. All of these delays have compounding effects and create a
``domino effect'' on schedules as Mr. Stephenson pointed out in
previous testimony.
Until recently, the IRIS process was an opaque process that had no
schedule deadlines and limited outside review. While the previous
Administration's proposed process wasn't perfect, it was the first time
that the process was formalized, thoroughly explained, and given strict
timelines. If nothing else, the previous Administration recognized the
untenable nature of the existing IRIS process and presented a proposal
to fix the problem.
While the previous process wasn't perfect, neither is this the new
process. Previous processes required EPA to develop a consensus
assessment - the original purpose of the IRIS process. The newly
proposed process does not require each EPA office to concur on
assessments. but rather to simply consult. Furthermore, these internal
agency consultations are not required to be available to the public,
which ultimately limits transparency. EPA's failure to develop
consensus assessments raises the question of how ?authoritative and
useful IRIS will be in the future.
One of the arguments for the new proposal is its new streamlined
process. As I mentioned earlier, the natural tension between
thoroughness and timeliness begs the question of whether a streamlined
process will ultimately sacrifice scientific credibility. especially
considering recent negative reviews from the National Academy of
Sciences. In order to streamline the process, the new Administration
has cut out quality control measures such as visibility into the
adjudication of peer review comments; the requirement for a qualitative
assessment review: the public review of that qualitative assessment:
the evaluation of agency interests in closing data gaps for mission
critical chemicals. the design and implementation of new studies for
mission critical chemicals, and the development of short-term research
projects that may aid in filling data gaps. More importantly, this new
streamlined process uses a bit of slight-of-hand to take the scientific
literature review and data call-in periods off the schedule entirely.
This work will still be done, but EPA doesn't account for this time in
its schedule, allowing them to create the appearance of a speedier
process.
One of the largest criticisms of the previous proposal was the role
played by the White House, and more importantly the Office of
Management and Budget (OMB) and the Office of Regulatory Information
and Affairs (OIRA). Despite these previous criticisms, the new process
states that White House offices will continue to be involved in the
interagency consultation process. Apparently this was only a concern
when it was politically fashionable. If anyone had a problem with the
previous Administration's ``meddling,'' you can probably expect more of
the same since OIRA is staffed almost exclusively by career civil
servants.
Some may try to dismiss this concern by noting that EPA is now
ultimately responsible for the process, but they always had final
authority, even under the previous process. It could be claimed that
even with that previous authority, EPA was still subordinate to the
influence of OMB. Similarly, one could argue that EPA will truly have
final authority under the new process, but the ultimately the EPA
Administrator still worked for the President. The only difference is
that now maybe the Administrator also works for the new Environment
Czar Carol Browner. We aren't really sure about this since she is
removed from any type of Congressional oversight, transparency, or
accountability. I hope that science's ``rightful place'' doesn't turn
out to be behind the cloak of deliberative process and executive
communication.
Despite concerns about White House meddling, OMB has provided
useful input into EPA assessments according to GAO's 2008 report. While
OMB should certainly not use this review process to obstruct or prevent
assessments, EPA also shouldn't be afraid to address valid scientific
inquiries. Additionally, OMB plays an important role in shepherding the
interagency process. Without OMB taking the lead in this process, it
remains to be seen if EPA will have enough clout to force or compel
other agencies to comply with its timelines and directions.
This also raises another question relating to who will ultimately
be the adjudicator of conflicts and arbiter of scientific disputes. In
an ideal world, neither the White House nor EPA would be involved in
this, as it truly is a discussion meant for the scientific community.
Unfortunately in the real world there needs to be a bureaucratic
referee. Is EPA truly an unbiased partner when they are the agency that
drafts the assessments? What incentive does EPA have to incorporate
peer reviewer's comments that may contradict their opinions? Are we
setting up a system where EPA will be responsible for monitoring its
own work? Even if EPA is unbiased, are the Office of Research and
Development (ORD) staff tasked to conduct these assessments experts on
every chemical and aware of all the science? If the answer is no, then
aren't we essentially making pure, but poorly informed assessments? If
none of these questions matter because assessments go through peer
review, why would it matter if other agencies, industry, or the White
House were involved since the final product will be peer reviewed?
As you can tell, I remain very skeptical of the new process but I
do see some commendable aspects. New transparency measures for the
interagency review process are promising even though they don't extend
to internal communications between EPA line offices which could prove
to be just as informative and important. Despite this potential bright-
spot, several other questions remain.
With that, Mr. Chairman, I am attaching a letter from Toxicology
Excellence for Risk Assessment (TERA) to my statement that I will enter
into the record. I appreciate your indulgence and look forward to the
witnesses' testimony.
[The information follows:]
Chair Miller. Thank you, Dr. Broun.
I ask unanimous consent that all additional opening
statements submitted by Members be included in the record.
Without objection, so ordered.
It is my pleasure now to introduce our witnesses. Dr. Kevin
Teichman is the Deputy Assistant Administrator for Science in
the Office of Research and Development at EPA, and Mr. John
Stephenson is back. He is the Director of Natural Resources and
Environment at the Government Accountability Office.
As our witnesses should know, you will each have five
minutes for your spoken testimony. Your written testimony will
be included in the record. When you all have completed your
spoken testimony, we will begin with questions. Each Member
will have five minutes to question the panel.
It is the practice of this subcommittee to receive
testimony under oath, although we have not made it our habit to
refer cases for perjury prosecution, which I am sure is a great
relief to Dr. Gray and Ms. Dudley. You also have the right to
be represented by counsel. Do any of you have any objection to
taking an oath?
Both witnesses indicated that they did not. You also have
the right to be represented by counsel. Do either of you have a
counsel here? Counsel with you?
Also, I understand that you may have--although both of you,
I know, have encyclopedic knowledge of this topic, you may have
other staff with you who may need to--who might need to help
with an answer. Would it be helpful if anybody else from your
staffs who might need to help you with an answer also take the
oath at the same time?
Okay. All right. Please stand and raise your right hand. Do
you swear to tell the truth and nothing but the truth?
The record will show that both witnesses have taken the
oath.
We will now begin with Dr. Kevin Teichman. Dr. Teichman,
please begin.
STATEMENT OF DR. KEVIN TEICHMAN, DEPUTY ASSISTANT ADMINISTRATOR
FOR SCIENCE, OFFICE OF RESEARCH AND DEVELOPMENT (ORD), U.S.
ENVIRONMENTAL PROTECTION AGENCY (EPA)
Dr. Teichman. Good afternoon, Mr. Chair and Members of the
Subcommittee. I am Dr. Kevin Teichman, the Deputy Assistant
Administrator for Science in EPA's Office of Research and
Development. I am also the Acting EPA Science Advisor, and in
this role I serve as a member of the Office of Science and
Technology Policy's Task Force on Scientific Integrity. I
appreciate this opportunity to discuss with you EPA's
Integrated Risk Information System, IRIS.
Before I begin I would like to thank Congressman Miller and
the Subcommittee for your support of the IRIS Program. The
importance of a successful IRIS Program to the health of the
American people was acknowledged by this subcommittee in two
past hearings and by Chair Miller's previous introduction of
legislation on this topic. Your continued interest in the
future of the IRIS Program is greatly appreciated.
IRIS is one of EPA's most important and most public
products. IRIS has been a highly-regarded resource for
providing information on the potential human health risks from
long-term exposures to contaminants. IRIS assessments are used
by EPA programs and regions as the scientific foundation for
Agency actions to protect human health.
IRIS assessments are also used by environmental and health
professionals and State and local governments, as well as
internationally. Because of the widespread use of IRIS risk
information, it is of utmost importance that the process used
to develop this information, and the resulting assessments
posted on IRIS, reflect the highest possible standards for
scientific quality, scientific integrity, transparency, and
timeliness.
Administrator Jackson, coming from careers at both EPA and
the New Jersey Department of Environmental Protection,
recognizes the critical role that EPA plays in disseminating
timely, high quality, and accessible human risk information on
environmental contaminants. Just four months after coming to
EPA she announced a new IRIS process that is more responsive to
the needs of the Agency and its work to effectively and
efficiently protect the health of all Americans.
The new IRIS process is more timely, transparent, and will
ensure the highest level of scientific integrity. It will rely
on an opportunity for public review and comment followed by a
rigorous, open, and independent external peer review process to
guarantee the scientific quality of the IRIS assessments.
There are several aspects of the new process that I would
like to highlight. First, the new IRIS process will be entirely
managed by EPA. Second, there is no longer an opportunity for
another federal agency to prolong the process by asking that
additional research be conducted before an assessment can be
produced.
Instead, EPA will announce the chemicals that will be
assessed far enough in advance so that any interested party
could conduct short-term studies that could add to the peer-
reviewed scientific literature.
Third, all written comments from other federal agencies and
White House offices will become part of the public record.
Opportunities for scientific comment by other federal agencies
and White House offices was maintained in the new process,
because EPA welcomes input from interested experts that may add
to the scientific quality of the draft or final assessment.
Also, the assessment process has been streamlined to ensure
that more new and updated assessments are included on IRIS.
While still robust, the assessment development process for most
chemicals will be shortened to 23 months, speeding the
availability of IRIS assessments.
There are two steps introduced in the previous process that
were retained in the new process. First, the opportunity for
any interested party to provide information to EPA prior to the
external peer review meeting. These listening sessions allow
interested parties to present scientific comments on draft IRIS
assessments during the public comment period and before the
external peer review period. EPA has found the listening
sessions to be a valuable step in public outreach and
participation.
Second, changes in EPA's scientific judgments from public
comments and peer review will be clearly documented and
explained, maximizing the transparency of the final product.
Finally, to give this new process an added boost, the
Administrator has directed that for fiscal year 2010, resources
for the IRIS program should be increased, and the President's
budget request includes an additional $5 million and ten FTEs
full-time equivalents, for the IRIS program.
In conclusion, EPA remains dedicated to listening and being
responsive to the public, to independent experts, and to
scientists and other federal science agencies as it develops
IRIS human health assessments. The ability of EPA's program to
succeed has been significantly improved now that some steps
have been removed or revised. EPA is confident that we can
continue to provide the critical human health risk information
to EPA's programs and regions that ensure the Agency's actions
protect the public health.
Thank you very much, and I am happy to answer any questions
that you may have.
[The prepared statement of Dr. Teichman follows:]
Prepared Statement of Kevin Teichman
Good afternoon, Mr. Chairman and Members of the Subcommittee. I am
Dr. Kevin Teichman, the Deputy Assistant Administrator for Science in
EPA's Office of Research and Development. I am also the Acting EPA
Science Adviser, and in this role I serve as a member of the Office of
Science and Technology Policy's (OSTP's) Task Force on Scientific
Integrity. I appreciate this opportunity to appear at this hearing and
discuss with you EPA's Integrated Risk Information System (IRIS). In
this written testimony, I will include a brief description of the
recent history of the IRIS program as well as discuss some of the
highlights of the new IRIS process that was announced by EPA
Administrator Lisa P. Jackson on May 21, 2009.
Before I begin, I would like to thank Congressman Miller and this
Subcommittee on behalf of EPA, and personally, for support of the IRIS
program. The importance of a functioning and successful IRIS program to
the health of the American people was acknowledged by this subcommittee
in two past hearings and by Chairman Miller's introduction of H.R.
7234, the Integrated Risk Information System Authorization Act. Since
the purpose of IRIS is to provide timely, high quality, and accessible
human health risk information on environmental contaminants that may
endanger the health of the American public, your continued interest in
the future of the IRIS program is greatly appreciated.
IRIS is one of EPA's most successful and most public products. IRIS
has been a highly regarded resource for providing information on the
potential human health risks from long-term exposure to various
contaminants. The IRIS assessments used by EPA's Program Offices and
Regions are the science foundation for Agency actions to protect human
health. IRIS assessments are also used by risk assessors and
environmental and health professionals in State and local governments,
as well as internationally. Because of the widespread recognition and
use of IRIS risk information, it is of utmost importance that the
process used to develop this information, and the resulting assessments
posted on IRIS, reflect the highest possible standards for scientific
quality and integrity, transparency, and timeliness.
On April 10, 2008, a new IRIS process was created via a memorandum
from former Deputy Administrator Marcus Peacock that codified the IRIS
process. This process introduced additional, time-consuming steps, some
of which were not transparent to the public.
On January 26, 2009, Lisa P. Jackson was sworn in as EPA's 11th
Administrator. On January 23, 2009, Administrator-Designee Jackson
wrote to all EPA staff that, ``As Administrator, I will ensure EPA's
efforts to address the environmental crises of today are rooted in
three fundamental values: science-based policies and programs,
adherence to the rule of law, and overwhelming transparency. By keeping
faith with these values and unleashing innovative, forward-thinking
approaches--we can further protect neighborhoods and communities
throughout the country.'' Coming from careers at both EPA and the New
Jersey Department of Environmental Protection, Administrator Jackson
recognized the critical role that EPA plays in disseminating timely,
high quality, and accessible human health risk information on
environmental contaminants. Thus, one of her highest priorities was to
take the necessary steps to strengthen and revitalize the process by
which EPA develops and disseminates human health risk information.
On May 21, 2009, just four months after coming to EPA,
Administrator Jackson announced a new IRIS process that is more
responsive to the needs of the Agency in its work to effectively and
efficiently protect the health of all Americans. The new IRIS
assessment development process, which was implemented immediately, is
more streamlined, transparent, and timely, and will ensure the highest
level of scientific integrity. It will rely primarily on an opportunity
for public review and comment followed by a rigorous, open, and
independent external peer review process to guarantee the scientific
quality of the IRIS assessments.
There are several aspects of the new process that I would like to
highlight. The first is that the new IRIS process will be entirely
managed by EPA. Second, there is no longer an opportunity for another
federal agency to prolong the assessment process by asking that
additional research be conducted before an assessment can proceed.
Instead, EPA will announce the chemicals that will be assessed far
enough in advance so that any interested party could conduct short-term
studies that could add to the peer-reviewed scientific literature for
that chemical. Third, all scientific comments from other federal
agencies and White House offices will become part of the public record
for that chemical assessment. Opportunities for scientific comment by
other federal agencies and White House offices was maintained in the
new process, because EPA welcomes input from interested experts that
may add to the science quality of the draft or final assessment.
Finally, the assessment process has been streamlined to ensure that
more new and updated assessments are included on IRIS. While still
robust, the assessment development process for most chemicals will be
shortened to 23 months, speeding the availability of IRIS assessments
to the human health risk assessor community and the public.
There are two aspects that were retained in the new process. First,
is the opportunity for any interested party to provide information to
EPA prior to the external peer review meeting. These listening
sessions, announced in the Federal Register, allow all interested
parties to present scientific and technical comments on draft IRIS
health assessments to EPA and other interested parties during the
public comment period and before the external peer review meeting. EPA
has found the listening sessions to be a valuable step in public
outreach and participation. The listening session comments are
considered by the Agency as it revises the draft assessment in response
to the independent external peer review and public comments. As with
scientific comments from other federal agencies, listening session
comments become part of the public record. Second, changes in EPA's
scientific judgments from public comments and peer review will be
clearly documented and explained, maximizing the transparency of the
final product.
Finally, to give this new process an added boost, the Administrator
has directed that for fiscal year 2010, resources for the IRIS program
should be increased, and the President's budget request includes an
additional $5 million and 10 FTEs for the IRIS program.
EPA remains dedicated to listening and being responsive to the
public, to independent experts, and to scientists in other federal
science agencies as it develops IRIS human health assessments. The
ability of EPA's IRIS program to succeed has been significantly
improved now that some steps have been removed or revised. EPA is
confident that we can continue to provide the critical human health
risk information to EPA's Programs and Regions that ensure the Agency's
actions protect the public health.
Thank you for the opportunity to discuss with you EPA's new and
improved IRIS program. I am happy to answer any questions that you may
have.
Biography for Kevin Teichman
Dr. Kevin Teichman is the Deputy Assistant Administrator for
Science in the Office of Research and Development (ORD); he is also the
Acting Science Advisor for the Agency. He previously served as the
Director of the Office of Science Policy (OSP) within ORD. In this
capacity, he coordinated ORD participation in EPA's policy-making in
all media (air, water, waste, pesticides and toxic substances) to
ensure these policies reflected sound science. In addition, he helped
lead the planning of EPA's research program, striving to ensure the
research program responded to the needs of EPA's Program and Regional
Offices and maintained its leadership role in the environmental
research community.
During the enactment of the Clean Air Act Amendments of 1990, Dr.
Teichman served as the Associate Director of Science in OSP, and OSP
Staff Director of the Air Staff prior to that, with similar
responsibilities to those above but limited to air pollution. In
addition, he managed EPA's indoor air quality research program,
including research devoted to characterizing indoor pollutants sources,
assessing indoor exposures, studying associated health effects,
assessing potential risks, and developing prevention/mitigation
approaches to indoor air pollution.
Dr. Teichman has B.S. and M.S. degrees from the Massachusetts
Institute of Technology and a Ph.D. degree from the University of
California at Berkeley, all in Mechanical Engineering. He lives in
Derwood, Maryland where he and his wife Marsha are proud ``empty
nesters.''
Chair Miller. Thank you, Dr. Teichman.
Mr. Stephenson is recognized for five minutes.
STATEMENT OF MR. JOHN B. STEPHENSON, DIRECTOR, NATURAL
RESOURCES AND ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY
OFFICE
Mr. Stephenson. Thank you, Mr. Chair. I am pleased to be
here today to discuss our prior findings and recommendations on
EPA's IRIS program as well as the results of our preliminary
review of EPA's most recently announced IRIS reforms announced
on May 21, 2009.
As you know, the IRIS database contains EPA's scientific
position on the potential human health effects of exposure to
more than 540 chemicals in the environment. It is the critical
component of EPA's capacity to support scientifically-sound
risk management decisions, policies, and regulations.
In March 2008, we reported that the IRIS program was at
serious risk of becoming obsolete because the Agency had not
been able to complete timely, credible chemical assessments or
decrease its backlog of 70 ongoing assessments. EPA completed
only five assessments last year and has only completed one
assessment so far this year.
We also found that the timeframes for completing
assessments were unacceptably long, often taking over a decade.
In many cases assessments became obsolete before they could be
finalized and were stuck in an endless loop of assessment and
reassessment.
In April 2008, EPA unveiled a revised process, and we were
disappointed to find out that it was not responsive to our
recommendations and was actually worse than the process that it
replaced, institutionalizing a process that would take six to
eight years at best to complete, enabling federal agencies to
delay ongoing assessments by requesting additional research and
declaring comments from other agencies deliberative and
excluded from the public record.
As we testified before this subcommittee last year, we were
extremely concerned about the consequences of these problems
because IRIS assessments are, after all, the cornerstone of
scientific integrity at the Agency. In fact, we added EPA's
toxic chemical assessment and control processes to our January
2009 report on government-wide, high-risk areas in need of
increased attention by executive agencies and the Congress, a
GAO designation reserved for only the most serious Federal
Government problems.
Today I am pleased to report that while it is too soon to
offer a blanket endorsement, the new IRIS process introduced by
EPA on May 21 of this year appears to be a giant step in the
right direction. In particular we believe that the new IRIS
process, if managed effectively, will be largely responsive to
the recommendations we made in our March 2008 report.
First the process will be managed by EPA rather than OMB as
the former process was. Second, it addresses key transparency
concerns by expressly requiring that all written comments
provided by other federal agencies on draft IRIS assessments be
part of the public record. Third, the new process streamlines
the previous one by consolidating and eliminating some steps
and committing to a two-year completion timeframe. Importantly,
it eliminates the step under which other federal agencies could
have IRIS assessments suspended indefinitely to conduct
additional research. We also believe that the requested
increase of $5 million and ten additional staff positions will
help ensure that more resources are allocated to the IRIS
program to meet user needs.
While these changes reflect a significant improvement that
can help EPA restore the integrity and productivity of the
program, we offer the following observations for EPA to
consider as it implements the new process.
First, there are no timeframes stated for the literature
search and data call in kind of the pre-Step 1. This tends to
understate the 23-month timeframe for completing assessments.
Second, it is not clear what purpose--what the purpose of
the interagency consultation meetings is, which is Step 3 and
Step 6B on the new process, what the role of OMB and other
White House offices are exactly, and whether decisions will be
documented in the public from decisions coming out of those
steps.
Third, it seems to us that comments from the federal
agencies, which is Step 3, could be solicited at the same time
draft assessments are sent to independent peer reviewers and
the public, which is Step 4, and saving additional time in the
process.
Fourth, it is not clear how EPA plans to respond to our
March 2008 report recommendation to provide at least a two-year
notice of planned assessments. The new process does not
specifically address such important planning steps as the call
for nominations of chemicals to be assessed and the
establishment of an IRIS agenda.
We believe that giving agencies and the public more
advanced notice to plan assessments would enable external
parties with an interest in a given chemical to complete
relevant research before the start of an IRIS assessment, and
thus, make the assessment even more efficient.
Finally, unlike a number of other EPA programs with
statutory deadlines for completing various activities, no
enforceable deadlines apply to the IRIS program. We believe
that legislating statutory deadlines could help EPA better
ensure the viability of this critical program.
Mr. Chair, that concludes the summary of my statement, and
I will be happy to answer 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 our prior findings and
recommendations on the Environmental Protection Agency's (EPA)
Integrated Risk Information System (IRIS) program as well as the
results of our preliminary review of EPA's most recent IRIS reforms,
announced on May 21, 2009. As you know, IRIS is one of the most
significant tools that EPA has developed to effectively support its
mission to protect people and the environment from harmful chemical
exposures. The IRIS database contains EPA's scientific position on the
potential human health effects of exposure to more than 540 chemicals
in the environment and is, therefore, a critical component of EPA's
capacity to support scientifically sound risk management decisions,
policies, and regulations.
In a March 2008 report, we identified significant deficiencies in
EPA's IRIS assessment process that threatened the viability of the
program, and we made a number of recommendations to correct them.\1\ In
response, EPA issued a revised assessment process in April 2008 that
did not respond to our recommendations but rather made changes likely
to further exacerbate the problems we had identified. Largely as a
result of the agency's lack of responsiveness, we added transforming
EPA's processes for assessing and controlling toxic chemicals as a
high-risk area in our January 2009 biennial status report on
government-wide high-risk areas requiring increased attention by
executive agencies and Congress.\2\ In announcing new reforms to the
IRIS assessment process on May 21, 2009, EPA echoed our findings--that
the April 2008 assessment changes reduced the transparency, timeliness,
and scientific integrity of the IRIS process--and highlighted both our
high-risk designation of this important EPA program and the President's
recent emphasis on the importance of transparency and scientific
integrity in government decision-making.
---------------------------------------------------------------------------
\1\ GAO, Chemical Assessments: Low Productivity and New Interagency
Review Process Limit the Usefulness and Credibility of EPA's Integrated
Risk Information System, GAO-08-440 (Washington, D.C.: Mar. 7, 2008).
\2\ GAO, High-Risk Series: An Update, GAO-09-271 (Washington, D.C.:
January 2009).
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In this context, my testimony today discusses (1) the findings from
our 2008 report and testimonies on the prior IRIS assessment
processes\3\ and (2) our preliminary evaluation of EPA's May 2009
process reforms. For this statement, we have supplemented our prior
work with a preliminary review of the EPA process reforms and some IRIS
productivity data. We conducted our work from May 28 to June 11, 2009,
in accordance with generally accepted government auditing standards.
Those standards require that we plan and perform our work 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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\3\ See the Related GAO Products section later in this statement.
The Viability of the IRIS Program Is at Risk
In March 2008, we reported that the IRIS program is at serious risk
of becoming obsolete because the agency has not been able to complete
timely, credible chemical assessments or decrease its backlog of 70
ongoing assessments. In addition, assessment process changes EPA had
recently made, as well as other changes EPA was considering at the time
of our review, would have further reduced the timeliness, credibility,
and transparency of IRIS assessments. Among other things, we concluded
the following:
EPA was unable to routinely complete IRIS assessments
in a timely manner. From 2000 to 2007, EPA completed on average
about five IRIS assessments a year. The more recent trend has
been a decline in productivity: In fiscal years 2006 and 2007,
EPA completed two assessments each year; in 2008, EPA completed
five assessments--four of which were related chemicals assessed
and peer reviewed together but finalized individually; and thus
far in fiscal year 2009, EPA has finalized one assessment.
Further, as we reported in 2008, because EPA staff
time was 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 was
limited. We found that 48 of the 70 assessments being conducted
as of December 2007 had been in process for more than five
years--and 12 of those, for more than nine years. These time
frames have lengthened. Currently, of those 70 assessments, 58
have now been ongoing for more than five years--and 31 of those
for more than nine years.
We also found that EPA's efforts to finalize IRIS
assessments have been thwarted by a combination of factors.
These factors include (1) the Office of Management and Budget's
(OMB) requiring two additional reviews of IRIS assessments by
OMB and other federal agencies with an interest in the
assessments, such as the Department of Defense, and (2) EPA
management decisions, such as delaying some assessments to
await the results of new research.
The two new OMB/interagency reviews of draft
assessments involve other federal agencies in EPA's IRIS
assessment process in a manner that limits the credibility and
transparency of, and hinders EPA's ability to manage, IRIS
assessments. For example, some of these agencies' review
comments could be influenced by the potential for increased
environmental 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.
Moreover, the input these agencies provide to EPA is treated as
``deliberative'' and is not released to the public. Regarding
EPA's ability to manage its IRIS assessments, in 2007 OMB
required EPA to terminate five assessments that for the first
time addressed acute, rather than chronic, exposure--even
though EPA had initiated this type of assessment to help it
implement the Clean Air Act.
The changes to the IRIS assessment process that EPA
was considering but had not yet issued at the time of our 2008
review would have added to the already unacceptable level of
delays in completing IRIS assessments and further limited the
credibility of the assessments. For example, the changes would
have allowed potentially affected federal agencies to have
assessments suspended for up to 18 months to conduct additional
research. As we reported in 2008, even one delay can have a
domino effect, requiring the assessment process to essentially
be repeated to incorporate changing science.
In April 2008, EPA issued a revised IRIS assessment process.
As we testified before this subcommittee in May 2008, the new
process was largely the same as the draft we had evaluated
during our review and did not respond to the recommendations in
our March 2008 report. Moreover, some key changes were likely
to further exacerbate the credibility and productivity concerns
we had identified. For example, EPA's revised process formally
defined comments on IRIS assessments from OMB and other federal
agencies as ``deliberative'' and excluded them from the public
record. As we have stated, it is critical that input from all
parties--particularly agencies that may be directly affected by
the outcome of IRIS assessments--be publicly available. In
addition, the estimated time frames under the revised process,
especially for chemicals of key concern, would have likely
perpetuated the cycle of delays to which the majority of
ongoing assessments have been subject. Instead of streamlining
the process, as we had recommended, EPA institutionalized a
process that from the outset was estimated to take six to eight
years for some chemicals of key concern that are both
widespread and likely to cause cancer or other serious health
effects. This was particularly problematic because of the
substantial rework often required to take into account changing
science and methodologies.
EPA's Latest IRIS Process Reforms Appear Largely Responsive to Our
Recommendations, But Their Success Will Depend on
Effective Management
Overall, EPA's May 2009 IRIS assessment process reforms represent
significant improvements and, if implemented effectively, would be
largely responsive to the recommendations made in our March 2008
report.
First, the new process and the memorandum announcing
it indicate that the IRIS assessment process will be entirely
managed by EPA, including the interagency consultations
(formerly called OMB/interagency reviews). Under EPA's prior
process, these two interagency reviews were required and
managed by OMB--and EPA was not allowed to proceed with
assessments at various stages until OMB notified EPA that it
had sufficiently responded to comments from OMB and other
agencies. The independence restored to EPA under the new
process is critical in ensuring that EPA has the ability to
develop transparent, credible IRIS chemical assessments that
the agency and other IRIS users, such as State and local
environmental agencies, need to develop adequate protections
for human health and the environment.
Second, the new process addresses a key transparency
concern highlighted in our 2008 report and testimonies. As we
recommended, it expressly requires that all written comments on
draft IRIS assessments provided during the interagency
consultation process by other federal agencies and White House
offices be part of the public record.
Third, the new process streamlines the previous one
by consolidating and eliminating some steps. Importantly, EPA
eliminated the step under which other federal agencies could
have IRIS assessments suspended in order to conduct additional
research, thus returning to EPA's practice in the 1990s of
developing assessments on the basis of the best available
science. As we highlighted in our report, as a general rule,
requiring that IRIS assessments be based on the best science
available at the time of the assessment is a standard that best
supports the goal of completing assessments within reasonable
time periods and minimizing the need to conduct significant
levels of rework.\4\
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\4\ As also stated in our report, we understand that under
exceptional circumstances, it may be appropriate to wait for the
results of an important ongoing study, such as a major epidemiological
study that will provide new, critical data for an assessment.
Fourth, as outlined in the EPA Administrator's
memorandum announcing the new IRIS process, the President's
budget request for fiscal year 2010 includes an additional $5
million and 10 full-time-equivalent staff positions for the
IRIS program, which is responsive to our recommendation to
assess the level of resources that should be dedicated to the
IRIS program in order to meet user needs and maintain a viable
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IRIS database.
We are encouraged by the efforts EPA has made to adopt most of our
recommendations, including those addressing EPA's ability to manage its
IRIS assessment process, transparency practices, and streamlining the
lengthy IRIS assessment process. The changes outlined above reflect a
significant redirection of the IRIS process that, if implemented
effectively, can help EPA restore the credibility and increase the
productivity of this important program. While these broad reforms
provide a sound general framework for conducting IRIS assessments, the
manner in which EPA implements the new process will determine whether
the agency will be able to overcome its long-standing productivity
problems and complete credible and transparent assessments.
Specifically, management attention is warranted on certain aspects of
the new process that are incomplete or lack clarity.
EPA's estimated time frames of about two years for
standard IRIS assessments--those that are not particularly
complex or controversial--do not include the time required to
complete two steps that are nonetheless included in the
assessment process. As a result, EPA has likely understated the
time required to complete an assessment. The steps lacking
timeframes--the scientific literature review and the request to
the public and other agencies to submit relevant research (the
data call-in)--are integral to developing an assessment. In
prior IRIS assessment processes, EPA provided timeframes for
these steps. Importantly, including the time frames for these
steps would likely bring the estimated overall time for
completing standard assessments closer to three years. We note
that this more realistic timeframe may be problematic because
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.
While EPA states that some IRIS assessments may take
longer because of their complexity, large scientific literature
base, or high profile, the agency does not provide any guidance
on likely or expected time frames for assessments of these
chemicals. This is noteworthy because we found that EPA has not
been able to complete assessments of the most important
chemicals of concern, such as those likely to cause cancer or
other significant health effects. For example, EPA's assessment
of dioxin has been ongoing for 18 years. It is critical that
EPA establish timeframes to enable the agency to manage complex
assessments.
EPA's new process does not include a discussion of
key planning steps. Specifically, it omits important pre-
assessment steps included in prior processes--such as a call
for nominations of chemicals to be assessed and the
establishment of the IRIS agenda, which is list of chemicals
that EPA plans to assess. Accordingly, it is not clear whether
or when EPA will implement our recommendation that it provide
at least two years' notice of planned assessments. Among other
things, doing so would give agencies and the public more
advance notice of planned assessments and enable external
parties with an interest in a given chemical to, for example,
complete relevant research before the start of an IRIS
assessment.
Particularly in light of the fact that EPA's
estimates for completing assessments are likely understated, we
believe that the agency should continue to look for additional
opportunities to streamline its process. For example, it is not
clear why EPA could not solicit comments from other federal
agencies at the same time it sends the initial draft assessment
to independent peer reviewers and publishes it in the Federal
Register for public comment. In addition to reducing overall
assessment time frames, this change could enhance transparency.
Specifically, by obtaining the first draft of the assessment at
the same time as the other federal agencies, the public and
peer reviewers could have greater assurance that the draft had
not been inappropriately biased by policy considerations of
these agencies, including ones that may be affected by the
assessment's outcome, such as the Departments of Defense and
Energy. Some of these agencies and their contractors could, for
example, 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.
The new assessment process states that ``White House
offices'' will be involved in the interagency consultation
process but does not indicate which offices. Given that (1) EPA
will be performing the coordinating role that OMB exercised
under the prior process and (2) the purpose of these
consultations is to obtain scientific feedback, it is unclear
whether OMB will continue to be involved in the interagency
consultation process.
EPA has specified in its new assessment process that
written comments provided by other federal agencies will become
part of the public record. However, it is silent as to the
purpose of the consultation meetings and, if applicable,
whether EPA plans to document for the public record any
significant oral agreements or decisions made at the
consultation meetings. In order to ensure transparency and
alleviate any concerns of potential bias in the assessments, it
will be important for EPA to be clear on these matters.
In addition to addressing these issues, the viability of the IRIS
program will depend on effective and sustained management and
oversight. Collectively, a number of factors that can impede the
progress of IRIS assessments present significant management challenges.
These include the following:
Unlike a number of other EPA programs with statutory
deadlines for completing various activities, no enforceable
deadlines apply to the IRIS program. We have stated in previous
testimonies on the IRIS program that if EPA is not able to
effectively maintain this critical program, other approaches,
including statutory requirements, may need to be explored. We
believe the absence of statutory deadlines may contribute to
EPA's failure to complete timely IRIS assessments. For example,
assessment schedules can easily be extended--and consistently
are. These chronic delays in completing IRIS assessments have
detrimental consequences for EPA's ability to develop timely
and scientifically sound decisions, policies, and regulations.
Science and methodologies are constantly changing.
Thus, there will always be a tension between assessing the best
available science and waiting for more information. IRIS will
remain viable only if it returns to its model of using the best
science available at the time of its assessments and plans for
periodic updates of assessments to identify the need for
revisions.
An overarching factor that affects EPA's ability to
complete IRIS assessments in a timely manner is the compounding
effect of delays--even one delay can have a domino effect,
requiring the process to essentially be repeated to incorporate
changing science. For example, delays often require repeating
reviews of the scientific literature on a chemical to take into
account the time that has passed since the literature review
was completed; this, in turn, may require detailed analyses of
any new studies found to be relevant.
Long-standing difficulties in completing assessments
of chemicals of key concern--those that are both widespread and
likely to cause significant health issues--stem in part from
challenges by external parties, including those that may be
impacted by EPA regulation of chemicals should an assessment
lead to such action. Such challenges are to be expected and can
be best addressed by EPA's focusing on the best available
science, credible expert review, and completing the
assessments.
The IRIS assessment process has been frequently
changed in recent years; IRIS process reforms, such as those
recently issued, are not established in a regulation or statute
and thus can easily be altered. As we have reported, EPA's
continual changes present a challenge to the chemical managers
who are undertaking the assessments, particularly in the
absence of current operating procedures to guide chemical
managers on basic procedures and program management
responsibilities for the development, review, and finalization
of IRIS assessments.
In conclusion, EPA's most recent changes to the IRIS assessment
process appear to represent a significant improvement over the process
put in place in 2008. That is, if implemented effectively, the changes
may appropriately restore to EPA its control of the IRIS process,
increase the transparency of the process, and streamline aspects of the
process, among other things. We believe that the agency's ability to
produce timely, credible, and transparent assessments will also depend
in large measure on clear implementation procedures and rigorous
management oversight, given the numerous factors that can impede EPA's
ability to complete timely IRIS assessments and the lack of clarity on
some aspects of the new process. Perhaps most importantly, EPA needs to
hold itself more accountable to the public and Congress for carrying
out this important component of its mission, especially since the IRIS
program is discretionary.
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.
GAO Staff Acknowledgments
Contributors to this testimony include Christine Fishkin (Assistant
Director), Laura Gatz, Richard P. Johnson, Summer Lingard, Nancy
Crothers, Antoinette Capaccio, and Carol Kolarik.
Related GAO Products
Scientific Integrity: EPA's Efforts to Enhance the Credibility and
Transparency of Its Scientific Processes. GAO-09-773T.
Washington, D.C.: June 9, 2009.
High-Risk Series, An Update. GAO-09-271. Washington, D.C.: January
2009.
EPA Science: New Assessment Process Further Limits the Credibility and
Timeliness of EPA's Assessments of Toxic Chemicals. GAO-08-
1168T. Washington, D.C.: September 18, 2008.
Chemical Assessments: EPA's New Assessment Process Will Further Limit
the Productivity and Credibility of Its Integrated Risk
Information System. GAO-08-810T. Washington, D.C.: May 21,
2008.
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.
Chemical Assessments: Low Productivity and New Interagency Review
Process Limit the Usefulness and Credibility of EPA's
Integrated Risk Information System. GAO-08-440. Washington,
D.C.: March 7, 2008.
Biography for John B. Stephenson
Mr. Stephenson is currently the Director of Natural Resource and
Environment issues for the U.S. Government Accountability Office--the
independent investigative arm of the Congress. In that capacity, he has
for the past nine years directed numerous studies and research
projects, issued hundreds of reports, and testified on many occasions
before several Senate and House Committees. His work has provided
invaluable assistance to the Congress in its oversight and legislative
role on diverse environmental protection issues such as clean air,
clean water, safe drinking water, chemical controls, toxic substances,
climate change, superfund, and hazardous materials spill prevention and
cleanup, as well as critical infrastructure protection.
Prior to his current position, he led numerous GAO studies and
investigation in the information technology and federal acquisition and
federal grant areas. He has extensive experience in dealing with
Congressional Committees and Members, federal agencies, trade
associations, special interest groups, and State and local governments.
From April 1998-February 2000, he was Deputy Staff Director for the
Senate Special Committee on the Year 2000 Technology Problem for the
Chairman (Senator Robert Bennett, R-UT), and Vice Chairman (Senator
Christopher Dodd, D-CT). In that capacity, he ran the day-to-day
operations of the Committee including orchestrating over 35 hearings,
preparing legislation, organizing briefings and Floor activities for
the Full Senate, working with the White House's Year 2000 Director and
staff, and organizing numerous press and public events. He returned to
GAO in March 2000 where he was Executive Assistant to the U.S.
Comptroller General (the head of GAO) until entering the Senior
Executive Service in October 2000.
Mr. Stephenson 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. He lives in Fairfax Station, Virginia with his wife, 11-year-
old daughter, and 9-year-old son. He also has two grown sons who reside
in Cincinnati, Ohio.
Discussion
Chair Miller. Thank you, Mr. Stephenson.
We will now begin our first round of questions, and I now
recognize myself for five minutes.
Ensuring EPA's Program Control
Mr. Stephenson, I want to talk about control of IRIS by
EPA. IRIS, as Dr. Broun pointed out in his opening statement,
has always provided for control, at least according to the
statute, stated control by EPA. But in the last eight years
certainly EPA's control was very much eroded by pressures from
other agencies, that although the IRIS listing has no
regulatory affect, it is a precursor to regulation. And there
were agencies that liked using chemicals without restrictions
and didn't want to have to mess with the risk management
issues. So it was easy to stymie a risk assessment through IRIS
and not have to worry about it.
And there were officials at OMB who seemed to be more than
happy to help them in that effort at OIRA. Whether it was the
other agencies or the manufacturers of the chemicals or simply
an anti-regulatory zeal, OIRA was more than happy to block it.
Mr. Stephenson, in light of all that history, how can we be
sure? Should we continue to worry that EPA will not, in effect,
be in control, even though it may, according to the stated
procedures, be in control?
Mr. Stephenson. A multi-faceted question. OMB does serve a
purpose in facilitating interagency comments. There is no
question. The problem with the old process was that all of
those comments were declared delivered evidence, so there was
no honest broker, if you will, as to what comments were being
provided and when. So we think the fact that this process
allows for complete transparency and all of those comments,
which are supposed to be comments on the scientific integrity
of the assessment, be made public. So that is huge.
Having said that, you know, EPA like every other agency
works for the White House, and OMB is an office of the White
House, and so the proof is going to be in the pudding as to how
much influence OMB may or may not have in this current process.
And now with you asking us to do so, we are going to be
watching that closely.
Chair Miller. Are there things for us to watch for? Are
there going to be early indicators that will tell us that EPA
is truly in charge or only nominally in charge, and it is still
being run out of OIRA or by the White House?
Mr. Stephenson. Well, the only thing you can really do is
track individual assessments through the process, and see what
kind of comments are made and by whom and what the reaction is
to those comments. Interestingly, in the old OMB, while it is
true they said that EPA was in charge, if you talked to OIRA,
if you talked to the other part of OMB, they would--who did the
part reviews if you are familiar with those, they clearly said
that OMB was in charge. So even within OMB it was unclear who
was in charge of that IRIS process.
The Effect of an IRIS Listing
Chair Miller. Mr. Stephenson, the opening statements kind
of raised the question of whether there should be more process,
more procedures, more of a chance to challenge EPA, that EPA
should not be the final decider, should not make the final
decision on IRIS listings. But do IRIS listings have any
regulatory effect? Is there anything that anybody cannot do or
has to do because of the way a chemical is listed in IRIS?
Mr. Stephenson. No. You correctly mentioned that it is a
precursor to deciding how to control dangerous chemicals, if
you need to at all, and so we view it as a purely scientific
process that shouldn't be meddled--you shouldn't be mixed with
science policy, which also has a legitimate role.
Chair Miller. Well, if there is a regulatory effort after
the--after an IRIS listing to manage the--a risk that IRIS, an
IRIS listing identifies, does--how is the science treated
there? Are all the same issues revisited in the regulatory
process?
Mr. Stephenson. Well, sure. I mean, you have an opportunity
to question the relevance of the science for a given
regulation, but each one is a case-by-case issue. The beauty of
IRIS is that it is the official agency position on a given
chemical, and therefore, the starting point to decide where you
want to go from there. It doesn't mean anything about
regulation purely.
Chair Miller. But if the formaldehyde industry, for
instance, wanted to argue that formaldehyde is actually good
for you, they could do that in the regulatory process for risk
management regulations. Is that correct?
Mr. Stephenson. Well, I would think they would do it in
both places; in the IRIS process as well as the regulatory
process.
Chair Miller. My time has expired.
I now recognize Dr. Broun for five minutes.
Mr. Broun. Thank you, Mr. Chair.
How IRIS Assessments Are Used
Just to go along with what Chair Miller was just talking
about, Mr. Stephenson, it is my understanding that a lot of
private sector stakeholders are basically using IRIS
assessments as a de facto regulatory statement. Is this true?
Mr. Stephenson. I have no way of knowing that.
Mr. Broun. Okay. What part in IRIS's process should outside
stakeholders play?
Mr. Stephenson. If they have--remember, IRIS is supposed to
be a collection and a synthesis of existing research that is
available at the time the assessment is--begins, essentially,
and so there are good researchers and scientists throughout
industry, throughout the other federal agencies, throughout
academia. All of those people are allowed to contribute to an
individual assessment once they see the draft assessment and it
goes out for public comment. And all of those comments can be
seen by the public and vetted by other scientists, and everyone
in this process seemingly can see how EPA dispenses with each
of those comments.
Transparency Process
Mr. Broun. Chair Miller referred to me as Dr. Broun. I am a
physician. There are some on this whole committee that would
argue that I am not a scientist, but I am. There are some
research scientists that would argue that, but I am an applied
scientist, and I believe in the scientific process and believe
in peer review and lots of it. The more peer review that enters
into the process, the greater I think we have in scientific
integrity.
When I graduated from medical school, the things I was
being taught at that time, to be absolutely factual, have
subsequently been shown to not be factual, and I think we have
a lot of things going on in public policy today such as climate
change caused by human effects on the climate are part of that,
but it is kind of--I don't want to go off on that tangent, but
to get back to IRIS, so is--I am just real concerned that there
is not enough transparency, Mr. Stephenson.
You talked about the transparency, but is all the
discussion within the agency or within anybody who has comments
on the assessments being done, is all of that available for
public peer review?
Mr. Stephenson. It is supposed to be.
Mr. Broun. Everything?
Mr. Stephenson. We hope so. Like you say, it is a
scientific process, and we would hope all of that is very
public and vetted in the public.
Mr. Broun. How about the oral arguments, interagency oral
arguments, any consultation meetings, things like that? Will
all of those things be available for public peer review?
Mr. Stephenson. We don't know, but that is why we say more
clarification is needed in those consultation steps within the
process, and if there are any decisions made, our
recommendation would be that they be made public. But EPA may
have a better clarification on that.
Mr. Broun. Doctor?
Dr. Teichman. It is certainly our intention to make sure
that all the written comments are put in the public docket, but
we also know that there is sometimes discussions that go on
orally. We would hope in those discussions, and what we have
tried to do since we will be controlling the process, is to
encourage people to provide the important points even in those
oral discussions in writing so they are made open and
transparent to the public. And that is just within the
interagency discussion steps at 3, Step 3 and Step 6A in your
chart number three, Mr. Chair, if I remember correctly.
I think it is also important to note that when there are
disagreements potentially between agencies, which can occur,
that that is when it is a good time, in fact, to turn to peer
review, Mr. Broun, just as you have identified. And so it is
the consultations both inside of the Agency where we may have
some scientific disagreements on a draft assessment, as well as
when we had the interagency discussions, that those become, in
fact, very good charge questions to the peer review panel for
them to opine on to inform us in the federal system.
Mr. Broun. Well, I hope that you can assure this committee
that all opinions, particularly dissentive views, within any
oral discussion, consultation is available for public preview,
because I think it is absolutely critical for scientific
integrity, first thing. Secondly is to guarantee that there is
a correct peer review process and that there is not a quashing
of opposing views by any entity, whether it is an agency or an
individual scientist, what have you. I think it is absolutely
critical for the health of this country and its science that
those things--so please assure this committee that that is
going to be the policy at EPA.
Dr. Teichman. It is certainly something as I think Mr.
Stephenson has mentioned that is a bit vague in the process as
identified and something that requires further discussion and
clarification to be more precise. So I would prefer to have
that discussion before I assure this committee at this
particular time. But it is something we will certainly have
discussion about.
If I may for just a brief moment, however, I want to make
sure we are distinguishing sometimes between those comments
that are scientific in nature and those that may be policy in
nature, because it is, indeed, we hope with our IRIS process to
really focus on the scientific comments, because, indeed, our
IRIS assessments are not regulatory.
And if I may draw attention actually to a report by the
bipartisan policy center that you may be familiar with since it
is co-chaired by Sherwood Boehlert, a friend, I believe, of
this committee in the past, okay, and has esteemed Members on
it such as Lynn Goldman and John Graham from, therefore, across
the political spectrum.
Chair Miller. I think the screen is actually obscuring the
portrait of Mr. Boehlert.
Dr. Teichman. That I can't see. I apologize. But, anyway, I
did want to make it clear that, indeed, your--the comments
about scientific disagreements we certainly want to make sure
are aired, but we want to distinguish those from policy
ramifications. These are the recommendations, in fact, from
Sherwood Boehlert's bipartisan committee:
L``Distinguishing between science and policy is not
always easy or straightforward, and scientists must
make choices based on values in the course of their
work. Nonetheless, policy debate would be clarified and
enhanced if a systematic effort were made to
distinguish between questions that can be resolved
through scientific judgments and those involved
judgments about values and other matters of policy.''
So what we are trying to do here is to keep the focus on
the scientific arguments that are the basis for the conclusions
drawn in our IRIS assessments, and it is later in subsequent
steps when regulations occur that the policy ramifications can
be debated as well.
Mr. Broun. Well, thank you, Doctor. My time is long up, and
the Chair----
Dr. Teichman. I apologize.
Mr. Broun.--has been very long suffering, but I just want
to make one statement from a--Mr. Chair. Policy makes a
difference, too, and it needs to be transparent, and we need to
make absolutely certain that any discussion, policy or
scientific, I think is available for the public.
Thank you, Mr. Chair.
Chair Miller. Thank you, Mr.--Dr. Broun.
I now recognize Ms. Dahlkemper for five minutes.
Ms. Dahlkemper. Thank you, Mr. Chair, and I want to thank
you and the Ranking Member for bringing forward this important
hearing and thank the witnesses for joining us today.
Program Schedule and Productivity
I want to talk a little bit about the productivity side of
things, and as we are looking at your new process here, you
have certain durations, Dr. Teichman, on there, and I want to
ask you about how EPA will guarantee that these dates are met.
Obviously, it is a good, aggressive schedule, I believe, but
how are you going to make sure that these dates are met with
the different processes?
Dr. Teichman. We are going to do our absolute best. In
terms of a guarantee, I cannot promise that every assessment
will last only 23 months. There will, indeed, be situations,
and we hope they are few and far between, and indeed, this is
stated in the Administrator's testimony as well that she gave
two days ago on the other side of the Hill, if you will, that
most assessments we expect to try and stick to the 23 months.
I have worked for the Administrator now for five months. I
can tell you she is a very intelligent, very aggressive
individual who keeps us on our toes and does everything she can
to support our efforts.
In that regard you also should hopefully take some solace
in the fact that the policy was discussed. I was certainly not
in the room, as it was, but among the Administrator and her
staff and officials within OMB, and I don't know, other
agencies, perhaps, too, and it was agreement across the board
on this particular process. So I believe there will be other
agencies who will be held to task as we try and hold to the
schedule to commitments that they made to the Administrator in
those initial negotiations.
Ms. Dahlkemper. Mr. Stephenson, do you have any comments on
this in terms of how you think this could be achieved?
Mr. Stephenson. We have already mentioned that some of the
early steps are missing, so you are already behind the eight
ball on the 23 months. Most importantly it is mentioned on the
chart here that you are going to do a comprehensive literature
search and data call, which will be in the notice, so there is
a process that has to be followed to do that, which will take
some time.
In addition, our recommendation from 2008, about the
importance of a two-year planning window is critical here so
that the whole research community, well in advance, will know
which chemicals are going to be assessed two years down the
road and can put together any research they deem appropriate
before the process actually starts. That will completely avoid,
you know, the development of research as the particular
chemical is being assessed and make the whole process more
efficient.
We think this is really ambitious, but we are going to be
watching.
Potential Improvements
Ms. Dahlkemper. Also, as you were speaking, Mr. Stephenson,
you were mentioning different--about five or six different
improvements that you would like to see, and I guess I want to
ask you, Dr. Teichman, about that, you know, about his, Mr.
Stephenson's testimony on that.
Mr. Stephenson. Well, some of them were just clarifications
but yes.
Dr. Teichman. Well, some were clarifications and some I
have written down. I am not sure I have got them all correctly
written, but I will state that as, hopefully, and I think I
can--if I parrot back correctly, the statement of my co-witness
here, that if managed effectively, the new EPA process for IRIS
would be considered very responsive to the GAO recommendations
of the past.
Therefore, we are trying to demonstrate a commitment to
seriously consider what GAO tells, and we will consider the
recommendations that the co-witness has asked. We would like to
have a chance to try the process as it has been agreed to, and
I think Mr. Stephenson has said it is worth a try, but we need
to take a look and see how we progress. I know the Chair has
asked GAO in a year to report back, and I think we are anxious
to follow that particular path. But we will still, nonetheless,
consider certainly for clarification, the recommendations from
GAO and even some of the potential changes if, indeed, they
enhance the process in our estimation as well.
Ms. Dahlkemper. I thank you, and I yield back.
Chair Miller. Thank you, and I now recognize myself for a
second round of questions.
My--we will be called for votes in maybe 20 minutes, half
an hour, and my intention will be just to have questions
probably until that time and then that will be the end of our
hearing when we get called for votes.
Deliberative Process
Dr. Teichman, there were questions about written,
everything written is going to be available. There is no
assertion that it is deliberative. We all get to see it.
Congress sees it, the American people sees it. It is public.
Dr. Broun asked questions about oral discussions, telephone
conversations, conversations at a water cooler, whatever,
meetings. And to the extent that they produce in writing, that
will then--the writing will be available. There is--it is
probably not reasonable to expect that everything will be
transcribed, but in the past when we have asked, specifically
Ms. Dudley, about who was involved in what conversations and
what conversations there were and what was said, she asserted a
deliberative process privilege, which I read the cases that
discuss deliberative process privilege, it is a very light
privilege. It is basically--it protects anything--discussions--
if the only reason that Congress or a court is asking for it is
out of idle curiosity, but if there is any real need for it at
all, that it should be available.
It--my understanding is the Administration does not--EPA
now does not assert a deliberative process privilege for any
oral conversations. So if Congress calls upon people involved
in the decision to tell us who was in the discussion, what they
had to say, that that would be--those would be questions that
you would answer as well as you could remember them. Is that
correct?
Dr. Teichman. I am not a lawyer, but that is certainly my
interpretation as well.
The GAO High-Risk List
Chair Miller. Okay. All right. I think Ms. Dahlkemper asked
around the high-risk list or came close to it. Mr. Stephenson,
I assume that being on the GAO's high-risk list is something
that a Federal Government agency would regard about the same
way a bank would regard being on the FDIC's watch list. It is
not a favorite place to be.
How long do you expect it would take IRIS to kind of earn
their way off that list?
Mr. Stephenson. The high-risk designation is not only
designated to IRIS, it has to do with TOSCA reform as well.
Chair Miller. Uh-huh.
Mr. Stephenson. So we need to wait and see proof that the
problems that we have observed have been addressed, and there
is no, you know, it is not--it is fairly subjective. It is up
to GAO when we decide to add or remove things from that risk.
It doesn't carry any designation other than the fact that we
hope that the Agency and the Administration will devote greater
attention to it, and the Congress for that matter. That is why
we do it.
So to get on that list we are very, very, very concerned.
We are a conservative agency, and it doesn't get put on that
list lightly. There were only three new additions to the list
this year, and this was one of them.
Chair Miller. Dr. Teichman, I assume it is a high priority
to get off that list?
Dr. Teichman. Most certainly, sir.
Royal Demolition Explosive
Chair Miller. Okay. Thank you. Mr. Stephenson, you examined
in the GAO report last year the IRIS process specifically for a
chemical called Royal Demolition Explosive or RDX. What is the
status of that?
Mr. Stephenson. We haven't done any specific work on that.
It was one of the chemicals we highlighted to illustrate how
broken the process was and how long it was taking. I believe it
had been in assessment over a decade. In updating for this
hearing we noticed that it had been removed from EPA's list of
chemicals undergoing assessment, and we haven't been able to
follow up onto exactly why that happened. It was on there a
month ago and removed as of a day ago.
Chair Miller. Dr. Teichman, do you know why RDX has gone
missing?
Dr. Teichman. I can tell you what response I got when I
posed that same question to the staff. Nonetheless, I would
prefer to give a full response to a question for the record on
where the chemical managers involved would be able to comment
on the decision process that is involved with that particular
chemical. But it was, indeed, listed for possible assessment
under the IRIS Program, but we have identified 48 assessments
that we think are priority chemicals, and in the second batch
an additional 48. RDX is in the second batch, so I would
prefer, again, for a question for the record to give the
decision process as to why it is in the second batch.
Chair Miller. If you would submit it on the record.
Mr. Whittaker, in a show of bipartisanship would you like
to--would you raise the screen so we can all see the portrait
of Mr. Boehlert?
I now yield back the remaining 10 seconds of my time and
recognize Dr. Broun for another round of questions.
Assessment Timeliness
Mr. Broun. Thank you, Mr. Chair. I understand there is a
natural tension between fairness and timeliness with
assessments. The question is, will this streamlined process
ultimately sacrifice scientific credibility, especially
considering the recent negative reviews of the assessments by
the National Academy of Science? And the question I have really
for both of you is, if EPA can't get the assessment right in 10
years, what makes you think, each one of you, that you can
produce better results in 23 months?
Mr. Stephenson. I mean, we are going to--we think 23 months
is optimistic. We are going to be looking, but the problem is
it is like a domino effect. If the assessment takes too long,
there is new research that becomes available. You have to
reconsider, and it goes back to square one again. That is what
I meant about the endless assessment and reassessment. This is
supposed to be a process that synthesizes existing research
that is available at the time and should be able to be done
fairly quickly and vetted. These assessments are supposed to be
updated routinely, you know, every 10 years. So with 540
chemicals on the list, if you are not doing at least 54 a year,
you are not even keeping up.
So we think this is very ambitious. We are not sure there
is enough resources devoted to this yet, but that is a very
good question.
Dr. Teichman. It is a very ambitious goal.
Mr. Stephenson. It is an ambitious goal. I don't disagree,
and we have certainly asked for additional resources to help us
meet that goal in the President's budget request. There are a
couple of things I think, though, that are different than
perhaps the past as we look at the new process.
The first is this new process as I mentioned earlier was
developed in consultation with other federal agencies, and
therefore, I believe there is a mutual commitment to try and
meet the schedule that has been identified. This does not mean
that it isn't aggressive and that we shouldn't take a look and
see in a year's time if we have been able to stick to it. We
welcome that type of a review and hope to be able to
successfully demonstrate we were able to meet that goal of 23
months.
Second is the listening sessions that I referred to earlier
are still maintained in this process. This is a chance where
the external peer review meeting that--where there used to be
an opportunity for somebody to speak for two or three minutes
or perhaps as many as five or seven minutes, no longer than I
was able to testify today, I would add, most likely, that that
was perhaps insufficient time for real discussion and exchange.
The listening sessions actually now are for much longer periods
of time, more interchanged with those who have any opinions
they wish about our draft assessments, and that listening
session is, indeed, also shared with the external peer review
panel and their assessment.
So I believe that is a very positive step that will
hopefully enable us to air for greater, longer periods of time
potential disagreements in the scientific facts and let the
external peer review panel tell us their position on those
arguments.
Mr. Broun. Has the timeframe for peer review changed at
all?
Dr. Teichman. I believe the time period is 60 days at this
point. I think it might have been a little longer. I have to
check. I apologize.
Mr. Stephenson. I got it at 105 days.
Mr. Broun. Mr. Chair, I am not real interested in a lot of
conversations that go around the water fountain, but those
conversations that do have to do with scientific integrity as
well as the scientific process I think are very important, and
I hope that we can, as a committee be reassured that those
conversations will be reported and will be open and for public
view. And it is just something that I think is absolutely
critical for scientific integrity, and I just want--I just
throw that out as a comment to both of you all.
And with that I will yield back to the Chair for the next
round, if we have one.
Chair Miller. Thank you. Just one more brief round.
I do want to point out that when we raised the screen to
reveal the portrait of Mr. Boehlert, we also revealed the
portrait of a substantially slimmer Chair Sensenbrenner, which
is perhaps more bipartisan than I really intended to be.
Peer Reviews
Dr. Teichman, Step 4 of the new process is an independent
expert peer review, which Dr. Broun has been asking about
already, and our staff understands that that will usually be
done on a face-to-face basis, meetings, and perhaps that could
be transcribed or--but in some cases it will also be done by
the National Academy of Sciences. We understand that peer
review can be done by mail, it can be done through the
Internet, it can be done face to face, it can be done through
an Academy of Sciences study.
Can you give us a sense of what each of those different
methods for peer review will cost and how you will decide which
method?
Dr. Teichman. First of all, let me since I was under oath
correct the statement I said before about 60 days indeed as my
co-witness has said it. Now that I have it in front of me, it
is 105. I was confusing with a different step.
In terms of the cost for each of the individual types of
peer reviews, I would like to provide that as information for
the record. However, it is important to state that we very
carefully consider the complexity of a given assessment as to
which form of peer review that we would use. To use a letter if
you want an IRIS assessment would be very rare. At the other
end of the spectrum to go the National Academy of Sciences,
which we have done, one of the most controversial chemicals, is
hopefully equally rare. More times than not we will convene a
peer review panel, which would have a face-to-face meeting that
might be the contractor choosing the panelists, or it might be
our own science advisory board.
And the cost for those four different options we will be
glad to provide, but certainly they vary as from the letter
review to the NAS, based on the complexity of the assessment.
Chair Miller. Can you, Dr. Teichman, can you tell us who
some of the contractors are who have been contracted with--that
EPA contracted with to conduct the peer review?
Dr. Teichman. I am only familiar with one and any mention
is not considered an endorsement, but nonetheless, I think the
Eastern Research Group has been one of the organizations that
our National Center for Environmental Assessment has used to
locate peer reviewers and pull together such panels.
Chair Miller. What procedures do you have in place to make
sure that there are no conflicts of interest with forums
conducting the peer review process?
Dr. Teichman. The firms themselves, again, I would prefer
to have a better chance to put this in the record than I will
be able to convey right now, but if you are talking about the
choice of the firms, those are competed, and I don't know what
confidentiality or impartiality statements they may have to be
to be a successful bidder on the contract.
However, the people who they hire as subcontractors, as
panelists there, there are, indeed, statements that have to be
provided where people state what their potential associations
are, and they demonstrate that they are impartial.
Chair Miller. Mr. Stephenson, are you familiar with any
work that the GAO has done on outside contractors for peer
reviews?
Mr. Stephenson. Not specifically contractors but there are
two different brands of scientific advisory committees the EPA
uses. There is 24 of them in total, and we noted in the
testimony in the Senate that seven of those have specific
conflict of interest procedures for their membership, but the
others do not. And they are--that may not be inappropriate
because you are trying to seek points of view on a given
chemical or giving a scientific assessment or a given
regulation. So we just observe that EPA should not confuse the
purpose of both of those two different kinds of scientific
advisory committees.
Chair Miller. Dr. Teichman, it seems that some of the most
widely-used chemicals with perhaps the most troubling health
consequences are the ones that are tied up for the longest time
in--or have been in the past in IRIS: formaldehyde, TCE, Perk,
Dioxin. How are you going to set priorities for completing
assessments?
Dr. Teichman. Well, indeed, we wish to tackle those
chemicals that we think pose the greatest risk to the American
public, and those become our priorities. It is not an issue of
any particular stakeholder group interest one way or the other,
anybody influencing our decision other than we believe it poses
a high risk, and those become the chemicals that we go after.
And we believe we do it in a rigorous fashion that
everybody has an opportunity to comment and to tell us if we
have gotten it right in our draft and hopefully we have done it
correctly by the time we have the final assessment.
Chair Miller. Okay. Are you going to include others, both
interagency suggestions or outside----
Dr. Teichman. We take suggestions from everybody as we
publish our list of potential chemicals we could be working on
and others that people wish to recommend, and that includes
other federal agencies, it includes State and health
organizations. It is a FR--a Federal Register notice asking for
people's thoughts on what our agenda should be.
Chair Miller. I yield back the remaining three seconds of
my time.
Dr. Broun, do you have any more questions?
Fairness and Time Constraints
Mr. Broun. Going back to peer review process, Doctor, I am
looking at the document actually here, and you were correct the
first time, that you are supposed to announce a public comment
period of 60 days for peer review, and again, as a physician I
am concerned that 60 days, 105 days may or may not be enough,
and 23 months may not be enough time to adequately evaluate
each of these chemicals.
How can you guarantee--but in the review process how can
you guarantee fairness in that IRIS process if you give the
public only 60 days to review?
Dr. Teichman. We believe 60 days will be adequate to give
the public fair opportunity to comment. We believe the
combination of the listening sessions gives them even a chance
to interact with us on the draft assessment prior to the
external peer review panel coming together. If indeed somebody
in a rare instance asks for an extension and indeed the
material in front of you discusses that potentiality, we do,
indeed, offer such an extension, but we can't promise, in fact,
that their comments will be before the peer review committee.
And we believe it is best for as many public comments to be
shared with the peer review committee as they make their
deliberations.
Mr. Broun. Was the 60-day number just picked somewhat
arbitrarily? Did you all just think that that is a good period
of time, or was there a particular thought in giving enough
time but not too much?
Dr. Teichman. I think that is a fair way of putting it. It
was not arbitrary in terms of we plucked it randomly, we
plucked it out of midair. We think this is an appropriate
amount of time. If it turns out as we have explored this that
people feel they must have 90 days, for example, it is
something to consider down the road.
More on the Transparency Process
Mr. Broun. All right. Thank you, sir. Back to the
transparency, will you commit to truly making the IRIS process
transparent by creating a public docket for all materials
received at EPA related to each IRIS assessment, including
materials that EPA has received but which it decides will not,
it will not allow them to make its assessment decisions?
Dr. Teichman. Yes, indeed. All comments that we receive in
the written form as we have discussed will be in the public
docket. We always include all the information that has been
given to us, whether or not it is what we use in our final
assessment, so that people see the total record, and they can
choose from among it as to what they think should be
influencing our final word.
Mr. Broun. So that it is a promise to us that that will be
done, and I hope you can promise us at some point that all
those oral discussions and those conversations and
consultations that do occur orally will be provided for the
public also.
With that, Mr. Chair, I yield back.
Dr. Teichman. May I just comment for a moment, Mr. Chair,
if I can?
Chair Miller. Dr. Teichman.
Dr. Teichman. Again, we will be--the oral comments I wish
to come back to the Agency and have further discussion on. On
the written, I am not aware that we have never or that we have
ever not put every written comment that we got from the public
or as part of the peer review in the docket. What is
interesting and new in this process is, in fact, now the
written comments we get from other agencies will also be in the
public docket.
Closing
Chair Miller. I think we are now done with our questions.
There is a phrase I have heard all my life, which I suspect
is a southern phrase. I am sure Dr. Broun has heard it as well
then. When we want to disassociate ourselves from someone else,
not take full responsibility for the conduct and other, we say,
``I didn't take him to raise.''
But it appears that I have taken IRIS to raise, this
subcommittee has taken IRIS to raise, GAO has taken IRIS to
raise. So we will continue to close--to watch IRIS closely. We
think it is important that IRIS perform its mission and produce
the right number of very sound, credible, scientifically-sound,
credible assessments.
Mr. Broun. Mr. Chair, would you yield?
Chair Miller. Mr.--Dr. Broun.
Mr. Broun. Thank you for yielding, sir. I am very happy you
have taken IRIS to raise and that we are having this hearing
and that you are continuing this process because I think it is
absolutely critical for the public to have total confidence in
what assessments are made by IRIS and by the government across
the board.
I think there are many things that are being put out by the
government that are declared scientific that aren't, and it
does not--things in the way of determinations that aren't
accepted by the public, and I think rightfully so. And so I am
glad you have taken IRIS to raise, sir, and I am eager to
continue in this process with you, so I thank you very much,
and I congratulate you on taking IRIS to raise.
Chair Miller. Thank you, Dr. Broun. We may not think alike,
but we do talk alike.
Before we bring the hearing to a close I want to thank our
witnesses today for testifying before the Committee. We may see
you again.
Under the rules of the Committee the record will remain
open for two weeks for additional statements from the Members
and for any answers to any follow-up questions the Committee
may have for the witnesses. Dr. Teichman, you had said you
wanted to provide additional information.
And with that the witnesses are excused, and the hearing is
now adjourned.
[Whereupon, at 2:15 p.m., the Subcommittee was adjourned.]
Appendix 1:
----------
Answers to Post-Hearing Questions
Responses by Kevin Teichman, Deputy Assistant Administrator for
Science, Office of Research and Development (ORD), U.S.
Environmental Protection Agency (EPA)
Questions submitted by Chairman Brad Miller
Q1. During the hearing, we discussed the status of the chemical called
Royal Demolition Explosive (RDX), in the IRIS process. Please explain
the decision process and process for removal of RDX from EPA's list of
chemicals undergoing IRIS assessment.
A1. There are over 80 assessments in progress in the IRIS program, all
at various stages of development.
EPA made a decision to focus its resources on those assessments
that were farthest along in the process and work as quickly as possible
to finish up that first set and then turn its attention to the second
set of chemicals/substances. The first set consisted of 48 assessments.
Each of those 48 was at the internal Agency review step or further in
the process. As assessments are completed and staff are available to
work on the next set of assessments, focus will shift to the
approximately 40 other assessments on the IRIS agenda, which will
become the priority list for 2010-2011. RDX was one of the assessments
where development of the IRIS toxicological review report had not
progressed to the point where a draft assessment was in, or ready, for
internal Agency review. Thus, RDX will be on the second set of IRIS
chemical assessments.
Q2. We also discussed the independent expert peer review step of the
new IRIS process. Please clarify the timeframes provided for peer
review and the anticipated costs for each method of peer review.
Moreover, please explain EPA's plan for mitigating conflicts of
interest during the peer review process.
A2. Part 1--Types of Reviews:
Timeframes for IRIS Peer Reviews
The timeframe provided in the new IRIS process provides for a 105-
day peer review process. We are working on processes to be put into
place for peer reviews conducted through a contractor convened peer
review panel and the EPA's Science Advisory Board (SAB) peer review
panel to meet that timeframe. We will also work with the National
Academy of Sciences (NAS) to determine if they would be able to meet
the 105-day timeframe. We recognize that, on occasion, there will be
particularly complex assessments that may take longer than 105 days.
Costs for IRIS Peer Reviews
Letter Review: All independent external peer reviews for IRIS draft
assessments are conducted at public meetings. Thus, letter reviews are
not used for external peer review of draft IRIS human health
assessments.
Contractor-Convened Panel: Extramural cost for these types of peer
reviews range from $35,000 to $70,000. Cost depends on the complexity
of the assessment, which determines the number of different types of
expertise needed, the number reviewers required, the number of days
scheduled for the public review meeting, and the cost of the meeting
venue. The staff time required is around 80 hours on average. This
includes four staff attending the day(s)-long panel meeting and
preparing materials for presentation at the meeting. The rest of the
staff time is spent by the work assignment manager, project officer,
and contracting officer writing and approving Statements of Work,
working out the details of the date and location of the meeting, making
sure the panel members have the needed range of expertise, etc.
Estimates:
Extramural costs: $35,000 to $70,000
Intramural costs: $5,000 to $7,000
Science Advisory Board (SAB) (chartered under Federal Advisory
Committee Act [FACA]): The estimated cost of a standard peer review by
the Agency's SAB is $200,000 to $250,000. The cost includes: contractor
support, travel, Special Government Employee (SGE) salary, plus EPA FTE
cost in the office of the SAB, Designated Federal Official (DFO),
management, and personnel staff. This does not, however, include EPA
scientist(s) or management staff time in the office requesting SAB's
review of the draft assessment. The staff time required is around 80
hours on average. This includes four staff attending the day(s)-long
panel meeting and preparing materials for presentation at the meeting.
Estimates:
SAB's costs: $200,000 to $250,000
Requesting office intramural costs: $5,000 to $7,000
National Academy of Sciences/National Research Council (NAS/NRC):
External peer review by the NAS/NRC is estimated to cost $800,000-
1,000,000. This does not, however, include EPA scientist(s) or
management staff time in the EPA office requesting NAS's review of the
draft assessment. The staff time required is difficult to estimate
because often times the NAS has multiple meetings; however, an estimate
may be 120 hours on average.
Estimates:
Extramural costs: $800,000 to $1,000,000
Intramural costs: $8,000 to $10,000
A2. Part 2: EPA's Plan for Mitigating Conflict of Interest (applies to
all types of reviews)
Since the Agency's Peer Review Policy was first affirmed in 1994,
EPA has made tremendous strides in building a strong and well
recognized peer review program. EPA's Science Policy Council has
updated and improved the EPA Peer Review Handbook including clarifying
conflict of interest and impartiality issues. This Handbook is used to
guide and implement peer review across the Agency, including IRIS peer
reviews. A recent report by the EPA Inspector General provided several
suggestions for how we can improve our peer review practices. We
welcome the opportunity for continuous improvement. EPA's Science
Policy Council is updating the EPA Peer Review Handbook to clarify the
definition of the ``appearance of a lack of impartiality.'' In
addition, our Office of Research and Development is updating some of
its procedures to enhance its use of peer review.
Q3. Will EPA place all interagency comments in the public record?
A3. On May 21, 2009, EPA Administrator Lisa Jackson announced a new
process for health assessment development and review for the IRIS
Program. The new process is summarized as follows:
Step 1--document development,
Step 2--internal EPA review,
Step 3--interagency science consultation,
Step 4--external peer review and public comment,
Step 5--document revision,
Step 6A--final internal EPA review,
Step 6B--interagency science discussion, and
Step 7--posting the final assessment on the IRIS database.
The new process affords federal agencies and White House offices
three opportunities to comment on science issues in draft IRIS
assessments (Steps 3, 4 and 6B). In Step 3, the Interagency Science
Consultation, federal agencies and White House offices will be invited
to provide written scientific comments on the draft Toxicological
Review and draft charge to external peer reviewers before the
assessment is released for public review and comment. Also, in Step 4,
the External Peer Review and Public Comment, the federal agencies and
White House offices may provide written comments on the draft
Toxicological Review during the public comment period. All comments
received during the announced public comment period automatically
become part of the public docket for the assessment. Finally, in Step
6B, the Interagency Science Discussion, federal agencies and White
House offices will be invited to provide written scientific comments
specifically on EPA's response to external peer review and public
comments before the final assessment is posted on IRIS.
As specified in the new IRIS process, all written comments received
during the Interagency Science Consultation (Step 3) and the
Interagency Science Discussion (Step 6B) will be documented in the
public record. This applies to all comments received on or after May
21, 2009. When the draft assessment is released for external peer
review and public comment, the following documents will be posted on
the docket at www.regulations.gov and on the National Center for
Environmental Assessment (NCEA) and IRIS web sites:
Interagency Science Consultation draft Toxicological
Review
Interagency Science Consultation draft external peer
review charge
All written comments as received from agencies as
part of the Interagency Science Consultation
External Peer Review draft Toxicological Review
Final Charge to External Peer Reviewers
When the final assessment is posted on the IRIS database, the
following documents will be posted on the NCEA and IRIS web sites:
Interagency Science Discussion draft Toxicological
Review with summary and disposition of external peer review and
public comments
Interagency Science Discussion draft IRIS Summary
All written comments as received from federal
agencies and White House offices as part of the Interagency
Science Discussion
Final Toxicological Review and IRIS Summary.
Appendix 2:
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Additional Material for the Record