[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
SCIENCE UNDER SIEGE: SCIENTIFIC INTEGRITY AT THE ENVIRONMENTAL PROTECTION
AGENCY
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
----------
SEPTEMBER 18, 2008
----------
Serial No. 110-149
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
SCIENCE UNDER SIEGE: SCIENTIFIC INTEGRITY AT THE
ENVIRONMENTAL PROTECTION AGENCY
SCIENCE UNDER SIEGE: SCIENTIFIC INTEGRITY AT THE ENVIRONMENTAL
PROTECTION AGENCY
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
SEPTEMBER 18, 2008
__________
Serial No. 110-149
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
U.S. GOVERNMENT PRINTING OFFICE
62-923 WASHINGTON : 2010
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COMMITTEE ON ENERGY AND COMMERCE
JOHN D. DINGELL, Michigan, Chairman
HENRY A. WAXMAN, California JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts Ranking Member
RICK BOUCHER, Virginia RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California BARBARA CUBIN, Wyoming
BART STUPAK, Michigan JOHN SHIMKUS, Illinois
ELIOT L. ENGEL, New York HEATHER WILSON, New Mexico
GENE GREEN, Texas JOHN SHADEGG, Arizona
DIANA DeGETTE, Colorado CHARLES W. ``CHIP'' PICKERING,
Vice Chair Mississippi
LOIS CAPPS, California VITO FOSSELLA, New York
MIKE DOYLE, Pennsylvania ROY BLUNT, Missouri
JANE HARMAN, California STEVE BUYER, Indiana
TOM ALLEN, Maine GEORGE RADANOVICH, California
JAN SCHAKOWSKY, Illinois JOSEPH R. PITTS, Pennsylvania
HILDA L. SOLIS, California MARY BONO MACK, California
CHARLES A. GONZALEZ, Texas GREG WALDEN, Oregon
JAY INSLEE, Washington LEE TERRY, Nebraska
TAMMY BALDWIN, Wisconsin MIKE FERGUSON, New Jersey
MIKE ROSS, Arkansas MIKE ROGERS, Michigan
DARLENE HOOLEY, Oregon SUE WILKINS MYRICK, North Carolina
ANTHONY D. WEINER, New York JOHN SULLIVAN, Oklahoma
JIM MATHESON, Utah TIM MURPHY, Pennsylvania
G.K. BUTTERFIELD, North Carolina MICHAEL C. BURGESS, Texas
CHARLIE MELANCON, Louisiana MARSHA BLACKBURN, Tennessee
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
______
Professional Staff
Dennis B. Fitzgibbons, Chief of Staff
Gregg A. Rothschild, Chief Counsel
Sharon E. Davis, Chief Clerk
David L. Cavicke, Minority Staff Director
7_____
Subcommittee on Oversight and Investigations
BART STUPAK, Michigan, Chairman
DIANA DeGETTE, Colorado JOHN SHIMKUS, Illinois
CHARLIE MELANCON, Louisiana Ranking Member
Vice Chairman ED WHITFIELD, Kentucky
HENRY A. WAXMAN, California GREG WALDEN, Oregon
GENE GREEN, Texas TIM MURPHY, Pennsylvania
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois MARSHA BLACKBURN, Tennessee
JAY INSLEE, Washington JOE BARTON, Texas (ex officio)
JOHN D. DINGELL, Michigan (ex
officio)
(ii)
C O N T E N T S
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Page
Hon. Bart Stupak, a Representative in Congress from the State of
Michigan, opening statement.................................... 1
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 3
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, opening statement................................. 5
Hon. Joe Barton, a Representative in Congress from the State of
Texas, opening statement....................................... 7
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 9
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 277
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, prepared statement......................... 278
Witnesses
John B. Stephenson, Director, Natural Resources and Environment,
U.S. Government Accountability Office.......................... 10
Prepared statement........................................... 13
Francesca Grifo, Ph.D., Senior Scientist, Director, Science
Integrity Program, Union of Concerned Scientists............... 48
Prepared statement........................................... 51
Deborah Rice, Ph.D., State of Maine, Department of Environmental
Protection..................................................... 101
Prepared statement........................................... 103
Jennifer Sass, Ph.D., Senior Scientist, Natural Resources Defense
Council........................................................ 104
Prepared statement........................................... 107
David Parshley, Project Manager, Glynn Environmental Coalition... 137
Prepared statement........................................... 139
Sharon H. Kneiss, Vice President, Products Division, American
Chemistry Council.............................................. 212
Prepared statement........................................... 214
George M. Gray, Ph.D., Assistant Administrator, Office of
Research and Development, U.S. Environmental Protection Agency. 245
Prepared statement........................................... 248
Submitted Material
Slide presented by Mr. Inslee.................................... 279
Charts on IRIS Process........................................... 280
Subcommittee exhibit binder...................................... 285
SCIENCE UNDER SIEGE: SCIENTIFIC
INTEGRITY AT THE ENVIRONMENTAL PROTECTION AGENCY
----------
THURSDAY, SEPTEMBER 18, 2008
House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Energy and Commerce,
Washington, D.C.
The subcommittee met, pursuant to call, at 10:08 a.m., in
room 2322 of the Rayburn House Office Building, Hon. Bart
Stupak (chairman) presiding.
Members present: Representatives Stupak, Melancon, Green,
Inslee, Dingell (ex officio), Shimkus, Walden, Burgess, and
Barton (ex officio).
Staff present: Scott Schloegel, John Sopko, John Arlington,
Paul Jung, Kyle Chapman, Katherine Graham, Alan Slobodin, Karen
Christian, and Whitney Drew.
OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Stupak. This meeting will come to order.
Today we have a hearing entitled ``Science under Siege:
Scientific Integrity at the Environmental Protection Agency.''
Each member will have 5 minutes for an opening statement. I
will begin.
The mission of the U.S. Environmental Protection Agency,
EPA, is to protect human health and the environment. This
mission is best accomplished by regulatory decisions based on
reliable science. However, indications are that the
Environmental Protection Agency may instead be using selective
science in regulatory decisions.
The purpose of our hearing is to review the apparent lack
of scientific integrity in parts of the EPA. We will examine
four specific examples. One, a report from the Union of
Concerned Scientists that found significant political
interference in scientific work at EPA; two, the supposed
``streamlining'' of the Integrated Risk Information System,
IRIS, which actually makes it more difficult for EPA to publish
scientific analyses on chemical risk; third, the removal of Dr.
Deborah Rice from a scientific peer review panel at the request
of the chemical industry; and fourth, the EPA's adoption of a
since-discredited clean-up plan for the chemical toxaphene at
the Hercules Superfund near Brunswick, Georgia.
The Union of Concerned Scientists, UCS, conducted a study
on political interference at the EPA. Scientists reported that
they personally experienced political interference in the last
5 years and being directed to inappropriately exclude or alter
technical information from EPA scientific documents. Scientists
often identified the White House Office of Management and
Budget as the primary source of external interference. The
Union of Concerned Scientists' study paints a picture far from
the open scientific debate that we should expect from a
science-based regulatory agency.
The Integrated Risk Information System, or IRIS, is the
U.S. government's catalog of the health effects of toxic
chemicals. To have information placed into IRIS, EPA scientists
carefully evaluate the science of each chemical and provide
relevant data in the system. On April 10, 2008, the EPA
instituted a new streamlined process for IRIS, which actually
increases the number of steps in the evaluation process.
Notably, the new process now requires approval by OMB at least
twice prior to final posting in IRIS. As expected, this new
process will delay the reporting of chemical hazards and make
it more difficult for EPA scientists to publish their data in
IRIS.
Dr. Deborah Rice was invited by EPA to chair a 5-member
peer review panel to update the IRIS assessment of the chemical
deca, a flame retardant used on plastics and textiles. After
the deca peer review panel concluded their business and posted
their final comments, the EPA removed Dr. Rice from the panel
and erased her comments from the report at the behest of the
American Chemistry Council. Their reasons included the fact
that Dr. Rice provided testimony to the Maine Legislature in
her capacity as the Maine state toxicologist on their proposal
to ban deca. Dr. Rice was informed of this decision by
telephone. She received no written explanation. It appears that
Dr. Rice was removed from the peer review panel because she had
expertise on the chemical in question and was asked to provide
that expertise to a state legislature.
Toxaphene is an insecticide that was widely used in the
United States on crops, fish, and livestock before it was
completely banned in 1990 due to health hazards. Brunswick,
Georgia, is the home of the Hercules 009 landfill, a superfund
site where toxaphene waste was dumped from 1975 to 1980. This
superfund site abuts the local elementary school and the
community is concerned that toxaphene and its harmful breakdown
products may persist at that site. Since the Hercules 009
became a superfund site in 1984, EPA continues to use an
outdated, inaccurate scientific method to detect the toxaphene,
while other federal agencies, including the Agency for Toxic
Substances and Disease Registry, ATSDR, the Army Corps of
Engineers, and EPA's Inspector General recommended the use of
the negative ion mass spectroscopy, NIMS, as they call it. EPA
has not adopted NIMS as their standard test. In addition, the
EPA's method to clean up the Hercules 009 site is based on an
article published in the journal Regulatory Toxicology and
Pharmacology, which has been assailed by scientists as having
an industry bias. In addition, it appears the Hercules
Corporation has hired the Weinberg Group, a consulting firm
under investigation by our committee, to determine the toxicity
of toxaphene. These actions paint a suspicious picture of
questionable regulatory decisionmaking.
Today we will hear from several witnesses. Our first panel
will include Dr. Francesca Grifo of the Union of Concerned
Scientists, who will discuss her organization's report, and Mr.
John Stephenson of the Government Accountability Office, who
will discuss GAO's report on the new IRIS changes.
Our second panel will include Dr. Rice, who will testify
about her removal from the EPA peer review panel, Dr. Jennifer
Sass from the National Resources Defense Council, who will tell
us how the new IRIS changes will affect environmental science,
Mr. Daniel Parshley of the Glynn Environmental Coalition to
discuss issues at the Hercules superfund site, and Sharon
Kneiss of the American Chemistry Council, who will testify
about ACC's role in the removal of Dr. Rice from the EPA's peer
review panel.
Finally, we will hear from Marcus Peacock, Deputy Director,
and George Gray, Ph.D., Assistant Administrator for Research
and Development at the Environmental Protection Agency.
I look forward to the testimony of all the witnesses. I
believe today's testimony will show how the EPA has dangerously
undermined the role of science in regulatory decision making.
The EPA under the Bush Administration appears to have put
politics before science, to the harm of not just the
environment but to the fundamentals of science. Science is not
a Republican or Democratic issue. It must be based on facts and
not political affiliation. I sincerely hope today's testimony
will be taken seriously by the EPA and that they will work
seriously to ensure the science will return to its proper role
within the Agency.
That concludes my opening statement.
Mr. Stupak. I will turn to my friend, Mr. Shimkus from
Illinois, for your opening statement, sir.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. Thank you, Mr. Chairman, for convening this
oversight hearing.
Over the last year, some individuals and advocacy groups
including some of the witnesses before us today have charged
that the EPA has interfered with certain scientific decisions
for political reasons or at the behest of industry. Dr.
Francesca Grifo of the Union of Concerned Scientists will
testify on the first panel as she has testified before the
House and Senate panels about her organization's report,
Interference at the EPA. After reviewing the testimony in that,
I guess part of the irony of this is that the Union of
Concerned Scientists not using a scientific poll in this
Interference at the EPA, which we all know about polling and we
know the scientific process and we know one that is not.
A number of hearings have been held in the House and Senate
discussing alleging interference, in particular this year's
hearing on the National Ambient Air Quality Standards, or
NAAQS. This committee and this subcommittee have a long history
of examining EPA on issues of scientific decisionmaking. These
issues are altogether appropriate topics for an oversight
hearing. What troubles me is the way this hearing has come
together and the title of the hearing implies that the Majority
has drawn a conclusion before we have even obtained testimony
and all the evidence. It is important in any investigation to
take the time to gather the facts, to hear both sides of the
story and to weight and vet the information you receive. Given
the amount of attention that has been devoted to alleged
political interference at the EPA over the last year, it may be
tempting to make assumptions and prematurely draw conclusions.
We are presented today with three separate cases that the
Majority contends are examples of science under siege, but
based upon the incomplete factual record of today, I cannot
conclude one way or the other that EPA made the decisions it
did because of political or industry influence or that anything
was done wrong. We all know there are good-faith disputes over
science and disagreements with policy calls that happen every
day at the EPA. In fact, the background on each of these cases
is complex and the three case studies may not even be
particularly strong examples in support of the charge of
political interference.
For instance, let us consider the case of the cleanup plan
for the Hercules site in Georgia. EPA implemented a plan to
clean up toxaphene, a pesticide, at a landfill site. A dispute
arose as to whether the EPA had picked the right method to test
for toxaphene in the soil and the groundwater. Two EPA Office
of Inspector General reports issued in 2005 essentially
concluded that EPA would not be able to determine whether its
cleanup plan was effective because its testing method was
incapable of measuring whether degraded toxaphene was present.
In responding to these reports, EPA cited an article published
in the Regulatory Toxicology and Pharmacology Journal as a
basis for its Hercules toxicity calculations. Now, some in the
scientific community believe this journal's efforts to identify
conflicts of interest among its board when selecting articles
for publication are inadequate and therefore the Agency's
reliance on this article was improper. It may be that this
article does not support the cleanup plan EPA adopted or does
not represent the best science on toxaphene. It may also be
that the Agency's delay in resolving the questions surrounding
the testing for toxaphene is indefensible. But this does not
mean that the EPA's decision was improperly influenced by
industry and we have yet to uncover any evidence to
substantiate that claim. Indeed, the Committee has not even
interviewed the EPA staff who worked on the cleanup plan or
collected a single document on the issue. Let me just highlight
that. The Committee has not interviewed the EPA staff who
worked on the cleanup plan or collected a single document on
this issue.
I have similar questions about the EPA's actions with
respect to peer review panel for deca, a flame retardant. Dr.
Deborah Rice was the chair of the panel but her comments were
removed from the peer review report due to possible appearance
of impartiality after the American Chemistry Council informed
EPA that Dr. Rice has testified before the Maine Legislature
about deca. Dr. Rice and the ACC are witnesses on the second
panel, and Dr. George Gray of EPA, who ultimately removed Dr.
Rice's comments, is on our third panel. At least with respect
to this case, we may be able to hear all sides of the story
because the parties are here. The removal of Dr. Rice's
comments is obviously a very sensitive issue because it
involves not only the integrity of the peer review process but
also Dr. Rice's professional reputation. So we must be
especially careful when we try to sort through the facts in
order to understand the EPA's rules on impartiality and peer
review panels and how they are applied in this case. Does the
fact that Dr. Rice believed that the evidence supported banning
deca and that reasonable alternatives exist to deca mean that
she is impartial when it comes to developing a toxicological
assessment of the chemical? Is a determination about banning
deca or that alternatives exist a separate issue from the types
of issues Dr. Rice reviewed as a member of the deca panel? Does
expressing any opinion on toxicity of a chemical prevent you
from serving on a peer review panel on IRIS matters? These
matters are not black and white and I think it is fair to say
that reasonable minds can disagree about when a person's
opinions or professional experience might cause them to be
impartial on a certain issue. I hope the witnesses today will
give us some guidance on this issue and their thoughts on
whether the EPA process are sufficient or whether they can be
improved.
Finally, Mr. John Stephenson of GAO is here to discuss his
office report on the recent changes to EPA's Integrated Risk
Information System, or IRIS. EPA made a number of changes to
the process to allow for participation by other government
agencies, the Office of Management and Budget, and the public.
The GAO report contends that these changes have slowed the IRIS
review process almost to a halt. I am interested in learning
why EPA made the changes it did and whether the process can be
improved so IRIS risk assessments are completed in a timely
manner, but again, I think we should not rush to conclude that
simply because changes were made that they were made by this
Administration that they are not valid reasons for interagency
involvement in the IRIS process, and that is my point. It is
one thing to conclude that EPA has been slow to adopt the
prevailing science and has made the wrong policy decisions. It
is an entirely different matter to attribute that mistake to
political or industry interference. That is a serious charge,
and if it is happening, EPA must be held accountable, but we
need to do our work and make sure that the facts support the
charge.
Thank you, Mr. Chairman. I yield back the balance of my
time.
Mr. Stupak. Thank you, Mr. Shimkus.
Mr. Dingell for an opening statement, please.
OPENING STATEMENT OF HON. JOHN D. DINGELL, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Dingell. Mr. Chairman, thank you.
First of all, this is an important hearing, and second of
all, I thank you and commend you for holding it.
Scientific integrity is an essential ingredient of every
decision that is made by the Environmental Protection Agency.
Unfortunately, there is a substantial question as to whether or
not that is always the case. I would note that this has been a
continuing problem to me and to this committee for years, and
it appears to be continuing under the current Administration.
So the question here is, is this the case under the current
Administration and why is there a problem under this
Administration?
There is growing evidence that the Congress, the States,
the local governments, the public, and even other countries
cannot rely on EPA for honest science. I repeat, I have found
that to be the situation which has confronted this committee
for a number of years.
The landmark survey of EPA scientists conducted by the
Union of Concerned Scientists, UCS, confirms what many had
feared, that the Bush Administration's political interference
now going on with EPA scientists is both pervasive and
frequent.
The UCS scientist survey found that more than 500 EPA
scientists knew of many or some cases where EPA political
appointees had interfered with scientific decisions.
Nearly 100 EPA scientists identified the White House Office
of Management and Budget as the primary source of external
interference and more than 500 scientists said they feared
retaliation for speaking candidly about EPA's scientific work.
Clearly then, there is reason to believe we are not talking
about an isolated instance.
The testimony we will hear today exposes a broad pattern of
political meddling by the Bush Administration directed at EPA
scientists and its science.
The prime example of the Administration's recent changes to
the Integrated Risk Information System, IRIS process, under
which chemicals are evaluated to determine the extent to which
they may be hazardous to the public health, is a matter of
concern to the committee. For 20 years, government agencies
both here and abroad have relied on IRIS for scientific,
reliable information on the human health effects of hundreds of
widely used chemicals. Drinking water standards and workplace
exposure standards are based on scientific data contained in
the IRIS database.
Undeterred by the success of the IRIS system, however, the
Bush Administration has changed the IRIS process to all but
halt the addition of new chemicals to the database. What was
once a careful and thoughtful scientific process managed by EPA
scientists has become a cumbersome, bureaucratic, political
exercise run by OMB, and the studies and the analysis that you
have on this matter, Mr. Chairman, will tend to buttress the
complexity that is now built into this system.
Under the new system, the two largest polluters in the
United States--the Department of Defense and the Department of
Energy--are permitted to provide secret comments to OMB, which
then has the final say on what goes into the IRIS system. We
must inquire why these two agencies should be permitted to
submit secret comments to OMB and why it is that even EPA is
not permitted to see these comments. It raises questions as to
the worth of the system under this kind of curious
modification. And because all of this is now done in secrecy,
it is entirely unclear as to who has or does not have a hand in
the process. In short, what was once a process marked by
transparency, candor, and credibility is now apparently marked
by secrecy, manipulation, influence, and probably connivers.
Mr. Chairman, I particularly want to welcome to this
hearing Dr. Deborah Rice, chief toxicologist for the State of
Maine. Dr. Rice's removal from the IRIS peer review panel at
the request of the chemical industry is curious, and it is to
be assumed that this is because she testified before the Maine
Legislature. Clearly, this is disgraceful. I look forward to
hearing from EPA management about specific steps they are
taking to rectify these problems and to protect the scientific
integrity of the Agency and at the Agency. I also will look
forward to hearing from the Administration what they propose to
do to see to it that the taint of possible political
manipulation or influence at the IRIS process is corrected in a
proper fashion.
Mr. Chairman, I thank you.
Mr. Stupak. I thank the chairman.
Mr. Barton for an opening statement, please.
OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Barton. Thank you, Chairman Stupak. Thank you for
convening this hearing concerning the Environmental Protection
Agency.
Republicans on the Committee welcome oversight of the
Environmental Protection Agency. The topics discussed in this
hearing, the EPA's Integrated Risk Information System, the
composition of EPA peer review panels, and the management of
Superfund sites are all important issues and important to
public health. The title of this hearing, however, does trouble
me. It in itself could be considered to be an attack on the
EPA, or if you want to say, a surrogate attack on the Bush
Administration. The title of this hearing makes a serious
charge that science at the EPA is under siege and that its
integrity may have been compromised. Has this really happened?
Have scientific conclusions been improperly influenced by
politics or by interested parties? These are certainly critical
questions but somehow I don't believe that we are going to get
too many facts at this hearing to really answer those
questions.
The Majority offers three case studies today to make the
argument that the EPA and its scientific conclusions have
somehow been improperly influenced. One case involves changes
to the IRIS system, which were the subject of a GAO report
issued last spring. The second involves a Hercules Superfund
cleanup site in Georgia, which has been the subject of some
dispute due to the cleanup methods that the EPA adopted for the
site. The third is a peer review of a chemical used in flame
retardants known as deca that took place in early 2007 for the
purpose of including certain information on the aforementioned
IRIS system. Reviewer's comments were struck from the peer
review report after concerns were raised about a potential
conflict of interest. Both Dr. Deborah Rice, the reviewer, and
the American Chemistry Council, the group that raised the
concern to EPA, will testify today and I think that is a good
thing. We will also hear from two organizations, the Union of
Concerned Scientists and the Natural Resources Defense Council,
about their experiences with the EPA decision making.
I am not prepared today to conclude one way or the other
whether the Agency was right or wrong or whether they
influenced data. In the Hercules case, for example, the
Committee has not even talked to the EPA project managers who
oversaw the cleanup to get a sense of why they adopted the
cleanup method that they did or why they didn't use certain
technologies to detect chemicals at the site. As far as I know,
no documents have been requested from the EPA or, for that
matter, anyone else. I understand that the Majority may suggest
that EPA improperly relied on a particular journal article
because a journal has an affiliation with industry. The
Agency's reliance on the article and its role in determining
the Hercules cleanup is a legitimate scientific issue. But at
least in my opinion, without talking to the people involved and
obtaining the documents, it is somewhat of a leap to judge the
EPA's motives. Shooting first and asking questions later does
get results, especially if you hit your target, but better
science probably won't be one of them.
The bottom line is, Mr. Chairman, that whether we are a
Republican or a Democrat, we all want the EPA to develop and
use the best science possible, and I emphasize the best science
possible, when making regulatory decisions. An agency like EPA
that is entrusted with the public health cannot be allowed to
ignore honest scientific reports. It must be required to apply
the data objectively but science is progressing and science
does change. Good faith disputes about what the data is are
just that, good-faith disputes. What we conclude from those
data points, we can all have a different opinion, especially
experts. It happens all the time. We should be very careful
before we assign motives to those disputes and attribute
differences in opinion to political meddling or industry
influence. It is our job to keep an eye on both the politics
and the science as members of this oversight subcommittee but
it is not our job sometimes simply just to shoot at specific
targets for political purposes.
We are having a hearing today, and again, I am not opposed
to having this hearing, but I do think that we should have
scheduled this particular hearing 2 years ago when the new
Majority took over. I think it is a legitimate question for a
different political majority to want to have an honest review
of a different politically affiliated Administration's opinions
and perhaps even system review processes about issues of this
type. I don't really have a problem with that. But we are
having this almost the last week that we are scheduled to be in
regular session and it is just simply not the time to find the
kind of facts and to develop the kind of database that we
really need to develop if we are going to make some conclusions
about the EPA, as the title of the hearing puts it, being under
siege.
Our oversight and investigation responsibility, and I mean
this, this subcommittee and the full committee under the
chairmanship of John Dingell in the past and Mr. Bliley, Mr.
Tauzin and myself in the recent past and now in the current
sense with you, Mr. Stupak and Mr. Dingell as the full
committee chairman is probably, and I shouldn't even say
``probably,'' I will say it is the most effective oversight
operation in the House of Representatives, so we should use it
in an objective fashion to get the facts and then come to the
conclusions.
Mr. Chairman, sometimes the risk of overlooking a problem
is outweighed by the risk of underinvestigating one, and I
really hope now that we have started this, and I mean this, let
us really get all the facts. We all need an EPA that is
objective. We all need an EPA that does use the best science
and we all need an EPA that does provide the Congress and the
country with the optimal solutions to our environmental
problems. So again, I have no problem with this hearing. I do
have a little bit of a problem with the timing of it and I hope
that as we progress in this particular inquiry, that we do get
the facts before we come up with conclusions.
With that, Mr. Chairman, I certainly respectfully yield
back my time.
Mr. Stupak. Well, thanks, Mr. Barton, and specifically as
to the Hercules cleanup, you raised a couple of questions there
and I just wanted to let you know that the committee staff on
both sides have done due diligence here. We did invite the head
of the Superfund program to testify but they said they couldn't
make it. We specifically asked for a briefing on Hercules prior
to the hearing. We are still waiting for the briefing. We also
invited the EPA to send a witness from Region 4 who would be
familiar with the site but again, we are still waiting for an
answer from the EPA whether or not these people can testify.
And you are right, we are running out of time so I guess bob-
and-weave can only go so long, so we had to have our hearing.
So some of those concerns are valid but I want you to know, we
did ask for those witnesses because we do always try to have a
full, complete hearing. Once in a while we just have to move
forward if an agency is not going to cooperate with you and we
didn't think a subpoena was necessary at this point in time.
Maybe it will be in the future on this issue.
Mr. Burgess, opening statement, please.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. Thank you, Mr. Chairman, and I appreciate the
recognition. I am going to submit my opening statement for the
record because this is an important hearing and I do want that
recorded but I do want to go off topic for just a moment and
talk about something else because we are up against the end of
a session and our time is limited.
This committee, this subcommittee in particular, has taken
a leadership role with issues relating to individual privacy.
We have focused on privacy-invading practices such as
pretexting, spyware, and hacking. We recognize correctly the
pernicious effects of information theft, identify theft, and
theft of information in a free society, but this morning we are
faced with stories on the news wires involving a governor of a
State, a vice presidential nominee, and these assaults on the
privacy of Governor Palin should be aggressively investigated
and the perpetrators prosecuted to the fullest extent of
federal law. This subcommittee has jurisdiction over this issue
and should take the lead in this investigation.
The fact that Governor Palin's e-mail account was hacked
and not only was it hacked but the information was then freely
distributed on the World Wide Web and the information posted
revealed only information of a personal nature because it was a
personal e-mail account. As the Subcommittee on Oversight and
Investigations, let us look to whether appropriate safeguards
are in place by e-mail carriers such as Yahoo, MSN and Google
against the malicious actions of those who would act to violate
the personal privacy of a public individual. Theft of personal
information is an asymmetric threat which can affect any one of
us in public service and certainly any one of the constituents
that we serve. We are obligated to maintain oversight of the
telecommunications industry and ensure that no personal
information is made inappropriately available. And if and when
transgressions are uncovered, they need to be fully
investigated and prosecuted under existing statutes.
Mr. Chairman, I thank you for the indulgence and I will
yield back the balance of my time.
Mr. Stupak. I thank the gentleman for his comments.
Mr. Melancon, opening statement?
Mr. Melancon. No, I am going to waive.
Mr. Stupak. OK. That concludes the opening statements by
members and I am going to ask the witnesses to come forward.
They are already seated, Mr. Stephenson and Dr. Grifo. It is
the policy of this subcommittee to take all testimony under
oath. Please be advised that you have the right under the rules
of the House to be advised by counsel during your testimony. Do
you wish to be represented by counsel?
Mr. Stephenson. No.
Mr. Stupak. Dr. Grifo?
Ms. Grifo. No.
Mr. Stupak. I am going to ask if you would please rise and
raise your right hand to take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect that the witnesses
replied in the affirmative. Each of you are now under oath and
you can give your opening statement. We would ask that you
please try to limit it to 5 minutes, and your full statement
will be made part of the record, so Mr. Stephenson, if you
would like to start, please.
STATEMENT OF JOHN B. STEPHENSON, DIRECTOR, NATURAL RESOURCES
AND ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY OFFICE
Mr. Stephenson. Thank you, Mr. Chairman and members of the
subcommittee. I am here today to discuss our recent work on
EPA's Integrated Risk Information System, or IRIS. It is a
database that contains EPA's scientific position on the health
effects and exposure of more than 540 toxic chemicals. IRIS is
a critical component of EPA's capacity to support
scientifically sound environmental decisions, policies, and
regulations and is a cornerstone of scientific integrity at the
Agency. My testimony today is based primarily on our March 2008
report and additional work we did to support a May 2008
testimony before the Senate.
Our work clearly shows that the IRIS database is at serious
risk of becoming obsolete because EPA has not been able to
complete timely, credible, scientific assessments or decrease
its backlog of 70 ongoing assessments. Efforts to improve IRIS
since 2000 have been thwarted by a combination of factors,
including OMB and interagency reviews, EPA decisions to delay
assessments to wait for new research or additional uncertainty
analysis, and the compounding effects of continuous delays.
Moreover, two new OMB interagency reviews involve other federal
agencies in a manner that limits the credibility of these
scientific assessments and hinders EPA's ability to manage
them. In addition, OMB is inserting itself into the
decisionmaking process by, for example, requiring EPA to
determine five assessments EPA's own Office of Air said that it
needed to help implement the Clean Air Act. The effect of all
of these changes to what should be a purely scientific process
is that chemicals can remain in the assessment process for as
much as 10 years and the backlog grows.
Our report included specific recommendations for
streamlining in the IRIS program, improving the transparency
and credibility of its assessments and ensuring that EPA has
the requisite independence to achieve its goals,
recommendations that EPA in responding to our March 2008 report
agreed to consider. However, when EPA released its new IRIS
process in April 2008, we were extremely disappointed.
The new IRIS process is not responsive to our
recommendations and in many respects is worse than the draft
process we reviewed for our report. For example, the draft
process would have made comments from other federal agencies
part of the public record. The new process expressly defines
such comments as deliberative, excluding them from public
scrutiny in what amounts to a black box. As a result, the first
assessment drafts to become publicly available are provided to
independent peer review committees incorporate undisclosed
changes from federal agencies such as the Departments of
Defense and Energy, the very agencies that may be affected by
the assessments should they lead to regulatory actions. You
cannot on one hand preach sound science and on the other hand
violate one of its principles: transparency.
Mr. Chairman, you will hear EPA say later in this hearing
that the IRIS process is transparent because final assessments
must undergo public and external peer review. However, in our
view, transparency at this late stage after OMB and other
agencies have had multiple opportunities to influence the
content of the assessment without any disclosure of their input
does not compensate for its absence earlier. Instead of
streamlining IRIS, EPA has institutionalized the process that
from the outset will take 6 to 8 years to complete a chemical
assessment. Under those time frames, the scientific assessments
will be obsolete before they can be completed.
To illustrate how bad the situation is, my testimony
includes several examples of dangerous chemicals that are stuck
in the endless loop of assessment and reassessment. For
example, trichloroethylene, or TCE, is a chemical degreasing
agent that has been linked to cancer and birth defects since
1995. It is the most commonly occurring contaminant in
groundwater today and it is used widely by many including the
Department of Defense. EPA initiated a scientific risk
assessment of TCE in 1998. EPA's Science Advisory Board
completed its peer review and released the assessment for
public comment in 2002. DOD and others questioned the
assessment and requested a National Academies of Science
Review. The Academies concluded its review in 2006 and found
that the weight of scientific evidence of cancer from TCE had
actually strengthened since the EPA's original assessment. So
after more than 10 years, EPA's TCE risk assessment is back to
the drawing board and is still not complete and won't be until
2010. In frustration, five Senators who heard about TCE
contamination in the drinking water at Camp Lejeune introduced
a bill last year that would require EPA to issue final IRIS
values and a drinking water standard within 18 months.
Mr. Chairman, as we stated in our March 2008 report, IRIS
is a critical process that is clearly broken and needs to be
fixed. In order to maintain the integrity of the IRIS process,
EPA must streamline its lengthy assessment process and adopt
transparency practices that provide assurances that IRIS
assessments are appropriately based on the best available
science and are not inappropriately based on the policy
considerations of OMB and other federal agencies that have a
vested interest in the results.
That concludes the summary of my statement, and I will be
happy to take questions at the appropriate time.
[The prepared statement of Mr. Stephenson follows:]
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Mr. Stupak. Thank you, Mr. Stephenson.
Dr. Grifo.
STATEMENT OF FRANCESCA GRIFO, PH.D., SENIOR SCIENTIST,
DIRECTOR, SCIENCE INTEGRITY PROGRAM, UNION OF CONCERNED
SCIENTISTS
Ms. Grifo. Good morning. I am a senior scientist and the
director of the Scientific Integrity Program at the Union of
Concerned Scientists, a leading science-based nonprofit working
for a healthy environment and a safer world. Thank you,
Chairmen Stupak and Dingell, Ranking Members Barton and
Shimkus, and members of the subcommittee for the opportunity to
speak to you this morning about the problem of political
interference in science. I thank the Committee for your
oversight and I strongly urge you to keep the pressure on. I
fear long-lasting consequences from both the abuses of science
we have documented and perhaps more so from those abuses still
cloaked in secrecy.
The United States has enjoyed prosperity and health in
large part because of its strong and sustained commitment to
independent science. As the Nation faces new challenges at home
and growing competitiveness abroad, the need for a robust
federal scientific enterprise remains critical. Unfortunately,
political interference in federal science threatens this
legacy. Allowing agencies who may be the source of toxic
chemicals greater control over the scientific information in
EPA's own toxicological database and withholding interagency
correspondence about these scientific assessments from public
view is emblematic of the problem of manipulation, suppression,
and distortion of science at EPA.
While I am sure we can all agree that the Environmental
Protection Agency has a skilled and dedicated set of public
servants that comprise its workforce, our research based on a
UCS census, not a poll--polls and censuses have very distinct
methodologies--conducted by Iowa State University including
responses from 1,586 scientists, combined with essays from 850
of those scientists, forces us to conclude that this is a
troubled agency. Hundreds of scientists reported direct
interference in their scientific work and fears of retaliation
and systemic disregard for the expertise of EPA's advisory
committees. Their good work is compromised by the inappropriate
influence of political appointees at the EPA and other agencies
as well as commercial and other non-governmental interests.
This influence takes the following forms: scientists being
told to exclude or alter technical information in an EPA
scientific document; scientists being told to provide
incomplete, inaccurate, or misleading information to the
public; selective or incomplete use of data to justify a
specific outcome; changes or edits that change the meaning of
scientific findings; disappearance or unusual delay in the
release of scientific information; statements by EPA officials
that misrepresent scientists' findings; and lack of a coherent
and consistent EPA policy that allows scientists to speak
freely to the news media about their research findings.
Our study found that 889 scientists reported personally
experiencing one of these events in the last 5 years. In essay
responses, nearly 100--and we didn't ask them the question,
this came freely, voluntarily--EPA scientists identified OMB as
the primary culprit in this interference. Hundreds of
scientists reported being unable to openly express concerns
about EPA's mission-driven work without fear of retaliation.
The percentage of scientists reporting political interference
was highest at headquarters and at the four program offices
with regulatory responsibilities: Office of Air and Radiation,
Office of Prevention, Pesticides and Toxic Substances, and the
Office of Solid Waste and Emergency Response. The National
Center for Environmental Assessment ranked amongst the worst in
the Office of Research and Development.
A bipartisan Congress passed 12 pieces of legislation that
authorized the Environmental Protection Agency to protect human
health and the environment. By suppressing, distorting, and
manipulating science, the White House has subverted this
mission, making an end run around the legislative branch.
Congress must work closely with the next occupants of the White
House, whoever they may be, to ferret out and address the
changes that undermine robust science and its application to
our Nation's health and environment. When agencies that would
be liable for costly cleanups of environmental poisons are
given expanded influence over EPA's scientific assessments of
chemical toxicity, the public loses.
Fortunately, this is not a problem without a solution. The
EPA should increase openness in its decisionmaking process. If
research results and analysis by EPA scientists are made public
before they drop into the black box of OMB, attempts to distort
science will be exposed. The expanded reach of the Office of
Management and Budget must be pushed back. Questioning the
scientific consensus of agency experts is not the proper role
for the Office of Management and Budget. The GAO should
identify changes that have become embedded in the Agency that
if not exposed will continue to harm scientific integrity. For
example, what has been the impact of centralization of power in
the White House on EPA decisionmaking? What needs to be done to
reverse centralization and restore scientific integrity? How
many agency employees are signing non-disclosure agreements and
why? Are there decisions where political interference has been
exposed that require an immediate review or reversal? All
important questions.
Finally, there are three actions that can and must happen
immediately. The House and Senate overwhelmingly approved
bipartisan legislation to strengthen whistleblower protections
for federal employees. It is crucial that the negotiations
between the two houses come to a close, producing final
legislation that contains strong, specific protections for
scientists who expose efforts to suppress or alter federal
research. EPA should adopt media, communication and scientific
publication policies that ensure taxpayer-funded scientists and
their research are accessible, and the scientists at the Agency
should be proactively made aware of these rights.
And last but not least, just as former EPA Administrator
William Ruckelshaus did 25 years ago, Administrator Johnson
should pledge to operate EPA in a fishbowl. The fishbowl memo,
which set the standard for an agency so open that it regained
the trust of the American people, was reaffirmed by several
subsequent EPA administrators. The original memo, still in the
history section of EPA's Web site, should be moved front and
center to its home page.
We look forward to continuing our work with Congress to
restore scientific integrity to federal policymaking. Thank
you.
[The prepared statement of Ms. Grifo follows:]
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Mr. Stupak. Thank you, and thank you both. We will go to
questions, and I think we are going to go 10 minutes and give
everybody an opportunity so we can move the panels right along.
You both mentioned transparency, the need for transparency
in the deliberations and in reports and studies that the EPA
does, but Dr. Grifo, let me ask you because you have done this
survey, and your survey shows that political interference with
science has increased over the past several years. What do you
think are the consequences of inaction, if nothing happens--you
gave us three recommendations, if the Congress did nothing--
from your point of view, on behalf of the scientists?
Ms. Grifo. From my point of view, I think one of the
scariest things that is going on or come out of my
conversations independent of this survey were conversations
that I have with young scientists at the EPA, scientists who
say to me, we are waiting, we are staying until January,
February to see what happens, but after that, we are leaving
because there is no place in this agency for innovation and for
a young scientist to really blossom and grow. And to me, that
is frightening. We are at a point anyway with the EPA where
retirements are happening because of the date that the Agency
was founded. Many of its scientists are at retirement age, and
if we don't have a young crop of scientists who are
enthusiastically there, I think that is a huge problem, but
obviously there are many other consequences.
Mr. Stupak. In your report, you mentioned, I think, about
500 scientists responded. One hundred mentioned the OMB as
being sort of a source of interference here. Can you give me
some examples of some of those comments? What did they mean,
like source of interference? What did they allude OMB does,
Office of Management and Budget?
Ms. Grifo. There were a number of things, and I want to be
clear that we did not ask them about OMB. We asked them how
could political interference at the EPA, or how could
scientific integrity be restored at the Environmental
Protection Agency, and as you said, nearly 100 scientists came
back and said, you know, it is about OMB. Some of the specific
quotes: ``Restrain the Office of Management and Budget. This
administration has not only watered down important rules
protecting public health, they have also altered internal
procedures so that scientific findings are accorded less
weight.'' Another one: ``In this administration, self-
censorship is almost as powerful as the political censorship.
Options that OMB or the White House wouldn't like aren't even
put forward,'' and I think that is another serious issue. I
think if the line is unclear in terms of what you can say or
do, you don't even want to come near that line and so we find
scientists not even approaching a study that they think could
potentially be controversial, and so on. There are many, many
comments and they are all on our Web site.
Mr. Stupak. Thank you.
Mr. Stephenson, if I may, I said that you had mentioned
transparency in your testimony, and why is transparency
important in this process?
Mr. Stephenson. Well, as I mentioned, it is a principle of
sound science, and even the appearance of a conflict of
interest is a problem, and what EPA has been doing lately is
mixing the science part of risk assessment with the management
and policy part. The science is the science. I can imagine a
situation where an agency would have a piece of research that
should be held deliberative. The science is the science so the
facts drive that. So if they want deliberative comments in the
policy or the policymaking part of this, that may be OK,
although I think the entire agency should be transparent.
Mr. Stupak. So is it fair to say the policy is spilling
over into the science part of it as to whether--like TCE, you
mentioned TCE in your testimony--or not that should be listed
as a cancer-causing agent. The science is one thing, policy is
another thing, how you handle it. They should be independent of
each other, should they not?
Mr. Stephenson. Right, and you have to do reassessments at
least every 10 years on all the 500 chemicals that are in
there, so if you are constantly reevaluating or holding until
additional research is done, there is lots of problems beyond
just transparency just in the length and the cumbersomeness of
the process itself. We have to get this done quicker.
Mr. Stupak. Well, the reason why I mentioned TCE, this
subcommittee has held a number of hearings on TCE at Camp
Lejeune which has gone way, way back many, many years and we
are still trying to get some kind of IRIS completed on TCE so
we can begin the process and the policy decisions can take
place and different administrations are going to disagree how
you handle it, but how do we move past that? How do you get TCE
on the IRIS? It has taken how long? Eight years? And is it
completed yet?
Mr. Stephenson. Ten plus. That is just one example that we
used. We offer several specific recommendations in our report
to handle this, for example, giving advance notice when an
assessment is going to begin so that the research can be done
prior to the assessment actually starting. Don't hold up a risk
assessment like TCE for 2 years waiting for the National
Academy to come up with additional information and then that
information simply confirms what EPA has already done. Do that
before that. The IRIS is supposed to capitalize on existing
scientific research. It is not doing anything new. Why does
that process take 10 years to assemble the best available
science on a given chemical?
Mr. Stupak. Well, if EPA had already made its decision and
required the National Academy of Science to look at it, they
reaffirm what EPA did, then why don't we have TCE out there as
on the IRIS and here is the risk associated with it?
Mr. Stephenson. That is a very good question. I can't
explain that.
Mr. Stupak. Do you know of any scientific information that
would prevent that from happening?
Mr. Stephenson. We are not a science organization but we
can read the research and we can read the science. What we are
suggesting, there needs to be more organization in this
process. TCE was done under the old process before comments
were declared deliberative and it took that long in the old
process. Now there are several new steps that have been
introduced into the new process like the two new OMB reviews.
OMB contends that EPA owns the process. All throughout our
investigation they said EPA owns this process yet if you look
at the OIRA part of OMB, they recognize that EPA loses control
of the process once the assessment goes to OMB, so it is a left
hand-right hand syndrome at OMB.
Mr. Stupak. So why is OMB's process in the dark? Why is
that not open to transparency?
Mr. Stephenson. Well, it is not OMB. OMB is trying to
facilitate and coordinate interagency comments, from DOD, from
the Department of Energy, but why that shouldn't be done in the
open for a scientific process like a risk assessment, we can't
explain.
Mr. Stupak. Well, in this flow chart--and Kyle, if you can
bring up the flow chart. Bring up the one, the current one,
post April 10, 2008.
[Chart shown.]
Mr. Stupak. And the reason why I bring that one up, it is
pretty wild, but not only is it hard to follow, but it looks
like it is open to review until we get to the OMB part, then we
go into sort of like secret and then it pops back out and there
is some more review and then we go back into OMB again, we are
secret, then we get right back to OMB one more time, the final
process. Why is this process open, closed, open, closed
throughout this? Any justification for it?
Mr. Stephenson. From an interagency comment point, it is
closed until the assessment becomes final and then it is
provided to the general public, it is peer reviewed, but no
one, no scientist, the general public, nobody knows what kind
of input that the Department of Defense or the Department of
Energy or OMB for that matter might have had. We don't--nobody
knows. The point is, the public has to have confidence that
this scientific assessment is done in the sunlight, and this
particular process doesn't support that objective.
Mr. Stupak. And this process probably doesn't show it. Is
it safe to say, does EPA even own this process anymore? Is it
basically OMB that controls this process?
Mr. Stephenson. Well, it depends upon which part of OMB you
ask, but the management part will say that EPA owns the process
but when you look at the part reviews, the OIRA part of OMB
admits in the part reviews that EPA loses control of that
process once the assessments are submitted to OMB.
Mr. Stupak. EPA is always going to say they control the
process because it is supposed to be their process but from the
testimony and studies I am seeing, OMB looks like they control
it. So you as a member of Government Accountability Office,
what is your assessment? Who owns this process? Who is
controlling this process, EPA or OMB?
Mr. Stephenson. We couldn't get past asking OMB the
question. OMB says EPA owns it. It appears to us that OMB owns
the process at a certain phase.
Mr. Stupak. So it would appear that OMB owns the process?
Mr. Stephenson. EPA can't move forward on a risk assessment
until it gets clearance from OMB, until the interagency reviews
are complete, so----
Mr. Stupak. OMB coming into this process, this is just--has
this occurred under this Administration or has it happened
under other Administrations?
Mr. Stephenson. OMB has always coordinated interagency
comments on anything. That is one of their functions. That is
part of the M in OMB, the management function to facilitate the
federal family of agencies. However, it should be done in this
case from a scientific process in the sunlight. That is our big
concern with this.
Mr. Stupak. Kyle, go back to Number 1, the first one of
this, the pre-2004.
[Chart shown.]
Mr. Stupak. This is the pre-2004. I don't really see much
where OMB is in that process. They don't have a designated spot
in there, do they, where they would come into this process
other than overall coordination?
Mr. Stephenson. No.
Mr. Stupak. OK. Then Kyle, go to the second one, and this
is from 2004 to 2008.
[Chart shown.]
Mr. Stupak. I see OMB in there two places, Number 9 on the
top there and then Number 13 in the lower right-hand corner
where final OMB interagency review and approval, and then Kyle,
go to the last one. I see OMB, and I am just doing a quick look
here, about three times in it, Number 9 again, Numbers 12A and
12E, and one place earlier too, I guess that would be pretty
close to four of them. But it just seems like this process gets
more bogged down. Have the chemicals being looked at, have they
been--has the process greatly slowed down under this new
schematic?
Mr. Stephenson. It has only been in force since April.
Mr. Stupak. It is hard to say then, I guess.
Mr. Stephenson. What we are suggesting is if DOD thinks
that the research or the scientific evidence isn't sound on a
given chemical, it can request additional studies like it did
on TCE of the National Academies. National Academies is a busy
place. It took them 2 years to complete their assessment, which
reaffirmed what EPA had already said when it amassed the
scientific evidence on TCE at the time. So this constantly
repetitive sending it back to OMB, do more research, look at
the sensitivity analysis, do more research, it just never gets
out of this process and it is supposed to assimilate existing
scientific research. It is not supposed to be creating new
research on a given chemical. How can that process take 10
years?
Mr. Stupak. My time is up. Mr. Shimkus for questions,
please.
Mr. Shimkus. Thank you. I want to ask Ranking Member
Barton, do you still want to--all right.
Kyle, if you would put the messy one up.
[Chart shown.]
Mr. Shimkus. No one is going to try to defend this process,
no one, so that is just bureaucratic slowing down the processes
and it is not efficient and you will find no one on our side
trying to defend that, and that definitely has to be
streamlined.
Dr. Grifo, who funds the Union of Concerned Scientists?
Ms. Grifo. We are funded by our membership and by
foundations.
Mr. Shimkus. And can you name the foundations?
Ms. Grifo. Not all of them. They are in our annual report
on the Web site but I can name the ones, a couple--Hewlett
Foundation, Packard Foundation, it is a long list.
Mr. Shimkus. Can you tell me how this report that you
published was peer reviewed, and was it done as we expect the
EPA to do it publicly and externally?
Ms. Grifo. Yes.
Mr. Shimkus. And can you tell me who peer reviewed it?
Ms. Grifo. Yes, it is on the acknowledgements page, roman
numeral VII. It is listed David Michaels, Mike Walsh, Eric
Shaffer, Molly Churchill, Rick Melburth, Michael Halpern, Kathy
Rest, Kurt Gottfried, and an unnamed former EPA scientist
providing valuable comments. We also had a steering committee
early on in the process as well.
Mr. Shimkus. Obviously I am going to base most of my
questions on the CRS report because my frustration is, you want
it both ways. I think because you knew we had the CRS report,
then you had a chance to respond in writing, which is in the
binder, but at one point you say it was a census but then in
your testimony in the questions you say, well, we are going to
extrapolate this to the whole body. You really can't have it
both ways. Either it is a census or it is a credible poll that
you can extrapolate to the whole body, and for scientists to
claim support of the scientific method and not use a scientific
process is frustrating. Some examples, on page 2 of the report,
the CRS report states that what constitutes such interference
as opposed to editorial differences and policy or substantive
disagreements is not spelled out for the respondents. One
person's political interference might be another's heavy-handed
editing. The report gives us examples of political
interference. Aside from that, how do you define it?
Ms. Grifo. It is actually defined in the questionnaire that
the scientists had.
Mr. Shimkus. Well, I am asking, how do you define it?
Ms. Grifo. Well, I can refer you to that page in the report
where it specifically lists a specific--it is on page 73 of the
report and it is a very long list of about 10 different things,
and this is the list that was given to the scientists when they
were given this to respond to.
Mr. Shimkus. How do you answer the concern that the way you
phrase questions about political interference may have in fact
influenced the way people answered these questions?
Ms. Grifo. We used political interference twice at the very
end of the survey and where we used it was just above this list
where we defined it. I would also like to say, I think there is
another misconception which is that the entire report and the
conclusions are based on the survey. They are not. The report
is comprised of both qualitative and quantitative information.
I think when we look at the list of incidents, we interviewed
and----
Mr. Shimkus. Let me reclaim my time and stay on this
political interference discussion. Your report in defining
political interference gave a number of examples of situations
that could construe to political interference. These include
directed to exclude or alter technical information in report,
changes or edits during review that change the meaning of
scientific findings. Is it possible that some of these
situations may be the result of good-faith disputes about
science rather than the product of interference?
Ms. Grifo. I think if we look at the long list of incidents
that we have documented at the EPA, I think we would be hard
pressed to call them heavy-handed editing. I think if we look
at, you know, the mercury in power plants, new source review,
OMB and the EPA----
Mr. Shimkus. You know, I can debate----
Ms. Grifo. There is a long list of documents.
Mr. Shimkus [continuing]. New source review from the
electricity generation debate which has a false premise that
when you replace a more efficient generator, that you have to
redo the whole EPA permitting when you get a bigger, higher
input versus that. So I mean, we can talk new source review all
we would like but----
Ms. Grifo. Could we go to page----
Mr. Shimkus. No, ma'am, it is my time. We deal with surveys
and polls all the time. Here is a summary. Terms and phrases
used in the questionnaire are vague. A control group was not
included. Longitudinal analysis was not conducted, which means
this environment of corporate culture at the EPA may have
existed in previous administrations but since you did not do a
longitudinal analysis, you make a political attack on this
Administration based upon an unscientific poll. Some
questions--and this is just from the CRS report. This is not
me. Some questions relied on what the respondent knew of or
hearsay.
Ms. Grifo. That was to get at the culture at the Agency.
That was not to document incidences.
Mr. Shimkus. Hearsay.
Ms. Grifo. In agencies like this, culture is very
important.
Mr. Shimkus. Hearsay, a scientist using hearsay to attack
the scientific process of the EPA. I just find that members of
Congress, if we would use hearsay, we would get held
accountable.
Ms. Grifo. We did not draw our conclusions based on
hearsay. The hearsay was there to measure the culture----
Mr. Shimkus. OK, let us go to another one. The respondents
likely included those beyond the intended sample such as non-
scientists and was biased toward senior scientists. The sample
was not designed so that results can be extrapolated to a total
population.
Ms. Grifo. Yes. Correct.
Mr. Shimkus. But your statement, in your opening statement,
you talk about, you making it widespread abuse. If you are
going to say widespread abuse, what are you saying? We are
going to extrapolate that. So that is why you can't have it
both ways.
Ms. Grifo. Could I respond?
Mr. Shimkus. If it is a census, then you can't say
widespread. If it is a poll that has a sample size and it has
been done randomly, we all know that, how polls operate, then
you could extrapolate for the whole body. But you can't have,
you just can't have it both ways. And I think the frustration
point here is again scientists attacking the Administration and
the EPA using an unscientific poll. The original questionnaire
and data limitations are not included in the analysis. The
conclusions drawn from the analysis may be inappropriate
instances in which no opinion responses to a question exceed 20
percent. And then the results of these investigations show an
agency under siege from political pressures, that is your
comment, on a number of issues ranging from mercury pollution
to groundwater, which you have mentioned, to climate change,
political appointees, the Administration have edited--and here
is a response to that statement. However, depending upon the
population base used, the percentage who personally experienced
at least one incident of political interference is either 56
percent or 15.3 percent, which may influence one's perception
of whether the EPA is under siege. Fifty-six percent, oh, we
got a problem. Fifteen percent, who knows. Maybe disgruntled
individuals.
Ms. Grifo. Eight hundred and----
Mr. Shimkus. In addition, the survey respondents were not
asked questions about specific environmental issues such as
those in the quote mercury pollution. This is not my report,
ma'am.
Ms. Grifo. Well, if I could----
Mr. Shimkus. This is a congressional resource.
Ms. Grifo. You know, later on in the----
Mr. Shimkus. Ma'am, it is my time. So it is unknown as to
which environmental issues survey respondents were referring to
when they indicated political interference had taken place.
That is my frustration. Now you have time, ma'am.
Ms. Grifo. Thank you. Also in the CRS report, they
acknowledge that they didn't have all the materials that they
needed in order to do this analysis. This report was not done
in any sort of consultation with us where we could have
provided them with the screens that the scientists saw when
they took the survey. They didn't have that information. They
didn't have information, other parts of our research
methodology.
Mr. Shimkus. Can I ask a question?
Ms. Grifo. And CRS--could I finish? I think this is my
time.
Mr. Shimkus. No, it is not. Ma'am, it is not your time.
Mr. Stupak. It is technically Mr. Shimkus's time.
Mr. Shimkus. Let me ask why didn't you just do a survey, a
scientific survey with a random sample to be able to
extrapolate to the whole?
Ms. Grifo. Because of the lack of transparency at the
Agency. We did not have access to a full list of the scientists
at the Agency. We had to construct that ourselves. We did not
have the cooperation of the Agency.
Mr. Shimkus. Did you ask?
Ms. Grifo. Absolutely we asked.
Mr. Shimkus. Was it in writing or by a phone call or an e-
mail? Do you have documents that support that request?
Ms. Grifo. We had conversations that we had trying to get
that list.
Ms. Shimkus. Do you have a phone log?
Ms. Grifo. I could probably find one.
Mr. Shimkus. That would be helpful to us. Science under
siege, if you are going to use science to attack that science
is under siege from the scientific community, I would request
that you have scientific background to do that.
I yield back, Mr. Chairman.
Mr. Stupak. Do you want to answer?
Ms. Grifo. I would love to.
Mr. Stupak. I will let you answer. It should also be noted
just for the record, and I am sure Mr. Shimkus realized that
their response to the CRS is found at tab number 29 in our
binder. It is right there----
Mr. Shimkus. That is true, Mr. Chairman, and I think it
would be fair for the Majority and for Dr. Grifo to appreciate
the fact that we are the ones who found the CRS timely manner
to the Majority so you had an opportunity to respond. It was
because of what the Minority did to give you the opportunity to
respond in writing.
Mr. Stupak. It is there. It is exhibit number 30. We never
move until the end of the hearing so without objection, tab
number 29 in our hearing book will be part of the record. We
will do it right now. If you care to respond, I will give you a
minute.
Ms. Grifo. Thank you.
Mr. Stupak. Mr. Shimkus has the right to take all 10
minutes to ask a question if he wants, but you have time and
then we will move on to Mr. Dingell.
Ms. Grifo. Thank you. Many, many things that need to be
clarified. First of all, the CRS report was sprung on us during
testimony at a hearing in May. There was no notice whatsoever.
The response was constructed after that hearing so this was not
a gift from anyone. I think we can turn to the last paragraph,
to the last page of the CRS report, and it says it is
difficult, you know, to tell whether or not any of the
critiques identified above would change the public's perception
of the survey results regarding this issue. Further, it is
important to keep in mind that for many in the science and
engineering community, even one case of political interference
would be considered to be improper. Independence is a critical
part of this community's value system regardless of whether
they are working for government, universities, or industry. In
the response that we did, we go into a lot of the specifics but
I think the key point is the conclusions that we made regarding
those other issues and regarding the Agency as a whole are not
based solely on the survey. They are based on qualitative
research as well as that quantitative research. Both of them
come together to produce those results. As I have said, there
is a long list of examples: mercury in power plants; OMB in
EPA; climate change. I hardly think that removing a reference
to numerous studies such that EPA itself didn't even leave the
chapter in a draft report in the environment in 2003, I think
that is a lot more than heavy-handed editing that we are
talking about here. And there are many examples: particulate
matter; ozone, peer review, risk assessment, IRIS, program
assessment tool rating; EPA and communication barriers;
communication of climate change science; right to publish;
particulate matter; and ozone, I have talked about--and on and
on--lead, NOOx, hydraulic fracturing, library
closures. It is a very long list. I believe that we have a lot
of evidence that supports our conclusion, and I would just end
with the statement that 889 scientists reporting interference
in the last 5 years, that is a number that is far too large to
be acceptable, and at a hearing in May, Dr. Gray accepted that,
that that number was too large. Thank you.
Mr. Stupak. OK. That concludes the questions of Mr.
Shimkus. Mr. Dingell is not back yet so we will go to Mr.
Melancon for questions, please, 10 minutes.
Mr. Melancon. Thank you, Mr. Chairman. I appreciate the
opportunity. I was going to offer Ms. Grifo the opportunity to
comment since the time for the other member had run out.
I guess one of the questions or one of the things that I
have observed in one of my previous careers was scientists that
feel that people are trying to direct their data to where they
want it to go. Is that, do they actually do the science, do the
report and then after the fact OMB and others are trying to
delete or change or alter the outcome, Dr. Grifo?
Ms. Grifo. Yes, I think one of the most startling examples
of that does have to do with mercury and power plants. It has
to do with the example where the clean air mercury rule. This
took place in 2005. We have evidence that the White House and
utility companies and power companies shaped this rule when in
reality it should have been based on the science that was
coming from the scientists at the EPA, and we have significant
documentation to that effect that I am happy to share, and that
is one example, you know, of many that we could bring up.
Mr. Melancon. And Mr. Stephenson, from your perspective,
the analogy that you can't have it both ways, do you feel that
that in fact is the case or do you feel that the information
that you were able to obtain and of course obviously not being
able to follow the paper trail all the way through the process
because it disappears at points in times, do you feel that
there is validity? I have always been a believer if there is
smoke, there is fire. Do you believe that from your review,
from, I would assume your interviews with people within the
Agency, that in fact there is interference?
Mr. Stephenson. We didn't try to ascribe blame or--what
actually transpired. Our problem is with the process itself. No
scientific process should be deliberative. You have just got to
be more organized in these risk assessments than get them done
quicker. We didn't try to say there was political influence or
anything else. We just noted how many times OMB can stop the
process at DOD's direction or anything else, ask for additional
research, ask for uncertainty analysis, ask for a lot of things
and continue to go back to the drawing boards on these
assessments. They simply have to be done quicker than 10 years
if they are going to be effective. We can't leave the public
exposed to a dangerous chemical while we are waiting for them
to complete a risk assessment.
Mr. Melancon. So for either or both, where do we get
someone to give us an objective diagram of how the process
works so that we take manipulation either from the Congress or
from any administration out of the process so that when we are
delivered a report, we know that report has got all the
scientific data right, draw your own conclusions if you would,
but is there a place or an organization that can help us
streamline, as Mr. Shimkus would like to do, which I agree
with, and to make it so that when the data is there, we know
that the data is in fact legitimate scientific data?
Mr. Stephenson. In our view, that is the importance of
transparency for the science to be done in the sunlight so it
would be huge to remove the black box. If the Department of
Defense or Department of Energy or OMB or any other agency, for
that matter, has a problem with the scientific assessments that
EPA has done and has additional research to provide towards
that science, it should be in the public. Why should that be
done in a backroom?
Mr. Melancon. I agree with you. I totally agree with you.
The peer review process, and I think at some point in time they
are talking about looking at what the science, and I think what
happens, my experience has been, scientists just don't go in a
cubicle all day long. They come out and they communicate with
their counterparts what they are thinking, what they are
hearing, what they are seeing, what they are feeling, because
that is where they get the food for thought to go forward. Has
there been a hindrance in that processing do you believe
because of the concern with OMB or any other agency or even the
Congress coming in and somebody--the fear of somebody looking
over your shoulder and saying well, you are going in the wrong
direction? I mean, is there a fear even working with your
fellow scientists that maybe somebody would cause you problems?
Ms. Grifo. In fact, we did ask a question in the survey
about retaliation and fear of retaliation, and hundreds of
scientists reported that but I think what is really telling is
that 492 felt that they could not speak candidly within the
Agency. This is not talking to the press, this is not talking
to colleagues at universities. This is simply within the
Agency, and 382 felt they could not do so outside the Agency,
but setting the survey aside for a moment, there are also many
other examples. If we look at the publication policies, the EPA
peer review handbook, if we look at several scientists
reporting problems with press contacts, if we look at, Dr.
Titus, who was a project manager, was not--had interference in
his desires to have an interview with the New York Times and so
on and so forth. So we also have examples of scientists not
being able to go to meetings. One colleague at a meeting went
so far as to say if the scientist doesn't come, we are going to
have 20 minutes of silence in the place where their talk would
have been because they were so baffled by the fact that this
scientist couldn't come. I think as you have rightly said,
secrecy is an anathema to the scientific process. Scientists
move ahead, the entire process moves ahead through this very
transparent deliberative process, and that I think is a really
frightening aspect of this closed-door deliberations, of these
closed-door deliberations.
Mr. Melancon. How many scientists do you have at the
Agency?
Ms. Grifo. We don't have a number. At the hearing in May,
Dr. Gray, I think, said 7,000 scientists at the EPA.
Mr. Melancon. That is a lot of scientists to be paranoid
now.
Ms. Grifo. Even one would be too many.
Mr. Melancon. Yes, ma'am. Thank you.
I yield back my time.
Mr. Stupak. Thank you, Mr. Melancon.
Mr. Barton for questions, please.
Mr. Barton. Thank you, Mr. Chairman. I am going to focus
most of my questions to Dr. Grifo.
I will just ask a general question to Mr. Stephenson
because we have, one of the examples before us is the removal
of Dr. Rice from a peer review panel on the chemical deca
because she had stated to the Maine Legislature that she
thought deca was a hazard, and if I understand correctly,
should be banned, so they put her on this panel and then the
industry complained that she was on the panel because she had
announced, basically, a conclusion before the panel did its
review. Mr. Stephenson, if you were accused of some crime and
were on trial, would you want somebody on the jury who already
had said publicly that you were guilty?
Mr. Stephenson. Of course not.
Mr. Barton. So there may be a valid reason that Dr. Rice
should have been on that panel but there also appears to be
sufficient reason that she shouldn't have been.
Mr. Stephenson. Well, there are special rules. The peer
review panels are large and balanced intentionally so----
Mr. Barton. But you don't normally----
Mr. Stephenson. One peer reviewer should not theoretically
make a difference.
Mr. Barton. But you wouldn't put somebody on a peer review
panel that already had a conclusion about the subject under
consideration?
Mr. Stephenson. I don't know the situation but logically it
doesn't seem like you would.
Mr. Barton. OK. Let us go to Dr. Grifo. You say in your
written testimony down at the bottom on your introduction, and
I quote, ``Our report documents changes in EPA policies
regarding risk assessments that allow polluting federal
agencies more control over the science.'' What is a polluting
federal agency?
Ms. Grifo. Well, I think in this instance, we were
referring to the Department of Defense and the chemical that
was already alluded to in the GAO report.
Mr. Barton. So you are just stipulating that at least the
Department of Defense is a polluting agency and you used the
plural ``agencies.''
Ms. Grifo. That is one. There are other instances.
Department of Energy. I can provide you with full documentation
of those instances.
Mr. Barton. You just assert that these federal agencies are
themselves polluters.
Ms. Grifo. The federal agencies are responsible for
chemicals that they are releasing in the course of their
mission-driven duties and releasing a chemical that is
potentially dangerous to public health into the environment, I
think we would have to--that would be my definition.
Mr. Barton. So you want us to eliminate or shut down the
Department of Defense and----
Ms. Grifo. No, I want----
Mr. Barton [continuing]. Energy?
Ms. Grifo. Sorry, sir. I didn't mean to interrupt. I think
that there has been in the past a deliberative process that was
more efficient and more transparent by which these things were
resolved. No one is saying that OMB should not have a
coordinating role. I think that is a very appropriate role for
the Office----
Mr. Barton. I didn't ask you about OMB yet. When you make
the assertion that our federal agencies are themselves
polluters, that does show to me somewhat of a bias, at least by
yourself. I would hate to know what you think about the House
of Representatives.
Ms. Grifo. We are all polluters, sir. I will grant you that
point. We are all certainly not perfect in that regard. But I
do think that if an agency is using a chemical or putting a
chemical into the environment that is potentially damaging to
public health, then that is a cause for deliberation and
concern and we need to have a process that respects that.
Mr. Barton. I agree with the last statement. In the second
page, you say, ``The White House has rewritten EPA's scientific
documents concerning climate change and pressured EPA
scientists to support predetermined conclusions regarding
mercury pollution.'' What predetermined conclusions did the
White House pressure EPA scientists to adopt?
Ms. Grifo. I don't think you have to take my word on that.
EPA Inspector General Nicky Tinsley confirmed in February 2005
that EPA scientists were pressured to change their analysis----
Mr. Barton. No, no, I want to know what the predetermined
conclusion is.
Ms. Grifo. Well, this particular example was about the
level of mercury that was allowable under the clean air mercury
rule.
Mr. Barton. But the level, the parts per billion or parts
per million, you are saying that the White House knew
beforehand what the level should be and forced the EPA to put
that level into the rule?
Ms. Grifo. I am saying that the Inspector General----
Mr. Barton. If you believe that, let us document it, OK?
Don't just say it, let us document it. I don't think that
statement can be substantiated but I don't know, but if you
know, let us put that in the record. That is what the oversight
subcommittee is all about.
Ms. Grifo. We will be happy to.
Mr. Barton. Now, later on on this same page you say,
``Political interference has penetrated deeply into the culture
and practices of federal agencies.'' Do you believe a president
of either political party should not have the right to put his
or her political appointees at the top of these federal
agencies?
Ms. Grifo. No, sir, I believe that is entirely appropriate.
Mr. Barton. If it is appropriate, and I agree with you on
that, should not these political appointees have some ability
to oversee and influence the culture and practice of the
federal agency that they are the appointee to?
Ms. Grifo. They should not have the ability to change the
science, to manipulate science----
Mr. Barton. That is not my question.
Ms. Grifo. And I don't think they should have the ability
to intimidate the scientists.
Mr. Barton. You said that----
Ms. Grifo. That is part of the culture, I would say.
Mr. Barton [continuing]. Political interference has
penetrated deeply into the culture and practices of a federal
agency, and I don't know how many federal employees we have on
the Administration side but it is tens of thousands, maybe
hundreds of thousands. We have got, I think, 500 presidential
appointees. Now, I could be wrong on that, and Mr. Stupak or
you can show me, but it is----
Ms. Grifo. Close enough.
Mr. Barton [continuing]. A small number. Those individuals,
whoever is fortunate enough to become President of the United
States, should have the right to appoint his or her appointees
and they should have some ability to influence the culture and
practice of that agency. If they don't, they shouldn't be
there. They should not be there. Now, so to make a statement
that the fact that they are appointees and the fact that they
try to manage, that somehow political interference is a
pejorative term. They shouldn't be there if they don't try to
manage in some way the agencies. Now, on page 3 of your
testimony, and you underlined this with a bullet point, you
say, ``Interference can take many different forms including
falsifying data and fabricating results.'' Can you give any
specific examples where a political appointee has flat
falsified the data or fabricated results?
Ms. Grifo. Yes, sir.
Mr. Barton. Can you give one off the top of your head?
Ms. Grifo. Off the top of my head, I would say this is an
example of both the things that we are talking about. I am
thinking of Assistant Deputy Secretary of Interior, Julie
McDonald, calling biologists in the field and bullying them
into reaching conclusions that----
Mr. Barton. Wait a minute. Wait a minute. Making a phone
call is not----
Ms. Grifo. Well, let me finish.
Mr. Barton. Falsifying data is----
Ms. Grifo. We have her changes, track changes----
Mr. Barton. You tell me the data point is 10 parts per
million and I say no, no, it is not, we are going to put that
it is 5 parts per million or we are going to put it as 100.
That is falsifying data. Having a difference of opinion or
challenging an assumption or a conclusion is one thing, and
that may be wrong past a certain point in time, but that is not
what you say. You said they falsify data and they fabricate
results. Now, if you all can prove that, Mr. Stupak and Mr.
Shimkus and myself and Mr. Dingell, we want to know it. I mean,
that is fraud.
Ms. Grifo. Yes, sir. Can I direct you to our A-Z guide to
political interference in science? We have nearly 90 examples
there of exactly what we mean by political interference. Every
single one of them is----
Mr. Barton. Well, wait a minute. You are changing the
terminology. We are not talking about political interference,
we are talking about falsifying data.
Ms. Grifo. Well, that is one of those kinds of----
Mr. Barton. Fabricating a result, now, that is different.
Now, my time is just about up, so I want to put something in
the record, Mr. Chairman, and we will give it to the Majority
staff before you agree to put it in but I am going to read from
it because later on in her testimony the doctor talks about
climate change and greenhouse gases and how that has been
impacted. I haven't verified this but I want to get your take
on it. This is a gentleman named David Evans. He is an
Australian scientist, and he participated in the Kyoto Protocol
and I am just taking his word so I can't verify under oath this
is true. I am going to quote, ``I have been following the
global warming debate closely for years. When I started the job
in 1999, the evidence that carbon emissions caused global
warming seemed pretty good. CO2 is a greenhouse gas.
The evidence wasn't conclusive but why wait until we were
certain when it appeared we needed to act quickly. Soon the
government and the scientific community were working together
and lots of science research jobs were created. But since 1999,
the new evidence has seriously weakened the case that carbon
emissions are the main cause of global warming, and by 2007,
the evidence was pretty conclusive that carbon played only a
minor role and was not the main cause of the recent global
warming. As Lord Kean famously said, when the facts change, I
change my mind. What do you do, sir. There hasn't been any
public debate about the causes of global warming and most of
the public and our decision makers are not aware of the most
basic facts. Number one, the greenhouse gas signature is
missing. We have been looking and measuring it for years and
cannot find it. Each possible cause of global warming has a
different pattern everywhere in the planet the warming occurs.
The signature of an increased greenhouse effect is a hot spot
about 10 kilometers up in the atmosphere over the tropics. We
have been measuring the atmosphere for decades using radiosons,
which are weather balloons with thermometers that radio back
the temperature as the balloon ascends through the atmosphere.
They show no hot spot whatsoever. If there is not a hot spot,
then an increased greenhouse effect is not the cause of global
warming. So we know for sure that carbon emissions are not a
significant cause of global warming. If we had found the
greenhouse signature, then I would be an alarmist again. When
the signature was found to be missing in 2007, after the latest
IPCC report, the alarmists objected that maybe the readings of
the radioson thermometers might not be accurate. Maybe the hot
spot was there but had gone undetected. Yet hundreds of
radiosons have given the same answer so statistically it is not
possible that they have missed the hot spot. Recently the
alarmists have suggested we ignore the radioson thermometers
but instead take on radioson wind measurements, apply a theory
about wind shear and run the results through the computers to
estimate the temperature. Then they say that the results will
show that we cannot rule out the presence of a hot spot. If you
believe that, you will believe anything.'' Do you think that
the Bush Administration has prevented this information from
being public?
Ms. Grifo. Is that to me?
Mr. Barton. Yes, ma'am.
Ms. Grifo. No idea.
Mr. Barton. Well, do you have an opinion?
Ms. Grifo. No, not my issue. Climate change is a
complicated debate.
Mr. Barton. Not your issue?
Ms. Grifo. No, I think----
Mr. Barton. You talk about patterns of abuse.
Ms. Grifo. Could I finish?
Mr. Barton. Scientists studying what may very well be the
most profound global change of the century, global warming, are
effectively barred from communicating their findings to the
news media and the public.
Ms. Grifo. Well, that I am happy to discuss. I mean, we do
have------
Mr. Barton. That is what I am asking about.
Ms. Grifo [continuing]. Examples of interference. We do
have many examples. I think James Hanson achieved great
notoriety.
Mr. Barton. Do you think that this might be an example of
the scientific community not wanting to acknowledge an
unpleasant fact, that in fact you can't prove that manmade
CO2 is a cause of global warming and it may be the
scientific community whose theory is wrong and so they don't
want to publicize this? You know, this isn't OMB preventing
this from becoming public or Dr. Johnson at the EPA or some
assistant secretary or something.
Ms. Grifo. The IPCC is a very thorough process, very peer
reviewed, very well constructed. It is the gold standard for
this information. I am sure that they have considered and
deliberated that gentleman's opinion and I am sure----
Mr. Barton. And I don't know that it is----
Ms. Grifo. But I don't know that it was suppressed. I have
no evidence of that. If you have evidence of that that you
would like to----
Mr. Barton. No, ma'am, I am not the one alleging
suppression.
Ms. Grifo. I am happy to investigate it and add it to our
list of examples, if you have that documentation.
Mr. Barton. Mr. Chairman, I have abused the privileges of
the subcommittee in terms of its time commitment.
Mr. Stupak. I was going to remind you of that.
Mr. Barton. I will submit this for the record if the
Majority and you determine it is worthy of being included, and
I do ask our Dr. Grifo to please supply the subcommittee with
specific facts and not just opinions and we will investigate
those facts and see where they lead.
Thank you, Mr. Chairman.
Mr. Stupak. Sure, and as to Dr. Grifo and the facts, their
report is under tab number 2 and has pretty much very specific
examples from former EPA Director Christie Todd Whitman and
others, so I think a lot of the stuff you are asking for is
probably there. As far as this report on climate change from
the Australian newspaper, this really isn't a hearing on
climate change but I have no objection if you want to include
it in the record.
Mr. Barton. Well, if there is no objection, I would like it
to be in the record, but I cannot verify that what it says is
totally true but it is something we need to look into.
Mr. Stupak. Right. Maybe we ought to have Mr. Evans come
here on a climate change hearing.
Mr. Barton. That might be a good idea.
Mr. Stupak. Thanks.
Mr. Stupak. Mr. Inslee for questions, please.
Mr. Inslee. Yes, that author of that report that Mr. Barton
is quoting could arrive on his UFO that he has told us about as
well. If the definition of successful political appointees are
ones that do in fact affect science, then this Administration
has been supremely successful. There is no question about that,
because they have suppressed it every chance they can and it is
pretty obvious it has gone on. We have seen it on multiple
occasions from Julie McDonald on up, and it is perverted
science and it has perverted what the taxpayers have paid for
and I don't really even think we need a study to know that. If
you talk to people at the EPA like I do, you just simply know
that. When I get on the ferry boat and talk to my neighbors who
work for the EPA, you know that, and you know it from the sort
of macro view. You know it because in December of 2007, the EPA
scientists essentially recommended allowing States to limit
greenhouse gases from cars and trucks and then the political
appointees deny that and refuse to allow that to happen. Now,
we know that. There is no dispute about this. The scientists
made a recommendation. The political appointees denied it. It
is out in the open, and that is a fraud and that is a travesty
and that is a rejection of science that is right out in the
open. We don't even have to have surveys about it. July 11,
2008, the EPA political appointees decided not to take any
steps to regulate greenhouse gases despite the fact they have
been ordered to do so if it affects human health. They have
concluded it does, but right out in the open, this was a bank
robbery out in the open, this wasn't at night. I mean, and I
really respect the people who work for the EPA who are trying
to do their jobs under these very, very difficult situations,
and I just want to tip my hat to them. It would be so easy to
be totally demoralized to do good science, to give it and then
have it squashed by the Bush Administration must be very
difficult for them and I want to honor them, and I want to tell
you why I am so concerned.
If somebody would put up this picture here, my staff can
help me, a little picture of what is at stake here. This is a
photograph of the--actually a graphical representation of
satellite information of the poles, the Arctic basically
showing the summer ice, the September ice in the upper left-
hand corner showing September 1979. The sort of light blue is
what is called the very new ice, the very, very thin ice, and
the white is the permanent ice, the long-term ice. Then you go
to down below that to September 1989, you see a very
significant reduction in the permanent or essentially long-term
ice. You go up in the right-hand corner, you will see September
1999, a continued reduction, and this is what is stunning.
September 2007, the bottom right-hand corner, the only new ice
are just basically little tiny vestigial remnants of the white
down at the bottom. We have had an absolute collapse of the
Arctic while we are sitting here debating about whether the
Administration has suppressed science in the EPA or not. It is
pretty doggone clear that this Administration has suppressed
the single-most important scientific inquiry probably in human
history in this issue of how rapidly this is happening, and I
want to show this because this is grounded in the real world.
In the Arctic, if people understand how important this is, this
is the heat shield for the planet. John Glenn, if you remember
when he came in, he had the heat shield. It shielded him. This
is the heat shield for the planet earth because it reflects
massive amount of radiation when there is snow there, but when
there isn't ice there, the ocean absorbs the energy, and this
is a tipping point potentially that the scientists are so
concerned about.
So to me, I appreciate our two witnesses today but it is so
obvious that the Administration has suppressed and ignored
scientists that it is not a survey that is private, it is a
public rejection of science that we have witnessed, and it
portends potential fairly cataclysmic results, and I am
astounded that we are still having these discussions, but we
are, and I just look forward to January 20, 2009, when this
country can get back to the job of science. If anybody wants to
comment on that, go ahead. Anybody want any comment?
Ms. Grifo. Touche.
Mr. Inslee. Thank you.
Mr. Stupak. All right. Mr. Shimkus has a question.
Mr. Shimkus. Just one follow-up. Dr. Grifo, you mentioned
the names of the peer reviewers who did your report. Were any
of those inside of your organization that were not outside?
Ms. Grifo. Two.
Mr. Shimkus. And can you name the two?
Ms. Grifo. I think it was Kathy Rest and Michael Halpern.
Mr. Shimkus. Kurt Gottfried.
Ms. Grifo. Kurt is not inside. He is on our board but he is
a physicist----
Mr. Shimkus. He is not just on the board, he is the
chairman.
Ms. Grifo. He is, but he is also a physicist at Cornell
University.
Mr. Shimkus. So there are three?
Ms. Grifo. Yes. Well, about your definition of inside, but
I will grant you that----
Mr. Shimkus. That is our problem. Yes, is that typical for
peer-reviewed scientific reports to be peer reviewed by people
within the organization?
Ms. Grifo. It is very typical for people within an
organization to comment on a report. They are included in the
list----
Mr. Shimkus. But to use that as the official peer review?
Ms. Grifo. There are other names on that list that are not
within the organization that are part of the official peer
review. I was talking about the review of the documents in
general since----
Mr. Shimkus. As you know, we have problems with your
presentation today.
I yield back. Thank you, Mr. Chairman.
Mr. Stupak. Let me ask this question, and I will ask either
Mr. Stephenson or Dr. Grifo. Peer review, explain it, what does
it do, peer review?
Mr. Stephenson. She is the scientist.
Mr. Stupak. OK. It is my understanding you gather
information. You are asked to look at it. You gather
information and then you do your individual assessment. In this
case, it would go, let us say, to the EPA and the EPA would
draw conclusions based upon the peer review. It is not unusual
for a peer review panel to have someone who may be in the
industry, outside the industry, academia. Is that basically a
peer review? You get people from all over, some whom might come
with some preconceived bias on this chemical and some who would
be just the opposite and academia and they look at the
unisphere or the universe of information and then they make an
assessment and they submit it to the Agency. It is the Agency
that makes the final decision, correct?
Ms. Grifo. Yes. I think what is important is to distinguish
between scientific advisory committees and scientific review
versus a stakeholder committee, and I think we have both kinds
of committees that are out there considering information and
advising agencies. I think on a stakeholder committee, you do
in fact have multiple points of view, you know, you do have
conflicts of interest. People are representing industry,
representing different aspects of society, but the key is that
a stakeholder panel should not make scientific judgments. I
think the topic that we have been dancing around here is that
there is a difference between scientific conclusions and a
political decision, a policy decision. ``Political'' may be too
loaded a word, a policy decision, and I think the root of the
problem that we have seen at EPA and multiple other agencies is
the firewall that should be between those decisions has come
down. You don't interfere with the science. You take the
scientific conclusions, as a policymaker you can ignore them if
the statutes will allow you.
Mr. Stupak. So the peer review would look at the
information, give it to the policy side and policy decision
makers make the decision?
Ms. Grifo. Depending on the statute that is governing. But
I think the other thing is, on a strictly scientific review
panel, you do want to look at conflict of interest, you want to
look at financial connections. It is a very different kind of a
group of people that is convened for a different purpose.
Mr. Stephenson. Could I add, from a layman's point of view,
the peer reviewer is there to assert to the reasonableness of
the scientific approach. There are very specific rules
governing the makeup of peer review panels that they must be
balanced, so you don't have to be a scientist to understand the
rules of peer review. You can argue with whom is on the peer
review but all agencies and all scientific organizations that
use peer reviewers are very careful about making sure there is
a balanced makeup across that, and EPA is as well.
Mr. Stupak. So a peer review panel would look at this
document that Mr. Barton put in the record, the Australian, and
Mr. David Evans, who disagreed with global climate change, if
they were looking at climate change, they might include that
one or they might----
Mr. Stephenson. Well, the IPCC would look into the basis
for that conclusion, the evidence that he used to draw that
conclusion and talk about the reasonableness of that.
Mr. Stupak. And one person may submit it in their
assessment where another peer review person may not?
Mr. Stephenson. The peer reviews try to come to consensus.
They are expected to have divergent views. But in the end,
there are safeguards that the approach used for the science is
in fact reasonable.
Mr. Stupak. Mr. Shimkus?
Mr. Shimkus. Mr. Chairman, I would just say that, and some
of the testimony talked about it, it being public and external,
at least for the EPA. I would think it would be more accurate
to identify those peer review people who are internal to the
organization versus those who are external to the organization,
and again, my problem with this whole debate is that the
accusations that are lobbed at the EPA, I would submit are the
same accusations that can be lobbed at this report that you
presented and it is very hard for--you just can't have it both
ways.
Ms. Grifo. Could I respond?
Mr. Stupak. Quickly.
Ms. Grifo. One sentence. In the paragraph in the
acknowledgements, it talks about how those people provided
comment. We do not use the words ``peer review'' in referring
to them. That was my answer to your question.
Mr. Shimkus. Not being specific. I mean, that is the whole
point of this whole frustration. You called them peer review.
You named them out and they are part of your organization.
Ms. Grifo. You asked me.
Mr. Stupak. All right. We have two frustrated people now in
the room and that is it, it is not getting any bigger, so why
don't we do this? Let us dismiss this panel. We have two votes
on the floor. We will take a break here. Let us go vote and we
will come right back, or do you want to do the testimony of the
next panel? We have four people on there. We would never get
in.
All right. Let us adjourn for recess for two votes.
Hopefully we are back here by 20 after, OK, so 12:20. We stand
in recess.
[Recess.]
Mr. Stupak. We will reconvene this hearing. I thank
everyone for your patience while we had a few votes on the
floor there. The second panel of witnesses that we have now is
Dr. Deborah Rice, who is the Epidemiologist at the State of
Maine's Department of Environmental Protection; Dr. Jennifer
Sass, who is Senior Scientist at the Natural Resources Defense
Council; Mr. Daniel Parshley, who is Project Manager at the
Glynn Environmental Coalition in Brunswick, Georgia, and Ms.
Sharon H. Kneiss, who is Vice President of Products Division at
the American Chemistry Council.
It is the policy of this subcommittee to take all testimony
under oath. Please be advised that you have the right to
counsel during your testimony. Do any of you wish to be
represented by counsel? Everyone is shaking their head no. Ms.
Kneiss?
Ms. Kneiss. Chairman, I do have counsel with me.
Mr. Stupak. They can advise you but not testify, OK? And if
you do consult him, we may ask who the name is at that time.
All right. I am going to ask you to take the oath, so if you
able to, raise your right hand.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect that the witnesses have
taken the oath. They are now under oath. We will hear an
opening statement for 5 minutes, please. If you have a longer
statement, just submit it for the record. It will be made part
of the official record. Dr. Rice we will start with you,
please.
STATEMENT OF DEBORAH RICE, PH.D., STATE OF MAINE, DEPARTMENT OF
ENVIRONMENTAL PROTECTION
Ms. Rice. Mr. Chairman, members of the committee, my name
is Dr. Deborah Rice. I am a toxicologist with over 30 years of
experience in basic research and risk assessment. I am
currently employed by the Maine Center for Disease Control and
Prevention. I previously served as a senior risk assessor in
the National Center for Environmental Assessment at the U.S.
Environment Protection Agency, which by the way is the home of
the IRIS program.
I am here today to outline the events related to my removal
from an expert panel reviewing an EPA assessment for four
polybrominated diphenyl ether flame retardants, so-called
PBDEs, and to offer my perspective on the events. To do that, I
need to describe my activities as part of my professional
duties for the State of Maine. In 2004, the Maine Legislature
approved a presumptive ban on one flame retardant, deca BDE,
pending a series of annual reports by State professional staff
on the health and environmental hazards of deca BDE and
potential available alternatives. I contributed to three
reports in 2005 to 2007 and spoke before the relevant
legislative committee regarding the Maine bill. In that
capacity, I conveyed my scientific opinion on the hazards of
deca BDE compared to possible alternatives.
In December 2006, EPA published a draft document for four
individual forms of PBDEs, including deca BDE. This document
consisted of a scientific review of the health effects and
derivation of a safe intake level, the so-called reference
dose, for each of these individual PBDEs. There is no
consideration in this type of document of banning a chemical or
of its use in specific products. I was invited to chair the
external panel convened to review this document by the
independent contractor responsible for organizing the peer
review. The panel met in February 2007. My function as chair
was to ensure that all scientific issues were discussed and all
reviewers had an opportunity to express their views. There is
no requirement for reviewers to reach consensus. The final
comments of each peer reviewer were posted on the EPA Web site
in March 2007.
In May 2007, I received a telephone call from Dr. George
Gray informing me that EPA had received a letter from the
American Chemistry Council requesting that I be removed from
the panel on the grounds that my comments in Maine concerning
deca BDE reflected bias. The ACC further argued that they
disagreed with the results in a scientific research paper that
I coauthored published subsequent to the EPA review. Dr. Gray
questioned me concerning my activities in Maine and indicated
that he was considering acquiescing to industry's request. A
later phone call informed me of that decision. I did not
receive any written notification that I was being removed from
the panel. I was told that only my comments on deca BDE would
be removed. In fact, my comments for all four chemicals were
removed from a revised peer review report published in August
and my name erased from the document. In September, EPA
published a third version of the document which added a
statement requested by the American Chemistry Council that
``one reviewer's comments were excluded from the report due to
the perception of a potential conflict of interest,'' a
statement also currently on the EPA IRIS Web site. The final
version of the EPA toxicological review included my name as a
peer reviewer but does not include response to my comments.
There are several points that I think are relevant to
interpreting the validity of my removal from the peer review
panel by EPA. First, my professional activities for the State
of Maine were required as part of my duties as the toxicologist
charged with providing expert scientific opinion to State
legislators. I had no opinion on the hazards posed by deca BDE
before I started my review. I believe that having an informed
scientific opinion constitutes neither bias nor conflict of
interest. Indeed, if this is the definition of bias, then only
individuals who are uninformed on a particular chemical would
be considered suitable to serve as peer reviewers.
Second, the bill before the Maine Legislature and the EPA
document on the derivation of reference doses address different
issues. The Maine bill dealt with whether safer chemicals were
available as substitutes for one specific flame-retardant
chemical. The EPA document addressed derivation of a safe level
of ingestion over a life span for four of these chemicals. My
view that safer chemicals were available did not reflect on my
ability to follow the EPA protocol for derivation of a
reference dose. I am very familiar with the process, having
worked as a senior risk assessor for EPA. In addition, EPA
regards these chemicals as hazardous or it would not have
derived reference doses for them.
Third, I believe my comments and recommendations were
objective and based on my 30 years of expertise as a
toxicologist. To give an example, in initial comments I was the
only reviewer to be critical of a specific feature of the
experimental design of the studies upon which the EPA
derivations were based. The identical argument was made by the
ACC in their comments to EPA. The only evidence provided by the
ACC that I performed in a biased manner with regard to the peer
review was that they disagreed that deca BDE produces a
specific health effect.
I thank the Committee for the opportunity to discuss this
issue.
[The prepared statement of Ms. Rice follows:]
Statement of Deborah Rice
My name is Dr. Deborah Rice. I am a toxicologist with over
30 years of experience in basic research and risk assessment. I
am currently employed by the Maine Center for Disease Control
and Prevention. I previously served as a senior risk assessor
in the National Center for Environmental Assessment at the U.S.
Environmental Protection Agency.
I am here today to outline the events related to my removal
from an expert panel reviewing an EPA assessment of four
polybrominated diphenyl ether flame retardants (PBDEs), and to
offer my perspective on the events. To do that, I need to
describe my activities as part of my professional duties for
the State of Maine. In 2004, the Maine legislature approved a
presumptive ban on one flame retardant, deca BDE, pending a
series of annual reports by state professional staff on the
health and environmental hazards of deca BDE and potential
available alternatives. I contributed to three reports in 2005
092007, and spoke before the relevant legislative committee
regarding the Maine bill. In that capacity I conveyed my
scientific opinion on the hazards of deca BDE compared to
possible alternatives.
In December, 2006, EPA published a draft document for four
individual forms of PBDEs, including deca BDE. This document
consisted of a scientific review of the health effects and
derivation of a safe intake level (reference dose) for each of
these individual PBDEs. There is no consideration in this type
of document of banning a chemical or its use in specific
products. I was invited to chair the external panel convened to
review this document by the independent contractor responsible
for organizing the peer review. The panel met in February 2007.
My function as chair was to ensure that all scientific issues
were discussed, and all reviewers had an opportunity to express
their views. There was no requirement for reviewers to reach
consensus. The final comments of each reviewer were posted on
the EPA Web site in March 2007.
In May 2007, I received a telephone call from Dr. George
Gray informing me that EPA had received a letter from the
American Chemistry Council requesting that I be removed from
the panel, on the grounds that my comments in Maine concerning
deca BDE reflected bias. The ACC further argued that they
disagreed with results in a scientific research paper that I
co-authored published subsequent to the EPA review. Dr. Gray
questioned me concerning my activities in Maine, and indicated
that he was considering acquiescing to industry's request. A
later phone call informed me of that decision. I did not
receive any written notification that I was being removed from
the panel. I was told that only my comments on deca BDE would
be removed. In fact my comments for all four chemicals were
removed from a revised peer review report published in August,
and my name erased from the document. In September, EPA
published a third version of the document, which added a
statement requested by the American Chemistry Council that
``one reviewer's comments were excluded from the report . due
to the perception of a potential conflict of interest,'' a
statement also currently on the EPA IRIS Web site. The final
version of the EPA toxicological review includes my name as a
peer reviewer, but does not include response to my comments.
There are several points that I think are relevant to
interpreting the validity of my removal from the peer review
panel by EPA.
First, my professional activities for the State of Maine
were required as part of my duties as the toxicologist charged
with providing expert scientific opinion to the state
legislators. I had no opinion on the hazard poised by deca BDE
before I started my review. I believe that having an informed
scientific opinion constitutes neither bias nor conflict of
interest. Indeed, if this is the definition of bias, then only
individuals who are uninformed on a particular chemical would
be considered suitable to serve as peer reviewers.
Second, the bill before the Maine legislature and the EPA
document on the derivation of reference doses addressed
different issues. The Maine bill dealt with whether safer
chemicals were available as substitutes for one specific flame
retardant chemical. The EPA document addressed derivation of a
safe level of ingestion over the lifespan for four of these
chemicals. My view that safer chemicals were available did not
reflect on my ability to follow the EPA protocol for derivation
of a reference dose. I am very familiar with the process,
having worked as a senior risk assessor for EPA. In addition,
EPA regards these chemicals as hazardous, or it would not have
derived reference doses for them.
Third, I believe my comments and recommendations were
objective and based on my 30 years of expertise as a
toxicologist. To give an example, in initial comments I was the
only reviewer to be critical of a specific feature of the
experimental design of the studies upon which the EPA
derivations were based. The identical argument was made by the
ACC in their comments to EPA. The only evidence provided by the
ACC that I performed in a biased manner with regard to the peer
review was that they disagreed that deca BDE produces a
specific health effect.
I thank the Committee for the opportunity to discuss this
issue.
----------
Mr. Stupak. Thank you, Doctor.
Dr. Sass, your opening statement, please.
STATEMENT OF JENNIFER SASS, PH.D., SENIOR SCIENTIST, NATURAL
RESOURCES DEFENSE COUNCIL
Ms. Sass. Good afternoon, and thank you for the opportunity
to testify on the failure of the EPA IRIS program to serve the
needs of the public. My name is Jennifer Sass and I am a Senior
Scientist in the health program at the Natural Resources
Defense Council. I worked there for 8 years. I have a
scientific background in toxicology, developmental biology, and
neurotoxicology, and my task with NRDC is primarily to review
and assess the science that underlies the regulation of
hazardous chemicals.
We commend the subcommittee for its interest in the EPA
IRIS review process and its oversight of recent changes made to
the program. IRIS is a cornerstone program at EPA which
provides the scientific information necessary to develop our
Nation's air and drinking water standards as well as hazardous
cleanup levels. It is the program that evaluates the scientific
evidence available on the potential for chemicals to cause harm
to human health.
The Administration's record of political interference with
the work of government scientists across a range of
environmental issues including global warming and endangered
species has been well documented. Things are no better in the
case of analyzing and regulating toxic chemicals that pose a
risk to human health. In this area, the Administration has
attempted and in some instances succeeded to block, weaken, or
delay health standards for a long list of dangerous pollutants
including the pesticides atrazine and carbofurin, the rocket
fuel additive perchlorate, and formaldehyde. Not content to
simply undermine health hazards for a host of toxic chemicals
one by one, the Administration officials have now set their
sights on the foundational process for assessing the risks of
toxic chemicals, the EPA Integrated Risk Information System, or
IRIS, that assesses hazardous substances. The new 2008 IRIS
process introduces three new opportunities for the White House
Office of Management and Budget and other non-health agencies
such as the Department of Defense and the Department of Energy
to comment on EPA's health assessments where previously there
has been only one opportunity. Thus, where the pre-2004 IRIS
process provided the agencies and OMB with the draft assessment
at the same time as it was provided to the public, the new
process invites the other agencies into the assessment process
at an earlier stage and obligates the IRIS staff to address the
queries of the agencies and OMB whether or not they are
consistent with health-protective policies. Following this
negotiation, the draft review is then publicly noticed, but
then there is a final intervention point provided to OMB and
the other agencies that requires IRIS staff to resolve any
outstanding concerns by OMB and the other agencies including
polluting agencies before the assessment can be finalized.
While the 2008 process boils down to death by a thousand
cuts, this ability to have the last word and to potentially axe
an assessment at the bitter end may be the deepest cut of all.
Although current EPA management argues that the new process was
developed to provide greater transparency, objectivity,
balance, rigor, and predictability to the IRIS assessments,
this new process gives the polluting agencies more access and
more influence to what has historically been a reasonably
objective scientific evaluation process. The new process
established by the White House invites interference by OMB and
other agencies at the outset of the process, in the middle, and
at the end. Importantly, the Administration has sought to
classify these newly introduced intervention points as
deliberative and hence shield them from public view, and
alarmingly, the new opportunities are not limited to data
critiques. One particularly misguided new feature offers
agencies outside of EPA up to 2 years to undertake their own
studies of mission-critical chemicals, potentially suspending
EPA's evaluation of these contaminants for a very substantial
period of time.
The IRIS program has always struggled to keep pace with
EPA's regulatory needs and many environmental contaminants
lacking IRIS assessments are quite important to public health.
For instance, there is no IRIS assessment for nearly one-third
of the 189 pollutants listed as hazardous under the Clean Air
Act. Furthermore, even when important chemicals are in the IRIS
database, the risk assessments for many of these are outdated.
The average IRIS assessment is over 13 years old. The oldest
one has not been significantly revised since the mid-1980s.
These problems greatly exacerbate the already long period of
time required for EPA standard-setting procedures, up to a
decade in some cases, and have been the focus of criticism for
some time. Clearly, constructive reform of the IRIS program
would focus on increasing resources available to undertake IRIS
reviews as well as policy changes that would streamline the
difficult decisionmaking inherent in the process. Properly
managed, the EPA IRIS program provides a critical scientific
service to the public. Speed is important but scientific
quality and integrity is paramount.
Another example of politics trumping science is the recent
dismissal by EPA of one of their most respected and credible
scientific reviewers, Dr. Rice, in response to a written
request from the Brominated Flame Retardant Industry Panel of
the American Chemistry Council. A notice posted on EPA's Web
site states that the exclusion is because due to the perception
of a potential conflict of interest. The way EPA management has
applied the peer review guidelines and expert scientists like
Dr. Rice could be disqualified by taking a public position
supporting the phase-out of chemicals where scientific evidence
is mounting that they are persistent, biocumulative, and toxic
and in cases where safer alternatives are available. This
position is not in conflict with the scientific consensus among
public health experts and it is not in conflict with many State
public health agencies where some PBDEs have been banned or
restricted. The only potential conflict that Dr. Rice seems to
have is with the American Chemistry Council and their member
companies that manufacture PBDEs. These groups continue to
defend the chemicals and testify against State bans.
In a book recently issued by David Michaels, former
Assistant Secretary of Energy, titled ``Doubt Is Their Product:
How Industry's Assault on Science Threatens Your Health,'' the
author emphasizes that the failures of EPA to regulate
hazardous materials are not the fault of most agency scientists
or career employees, many of whom are heartsick that their work
has been so undermined.
We requested this subcommittee and full committee work with
colleagues to defend our public servant scientists as the
Nation's brain trust. Thank you.
[The prepared statement of Ms. Sass follows:]
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Mr. Stupak. Thank you.
Mr. Parshley, your testimony, please.
STATEMENT OF DAVID PARSHLEY, PROJECT MANAGER, GLYNN
ENVIRONMENTAL COALITION
Mr. Parshley. Good afternoon, Chairman Dingell, Chairman
Stupak and members of the Committee. My name is Daniel
Parshley. I am the Project Manager for the Glynn Environmental
Coalition, a community nonprofit organization ensuring a clean
environment and healthy economy for citizens of coastal
Georgia.
The committee's February 5, 2008, letter to the Weinberg
Group and its April 2, 2008, letter to the American Chemistry
Council concerning the journal Regulatory Toxicology and
Pharmacology was of great interest to the Glynn Environmental
Coalition since this journal has been used to deny our
community the basic protections that most Americans take for
granted. Toxaphene, a now-banned pesticide composed of more
than 670 chemicals, was manufactured in Brunswick, Georgia, by
the Hercules Corporation from 1948 to 1980 and disposed of in
many landfills and our estuaries. Now this toxic waste has
spread throughout our community, including two Superfund sites,
one of which, the Hercules 009 landfill, is located next to an
elementary school. In 1991, EPA Region 4, the State of Georgia,
and the Hercules Corporation, which manufactured the pesticide,
met and agreed to use an analytical method that only reported a
few of the toxaphene chemicals present. The EPA Office of
Inspector General found this analytical method was
inappropriate and that it did underreport the amount of
chemicals present. The Inspector General ordered new and
appropriate analytical methods be developed. The Inspector
General was joined by other federal agencies including the
Agency for Toxic Substance and Disease Registry and the Army
Corps of Engineers.
In response, EPA Region 4 and the Georgia Environment
Protection Division toxicologists published a paper in the
journal Regulatory Toxicology and Pharmacology by Drs. Ted
Simon and Randall Manning, advocating the reporting of only
three of the 670 chemicals in the toxaphene mixture. The
article did not present any new data but was rather a creative
reinterpretation of existing scientific studies that came to a
radically different conclusion about the toxic and carcinogenic
properties of toxaphene. The Inspector General noted that the
Simon and Manning method would underestimate the amount of
toxaphene chemicals present and would exclude the toxaphene
chemicals present in the largest amounts in our community.
Furthermore, the Inspector General accepted the report under
the condition that the authors produce the calculations used to
reach the conclusions. Neither EPA Region 4 nor the authors
have been able to produce the calculations. The Simon and
Manning article has been extensively reviewed and commented
upon by the Glynn Environmental Coalition and numerous outside
biochemists and toxicologists who found deficiencies and
inaccuracies in the journal article as well as the journal's
bias toward industry.
Scientific standards require transparency and
reproducibility. We believe that our community's needs are not
being properly met by the EPA's reliance on such questionable
science. Our request of EPA Region 4 is very simple: test our
elementary school and report all the chemicals present. For
more than 10 years, the Glynn Environmental Coalition has asked
EPA Region 4 to retest by an appropriate analytical method
Altama Elementary School, which abuts the Hercules 009
Superfund site. We want all chemicals present to be tested for
and appropriately reported. For more than 10 years, EPA has
been unresponsive. Earlier this year, EPA Region 4 made a
presentation to our board of education that used the Simon and
Manning article from Regulatory Toxicology and Pharmacology to
conclude that even if toxaphene was present on school property,
the chemicals are not a health risk to elementary school
children. There appears to be a scientific consensus in
addition to a general consensus among federal agencies except
EPA that the Simon and Manning method is inadequate to test for
toxaphene. In addition, the Weinberg Group has been hired by
Hercules to reassess toxaphene's toxicity. Tactics noted by the
Committee in its February 5, 2008, letter have been put in
motion including a scientific advisory panel to design two
studies to determine the toxicity of only a few chemicals in
the toxaphene mixture. We fear that there is a concerted effort
by industry and EPA that is opposed to the appropriate testing
of our community.
In closing, the Glynn Environmental Coalition is grateful
for your attention to the abuses being perpetrated under the
guide of science through the journal Regulatory Toxicology and
Pharmacology and consulting firms such as the Weinberg Group.
We have tried to briefly outline how EPA has delayed the proper
testing of toxaphene in our community. I conclude by asking the
simple question: do we ask too much when we ask that our
elementary school be tested by an appropriate method and report
all the chemicals present?
Thank you for allowing me to testify, and I look forward to
answering any questions you might have.
[The prepared statement of Mr. Parshley follows:]
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Mr. Stupak. Thank you, Mr. Parshley.
Ms. Kneiss, your testimony, please.
STATEMENT OF SHARON H. KNEISS, VICE PRESIDENT, PRODUCTS
DIVISION, AMERICAN CHEMISTRY COUNCIL
Ms. Kneiss. Thank you, Mr. Chairman, and good afternoon. My
name is Sharon Kneiss and I am the Vice President of the
Products Division at the American Chemistry Council. I
appreciate the opportunity to be here today to talk about a
flawed EPA process used to revise a very important health
effects value for a lifesaving chemical.
The process failings go directly to the integrity of the
science at EPA. Fundamentally, if you don't have confidence in
the process, you can't have confidence in the result. In this
case, EPA's procedures on paper are appropriate. Had EPA
followed them, we wouldn't be here today. This June, EPA
revised the oral reference dose, or RfD, for deca bromodiphenyl
ether, a crucial flame retardant. EPA's failure to follow its
own processes has produced an RfD in which EPA itself says it
has low confidence. If these shortcomings are widespread, they
could seriously undermine the integrity of IRIS.
ACC represents the leading companies in the business of
chemistry. We have worked hard over the last decade to improve
the quality and reliability of IRIS. Deca BDE is the most
studied flame retardant and is widely used to help prevent
fires and slow their spread. A prime example of the difference
that flame retardants make is the Air France airliner that
skidded off the runway and burst into flames in Toronto in
2005. Ignition of the seats and other fabrics on the plane was
delayed for those vital few minutes so that all 309 passengers
and crew could escape safely. It is important to remember that
the reliability of this scientific review is not a theoretical
or an academic exercise but poses real human consequences.
Because EPA did not follow its own guidelines for peer
review processes and study integrity, two major failures
occurred in the deca assessment. First, EPA used a completely
inappropriate study to set the reference dose. Second, EPA did
not vet the panel properly and appointed a chair who had made
numerous public statements indicating she had already made her
mind up on the science and had taken sides. In relying on the
Viberg study to set an RfD, EPA failed to uphold its own most
important science processes. The study did not follow EPA's
Good Laboratory Practices or EPA's study protocols. EPA's TSCA
Office said the study's methodology had a fundamental flaw and
its author repeatedly ignored requests for the study data. Both
EPA and the European Union regulators have concluded that the
Viberg study is not adequate for quantitative risk assessment,
and yet EPA used it even though the National Academies of
Science had already derived an RfD using top-quality studies
conducted by the National Toxicology Program.
EPA also failed to follow its own peer review handbook
which ACC and NGOs alike endorse. The handbook is clear that
the choice of peer reviewers should be based primarily upon the
reviewer's expertise and experience and that reviewers should
be sufficiently broad and diverse to fairly represent a
balanced range of technical points of view. The handbook also
recognizes, however, that experts with a stake in the outcome
and therefore a conflict or appearance issue may be the most
knowledgeable and up-to-date experts but federal law prohibits
EPA from using peer reviewers who either have current financial
conflicts of interest or appear to lack impartiality. It says
as a general rule, experts who have clearly taken sides may
have an appearance of a lack of impartiality and should be
avoided. The National Academies and NGO groups draw a similar
line.
To ensure that EPA gets this difficult balancing act right,
the peer review handbook recommends that EPA notify the public
before a peer review panel is formed, so interested parties can
nominate proposed reviewers and provide the public with the
list of proposed reviewers, so interested parties can comment
on their qualifications and potential sources of conflict or
bias. EPA did neither of these things. The peer review panel's
composition did not reflect a wide range of expertise and was
chaired by an individual who had not been adequately vetted and
appeared to have made up her mind. For example, she told one
newspaper that there was no question in her mind that deca
should be eliminated because it is a persistent toxin that
accumulates in the food chain. She told another, we know enough
to ban deca, we don't need to wait another 2 years and let it
increase in the environment while we nail down every possible
question we have.
With all these concerns surrounding the panel and its
deliberations, we wrote and met with EPA to express our
concerns. We did not ask that the chair be removed from the
panel or argue that the scientific expertise was the basis for
the disqualification from the peer review board. But at that
late date, there really was no satisfactory way to undo the
damage caused by these process failures. As a result, we were
reduced to asking EPA to base its final toxicological review on
data, opinions, and conclusions other than the chairperson's.
EPA ultimately deleted the chair's statements from the peer
review panel's report but the damage was done. EPA's attempt to
unring the bell thus had no effect on the ultimate result and
did not benefit ACC. EPA has set an RfD for deca that is three
orders of magnitude lower than the best available science
supports.
ACC thanks the subcommittee for shedding light on the
numerous process failures involved in the deca reassessment. I
would be happy to answer any questions you might have.
[The prepared statement of Ms. Kneiss follows:]
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Mr. Stupak. Well, thank you for your testimony. We will
start with questions.
Ms. Kneiss, as I read your testimony, I get the impression
that ACC thinks that the deca peer review process was flawed
not just because of Dr. Rice's participation but also because
you didn't have a say in the selection of the peer reviewers,
and I think in your opinion, the peer reviewers relied on a
scientific study you don't agree with. Is that correct?
Ms. Kneiss. Our concern was with the lack of following the
process that EPA has in their handbook to follow on how to form
a peer review panel.
Mr. Stupak. But they don't need your input to do a peer
review panel.
Ms. Kneiss. The guidelines do state that they should
consider putting together a panel and they start by----
Mr. Stupak. Right, but they don't----
Ms. Kneiss [continuing]. Alerting the public that they are
going to do a peer review and seeking input on those panels
and----
Mr. Stupak. So you wanted input on the panel, who was going
to be on the panel?
Ms. Kneiss. We would like them to follow the handbook as
they have----
Mr. Stupak. That is not what I asked you. ACC wanted input
on who was going to be on the panel?
Ms. Kneiss. We wanted input on an open and transparent
process, open to the public.
Mr. Stupak. Well, if you have input, then how can the panel
be said it is not biased then, if you put your people on it?
Don't they come with preconceived ideas then or biases, as you
said?
Ms. Kneiss. The key with a peer review panel is that it is
broadly constructed, first of all, that I have the----
Mr. Stupak. Sure. There are five people on this panel,
right?
Ms. Kneiss. Correct.
Mr. Stupak. OK. So they represent different views, right?
Ms. Kneiss. I would assume so.
Mr. Stupak. OK. And some of them might agree with your view
and others might not, right?
Ms. Kneiss. That is possible.
Mr. Stupak. And a peer review panel analyzes everything
including that Viberg report that you mentioned. They can take
that into consideration. They can take all kinds of information
and they make an assessment and give it to the EPA, right?
Ms. Kneiss. Correct.
Mr. Stupak. And then there is time for public comment,
correct?
Ms. Kneiss. Yes.
Mr. Stupak. So why would you have Dr. Rice, why would you
want Dr. Rice removed then?
Ms. Kneiss. It goes to the open process, the transparency
of the process, the need to form a panel----
Mr. Stupak. What was not transparent in this process?
Ms. Kneiss. We had no idea who was on the panel until the
panel actually met and deliberated. We had no opportunity----
Mr. Stupak. Then why didn't you ask all five people on the
panel be removed then? Why just Dr. Rice?
Ms. Kneiss. Because the process was so flawed and it was so
late in the process, we felt that our opportunities, quite
frankly, were limited on how we could rectify the many problems
with the process.
Mr. Stupak. So why do you pick on one of the peer
reviewers, why not all five of them then?
Ms. Kneiss. There were clear indications in the media and I
might note that the EPA handbook clearly says that while you
need knowledgeable experts as a general rule, those who have
taken sides should not be put on the peer review panel because
there is----
Mr. Stupak. Were these statements of Dr. Rice before or
after she was on the panel?
Ms. Kneiss. It is both.
Mr. Stupak. Both? OK. Well, on page 4 of your testimony you
state that deca was subject to an extensive 10-year study by
the European Union as well as other major studies and has been
found to present no significant risk to human health or the
environment. Is that correct?
Ms. Kneiss. That is correct.
Mr. Stupak. Didn't EU ban deca in 2002?
Ms. Kneiss. No, not deca.
Mr. Stupak. They didn't?
Ms. Kneiss. It was other brominated flame retardants.
Mr. Stupak. OK. Did they just ban it this year, deca?
Ms. Kneiss. No, it is still in use--oh, excuse me. I am
sorry. I am confused. But they do have a risk assessment that
had found that it is safe for use.
Mr. Stupak. That is safe for use?
Ms. Kneiss. Yes. There is a risk assessment that took 10
years to complete and looked at 580 studies.
Mr. Stupak. OK. Has deca been banned in Maine and
Washington?
Ms. Kneiss. That is my understanding.
Mr. Stupak. OK. On page 8 of your testimony, you state very
strongly that transparency about data and methods is an
indispensable element of influential scientific information
such as the IRIS file, correct?
Ms. Kneiss. That is correct.
Mr. Stupak. So I gather you would agree with the GAO, who
testified earlier, and I noticed you were in the room at the
time, that comments made on IRIS assessment by OMB and other
federal agencies should be part of the public record. Do you
agree with that?
Ms. Kneiss. We have supported improvements in the IRIS
process for many years, improvements that would----
Mr. Stupak. So you would agree with the GAO testimony
earlier today then?
Ms. Kneiss. We agree with many of the recommendations from
GAO that----
Mr. Stupak. No, I am asking about their testimony today
about the IRIS and transparency. Would you agree or disagree?
Ms. Kneiss. We agree with IRIS and the need for
transparency.
Mr. Stupak. OK. You allege that Dr. Rice--this is on page
12 now--testified before the Maine Legislature in support of a
report specifically advocating that the State mandate a phase-
out of deca BDE. Isn't it true that what Dr. Rice really
testified on was the issue of whether there were safer
chemicals available as substitutes? Isn't that what she
testified?
Ms. Kneiss. My understanding is one of the statements was
that there should be a phase-out of deca BDE.
Mr. Stupak. Do you have a copy of her----
Ms. Kneiss. She did address other----
Mr. Stupak. Do you have a copy of her testimony or anything
where you could point to that?
Ms. Kneiss. I do have it, but not with me. We can get it to
you.
Mr. Stupak. Isn't it true that she did not testify before
the Maine Legislature to recommend the phase-out of deca? She
never recommended a phase-out of deca to Maine, did she?
Ms. Kneiss. She supported a report that recommended a
phase-out.
Mr. Stupak. Right, but my question was, she never testified
before the Maine Legislature the phase-out, did she?
Ms. Kneiss. Part of her testimony was the support of a
report that recommended a phase-out.
Mr. Stupak. Do you have that report?
Ms. Kneiss. Yes, we will submit it to the Committee.
Mr. Stupak. So let me ask you this. The role of the peer
review panel is to receive an array of opinions on the safety
of the chemical in question, and this one is deca, right?
Ms. Kneiss. Correct.
Mr. Stupak. And isn't it the opinion of your organization,
ACC, that only likeminded individuals should be on that panel
then?
Ms. Kneiss. Oh, absolutely not. We believe that it is
important to the credibility of the process that it be broadly
constructed, that it reflect all of the technically legitimate
beliefs.
Mr. Stupak. Well, on this review panel, there are five
people. Did they all submit their comments to the EPA on this
deca?
Ms. Kneiss. As part of the process?
Mr. Stupak. Yes.
Ms. Kneiss. Yes.
Mr. Stupak. And did they all reach the same conclusion as
Dr. Rice, all five of them?
Ms. Kneiss. I can't speak directly to--they all commented
on different aspects.
Mr. Stupak. And they all basically came to the same
conclusion, did they not?
Ms. Kneiss. On certain aspects.
Mr. Stupak. So they all agreed?
Ms. Kneiss. I guess so.
Mr. Stupak. So if you are concerned about the makeup of
this panel and Dr. Rice, it sounds like the other four people
agreed with Dr. Rice, correct?
Ms. Kneiss. We have concerns that go far beyond Dr. Rice.
It goes to the process and how the process was conducted and
the failed process that resulted in the result that it did. It
had many failings.
Mr. Stupak. But these other four people gave the same
conclusion as Dr. Rice so they are all wrong?
Ms. Kneiss. What we were saying was, the appropriate
response would have been to reconstruct the entire panel to
make sure that it reflected the broad range of views and we
didn't have that.
Mr. Stupak. Why didn't you object to the other four?
Because they did exactly what you wanted. They got Dr. Rice off
and the other four agreed with Dr. Rice so the report should
really be that we should ban deca.
Ms. Kneiss. This was a process in our view that was
conducted in the early stages in secret. We had no idea who the
peer reviewers were. We had no idea what their credentials were
or what their potential conflicts of interest were. By the time
we found out, we were so far into the process, we felt that our
options were very limited.
Mr. Stupak. Dr. Rice, let me ask you this. What were you
asked to do in this panel? What were you tasked to do, this
peer review panel on deca?
Ms. Rice. A peer review panel, the chair of a peer review
panel, really, their only obligation or their obligation is to
hear all of the scientific opinions. We are presented with a
series of charge questions by the Environmental Protection
Agency. We can address other questions as well if we want to.
But what I did in the peer review meeting was, I basically went
around the table for each charge question and made sure that
the opinions of all of the scientists, all four of the other
scientists as well as myself, were heard and I think it is
important to understand that these peer review panels, unlike
some other panels that EPA convenes, there is no requirement
for consensus. We don't have to reach a conclusion. We really
submit our individual comments to EPA and then EPA responds to
those.
Mr. Stupak. And when all five people entered their comments
to the EPA, were they similar to your comments?
Ms. Rice. I think that all of the comments for the most
part were very similar. The bottom line, the whole purpose of
this is to derive a so-called safe level, and the comments of
all of us really came down in just ultimately just about the
same place, so my comments were not outliers.
Mr. Stupak. And one of the panel members had ties to
industry?
Ms. Rice. Yes.
Mr. Stupak. And they reached the same conclusion you did?
Ms. Rice. Yes. He was a perfectly reasonable scientific
member of the panel.
Mr. Stupak. Do you know, did ACC ask for the removal of any
other member other than yourself?
Ms. Rice. To my knowledge, no, not from the correspondence
I have seen.
Mr. Stupak. OK. My time is up. We will come back for a
second round. I will go to Mr. Shimkus for questions right now.
Mr. Shimkus. Thank you, Mr. Chairman. Because Greg Walden
was so gracious in helping me out, I am going to defer and let
him take it.
Mr. Walden. All right. Thank you. Thank you, Mr. Chairman,
and thank you to our ranking member.
Ms. Kneiss, I want to go back to what you were saying. It
sounds to me like the EPA didn't follow its own guidelines.
That is your argument?
Ms. Kneiss. That is correct.
Mr. Walden. And the part of the guidelines they didn't
follow was how you impanel and make sure the public whether you
are for or against, in between has a right under their own
guidelines to understand that a panel is going to be created
and to have some ability to have input into how that panel is
structured.
Ms. Kneiss. Correct.
Mr. Walden. Or who is on it. Is that right?
Ms. Kneiss. Correct.
Mr. Walden. And so our friend Dr. Sass at NRDC, has your
organization ever weighed in on the creation of a panel? Has
your organization ever weighed in on any particular panel
member?
Ms. Sass. I have been there 8 years, and one of my primary
tasks is to look at these kinds of issues, and I have never
commented on a peer reviewer. I have never contested a peer
reviewer and I didn't contest any of the peer reviewers on this
panel.
Mr. Walden. So your testimony is, NRDC has never done that
in any case?
Ms. Sass. Not on a peer review panel.
Mr. Walden. Not on Dr. Bull?
Ms. Sass. Not on a peer review panel. Dr. Bull, when I
contested him, was on a National Academies panel, very
different from this peer review panel. They draft the document
in a single consensus report as the final outcome, and at that
point I showed evidence that he was on the payroll to Lockheed
Martin on an issue in litigation on a pollutant that Lockheed
Martin would be responsible for.
Mr. Walden. And you wrote that to EPA?
Ms. Sass. It was not an EPA panel. It was National
Academies and it was a panel that would write a consensus
report on that chemical.
Mr. Walden. But did you raise that issue, that information
with EPA at any time?
Ms. Sass. To try and contest Dr. Bull's----
Mr. Walden. No, did you present any information to EPA
relative to Dr. Bull that concerns you on the deca panel?
Ms. Sass. The letter that I wrote said why should someone
like Dr. Rice be removed from a panel when there are other
people that have actual biases that weren't removed, but I
never----
Mr. Walden. So you never specifically referenced Dr. Bull
then in your correspondence?
Ms. Sass. In that letter I did but I never opposed his----
Mr. Walden. Could you provide that letter to us?
Ms. Sass. Sure. Also you might want to look at the peer
review handbook guidelines, page 61, because it refers to the
specific panel as actually put together by a contractor. But
for the contract mechanism, the contractor may have its own
pool of scientific and technical experts that it chooses from
and EPA is actually not permitted to direct the prime
contractor or the subcontractor in that process.
Mr. Walden. OK. So is there a process ahead of that though
that EPA is supposed to follow in selecting the contractor or--
so what you are reading overrides the other EPA guidelines? Is
that what you are testifying to?
Ms. Sass. No. There is a real confusion about panels and
committees here. But there is basically three different types.
This committee was a peer review and there is not a consensus
report that comes from it.
Mr. Walden. Correct. I understand.
Ms. Sass. And every opinion counts, so I agree that it is
important to have a wide variety of opinions coming in as long
as they are scientific criticisms. That is what EPA would want
to collect. For a federal advisory committee, they have a
single report and then for the National Academies also a single
report and consensus. They write the report.
Mr. Walden. So what impact, Dr. Sass, did removing Dr.
Rice's comments have on the substance of the peer review? Are
you aware of, did it affect the substance in the end?
Ms. Sass. As much as I am aware, it didn't change the
outcome very much at all. Essentially most of the peer
reviewers had basic agreement. So there was really no reason to
contest--I would not contest a peer reviewer at all.
Mr. Walden. I understand.
Ms. Kneiss, if I could go back to you, because the question
has been raised, why did you pick on Dr. Rice. I mean, that is
the substance of the question here, and what you have testified
is, there were public comments attributed to her that indicated
from your perspective that she had a bias going in.
Ms. Kneiss. That is correct.
Mr. Walden. Were there public comments attributed to other
members on that peer review panel that showed bias either for
or against----
Ms. Kneiss. We weren't aware of any.
Mr. Walden. Is she the only one then that you had public
information on that indicated----
Ms. Kneiss. In terms of public comments, yes.
Mr. Walden. And is that why your organization----
Ms. Kneiss. That is correct. At that late point in the
process, from our perspective and according to the guidelines,
this should have all been resolved before the panel was put in
place. There was not the opportunity to do that.
Mr. Walden. Now, what about this issue Dr. Sass just
raised, that this was a different type of panel that was
created under a contractor and therefore, I assume you are
saying, not subject to that rule. Is that your understanding of
it?
Ms. Kneiss. Our understanding is that the guidelines are
still important to that process and there is a lot of
requirements in there that suggest that it be open and it be an
open and transparent process.
Mr. Walden. Personally, I think that is the way they all
should be, regardless of the side of the issue you are on. I
know we had a situation in my district where an organization
that was on the GAO approved list to simply take data that had
been accumulated and transcribe it. No scientific input
whatsoever. And an environmental organization objected and
there was quite a stir raised including a full investigator IG
report done because the allegation was this group was biased
because they also were certified to do consulting work with
mining organizations. At the end of the day, the IG said it was
all bogus, this group did what they were supposed to do, it was
all legitimate but not before it was a page 1 story and all
that. So there is a lot of give and take when it comes to areas
of dispute and especially when it comes to this type of science
because there are a lot of high emotions. If you have bad
chemicals running around a school, you want to make sure your
kids are safe. So I guess the question is, how do we fix this?
How do we fix this? And Dr. Rice, does something need to be
changed here? If there was somebody--let us say--sorry, I will
let you answer. Let us say somebody had the opposite view you
held or allegedly hold, which is that this is a wonderful
chemical and there are no problems to it, should somebody be
able to object to that person being on a peer review panel?
Ms. Rice. Yes, I think that people should be able to object
before the fact. I agree with that. EPA personnel can also
challenge the--I mean, when I was at EPA, EPA people could also
challenge the choices of the contractors for conflict of
interest or for lack of the appropriate expertise, which is the
only two things that really should matter.
Mr. Walden. So you don't have an objection to--I mean,
personally you might, I understand and respect that--either Dr.
Sass or Ms. Kneiss being part of that public process to weigh
in for or against somebody being on one of these panels but
then it is ultimately up to the----
Ms. Rice. Ultimately it is up to the contractor to respond
to that or not. That is the level at which it should have
happened. After a panel is held to go back to EPA, which was
the only thing that they could do at that point, is not----
Mr. Walden. Was there an opportunity to object to the
contractor?
Ms. Kneiss. No.
Mr. Walden. So that was the issue here at the core?
Ms. Kneiss. We were not--we had no idea what this process
was, what it looked like, what the panel looked like, until
their first meeting.
Mr. Walden. Do you concur with that, Dr. Sass, in this
case?
Ms. Sass. Yes, and I think that we agree too that
transparency is really paramount, because even if there is not
a real problem, if you don't have transparency, the perception
of the problem could be the problem. So I agree that EPA needs
to be left to do its work and I also agree that anybody should
be able to comment or write letters and provide information if
they think it is relevant and that EPA should weigh the
scientific comments appropriately and as much transparency as
you can put in that process means you don't have to have a
problem later.
Ms. Kneiss. Again, if you don't have confidence in the
process, you don't have confidence in the result.
Mr. Walden. And the irony is, even with this dispute, those
who don't like this chemical, actually the report seems to back
up their view over what your organization would like to see
come out of this whole process, right?
Ms. Kneiss. That is the result of the report, correct.
Mr. Walden. Mr. Chairman, I will yield back to my colleague
from Illinois the final 57 seconds on my clock.
Thank you all for your testimony today.
Mr. Stupak. Mr. Shimkus for questions.
Mr. Shimkus. Thank you, Mr. Chairman.
Dr. Rice, first of all, for everyone here, I have calmed
down a little bit. So that should be good news. But you worked
for EPA from 1993 to 2003. In fact, you received a level I
scientific and technological achievement award from EPA for the
high quality of your research, and I wanted to put that into
the record and just thank you for your service. I thought about
the first panel, I thought this is scientists playing politics
or politicians playing scientists. I was trying to figure out.
But that is part of this basic debate of peer review, whether
they have--can they be objective if they come to the panel with
already preconceived statements. So I am learning a lot, so I
appreciate the first panel and this one, and I apologize for
not being here for opening statements.
Dr. Rice, we have already had some discussions about
Richard Bull as a member of the peer advisory panel and we all
know that. Dr. Sass has obviously raised the issue. In your
experience with the panel, do you believe Mr. Bull was
impartial when reviewing the literature?
Ms. Rice. Yes, I believe that all five of us were
impartial.
Mr. Shimkus. Yes. I mean, that is just part of this whole
debate on both sides. So do you think it is possible to have
ties or an affiliation with an advocacy group or industry and
still be able to objectively interpret the data?
Ms. Rice. It is possible, yes.
Mr. Shimkus. If so, how can the EPA determine when
someone's ties would make them impartial? What should the test
be and how could it be implemented before a peer review panel
is selected?
Ms. Rice. Well, I think one litmus test is whether a person
has financial ties. I think that would delete them from the
panel right from the get-go. But then after that, I think it
gets a little bit murkier and I think that you have to look to
whether the particular person is speaking from the science and
certainly reasonable people, reasonable scientists can disagree
on the interpretation of the science and that is OK. I mean,
that is the way it works. But if there is a perception that the
person is going beyond the science to talk about policy and
that that is coming from some special interest, financial or
otherwise, then that should disqualify them from the panel.
Mr. Shimkus. But in Bull's case, he had a financial tie.
Ms. Rice. Excuse me?
Mr. Shimkus. Bull's case, or was this another case?
Ms. Rice. It was another case that you are thinking of,
yes. For this panel, he did not. I don't think he was in
conflict.
Mr. Shimkus. So when these scientists are all in this room,
five of you, if someone, and you are going on the scientific
data, you all are professionals so you could probably tell if
someone is way off the deep end on their analysis?
Ms. Rice. I think so.
Mr. Shimkus. OK. You went to Maine and of course we have
covered the testimony and you reported to the Maine
Legislature. How do you characterize your testimony before the
Maine Legislature? We have heard what was asked. How would you,
give us in your own words.
Ms. Rice. Well, the Maine bill was very specific, and the
question before me, the question before the legislature was,
were there safer alternatives to deca, and so, to do my job as
a toxicologist, I had to look at the properties of deca and
then the properties of the alternatives, and I have to say that
my main concern with regard to deca was not really the
toxicity. I think we know less about the toxicity than I would
like to know. My concern really was that it is persistent in
the environment, that it bioaccumulates up the food chain. It
is found in breast milk. Most of us are carrying body burdens
of deca. It breaks down in our bodies, into the environment to
some of the chemicals, some of the PBDEs that had already been
banned by Maine. You know, so that was the framework. That was
the context. And in fact, the ACC has a quote from me in a
newspaper where I say that there are hints about the toxicity,
and it is important to understand that the EPA peer review
panel was about toxicity. It didn't include at all anything
about persistence, bioaccumulation, breakdown, to other forms
of these PBDEs which I am on record as saying that those were
my main concerns, and when I testified from Maine, the real
problem that I had was determining, trying to determine whether
the alternatives were safer, and the reason for that was
because we know less about the alternatives than we do about
deca or many of the alternatives than we do about deca. The
toxicity data in particular aren't there and I ended up going
to the European industry and getting some toxicity data from
them for some of these alternatives because, you know, as a
person advising the legislature, I really didn't want it on my
conscience that I said there are safer alternatives when it
turned out that there weren't.
Mr. Shimkus. Why would the--again, we are laymen so you are
kind of saying there are two separate issues here. Why would
the ACC say they are not, they are linked?
Ms. Rice. I personally think it is a mischaracterization
because--in my testimony I said that the peer review of the EPA
document and my work for the State of Maine were really two
entirely different things. I feel that I am perfectly capable
of being very objective about following EPA guidelines on how
to set a reference dose. In fact, I did that for the Agency. I
had no preconceived ideas about what the reference dose should
be at all and I don't even think about the final number. I
mean, I never do. I just follow the process and whatever it
ends up being is whatever it ends up being.
Mr. Shimkus. Thank you.
Ms. Kneiss, the ACC raised a concern. Why did you all
concur that there is a connection? Do you know?
Ms. Kneiss. It all goes to the flawed process to begin
with. We had no information about how this process was going to
move along, who was on it, what the credentials for the
panelists even were. We had to FOIA that to find out the
credentials of the panelists. And so it was a process in which
we had very little confidence to begin with because it wasn't
open and transparent. And then we had concerns with how the
Agency took on studies and looked at studies which didn't
follow their own scientific guidelines.
Mr. Shimkus. Great.
Dr. Rice, do you think this qualified as, in essence, the
public pronouncement issue that the EPA uses to say oh, maybe
she shouldn't be on the board, your testimony as a public
pronouncement?
Ms. Rice. No, I don't at all because I really think that
they are different issues, and I am perfectly capable of being
objective in following the process to set a reference dose.
Mr. Shimkus. And I really appreciate these testimonies and
this hearing.
Dr. Rice, having worked in the EPA, say going back to the
last panel, did you as a scientist ever feel that you were
bullied or pushed into making a scientific judgment based upon
the political hacks that were appointed at the EPA?
Ms. Rice. Well, I left in 2003, and that was just beginning
to happen, and I didn't leave because of that. A lot of people
have asked me that, and I didn't. That was not the reason I
left. But I really personally didn't.
Mr. Shimkus. Thank you.
Mr. Chairman, I think I am done. Thank you.
Mr. Stupak. Let me just clarify a couple things. Dr. Rice,
when you worked with the Maine Legislature at the time when you
were talking to the Maine Legislature about deca, your work had
already been done on this peer review panel, correct?
Ms. Rice. I think they overlapped. I think--I have handouts
that are dated in April. The peer review met in February. I
think I had testified before that once but I am not--I have to
say that I am not really clear on the timeline because to me,
these were completely separate events that really had nothing
to do with each other.
Mr. Stupak. And you are the State toxicologist so it would
be normal for you to talk to the legislature about chemicals
and on legislation they are proposing, things like that?
Ms. Rice. Yes. Their committee meetings are called work
groups and I think----
Mr. Stupak. It was a work group?
Ms. Rice. It was a work group and they asked me questions
for an hour, and I was charged as the toxicologist to do this
for the legislature.
Mr. Stupak. And when you were put on this peer review, they
knew you were the toxicologist for the State of Maine?
Ms. Rice. Yes, certainly.
Mr. Stupak. Let me ask you this, Ms. Kneiss. You are
familiar with the Peer Review Handbook, 3rd edition?
Ms. Kneiss. Yes.
Mr. Stupak. OK. These are only guidelines.
Ms. Kneiss. That is correct.
Mr. Stupak. There is nothing in there that requires
industry to be consulted or to be made known of who is on peer
review panels.
Ms. Kneiss. But it does recommend it.
Mr. Stupak. Recommendation. It is a guideline. They are not
required to get your approval before they do a peer review
panel, correct?
Ms. Kneiss. That is correct.
Mr. Stupak. OK. You have talked an awful lot about
transparency, and you were here at the last panel so the new
IRIS process doesn't allow for much transparency when OMB is
involved, correct?
Ms. Kneiss. Well, what we believe--we have been supporters
of an improved IRIS process for many years.
Mr. Stupak. So you don't think----
Ms. Kneiss. And we believe transparency is very important
in that process.
Mr. Stupak. So in the IRIS process, OMB should open up
their deliberations and their reports from Department of
Energy, Department of Defense so we have this transparency you
want, correct?
Ms. Kneiss. I can tell you, we haven't taken--we haven't
looked specifically at that aspect of it. I can tell you----
Mr. Stupak. Right, but----
Ms. Kneiss. From the broader point of view, we----
Mr. Stupak. I am asking you, from your passionate concern
for transparency, shouldn't we have transparency then in IRIS,
including OMB, DOD, and DOE?
Ms. Kneiss. We should have transparency in the process. I
do not know the specific issues surrounding that to make a
statement on that particular aspect.
Mr. Stupak. OK. Dr. Rice, in our exhibits here, in our
exhibit book right there if you want to look at it, Exhibit
#10, there is a letter from the governor of Maine, Governor
Baldacci, to the EPA protesting your removal from the panel.
Did you have anything to do with the governor writing that
letter? Did you ask the governor to write the letter?
Ms. Rice. No, I found out about it after the fact actually.
I appreciated it but I found out about it after the fact.
Mr. Shimkus. And Mr. Chairman, he is a former colleague of
ours and I think we all hold him in high regard. I know I do.
Mr. Stupak. Dr. Sass, can you say a little bit more about
the increased secrecy under the new process of IRIS that
undermines the scientific method and the public's right to
know? Could you say a little bit more about that? You seem
pretty familiar with it.
Ms. Sass. Right. I will comment on it but also I think I
can't refer the whole group but at least in my written
testimony that is being submitted because it has a table on
page 9 and 10 where I really struggled to clarify the old and
the new because, as you know, the new is far more complicated.
But in essence, there was always an opportunity for interagency
review and of course, the agencies are allowed to call each
other any time they want, so that hasn't changed and they
always had that opportunity under the old process, and also of
course these always go to OMB for review. That was always done.
The difference is that at this point they have inserted a
number of new opportunities. They have obligated the IRIS
process to incorporate new opportunities for interagency and
OMB review, both early but also a final one at the end, and
that the public doesn't have an opportunity during those times
to comment. So they haven't increased public transparency or
participation at all but they have increased the interagencies.
Mr. Stupak. So with OMB at the end there, the public
doesn't really have any input until the final rule comes out
then so they don't know what happened between OMB and the final
decision?
Ms. Sass. Right, which is very concerning to us, but the
new rules do obligate the IRIS staff to have to respond and
resolve those OMB concerns and our concerns are that they may
not all be scientific so that there is agencies like DOD and
DOE that are not public health agencies and we are concerned
that comments that are not scientific comments may derail or
alter the process.
Mr. Stupak. Since you are the scientist familiar with this,
Mr. Parshley mentioned this journal Regulatory Toxicology and
Pharmacology as not being very credible in the eyes of some
people but having a bias towards industry. Your opinion on
that? Is Mr. Parshley right in his testimony?
Ms. Sass. This is a journal that has a number of industry-
affiliated people on its editorial board and associate
editorial boards and it is shown, has a tendency, a pattern of
publishing articles that are very friendly to the industry
perspective and they are specifically targeting regulatory
decisions or chemicals that are undergoing regulatory review.
Mr. Stupak. Let me ask Mr. Parshley, if I may. You take the
mic there, if you would. You talked about toxaphene, and how
does toxaphene damage your health? Do you know?
Mr. Parshley. I am a project manager, and my job is really
to get that information from the experts, and so I avoid trying
to be the expert but when people ask me those type of
questions, in my community when they come to me and ask those
questions, I very often refer to ATSDR's toxicological profile
for toxaphene, and then depending on whether it is adults or
children, they get more specific about the different threats.
Mr. Stupak. Well, do you have some understanding of the
health risks of toxaphene? I mean, you are concerned about it
being next to an elementary school. Why are you concerned? What
are the health effects you are concerned about?
Mr. Parshley. I am familiar with the issue. You know, my
concerns are more than just with the elementary school, but at
the elementary school itself, toxaphene is shown to have some
developmental delays and so the very early years in school are
important for children. Children's immune systems are not as
robust, are not fully developed.
Mr. Stupak. OK. Well, let me ask this question. Why are you
after the EPA to do more studies then, your Glynn Environmental
Coalition there?
Mr. Parshley. We are not asking for more studies actually.
Mr. Stupak. What are you asking the EPA to do then?
Mr. Parshley. A process for measuring toxaphene that was
developed it was only used in our community that did not report
all the chemicals present. The Office of Inspector General
found, agreed with us, and it was appropriate, particularly--we
are not just dealing with toxaphene. We are dealing with
toxaphene manufacturing waste, and so, you know, the argument
of what is and what isn't toxaphene has gotten very convoluted
but what we want is very simple, test, report all the chemicals
present. Then the toxicologists can look at it and tell what we
need to protect our children and our families.
Mr. Stupak. Well, what chemicals do you think aren't being
reported?
Mr. Parshley. The Office of Inspector General was very
specific. The previous method looked at only one part of the
chromatogram and eliminated everything else. Well, in that part
that they eliminated, there was chemicals in the toxaphene
mixture that have six and seven chlorines, it is a whole group,
and that is what is mostly in our community and it is the
stable form and what is going to hang around for a long time.
And he said, gee, you know, you are not reporting the chemicals
that are present in the most amounts in the community. So
other--why we need the data, we need to know, can public works
clean out the drainage ditch and not re-contaminate the school?
When the life of the school is gone, does our community have an
encumbered piece of property? These are other questions in
addition to, are our children safe.
Mr. Stupak. So what you are basically saying, you don't
believe the EPA has adequately tested for toxaphene or the
breakdown chemicals that come from toxaphene in the landfill
near the school and in your community. Is that what you are
saying?
Mr. Parshley. Yes, but if I could clarify, there has been
technical toxaphene, weathered toxaphene, breakdown toxaphene,
I will tell you the definition we use. We went to the Hercules
patent and they said, well, this is what we patent-protected
and that is what we call toxaphene. All these different
definitions all fall in there. It is all toxaphene. What has
happened is, the different amounts or ratios of the individual
chemicals have changed but it is all still toxaphene, so that
is a good clarification. Over time, the ratio of the different
chemicals has changed, how much the different chemicals are
there, but it is still there. But what we need for our
community, not only for protection of our children, we have an
estuary where 2 to 3 million pounds were released. We need to
be looking at what disciplines are going to use this data, the
actual resource managers, people that are going to be looking
at fisheries, not only protecting people from contaminated fish
but what is the effect on wildlife and the recovery of our
natural resources.
Mr. Stupak. Have you asked EPA to do these studies?
Mr. Parshley. Well, a study is built off of good, sound
data. We need to know what is there is the first step and that
is what we are asking is why I came here today is, we have a
very simple request: test and report all the chemicals that are
there. There is no reason on this earth to test and not report
the chemicals that are there.
Mr. Stupak. Very good.
Questions?
Mr. Shimkus. Thank you, and I will be brief. First of all,
I was thinking about these rules of guidelines and I was
thinking about Pirates of the Caribbean, are they rules or are
they guidelines. That is part of the legislative challenges we
have, the pirate rule.
I was interested in this magazine, Regulatory Toxicology
and Pharmacology Journal, which now, Dr. Rice, are they a
credible magazine, would you feel?
Ms. Rice. I agree with Dr. Sass that they tend to be biased
toward industry.
Mr. Shimkus. So in your letter to the editor in 2004,
titled ``Critical Effect of Perchlorate on Neonates in Iodine
Uptake Inhibition,'' why did you send the letter?
Ms. Rice. Because perchlorate is something that industry as
well as government and various states are very concerned with.
It was an appropriate place to put it. It was an appropriate
audience for it.
Mr. Shimkus. Did you place it elsewhere?
Ms. Rice. No.
Mr. Shimkus. So they are credible enough for you to write a
letter to inform the scientific community of this issue?
Ms. Rice. Yes, I am not saying that nothing is published in
the journal that isn't reasonable and I am not saying that
everything in the journal is biased. I am saying that when you
take the body of studies as a whole, there tends to be a bias
toward the industry point of view. But it is not an industry
publication.
Mr. Shimkus. Great. I appreciate it. I was just trying to
clarify. And I am not going to go long into this. On the next
panel we have George Gray, who is the EPA director now. Dr.
Sass, you have laid some pretty serious charges against him, a
former member of the faculty of Harvard Center for Risk
Analysis. Instead of just going into the excitable debate, can
you provide for us e-mail, documents, memos, or anything that
substantiates some of these touch charges you have laid up
against Dr. Gray?
Ms. Sass. I don't think I have made any charges that would
require e-mails to substantiate. I think what I--you would have
to tell me but I believe what we have said is about the Harvard
Center for Risk Analysis is that it takes money and it gets
support from a number of industries. I mean, I can give you
documentation for that.
Mr. Shimkus. You specifically cite the IRIS review of perc
in the example showing Dr. Gray's interference with the IRIS
process.
Ms. Sass. That was reported by a reporter in the trade
press and I can provide that for you.
Mr. Shimkus. That is what we are asking. Do you have
anything other than the trade press?
Ms. Sass. You have to go case by case and I will tell you
what I have as evidence and provide it for you.
Mr. Shimkus. OK. And I will end there. Thank you, Dr. Sass.
Mr. Stupak. Well, let me thank this panel for their
attendance here today. I am going to dismiss you. We have votes
on the floor. Dr. Sass, Mr. Shimkus, all members have a right
to follow-up questions in writing, and I would urge the ranking
member to do that if he so wishes to get more detailed
information and we may do the same thing, Ms. Kneiss. So I
thank you all for being here. Thank you for your testimony. We
are going to be in recess for the next half-hour. We have four
votes on the floor, so we are in recess.
[Recess.]
Mr. Stupak. The hearing will come back to order. Sorry
about the delay. We had an extra vote you guys threw in there
we didn't know about, so we had a couple extra ones there. Let
us get our last panel here and hear from them. On our third
panel, we have the Hon. Marcus Peacock, who is Deputy
Administrator of the U.S. EPA, and Dr. George Gray, who is the
Assistant Administrator for the Office of Research and
Development at the U.S. Environmental Protection Agency.
Gentlemen, as you know, it is the policy of this subcommittee
to take all testimony under oath. Please be advised that you
have the right under the rules of the House to be advised by
counsel during your testimony. Do you wish to be represented by
counsel, Mr. Peacock, Mr. Gray?
Mr. Peacock. No.
Mr. Gray. No.
Mr. Stupak. OK. Then I am going to ask you to please rise
and raise your right hand to take the oath.
[Witnesses sworn.]
Mr. Stupak. Let the record reflect our witnesses replied in
the affirmative. They are under oath. We will start with
opening statements for 5 minutes. Your full statement will be
part of the record. Mr. Peacock, should we start with you, sir?
Mr. Peacock. I don't have an opening statement, Chairman. I
am here to answer any questions you may have.
Mr. Stupak. Dr. Gray?
STATEMENT OF GEORGE M. GRAY, PH.D., ASSISTANT ADMINISTRATOR,
OFFICE OF RESEARCH AND DEVELOPMENT, U.S. ENVIRONMENTAL
PROTECTION AGENCY
Mr. Gray. Well, thank you. Good afternoon, Chairman Stupak,
members of the committee. I am George Gray, the Assistant
Administrator for the Office of Research and Development at the
Environmental Protection Agency. Thank you for the opportunity
to appear before the subcommittee to discuss two important
things: first, our ongoing efforts to maintain the highest
levels of scientific integrity and research assessment and
analyses at the U.S. EPA and our recent improvements to the
Integrated Risk Information System, or IRIS.
First, research that is conducted by our scientists and
grantees provides the scientific and technical information that
we need to protect human health and the environment. During the
past several years, EPA has taken a number of steps to maintain
a program of sound scientific research to inform agency
decisions without allowing regulatory objectives to guide or
distort scientific findings or analyses. These steps include
open, transparent, and peer-reviewed research planning and
competitively awarded extramural research grants. It includes
independent peer review of our science studies, publications,
and assessments and rigorous independent evaluations of EPA's
research laboratories and centers.
Science informs and provides a foundation for EPA's
regulatory decisions. At the same time, it is very important to
recognize that many scientific questions or assessments
generally involve both science and science policy
considerations. Similar to other federal agencies that are
required to produce scientific assessments and also make
regulatory decisions, EPA views the relationship between
science, science policy, and decisionmaking as a continuum. To
start, science is conducted by individuals or teams working in
our laboratories, out in the field, or in academic institutions
across the country. Their work is reviewed by subject matter
experts in accordance with EPA's highly regarded peer review
process and our information quality guidelines. Our scientists
are encouraged to publish and otherwise communicate their
findings. Our scientists and grantees published over 1,000 EPA
scientific studies last year.
But by their very nature, scientific studies involve
varying degrees of uncertainty so there is rarely a single best
study or a single best answer that we can use in
decisionmaking. Therefore, we rely on science policy and we
need to synthesize and assess and make choices when we have a
wide range of scientific opinions and data points. The science
policy process may involve: filling in knowledge gaps with
default assumptions; using weight of evidence approaches to
make scientific inferences; or making specific choices. Science
policy work draws on expert insight from multiple scientific
disciplines and is further strengthened by agency, interagency,
and public review.
In the mid-1980s, EPA program offices sometimes published
very different toxicity values for the same chemical in spite
of having access to the same scientific data. The original data
was the product of science whereas the Agency toxicity values
were a product of science policy as they included inferences,
assumptions, and choices. EPA developed IRIS, the Integrated
Risk Information System, exactly to help standardize the
science policy process that is inherent in risk assessment.
IRIS was originally intended to be an internal EPA system that
provided EPA risk assessors and managers with an agency
position on the potential human health risks of toxic
substances. But to meet the growing public demand, the IRIS
process has evolved over time. Examples of components that have
changed include the setting of the annual IRIS agenda, levels
of external peer review, and opportunities for public and
interagency review.
In 2005, EPA initiated a formal process to document the
steps in the IRIS process including formalizing recent
improvements. On April 10, 2008, EPA announced the revised IRIS
process, the first time that EPA has documented the entire
process and made it available to the public. Prior to the
release, the IRIS process had often been viewed as a black box,
both within and outside of the Agency. It was unclear what
steps compromised the process and what the timing was for each
step or where opportunities existed for internal and external
involvement. Our improvements in the IRIS process helped define
the appropriate roles for public, agency and interagency
comments and they also helped promote greater communication and
sharing of information between all interested parties and EPA.
This revised IRIS process is designed to provide greater
transparency, objectivity, rigor, and predictability in IRIS
assessments.
So in conclusion, EPA has a proud history of producing
science that has informed decisions to help protect human
health and the environment. We are committed to using the best
available science and constantly evaluating our science policy
choices to achieve our strategic goals and fulfill our mission.
From the lab bench to the administrator's desk, we follow a
science-to-decisionmaking continuum that is in common with
other federal agencies that rely on both science and science
policy considerations in their decision making.
So thank you, Chairman Stupak and members of this committee
for this opportunity to describe EPA's critical scientific
work, and I look forward to answering any questions you may
have.
[The prepared statement of Mr. Gray follows:]
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Mr. Stupak. Thank you for your testimony. Let me ask you
this. Page, it looks like 5, on your testimony, you say once an
EPA scientific product meets scientific standards, you go on,
you say note these independent--I am trying to find the part
here where you said about they get to communicate. You said
something about you hope that they communicate their findings,
right?
Mr. Gray. Yes.
Mr. Stupak. Once an EPA scientific product meets
scientific--scientists are encouraged to publish or otherwise
communicate their findings. So why would you remove Dr. Rice
then if she is communicating her findings to the Maine
Legislature?
Mr. Gray. Well, I was here for a large part of the last
panel and it is clear to me that there is a lot of confusion
about the situation with Dr. Rice. What I would like to do----
Mr. Stupak. Well, you removed her, right?
Mr. Gray. No, she was not removed. The peer review had
already taken place. What I would like to do is to----
Mr. Stupak. The peer review had already taken place. OK. So
why did you redact her testimony and take it offline?
Mr. Gray. That is why I would like to call your attention
to a letter that was sent by the Agency, signed by Chris
Bliley, who is the director of our Office of Congressional and
Intergovernmental Relations, to the chairman of the full
committee in response to several of his questions, and it lays
out the situation with Dr. Rice. The first thing that I want to
say is that we have a great deal of respect for Dr. Rice and
for the work that she does and her scientific expertise. It is
why she was chosen as or was a potential member of one of our
peer reviews. But we have very specific rules that we follow in
our peer review. As----
Mr. Stupak. Now wait. Do you have rules or do you have
guidelines? What are we talking about here? Or is this the
pirate code?
Mr. Gray. This is back to our discussion of the arm's-
length relationship that we have with contractors who do our
peer reviews. Those contractors do have a series of questions
that are asked of each of the members of the peer review panel,
partially to establish things like conflict of interest, to
establish expertise, and things like that.
Mr. Stupak. Right. So the independent contractor didn't
find any conflict of interest of Dr. Rice because they put her
on the panel, right?
Mr. Gray. The potential peer reviewers are asked to answer
a series of questions and then just before they get together
again as a peer review panel, they are asked the questions
again.
Mr. Stupak. OK. Was that done in this case?
Mr. Gray. This is about----
Mr. Stupak. Was that done in this case?
Mr. Gray. Yes, it was.
Mr. Stupak. OK.
Mr. Gray. And disclosure is a very important part here. We
look for expertise, and if there are potential conflicts, we
want them to be disclosed. The Agency does not make a
determination about potential conflicts, the contractor does,
but they need good information to do that.
Mr. Stupak. So the contractor made the decision to seat Dr.
Rice?
Mr. Gray. In this particular case----
Mr. Stupak. I don't want you to filibuster me. I am trying
to ask a question.
Mr. Gray. OK. In this particular case, let us come to the
crux of this issue.
Mr. Stupak. Let us get right to it.
Mr. Gray. Dr. Rice was asked just before the peer review
panel got together, ``have you made any public statements or
taken positions on this or other subjects closely related to
the chemical or topic under review?'' She was asked this
question on February 16 and said no.
Mr. Stupak. OK.
Mr. Gray. And February 15 was one of her testimonies before
the Maine Legislature, so we were in a situation in which our
contractor did not have the full disclosure to be able to make
their judgments----
Mr. Stupak. And did you realize that what she testified on
the day before was not about deca?
Mr. Gray. ``Have you made any public statements or taken
positions on or closely related to the subject chemical or
topic underway?''
Mr. Stupak. Right. And the day before, what did she testify
to or talk to the working group in Maine on?
Mr. Gray. She talked about exactly the chemical that was
the topic under review.
Mr. Stupak. You are sure of that?
Mr. Gray. Yes.
Mr. Stupak. OK.
Mr. Gray. Our judgment in this case, and this was a
judgment that was made by the staff-level folks who run our
National Center for Environment Assessment. They are the ones
who made the judgment that----
Mr. Stupak. So what did she testify to on February 15 about
deca before the Maine working group?
Mr. Gray. The subject of her testimony is not what is
important here. What is important is the fact that it wasn't
disclosed to us so that we could not make an appropriate
decision----
Mr. Stupak. Wait a minute. Did she testify about deca on
the 15th? If so, what is it she said that would violate that
standard?
Mr. Gray. According to our letter to the chairman, Dr. Rice
had testified on February 15 before the Maine Legislature in
support of a state ban of deca bromodiphenyl ether, or PBDE.
Mr. Stupak. OK. And I think Dr. Rice testified at the last
panel that is not what she testified to. They talked about a
safer substitute. She never reached----
Mr. Gray. You have to have a substitute for something.
Mr. Stupak. Pardon? If her testimony is talking to a
working group of the Maine Legislature and they are asking
about deca and they are talking about are there safer
substitutes, how is that a conflict?
Mr. Gray. This is not about a conflict. This is about non-
disclosure of having made public statements or taken positions
on this or other closely related subjects, and in this case,
when this came to light, the decision was made by the director
of our National Center for Environmental Assessment----
Mr. Stupak. Well, Dr. Rice is still here. Dr. Rice, do you
mind coming back up and I will ask you testify on this? Because
I think there is a lot of confusion. I want to get this cleared
up.
Ms. Rice. I kind of wish I had left.
Mr. Stupak. First of all, I have to remind you, you are
still under oath, Dr. Rice, still under oath.
Ms. Rice. Yes.
Mr. Stupak. So on February 15, did you testify before the
Maine Legislature about deca?
Ms. Rice. I testified to one of the committees.
Mr. Stupak. Pardon?
Ms. Rice. I testified to one of the committees of the Maine
Legislature.
Mr. Stupak. OK. Testified on what?
Ms. Rice. On the Maine bill, which had a presumptive ban
for deca BDE on the provision that safer alternatives were
available.
Mr. Stupak. And was it about safer alternatives or was it
about deca and if it was bad or good or should be banned?
Ms. Rice. It was really about both in that my concern was
whether I could really say that the safer alternatives were
better, whether the potential alternatives were safer than
deca. So I really had to in some ways compare and contrast, and
what I indicated to the committee was that we didn't know
enough about the toxicity of the alternatives. We had limited
information on the toxicity of deca, which was the subject of
the peer review, but we did know a lot about the persistence
and biocumulative properties of deca.
Mr. Stupak. So when you answered the question the next day,
did you feel it was wrong, that you failed to disclose?
Ms. Rice. Well, in retrospect, I probably should have said
that I had testified to the Maine Legislature, but in my mind,
the two exercises, the two topics were completely separate
because derivation of a reference dose is a very limited
exercise and it talks only about the hazards, it talks only
about the toxicity and not about the other properties, and
really I was talking about the other properties, so I
considered that I hadn't said--I certainly never said anything
about my opinion about what the reference dose of deca should
be or--and we keep talking about deca but in fact there were
four chemicals and I never talked about the other three
chemicals at all, and so in my mind at that time, the two
things didn't have anything to do with each other. In
retrospect, I would have put it on the form.
Mr. Stupak. Before they pulled down your statement on the
Web site, did they inform you why they were taking down your
testimony and your findings?
Ms. Rice. Well, I got a telephone call from Dr. Gray and
didn't take notes, so it is hard to remember a year-and-a-half
later exactly what was discussed. But he told me that they had
gotten this letter from the ACC and he asked me questions about
the form and--well, not the form specifically but the timeline,
when I had testified and what had happened when, and then he
indicated to me that he was actually thinking about removing me
from the panel, and I have to say that I was so surprised by
that that a lot of the rest of the conversation just went out
the window.
Mr. Stupak. Dr. Gray, page 5, you go and you say, ``Because
the scientific method encourages critical thinking and
professional disagreement, it does not commonly lend itself to
a bright line that decision makers can use as a reliable
reference point.'' It seems to me you are using a rather bright
line here to exclude Dr. Rice.
Mr. Gray. No, sir, I am not. The decision was made on Dr.
Rice, it was made by our National Center for Environmental
Assessment, and I did support it, was that because the
disclosure rules had not been followed, it was inappropriate
for her comments to be part of that record simply because our
contractor did not have the information they needed to make an
appropriate judgment. If she would have disclosed this, I am
guessing that she probably--the contractor would not have
changed the situation, would not have had anything to say about
her position on that board.
Mr. Stupak. So even though the other four people on this
peer group agreed with Dr. Rice or they all came basically to
the same conclusion, that is not the issue here in your mind,
it was just that she didn't disclose this meeting with the
Maine Legislature?
Mr. Gray. I am glad that you have really exactly identified
the issue. This is not a situation about----
Mr. Stupak. Yes, I did, and I can't believe you would
disqualify her on that.
Mr. Gray. This is about process. If we have a process that
cannot be trusted, when we tell people, we ask all of these
conflict of interest questions and we don't have--we can't tell
them that we have confidence that those are being answered----
Mr. Stupak. A process that can't be trusted with this IRIS
program where you have OMB and things are done in secret, there
is no transparency, that is a process that cannot be trusted.
Mr. Gray. No, that process, remember, comes back to the
peer review that we both support very much. There is no way for
other federal agencies or anyone to play scientific shenanigans
with the IRIS process when it has to go through a peer review
process by independent expert peer reviewers at the end.
Mr. Stupak. Do you want to put up the last one?
[Chart shown.]
Mr. Stupak. So where is the--I am looking at the IRIS
process, the latest one, post April 10. I am on 12A. OMB
interagency review and approval. I don't see anywhere in there
where there is a public review of that, goes right to the EPA
and final rule is made, so where is the transparency, where is
the peer review of the OMB interagency review and approval in
12A of your IRIS process?
Mr. Gray. In this case, this is simply the end of the
process. It has been through peer review, and this is the
final----
Mr. Stupak. Right, and that is done in secret. OMB stuff
isn't disclosed. I think the record has very clearly been
established.
Mr. Gray. No, it is very much like the way we do our
internal agency reviews where we don't share the comments that
we get from other parts of EPA either, and here you will notice
the very last line of section 12 is of course that the final
decision on IRIS rests with EPA.
Mr. Stupak. It is already done by then.
Mr. Gray. We make the final decisions.
Mr. Stupak. Based on what you heard from the
Administration, which is OMB, which deliberations are in
secret, we have established, right?
Mr. Gray. I am sorry.
Mr. Stupak. Your final decision is based upon
recommendations from OMB, which is the Administration, and that
is a secretive deliberation.
Mr. Gray. It is EPA's decision. That is the important
point.
Mr. Stupak. My time is up. Mr. Shimkus for questions. We
will come back to this panel.
Mr. Shimkus. Thank you, Mr. Chairman. Don't come back up to
the table, Dr. Rice. Again, I think, I know I have been caught
in a bureaucratic, legalistic period of time and I just
apologize for this, and unfortunately, people end up getting
caught up in messes like this because of our rules and
regulations and the like. You know, the hearing is trying to
prove political attacks on the scientific community within the
EPA and I understand the intent of what we are trying to do. I
don't think there is going to be success. There is frustration
and I share the frustration of the handling of your case, and
the reality is, I had an ethics issue, and I got called in for
3 hours with attorneys going over what I said, what I didn't
say and all this other stuff, and you just can't win. They
start splitting hairs so much that people get hurt. So again, I
just do it to apologize and that is sometimes what happens here
in a legalistic environment. That is why I am not a lawyer and
I am never going to be one.
The issue is more clarity. Let me talk about how do we--
here is another example from politics is, there will be times
when a reporter will ask us, can we get you to speak not for
attribution. That means can you speak clearly, and we are not
going to attribute that to you so we can get the truth. We have
reporters back there. They know. They like us to do that
sometimes. So my sense is, sometimes in this process, you want
to have scientists in a room where they can speak not for
attribution, so they can fully say what they want to say in
this analysis and then put it together and share that. Dr.
Gray, is that along the same lines?
Mr. Gray. That is a very, very good description of the
situation that we go through, not just within the Agency where
we have those same kinds of discussions and they are not always
just holding hands and agreeing but also in the interagency
process, and we believe that that ultimately makes our product
stronger. We are getting scientific input, scientific expertise
from a variety of different experts that we think makes our
product better, and then at the end, the important thing again
is that that product has to go through an independent peer
review and pass muster with the scientific community.
Mr. Shimkus. And that is how really how--because the
follow-up question is, how do you balance, and so you would say
you balance it by the independent peer review?
Mr. Gray. And we get independent peer reviews and not
infrequently that will come back and tell us we don't think you
did this right, go back and do it again, so that even with the
best process that we can come up with, there is still often
scientific disagreement and it is what makes this process
strong. We can go back, do it again, and learn from the
scientific input.
Mr. Shimkus. Now, based upon the other panels and stuff,
when we are talking about peer reviews, either internal peer
reviews or other agencies' reviews and if there are other
agencies, are you able to see--there is always a great
receptivity to transparency. Politicians use it all the time,
bring the sunlight on, it sanitizes the system. Of course, we
know that we don't always use that, an example again with the
media. You want to have confidential discourse so you can fully
lay out the case. Talk about the peer review, internal and
external.
Mr. Gray. OK. Well, we think that the process, this new
IRIS process really does allow greater opportunity for broader
participation by all stakeholders, not just at other federal
agencies. We have more opportunities for the public to be
involved, more opportunities for the rest of EPA to be involved
when we are developing IRIS profiles. We go through that
process with articulated time frames, which has never been in
the IRIS process before that says how long steps are going to
take and then we go into these various forms of review. We have
review within the Agency. This is followed by interagency
review followed by public review and peer review. All of those
are ways in which we strengthen our process. If there is some
specific things about the peer review process that I can
answer----
Mr. Peacock. So for clarity, the internal review and the
interagency review is confidential. You can call it secret or
black box but the fact is, it is confidential just like a peer
review at a scientific journal is confidential so that you can
have a free flow of ideas and exchange within the scientific
community, make sure the product at the end is as strong as
possible. It is not an unusual idea.
Mr. Shimkus. Right, but then of course the other flip side
would be, how do we ensure that the public has confidence in
the product?
Mr. Peacock. And my answer there then comes back to that
independent peer review. When EPA is done with its process, we
have talked to our agency, other agencies, we have comments
from the public. We give that to independent peer reviewers who
are again arm's length, not chosen by us, and ask them to
review the work that we have done. If there is funny business
that is being tried, if there are interpretations that are not
scientifically tenable, if there are decisions that are being
made that don't have scientific support, we will hear that back
and the public can be confident in fact because of this
independent scientific peer review.
Mr. Shimkus. Let me just add two comments. One, the time
frame thing sounds good, but the record on our ability to move
does not support the fact that this is an efficient system that
gives a timely response, and you are going to find me defending
that. Do you want to comment on that?
Mr. Peacock. Yes, I would like to comment on that. One of
the things I focused on as the chief operating officer is
making sure people can see how EPA is performing. We are the
first agency to have quarterly performance measures we make
available to the public. We are going to put on this report how
quickly we are now doing IRIS reviews compared to how quickly
we have done them in the past, so everybody, every 3 months is
going to be able to see whether or not we are going to deliver
on what we have said we are going to deliver on, which is
faster IRIS reviews and keep the quality up.
Mr. Shimkus. So you are going to tell me that this system
is going to be quicker than this system?
Mr. Gray. Well, sir, I think--well, if you look right now
at the average of the IRIS assessments currently underway is
5\1/2\ years, and we have some that have been going on for 10
years, 15 years, because we have never before had a process
written down with timelines that hold our agency accountable,
that hold other agencies accountable, that hold the peer review
process accountable. That is what we have written down there
and that is what the deputy administrator has asked us to find
a way to report out to the public to demonstrate how we are
doing meeting our goals, if there are problems, where they are,
are they coming from the interagency process or are they coming
from the public process, are they coming from our own work. We
are trying to open this up.
Mr. Shimkus. We would love to see that. We would love to
see these reports so that we can then say, hey, the system is
really working.
Mr. Gray. Or if not, why not.
Mr. Shimkus. Yes, which right now we are not assured, but
hopefully we will be. The backlog, will it be prioritized?
Mr. Gray. We are working through a number of ways in which
we identify the best--how we set our agenda for each year and
out the people and the resources that we have in the IRIS
program to work. We are consulting more broadly than we have
before with the public, with other federal agencies, and with
others to find out what are the highest priority compounds and
we will move those forward. We have put significant increases
in resources both people and money into the IRIS program over
the last 4 or 5 years and we are trying to make it work.
Mr. Shimkus. I am not going to be silly, but is that open
for public comment?
Mr. Gray. Yes, it is. Step one, we publish an IRIS agenda
in the Federal Register every year and you are very welcome to
tell us what you think are the highest priority chemicals for
us to work on and that goes into part of our process.
Mr. Shimkus. If that is the case, then that is great
because hopefully we get the worst ones first, I would assume.
Mr. Chairman, that is all the questions I have. Thank you.
Mr. Stupak. Well, thanks. I have a few more questions.
Kyle, put up that flow chart again, the post April 10.
[Chart shown.]
Mr. Stupak. Dr. Gray, you said that, I think I quoted you
right, you have independent scientific peer review in this
process. The only place I can find that is number 9 way up
there in the top, and then right there, 10A, independent. OK.
But then OMB comes back in at 12A. So the independent peer
review and comment, when the Agency, EPA, makes its final
decision after it gets its input from OMB, there is no review
of that decision. You do it and then you go back into secretive
or your closed interagency review.
Mr. Gray. Well, you will notice that in fact that splits
there. There is something we do to maintain the value of our
peer review process.
Mr. Stupak. Don't tell me you have another box you want to
put in there.
Mr. Gray. It is a new step that we have put in there where
we send our response to their comments and a revised document
back to the peer reviewers and we ask them to comment, how have
we done----
Mr. Stupak. So at 12A, you send it back to 10A?
Mr. Gray. No, you can see that it splits. In parallel, we
are asking our peer reviewers to say how we did with your
advice because we have had a lot of concern that though we do
this internal peer review, we don't take their advice. This way
these advisors do not have an opportunity to----
Mr. Stupak. OK, it splits there, 12A and 12C, that is what
you are talking about the split, right? Are you trying to tell
me you bypass OMB? If you don't go 12B, you go 12C, right?
Mr. Gray. I am saying that our revised final document also
goes out for scientific review as well to ensure that the way
in which we have addressed----
Mr. Stupak. Yes, but the order is already done.
Mr. Gray. What is that?
Mr. Stupak. The order is done. Your final EPA clearance,
you have already issued the order. Sure, the science community
can comment on it then, but it is a little bit too late, the
horse is out of the barn by the time you get a chance to review
it one more time. Go ahead.
Mr. Gray. The idea here is that when we have taken all of
these comments into advisement, we have revised our document.
We have written another document that says here is the comment
we got and here is why we either took or didn't. We send that
as part of the final document that is going back to the
interagency process. We also send that out to the peer
reviewers, and we are asking them, how did we do on our
science.
Mr. Stupak. So that is 12C, right? That is 12C is what you
are talking about?
Mr. Gray. No, that is when it goes to the EPA group to look
at as well. One of the things that----
Mr. Stupak. Give me the number. Where does this occur in
your flow chart here? After the last time the OMB gets their
hands on it, when does it go back for this independent
scientific peer review? Tell me that on this flow chart.
Mr. Gray. Well, it is another peer review. It is another
opportunity for the peer reviewers to comment on how we have
done with their scientific expertise.
Mr. Stupak. Where does that occur on this goofy flow chart?
Mr. Gray. That occurs--well, these flow charts are
something that I can't endorse. I did not put these together so
I am not sure how those work.
Mr. Stupak. Neither do we. That is why we are asking the
questions. I don't think anyone understands how this thing
works. This came from you. This came from the EPA.
Mr. Gray. No, but that--well, the document that was part of
the memo that came out announcing this is the place that to me
gives us the best review of the process, and it is in step 11.
Mr. Stupak. Step 11. OK, 11, there we go, but see 12A now,
you have OMB back in there, and if you want to split it like
you said, go to 12E, you get OMB in there again. OMB gets about
four bites of the apple for secretive deliberations that we
don't get to know about. Let me ask you this though. You
mentioned timelines. If I start request for chemical
nominations for IRIS, until I get to 13D, post final assessment
on IRIS, what is my timeline? How is it going to take me?
Mr. Gray. Depending on, because all of these are ranges,
somewhere between 3 and 4\1/2\ years.
Mr. Stupak. Three and 4\1/2\ years?
Mr. Gray. Yes. The current average is 5\1/2\.
Mr. Stupak. OK. GAO says it is 6 to 8, so your average
would be 7.
Mr. Gray. They might want to check their math.
Mr. Stupak. Or is that the new revised one since post April
10?
Mr. Gray. There is nothing revised since April 10.
Mr. Stupak. Yes, your revised process, IRIS process.
Mr. Gray. No, that was the process that was released on
April 10.
Mr. Stupak. All right. So dioxin, we have been waiting
since 1991. When can we expect that one to be done?
Mr. Gray. Dioxin is a terrific example of both why we need
a better process.
Mr. Stupak. Well, we are on our third draft of this
process.
Mr. Gray. You know why? Because we went to the National
Academies of Science with our last draft and they said you have
not done your science right. That is a problem. You need a
process to make sure we are doing the science correctly----
Mr. Stupak. With your new revised process, which has all
the science so great, when can we see something on dioxin? We
have been waiting since 1991.
Mr. Gray. Dioxin is entering into a process and the amount
of time it will take we are hoping is in that 3 to 4\1/2\-year
process.
Mr. Stupak. So another 3 to 4 years?
Mr. Gray. I am afraid so. We were told by the National
Academies that we had a lot of work to do.
Mr. Stupak. Has National Academy approved this flow chart?
Mr. Gray. Oh, no, no, they are occasionally used as one of
our peer reviewers on very high-profile chemicals----
Mr. Stupak. How about TCE?
Mr. Gray. There is another one. We went to the National
Academies and they told us that they didn't agree with our
interpretation of the science.
Mr. Stupak. Right, and they took 2 years, they came back
with a report so now----
Mr. Gray. We are now expecting to have the draft report
ready by the end of this year.
Mr. Stupak. Draft report. Then how long are you going to
sit on it before it is a final report?
Mr. Gray. Our expectation is to meet the timelines that are
within the new process.
Mr. Stupak. So what is the timeline after you get a draft
report? How much time do you have then to issue a final report?
Mr. Gray. I haven't done the math from individual parts in
this process but it will then go through this process----
Mr. Stupak. So there is not a timeline like 60 days, 90
days, 180 days, is there?
Mr. Gray. Yes.
Mr. Stupak. Well, why can't you tell me the time then?
Mr. Gray. The document here that was released describing
the process has timelines for each step. Again, that is
something that didn't exist in the past and that we have put
down to keep accountability both for our work and for the other
parts of the process.
Mr. Stupak. I agree, and I don't think anyone can
understand it. Let me ask you this. Has there ever been an
instance where someone forgot to disclose something on the
disclosure form but were not removed from the peer panel?
Mr. Gray. Not to the best of my knowledge.
Mr. Stupak. How many other instances have you removed
someone for an oversight on the disclosure form? Did you ever
do that before?
Mr. Gray. I don't--not to the best of my knowledge, and
again, this was a decision that was--this was made by our IRIS
staff and I supported it, but this was----
Mr. Peacock. Chairman, that is probably something we can
research and get back to you on.
Mr. Stupak. All right. Well, after you redacted Dr. Rice's
name and comments from the deca peer review panel comments, you
later posted a version with her redactions, but you also put a
disclaimer on indicating she was removed due to a potential
conflict of interest. It is Exhibit #14 right there in the
binder. Why would you do this disclaimer? Why not just redact
it? Don't you think you cast aspersions on Dr. Rice by saying
she had a conflict of interest that wasn't disclosed?
Mr. Gray. And Mr. Chairman, you are right, and Mr. Shimkus
was right on this too. This is a situation that was very, very
difficult for us. As I said, we have great respect within the
Agency for Dr. Rice and for the work that she has done. She is
serving a very valuable service to the Agency, but we also have
a situation in which we have got one of our very specific rules
and steps that hasn't been followed. And I may not have
described that in the best way.
Mr. Stupak. Well, if you have so much respect for Dr. Rice,
and I believe you do, so she made an oversight and her
conclusions were supported by the other four people on this
peer review, they all reached the same conclusion, including
the industry person who was on there who was pro-industry, why
did you go through all this then? Why didn't you just say to
ACC, we are sorry that there was this oversight but you know,
we have known her for 30-some years, she worked at the EPA, she
is the toxicologist for the State of Maine, I can see why she
talked to the legislature, the conclusions are the same. Isn't
that what is important in this thing, the conclusions that this
panel came up with?
Mr. Gray. It is also important to have a process with
integrity that people can trust, and as I said, this was a
very, very difficult situation and a very difficult call but we
believed that having a situation in which we knew some of the
important rules for disclosure, which are important to us being
able to have our peer review process hadn't been followed made
it----
Mr. Stupak. Were you here when Ms. Kneiss testified on
behalf of the American Chemical Council?
Mr. Gray. No, I was not here for her testimony.
Mr. Stupak. Well, she said the whole process was flawed.
She said their concern was that whole process was flawed. So
why wouldn't you just take down the whole peer review and not
have them on the Web site?
Mr. Gray. Because we didn't want to start over. We felt
that this was a way to continue to move our timelines forward,
to do the work the right way so that it was an appropriate
response in the middle of this process.
Mr. Stupak. As you are selecting these peer review panels,
do you need ACC's permission or approval of the people who are
going to be the peer reviewers on these panels?
Mr. Gray. Well, first of all, we don't select the peer
reviewers.
Mr. Stupak. I know. You have the----
Mr. Gray. No, our contractor doing that at arm's length is
a very important thing to the integrity of the process.
Mr. Stupak. Do you need the industry's approval before you
do this? Does that independent contractor who picks the peer
reviewers, do they need industry's approval?
Mr. Gray. No, they make these decisions independently.
Mr. Stupak. Exhibit 6 in the book there is ACC's letter to
EPA asking for Dr. Rice's removal. Prior to this letter, has
EPA ever received a letter from industry calling for removal of
a peer review panelist? Is this the first time you have ever
seen one of these where industry comes and says remove this
person?
Mr. Gray. In my experience, I believe this was the first
one I had seen.
Mr. Stupak. OK. Do you believe that the science, there is
uncertainty related to individual studies and a judgment call
to be made with regard to the weight of the evidence given to
that science?
Mr. Gray. I am not quite sure of the question, but of
course, there is always uncertainty in science in the way that
we want to apply it, yes.
Mr. Stupak. Sure. OK. I have no further questions. Mr.
Shimkus?
Mr. Shimkus. Thank you, Mr. Chairman, and I will be brief.
Dr. Gray, do you know if Dr. Rice is on a panel right now?
Mr. Gray. I don't know.
Mr. Shimkus. Are you? Sorry.
Ms. Rice. That is OK. Subsequent to serving on the PBDE
panel, it really wasn't just a deca panel, I later served on a
peer review panel for thallium.
Mr. Shimkus. Great. Thanks. Again, I think this has been
educational for a lot of us who aren't in the scientific
community. Dr. Gray, in your long scientific career, you have
had disagreements with scientists who have worked with you in
the past, I am assuming. Is that correct?
Mr. Gray. It is unusual to find unanimity among any group
of scientists larger than one.
Mr. Shimkus. So how does a supervisor walk the fine line
between engaging in scientific debate with staff who disagree
and who may think that the debate is an attempt to influence
them?
Mr. Gray. One of the things that we really encourage and
one of the strongest core values of EPA and especially the
Office of Research and Development in our science and
technology arm is that this open debate and open sharing of
scientific information is the best way to serve the Agency, to
serve the public.
Mr. Shimkus. Is it important for supervisors to challenge
staff?
Mr. Gray. I think that it is important for--in many ways,
it may not be the role of the supervisor although supervisors
are there to make sure that people are doing the work they are
supposed to be doing in the appropriate ways and then that work
has to go through, as our products do at EPA, through some sort
of peer review to check on their scientific quality.
Mr. Shimkus. On the flip side, is it important for staff to
challenge supervisors?
Mr. Gray. I think what you learn in science school is, it
is important to ask questions no matter who you are asking them
of.
Mr. Shimkus. Yes, and I would agree, and I know sometimes
we don't like to get in those debates and discussions. I think
that is all the questions I have, Mr. Chairman. Thanks.
Mr. Stupak. Just a couple for Mr. Peacock. Mr. Peacock, the
report there by the Union of Concerned Scientists, you must
have seen the report, right?
Mr. Peacock. Yes.
Mr. Stupak. What did you think of the report? You had 800
and some scientists, 500 and some said they felt political
pressure.
Mr. Peacock. I have three things to say about the report.
First of all, I was concerned about it. We don't tolerate
political interference with science at the Agency, just like we
don't tolerate manipulation of peer review panels. So I took a
serious look at it. The second thing I would say about it is,
it didn't take too long for me to find what I thought were a
number of fatal flaws in the report and I am sure they are not
complete, and some of them I think have been mentioned today,
including the response rate. Most of the--over a third of the
respondents do not do scientific duties as the main part of
their job so I don't know why we are calling them all
scientists. There are issues regarding the wording of the
questions themselves. Undue delays in a Web site or a press
release being released is automatically considered political
interference, so I didn't put a lot of faith in the report. It
still concerned me, so then I thought, well, what other signs
would I see if there was political interference, and I just
don't see those signs. I do all-hands meetings as the
administrator does with almost all the offices in EPA every
year. This is not an issue that comes up frequently. Rarely, if
at all, I would say. EPA is one of the top 10 places to work,
has resulted in that way due to surveys consistently year after
year, so I don't get the sense--and we have a lot of
scientists. I don't get the sense that people are actually
seeing that.
Mr. Stupak. In these yearly surveys, do you ask about
political pressure?
Mr. Peacock. It is a survey done by OPM and they ask a lot
of questions about how people feel about the workplace, about
their supervisors, about benefits, and it is not an issue that
comes up.
Mr. Stupak. Is it just yes and no on these surveys?
Mr. Peacock. I don't know. I am only familiar with the
results where they rank the agencies and we are always in the
top 10.
Mr. Stupak. So you don't know anything about the survey, if
they even ask about pressure from supervisors or----
Mr. Peacock. They ask about the relationships with
supervisors, and I don't--they certainly don't go over the
specificity of political interference on questions of science.
Mr. Stupak. Let me ask you this. Dr. Gray says in his
testimony on page 4 about the risk assessment process that, and
I am quoting now, ``The criteria for transparency were written
to ensure that the public``--I am talking about IRIS now--
``that the public would understand all the steps, logic, key
assumptions, limitations, and decisions and the assessment
process and also comprehend the supporting rationale that led
to a particular decision or outcome.'' Now, to accomplish these
lofty goals, don't you agree that the Agency comments provided
to OMB then should be made public along with OMB's comments?
Mr. Peacock. No, I don't, and it goes----
Mr. Stupak. Aren't you contradicting that testimony then?
Mr. Peacock. Well, I go back to Mr. Shimkus's point. There
is a balance here, and you see this throughout science of
people having the ability to have a fair and honest discourse
about a scientific product which involves policy judgment and
then also at some point having them come into the light of day
and have to withstand the crucible of public review, and to me,
this process strikes a balance.
Mr. Stupak. So what is more important, OMB or public review
and comment?
Mr. Peacock. They are both important. The reason IRIS
exists is because there is disagreements between agencies on
what the right level--FDA may want to set one level and EPA
another. We have to speak with one voice and OMB has the
responsibility to bring those agencies together and find what
that one voice is.
Mr. Stupak. Kyle, go to the first IRIS one, the pre-2004,
the simple one. OK.
[Chart shown.]
Mr. Stupak. OMB had one input in that one, and that was,
they were involved one time. Under the new process, OMB gets
involved on three separate times. Kyle, go to the last one
there, the post-April 10 one.
[Chart shown.]
Mr. Stupak. So what special scientific knowledge does OMB
bring to the process that EPA, its advisors, and peer reviews
don't have that they go from one time into the process, now
they are in three times and they have the last say on it. So
what special knowledge does OMB bring that EPA and its advisors
and peer reviewers don't have?
Mr. Peacock. It is OMB's responsibility to bring the
federal agencies together to come up with one answer, and that
is the deal with IRIS. You have to have one answer. So
scientists from whatever agency----
Mr. Stupak. Was OMB failing to do that prior to 2004,
bringing it together?
Mr. Peacock. No, the problem with this process, which I
think the GAO report certainly highlights and that you have
highlighted, is, we don't get these--there was never a process
laid out and we don't get these reviews done very quickly. In
fact, they are done very late. They are very slow. So for the
first time, and I give Dr. Gray a lot of credit for this, we
laid out what the process looked like and said how can we
improve this process to make sure that it is going to work
faster.
Mr. Stupak. So if you are trying to improve the process,
and my question was, what special expertise does OMB have that
you don't have?
Mr. Peacock. You need to have one entity in the government,
which is going to bring together diverse scientific views. That
is OMB's responsibility. I don't know who else would do it.
Mr. Stupak. So during this process, they have to do it
three times?
Mr. Peacock. Well, I have to tell you, this reminds me of a
project my daughter did. She was supposed to do a diagram of
how you make breakfast in the morning and she did one of me
making waffles, and it looked something like that, and I got to
tell you, I make pretty good waffles and it seems pretty simple
to me and she does eat breakfast, so you can make anything look
pretty complicated depending on how much specificity you go to.
I am not familiar with these diagrams.
Mr. Stupak. This is your chart. We didn't make it up. We
can't understand it.
Mr. Peacock. I am familiar with the process that I signed
out in the memorandum which lays out the steps which Dr. Gray
was referring to. This to me is a logical process and each step
of the process has a certain number of days assigned to it.
Mr. Stupak. What is this then?
Mr. Peacock. I have no idea. The first time I have seen
that chart is today in this hearing room.
Mr. Stupak. Your staff briefed us with this chart. They
gave us these charts and tried to get us to understand your
process.
Mr. Peacock. Well, I would just suggest the subcommittee
stay with what I sent out in my memorandum, which I think is
pretty clear.
Mr. Stupak. Who do we believe in the EPA then, you or the
people who----
Mr. Peacock. I am not saying that chart is inaccurate. I am
saying I am not familiar with it.
Mr. Stupak. So do you think OMB should be involved three
times in the IRIS process?
Mr. Peacock. I don't see how you keep OMB out of any
process where you have to bring interagency comments in.
Mr. Stupak. Right, but three times? I can see them getting
everyone together like they did in 2004, before 2004.
Mr. Peacock. When we do a rulemaking, for instance, they
are involved twice. So once again----
Mr. Stupak. And do you think their deliberations should be
open to the public?
Mr. Peacock. No, I don't think. I think you have two
effects if you do that. One is to chill the discussion that you
need in order to get good science and good policymaking, and
the second is, you confuse the public sometimes.
Mr. Stupak. And also if no one is watching you, you can do
whatever you want with the proposed science.
Mr. Peacock. Well, that is a cynical view and there are
certainly examples where that has happened. I am not convinced
that it is happening right now. I don't see the evidence for
it.
Mr. Stupak. I have no further questions. Mr. Shimkus?
Mr. Shimkus. I don't have any questions either, Mr.
Chairman.
Mr. Stupak. Well, thank you. Thank you for coming, and this
panel is dismissed.
That concludes all questioning. I want to thank all the
witnesses for coming today and for their testimony. I ask
unanimous consent that the hearing record will remain open for
30 days for additional questions for the record. Without
objection, the record will remain open. I ask unanimous consent
that the contents of our document binder be entered into the
record. Without objection, the documents will be entered the
record.
That concludes our hearing, and without objection, this
meeting of the subcommittee is adjourned.
[Whereupon, at 3:48 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Gene Green
Thank you Mr. Chairman for holding this hearing on the
integrity of EPA science, an important issue of mutual interest
to our two Subcommittees.
The Subcommittee on Oversight and Investigations has done a
valuable and important job this Congress is identifying and
investigating issues that require legislative follow-up by our
legislative Subcommittees.
As the new Chairman, I would like to assure everyone that
the Subcommittee on the Environment and Hazardous Materials is
following these proceedings and investigations closely.
Chairman Stupak is a persistent investigator and legislator
and I know this Subcommittee will follow the trail wherever it
leads.
If these investigations determine that legislative follow-
up is needed to ensure the integrity of EPA science for the
public, then the Environment and Hazardous Materials
Subcommittee will stand ready to develop whatever legislative
changes may be necessary.
Risk assessment is a critical component in the protection
of public health and the environment. Without adequate risk
assessment, legislators and regulators cannot make informed and
wise decisions about risk management.
The testimony of John Stephenson from the Government
Accountability Office is not encouraging on this point.
EPA has a responsibility to manage the Integrated Risk
Information System (IRIS) to inform the public, industry, and
policy-makers with the strongest and best available science on
a variety of potentially hazardous materials.
I am particularly concerned that EPA has not been able to
complete an IRIS assessment for dioxin, a compound that we know
is very dangerous and is far to prevalent in and around my
district along the Houston Ship Channel.
Just outside our district we have the San Jacinto Waste
Pits Superfund site, which consists of submerged waste pits
from an old paper mill that were recently discovered to be
leaching high levels of dioxin out into the San Jacinto River,
and from there possibly to Galveston Bay.
Fish advisories have been extended to larger and larger
areas, creating a threat both to people who fish for food and
for the large sport fishing industry in the area.
Dioxin's status as a toxic compound should not be
controversial, so the lack of a complete its risk assessment is
very discouraging. Apparently only four risk assessments have
been completed this year, with a backlog of 70 more waiting
behind them.
Twelve of these backlogged risk assessments have been in
process for more than 9 years. EPA is taking as long to
complete a risk assessment as Congress takes to rewrite the
Clean Air Act.
While EPA appears to make little progress on the backlog of
70 assessments, GAO's testimony indicates that nearly half of
the 540 existing assessments may be out of date.
Making matters worse, hundreds of requested assessments on
additional chemicals have not yet made their way into the IRIS
database.
With the recent public attention to chemicals such as Thah-
Lates (pthalates), BPA, and flame retardants, it seems that our
chemical regulatory system is lurching from one public flash-
point to another, while systematic risk assessment and risk
management are stuck in neutral.
If the wheels are just spinning over at EPA, Congress will
be forced move on its own in response to a public outcry for
protection from potentially hazardous chemicals.
We need to restore public confidence in EPA's risk
assessment and chemical regulatory system, and the first step
must be to ensure the integrity of EPA's scientific information
and practices.
Mr. Chairman, thank you for holding this hearing. The
Subcommittee on Environment and Hazardous Materials looks
forward to working with this Subcommittee on any and all issues
that you identify involving problems with EPA science.
----------
Prepared statement of Hon. Marsha Blackburn
Mr. Chairman, thank you for holding this hearing and I want
to thank the witnesses for testifying before this committee on
scientific integrity at the EPA.
Some members in this committee and witnesses on these
panels believe the current administration has significantly
interfered with science review and policy in the EPA over the
past 8 years.
Yet there is also evidence of staff and scientists within
EPA either interfering or not complying with the peer review
process
These actions severely undermine the credibility of EPA to
objectively regulate environmental pollutants.
One recent example is EPA's reliance on NOAA's ``Unified
Synthesis Product'' to support its proposed greenhouse gas
regulations.
This document was made to look like real science. It was
touted as a highly influential scientific assessment.
But in fact there was no actual research, and the
scientific method was thrown to the wayside.
A proper peer review would have excluded this document from
consideration.
Another example is the recent comments made at the December
2007 meeting of the Board of Scientific Counselors
Computational Toxicology Subcommittee.
These comments revealed how EPA investigators are cheating
on their results for suitable data and the lack of any
evidentiary support for EPA's current use of linear modeling
for low dose toxic claims.
Has a proper peer review been conducted on these issues? It
appears not.
Mr. Chairman, scientific integrity is a commitment to
truthfulness, personal accountability, and adherence to
standards of professional conduct.
But conflicts of interest can threaten scientific integrity
and improperly influence decision makers who must rely on the
assessments for public policy.
And the conflicts need not be financial. They may stem from
personal views or desire for more power in a position.
Or, in some cases, the conflicts can come from dependence
upon a source that funds the research--industry, government,
and even NGOs.
I urge my colleagues to look at the issue on a broad basis
and not merely focus on one side of the equation.
I yield the balance of my time.
----------
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