[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]



 
     CHEMICAL RISK ASSESSMENT: WHAT WORKS FOR JOBS AND THE ECONOMY?

=======================================================================

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON ENVIRONMENT AND THE ECONOMY

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED TWELFTH CONGRESS

                             FIRST SESSION

                               __________

                            OCTOBER 6, 2011

                               __________

                           Serial No. 112-93



      Printed for the use of the Committee on Energy and Commerce

                        energycommerce.house.gov



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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman

JOE BARTON, Texas                    HENRY A. WAXMAN, California
  Chairman Emeritus                    Ranking Member
CLIFF STEARNS, Florida               JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky                 Chairman Emeritus
JOHN SHIMKUS, Illinois               EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania        EDOLPHUS TOWNS, New York
MARY BONO MACK, California           FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon                  BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska                  ANNA G. ESHOO, California
MIKE ROGERS, Michigan                ELIOT L. ENGEL, New York
SUE WILKINS MYRICK, North Carolina   GENE GREEN, Texas
  Vice Chairman                      DIANA DeGETTE, Colorado
JOHN SULLIVAN, Oklahoma              LOIS CAPPS, California
TIM MURPHY, Pennsylvania             MICHAEL F. DOYLE, Pennsylvania
MICHAEL C. BURGESS, Texas            JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee          CHARLES A. GONZALEZ, Texas
BRIAN P. BILBRAY, California         JAY INSLEE, Washington
CHARLES F. BASS, New Hampshire       TAMMY BALDWIN, Wisconsin
PHIL GINGREY, Georgia                MIKE ROSS, Arkansas
STEVE SCALISE, Louisiana             JIM MATHESON, Utah
ROBERT E. LATTA, Ohio                G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington   JOHN BARROW, Georgia
GREGG HARPER, Mississippi            DORIS O. MATSUI, California
LEONARD LANCE, New Jersey            DONNA M. CHRISTENSEN, Virgin 
BILL CASSIDY, Louisiana              Islands
BRETT GUTHRIE, Kentucky              KATHY CASTOR, Florida
PETE OLSON, Texas
DAVID B. McKINLEY, West Virginia
CORY GARDNER, Colorado
MIKE POMPEO, Kansas
ADAM KINZINGER, Illinois
H. MORGAN GRIFFITH, Virginia

                                 7_____

              Subcommittee on Environment and the Economy

                         JOHN SHIMKUS, Illinois
                                 Chairman
TIM MURPHY, Pennsylvania             GENE GREEN, Texas
  Vice Chairman                        Ranking Member
ED WHITFIELD, Kentucky               TAMMY BALDWIN, Wisconsin
JOSEPH R. PITTS, Pennsylvania        G.K. BUTTERFIELD, North Carolina
MARY BONO MACK, California           JOHN BARROW, Georgia
JOHN SULLIVAN, Oklahoma              DORIS O. MATSUI, California
CHARLES F. BASS, New Hampshire       FRANK PALLONE, Jr., New Jersey
ROBERT E. LATTA, Ohio                DIANA DeGETTE, Colorado
CATHY McMORRIS RODGERS, Washington   LOIS CAPPS, California
GREGG HARPER, Mississippi            JOHN D. DINGELL, Michigan
BILL CASSIDY, Louisiana              HENRY A. WAXMAN, California (ex 
CORY GARDNER, Colorado                   officio)
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)

                                  (ii)


                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. John Shimkus, a Representative in Congress from the State of 
  Illinois, opening statement....................................     1
    Prepared statement...........................................     3
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     5
Hon. Joe Barton, a Representative in Congress from the State of 
  Texas, prepared statement......................................   141
Hon. Mary Bono Mack, a Representative in Congress from the State 
  of California, prepared statement..............................   144

                               Witnesses

Paul Anastas, Assistant Administrator, Office of Research and 
  Development, Environmental Protection Agency...................     6
    Prepared statement...........................................     9
    Answers to submitted questions...............................   151
David C. Trimble, Director, Natural Resources and Environment, 
  Government Accountability Office...............................    16
    Prepared statement...........................................    18
    Answers to submitted questions...............................   163
David C. Dorman, Dean for Research and Graduate Studies, North 
  Carolina State University, on behalf of the National Academy of 
  Sciences.......................................................    28
    Prepared statement...........................................    30
Michael Honeycutt, Director of Toxicology Division, Texas 
  Commission on Environmental Quality............................    57
    Prepared statement...........................................    60
    Answers to submitted questions...............................   166
Harvey Clewell, Director, Center for Human Health Assessment, The 
  Hamner Institutes for Health Sciences..........................   100
    Prepared statement...........................................   102
    Answers to submitted questions...............................   175
Jerry A. Cook, Technical Director, Chemical Products Corporation.   105
    Prepared statement...........................................   107
    Answers to submitted questions...............................   179
Thomas A. Burke, Associate Dean for Public Health Practice and 
  Training, Department of Health Policy and Management, The Johns 
  Hopkins Bloomberg School of Public Health......................   120
    Prepared statement...........................................   122
    Answers to submitted questions...............................   198

                           Submitted Material

Letter, dated September 1, 2011, from Sunil Widge, Chairman, 
  Specialty Steel Industry of North America, to Lisa Jackson, 
  Administrator, Environmental Protection Agency, submitted by 
  Mr. Murphy.....................................................    48
Letter, dated October 4, 2011, from Cal Dooley, President and 
  CEO, American Chemistry Council, to subcommittee leadership, 
  submitted by Mr. Shimkus.......................................    55
Majority memorandum, dated October 4, 2011, submitted by Mr. 
  Shimkus........................................................   145


     CHEMICAL RISK ASSESSMENT: WHAT WORKS FOR JOBS AND THE ECONOMY?

                              ----------                              


                       THURSDAY, OCTOBER 6, 2011

                  House of Representatives,
       Subcommittee on Environment and the Economy,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 9:07 a.m., in 
room 2123 of the Rayburn House Office Building, Hon. John 
Shimkus (chairman of the subcommittee) presiding.
    Members present: Representatives Shimkus, Murphy, Pitts, 
Bass, Harper, Cassidy, Gardner, Barton, Green, Butterfield, 
Barrow, and DeGette.
    Staff present: Caroline Basile, Staff Assistant; Anita 
Bradley, Senior Policy Advisor to Chairman Emeritus; Jerry 
Couri, Senior Environmental Policy Advisor, Environment; Dave 
McCarthy, Chief Counsel, Environment/Economy; Carly McWilliams, 
Legislative Clerk; Tina Richards, Counsel, Environment/Economy; 
Chris Sarley, Policy Coordinator, Environment/Economy; Brett 
Scott, Staff Assistant; Lyn Walker, Coordinator, Admin/Human 
Resources; Tom Wilbur, Staff Assistant; Alex Yergin, 
Legislative Clerk; Jacqueline Cohen, Democratic Counsel; and 
Billie McGrane, Democratic Assistant Clerk.
    Mr. Shimkus. The hearing will come to order. We want to 
welcome the first and second panels, and I will start with my 
first opening statement. And I recognize myself for 5 minutes.

  OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF ILLINOIS

    It has been no secret to anyone following our Committee 
that we have been taking a very specific look at the regulatory 
climate in this country where it is imbalanced and unworkable. 
In doing so, I and others have been clear that while we 
advocate the maintenance of commonsense environmental and 
public health protections, we also need to be careful about the 
impacts of government encroachment and that these efforts not 
discourage job protection and economic growth. Today's hearing 
is another step to appreciate these issues.
    To understand the final regulatory product and the economic 
impacts of EPA activities, I think it is important to 
appreciate the process used by the Agency to get those results. 
Our hearing will delve into one of the foundational parts of 
EPA's activities: the work of the Integrated Risk Information 
System, also known as IRIS.
    I have been a strong advocate for high-quality science that 
is objective and valid. Moreover, I understand that many are 
concerned about IRIS's activities on specific chemicals. I am 
not here to defend any particular chemical. This hearing is not 
about specific chemicals. To truly protect the public from harm 
and negative economic outcomes, we need an unbiased process 
informing policymakers about the science, not policymakers 
informing the science.
    IRIS was created over 25 years ago to provide EPA with 
information to develop policy surrounding human health effects 
from exposure to chemicals. There is no doubt providing such 
high-quality science-based assessment is critical to EPA's 
mission. The question is whether IRIS is in fact fulfilling 
this goal, or have results begun to develop to support specific 
policy objectives?
    From our subcommittee's perspective, we need to grasp that 
IRIS is the program making scientific assessments about 
chemical substances that EPA program offices use to set federal 
limits for various environmental laws, including the Safe 
Drinking Water Act and the Solid Waste Disposal Act. In 
addition, many states rely on IRIS data for their own 
environmental program purposes.
    We are honored today to have a collection of very 
distinguished witnesses and I appreciate the time and 
sacrifices they have made to be with us. Among the testimony we 
will receive is from the administration and their view of IRIS 
and its role. I look forward to getting an update on EPA's 2009 
reforms to IRIS, as well as where things stand with the Chapter 
7, the long-term recommendations of the National Academies of 
Science for IRIS.
    In addition, we will have insight on whether IRIS 
assessments are doing what they should, if states are finding 
IRIS work reliable, how much we should care about IRIS 
assessment impacts on jobs and the economy, and is there a 
better way for EPA to perform these assessments? These 
recommendations could be helpful as we think about more global 
issues affecting the EPA.
    I hope all members will use this opportunity to understand 
the process, discuss the integrity of the basic science 
assessed at EPA, and appreciate how and when policy 
considerations converge in this process and their impact on 
jobs and the economy.
    And I will now yield back my time and recognize the ranking 
member, Mr. Green, for 5 minutes.
    [The prepared statement of Mr. Shimkus follows:]

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   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Thank you, Mr. Chairman. I thank you for holding 
this hearing today entitled ``Chemical Risk Assessment: What 
Works for Jobs in the Economy?''
    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. EPA has the 
responsibility to manage the Integrated Risk Information 
System, or IRIS, to inform the public, industry, and 
policymakers with the strongest and best-available science on a 
variety of potentially hazardous materials in the most non-
political manner.
    In 1985, they established IRIS to help the Agency develop 
consensus opinions within the Agency about the health effects 
from the chronic exposure to chemicals. Currently, the EPA has 
assessments of 550 chemicals. These assessments are utilized by 
the EPA to further their mission and to set standards to 
protect human health and environment. IRIS assessments can be 
used in regulations that garner a lot of attention. In recent 
years, this attention has not been positive.
    In 2008, the Energy and Commerce Committee held a hearing 
in the Oversight and Investigations Subcommittee on IRIS and a 
GAO report that exposed concerns about the IRIS program. At the 
hearing, the GAO testified that there was a backlog of 70 
chemicals in the IRIS system that needed to be completed but 
that only four had been completed in 2008. And half the 540 
chemicals that were currently in IRIS possibly had outdated 
risk assessments. On tops of that, there are hundreds of other 
chemicals that have been referred to the IRIS system but have 
not even begun the assessment process. I also note that since 
the hearing in 2008, IRIS has only released assessments on 10 
additional chemicals.
    In that 2008 hearing, I expressed concern regarding the 
IRIS assessment of dioxin. If you look at the dioxin section on 
IRIS webpage, you see a timeline. It appears that IRIS has been 
assessing dioxin since 1985. I asked questions about this 
assessment in 2008, and now 3 years later, EPA released a 
statement that IRIS's assessment on dioxin will be finalized in 
2012.
    Dioxin is a compound that we know is very dangerous and far 
too prevalent in and around the district I represent along the 
Houston Ship Channel. Just outside our district, we have the 
San Jacinto Waste Pits Superfund site which consisted of 
submerged waste pits from an old paper mill that were recently 
discovered to be leaching high levels of dioxin in the San 
Jacinto River and there into the Galveston Bay. Fish advisories 
have been extended to larger and larger areas, creating a 
threat both to the people who fish for food and for the large 
port fishing industry in the area.
    Dioxin status as a toxic compound should not be 
controversial, so the fact that it has still taken an 
additional 3 or 4 years for IRIS to complete its risk 
assessment is very discouraging. If the EPA wants IRIS's 
assessments to be viewed as legitimately scientific and 
reliable, they must take steps to streamline their reviewing 
process to issue assessments in a timely manner so they are not 
outdated or make the assessments clearer and easier to 
understand.
    The National Academy of Sciences issued guidance on how to 
improve IRIS assessments, and I hope the EPA witness can update 
the committee on the improvements being made in the IRIS 
program and what they intend to do in the future to correct the 
problems within the program. We need to restore the 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.
    I look forward to hearing the testimony of all of our 
witnesses, but particularly Dr. Honeycutt from TCEQ who is from 
my home State of Texas and we work with them particularly on 
that dioxin facility in the San Jacinto area.
    And Mr. Chairman, I yield back my time.
    Mr. Shimkus. The gentleman yields back his time.
    Does the gentleman from Mississippi seek time for an 
opening statement? Gentleman from Louisiana? Having no other 
members present to seek time, I would like to welcome the first 
panel.
    First of all, let me introduce the entire panel, and then 
we will go to 5-minute opening statements.
    First we have Dr. Paul Anastas, the Assistant Administrator 
to the Office of Research and Development in the United States 
Environmental Protection Agency. Sir, welcome. Also, Mr. David 
Trimble, Director of Natural Resources and Environment for the 
U.S. Government Accountability Office; and Mr. David C. Dorman, 
Dean for Research and Graduate Studies at North Carolina State 
University on behalf of the National Academy of Sciences.
    We have two great panels and we again welcome you. And I 
would like to first turn to Dr. Anastas from the EPA for a 5-
minute opening statement. We have got a lot of members. We have 
got time if you go over. That is not a problem. If it goes too 
far, then it might be a problem.
    So welcome and you are recognized, sir.

STATEMENTS OF PAUL ANASTAS, ASSISTANT ADMINISTRATOR, OFFICE OF 
  RESEARCH AND DEVELOPMENT, ENVIRONMENTAL PROTECTION AGENCY; 
DAVID C. TRIMBLE, DIRECTOR, NATURAL RESOURCES AND ENVIRONMENT, 
GOVERNMENT ACCOUNTABILITY OFFICE; AND DAVID C. DORMAN, DEAN FOR 
 RESEARCH AND GRADUATE STUDIES, NORTH CAROLINA UNIVERSITY, ON 
           BEHALF OF THE NATIONAL ACADEMY OF SCIENCES

                   STATEMENT OF PAUL ANASTAS

    Mr. Anastas. Good morning, Chairman Shimkus, Ranking Member 
Greene and other members of the Committee. My name is Paul 
Anastas and I am the assistant administrator for the Office of 
Research and Development at the Environmental Protection Agency 
and the Agency's science advisor. Thank you for the opportunity 
to be with you here this morning to discuss the Integrated Risk 
Information System, also known as IRIS.
    At the EPA, we firmly believe that the American people 
deserve the best possible scientific information about the 
chemicals that they may encounter in their air, water, and 
land. When those chemicals may potentially affect their health, 
their children, and the health of their communities, we have 
the duty to vigorously study them and share what we know with 
our citizens.
    Every day, expert scientists in EPA's IRIS program work to 
fulfill that duty providing this information by drawing upon 
the best science both from the Agency as well as from 
universities and research institutes around the world. The 
assessments that we develop as part of the IRIS program are 
scientific documents, not regulations. This is an important 
distinction. While the information they contain is useful in 
our agency decisions, it is also widely used by communities, 
businesses, environmental groups, and public citizens. For 
those reasons and more, we recognize the importance of 
maintaining the highest level of scientific integrity when 
generating these IRIS assessments. That is why every draft IRIS 
assessment is made available to the public, to our sister 
federal agencies, and to the broader scientific community for 
their review and comment.
    The draft assessments we produce undergo one of the most 
rigorous, independent peer review processes in any scientific 
field. This peer review process makes our IRIS assessments 
stronger. The comments that we receive are valued and 
addressed. This is precisely why we undergo such rigorous 
review. This is how the scientific process works.
    We also recognized that continuous improvement is what 
science is all about. That is why in May 2009, Administrator 
Jackson put into place a strengthened and streamlined IRIS 
process. This new process not only strengthened the scientific 
integrity of the IRIS program, it also shortened the average 
time frame for generation of IRIS assessments from 5 years to 
just 23 months. Since 2009, EPA has completed 20 IRIS 
assessments, twice as many assessments as were finalized in the 
previous 4 years combined.
    But our efforts to continuously improve didn't stop there. 
This past July, I announced a plan to further strengthen the 
IRIS program. Because our assessments are widely used in the 
decisions of state and local governments, businesses, and 
American citizens, we have focused on making them clearer, more 
concise, and ensuring that our methods and scientific 
assumptions are more transparent to the users. These 
improvements, which we began aggressively implementing in July, 
directly address the suggestions from the National Academy of 
Sciences and other independent experts. The NAS made six major 
suggestions to improve the generation of IRIS documents, and we 
are implementing all of those recommendations. Those 
recommendations and how we are dealing with them are detailed 
in my written testimony, and I will be happy to expand on 
those.
    We will pursue continuous improvement, but we will proceed 
in a way that does not slow or prevent our ability to provide 
the best scientific information to the public. That is what the 
American people expect and deserve. We recognize that the only 
reason to deeply understand a problem is to inform and empower 
its solution. When we look at the information that is being 
transmitted through our IRIS assessments, information about 
what makes a chemical hazardous, that information can be used 
to design the next generation of chemicals so that they are not 
hazardous in the first place. We believe this information 
empowers innovation in the marketplace.
    Leading companies understand this potential for innovation 
and are pursuing it aggressively through the use of green 
chemistry. Green chemistry is the design of chemical products 
and processes that reduce or eliminate the use and generation 
of hazardous substances. By understanding the properties that 
make a chemical hazardous, scientists and industry and in 
academia are meeting environmental and economical 
simultaneously through the principles of green chemistry 
design.
    New life-saving medicines are being developed in ways that 
produce dramatically less waste through green chemistry. New 
high-performing materials are being invented to serve their 
purpose and then degrade harmlessly into the environment 
through green chemistry design. New products are being 
introduced into the marketplace that are safe for children and 
attractive to consumers through green chemistry. All of this 
progress is being made in sectors ranging from agriculture to 
energy, transportation to telecommunications, and cosmetics to 
computing. Companies across the American economy are increasing 
profits and enhancing competitiveness through green chemistry. 
That is the power and the potential of green chemistry. And 
that is why the lessons we learn from toxicology and the IRIS 
program are important for feeding innovation.
    In conclusion, whether it is through IRIS or our other 
cutting-edge scientific research, EPA is providing critical 
information to companies, entrepreneurs, and researchers so 
they can make new discoveries and develop new innovations all 
while protecting health and the environment. That is the real 
power of understanding chemical hazard and that is why EPA's 
IRIS program is so critically important.
    We will continue to improve this program using the best 
science not only to understand the problems of today, but to 
inform and empower the solutions of tomorrow. It is what is 
necessary for the environment, for public health, for the 
economy, and I think we can all agree that it is what the 
American people deserve.
    Thank you for the opportunity to speak here this morning. I 
will be happy to answer any questions as is appropriate.
    [The prepared statement of Mr. Anastas follows:]

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    Mr. Shimkus. Thank you, Dr. Anastas.
    And we would now like to recognize Mr. David Trimble. Sir, 
you are recognized for 5 minutes likewise. Take your time and 
get through it, and we welcome you here.

                 STATEMENT OF DAVID C. TRIMBLE

    Mr. Trimble. Chairman Shimkus, Ranking Member Green, and 
members of the subcommittee, I am pleased to be here today to 
discuss our prior work and recommendations on EPA's Integrated 
Risk Information System.
    As you know, the IRIS database contains EPA's scientific 
position on the potential human health effects of exposure to 
more than 550 chemicals in the environment. IRIS assessments 
are a critical component of the EPA's capacity to support 
scientifically sound risk management decisions, policies, and 
regulations.
    In March 2008, we reported that the IRIS program was at 
serious risk of becoming obsolete because the Agency has not 
been able to complete timely credible chemical assessments or 
decrease its backlog of 70 ongoing assessments. We found that 
the time frames for completing assessments were unacceptably 
long, often taking over a decade. In many cases, assessments 
became obsolete before they could be finalized and were stuck 
in an endless loop of assessment and reassessment.
    In April of 2008, EPA revised the IRIS process, but the 
changes made were not responsive to our recommendations. The 
new process was actually worse than the one it replaced, 
institutionalizing process that resulted in frequent delays by 
enabling OMB to determine when an IRIS assessment could move 
forward. Further, this process effectively excluded the content 
of OMB's comments to EPA and those from other interested 
federal agencies from the public record.
    Concerned with these programs and the Agency's lack of 
responsiveness, we added EPA's process for assessing and 
controlling toxic chemicals to our January 2009 report on 
government-wide high-risk areas in need of an increased 
attention by executive agencies and Congress. In May 2009, EPA 
had made significant changes to the IRIS process. In June of 
that year, we testified that these changes, if implemented and 
managed effectively, would be largely responsive to the 
recommendations we made in our March 2008 report. Let me 
highlight three of these key changes.
    First, the IRIS process would be managed by EPA rather than 
OMB as the former process was, restoring independence to EPA. 
Second, it required that all written comments provided by OMB 
and other federal agencies and draft IRIS assessments be part 
of the public record, adding transparency and credibility to 
the process. Third, the procedures consolidated and eliminated 
steps, streamlining the process.
    Notably, the new process eliminated the step under which 
other federal agencies could have IRIS assessments suspended 
indefinitely to conduct additional research. As we have 
reported, we understand that there may be exceptional 
circumstances under which it may be appropriate to wait for the 
results of an important ongoing study. However, as a general 
rule, we believe that the IRIS assessments that are based on 
the best available science is a standard that would best 
support the goal of completing assessments within reasonable 
time periods and minimizing the need to conduct wasteful 
rework.
    While the May 2009 IRIS process changes reflect a 
significant improvement that can help EPA restore the integrity 
and productivity of the IRIS program, EPA still faces 
significant management challenges as it seeks to completely 
timely, credible IRIS assessments.
    First, EPA must continue to balance the need for using the 
best available science with completing IRIS assessments in a 
timely manner. As we have reported, even 1 delay can have a 
domino effect requiring the process to essentially be repeated 
to incorporate changing science.
    Second, EPA faces long-standing difficulties in completing 
assessments of chemicals of key concern, those that are both 
widespread and likely to cause significant health issues. We 
believe that EPA must continue to focus on the best available 
science, obtaining credible expert review, and finalizing IRIS 
assessments.
    Third, EPA must be disciplined in keeping the timelines 
even in the absence of fixed statutory deadlines for completing 
IRIS assessments.
    Lastly, we believe that to produce timely credible IRIS 
assessments over a sustained period of time, it will be 
important for EPA to maintain a consistent process going 
forward.
    We are currently reviewing EPA's implementation of its 
revised 2009 IRIS assessment process and its response to our 
previous recommendations. As part of this review, we will be 
examining EPA's response to NAS's recommendations for 
improvements to the IRIS process. We plan to issue this report 
later this year.
    That concludes the summary of my statement. I will be happy 
to answer any questions any member of this committee may have.
    [The prepared statement of Mr. Trimble follows:]

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    Mr. Shimkus. Thank you very much.
    Now, I would like to recognize for 5 minutes Dr. David 
Dorman, who is testifying on behalf of the National Academy of 
Sciences. Sir, welcome. You have 5 minutes, and take your time 
on the opening statement.

                  STATEMENT OF DAVID C. DORMAN

    Mr. Dorman. Thank you. Good morning, Mr. Chairman and 
members of the subcommittee. My name is David Dorman. I am a 
professor of toxicology at North Carolina State University and 
I served on the National Research Council's Committee to Review 
EPA's Draft IRIS Assessment of Formaldehyde.
    The NRC report was developed by 15 scientists drawn by 
academia, federal laboratories, state government, and other 
organizations. The scientists that served on the NRC committee 
were selected by the National Academies and had a wide array of 
scientific expertise related to this effort. As part of the 
Academy's process, a draft of the committee's report was 
subjected to extensive peer review prior to release by the NRC.
    It is important to note that the NRC was not asked to 
conduct an independent assessment of formaldehyde but rather we 
were charged with examining EPA's identification of potential 
cancer and non-cancer health effects, the toxicological basis 
for those health effects, and the way uncertainty factors used 
to derive the reference concentrations and the quantified 
cancer unit risk estimates for formaldehyde. The major findings 
of our NRC committee were as follows:
    First, we found that the U.S. EPA was faced with the 
daunting task of compiling a complex and large toxicological 
database for formaldehyde. For the most part, the committee 
agreed that EPA achieved this goal. The EPA's draft assessment 
for formaldehyde was prepared using the Agency's current format 
and approach for IRIS documents. Our committee found the EPA's 
document to be quite cumbersome and was too often lacking in 
clarity and transparency. We were troubled that previous NRC 
committees reviewing similar assessments for other chemicals 
had identified similar deficiencies.
    Third, our committee therefore offered a set of suggestions 
for changes in the IRIS development process that might help EPA 
improve its approach. In essence, we provided EPA with a 
roadmap for changes in the development process. The term 
roadmap was used because the topics that needed to be addressed 
were set out, but detailed guidance was not provided by the 
committee since that was seen as beyond our committee's charge.
    Thus, the committee provided general guidance for the 
overall process and some specific guidance on the specific 
tests and steps of evidence identification, evidence review and 
evaluation, weight-of-evidence evaluation, selection of studies 
for derivation and calculation of reference concentrations and 
unit risk. For each of these steps, there are underlying 
processes that would need to be examined and reconsidered. The 
NRC report provides further details on these recommendations.
    Finally, the committee recognized that any revision of the 
approach would involve an extensive effort by EPA staff and 
others, and consequently, it did not recommend that EPA delay 
the revision of the formaldehyde assessment while revisions of 
the IRIS approach were undertaken. In fact, we provided 
specific guidance as to the steps needed to revise the existing 
draft IRIS assessment. Models for conducting IRIS assessments 
more effectively and efficiently are available, and the 
committee provided several examples in the present report. 
Thus, EPA might be able to make changes in its process 
relatively quickly by selecting and adapting existing 
approaches as it moves towards a more state-of-art process.
    As a member of the committee, I have been pleased to hear 
that Dr. Anastas and other EPA administrators plan on 
implementing suggestions found in the NRC formaldehyde report.
    In closing, I would like to thank all of you for inviting 
me here to discuss the NRC's report and I welcome your 
questions.
    [The prepared statement of Mr. Dorman follows:]

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    Mr. Shimkus. Thank you very much. And we will start.
    And I will recognize myself for 5 minutes for the first 
round of questions.
    First to Dr. Anastas, you have been clear in the past that 
IRIS does not perform risk assessments; rather this is done by 
risk managers in the program office, and I have been trying to 
handle those differences. EPA's Web site, though, states that 
IRIS is ``a human health assessment program that evaluates 
quantitative and qualitative risk information on effects that 
may result from exposure to specific chemical substances found 
in the environment. If this is true, how can IRIS not be doing 
``risk assessments'' if it has to distill qualitative risk 
information and quantitative risk information?
    Mr. Anastas. The elements of a full risk assessment have 
been outlined in a landmark 1983 NAS report that looks at risk 
identification and characterization, dose response as well as 
exposure. What an IRIS assessment is today is looking at the 
hazard identification and characterization and the dose 
response. Until that information--which is powerful and 
actually fundamental to a risk assessment--is combined with the 
exposure models and the exposures that are expected and 
anticipated under a regulatory program or some other scenario, 
that is when it becomes a full risk assessment and is used in 
risk management. This is the important but only the front-end 
part of that overall calculus.
    Mr. Shimkus. Thank you. You did answer this question in 
your opening statement. I am just going to go through three 
quick ones. You stated in your opening statement that the IRIS 
office evaluates peer review recommendations, correct? Is that 
what you said in your opening statement?
    Mr. Anastas. Right. When we get any peer review comments, 
we always review them and address them, yes.
    Mr. Shimkus. Do you write draft assessments and evaluate 
public comments?
    Mr. Anastas. We submit our draft assessments for public 
comment and the public and the scientific community comments on 
those drafts.
    Mr. Shimkus. Does your office decide what to include and 
exclude and what other changes to be made to its own work based 
upon those two responses?
    Mr. Anastas. Through an extensive and iterative process, we 
receive those comments, address those comments, and 
transparently show how we have addressed those comments.
    Mr. Shimkus. Thank you.
    Mr. Trimble, what effect does IRIS risk values have on the 
regulated community or the private marketplace?
    Mr. Trimble. Well, as Dr. Anastas has indicated, it forms 
the basis for many of EPA's regulatory decisions. For example, 
in drinking water standards, the information in IRIS will be 
married up with occurrence data whether or not the contaminant 
has been found in water across the country to inform decisions 
about whether or not, for example, to regulate a contaminant. 
So it is the building block for many of EPA's regulatory 
decisions.
    Mr. Shimkus. But if the IRIS assessment is not finalized 
for over a period, then what is that effect?
    Mr. Trimble. Then basically everything comes to a 
screeching halt because the mission teams like the water office 
or air, they don't have sort of the basic science they need to 
carry out their mission.
    Mr. Shimkus. And then the private sector who might be 
preparing for this are----
    Mr. Trimble. Everyone is left hanging.
    Mr. Shimkus. Thank you. And Dr. Dorman, I have talked about 
this numerous times in my years here on the committee. What is 
the value of a risk assessment value that identifies a level 
below a natural occurring background level?
    Mr. Dorman. So that is a dilemma for a number of chemicals 
that exist endogenously, and my own opinion--and I think it 
also was echoed in a report--is that for formaldehyde in 
particular, those endogenous levels need to inform the 
assessment as performed by EPA or other agencies. On a personal 
note, kind of speaking not for the committee, I think that 
becomes a challenge and I think that oftentimes we don't 
regulate chemicals, we don't consider the risk assessment in 
light of that endogenous background.
    Mr. Shimkus. And endogenous meaning?
    Mr. Dorman. That is what is present normally in the body 
just from consumption of food or for metabolism. It is 
basically what your body produces.
    Mr. Shimkus. So in the numerous years I have been on this 
committee and dealing with--you know, we have water issues that 
would have endogenous elements in it, we have ground that has 
endogenous elements, so I guess for the layman, having a 
standard that is lower than naturally occurring, cleaning the 
soil up and then you can't replace it with the same soil. This 
same soil is still higher than the standard established by this 
risk assessment, is that correct?
    Mr. Dorman. Correct. That could be the case.
    Mr. Shimkus. Thank you very much.
    Now, I would like to recognize my colleague, Mr. Green, for 
5 minutes.
    Mr. Green. Thank you, Mr. Chairman.
    And I guess why IRIS is so important--and I happen to 
represent the largest petrochemical complex in the country--is 
that all the chemicals used properly are something that we 
really benefit from, but that is why IRIS is so important 
because of those beneficiary uses, but in certain levels. And 
the best example is formaldehyde and dioxin. We need those but 
when used properly and that is why IRIS is so important to do.
    Mr. Administrator, I mentioned in my opening statement I 
was concerned with the length of time it has taken IRIS to 
complete assessment of dioxin due to the presence of dioxin 
super flight in our district. It is my understanding that IRIS 
is expected to release a portion of the final dioxin assessment 
in January of 2012. Is that correct? And can you elaborate very 
briefly on why this is a two-part assessment? Yes, sir.
    Mr. Anastas. One of the things that I did try to emphasize 
is that when we receive comments on an assessment, we take them 
extremely seriously and we want to fully address all of these 
comments. We follow the science. The science is what dictates 
when we can release a final assessment. We submitted the dioxin 
assessment most recently the received comments on both the 
cancer portion of the dioxin assessment and the non-cancer 
portion of the assessment. It is clear that the comments on the 
non-cancer portion of the assessment are things that can be 
readily dealt with, addressed, and that we can move quickly 
ahead.
    The complexity of the dioxin cancer portion of the 
assessment are far more complex and will not be completed on 
the same time frame as the non-cancer portion of the 
assessment. And that is based on the science and the complexity 
of the science and the scientific issues.
    Mr. Green. This is not the first hearing that our committee 
has had on IRIS and it is an important program that has been 
subject to review by the GAO and the National Academy of 
Sciences Committee for years. It has been targeted because of 
lengthy delays and because sometimes the politicalization--
surprise, surprise--in Washington what should be scientific 
process. We saw this during the Bush Administration when the 
OMB took over management of the IRIS program and the pace of 
the assessments slowed to a crawl. The Government 
Accountability evaluated the peer review process in 2004 and 
raised certain concerns.
    Mr. Trimble, can you briefly explain the concern GAO had 
with IRIS review system that was in place from 2004 to 2008? 
And again I am trying to remember. Obviously, OMB reviews all 
regulations from agencies, but this is the first time I had 
seen that OMB would actually control the process between 
agencies for input. So I appreciate, you know, you answering 
that.
    Mr. Trimble. Briefly, what we found at the time was we had 
concerns regarding productivity with the IRIS program, which we 
have talked about. At that time one of the things that we noted 
in our reports was that OMB had involved itself and taken 
control of 2 key steps within the process so that reports and 
IRIS assessments could now move forward without OMB's 
concurrence. And that was I believe when reports were being 
sent out for review and when they were being finalized.
    So there was one aspect that dealt with productivity and 
EPA's independent ability to control the process, but the other 
aspect that we reported on that was troubling was that OMB's 
involvement and comments were non-transparent so there was a 
lack of transparency in the public regarding what changes were 
being made and what those comments were. OMB brought in other 
federal agencies and also those comments were not transparent 
being deemed by OMB at the time as deliberative in nature. And 
so it was those two factors that we reported on at the time.
    Mr. Green. And again that is a different system than I 
think we are used to, and there are times that as Members if we 
lose at the Agency, whether the EPA or somewhere else, we will 
go to OMB and talk about the economic impacts. And that is what 
OMB should be doing----
    Mr. Trimble. Um-hum.
    Mr. Green [continuing]. And not getting involved in the 
actual scientific assessment.
    Dr. Dorman, I know you briefly described some of the 
recommendations that National Science made. Can you talk about 
particularly with the issue of formaldehyde?
    Mr. Dorman. So I think in the case of formaldehyde, we 
found largely that we had a number of areas in which we agreed 
fully with the recommendations or the conclusions that the EPA 
had in the IRIS document. We did have some areas in which we 
differed as far as our interpretation of the EPA document in 
light of the scientific evidence that is available. We did give 
the Agency some specific recommendations regarding not relying 
on certain studies. We felt they weren't the best studies 
available for certain endpoints like sensory irritation and 
others but hopefully that addresses your concern.
    Mr. Green. OK, thank you. Thank you, panel.
    Mr. Shimkus. The gentleman's time has expired.
    The chair now recognizes the chairman emeritus, Mr. Barton, 
for 5 minutes.
    Mr. Barton. Thank you, Chairman Shimkus.
    Let me ask Dr. Anastas. Are you career or you a political 
appointee?
    Mr. Anastas. I am a political appointee.
    Mr. Barton. OK. And you have been in your position since 
the Obama Administration took office?
    Mr. Anastas. Shortly thereafter. Actually, it was January--
--
    Mr. Barton. OK.
    Mr. Anastas [continuing]. Of 2010.
    Mr. Barton. Very good. I am going to ask you a little bit 
different series of question in the hearing because my 
interest, while I share some of the interest on chemical 
issues, I am very involved in the air quality issue.
    Does your office do any of the studies that relate to 
ozone?
    Mr. Anastas. We produce integrated scientific assessments 
on a wide range of national ambient air quality standards, 
including ozone.
    Mr. Barton. OK. And mercury?
    Mr. Anastas. Yes, all of those substances under the 
program.
    Mr. Barton. And PM2.5?
    Mr. Anastas. Correct.
    Mr. Barton. OK. Is there any other office within EPA that 
does studies on those similar to your office?
    Mr. Anastas. We work closely with our Office of Air and 
Radiation and while we do the underlying scientific assessments 
of the kind that we are discussing in IRIS and integrated 
scientific assessments, the Office of Air and Radiation takes 
those basic scientific documents into their regulatory process.
    Mr. Barton. When the administrator is looking at tightening 
the standards on the various criteria of pollutants under the 
Clean Air Act, who make the decision whether the study to look 
at the health effects is going to be done internally by your 
office or externally?
    Mr. Anastas. The process of generating a scientific 
assessment on these chemicals would take place internally, 
relying on a wide range of external studies--universities, 
research institutes--and those assessments are conducted 
internally and then put out for peer review.
    Mr. Barton. Would there ever be an instance where your 
office did not do an internal study, even if the decision was 
made to do an external study?
    Mr. Anastas. I am not familiar with a case where it would 
be conducted completely externally. We rely on a wide range of 
external studies to inform our assessments, but the assessments 
that are fed into the regulatory process are constructed 
internally.
    Mr. Barton. Is it your decision whether to do the external 
study or the administrator's decision or the deputy 
administrator's decision or kind of a collective all of the 
above?
    Mr. Anastas. The conduct of the studies are dictated by the 
needs of our regulatory and program offices and they work 
closely with the Office of Research and Development to identify 
which studies are necessary to inform their regulatory actions 
and then we proceed. So that is the process that is used.
    Mr. Barton. I don't necessarily understand that answer, but 
I don't have but a minute and a half. So can you give me a 
definition that is generally accepted of what a premature death 
is?
    Mr. Anastas. One would look at statistically a life 
expectancy using epidemiological models and the absence of a 
particular effect if you are looking at, for instance, a 
respiratory----
    Mr. Barton. Well, give me a layman's definition. I mean my 
friends on the Democratic side, when we debate these 
environmental bills where we are attempting to delay some of 
the EPA regulation, they trot out these studies, and they are 
usually 10 to 15 years old, they are usually external, and they 
all seem to predict 30,000 premature deaths a year, but we have 
never gotten a definition of what a premature death is.
    Mr. Anastas. A premature death would be something that 
shortens the otherwise----
    Mr. Barton. I want to know what the definition is. Is a 
premature death somebody who has a life expectancy of 80 who 
dies at 40 because of exposure to ozone, dies at 50, dies at 
35? I mean there should be some standard definition. 
Apparently, there is not. Premature death is in the eyes of the 
beholder.
    Mr. Anastas. Their life expectancy would be shortened from 
what it would otherwise be. So it is not set at a cutoff point 
of how much shorter. That is----
    Mr. Barton. Could you provide for the record a written 
answer to what a premature death is?
    Mr. Anastas. I would be happy to.
    Mr. Barton. Whatever the definition is that your agency 
uses, I would like to have it in writing.
    Mr. Anastas. Certainly.
    Mr. Barton. Thank you, sir.
    Thank you, Mr. Chairman.
    Mr. Shimkus. The chair now recognizes the gentleman from 
Mississippi, Mr. Harper, for 5 minutes.
    Mr. Harper. Thank you, Mr. Chair.
    Dr. Anastas, just a question. Who selects who does the peer 
review? Who is invited to join in that? Is that open? Tell me 
how that works.
    Mr. Anastas. Certainly. The peer reviews can be done, for 
instance, by the National Academy of Sciences. They can be 
conducted by our Science Advisory Board. They can be conducted 
by panels of scientific experts. In the case of the National 
Academies, they are selected certainly by the Academy. The 
Science Advisory Board assembled ad hoc panels for those 
reviews, and each of these types of processes is a vetting for 
balancing different scientific expertise and ensuring that 
there aren't ethical or conflicts of interest.
    Mr. Harper. When a draft is prepared and done, if there is 
conflicting opinions by the peer review, how is that dealt 
with? Does that appear in your draft assessment that there are 
conflicting reports?
    Mr. Anastas. The results of conflicting opinions are 
resolved within the peer review committee themselves. They can 
represent the different perspectives in their peer review 
report and we would receive that report.
    Mr. Harper. So is the public ever made aware that there may 
have been a difference of opinion before that came to you?
    Mr. Anastas. Thank you. What is a very important point that 
I should have emphasized is that these peer review panels are 
publicly held. We receive public comment. The peer reviews are 
publicly available so actually one of the things that was 
emphasized by GAO is the necessary transparency, and that is 
something that is very transparent in this process is the peer 
review.
    Mr. Harper. When the peer review is being completed, once a 
final assessment is done, is that final assessment on track to 
be reevaluated? Is it a perpetual continuous reevaluation? Or 
something new comes in, is that subject to being changed?
    Mr. Anastas. There are over 500 assessments on the IRIS 
database currently, and one of the ongoing processes where we 
seek public input, we receive input from our various program 
offices and regional offices is input on what should be in the 
pipeline for highest priority either due to knowledge of 
additional scientific information that requires updating or a 
need to address actions that need to be taken. So that is how 
we inform how things get updated in what order. As was 
referenced earlier, this is an ongoing challenge and why it is 
so important that we have increased the pace of these 
assessments.
    Mr. Harper. Can you give me the difference between 
chemistry and green chemistry?
    Mr. Anastas. Certainly. Chemistry is the study of all 
matter and material and its transformations and green chemistry 
is looking at how you manipulate the molecules, how you build 
them from the atoms up so that they have a reduced ability to 
cause toxicity to humans or the environment. In the same way 
that we can design a substance to be green or blue, flexible or 
brittle, we can design it so that it is either capable of 
causing harm or far less capable of causing harm.
    Mr. Harper. Well, when I went to college, you could major 
in biology or chemistry. Do you anticipate that we will see 
green chemistry majors in our universities?
    Mr. Anastas. As a matter of fact, there are Ph.D. programs 
in major universities both in the United States and elsewhere 
in green chemistry. There are degree programs in everywhere 
from the U.S., India, China, Australia, and the U.K.
    Mr. Harper. If I have time, I would like to ask Dr. Trimble 
a question if I may. And I am going to reach a quick peer 
review committee. This was the NRC formaldehyde committee 
review just a quote here.
    It says, ``the committee is concerned about the persistence 
of problems encountered with IRIS assessments over the years 
and the draft was not prepared in a consistent fashion. It 
lacks clear links to an underlying conceptual framework and it 
does not contain sufficient documentation on methods and 
criteria for identifying evidence from epidemiologic and 
experimental studies, for critically evaluating individual 
studies, for assessing the weight of evidence, and for 
selecting studies for derivation of the RFCs and unit risk 
assessments.''
    Tell me your opinion on that, what that statement was.
    Mr. Trimble. This may be better directed to NAS since GAO 
has not looked or assessed the NAS's study.
    Mr. Harper. Well, certainly defer then.
    Mr. Dorman. Yes, sir. So what we mean by that is that 
oftentimes when one is trying to put together a database, when 
you are basically doing literature reviews, before you begin 
that process, you start to lay out a framework by which you are 
going to evaluate the literature. And so as you are starting to 
go looking at literature, you will find, per se, a chemical 
like formaldehyde there is literally thousands of articles 
available in the published literature on a chemical where if 
you search the database using a word like formaldehyde you will 
find. And so one needs to have a process by which you start to 
kind of weed that evidence down to a sub-selection of studies 
and then eventually key studies that you start to use in your 
assessment, and we just felt that EPA was not transparent in 
defining that process by which they would both identify what 
literature you were finding and then either accept or not 
accept certain studies and bring them forward in their 
assessment.
    Mr. Harper. I realize I am out of time and if I may, Dr. 
Trimble, what I was wanting to ask was this: the conclusions in 
that formaldehyde review committee seemed to indicate that the 
same problems that were noted by GAO in '06 are still evidence 
in IRIS and I just want to know if you agree or disagree?
    Mr. Trimble. I will probably punt on this. This is going to 
be part of our ongoing review, which we will be reporting on in 
the next couple of months looking at how the process has gone 
since then and part of that review will be looking at the NAS.
    Mr. Harper. That was a very polite way of not----
    Mr. Trimble. Yes, I apologize.
    Mr. Harper. Thank you.
    Mr. Shimkus. The gentleman yields back his time.
    The chair now recognizes the gentleman from North Carolina, 
Mr. Butterfield, for 5 minutes.
    Mr. Butterfield. Let me thank you, Mr. Chairman, for 
convening this very important hearing today and particularly we 
thank the witnesses for their testimony.
    Mr. Chairman, IRIS, as we all know, is the foundation of 
our public health and environmental policy and it should be 
reviewed periodically to ensure it is being carried out at peak 
performance. And so the witnesses' testimony today has been 
very helpful on this subject.
    I believe to properly evaluate IRIS's performance, we must 
have absolute clarity on the function of IRIS. Dr. Anastas, let 
me start with you. Does IRIS make risk assessments?
    Mr. Anastas. No, what IRIS does is provide important 
scientific information that gives insight on the hazards of 
chemicals and potential health consequences of various 
chemicals, but in order to have it be a full risk assessment, 
it needs to have the exposure component. So while this 
information is fundamental and essential, it is not a full and 
complete risk assessment.
    Mr. Butterfield. So do you only make hazard assessments or 
do you do both?
    Mr. Anastas. The risk assessments are done as part of the 
regulatory process in our regulatory office.
    Mr. Butterfield. But don't you agree that this is a very 
important distinction between these two?
    Mr. Anastas. It is a tremendously important distinction, 
one that is often confused. Many people do view IRIS members as 
regulations, as risk assessments, and it is an important 
distinction that this is looking at just this element of the 
scientific information.
    Mr. Butterfield. That is very helpful.
    Now, does IRIS make EPA regulations? I think we know the 
answer but I want you to go on the record and say that.
    Mr. Anastas. Well, we know how important IRIS values are to 
regulations. They are not regulations and they are not making 
regulations.
    Mr. Butterfield. So could we say, then, that the primary 
work of IRIS is to evaluate and integrate existing scientific 
literature into assessments of potential hazard which are then 
used by EPA program offices and others to gauge risk and 
eventually set thresholds for exposure in programs? Is that 
correct?
    Mr. Anastas. That is correct.
    Mr. Butterfield. In a little while, Dr. Anastas, we are 
going to hear from Dr. Honeycutt of the Texas Commission on 
Environmental Quality. He will claim that the EPA's most recent 
assessment on formaldehyde calls into question the safety of 
its hailing. Dr. Honeycutt will state that using EPA's most 
recent assessment, formaldehyde in your breath that results 
from normal body functions would be five times higher than the 
highest level of EPA would call safe. Was the IRIS assessment 
asserting that this room is now unsafe due to all of the 
formaldehyde producers currently being breathed at this time? 
How would you respond to this assertion and what are the 
implications?
    Mr. Anastas. Well, the IRIS assessment was not concluding 
or implying that this room is unsafe because of the air that we 
exhale. The formaldehyde assessment benefitted greatly from the 
comments that were supplied by the National Academies and the 
comments that the National Academies provided are being 
addressed to strengthen that assessment. But no, the answer is 
no, the assessment did not imply that we are at risk because of 
the air that we are breathing in this room.
    Mr. Butterfield. Yes. Thank you very much.
    Thank you, Mr. Chairman. I yield back.
    Mr. Shimkus. I thank my colleague. I would just note, Dr. 
Anastas, in your response you said ``not concluding,'' brings 
up my question about are you doing a risk assessment? So that 
is the part of this whole debate that we are looking into.
    The chair now recognizes the gentleman from Pennsylvania, 
Mr. Pitts, for 5 minutes.
    Mr. Pitts. Thank you, Mr. Chairman.
    Dr. Anastas, is the source of a study's funding an 
automatic disqualifier of the contents or quality of the 
research no matter how well characterized or high quality such 
a study is?
    Mr. Anastas. The evaluation of a study is based on the 
scientific integrity of the study. So the short answer to your 
question is no. The importance of the rigor of the study, the 
way that the study is conducted are the important determining 
factors. With regard to such things as the peer review and peer 
review panelists, ethical and conflict of interest are 
considered at that point, for instance, for peer reviewers, but 
in the conduct of the study, it is the scientific rigor of the 
study.
    Mr. Pitts. Other than industry funded, please tell the 
committee what other types of funding exist for high-quality 
scientific work?
    Mr. Anastas. I think there is extensive funding for high-
quality research provided by the Federal Government. There is 
certainly a wide range of our scientific agencies provide 
funding to researchers to conduct on a wide range of topics 
including toxicology, epidemiology, and these are important 
sources of funding. Whether it is the National Science 
Foundation, the National Institutes of Health, and of course 
the Environmental Protection Agency.
    Mr. Pitts. Has the EPA ever contracted with the private 
sector or intentionally obtained scientific research that was 
paid for by a private interest?
    Mr. Anastas. I want to make sure that I give you an 
accurate answer so I don't want to be definitive without 
checking all of the facts. What I will pledge to do is get back 
with you with a clear answer on that question.
    Mr. Pitts. All right. To what extent does IRIS rely on the 
scientific pronouncements made by other federal agencies or 
coordinate with them on their activities like NTP or ATSDR?
    Mr. Anastas. One of the things that we ensure doing is 
coordinate what assessments will be done so that we certainly 
wouldn't want to be duplicative or overlapping or redundant. We 
coordinate with sister agencies not only which assessments to 
do to make sure that we are complementary wherever appropriate 
but also coordinate in our interagency reviews. Interagency 
reviews are transparent and inclusive and we rely heavily on 
the scientific expertise on our sister scientific agencies and 
health agencies, as well as others.
    Mr. Pitts. Thank you.
    Dr. Dorman, in your opinion, has EPA's IRIS process evolved 
to reflect improvements in the field of risk assessment?
    Mr. Dorman. So speaking for myself and not as a member of 
the panel, I think that approaches have been kind of mixed. In 
some areas, IRIS has been more considerate of modeling efforts 
and things like that which reflect more state-of-the-art. I 
think there are other areas in which the IRIS assessment 
program probably lags a little bit behind. But I think that 
IRIS does try to keep up and I think the EPA should be, you 
know, recognized for trying to keep up with the science as it 
is evolving.
    Mr. Pitts. Are you familiar with other branches of the 
Federal Government that are engaged in risk assessment, and if 
so, do those offices employ best practices that could be 
applied here?
    Mr. Dorman. I serve and do an advisory role on different 
aspects for the Federal Government, and I think there are some 
examples of best practices. Speaking on behalf of the 
committee, we did identify some of those best practices that we 
thought could serve a template for the Agency as they move 
forward on looking at revising the IRIS program.
    Mr. Pitts. How important is it for the American public that 
the integrated risk assessment process results in a reasonably 
correct assessment and what are the practical consequences of 
an overly precautionary assessment? What are the practical 
consequences of an assessment that does not identify risk?
    Mr. Dorman. Again, I think as Dr. Anastas pointed out the 
IRIS program is not doing the risk assessment per se; they are 
trying to compile the data regarding hazard identification, but 
I think that is extremely critical for folks. And I think it is 
not only an issue of an economic issue, but it is also a public 
health issue where the public doesn't become alarmed over 
health effects that may or may not be present with a certain 
chemical. And I think that is another area that, you know, the 
EPA IRIS documents do try to identify hazard identification and 
I think it is very critical for the public that it is done in 
the right way.
    Mr. Pitts. Thank you, Mr. Chairman.
    Mr. Shimkus. The gentleman's time has expired.
    The chair recognizes that we have been joined by my 
colleague from Georgia, which I think he will----
    Mr. Barrow. I thank the chairman. I will waive.
    Mr. Shimkus. He waives. The chair now recognizes the vice 
chairman of the subcommittee, Mr. Murphy, for 5 minutes.
    Mr. Murphy. Thank you, Mr. Chairman.
    Dr. Anastas, the EPA has a draft of the IRIS toxicology 
report for hexavalent chromium, is that correct?
    Mr. Anastas. Correct.
    Mr. Murphy. Are you aware that on May 12, 2011, a panel of 
independent chromium experts had significant concerns with that 
draft?
    Mr. Anastas. I am aware of that peer review.
    Mr. Murphy. And is the EPA prepared to incorporate more up-
to-date scientific research in that based upon the information 
that came from the peer review and other input?
    Mr. Anastas. We are evaluating that peer review. We are 
evaluating the comments and concerns. While no decisions have 
been made, it is the practice that I have stated and I 
appreciate the opportunity to emphasize that we consider and we 
address the concerns raised in peer review.
    Mr. Murphy. Is there anything you recall in that peer 
review study that sticks out that says there is something that 
raises concerns of a particularly salient nature for you?
    Mr. Anastas. I think that this peer review has raised a 
number of questions about the science that is currently being 
conducted and the potential value of that science informing the 
assessment upon its completion.
    Mr. Murphy. Are you aware also of the NTP study, the doses 
given to test animals, that something like 5,000 parts per 
billion but the national drinking water standard for total 
chromium is 100 parts per million, and drinking water 
monitoring indicates that hexavalent chromium in drinking water 
is only about 1 to 4 parts per billion? I mean these seem to be 
pretty radical differences in terms of information that has 
come out on hexavalent chromium research versus what is really 
out there. How do you evaluate that sort of information when 
you see studies looking at some extremely high levels and then 
related to what is really out there?
    Mr. Anastas. It is certainly I will say a traditional 
methodology when studying the toxicity of a particular chemical 
that you want to be able to get up to the level where you see a 
particular toxic effect, and sometimes these levels that are 
required are fairly high as you mentioned. And then there is 
the necessary extrapolation. So this is not necessarily unusual 
for studies of this type.
    Mr. Murphy. But you are also drawing conclusions based upon 
having toxic levels can give us some misinformation. For 
example, a person can reach a toxic level of ingestion of H2O, 
but that doesn't mean we draw conclusions based upon that. And 
I just want to make sure that we are also looking at these 
levels. I mean what is the real risk? Because none of us want 
to misdiagnose and then mistreat the problem.
    Mr. Anastas. This is the basis of dose response----
    Mr. Murphy. Um-hum.
    Mr. Anastas. --and getting these dose response curves, the 
ability to determine at which dose an effect may take place or 
a no-effect level is the basis of dose response, and so this is 
something that I know that Dr. Dorman teaches in his classes 
all the time in North Carolina.
    Mr. Murphy. I also heard our EPA administrator talk about 
dose response curves and we should look at that.
    Now, the Natural Resources Defense Council I believe 
suggested that chromium alloys pollute our soil and water 
supplies, but I want to make something clear. Isn't it true 
that there is no association between the use of chromium alloys 
in stainless steel in any pollution or illness? Am I correct in 
that?
    Mr. Anastas. What we are looking at in the IRIS assessments 
is the toxicity and the one we are discussing is the toxicity 
of chromium-6 and different matrices you can expect different 
considerations, and that is part of the risk assessment/risk 
management calculation.
    Mr. Murphy. OK. Is that chromium-6 something that is used 
in stainless steel?
    Mr. Anastas. I believe chromium-6 is used in stainless 
steel.
    Mr. Murphy. When it is used in stainless steel, I mean 
stainless steel is also seen as containers for clean drinking 
water, surgical equipment, et cetera. Is that an issue that 
that chromium is actually leaching out of that stainless steel 
and contaminating those things?
    Mr. Anastas. Nothing in the IRIS assessment addresses any 
of those risk scenarios.
    Mr. Murphy. But you can look at things outside of the IRIS 
assessment? Here is my concern: If we are saying that that is a 
toxic chemical but it is used in containers which are used to 
have non-toxic water and sterile equipment, is it correct, 
then, in saying that that chromium is actually leaching out and 
causing problems?
    Mr. Anastas. You are identifying extremely important risk 
management decisions and exposure factors. Those are exactly 
the type of questions that are----
    Mr. Murphy. You are not giving me an answer. You are just 
saying it is important. I need to know----
    Mr. Anastas. What I am saying is that nothing in this 
health assessment would address those questions.
    Mr. Murphy. I still don't have an answer but I realize my 
time is up. Thank you, Mr. Chairman.
    Mr. Shimkus. Thank you. And at this time I recognize my 
friend from Colorado, Ms. DeGette, for 5 minutes.
    Ms. DeGette. Thank you very much, Mr. Chairman.
    Dr. Anastas, I want to ask you a couple of things I read in 
your written testimony. One is about this rider that was 
attached to the interior EPA appropriations bill this summer 
that would have delayed all IRIS assessments until the NAS 
recommendations were adopted and would have required NAS review 
of additional draft assessments. Does the administration 
support that policy?
    Mr. Anastas. What I can say is that the effect of those 
letters would be significant. I believe that Mr. Trimble did 
mention the concern I think that we all share of making sure 
that assessments come out in a timely way. The result of these 
riders would be significant delay of perhaps as much as a year 
or 2 years, and an important factor to consider is during that 
delay, would the assessments that are in development be brought 
out of date? So the impacts of this would be significant and 
cascading throughout not only the development of the 
assessments themselves but the use of these assessments.
    Ms. DeGette. What types of significant and cascading 
developments would there be?
    Mr. Anastas. As was mentioned earlier, these assessments 
are important as a foundation for different decisions and 
actions not only in the Agency but by States and municipalities 
and industry. Would these assessments then be able to inform 
regulatory decisions or other decisions? The answer of course 
is no because they would be delayed by these actions.
    Ms. DeGette. Do you think there would be an effect on 
public health or the environment by these delays?
    Mr. Anastas. I certainly believe that our regulatory 
decisions, the decisions at the state and local level and 
decisions made by companies and individuals impact human health 
and the environment, and so yes, if----
    Ms. DeGette. OK. Your answer is yes.
    Mr. Anastas. My answer is yes.
    Ms. DeGette. Thank you. Now, thinking about it from the 
other side of the issue, the chemical industry and economy in 
general, if we had uncertainty in these standards, would that 
potentially also be harmful to them since they wouldn't know 
what was coming down the pike?
    Mr. Anastas. I think the lack of knowledge is always 
difficult and something to try to avoid, which is why we try to 
get this information out.
    Ms. DeGette. Mr. Trimble, GAO has raised concerns about the 
delays in the IRIS process, and you talked about that earlier 
and what that would mean for the credibility of assessments. 
Would suspending all assessments and all actions on past 
assessments impact the utility and credibility of the program?
    Mr. Trimble. I think as Dr. Anastas indicated, the impact 
would be felt most immediately by the program offices at EPA, 
as well as the States and others that rely on that to make 
regulatory decisions.
    Ms. DeGette. So there would be a lack of certainty?
    Mr. Trimble. Yes, certainly there would be a lack of 
certainty and predictability. Certainly.
    Ms. DeGette. Now, in your testimony you talk about the 
compounding effects of delays on assessments and Dr. Anastas 
referred to that. Can you please explain what you mean by that?
    Mr. Trimble. Yes, what we have reported on in the past is 
that when studies in the past have been suspended or delayed, 
what happens is that science keeps marching so that when you 
start to restart that study, a lot of the work has to be redone 
because there is new scientific literature. We have talked 
about evolving scientific methods, for example, you know, 
quantifying risk and things like that. All of those, the state-
of-the-art practices change over time, so when you stop and 
delay, you have to catch up to what is now cutting-edge science 
to move forward and that causes delays.
    Ms. DeGette. In your testimony you mention that IRIS 
processor forms are not established in regulation or statute. 
Do you have any ideas for this committee about what we can do 
about that that you would like to share with us?
    Mr. Trimble. Well, with that I would politely demur on 
this.
    Ms. DeGette. I thought you might.
    Mr. Trimble. We have a report that is coming out by the end 
of this year looking at the implementation of the IRIS programs 
since the 2009 changes, so we will be reporting on that 
shortly.
    Ms. DeGette. Mr. Chairman, we will all look forward to 
getting a copy of that report. And I yield back.
    Mr. Shimkus. The gentlelady yields back her time.
    I ask unanimous consent for Mr. Murphy to do a unanimous 
consent request.
    Mr. Murphy. Mr. Chairman, I just ask this letter from the 
Specialty Steel industry of North America be submitted for the 
record in which it states, ``no hexavalent chromium is present 
in steel alloys.''
    Mr. Shimkus. That has been shared with the minority? Is 
there objection? Hearing no objection, so ordered.
    [The information follows:]

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    Mr. Shimkus. The chair now recognizes the gentleman from 
New Hampshire for 5 minutes, Mr. Bass.
    Mr. Bass. Thank you very much, Mr. Chairman.
    I want to thank you all for your time and interest in being 
here today.
    Dr. Anastas, OMB guidance defines ``highly influential 
scientific assessment'' as ``a scientific assessment that could 
have a potential impact of more than $500 million in any year 
on either the public or private sector or is a novel, 
controversial, or precedent setting or has significant 
interagency interest.'' Because the estimates support the 
Agency's regulatory activities, including costly cleanups, are 
the IRIS assessments routinely recognized as highly influential 
scientific assessments subject to the information quality and 
peer review guidelines?
    Mr. Anastas. I think the important discussion that we have 
been having has shown that these assessments are scientific 
inputs into regulatory decisions. They are not regulations; 
they are not regulatory conclusions. The considerations for 
economic impact are important and essential and a serious part 
of the deliberations that the Agency has, but these assessments 
are not regulations and should not be viewed as such.
    Mr. Bass. Well, I guess then in making the determination 
whether an IRIS assessment is ``highly influential,'' how does 
the EPA determine whether more than $500 million worth of 
future impacts are likely?
    Mr. Anastas. The results of regulatory decisions undertake 
extensive cost-benefit and regulatory impact analyses. Perhaps 
the most important point that I could make on this is that 
while we are, through these assessments, identifying the hazard 
profile of these substances, in the absence of exposure, there 
is no risk. If there is no exposure, there is no risk and so 
there would be no reason for its management. And so while these 
are important inputs, it would be wrong to assume that because 
something has a particular hazard profile it is necessarily 
going to trigger a regulatory action.
    Mr. Bass. Is it possible that any IRIS assessment could 
later be incorporated in a regulation that has impacts of more 
than $500 million?
    Mr. Anastas. Yes.
    Mr. Bass. OK. All right. I am all set, Mr. Chairman. Thank 
you.
    Mr. Shimkus. The gentleman yields back his time.
    The chair now recognizes the gentleman from Louisiana, Mr. 
Cassidy, for 5 minutes.
    Mr. Cassidy. Mr. Anastas, you mention, going back to Mr. 
Barton's questions, regarding how you define premature. Let us 
take a person with emphysema. We know that person with 
emphysema is more likely to have complications from an inhaled 
toxin, pick ozone, so if the person with emphysema dies at 74 
because of a bronchospastic asthmatic event triggered by ozone, 
is he, compared to the average age someone dies, say 82 for a 
man, or is he compared to the average age that somebody with 
emphysema dies?
    Mr. Anastas. So when we are looking at statistical 
population distributions, that distribution is going to have 
various susceptibilities--people who are particularly 
susceptible----
    Mr. Cassidy. Correct.
    Mr. Anastas [continuing]. And people who are particularly 
resilient. So what we are talking about is average lifespan and 
how different effects would affect a----
    Mr. Cassidy. Correct.
    Mr. Anastas [continuing]. Population. So I would not draw 
that conclusion based on an individual because I believe that 
that would not be a statistically robust approach.
    Mr. Cassidy. Wait, you don't adjust for co-morbidities when 
determining whether somebody dies prematurely because of 
exposure to a toxin?
    Mr. Anastas. No, I am saying that certainly susceptible 
populations do reside within that overall population----
    Mr. Cassidy. But I think----
    Mr. Anastas [continuing]. But I am saying that I wouldn't 
apply it to an individual.
    Mr. Cassidy. I can tell you that that would be counter to 
what you would do--I am a doctor. That is what you would do in 
medicine. You would account for co-morbidities knowing that co-
morbidities have a huge influence upon the body's reaction to 
an external event.
    Mr. Anastas. And I absolutely agree that in dealing with an 
individual you absolutely need to factor in the individual's 
susceptibility.
    Mr. Cassidy. But I gather that you are not comparing them--
--
    Mr. Anastas. That would be the logical calculation.
    Mr. Cassidy. But I actually think that you actually could 
find--go to the VA database, for example--find the average 
lifespan for somebody with a certain level of pulmonary 
impairment and you would find, yes, for this degree of 
impairment they die and this degree they die at this age. But I 
gather that is not necessarily done?
    Mr. Anastas. I am saying that in many of the 
epidemiological studies that are relevant to the discussion 
that we were having about decreased lifespan, that that has not 
been the basis of those types----
    Mr. Cassidy. OK. I got my answer. And I didn't mean to be 
rude. I don't mean to be curt. I apologize.
    Dr. Dorman, did you participate in the critique of this 
report, the IRIS report for formaldehyde?
    Mr. Dorman. Yes, sir.
    Mr. Cassidy. Now, I am struck because I just kind of 
quickly eyeball it. I am quickly eyeballing it so it may come 
in totally wrong. Join my wife on most occasions.
    If the lack of knowledge is a bad thing, misinterpretation 
of knowledge is even worse. As I look at the summary of your 
report, you say that ``the committee concludes the weight of 
evidence suggests formaldehyde unlikely to appear in blood as 
an attack molecule.'' You go on to say that, you know, kind of 
absorbed, quickly metabolized, it goes away, unlikely to have a 
systemic effect. That is kind of the, you know, as I scan what 
I am getting. So even though this is 1,000 pages--I looked it 
up--it is 1,043-page report talking about all the things it 
will do to rat urine and, you know, to human nasal mucosa, 
really all that strongly suggests there is pertinent physical 
effects, and yet your report finds that that may be overstated. 
Is that a fair statement?
    Mr. Dorman. So I think it is a fair statement that the 
Academy concluded that the current best evidence indicates that 
formaldehyde does not reach the systemic circulation in an 
appreciable way. And so what we did recognize as well, though, 
is that formaldehyde might have certain health effects that may 
not require it being delivered systemically. And so, for 
example, if we have say rhinitis or an irritation in the nose, 
you might also have headache. Even though that chemical never 
got to the brain, that would be an example say of a stress that 
might be associated with that inflammation in the nose.
    Where we differed from the conclusions probably related 
most to the motive action that EPA was considering for the 
leukemogenic responses that have been associated with 
formaldehyde exposure where we felt that the weight of evidence 
didn't strongly support their conclusions.
    Mr. Cassidy. Yes, I am kind of struck that there is 1,043 
pages of stuff which documents and if you just read it, you 
think oh my gosh, isn't this terrible? Then I read your report 
and when you actually analyze it and put it in context, it 
isn't quite so frightening. Worrisome, but not quite that 1,043 
pages of we have got to regulate. I agree with that.
    I also say, as a physician, it seems kind of routine. I am 
not sure why it has taken you so long to implement these 
suggestions I put forth because frankly, as a physician, if 
there is not rigor of methodology being explained, then the 
paper would never be published in a peer reviewed journal. That 
seems to be kind of a standard sort of scientific method of 
presentation.
    Mr. Anastas. If I could just mention that this is a draft 
assessment. We put out draft assessments for the purpose of 
getting this kind of critique so that we improve it for the 
final assessment. This is what we do. This is why we seek it 
out.
    Mr. Cassidy. Can I have just a minute more?
    Mr. Shimkus. Without objection, gentleman is recognized for 
another minute and a half.
    Mr. Cassidy. OK. Thank you.
    Going back to green chemistry, it seems to me as if that 
would be the basis for a proposal regarding inherently safer 
technology.
    Mr. Anastas. Correct.
    Mr. Cassidy. Now, that actually seems you move beyond I 
think Mr. Butterfield suggested your role as analytic--and I 
will maybe paraphrase--analytic not prescriptive, but that is a 
little disingenuous if you are saying listen, we are going to 
make a value judgment as to whether or not this has a toxic 
effect and this does not. And frankly, there will be 
assumptions that credible scientists may disagree with your 
assumptions, and yet your findings are going to be the basis, I 
bet you, for regulation promoting inherently safer technology. 
How would you disagree with that?
    Mr. Anastas. What I tried to emphasize in my statement was 
when the information that we generate gives us insights not 
only that an individual substance may or may not be toxic and 
in what ways but how it is toxic, that gives us insights into 
the design----
    Mr. Cassidy. But you are making an assumption of toxicity 
that again scientists in a peer reviewed journal would disagree 
with your assumption, but yet your assumptions are going to 
guide this green chemistry which is going to guide an IST 
regulation.
    Mr. Anastas. With all due respect, what I am saying is not 
on the level of toxicity but the mechanisms by which it has any 
kind of biological effect. This informs the design of the 
molecular structures of future chemicals so that we can 
minimize the possibility, the probability----
    Mr. Cassidy. Give me a specific because right now that 
sounds very nice, but as I try and think of the particular, it 
seems you can't divorce yourself from assumptions of the 
toxicity and we already see credible dispute with your 
assumptions of toxicity.
    Mr. Anastas. When I am looking at a molecular structure, I 
know that whether or not a substance has the ability to even 
cause any type of toxic effect----
    Mr. Cassidy. But water can drown. Do you see what I am 
saying? Water has a toxic effect if you put your head 
underneath it for too long. And so you are right, there has to 
be a dose effect, and there has to be a certain substrate in 
which it interacts. How do you account for that?
    Mr. Anastas. If a substance cannot be inhaled, if a 
substance cannot be respired, ingested across biological 
membranes, those are all based on its physical/chemical 
properties. What chemists do is develop structures to control 
their physical/chemical properties. You can design a substance 
to have those physical/chemical properties so as to reduce the 
probability that it can cause hazardous adverse consequences.
    Mr. Cassidy. I still can't--so formaldehyde----
    Mr. Shimkus. The gentleman's time has expired.
    Mr. Cassidy. Thank you. I yield back.
    Mr. Shimkus. There are too many doctors in this room. The 
IQ has gone up and I can't even understand the English being 
spoken here sometimes. I ask unanimous consent. My colleague 
Mr. Green wanted to make a statement before we adjourn this 
panel.
    Mr. Green. Mr. Chairman, I know we have votes going to be 
scheduled and I think we have exhausted our questions of the 
panel. I want to thank the panel. I know, Doctor, you had to 
change your plans to be here but when I referred to the dioxin 
facility in our district--actually in Ted Poe's district--but 
EPA worked in both administrations, both in '08 and '09, what I 
consider bureaucratic light speed to get that site on there, 
and we actually have it encapsulated now. And the next panel we 
have our Texas Commission on Environmental Quality. They 
actually are the ones that did the research to trace where all 
this dioxin would be coming from in the San Jacinto River, so 
that is a great example. Most people get mad at EPA. Here in 
Texas, you all don't think we do anything for the environment, 
but we do. Thank you.
    Mr. Shimkus. And the chair now also wants to ask unanimous 
consent that the letter dated October 4 from the American 
Chemistry Council be submitted for the record. That has been 
shared with the minority. Without objection, so ordered.
    [The information follows:]

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    Mr. Shimkus. I too want to thank the first panel and for 
the second panel we will convene you after votes and they 
should be calling them any minute. So it really is not 
productive for us to start. And we will reconvene after votes. 
So with that, I will recess this hearing.
    [Recess.]
    Mr. Shimkus. We can get through the next panel and also get 
in between votes on the floor of the House, but I think we have 
got plenty of time, but we do want to get started.
    We want to welcome you. Thank you for your patience. I will 
do as I did with the first panel I am going to introduce you 
all across the board, and then we will recognize you 
individually for your 5-minute opening statements. Because of 
the time that we have, you know, I won't hold you strictly to 
the 5 minutes, so take your time. Make sure what you want to 
present is not rushed.
    So on this second panel, we again appreciate you all for 
being here. We have Dr. Michael Honeycutt, Director of 
Toxicology Division, Texas Council on Environmental Quality. We 
also have Dr. Harvey Clewell, the Hamner Institutes for Health 
Sciences. We have also have Mr. Jerry A. Cook, Technical 
Director, Chemical Products Corporation. It is good to see a 
mister and not all doctors. And then finally Dr. Thomas A. 
Burke, Associate Dean for Public Health Practice and Training, 
Department of Health Policy and Management at Johns Hopkins 
Bloomberg School of Public Health.
    Gentlemen, thank you for joining us, and I would like to 
recognize Dr. Honeycutt for 5 minutes for his opening 
statement.

    STATEMENTS OF MICHAEL HONEYCUTT, DIRECTOR OF TOXICOLOGY 
  DIVISION, TEXAS COMMISSION ON ENVIRONMENTAL QUALITY; HARVEY 
  CLEWELL, DIRECTOR, CENTER FOR HUMAN HEALTH ASSESSMENT, THE 
HAMNER INSTITUTES FOR HEALTH SCIENCES; JERRY A. COOK, TECHNICAL 
 DIRECTOR, CHEMICAL PRODUCTS CORPORATION; AND THOMAS A. BURKE, 
    ASSOCIATE DEAN FOR PUBLIC HEALTH PRACTICE AND TRAINING, 
 DEPARTMENT OF HEALTH POLICY AND MANAGEMENT, THE JOHNS HOPKINS 
               BLOOMBERG SCHOOL OF PUBLIC HEALTH

                 STATEMENT OF MICHAEL HONEYCUTT

    Mr. Honeycutt. Good morning, Mr. Chairman and members of 
the committee. My name is Michael Honeycutt. I am director of 
the Toxicology Division at the Texas Commission on 
Environmental Quality. I would like to touch briefly on Texas' 
perspective on the science that EPA is using or not using for 
chemical risk assessments in recent years and the implications 
for regulatory agencies and the public.
    I have been a toxicologist and a risk assessor for Texas 
for over 15 years. In past years, we have had disagreements 
with EPA, but they have not really been based on science issues 
so much as on policy issues. An example of this would be that 
EPA does not want to consider TCEQ rules, which in many cases 
are more stringent than their cleanup values when addressing a 
cleanup site in Texas. However, we have always been able to 
work out our differences amicably.
    In recent years, though, EPA chemical risk assessments have 
become more precautionary in nature instead of relying on 
scientific data. The heart of the matter is that EPA is moving 
toward the philosophy that there is no safe level of exposure 
to a chemical and this is contrary to the cornerstone of the 
science of toxicology. This change in philosophy results in 
unrealistically low regulatory levels. And as a result, 
naturally occurring levels of chemicals may be higher and often 
cases it is higher than EPA-safe level.
    As an example, using EPA's most recent draft assessment of 
formaldehyde, the formaldehyde in your breath that results from 
normal body functions would be over five times higher than the 
highest level that EPA would call safe. Formaldehyde is 
naturally formed in the air from the breakdown of chemicals 
released from vegetation, and according to available air data, 
the only places that would have safe air would be remote 
locations such as the arctic and South Pacific islands.
    In another example, using EPA's most recent draft 
assessment of arsenic, all fish and shellfish would contain 
levels of inorganic arsenic that are higher than the highest 
levels EPA would consider safe. And it is not just fish. Normal 
dietary food and drinking water consumption would also have 
arsenic levels substantially higher than EPA-safe level. And we 
just know that this isn't true. We aren't seeing the health 
effects that would be predicted or expected in the general 
population based on EPA's new values.
    While we do agree with EPA on being precautious in areas 
where we don't have good science, we strongly believe that good 
science should not be ignored and should trump EPA's overuse of 
precaution. Hexavalent chromium is a good example of this. 
EPA's recent conclusion that ingesting hex chrome likely causes 
cancer in humans is based on a study where mice received 
extremely high levels of hex chrome, and EPA dismissed the 
human epidemiology and the wealth of other data that contradict 
this. And in those human studies, there was an occupational 
study where workers actually had yellow teeth and yellow 
tongues from ingesting so much arsenic.
    And TCEQ isn't the only organization concerned about the 
science behind EPA's recent assessments. The National Academy 
of Sciences, many prominent academic researchers, other states 
and other countries have noted the lack of good science in 
these assessments.
    Because of the lack of scientific defensibility and the 
implications of EPA's new chemical assessments, Texas has 
recently decided to develop our own chemical assessments. We 
have written two state-of-the-science guidance documents and 
had them externally scientifically peer reviewed by panels of 
imminent scientists, including scientists from EPA, California 
EPA, and Canada, and we are in the process of putting our 
latest document through a second round of public comment.
    We had no desire at all to use our limited resources to 
develop these chemical risk assessments that we have 
historically been able to rely on EPA for. However, the 
implications of EPA's new assessments have forced our hand. 
EPA's new assessments will unnecessarily scare the public and 
may actually harm public health by diverting public, industry, 
and government attention and resources away from public health 
issues that may pose more of a risk.
    As an example, EPA currently encourages pregnant women to 
limit their consumption of fish due to concerns of mercury. 
However, numerous recent studies show that the health benefit 
from pregnant women eating fish outweighs the potential risk 
for mercury. If EPA finalizes their draft arsenic value as it 
currently stands, then the public, the media, and advocacy 
groups would perceive fish as being even more unsafe resulting 
in even more pregnant women avoiding fish and its proven health 
benefits for them and their infants.
    There are also significant implications for remediation 
programs all across the country. Typical soil and water 
concentrations of chemicals, even some naturally occurring, 
would be considered unsafe. In other words, there is no safe 
place to live. How can you cling to below-background levels if 
background levels are unsafe? All replacement soils that we 
would use to fill in a backyard would also contain these unsafe 
background levels. So where are we going to put this so-called 
contaminated soil that we would have to dig up from somebody's 
yard?
    Your constituents will not stand for having soil and water 
that is deemed unsafe by EPA's new risk assessments even if it 
is naturally occurring and we can't do anything about it. So 
these are just some of the issues that we will have to face if 
EPA stays on their course, and I thank you for this opportunity 
to testify.
    [The prepared statement of Mr. Honeycutt follows:]

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    Mr. Shimkus. Thank you for your testimony.
    And now I would like to recognize Dr. Harvey Clewell. Sir, 
you have 5 minutes. And we are getting you fresh water. And you 
are recognized.

                  STATEMENT OF HARVEY CLEWELL

    Mr. Clewell. Thank you, Mr. Chairman. Good morning, Mr. 
Chairman, members of the subcommittee. My name is Harvey 
Clewell. I am the director for the Center for Human Health 
Assessment at the Hamner Institutes for Health Sciences in 
Research Triangle Park, North Carolina.
    In my position at the Hamner, as well as in my previous 
consulting positions, I have performed risk assessment research 
and consulting for a large number of government and industry 
clients, including the EPA. I am here today to present my 
professional opinions. I am not representing the Hamner or any 
other organization.
    I am very familiar with EPA risk assessment practices. Over 
the last 30 years, I have assisted EPA on risk assessments for 
a number of compounds including methylene chloride, cadmium, 
styrene, vinyl chloride, trichloroethylene, chloroform, and 
perchlorate. I have served on the EPA's FIFRA Scientific 
Advisory Panel and the recent EPA Science Advisory Board on 
IRIS assessments for dioxin. I have also served as a peer 
reviewer for a number of recent EPA guidelines, including those 
for cancer risk assessment and risk characterization.
    I consider EPA to be a leader in advancing risk assessment 
methods and have been favorably impressed by a number of recent 
IRIS assessments for which I was a peer reviewer, including 
those for one for dioxane and acrylamide. Nevertheless, I am 
concerned that the lack of objectivity and transparency in some 
recent IRIS assessments will impair the ability of decision-
makers to make informed risk management decisions.
    I am particularly concerned that in some recent IRIS 
assessments, such as those for inorganic arsenic, formaldehyde 
and dioxin, only a single cancer risk assessment approach has 
been presented: a low-dose-linear default that assumes these 
chemicals are carcinogenic at any concentration. However, there 
is strong evidence for each of these chemicals that the true 
dose-response is nonlinear, and that the default greatly 
overestimates the actual risk at current human exposure levels.
    This IRIS practice of presenting only a single approach 
disregards the recommendation in the OMB memorandum entitled, 
``Updated Principles for Risk Analysis,'' to provide a 
characterization of the dispersion of risk estimates associated 
with different models, assumptions, and decisions. The OMB 
principles provide valuable guidance for assuring that risk 
assessments adequately inform decision-makers faced with 
complex risk management options. Following the OMB 
recommendations should be a key objective of all IRIS 
assessments.
    The failure to objectively describe the evidence for 
alternative risk assessment approaches and to provide risk 
estimates other than the default has been a major deficiency in 
the IRIS risk assessment process. Even in the case of IRIS 
cancer assessments where alternative low-dose extrapolation 
options are discussed, there has been a clear bias towards 
presenting evidence that supports the selection of the default 
linear approach, even in cases where there is strong support 
for a nonlinear approach in the scientific community. Decision-
makers would be better informed by a balanced and objective 
discussion of both alternatives and the presentation of 
analyses based on both alternative approaches in the risk 
characterization section of the assessment.
    As a justification for presenting only the default low-
dose-linear risk assessment approach, the IRIS assessments have 
cited uncertainty in the evidence for alternative approaches. 
However, EPA guidance states that in the face of uncertainty, 
multiple approaches can be presented. The EPA's 2005 Guidelines 
for Carcinogen Risk Assessment state that ``Nonlinear 
extrapolation having a significant biological support may be 
presented in addition to a linear approach when the available 
data and a weight of evidence evaluation support a nonlinear 
approach, but the data are not strong enough to ascertain the 
mode of action applying the Agency's mode of action framework. 
If more than one approach, e.g. both a nonlinear and linear 
approach are supported by the data, they should be used and 
presented to the decision-maker.''
    In a number of cases, NAS and the EPA Science Advisory 
Board peer reviews have requested that the IRIS assessment be 
modified to objectively present multiple risk assessment 
options but the Agency has not complied. I believe that the 
repeated refusal of the EPA to implement recommendations from 
the NAS and SAB peer reviews to objectively present alternative 
risk assessment options has greatly delayed the completion of 
the IRIS assessments for a number of important chemicals, in 
some cases for more than a decade.
    In addition to being inconsistent with agency guidance, 
presentation of only a conservative default approach when there 
is a viable alternative provides the decision-maker with an 
inaccurate characterization of risk that compromises his 
ability to make informed risk management decisions.
    In my opinion, IRIS assessments currently do not provide an 
objective and transparent characterization of the potential 
risks associated with chemical exposure. The inadequacy of the 
risk characterization in IRIS assessments, coupled with the 
sole use of conservative default approaches, hampers the 
ability of decision-makers to make informed risk management 
decisions and gives the public an inaccurate impression of 
their potential risks from chemical exposure. I believe that 
this deficiency could to a large extent be addressed by 
assuring that IRIS assessments adhere to the risk assessment 
principles elaborated in the OMB memorandum in the information 
quality principles.
    Thank you.
    [The prepared statement of Mr. Clewell follows:]

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    Mr. Shimkus. Thank you. Now, I would like to recognize Mr. 
Cook for 5 minutes, sir.

                   STATEMENT OF JERRY A. COOK

    Mr. Cook. My name is Jerry Cook. I am the technical 
director of Chemical Products Corporation, a small 78-year-old 
Georgia corporation which employs about 200 people in 
Cartersville, Georgia, which is in the metropolitan Atlanta 
area, on the fringe I guess you would say. We are the last U.S. 
producer of barium chemicals and I have been dealing with 
barium toxicology and regulation for more than 28 years. I 
joined Chemical Products in late October 1982 as technical 
director.
    The IRIS database is supposed to determine sound science 
concerning the toxicology of chemicals to guide EPA's 
regulatory activities as we have heard today. If IRIS 
functioned properly, that could be used as a basis for sane 
regulation of various chemicals in the environment. 
Unfortunately, in the case of the IRIS barium file, I have 
found that the IRIS chemical managers and their superiors were 
not nearly as interested in sound science as they were in 
bureaucratic expediency. They simply did not want to hear sound 
science if it caused them to have to reevaluate the positions 
that they had previously taken.
    A brief history of barium regulation is as follows: in 1975 
in the statement of basis and purpose for the national interim 
primary drinking water regulations, under barium, EPA stated, 
``No study appears to have been made of the amounts of barium 
that may be tolerated in drinking water or of effects from 
prolonged feeding of barium salts from which an acceptable 
water guideline may be set.'' They arbitrarily chose a value at 
that time based on the hypothesis that perhaps barium in 
drinking water could cause a small but significant increase in 
blood pressure and that that would be a danger to those already 
suffering from high blood pressure. That was a hypothetical 
effect that they derived from the fact that acute toxicity from 
barium salt ingestion does include heart effects including 
hypertension for the period of time until the barium is cleared 
from the body.
    The barium chemicals manufactured by Chemical Products 
Corporation are used in the ceramics industry to manufacture 
bricks and tiles, in the manufacture of luminous paints for 
highway signage and airport striping, and in heat treating of 
high-strength steel and the manufacture of catalysts. Many of 
our customers are small and medium-sized U.S. companies which 
are literally fighting for survival. Our customers tell us that 
the costs associated with retroregulation of barium are a 
substantial burden on them.
    In our efforts to change the retroregulation of barium, the 
IRIS determination of what was considered a safe level was 
cited as the reason why the retroregulations were not going to 
change. So that is how IRIS functions. IRIS is the basis upon 
which regulatory decisions are made. If the science in IRIS is 
bad, the regulatory decisions are going to be bad.
    The CEO of Summitville Tile, one of our customers, asked me 
to convey the following message to the members of this 
committee. ``The overregulation of American industry is making 
it increasingly more difficult for American manufacturers to 
compete in today's global economy. Summitville Tiles is a case 
in point. It is a 100-year-old manufacturer of quarry tile and 
brick products based in Eastern Ohio. In recent years, it has 
had to close 2 tile manufacturing facilities and 16 
distribution centers, laying off over 450 employees. 
Summitville Tile is today one of the last American tile 
companies to remain in business. In fact, it is the only 
remaining charter member of the tile industry's National Trade 
Association, the Tile Council of North America. With foreign 
imports now comprising approximately 80 percent of the U.S. 
domestic tile market, the last thing that the tile industry 
needs is more regulations. What is needed more than anything 
else is regulatory relief.''
    I think that sums up the feeling of many of the small and 
medium-sized manufacturers in this country today. As a small or 
medium-sized company, they are really not equipped to deal with 
unnecessary regulatory burdens, and I think that that is 
exactly how I would characterize the regulation of barium 
because when a sound scientific study became available in 1994, 
when the NTP published a lifetime study of the effect of barium 
on rats and mice, IRIS greatly resisted acknowledging that 
study because it did not find the effect that was listed in 
IRIS. It did not find increased blood pressure. It instead 
found at much higher levels that barium would have an effect on 
the kidneys but the levels to find that effect were orders of 
magnitude higher than the level that was promulgated in IRIS.
    Let me tell you a little bit about barium if I may. Barium 
is an alkaline earth metal, one of the group which includes 
magnesium and calcium. It is not carcinogenic and barium is 
rapidly eliminated from the body. In cases of acute barium 
ingestion, the effects are usually gone within a week. Barium 
is widely dispersed in the natural environment in the mineral 
barite, barium sulfate, which is insoluble in water and acids. 
Because it is insoluble, barium sulfate is not toxic. This is 
the chemical administered as an x-ray contrast medium for 
gastrointestinal x-rays. The infamous barium meal, I have never 
had one, but I understand it is not particularly tasty. It 
doesn't matter which end you put it in, it works for 
gastrointestinal x-rays.
    If a large amount of soluble barium is ingested or inhaled, 
it is toxic because it temporarily interferes with the body's 
cellular potassium transport. EPA's IRIS database deals with 
chronic toxicity, which is a different situation. It is smaller 
amounts of a chemical consumed daily for many years over a 
lifetime. There is no known instance of any chronic toxic 
effect in a human due to barium and no animal studies were 
available as I read to you when EPA began regulating barium in 
the mid-1970s.
    Mr. Shimkus. Mr. Cook, I did tell folks they could go over 
5. You are almost at 3 minutes over that so if you can kind 
of----
    Mr. Cook. Yes, sir. I appreciate it very much. I think you 
have gotten the gist of my situation.
    Mr. Shimkus. We have and we will follow up with questions.
    Mr. Cook. Thank you.
    [The prepared statement of Mr. Cook follows:]

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    Mr. Shimkus. Thank you.
    The chair now recognizes Dr. Burke for 5 minutes.

                  STATEMENT OF THOMAS A. BURKE

    Mr. Burke. Thank you, Mr. Chairman. I appreciate this 
opportunity. I am Tom Burke and I am the associate dean and a 
professor at the Johns Hopkins School of Public Health, I also 
direct the Johns Hopkins Risk Sciences and Public Policy 
Institute, I served as a member of the Board on Environmental 
Sciences and Toxicology at the National Academy, I am a member 
of the EPA Science Advisory Board, and I chaired the National 
Academy report Science and Decisions, which really took a hard 
look at risk assessment practices at the EPA.
    Perhaps most relevant to today's hearing, though, is I have 
served as a state official. I was the director of the Toxics 
Program, the director of Science and Research at the New Jersey 
DEP, and the deputy health commissioner in charge of 
environmental issues in that State. So I worked closely with 4 
governors on very challenging issues, responding to public 
health emergencies, which ranged from water contamination to 
contamination of our beaches to food contamination to the 
cleanup of hazardous waste sites.
    So as a frontline health official, I can tell you that risk 
assessment is really important. We need information when things 
bang in the night. And it is an essential tool for protecting 
the public's health. IRIS has been a part of that. So I would 
like to address 3 points today.
    One is risk assessment itself as an important tool. Second 
is the IRIS program, and the third I would like to say a little 
bit about, Science and Decisions and the National Academy 
recommendations to change the way we approach risk assessment.
    So first, as I mentioned, risk assessment is really 
important to public health officials and it is used by not just 
EPA but public health agencies around the world. I have helped 
most of our national agencies from DOD to USDA to use risk 
assessment. And as a state official, I have worked with other 
state officials in doing this. And EPA is recognized as 
providing most of us with the gold standards for evaluating 
hazards. Part of this is a tremendous use of the IRIS 
documents, but unfortunately, there are inherent uncertainties.
    And as you heard from the panel, there are lots of things 
about toxicology and epidemiology that are uncertain and they 
provide the basis for risk assessment. So for instance, does 
cancer in laboratory animals necessarily mean that exposure 
will cause cancer in humans? Or more appropriate perhaps in 
some of the debates about IRIS, if you have 2 conflicting 
studies, one says you see a health hazard and the other 
doesn't, which one does EPA go with and how do you make that 
decision? Well, there have been lots of arguments about this. 
There is lots of uncertainty that has led to a very polarized 
confrontation, as you might imagine. So I am no stranger to 
this phenomenon called dueling risk assessments. An agency will 
present their risk assessment and their approach to a problem 
and there is the opposite approach. And we have this situation 
where EPA is being called way to precautionary and industry's 
risk assessments aren't listened to because they are seen as 
not being protective of public health.
    So the challenge before us is this process itself, how to 
be more transparent, meet the needs of decision-makers, and 
break the log jam we now have. Now, the IRIS program, as you 
heard today, has a very unenviable task of synthesizing a lot 
of scientific information, and it appears to be the program 
everyone loves to hate. So they provide these very 
comprehensive overviews of health effects and they weigh the 
scientific evidence, and it is very important in determining if 
we have hazards. Not surprisingly, this is controversial. They 
are the starting point for many of the Agency's most difficult 
decisions. They provide insight into the magnitude of risk but 
they don't tell us how to manage risks.
    I am very familiar with the challenges of IRIS and I 
actually think the NAS report on formaldehyde provides a sound 
roadmap for them to improve that.
    Now, I would like to finish with a few words about risk 
assessment. We have blurred the line today I think between risk 
assessment and the IRIS hazard assessments. Risk assessment is 
about decisions and should start with, as Science and Decision 
lays out, the problem formulation making sure we ask the right 
questions, including the assessment that looks at the various 
options for control.
    And finally, with risk management decision justification, 
very important to this committee, is this decision justified, 
particularly in light of costs? So I think just to kind of sum 
up, the framework that Science and Decisions offers perhaps can 
help us improve the application of IRIS and risk assessment and 
risk management and consider the very important considerations 
of economics and jobs.
    So finally, can risk assessments work for jobs and the 
economy? Well, in my experience as a state official in New 
Jersey, a clean environment is definitely good for business, 
just ask the resort owners of the Jersey Shore or the 
businesses along the redeveloped Brownfields and the Hudson 
River shoreline. Getting better solutions for environmental 
problems goes well beyond IRIS and should focus on advancing 
risk assessment to better inform our public policies.
    Thank you for the opportunity to speak to you today.
    [The prepared statement of Mr. Burke follows:]

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    Mr. Shimkus. Thank you, Dr. Burke.
    And now I would like to recognize myself for 5 minutes for 
opening questions in this panel. I will start with Mr. Cook 
because a lot of our focus here in this Congress has been on 
the effects of regulations on jobs and the economy. We do want 
to make sure that that is balanced, but we also, especially in 
the environment that we are in, we know that excessive 
regulations really are creating a burden.
    You have highlighted some of those burdens in your opening 
statement. If the chemicals you produce are not available, what 
substitutes would be made?
    Mr. Cook. In some cases, there would be substitutes 
available. In other cases, I am not sure there would be. In the 
case of the airport striping and signage, our barium carbonate 
is formulated by 2 manufacturers in the United States into very 
tiny barium glass beads. Barium gives that glass a very high 
refractive index, so when light shines on a paint containing 
these glass beads, it glows. I think that is a major safety 
consideration for airports and certainly it helps visibility of 
highway signs and probably has a safety impact there, too. I am 
not sure what material other than lead--lead glass also has a 
high refractive index.
    Mr. Shimkus. Barium would probably be better than lead.
    Mr. Cook. Given as I say there really is no chronic effect 
to barium until you get to very, very high levels that are just 
not found anywhere in nature.
    Mr. Shimkus. And let us just talk through this. Also, you 
opening statement mentioned if we are not certain that the IRIS 
analysis is based upon credible sound science, what effect does 
that have on you?
    Mr. Cook. Well, for the past almost 29 years now, I have 
been trying to effect a change in the regulatory limit. And as 
I said, that regulatory limit was established back in the '70s 
when there was no data. Unfortunately, when IRIS came along in 
1987, by that point, EPA had funded two studies. One found a 
slight but--they claimed--significant blood pressure increase 
at low levels of barium in drinking water. The study in EPA's 
own health effects research lab, giving the rats 10 times as 
much barium for a longer period of time found no blood pressure 
increase. EPA chose to go with this study that found the blood 
pressure increase and said aha, here it is, once again, over-
precautionary. It was not a particularly good study. They 
recognized that and yet they set their limits on that.
    Mr. Shimkus. And there is terminology, abundance of 
caution, at the different levels as the regulation moves 
forward, and I think you are highlighting that.
    Mr. Cook. Yes.
    Mr. Shimkus. Dr. Honeycutt, in your written testimony, you 
are pretty blunt. You say, ``because of the lack of scientific 
defensibility and the implications of EPA's new chemical 
assessments, we decided to develop our own chemical 
assessments.'' Can you describe the scientific defensibility 
that you refer to? Because I hear Mr. Cook talk about barium 
and I am not sure anyone in essence disagrees with that 
analysis, but can you talk about what you are referring to 
here?
    Mr. Honeycutt. Sure. There is no doubt that EPA comes up 
with safe levels. I mean there is no doubt about that. The 
question is can you have a higher level that is still just as 
safe? And that is where you have to get away from default 
procedures and actually look at how a chemical work in the 
body. How does it work in the rat versus how does it work in 
the human and then at what levels are they exposed to? Because 
chemicals will exhibit different levels of toxicity depending 
on the dose. A good example is Tylenol. Twenty tablets will 
kill you, two tablets will cure your headache, a half a tablet 
or a quarter of a tablet won't do anything to you that is an 
adverse effect. So you have to look at those differences in 
dose.
    Mr. Shimkus. In your opinion, is the IRIS program receptive 
to suggestions for program improvements to address this example 
you just gave?
    Mr. Honeycutt. Well, they actually have guidance on some of 
the things that we are talking about. The problem is their 
inconsistency in using their own guidance. They talk the talk 
but when it comes to doing the assessment, they just revert 
back to their old precautionary selves.
    Mr. Shimkus. Thank you. My time has expired. And depending 
upon how many people show up, we may go around a second time. I 
know there is more I want to address.
    So I would like to recognize Mr. Green for 5 minutes.
    Mr. Green. Thank you, Mr. Chairman.
    Both Houses of Congress seem to be interested in addressing 
the IRIS recommendations whether it is strengthening IRIS or 
suspending it. And our colleagues in the Senate sent a letter 
to one of our first panelists calling for suspension of IRIS 
assessments until the NAS recommendations can be incorporated. 
On the first panel, we heard from Dr. Anastas and the NAS on 
why such a suspension is not necessary and wouldn't protect 
public health. Now, with this panel, we are fortunate to have 
an expert on risk assessment who was quoted in that Senate 
letter.
    Dr. Burke, you are quoted as saying, ``A sleeping giant is 
the EPA sciences on the rocks and if you fail you become 
irrelevant.'' Would you explain that statement?
    Mr. Burke. Sure, and thanks for asking that question. So 
that statement was made at a meeting of the EPA Science 
Advisory Board where we presented with the ORD vision for how 
science will be conducted in the future. And knowing the 
incredible pressures and having been on those frontlines, 
applying science to society's problems, I issued that as a 
warning statement. Obviously, there is lots of criticism; then 
the credibility of science is really important.
    So why is EPA in a crisis? Well, because of the incessant 
attacks on their credibility not because they are not trying to 
put together the best science and not because they don't have a 
good Science Advisory Board that provides them, but I think it 
is important to put that into context. EPA is under siege. The 
very mission of protection of our environment is being 
questioned, sometimes with good cause because of the economic 
considerations. But I think there is a crisis. There is a 
crisis in credibility and that roadmap of improving IRIS will 
be a very important step toward addressing that crisis.
    Mr. Green. OK. And you are familiar with the rider that I 
mentioned and do you think that rider would strengthen the IRIS 
program?
    Mr. Burke. Unfortunately, I think it would be a disservice 
to public health agencies throughout the country and even 
perhaps the world and it would bring things to a halt in a way 
that would not serve us well.
    Mr. Green. OK. It seems there is a difference of opinion 
among our panel members on IRIS assessments and what they 
should be. Dr. Honeycutt suggested in his testimony the IRIS 
assessment provides EPA's judgment in how much a chemical can 
be in fish or apple juice for it to be considered safe, but 
these evaluations require assessing that exposure, something 
IRIS does not do. Dr. Burke, can you clarify the distinction 
between assessing the hazard and assessing the risk?
    Mr. Burke. Yes, so understanding the hazard it is like 
knowing. So this is anthrax over here and this is bad stuff, 
can cause a real problem and it can cause problem at different 
levels. So it allows us to understand what the risks might be 
to people who are exposed. That is very different than the 
problem-oriented process of risk assessment that says we have a 
facility here that has a problem and potentially emitting 
things into the environment. How do we evaluate what is 
acceptable in terms of a response to manage that risk. So the 
risk assessment is site-specific; it is population-specific, 
very different than just identifying the hazard and evaluating 
the epidemiology and toxicology.
    Mr. Green. So there is a difference between the risk 
assessment and what risk is acceptable?
    Mr. Burke. Yes. And the hazard assessment will never tell 
you what risk is acceptable. That is a societal issue. It can 
consider social issues. There are lots of things that we don't 
regulate to very low levels because they are naturally 
occurring, and it is a policy question, not a science question 
except ability of risk. But understanding a hazard, that is all 
about good science.
    Mr. Green. Well, here we understand asbestos is a toxic 
substance but you can go out in some places and dig up asbestos 
since it is a rock. And we know we can't prohibit it because 
you can be exposed by just digging it up. Although asbestos for 
decades was used very substantially to retard fire risks, so an 
assessment of the danger and also what could be acceptable if 
you encapsulate it and do lots of things you can deal with 
that.
    Dr. Honeycutt, I want to thank you for appearing before the 
committee, and you have heard, I have worked with TCEQ over the 
years and TCEQ actually alerted our office because for years we 
have had a heightened dioxin level in upper Galveston Bay and 
the Houston Ship Channel and most of my industries are getting 
blamed for it. And there was some concern because we couldn't 
quantify it until TCEQ did. Can you tell us what efforts TCEQ 
has taken in regard to dioxin just as a substance? Like I joke 
I want dioxin, I want white shirts, but I also know that I 
don't want to drink it. So if you can tell us what TCEQ in 
Texas has done with it.
    Mr. Honeycutt. Yes, sir. Thank you. I am very familiar with 
the San Jacinto pit site. We have developed our own policy-
based number that we have used over the years for dioxin, and 
as I mentioned in my testimony, we are developing our own 
procedures for coming up with these toxicity values that has 
been through a peer review and that is out for public comment 
right now. So once that is finalized, we are going to run 
dioxin through a process and see what our number looks like. So 
we are actively looking at that. I can't tell you right now 
where the number will come, whether ours is more or less or 
higher or lower than EPA's but we are going to be actively 
involved in that.
    Mr. Green. OK. Is there going to be any conflict between 
when EPA is coming out in 2012 or will the TCEQ's be earlier 
than, you know, a year from now?
    Mr. Honeycutt. It won't be earlier than a year from now 
definitely.
    Mr. Green. OK. It would be good to have two different 
assessments because, one, that is how you get what we can do 
with the risk and also I know I am over time but I appreciate 
your testimony that having spent 20 years in the Texas 
legislature and getting mad at EPA on a regular basis, we also 
recognize, as you said in your testimony, we sit down and can 
work things out but sometimes we have to lower the decibel 
level to get there.
    So thank you, Mr. Chairman.
    Mr. Shimkus. The gentleman yields back his time.
    The chair recognizes the gentleman from Louisiana, Mr. 
Cassidy, for 5 minutes.
    Mr. Cassidy. Thank you. I am an erstwhile academic so I 
will speak to Dr. Clewell and Dr. Burke because clearly as I 
gather IRIS is supposed to be here to use science to inform 
policy. The concern, though, is that policy is manipulating 
process in science to achieve an advocacy as opposed to 
achieving truth, truth being the highest calling of science. 
Fair statement? And that is, if you will, the question before 
us.
    Now, Dr. Clewell, when I read yours that there is clear 
bias towards presenting evidence that supports the selection of 
a default linear approach even when there is support for a 
nonlinear approach in the scientific community, if I was co-
writing a paper with a medical student and she brought 
something to me that had only one explanation even though I 
knew that there was an alternative explanation which she does 
not address, I would give her a mulligan. I would say you are a 
medical student; you need to learn to do better. Bring it back 
discussing the alternative explanation and use this as a 
teaching moment. When EPA is using it to drive public policy, 
my blood pressure goes up. I must have just taken a boatload of 
barium because, you know, why in the world are we making 
decisions that affect an incredible number of jobs on something 
which doesn't have a plausible alternative explanation. So you 
have made your point.
    Let me ask Dr. Burke whether or not you disagree with the 
point Dr. Clewell made but by the way is a similar point to 
what NAS made that the neurobiological effects of the 
formaldehyde could be attributed to other things, which the 
thousand-page document did not discuss. So Dr. Burke?
    Mr. Burke. I don't think we fundamentally disagree that EPA 
should present as comprehensive a picture as possible with the 
alternatives. I think we probably disagree in the fundamental 
mission of EPA and there in my testimony----
    Mr. Cassidy. Can I stop you for a second?
    Mr. Burke. Yes.
    Mr. Cassidy. Because I am actually talking about not EPA 
but IRIS.
    Mr. Burke. OK.
    Mr. Cassidy. IRIS and a thousand-page document presumably 
presenting a comprehensive discussion----
    Mr. Burke. Right.
    Mr. Cassidy [continuing]. Did not present a plausible 
alternative explanation that NAS came up with.
    Mr. Burke. Right.
    Mr. Cassidy. Now, this is not, you know, industry. This is 
NAS.
    Mr. Burke. Right.
    Mr. Cassidy. And so you open a thousand-page document, IRIS 
did not discuss it. It has to beg the question have they moved 
beyond advocating science for truth to selective presentation 
of science to pursue policy?
    Mr. Burke. OK. Well, again, not being part of the IRIS 
program and not being part of that review, I know that the 
standard default that not just EPA but public health officials 
use, again, throughout the world particularly for carcinogens 
is the linear default, that we are not quite sure because 
genetic damage can happen at very low levels, just how low that 
straight line might go. However----
    Mr. Cassidy. Now, that I have to say surprises me because 
we know that a 20-pack a year history of cigarette smoking is 
strongly related to a risk of something less is a threshold 
effect. Indeed, Dr. Anastas spoke about how--I have it written 
down here someplace and of course I have lost it--that they 
look for a dose-related effect.
    Mr. Burke. Yes.
    Mr. Cassidy. So that would be a nonlinear effect. I am not 
sure why we are still mired in something conceived of 3 decades 
ago as defining how we should approach a problem in this year.
    Mr. Burke. Well, I think it is the strength of evidence, 
and when we are looking at hormonal effects and we are looking 
at neurological effects on the unborn, the fundamental question 
is, a very important one, shouldn't we present the whole 
picture about what the alternatives may be. But that may not 
change the public health decision that where there is 
uncertainty we have to make decisions.
    Mr. Cassidy. But my concern is apparently they are not 
presenting the whole picture which in effect skews the----
    Mr. Burke. That is where I think we agree.
    Mr. Cassidy. Excuse the assumption. Dr. Clewell, I am kind 
of speaking for you. Could you speak for yourself?
    Mr. Clewell. Thank you, sir. I am particularly troubled 
because I worked closely with William Farland when they were 
developing the cancer guidelines trying to change from the old 
way of doing things with just a default. And the cancer 
guidelines was important because it was the first time that 
priority was given to a chemical-specific decision that did not 
rely on the default and a justification was required that there 
was insufficient data to support using a default. But in recent 
years there has been use of 1968 guidelines. It is a default. 
They don't demonstrate a balanced presentation of the different 
alternatives that are being discussed in the scientific 
community. They paint a picture of evidence supporting the 
default.
    Mr. Cassidy. That is either suggesting incompetence or it 
is suggesting the pursuit of a political agenda.
    Mr. Clewell. Absolutely not incompetence. They are very 
competent people. I believe that they are public health 
professionals who are very concerned about public health and 
want to make sure they are conservative. And in trying to make 
sure that the protection is provided, they may not provide 
complete descriptions of alternative approaches that would 
generate a lower-risk estimate.
    Mr. Cassidy. That is a patronizing approach to the use of 
truth in science. And I as a person who is sitting on here 
trying to make an informed decision am offended that they 
assume I don't have the intellectual firepower to figure it 
out. And that is a disservice to the American people.
    Mr. Clewell. Actually, the Office of Water has the same 
problem. They are pretty much hamstrung by the arsenic risk 
assessment and decisions they would like to make like saying 
you don't have to clean up the entire western country of 
arsenic in soil and river water are difficult to make when 
there is only a linear risk estimate.
    Mr. Cassidy. I agree with Dr. Burke that there is indeed a 
threat to IRIS's reputation and I think we are seeing it in 
terms of an uncovering of how they present facts. I yield back.
    Mr. Shimkus. The gentleman yields back his time.
    For the sake of getting my colleagues angry at me, I would 
like to go to a second round. I think the panel is well 
informed. We are learning a lot. The risk will be members may 
come back which might hold you a little bit longer, but I would 
like to go a second round if that is oK with our guests and my 
colleagues here. If no objection, then so ordered. We will go 
to a second round, 5 minutes each. And I may not take my whole 
5 minutes, but with that, I will recognize myself.
    And this is just a great debate. My concern is an 
overabundance of caution at IRIS and an overabundance of 
caution at EPA with the policymakers could create job loss, 
economic dislocation, and movement of production overseas. So 
we have got to get the science right and I don't question the 
public health officials' intent to protect human health. I do 
agree that this debate on dosage and what is really harmful is 
very, very important.
    So with that, Dr. Burke, I want to address just one 
question on the delay because the question is what would you 
deem more harmful to human health and the economy? A 1- or 2-
year delay in an assessment that would ensure the scientific 
robustness of the result or an assessment based on poor 
processes that is pushed through with questionable science?
    Mr. Burke. I think we owe it to the American public, I 
think we owe it to the scientific community to use the data 
appropriately and to synthesize the scientific information to 
inform decisions. However, having been in emergency situations 
where the data wasn't perfect, for instance, the trailers in 
Louisiana where the data on formaldehyde weren't perfect, I 
worked with the CDC to try and make sure we didn't have acute 
exposures. So sometimes in public health we have imperfect 
information. However, I agree with you, Mr. Chairman, that it 
would be better to do it right than to destroy the credibility 
of the process.
    Mr. Shimkus. And that is this whole debate from the Senate, 
from what we did on the rider to say let the National Academy 
of Sciences' report be, you know, followed before we continue 
to move forward just so we get it right. But the great thing 
about a lot of things we do on this committee and on our health 
subcommittee is that people in this arena are public servants 
and want to do things right. But again we wanted to raise that 
issue.
    To Dr. Honeycutt, I raised this in maybe my opening 
statement or the first round. We have talked about it before 
and we just mentioned it with the water and arsenic in the 
Southwest. I remember it well because one of my colleagues, 
Heather Wilson, always talked about that, arsenic levels in 
drinking water although it was naturally occurring. So with 
that, this question: In your opinion are there broader economic 
consequences associated with publishing an IRIS value that is 
lower than background levels, and if so, what impact do you 
feel it has on the jobs in the economy?
    Mr. Honeycutt. Oh, absolutely there is an impact. Two real 
quick examples, one is mercury. EPA is actually, they are 
outliers from the rest of the world and what is a safe level of 
mercury in fish. All other regulatory agencies have higher safe 
levels. And they came home to Texas just a few weeks ago.
    Mr. Shimkus. Let me interrupt. Is that true in the European 
standards?
    Mr. Honeycutt. Yes, the World Health Organization has a 
higher safe level for mercury in fish than EPA does.
    Mr. Shimkus. That is funny. I never hear my colleagues 
mention that when we debate that issue.
    Mr. Honeycutt. But Lumina Energy laid off 500 people just a 
couple of weeks ago. So it does have direct or indirect--it 
depends on how you look at it--economic consequences.
    And another example is the arsenic that you are talking 
about. In Texas, there are a lot of really small locally owned 
utilities that won't be able to meet this, so they are going to 
close down. And so people then will have to drill their own 
water wells and that is a real public health concern because 
that water won't be tested or monitored and they are going to 
be at their own risk that the public water systems won't be 
able to provide that level of safety.
    Mr. Shimkus. And let me just finish with this. Mr. Cook 
talked about barium quite a bit in his analysis and his 
response. His statements on barium and the health risk--and I 
kind of assumed everyone sort of agreed with that analysis--can 
you go on record saying you agree with Mr. Cook on his analysis 
on barium?
    Mr. Honeycutt. Yes, sir. Barium in the grand scheme of 
things is not a very toxic chemical at all.
    Mr. Shimkus. Dr. Clewell?
    Mr. Clewell. Yes, I agree.
    Mr. Shimkus. Dr. Burke?
    Mr. Burke. I really don't know the issue. I will have to--
--
    Mr. Shimkus. That is fine. That is fine. And that is why I 
wanted to clarify because I did make an assumption. I didn't 
want to do that.
    So I am going to yield back 18 seconds and ask my 
colleague, Mr. Green, to be recognized for 5 minutes.
    Mr. Green. Thank you, Mr. Chairman.
    Dr. Burke, in listening to my colleague from Louisiana, Dr. 
Cassidy, and I think your comments sound like it blurs the line 
between the mission of IRIS, which is to assess the risk and 
not the issue of regulations, which is the management of that 
risk, which is EPA's job. I guess there may be some concern 
that by the assessment from IRIS, it may raise the level of 
concern but, you know, like we have heard from Dr. Honeycutt, 
you know, IRIS is supposed to give the assessment but the risk 
is an EPA decision and not necessarily what may come out of the 
study.
    For example, the water, you know, obviously water we need 
for our lives, but if you take it from a fire hose, you are 
going to drown. And so there is a reasonable amount that you 
can have that is necessary but it is, you know, too much of 
anything is bad.
    And Dr. Burke, naturally occurring levels of chemicals, 
they are not always safe. A good example of arsenic in water, I 
can tell you in West Texas and all over the West there are 
waterholes or water that people should not drink and know they 
shouldn't drink because of whatever the chemical is in there 
that are naturally occurring. So just because they are 
naturally occurring doesn't mean it is safe. You just have to 
have a certain level of it I guess to keep it. And is that 
something we are continually confused, the difference between 
assessment and risk?
    Mr. Burke. Well, it is a very important point. We can't 
possible clean up the Earth's crust, nor can we regulate 
volcanoes for spewing mercury. And we have these naturally 
occurring materials and we have to balance that in the 
decision-making. On the other hand, what we know about arsenic 
comes from actually naturally occurring contaminated wells in 
other parts of the world where people drank very high amounts 
and had acute effects as well as cancer effects. And so it 
comes down to being reasonable about how we approach regulation 
with the right information on the public health effects to help 
us make those decisions.
    Mr. Green. OK. You know, I have announced where I come 
from. I have the biggest petrochemical complex in the world in 
our district--in the country, second largest in the world, and 
so I guess my focus is on the relationship. Dr. Burke, as a 
former state regulator and you have seen the risk assessment 
and effective risk management, what effect can it have on the 
jobs? Every product we make in the Houston Ship Channel, it 
wouldn't be made if somebody didn't need it. I mean industries 
don't do that. They don't make any money on it. So someone 
needs it but it depends on how you make it and how that product 
is used, whether it be in gasoline or some other additive or 
something else.
    But is there a direct correlation between effective risk 
management and the impact on jobs and the economy, which is I 
think what the whole subcommittee was getting at?
    Mr. Burke. I think that is a very important point in major 
regulatory decisions. I am not an economist. I can only speak 
from experience, and clearly there are regulations that have 
added cost to industry and therefore may impact jobs and may 
impact the general public as well. But as we recommended in 
Science and Decisions, that should be part of the deal in 
conducting the assessment to make sure you are making the right 
risk management choice.
    That doesn't change what happens in the epidemiologic 
studies or in the mice, but we can take that data and if it is 
properly presented make good decisions. So in my experience 
again, New Jersey, very industrialized, lots of heavy industry, 
lots of refineries, pollution was much worse for jobs and 
unsafe workplaces were much worse for jobs than environmental 
regulations. However, I completely understand that analyzing 
the impacts on the economy on jobs should be part of the 
decision process.
    Mr. Green. Thank you, Mr. Chairman. And following your 
lead, I will yield back my 46 seconds.
    Mr. Shimkus. I thank my friend.
    The chair now recognizes the gentleman from Louisiana, Mr. 
Cassidy, for 5 minutes.
    Mr. Cassidy. Again, I am learning a heck of a lot in this 
meeting, so thank you all for all being here. I am struck how 
sometimes processes used to manipulate the response to the 
findings. Now, Dr. Honeycutt, I am impressed that you all--I 
haven't read about a regression coefficient since I have been 
here, you know, been practicing whatever, and you all did an 
analysis--now, that is a 1,043-page document which is 
stultifying, redundant, and sometimes irrelevant, and yet you 
had to do all 1,043 pages. Now, it makes me think that it would 
be incredibly time-intensive, resource-intensive to really do 
an adequate review. If you have a statistician doing a 
regression coefficient on nasopharyngeal cancer mortality to 
criticize or critique the method by which they determined 
incidents, you got some money tied up in staff working on this 
project. Fair statement?
    Mr. Honeycutt. Yes, sir, it is.
    Mr. Cassidy. Now, if it is 1,000 pages do they give you 120 
days or--do you see what I am saying?
    Mr. Honeycutt. Yes, sir. No, you get the same amount of 
time. And the deal with IRIS is you don't get to give input on 
the front end; you give input on the back ends after EPA has 
already--the train has left the station and they are 
recalcitrant to change their mind. So that is what you are left 
with.
    Mr. Cassidy. I see everybody nodding their head yes. Now, 
that is disturbing because again if we have a premise which I 
think you all agree with is that sometimes they are not given 
the complete picture but at the same time it takes an 
incredibly intensive process in order to uncover how that is 
not complete, then you are going to have policy decisions made 
upon something which may, some cynics would say, deliberately 
made onerous upon which to review. Again, it goes back to is 
science deriving policy or is science being presented in such a 
way as to serve as advocacy for a policy end?
    Now, we heard in the first panel and NAS and others 
criticize the fact that OMB was allowed to at times review the 
EPA documents in order to say, oK, wait a second, time out, let 
us look at this. But Dr. Burke, I had a sense from you that in 
this whole analysis needs to be some sort of cost-benefit 
return on investment, what is the true sort of economic cost? 
Here we have people losing their jobs for something which is 
nominally and maybe even speciously toxic. Now I am thinking 
maybe OMB needs to be involved. I mean maybe there needs to be 
a delay if once the train has left the station you have so 
little time to review something which is so complex to review.
    Dr. Clewell, what would be your comments on that?
    Mr. Clewell. I am not what sure what would be the level of 
oversight, but I do believe that OMB plays an important role in 
verifying that the agencies are doing the best job to make the 
process reviewable, and so I would be in favor of there being a 
better dialogue between OMB and EPA so that that could be 
accomplished.
    Mr. Cassidy. And in fairness, I think the critique is that 
they should be more transparent in their questions, but I think 
there was also a criticism as regards sending EPA back to 
repeat an analysis. What I have learned today is that maybe EPA 
does need to be sent back to be more inclusive in their 
analysis. I am feeling more sympathy for OMB right now. So let 
us see if there is anything else in this.
    Now, who is a chemist? Anybody up there a chemist? The idea 
that Dr. Anastas said that with green chemistry they know the 
actual effect of every chemical compound is going to have upon 
skin, respiratory system, digestive system, et cetera seems to 
me like the epitome of intellectual kind of hubris.
    Mr. Clewell. It might have been somewhat hyperbolic. I 
think he is trying to indicate that there is an ability--and 
drug companies use it all the time--to try to estimate activity 
from structural properties and that is trying to be harnessed. 
They are trying to harness that in order to develop safer 
compounds.
    Mr. Cassidy. There is also the presumption, though, that 
you can make everything inert, and I am not sure you can make 
life inert.
    Mr. Clewell. I am fairly confident you cannot.
    Mr. Cassidy. Yes, so I agree with that.
    Let me finish up. I will also yield back by saying to Mr. 
Cook, Mr. Cook, you are the only guy in this whole room that 
creates jobs, so on behalf of the American people, thank you 
for creating jobs, and I am very sorry for the impediments put 
in front of you by the Federal Government. We sincerely wish we 
could be creating a lot more jobs.
    Thank you. I yield back.
    Mr. Shimkus. The gentleman yields back. At this time, the 
chair now recognizes Mr. Harper from Mississippi for 5 minutes.
    Mr. Harper. Thank you, Mr. Chairman. And thank you, 
witnesses, for being here today and giving your insight into 
what is continuing to be a very important issue for us.
    And I will start if I may with you, Dr. Honeycutt, if I 
could just with some follow up questions on what you had 
earlier.
    And I have to ask what types of evidence are necessary to 
establish a causal relationship between exposure to a substance 
and some health effect or health risk. What are you looking 
for?
    Mr. Honeycutt. Yes, that is a very good question and it is 
well known. It is called the Hill criteria for causation. It is 
well documented. What you need to do is show that a chemical 
can cause the effect that you are looking at and it can cause 
it at the concentrations you are looking at and that it is 
reproducible. It happens over and over again, not just one time 
in one study, and that the effect happens after the exposure. 
Sometimes we regulate chemicals on if the effect happens before 
the exposure.
    Mr. Harper. Um-hum.
    Mr. Honeycutt. And that it is not just a background 
occurrence, the health effect that you are looking at, that if 
there is an increased incidence of cancer in this community 
that it is indeed increased, it is well above background, not 
just a tiny bit above background.
    Mr. Harper. Are you always able to figure those problems 
out? It is a search I am sure many times.
    Mr. Honeycutt. Sometimes it happens very easily and 
sometimes it is harder. The health effects of ozone are based 
on a 1 to 4 percent increase in premature mortality, whatever 
that is, and how do you quantitate that? It is very, very 
difficult. And in studies the EPA use, you can't quantitate 
that.
    Mr. Harper. And is it true that substances at a high level 
which may create that risk, they may be safe, perhaps even 
necessary at a low level. Would that be certainly true to say?
    Mr. Honeycutt. Absolutely. Every vitamin you take, most of 
the minerals in your food that you eat, some of them are 
essential nutrients that if you get too much of them, they will 
kill you.
    Mr. Harper. If I could, Dr. Cook, I wanted to ask you----
    Mr. Cook. Mr. Cook.
    Mr. Harper. Mr. Cook, I am sorry. That just shows you the 
respect that we have for your being here today.
    Earlier today we had on the first panel--I believe you were 
in the room when they were here--Mr. Trimble from GAO testified 
on panel one that the EPA should take the IRIS program back in-
house to avoid meddling from OMB or other departments or 
agencies. Based upon your experience, do you think that is a 
wise move?
    Mr. Cook. If it had not been for OMB's implementation of 
the Information Quality Act in 2002, I do not believe we ever 
would have seen IRIS recognize the true chronic effect from 
barium. Four years after the 1994 NTP study, the definitive 
study was published on barium chronic toxicity, the revised 
IRIS assessment in 1998 still argued and ignored the sound 
scientific evidence that there was no blood pressure effect 
from small low levels of barium, if it had not been for OMB's 
intervention, I don't think we ever would have gotten any 
response from EPA to make the change that was finally put into 
effect in IRIS in 2005.
    Mr. Harper. Thank you. Also, Mr. Cook, another question I 
have is, you know, some concerns about IRIS relate to cleanup 
levels that must be attained under our federal environmental 
laws. Do you have any experience where IRIS's uncertainty or 
inappropriate values caused a hazardous waste cleanup to either 
stall or be delayed or the costs rise substantially?
    Mr. Cook. We are still in the throes of determining 
financial responsibility for a superfund cleanup that is still 
ongoing in North Carolina. Ward Transformer Company operated 
just near the Raleigh, North Carolina, Airport rebuilding 
transformers from 1963 until they finally went out of business 
I think in 2004. They were designated as a superfund site, the 
plant site there I think in about 1979. Some of the potentially 
responsible parties negotiated a settlement with EPA to clean 
up the actual plant site. The contamination is all PCBs from 
transformer oil. And they were given a choice at the time that 
they came to a settlement with EPA of either cleaning up to a 
25-parts-per-million standard or a 1-part-per-million standard. 
The consultant that was working with them reported in the 
document that I obtained from Region 4 EPA that the choice to 
clean up to a very stringent 1-PPM standard was made primarily 
because of a fear that EPA would come back later and require a 
further cleanup because the safe level had not been clearly 
defined in IRIS and they were not sure what might come down the 
pike.
    Mr. Harper. So an abundance of caution made them do that at 
a much greater cost than probably what was necessary.
    Mr. Cook. Yes. I think they even ended up spending about 2-
1/2 times what they thought they were going to spend to clean 
up to a 1-PPM standard.
    Mr. Harper. I thank each of you and I yield back.
    Mr. Shimkus. I thank my colleagues for joining and for you, 
thank you for putting up with 2 rounds of questions from us. We 
really appreciate it. And you can tell from the questions by my 
colleagues that they were sincere in trying to work through 
this process.
    I want to put on the record that the record will be open 
for 10 days. You all may see some additional written question 
as the first panel might from us. If you could answer those 
questions in writing and send them back within that period of 
time or as soon as possible, we would greatly appreciate that. 
We do appreciate your time and I adjourn the hearing.
    [Whereupon, at 12:49 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

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