[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]


 
                     FIXING EPA'S BROKEN INTEGRATED
                        RISK INFORMATION SYSTEM

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

                                HEARING

                               BEFORE THE

                   SUBCOMMITTEE ON INVESTIGATIONS AND
                               OVERSIGHT

                  COMMITTEE ON SCIENCE AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 11, 2009

                               __________

                           Serial No. 111-33

                               __________

     Printed for the use of the Committee on Science and Technology


     Available via the World Wide Web: http://www.science.house.gov

                                 ______

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                  COMMITTEE ON SCIENCE AND TECHNOLOGY

                   HON. BART GORDON, Tennessee, Chair
JERRY F. COSTELLO, Illinois          RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas         F. JAMES SENSENBRENNER JR., 
LYNN C. WOOLSEY, California              Wisconsin
DAVID WU, Oregon                     LAMAR S. SMITH, Texas
BRIAN BAIRD, Washington              DANA ROHRABACHER, California
BRAD MILLER, North Carolina          ROSCOE G. BARTLETT, Maryland
DANIEL LIPINSKI, Illinois            VERNON J. EHLERS, Michigan
GABRIELLE GIFFORDS, Arizona          FRANK D. LUCAS, Oklahoma
DONNA F. EDWARDS, Maryland           JUDY BIGGERT, Illinois
MARCIA L. FUDGE, Ohio                W. TODD AKIN, Missouri
BEN R. LUJAN, New Mexico             RANDY NEUGEBAUER, Texas
PAUL D. TONKO, New York              BOB INGLIS, South Carolina
PARKER GRIFFITH, Alabama             MICHAEL T. MCCAUL, Texas
STEVEN R. ROTHMAN, New Jersey        MARIO DIAZ-BALART, Florida
JIM MATHESON, Utah                   BRIAN P. BILBRAY, California
LINCOLN DAVIS, Tennessee             ADRIAN SMITH, Nebraska
BEN CHANDLER, Kentucky               PAUL C. BROUN, Georgia
RUSS CARNAHAN, Missouri              PETE OLSON, Texas
BARON P. HILL, Indiana
HARRY E. MITCHELL, Arizona
CHARLES A. WILSON, Ohio
KATHLEEN DAHLKEMPER, Pennsylvania
ALAN GRAYSON, Florida
SUZANNE M. KOSMAS, Florida
GARY C. PETERS, Michigan
VACANCY
                                 ------                                

              Subcommittee on Investigations and Oversight

                HON. BRAD MILLER, North Carolina, Chair
STEVEN R. ROTHMAN, New Jersey        PAUL C. BROUN, Georgia
LINCOLN DAVIS, Tennessee             BRIAN P. BILBRAY, California
CHARLES A. WILSON, Ohio              VACANCY
KATHY DAHLKEMPER, Pennsylvania         
ALAN GRAYSON, Florida                    
BART GORDON, Tennessee               RALPH M. HALL, Texas
                DAN PEARSON Subcommittee Staff Director
                  EDITH HOLLEMAN Subcommittee Counsel
            JAMES PAUL Democratic Professional Staff Member
       DOUGLAS S. PASTERNAK Democratic Professional Staff Member
           KEN JACOBSON Democratic Professional Staff Member
            TOM HAMMOND Republican Professional Staff Member
                      JANE WISE Research Assistant


                            C O N T E N T S

                             June 11, 2009

                                                                   Page
Witness List.....................................................     2

Hearing Charter..................................................     3

                           Opening Statements

Statement by Representative Brad Miller, Chair, Subcommittee on 
  Investigations and Oversight, Committee on Science and 
  Technology, U.S. House of Representatives......................     7
    Written Statement............................................    14

Statement by Representative Paul C. Broun, Ranking Minority 
  Member, Subcommittee on Investigations and Oversight, Committee 
  on Science and Technology, U.S. House of Representatives.......    15
    Written Statement............................................    17

                               Witnesses:

Dr. Kevin Teichman, Deputy Assistant Administrator for Science, 
  Office of Research and Development (ORD), U.S. Environmental 
  Protection Agency (EPA)
    Oral Statement...............................................    26
    Written Statement............................................    28
    Biography....................................................    29

Mr. John B. Stephenson, Director, Natural Resources and 
  Environment, U.S. Government Accountability Office
    Oral Statement...............................................    30
    Written Statement............................................    31
    Biography....................................................    36

Discussion
  Ensuring EPA's Program Control.................................    37
  The Effect of an IRIS Listing..................................    38
  How IRIS Assessments Are Used..................................    38
  Transparency Process...........................................    39
  Program Schedule and Productivity..............................    41
  Potential Improvements.........................................    42
  Deliberative Process...........................................    42
  The GAO High-Risk List.........................................    43
  Royal Demolition Explosive.....................................    43
  Assessment Timeliness..........................................    44
  Peer Reviews...................................................    45
  Fairness and Time Constraints..................................    47
  More on the Transparency Process...............................    47
  Closing........................................................    48

             Appendix 1: Answers to Post-Hearing Questions

Dr. Kevin Teichman, Deputy Assistant Administrator for Science, 
  Office of Research and Development (ORD), U.S. Environmental 
  Protection Agency (EPA)........................................    52

             Appendix 2: Additional Material for the Record

Nipping IRIS in the Bud: Suppression of Environmental Science by 
  the Bush Administration's Office of Management and Budget, 
  Staff Report by the Majority Staff of the Subcommittee on 
  Investigations and Oversight, June 11, 2009....................    56

The IRIS Information Roadblock: How Gaps in EPA's Main 
  Toxicological Database Weaken Environmental Protection, Center 
  for Progressive Reform White Paper #904, June 2009.............   125


         FIXING EPA'S BROKEN INTEGRATED RISK INFORMATION SYSTEM

                              ----------                              


                        THURSDAY, JUNE 11, 2009

                  House of Representatives,
      Subcommittee on Investigations and Oversight,
                       Committee on Science and Technology,
                                                    Washington, DC.

    The Subcommittee met, pursuant to call, at 1:11 p.m., in 
Room 2318 of the Rayburn House Office Building, Hon. Brad 
Miller [Chair of the Subcommittee] presiding.



                            hearing charter

              SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT

                  COMMITTEE ON SCIENCE AND TECHNOLOGY

                     U.S. HOUSE OF REPRESENTATIVES

                     Fixing EPA's Broken Integrated

                        Risk Information System

                        thursday, june 11, 2009
                          1:00 p.m.-3:00 p.m.
                   2318 rayburn house office building

Purpose

    On Thursday, June 11, 2009, the Subcommittee on Investigations and 
Oversight of the House Committee on Science and Technology will hold a 
hearing entitled ``Fixing EPA's Broken Integrated Risk Information 
System.'' We will receive testimony from two witnesses at this hearing: 
Mr. John Stephenson, Director, Natural Resources and Environment, U.S. 
Government Accountability Office, and Dr. Kevin Teichman, the Deputy 
Assistant Administrator for Science, Office of Research and 
Development, the Environmental Protection Agency. They will testify 
about the new Integrated Risk Information System (IRIS) process 
announced by EPA Administrator Lisa Jackson on May 21, 2009.

Background

    By the end of the Bush Administration, the Environmental Protection 
Agency's (EPA) IRIS process was broken. What began two decades ago as 
an initiative at EPA to establish a reliable database on what science 
said about the risks of particular chemicals devolved by the end of the 
Bush Administration into a tortured round of interagency bickering, 
mediated by the Office of Information and Regulatory Affairs (OIRA). As 
a result of the IRIS process breaking down, public health offices 
across the country and around the world, as well as concerned citizens, 
were left without the reliable, expanding, up-to-date database of 
chemical risks that they had come to count on.\1\
---------------------------------------------------------------------------
    \1\ The Subcommittee has carried out extensive work on OIRA's role 
in relationship to IRIS. In 2008, the Subcommittee held two hearings on 
this subject. The first of these hearings was on May 21, 2008, when the 
Subcommittee took testimony from Dr. George Gray, the then-Assistant 
Administrator for Research and Development at EPA, and Ms. Susan 
Dudley, the then-Administrator of the Office of Information and 
Regulatory Affairs (OIRA) at the Office of Management and Budget. 
Additionally, Mr. John Stephenson of GAO testified on findings 
regarding the lack of productivity in the IRIS process. In the second 
hearing, on June 12, 2008, the Subcommittee received testimony from Mr. 
Jerry Ensminger (U.S.M.C., retired), Mr. Lenny Seigel (Executive 
Director, Center for Public Environmental Oversight), and Dr. Linda 
Greer (Director of the Health Program at the Natural Resources Defense 
Council). On June 11, 2008 Chair Miller sent a document request to OMB 
asking for all materials relating to OIRA's involvement in the proposed 
IRIS entry for trichloroethylene (TCE). In response, the Committee 
received a few boxes of materials. The great majority of those 
materials were either peer reviewed articles, articles done by EPA 
staff, or research reports done under contract to industry or polluting 
agencies. Subcommittee staff were obliged to visit OMB's office to 
review thousands of pages of documents and take notes because the 
office refused to provide copies. A clear picture of OIRA's almost 
daily involvement on TCE emerged from that review. However, OIRA 
refused to provide access to most documents regarding interagency 
communications or internal communications surrounding TCE. Because the 
110th Congress was drawing to a close, it was not practical to push for 
a subpoena for these records. We were never shown any document that 
could have been construed as having Executive Privilege attached to it. 
OIRA's entire approach appeared to amount to little more than 
obstruction of the work of the Subcommittee; in a sense, OIRA did to 
the Subcommittee's investigation what they have perfected in terms of 
slow-rolling IRIS proposals.
---------------------------------------------------------------------------
    A chemical's entry in the IRIS database is nothing more than a 
science-based assessment of risks associated with a particular 
chemical. IRIS entries are produced in the Office of Research and 
Development (ORD) of EPA, and those entries are not an expression of 
regulatory intent or advice. The entries are not even all that is 
required of a complete risk assessment as defined in the seminal 
National Academies of Science report, Risk Assessment in the Federal 
Government: Managing the Process (1983).\2\ And risk assessment is a 
long step away from a regulatory effort, which is described in the 
terminology of the panel as ``risk management.'' However, the absence 
of IRIS entries for widely used, toxic chemicals leaves State and local 
regulators, first responders, and citizens without crucial information 
that can guide their response to an emergency or an emerging health or 
environmental threat.
---------------------------------------------------------------------------
    \2\ In that 1983 report, ``Risk Assessment in the Federal 
Government: Managing the Process,'' the National Research Council panel 
identified four components of a complete risk assessment: hazard 
identification, dose-response evaluation, exposure assessment, and risk 
characterization. IRIS reflects science that addresses the first two 
conditions. In discussing the difference between risk assessment and 
risk management, the Academy panel wrote: ``Risk assessment is the use 
of the factual base to define the health effects of exposure of 
individuals or populations to hazardous materials and situations. Risk 
management is the process of weighing policy alternatives and selecting 
the most appropriate regulatory action, integrating the results of risk 
assessment with engineering data and with social, economic and 
political concerns to reach a decision.'' See the discussion on page 3 
of the 1983 report.
---------------------------------------------------------------------------
    OIRA has been involved in the IRIS process since the closing years 
of the Clinton Administration. Initially OIRA was pulled into the 
process to facilitate interagency discussions about particular 
chemicals proposed for IRIS listings. Agencies that had a record of 
pollution with certain chemicals were concerned that new IRIS standards 
would trigger the long march to new regulations and the end result 
would be that the polluting agencies would have to change their 
practices and clean up legacy wastes. Those who polluted saw that 
disputing what scientific research had found about the risks of a 
particular chemical could become the first line of defense against the 
distant possibility of regulation.\3\ By the late 1990s, OIRA was 
playing a role as facilitator for contentious interagency discussions 
for some particular proposed IRIS listings.\4\
---------------------------------------------------------------------------
    \3\ This effort by polluters, or those who fear regulation of 
whatever stripe, of pushing the struggle back to what the science says 
about a particular risk rather than arguing over how to structure a 
regulation has been described as ``paralysis by analysis.'' Science 
lends itself to endless study because there is never an absolute, final 
answer to any question, but always another layer of research that could 
add to the body of accumulated knowledge. If those who want to avoid 
regulation can shift the terms of discussion from the risk management 
end of the spectrum to the science and what uncertainties remain, a 
regulatory struggle need never begin. For analysis of how this process 
has unfolded among regulated industries, see David Michaels, Doubt Is 
Their Product: How Industry's Assault on Science Threatens Your Health, 
Oxford University Press, New York, 2008.
    \4\ The Subcommittee was also able to review records from 1998 when 
OIRA first began to push into the interagency struggles over 
characterizing risks to former marines and their families from TCE and 
other chemicals at Camp LeJeune. At that time, OIRA's interest was more 
in the costs of the studies and making sure the then-proposed survey 
study met OIRA quality standards. OIRA reviews all survey instruments 
as part of its authority under the Paperwork Reduction Act of 1980.
---------------------------------------------------------------------------
    Suppressing IRIS entries essentially shuts down the flow of 
coherent, reliable information about what chemicals pose what kinds of 
risks. Testimony received by the Subcommittee at the second day of 
hearings on this subject in 2008 emphasized the important role of IRIS 
as a public health and safety resource. That hearing, entitled ``Toxic 
Communities: How EPA's IRIS Program Fails the Public,'' took testimony 
from U.S.M.C. (retired) Master Sergeant Jerry Ensminger, the Executive 
Director of the Center for Public Environmental Oversight, Mr. Lenny 
Siegel, and Dr. Linda E. Greer, Director for Health Programs at the 
Natural Resources Defense Council. Mr. Ensminger was particularly 
compelling in making a case for why polluting agencies such as DOD 
should not be allowed privileged access to discussions about the 
science of potential pollutants.

         It is a known fact that the United States Department of 
        Defense is our nation's largest polluter. It is beyond my 
        comprehension why an entity with that type of reputation and 
        who has a vested interest in seeing little to no environmental 
        oversight would be included in the scientific process. Not only 
        are they obstructing science, they are also jeopardizing the 
        public health for millions of people all around the world . . . 
        and yet this Administration and past Congresses have allowed 
        DOD's tentacles to infiltrate the realm of science.\5\
---------------------------------------------------------------------------
    \5\ ``Toxic Communities: How EPA's IRIS Program Fails the Public,'' 
Hearing before the Subcommittee on Investigations and Oversight, 
Committee on Science and Technology, June 12, 2008, p. 132.

    Mr. Ensminger was stationed at Camp LeJeune. His daughter, Janey, 
died of acute lymposytic leukemia. Water at the Camp was contaminated 
with trichloroethylene (TCE) and perchlorate (perc) and these 
chemicals, as well as other volatile organic compounds in the water 
system at the Camp, may have caused Janey's condition. DOD has been 
working for many years to block new IRIS standards on TCE and perc.
    During the Bush Administration, OIRA's involvement changed in scope 
and kind from what it had been in the Clinton Administration. John 
Graham, the first Director of OIRA in the Bush Administration, brought 
in technical specialists--including toxicologists--to tend to science-
based discussions of proposed environmental regulations, guidance and 
IRIS entries. Graham also oversaw a complete overhaul--some might 
describe it as an endless evolution--of the review and approval process 
for IRIS proposals.

IRIS Process Reforms Past and Present

    On April 10, 2008, EPA announced a new IRIS review process for 
future entries into the IRIS database. In testimony before the 
Subcommittee, the then Assistant Administrator for Research and 
Development at EPA, Dr. George Gray, described this new process as 
``streamlined.'' Comparing the process as it existed before 2004 and 
the process announced on April 10, 2008, it is hard to understand in 
what sense the process could be described as ``streamlined'' (see 
Attachments 1 and 2). The fruits of this new process were exactly four 
new IRIS entries in the years since that process was announced 
(actually, they had gone through as a single proposal as they were four 
variants on one chemical compound so this could be counted as ``one'' 
new entry and not distort the record). In the two years prior to 
announcing this new process, EPA had been allowed to post four new 
entries (two each year).
    GAO issued a very strong report concerning mismanagement of the 
IRIS program in a March, 2008 report (``Chemical Assessments: Low 
Productivity and New Interagency Review Process Limit the Usefulness 
and Credibility of EPA's Integrated Risk Information System,'' GAO-08-
440). In addition, GAO added the IRIS program to its ``High Risk'' 
report in January of 2009--placing additional pressure on EPA and the 
new Administration to take steps to fix this broken process.
    On May 21, EPA Administrator Lisa Jackson announced a new IRIS 
process that appears to be much improved over the system she inherited 
(see Attachment 3). It imposes transparency on interagency comments 
concerning proposed IRIS entries; it eliminates the ability of 
polluting agencies (such as the Department of Energy, NASA, or the 
Department of Defense) to further drag out assessments by declaring 
particular chemicals as ``mission critical''; it puts EPA solidly in 
charge of the entire process with a timeline for each step in the 
process.
    All of these steps away from an OIRA-dominated system are positive. 
However, questions still remain about how this process will perform in 
actual practice.

        1.  Control: Will EPA really have the muscle to stand up to 
        pressure from more powerful agencies that have historically 
        obstructed IRIS entries as a way of strangling potential 
        regulation? Will EPA be able to withstand pressure from offices 
        inside the White House should those offices mobilize to block 
        or significantly redo a proposed IRIS listing? EPA faired badly 
        during the prior Administration in struggles over science and 
        regulation. Some of those problems reflected the political 
        preferences of the Bush Administration, but some of those 
        problems reflect the ingrained institutional interests of other 
        agencies who do not want to be regulated and White House 
        offices that want to have a great measure of control over what 
        EPA (among many agencies) can and cannot do. Institutional 
        interests do not change with elections, and EPA will still face 
        some pressure on that front. The Chair's position has been that 
        EPA scientists should be in charge of EPA science products.

        2.  What role will OIRA play? This is really a more specific 
        observation related to control, but the new plan announced by 
        Administrator Jackson is ambiguous about what White House 
        offices will be involved in reviews of EPA IRIS proposals. 
        Because discussion of proposed listings is supposed to be 
        limited solely to ``science'' matters, it is hard to imagine 
        any White House office actually having the time or resources to 
        appropriately weigh in on science matters--even the Office of 
        Science and Technology Policy. There is no office in the White 
        House that does ``science'' per se. OIRA is really designed to 
        weigh in on the ``risk management'' side of the regulatory 
        equation, not the ``risk assessment'' or science side which 
        comes well before any regulatory proposal is even contemplated. 
        No office in the White House is more influential with agencies 
        than is the Office of Management and Budget (OMB) precisely 
        because OMB controls every agency's budget request. OIRA is 
        housed at OMB and that location gives them a very powerful 
        voice, when they raise it, in the work of the line agencies. Is 
        it appropriate to let OIRA play any role at all in science 
        matters?

        3.  Productivity: While the newly announced process does 
        eliminate some steps in the IRIS approval process, it remains 
        to be seen whether it will allow for a substantial increase in 
        IRIS entries being finalized by EPA. With 700 new chemicals 
        entering the marketplace each year, and a backlog of needed 
        updates and new entries, the bare minimum standard for success 
        of IRIS is probably 20 entries a year--which is what the new 
        process promises to deliver.

    The Subcommittee will pursue these matters, and others, during the 
hearing. If IRIS is unable to function effectively, public health and 
safety will ultimately suffer. Getting this program right is a high 
priority for the Subcommittee and the country. The Subcommittee Chair 
expects to send a request letter to the Government Accountability 
Office to have them continue to monitor the new IRIS process.
    Chair Miller. Good afternoon. The hearing will now come to 
order. Welcome to today's hearing entitled ``Fixing EPA's 
Broken Integrated Risk Information System.''
    A little more than a year ago Susan Dudley, then the head 
of the Office of Information Regulatory Affairs at OMB, OIRA, 
and Dr. George Gray, then the head of the Office of Research 
and Development at EPA, testified before this subcommittee. The 
hearing was to examine the stunning lack of productivity in a--
in new and revised risk assessments for chemicals in the EPA's 
Integrated Risk Information System, IRIS.
    Dudley and Gray testified that the productivity was a 
complicated approval process for assessments which this 
flowchart produced by EPA, Mr. Whittaker, illustrated. This is 
the complicated process that they needed to fix.




    So they testified that they had solved the problem by 
developing a streamlined approval process which this flowchart, 
also produced by EPA, illustrates.




    Again, Mr. Whittaker, if you could show the complicated 
system, chart one, okay, and then the simplified system, chart 
two.
    Gray's and Dudley's testimony reminded me of a famous 
quotation from Marx--not Karl, Chico. ``Well, who are you going 
to believe? Me or your own eyes?'' Gray's and Dudley's 
testimony strained credulity in other ways. Dudley explicitly 
denied in her testimony that OIRA, the office that she headed, 
ever challenged scientific assessments by EPA scientists. 
Scientific assessment of a toxic effect of chemical exposure 
would not even remotely be OIRA's job. Our staff today released 
a report on IRIS that shows that OIRA did just that on several 
occasions, enough to conclude that intruding on scientific 
assessments was routine for OIRA. Dudley testified that the 
streamlined process, that was chart two, for approving IRIS 
listings was entirely EPA's handiwork. Our staff's report shows 
that the process was a result of a multi-year, interagency 
process that was driven by OIRA, not by EPA.
    OIRA's conduct in requiring a perpetual paralysis in 
approval procedures and intruding on the independence of EPA's 
scientists appears to have been intended to keep IRIS from 
doing its job and to keep us all in the dark about the public 
health consequences of chemical exposures. It certainly had 
that effect. While 70 chemicals were in some stage of review by 
EPA, EPA averages three new and revised IRIS entries a year.
    The new EPA Administrator, Lisa Jackson, announced a new 
process on May 21, 2009. This chart illustrates the new 
process.












    If we are to believe our own eyes, the new process is 
substantially streamlined.
    Just as important, discussions between Federal Government 
agencies about IRIS listings will be transparent. There is no 
excuse for keeping interagency discussions secret from Congress 
and from the American people. We are entitled--I am speaking as 
a Member of Congress and as one of the American people, we are 
entitled to know the potential health effects of chemical 
exposures even if various government agencies find the 
chemicals very useful.
    And no agency can trigger an even more tortured approval 
process by declaring that a chemical is ``mission critical.'' 
Under strict rules of grammar the word ``perpetual'' is like 
the word ``naked'' or ``nude.'' Neither allows for degrees, but 
the IRIS approval process devised by Dudley's OIRA was 
perpetual for all chemicals and more perpetual for ``mission 
critical'' chemicals.
    We are interested in hearing today about EPA's new 
procedures, and there should be little doubt that the 
procedures are an improvement, but we need to see how the 
procedures work in practice to know whether the procedures are 
enough of an improvement. The institutional interests and 
ambitions of federal agencies survive presidential transitions. 
There will still be agencies that want to use chemicals without 
annoying restrictions and may try to avoid risk management 
issues by obstructing the risk assessment of an IRIS listing. 
And it is human nature to forsake power reluctantly, even the 
unwholesome, even sinister power that OIRA exercised over EPA's 
scientific assessments.
    The American people need and deserve credible, 
scientifically-sound assessments of the health effects of 
chemical exposures. That means EPA must be in charge, not OIRA.
    The Subcommittee will continue to work to follow the work 
of IRIS, and I have written the GAO to ask that they closely 
monitor the new IRIS process as well. And I have now included 
both our staff report on IRIS as well as a new report from the 
Center for Progressive Reform with my statement for the record. 
[See Appendix: Additional Material for the Record.]
    I now recognize my distinguished colleague, Dr. Broun, for 
his opening statement.
    [The prepared statement of Chair Miller follows:]

                Prepared Statement of Chair Brad Miller

    A little more than a year ago, Susan Dudley, then the head of the 
Office of Information and Regulatory Affairs in OMB, and Dr. George 
Gray, then the head of the Office of Research and Development at EPA, 
testified before this subcommittee.
    The hearing was to examine the stunning lack of productivity in new 
and revised risk assessments for chemicals in the EPA's Integrated Risk 
Information System (IRIS).
    Dudley and Gray testified that the productivity problem was a 
complicated approval process for assessments, which this flow chart 
produced by EPA illustrated.
    But Gray and Dudley said they had solved the problem by developing 
a streamlined approval process, which this flow chart, also produced by 
EPA, illustrated.
    Gray's and Dudley's testimony reminded me of a famous quotation 
from Marx--not Karl, but Chico: ``Well, who you gonna believe, me or 
your own eyes?''
    Gray's and Dudley's testimony strained credulity in other ways.
    Dudley explicitly denied in her testimony that OIRA, the office 
that she headed, ever challenged scientific assessments by EPA's 
scientists. Scientific assessment of the toxic effect of chemical 
exposure would not even remotely be OIRA's job. Our staff today 
released a report on IRIS that shows that OIRA did just that on several 
occasions, enough to conclude that intruding on scientific assessments 
was routine for OIRA. Dudley testified that the ``streamlined'' process 
for approving IRIS listings was entirely EPA's handiwork. Our staff's 
report shows that the process was the result of a multi-year, 
interagency process driven by OIRA, not EPA.
    OIRA's conduct in requiring a perpetual paralysis in approval 
procedures and intruding on the independence of EPA's scientists 
appears to have been intended to keep IRIS from doing its job, and to 
keep us all in the dark about the public health consequences of 
chemical exposures. It certainly had that effect. While 70 chemicals 
were in some stage of review by EPA, EPA averaged three new and revised 
IRIS entries a year.
    The new EPA Administrator, Lisa Jackson, announced a new process on 
May 21, 2009. This chart illustrates the new process. If we are to 
believe our own eyes, the new process is substantially streamlined.
    Just as important, discussions between Federal Government agencies 
about IRIS listings will be transparent. There is no excuse for keeping 
interagency discussions secret from Congress and the American people. 
We are entitled to know the potential health effects of chemical 
exposures, even if various government agencies find the chemicals very 
useful.
    And no agency can trigger an even more tortured approval process by 
declaring that a chemical is ``mission critical.'' Under strict rules 
of grammar, the word ``perpetual'' is like the word ``naked'': neither 
allows for degrees. But the IRIS approval process devised by Dudley's 
OIRA was perpetual for all chemicals, and more perpetual for mission 
critical chemicals.
    We are interested in hearing today about EPA's new procedures, and 
there should be little doubt that the procedures are an improvement. 
But we will need to see how the procedures work in practice to know 
whether the procedures are enough of an improvement. The institutional 
interests and ambitions of federal agencies survive presidential 
transitions. There will still be agencies that want to use chemicals 
without annoying restrictions, and may try to avoid risk management 
issues by obstructing the risk assessment of an IRIS listing. And it is 
human nature to forsake power reluctantly, even the unwholesome, even 
sinister power that OIRA exercised over EPA's scientific assessments.
    The American people need and deserve credible, scientifically sound 
assessments of the health effect of chemical exposures. That means the 
EPA must be in charge, not OIRA.
    This subcommittee will continue to follow the work of IRIS, and I 
have written the GAO to ask that they closely monitor the new IRIS 
process as well.

    Mr. Broun. Thank you, Mr. Chair.
    The Integrated Risk Information System (IRIS) process was 
originally developed in the mid 1980's for a specific task. 
Different offices throughout the EPA were relying on different 
assessments of the health effects of exposure to chemicals.
    IRIS was intended to establish a uniform database within 
EPA to--that represented a consensus determination. Over time, 
however, IRIS became an authoritative resource on chemical 
toxicity. As a credit to the agency's diligence, other 
agencies, states, and the international community and 
industries increasingly began to rely on IRIS, and assessments 
took on increased importance. These outside groups have sought 
to impact a process that was not initially designed to handle 
external pressures. The result has been an IRIS process that 
has effectively broken down.
    As we learned from GAO last year, EPA had a backlog of 70 
ongoing assessments and managed to complete only two 
assessments in each of the last two years. Even when EPA 
managed to produce assessments, the National Academy of 
Sciences has roundly criticized their work. The competing 
priorities of issuing assessments in a timely manner and 
producing assessments that are scientifically credible are 
central to the problems we face today.
    The completely unsatisfactory timeframes for these 
assessments are the results of several factors. Reviews are 
becoming more complex as attention increases for high-profile 
chemicals. EPA management and program decisions are delaying 
completion. Outside stakeholder reviews are becoming more 
detailed, and Congressional action is becoming more prevalent.
    All of these delays have compounded effects and create a 
domino effect on schedules as Mr. Stephenson pointed out in 
previous testimony. Until recently the IRIS process was an 
opaque process that had no schedule deadlines and limited 
outside review. While the previous Administration's proposed 
process wasn't perfect, it was the first time that the process 
was formalized, thoroughly examined, and given strict 
timelines. If nothing else, the previous Administration 
recognized the untenable nature of the existing IRIS process 
and presented a proposal to fix the problem.
    While the previous process wasn't perfect, neither is this 
new process. Previous processes required EPA to develop a 
consensus assessment, the original purpose of the IRIS process. 
The newly-proposed process does not require each EPA office to 
concur on assessments but rather to simply consult.
    Furthermore, these internal agency consultations are not 
required to be available to the public, which ultimately limits 
transparency. EPA's failure to develop consistent assessments 
raises the questions of how authoritative and useful IRIS will 
be in the future.
    One of the assessed arguments for the new proposal is its 
new streamlined process. As I mentioned earlier, the natural 
tension between fairness and timeliness begs the question of 
whether a streamlined process will ultimately sacrifice 
scientific credibility, especially considering recent negative 
reviews from the National Academy of Sciences. In order to 
streamline the process, the new Administration has cut out 
quality control measures such as visibility and the 
adjudication of peer review comments, the requirement for a 
qualitative assessment review, the public review of that 
qualitative assessment, the evaluation of agency interest in 
closing data gaps for mission-critical chemicals, design and 
implementation of new studies for mission-critical chemicals, 
and the development of short-term research projects that may 
aid in filling data gaps.
    More importantly, this new streamlined process uses a bit 
of slight of hand to take the scientific literature review and 
data culling periods off the schedule entirely. This work will 
still be done, but EPA doesn't account for this time in its 
schedule, allowing them to create the appearance of a speedier 
process.
    One of the largest criticisms of the previous proposal was 
the role played by the White House and more importantly OMB and 
Office of Regulatory Information and Affairs. Despite these 
previous criticisms, the new process states that White House 
offices will continue to be involved in the interagency 
consultation process.
    Apparently this was only a concern when it was politically 
fashionable. If anyone had a problem with the previous 
Administration's meddling, you can probably expect more of the 
same since OIRA is staffed almost exclusively by career civil 
servants.
    Somebody tried to dismiss this concern by noting that EPA 
is not ultimately responsible for the process but they always 
had final authority. Even under the previous process it could 
be claimed that even with that previous authority, EPA was 
still subordinate to the influence of OMB.
    Similarly, one could argue that EPA will truly have final 
authority under the new process, but ultimately the EPA 
Administrator still works for the President. The only 
difference is that now maybe the Administrator also works for 
the new environment czar, Carol Browner. We aren't really sure 
about this since she is removed from any type of Congressional 
oversight, transparency or accountability.
    I hope that science's rightful place doesn't turn out to be 
behind the cloak of deliberative process and executive 
communication.
    Despite concerns about White House meddling, OMB has 
provided useful input into EPA assessments according to GAO's 
2008 report. While OMB should certainly not use this review 
process to obstruct or prevent assessments, EPA also shouldn't 
be afraid to address valid scientific inquiries.
    Additionally, OMB plays an important role in shepherding 
the interagency process. Without OMB taking the lead in this 
process, it remains to be seen if EPA will have enough clout to 
force or compel other agencies to comply with its timelines and 
directions.
    This also raises another question relating to who will 
ultimately be the adjudicator of conflicts, an arbiter of 
scientific disputes. In an ideal world neither the White House 
nor EPA would be involved in this as it is truly a discussion 
meant for the scientific community.
    Unfortunately, in the real world there needs to be a 
bureaucratic referee. Is EPA truly an unbiased partner when 
they are the agency that drafts the assessments? What incentive 
does EPA have to incorporate peer review as comments that may 
contradict their opinions? Are we setting up a system when EPA 
will be responsible for monitoring its own work?
    Even if EPA is unbiased or the Office of Research and 
Development's staff tasks to conduct these assessment experts 
on every chemical are aware of all the science? If the answer 
is no, then aren't we essentially making pure but poorly 
informed assessments? If none of these questions matter because 
assessments go through peer review, why would it matter if 
other agencies, industry or the White House, were involved 
since the final product will be peer reviewed?
    As you can tell, I remain very skeptical of the new 
process, but I do see some commendable aspects. New 
transparency measures for the interagency review process are 
promising, even though they don't extend into internal 
communication between EPA line offices, which could prove to be 
just as informative and important.
    Despite this potential bright spot, several other questions 
remain.
    With that, Mr. Chair, I am attaching a letter from 
Toxicology Excellence for Risk Assessment to my statement that 
I will enter in the record, and I appreciate your indulgence 
and look forward to the witnesses' testimony.
    [The prepared statement of Mr. Broun follows:]

           Prepared Statement of Representative Paul C. Broun

    The Integrated Risk Information System (IRIS) process was 
originally developed in the mid-1980's for a specific task. Different 
offices throughout the Environmental Protection Agency (EPA) were 
relying on different assessments of the health effects of exposure to 
chemicals. IRIS was intended to establish a uniform database within EPA 
that represented consensus determinations.
    Over time, however, IRIS became an authoritative resource on 
chemical toxicity. As a credit to the agency's diligence, other 
agencies, states, the international community, and industries 
increasingly began to rely on IRIS, and the assessments took on 
increased importance. These outside groups have sought to impact a 
process that was not initially designed to handle external pressures. 
The result has been an IRIS process that has effectively broken down.
    As we learned from GAO last year, EPA had a backlog of 70 ongoing 
assessments and managed to complete only two assessments in each of the 
last two years. Even when EPA managed to produce assessments, the 
National Academy of Sciences has roundly criticized their work. The 
competing priorities of issuing assessments in a timely manner and 
producing assessments that are scientifically credible are central to 
the problems we face today.
    The completely unsatisfactory timeframes for these assessments are 
the result of several factors. Reviews are becoming more complex as 
attention increases for high profile chemicals, EPA management and 
program decisions are delaying completion, outside stakeholder reviews 
are becoming more detailed, and Congressional action is becoming more 
prevalent. All of these delays have compounding effects and create a 
``domino effect'' on schedules as Mr. Stephenson pointed out in 
previous testimony.
    Until recently, the IRIS process was an opaque process that had no 
schedule deadlines and limited outside review. While the previous 
Administration's proposed process wasn't perfect, it was the first time 
that the process was formalized, thoroughly explained, and given strict 
timelines. If nothing else, the previous Administration recognized the 
untenable nature of the existing IRIS process and presented a proposal 
to fix the problem.
    While the previous process wasn't perfect, neither is this the new 
process. Previous processes required EPA to develop a consensus 
assessment - the original purpose of the IRIS process. The newly 
proposed process does not require each EPA office to concur on 
assessments. but rather to simply consult. Furthermore, these internal 
agency consultations are not required to be available to the public, 
which ultimately limits transparency. EPA's failure to develop 
consensus assessments raises the question of how ?authoritative and 
useful IRIS will be in the future.
    One of the arguments for the new proposal is its new streamlined 
process. As I mentioned earlier, the natural tension between 
thoroughness and timeliness begs the question of whether a streamlined 
process will ultimately sacrifice scientific credibility. especially 
considering recent negative reviews from the National Academy of 
Sciences. In order to streamline the process, the new Administration 
has cut out quality control measures such as visibility into the 
adjudication of peer review comments; the requirement for a qualitative 
assessment review: the public review of that qualitative assessment: 
the evaluation of agency interests in closing data gaps for mission 
critical chemicals. the design and implementation of new studies for 
mission critical chemicals, and the development of short-term research 
projects that may aid in filling data gaps. More importantly, this new 
streamlined process uses a bit of slight-of-hand to take the scientific 
literature review and data call-in periods off the schedule entirely. 
This work will still be done, but EPA doesn't account for this time in 
its schedule, allowing them to create the appearance of a speedier 
process.
    One of the largest criticisms of the previous proposal was the role 
played by the White House, and more importantly the Office of 
Management and Budget (OMB) and the Office of Regulatory Information 
and Affairs (OIRA). Despite these previous criticisms, the new process 
states that White House offices will continue to be involved in the 
interagency consultation process. Apparently this was only a concern 
when it was politically fashionable. If anyone had a problem with the 
previous Administration's ``meddling,'' you can probably expect more of 
the same since OIRA is staffed almost exclusively by career civil 
servants.
    Some may try to dismiss this concern by noting that EPA is now 
ultimately responsible for the process, but they always had final 
authority, even under the previous process. It could be claimed that 
even with that previous authority, EPA was still subordinate to the 
influence of OMB. Similarly, one could argue that EPA will truly have 
final authority under the new process, but the ultimately the EPA 
Administrator still worked for the President. The only difference is 
that now maybe the Administrator also works for the new Environment 
Czar Carol Browner. We aren't really sure about this since she is 
removed from any type of Congressional oversight, transparency, or 
accountability. I hope that science's ``rightful place'' doesn't turn 
out to be behind the cloak of deliberative process and executive 
communication.
    Despite concerns about White House meddling, OMB has provided 
useful input into EPA assessments according to GAO's 2008 report. While 
OMB should certainly not use this review process to obstruct or prevent 
assessments, EPA also shouldn't be afraid to address valid scientific 
inquiries. Additionally, OMB plays an important role in shepherding the 
interagency process. Without OMB taking the lead in this process, it 
remains to be seen if EPA will have enough clout to force or compel 
other agencies to comply with its timelines and directions.
    This also raises another question relating to who will ultimately 
be the adjudicator of conflicts and arbiter of scientific disputes. In 
an ideal world, neither the White House nor EPA would be involved in 
this, as it truly is a discussion meant for the scientific community. 
Unfortunately in the real world there needs to be a bureaucratic 
referee. Is EPA truly an unbiased partner when they are the agency that 
drafts the assessments? What incentive does EPA have to incorporate 
peer reviewer's comments that may contradict their opinions? Are we 
setting up a system where EPA will be responsible for monitoring its 
own work? Even if EPA is unbiased, are the Office of Research and 
Development (ORD) staff tasked to conduct these assessments experts on 
every chemical and aware of all the science? If the answer is no, then 
aren't we essentially making pure, but poorly informed assessments? If 
none of these questions matter because assessments go through peer 
review, why would it matter if other agencies, industry, or the White 
House were involved since the final product will be peer reviewed?
    As you can tell, I remain very skeptical of the new process but I 
do see some commendable aspects. New transparency measures for the 
interagency review process are promising even though they don't extend 
to internal communications between EPA line offices which could prove 
to be just as informative and important. Despite this potential bright-
spot, several other questions remain.
    With that, Mr. Chairman, I am attaching a letter from Toxicology 
Excellence for Risk Assessment (TERA) to my statement that I will enter 
into the record. I appreciate your indulgence and look forward to the 
witnesses' testimony.

    [The information follows:]

    
    
    
    
    
    
    
    
    
    
    
    

    Chair Miller. Thank you, Dr. Broun.
    I ask unanimous consent that all additional opening 
statements submitted by Members be included in the record. 
Without objection, so ordered.
    It is my pleasure now to introduce our witnesses. Dr. Kevin 
Teichman is the Deputy Assistant Administrator for Science in 
the Office of Research and Development at EPA, and Mr. John 
Stephenson is back. He is the Director of Natural Resources and 
Environment at the Government Accountability Office.
    As our witnesses should know, you will each have five 
minutes for your spoken testimony. Your written testimony will 
be included in the record. When you all have completed your 
spoken testimony, we will begin with questions. Each Member 
will have five minutes to question the panel.
    It is the practice of this subcommittee to receive 
testimony under oath, although we have not made it our habit to 
refer cases for perjury prosecution, which I am sure is a great 
relief to Dr. Gray and Ms. Dudley. You also have the right to 
be represented by counsel. Do any of you have any objection to 
taking an oath?
    Both witnesses indicated that they did not. You also have 
the right to be represented by counsel. Do either of you have a 
counsel here? Counsel with you?
    Also, I understand that you may have--although both of you, 
I know, have encyclopedic knowledge of this topic, you may have 
other staff with you who may need to--who might need to help 
with an answer. Would it be helpful if anybody else from your 
staffs who might need to help you with an answer also take the 
oath at the same time?
    Okay. All right. Please stand and raise your right hand. Do 
you swear to tell the truth and nothing but the truth?
    The record will show that both witnesses have taken the 
oath.
    We will now begin with Dr. Kevin Teichman. Dr. Teichman, 
please begin.

STATEMENT OF DR. KEVIN TEICHMAN, DEPUTY ASSISTANT ADMINISTRATOR 
  FOR SCIENCE, OFFICE OF RESEARCH AND DEVELOPMENT (ORD), U.S. 
             ENVIRONMENTAL PROTECTION AGENCY (EPA)

    Dr. Teichman. Good afternoon, Mr. Chair and Members of the 
Subcommittee. I am Dr. Kevin Teichman, the Deputy Assistant 
Administrator for Science in EPA's Office of Research and 
Development. I am also the Acting EPA Science Advisor, and in 
this role I serve as a member of the Office of Science and 
Technology Policy's Task Force on Scientific Integrity. I 
appreciate this opportunity to discuss with you EPA's 
Integrated Risk Information System, IRIS.
    Before I begin I would like to thank Congressman Miller and 
the Subcommittee for your support of the IRIS Program. The 
importance of a successful IRIS Program to the health of the 
American people was acknowledged by this subcommittee in two 
past hearings and by Chair Miller's previous introduction of 
legislation on this topic. Your continued interest in the 
future of the IRIS Program is greatly appreciated.
    IRIS is one of EPA's most important and most public 
products. IRIS has been a highly-regarded resource for 
providing information on the potential human health risks from 
long-term exposures to contaminants. IRIS assessments are used 
by EPA programs and regions as the scientific foundation for 
Agency actions to protect human health.
    IRIS assessments are also used by environmental and health 
professionals and State and local governments, as well as 
internationally. Because of the widespread use of IRIS risk 
information, it is of utmost importance that the process used 
to develop this information, and the resulting assessments 
posted on IRIS, reflect the highest possible standards for 
scientific quality, scientific integrity, transparency, and 
timeliness.
    Administrator Jackson, coming from careers at both EPA and 
the New Jersey Department of Environmental Protection, 
recognizes the critical role that EPA plays in disseminating 
timely, high quality, and accessible human risk information on 
environmental contaminants. Just four months after coming to 
EPA she announced a new IRIS process that is more responsive to 
the needs of the Agency and its work to effectively and 
efficiently protect the health of all Americans.
    The new IRIS process is more timely, transparent, and will 
ensure the highest level of scientific integrity. It will rely 
on an opportunity for public review and comment followed by a 
rigorous, open, and independent external peer review process to 
guarantee the scientific quality of the IRIS assessments.
    There are several aspects of the new process that I would 
like to highlight. First, the new IRIS process will be entirely 
managed by EPA. Second, there is no longer an opportunity for 
another federal agency to prolong the process by asking that 
additional research be conducted before an assessment can be 
produced.
    Instead, EPA will announce the chemicals that will be 
assessed far enough in advance so that any interested party 
could conduct short-term studies that could add to the peer-
reviewed scientific literature.
    Third, all written comments from other federal agencies and 
White House offices will become part of the public record. 
Opportunities for scientific comment by other federal agencies 
and White House offices was maintained in the new process, 
because EPA welcomes input from interested experts that may add 
to the scientific quality of the draft or final assessment.
    Also, the assessment process has been streamlined to ensure 
that more new and updated assessments are included on IRIS. 
While still robust, the assessment development process for most 
chemicals will be shortened to 23 months, speeding the 
availability of IRIS assessments.
    There are two steps introduced in the previous process that 
were retained in the new process. First, the opportunity for 
any interested party to provide information to EPA prior to the 
external peer review meeting. These listening sessions allow 
interested parties to present scientific comments on draft IRIS 
assessments during the public comment period and before the 
external peer review period. EPA has found the listening 
sessions to be a valuable step in public outreach and 
participation.
    Second, changes in EPA's scientific judgments from public 
comments and peer review will be clearly documented and 
explained, maximizing the transparency of the final product.
    Finally, to give this new process an added boost, the 
Administrator has directed that for fiscal year 2010, resources 
for the IRIS program should be increased, and the President's 
budget request includes an additional $5 million and ten FTEs 
full-time equivalents, for the IRIS program.
    In conclusion, EPA remains dedicated to listening and being 
responsive to the public, to independent experts, and to 
scientists and other federal science agencies as it develops 
IRIS human health assessments. The ability of EPA's program to 
succeed has been significantly improved now that some steps 
have been removed or revised. EPA is confident that we can 
continue to provide the critical human health risk information 
to EPA's programs and regions that ensure the Agency's actions 
protect the public health.
    Thank you very much, and I am happy to answer any questions 
that you may have.
    [The prepared statement of Dr. Teichman follows:]

                  Prepared Statement of Kevin Teichman

    Good afternoon, Mr. Chairman and Members of the Subcommittee. I am 
Dr. Kevin Teichman, the Deputy Assistant Administrator for Science in 
EPA's Office of Research and Development. I am also the Acting EPA 
Science Adviser, and in this role I serve as a member of the Office of 
Science and Technology Policy's (OSTP's) Task Force on Scientific 
Integrity. I appreciate this opportunity to appear at this hearing and 
discuss with you EPA's Integrated Risk Information System (IRIS). In 
this written testimony, I will include a brief description of the 
recent history of the IRIS program as well as discuss some of the 
highlights of the new IRIS process that was announced by EPA 
Administrator Lisa P. Jackson on May 21, 2009.
    Before I begin, I would like to thank Congressman Miller and this 
Subcommittee on behalf of EPA, and personally, for support of the IRIS 
program. The importance of a functioning and successful IRIS program to 
the health of the American people was acknowledged by this subcommittee 
in two past hearings and by Chairman Miller's introduction of H.R. 
7234, the Integrated Risk Information System Authorization Act. Since 
the purpose of IRIS is to provide timely, high quality, and accessible 
human health risk information on environmental contaminants that may 
endanger the health of the American public, your continued interest in 
the future of the IRIS program is greatly appreciated.
    IRIS is one of EPA's most successful and most public products. IRIS 
has been a highly regarded resource for providing information on the 
potential human health risks from long-term exposure to various 
contaminants. The IRIS assessments used by EPA's Program Offices and 
Regions are the science foundation for Agency actions to protect human 
health. IRIS assessments are also used by risk assessors and 
environmental and health professionals in State and local governments, 
as well as internationally. Because of the widespread recognition and 
use of IRIS risk information, it is of utmost importance that the 
process used to develop this information, and the resulting assessments 
posted on IRIS, reflect the highest possible standards for scientific 
quality and integrity, transparency, and timeliness.
    On April 10, 2008, a new IRIS process was created via a memorandum 
from former Deputy Administrator Marcus Peacock that codified the IRIS 
process. This process introduced additional, time-consuming steps, some 
of which were not transparent to the public.
    On January 26, 2009, Lisa P. Jackson was sworn in as EPA's 11th 
Administrator. On January 23, 2009, Administrator-Designee Jackson 
wrote to all EPA staff that, ``As Administrator, I will ensure EPA's 
efforts to address the environmental crises of today are rooted in 
three fundamental values: science-based policies and programs, 
adherence to the rule of law, and overwhelming transparency. By keeping 
faith with these values and unleashing innovative, forward-thinking 
approaches--we can further protect neighborhoods and communities 
throughout the country.'' Coming from careers at both EPA and the New 
Jersey Department of Environmental Protection, Administrator Jackson 
recognized the critical role that EPA plays in disseminating timely, 
high quality, and accessible human health risk information on 
environmental contaminants. Thus, one of her highest priorities was to 
take the necessary steps to strengthen and revitalize the process by 
which EPA develops and disseminates human health risk information.
    On May 21, 2009, just four months after coming to EPA, 
Administrator Jackson announced a new IRIS process that is more 
responsive to the needs of the Agency in its work to effectively and 
efficiently protect the health of all Americans. The new IRIS 
assessment development process, which was implemented immediately, is 
more streamlined, transparent, and timely, and will ensure the highest 
level of scientific integrity. It will rely primarily on an opportunity 
for public review and comment followed by a rigorous, open, and 
independent external peer review process to guarantee the scientific 
quality of the IRIS assessments.
    There are several aspects of the new process that I would like to 
highlight. The first is that the new IRIS process will be entirely 
managed by EPA. Second, there is no longer an opportunity for another 
federal agency to prolong the assessment process by asking that 
additional research be conducted before an assessment can proceed. 
Instead, EPA will announce the chemicals that will be assessed far 
enough in advance so that any interested party could conduct short-term 
studies that could add to the peer-reviewed scientific literature for 
that chemical. Third, all scientific comments from other federal 
agencies and White House offices will become part of the public record 
for that chemical assessment. Opportunities for scientific comment by 
other federal agencies and White House offices was maintained in the 
new process, because EPA welcomes input from interested experts that 
may add to the science quality of the draft or final assessment.
    Finally, the assessment process has been streamlined to ensure that 
more new and updated assessments are included on IRIS. While still 
robust, the assessment development process for most chemicals will be 
shortened to 23 months, speeding the availability of IRIS assessments 
to the human health risk assessor community and the public.
    There are two aspects that were retained in the new process. First, 
is the opportunity for any interested party to provide information to 
EPA prior to the external peer review meeting. These listening 
sessions, announced in the Federal Register, allow all interested 
parties to present scientific and technical comments on draft IRIS 
health assessments to EPA and other interested parties during the 
public comment period and before the external peer review meeting. EPA 
has found the listening sessions to be a valuable step in public 
outreach and participation. The listening session comments are 
considered by the Agency as it revises the draft assessment in response 
to the independent external peer review and public comments. As with 
scientific comments from other federal agencies, listening session 
comments become part of the public record. Second, changes in EPA's 
scientific judgments from public comments and peer review will be 
clearly documented and explained, maximizing the transparency of the 
final product.
    Finally, to give this new process an added boost, the Administrator 
has directed that for fiscal year 2010, resources for the IRIS program 
should be increased, and the President's budget request includes an 
additional $5 million and 10 FTEs for the IRIS program.
    EPA remains dedicated to listening and being responsive to the 
public, to independent experts, and to scientists in other federal 
science agencies as it develops IRIS human health assessments. The 
ability of EPA's IRIS program to succeed has been significantly 
improved now that some steps have been removed or revised. EPA is 
confident that we can continue to provide the critical human health 
risk information to EPA's Programs and Regions that ensure the Agency's 
actions protect the public health.
    Thank you for the opportunity to discuss with you EPA's new and 
improved IRIS program. I am happy to answer any questions that you may 
have.

                      Biography for Kevin Teichman

    Dr. Kevin Teichman is the Deputy Assistant Administrator for 
Science in the Office of Research and Development (ORD); he is also the 
Acting Science Advisor for the Agency. He previously served as the 
Director of the Office of Science Policy (OSP) within ORD. In this 
capacity, he coordinated ORD participation in EPA's policy-making in 
all media (air, water, waste, pesticides and toxic substances) to 
ensure these policies reflected sound science. In addition, he helped 
lead the planning of EPA's research program, striving to ensure the 
research program responded to the needs of EPA's Program and Regional 
Offices and maintained its leadership role in the environmental 
research community.
    During the enactment of the Clean Air Act Amendments of 1990, Dr. 
Teichman served as the Associate Director of Science in OSP, and OSP 
Staff Director of the Air Staff prior to that, with similar 
responsibilities to those above but limited to air pollution. In 
addition, he managed EPA's indoor air quality research program, 
including research devoted to characterizing indoor pollutants sources, 
assessing indoor exposures, studying associated health effects, 
assessing potential risks, and developing prevention/mitigation 
approaches to indoor air pollution.
    Dr. Teichman has B.S. and M.S. degrees from the Massachusetts 
Institute of Technology and a Ph.D. degree from the University of 
California at Berkeley, all in Mechanical Engineering. He lives in 
Derwood, Maryland where he and his wife Marsha are proud ``empty 
nesters.''

    Chair Miller. Thank you, Dr. Teichman.
    Mr. Stephenson is recognized for five minutes.

    STATEMENT OF MR. JOHN B. STEPHENSON, DIRECTOR, NATURAL 
   RESOURCES AND ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY 
                             OFFICE

    Mr. Stephenson. Thank you, Mr. Chair. I am pleased to be 
here today to discuss our prior findings and recommendations on 
EPA's IRIS program as well as the results of our preliminary 
review of EPA's most recently announced IRIS reforms announced 
on May 21, 2009.
    As you know, the IRIS database contains EPA's scientific 
position on the potential human health effects of exposure to 
more than 540 chemicals in the environment. It is the critical 
component of EPA's capacity to support scientifically-sound 
risk management decisions, policies, and regulations.
    In March 2008, we reported that the IRIS program was at 
serious risk of becoming obsolete because the Agency had not 
been able to complete timely, credible chemical assessments or 
decrease its backlog of 70 ongoing assessments. EPA completed 
only five assessments last year and has only completed one 
assessment so far this year.
    We also found that the timeframes for completing 
assessments were unacceptably long, often taking over a decade. 
In many cases assessments became obsolete before they could be 
finalized and were stuck in an endless loop of assessment and 
reassessment.
    In April 2008, EPA unveiled a revised process, and we were 
disappointed to find out that it was not responsive to our 
recommendations and was actually worse than the process that it 
replaced, institutionalizing a process that would take six to 
eight years at best to complete, enabling federal agencies to 
delay ongoing assessments by requesting additional research and 
declaring comments from other agencies deliberative and 
excluded from the public record.
    As we testified before this subcommittee last year, we were 
extremely concerned about the consequences of these problems 
because IRIS assessments are, after all, the cornerstone of 
scientific integrity at the Agency. In fact, we added EPA's 
toxic chemical assessment and control processes to our January 
2009 report on government-wide, high-risk areas in need of 
increased attention by executive agencies and the Congress, a 
GAO designation reserved for only the most serious Federal 
Government problems.
    Today I am pleased to report that while it is too soon to 
offer a blanket endorsement, the new IRIS process introduced by 
EPA on May 21 of this year appears to be a giant step in the 
right direction. In particular we believe that the new IRIS 
process, if managed effectively, will be largely responsive to 
the recommendations we made in our March 2008 report.
    First the process will be managed by EPA rather than OMB as 
the former process was. Second, it addresses key transparency 
concerns by expressly requiring that all written comments 
provided by other federal agencies on draft IRIS assessments be 
part of the public record. Third, the new process streamlines 
the previous one by consolidating and eliminating some steps 
and committing to a two-year completion timeframe. Importantly, 
it eliminates the step under which other federal agencies could 
have IRIS assessments suspended indefinitely to conduct 
additional research. We also believe that the requested 
increase of $5 million and ten additional staff positions will 
help ensure that more resources are allocated to the IRIS 
program to meet user needs.
    While these changes reflect a significant improvement that 
can help EPA restore the integrity and productivity of the 
program, we offer the following observations for EPA to 
consider as it implements the new process.
    First, there are no timeframes stated for the literature 
search and data call in kind of the pre-Step 1. This tends to 
understate the 23-month timeframe for completing assessments.
    Second, it is not clear what purpose--what the purpose of 
the interagency consultation meetings is, which is Step 3 and 
Step 6B on the new process, what the role of OMB and other 
White House offices are exactly, and whether decisions will be 
documented in the public from decisions coming out of those 
steps.
    Third, it seems to us that comments from the federal 
agencies, which is Step 3, could be solicited at the same time 
draft assessments are sent to independent peer reviewers and 
the public, which is Step 4, and saving additional time in the 
process.
    Fourth, it is not clear how EPA plans to respond to our 
March 2008 report recommendation to provide at least a two-year 
notice of planned assessments. The new process does not 
specifically address such important planning steps as the call 
for nominations of chemicals to be assessed and the 
establishment of an IRIS agenda.
    We believe that giving agencies and the public more 
advanced notice to plan assessments would enable external 
parties with an interest in a given chemical to complete 
relevant research before the start of an IRIS assessment, and 
thus, make the assessment even more efficient.
    Finally, unlike a number of other EPA programs with 
statutory deadlines for completing various activities, no 
enforceable deadlines apply to the IRIS program. We believe 
that legislating statutory deadlines could help EPA better 
ensure the viability of this critical program.
    Mr. Chair, that concludes the summary of my statement, and 
I will be happy to answer questions.
    [The prepared statement of Mr. Stephenson follows:]

                Prepared Statement of John B. Stephenson

Mr. Chairman and Members of the Subcommittee:

    I am pleased to be here today to discuss our prior findings and 
recommendations on the Environmental Protection Agency's (EPA) 
Integrated Risk Information System (IRIS) program as well as the 
results of our preliminary review of EPA's most recent IRIS reforms, 
announced on May 21, 2009. As you know, IRIS is one of the most 
significant tools that EPA has developed to effectively support its 
mission to protect people and the environment from harmful chemical 
exposures. The IRIS database contains EPA's scientific position on the 
potential human health effects of exposure to more than 540 chemicals 
in the environment and is, therefore, a critical component of EPA's 
capacity to support scientifically sound risk management decisions, 
policies, and regulations.
    In a March 2008 report, we identified significant deficiencies in 
EPA's IRIS assessment process that threatened the viability of the 
program, and we made a number of recommendations to correct them.\1\ In 
response, EPA issued a revised assessment process in April 2008 that 
did not respond to our recommendations but rather made changes likely 
to further exacerbate the problems we had identified. Largely as a 
result of the agency's lack of responsiveness, we added transforming 
EPA's processes for assessing and controlling toxic chemicals as a 
high-risk area in our January 2009 biennial status report on 
government-wide high-risk areas requiring increased attention by 
executive agencies and Congress.\2\ In announcing new reforms to the 
IRIS assessment process on May 21, 2009, EPA echoed our findings--that 
the April 2008 assessment changes reduced the transparency, timeliness, 
and scientific integrity of the IRIS process--and highlighted both our 
high-risk designation of this important EPA program and the President's 
recent emphasis on the importance of transparency and scientific 
integrity in government decision-making.
---------------------------------------------------------------------------
    \1\ GAO, Chemical Assessments: Low Productivity and New Interagency 
Review Process Limit the Usefulness and Credibility of EPA's Integrated 
Risk Information System, GAO-08-440 (Washington, D.C.: Mar. 7, 2008).
    \2\ GAO, High-Risk Series: An Update, GAO-09-271 (Washington, D.C.: 
January 2009).
---------------------------------------------------------------------------
    In this context, my testimony today discusses (1) the findings from 
our 2008 report and testimonies on the prior IRIS assessment 
processes\3\ and (2) our preliminary evaluation of EPA's May 2009 
process reforms. For this statement, we have supplemented our prior 
work with a preliminary review of the EPA process reforms and some IRIS 
productivity data. We conducted our work from May 28 to June 11, 2009, 
in accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform our work to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives.
---------------------------------------------------------------------------
    \3\ See the Related GAO Products section later in this statement.

The Viability of the IRIS Program Is at Risk

    In March 2008, we reported that the IRIS program is at serious risk 
of becoming obsolete because the agency has not been able to complete 
timely, credible chemical assessments or decrease its backlog of 70 
ongoing assessments. In addition, assessment process changes EPA had 
recently made, as well as other changes EPA was considering at the time 
of our review, would have further reduced the timeliness, credibility, 
and transparency of IRIS assessments. Among other things, we concluded 
the following:

          EPA was unable to routinely complete IRIS assessments 
        in a timely manner. From 2000 to 2007, EPA completed on average 
        about five IRIS assessments a year. The more recent trend has 
        been a decline in productivity: In fiscal years 2006 and 2007, 
        EPA completed two assessments each year; in 2008, EPA completed 
        five assessments--four of which were related chemicals assessed 
        and peer reviewed together but finalized individually; and thus 
        far in fiscal year 2009, EPA has finalized one assessment.

          Further, as we reported in 2008, because EPA staff 
        time was dedicated to completing assessments in the backlog, 
        EPA's ability to both keep the more than 540 existing 
        assessments up to date and initiate new assessments was 
        limited. We found that 48 of the 70 assessments being conducted 
        as of December 2007 had been in process for more than five 
        years--and 12 of those, for more than nine years. These time 
        frames have lengthened. Currently, of those 70 assessments, 58 
        have now been ongoing for more than five years--and 31 of those 
        for more than nine years.

          We also found that EPA's efforts to finalize IRIS 
        assessments have been thwarted by a combination of factors. 
        These factors include (1) the Office of Management and Budget's 
        (OMB) requiring two additional reviews of IRIS assessments by 
        OMB and other federal agencies with an interest in the 
        assessments, such as the Department of Defense, and (2) EPA 
        management decisions, such as delaying some assessments to 
        await the results of new research.

          The two new OMB/interagency reviews of draft 
        assessments involve other federal agencies in EPA's IRIS 
        assessment process in a manner that limits the credibility and 
        transparency of, and hinders EPA's ability to manage, IRIS 
        assessments. For example, some of these agencies' review 
        comments could be influenced by the potential for increased 
        environmental cleanup costs and other legal liabilities if EPA 
        issued an IRIS assessment for a chemical that resulted in a 
        decision to regulate the chemical to protect the public. 
        Moreover, the input these agencies provide to EPA is treated as 
        ``deliberative'' and is not released to the public. Regarding 
        EPA's ability to manage its IRIS assessments, in 2007 OMB 
        required EPA to terminate five assessments that for the first 
        time addressed acute, rather than chronic, exposure--even 
        though EPA had initiated this type of assessment to help it 
        implement the Clean Air Act.

          The changes to the IRIS assessment process that EPA 
        was considering but had not yet issued at the time of our 2008 
        review would have added to the already unacceptable level of 
        delays in completing IRIS assessments and further limited the 
        credibility of the assessments. For example, the changes would 
        have allowed potentially affected federal agencies to have 
        assessments suspended for up to 18 months to conduct additional 
        research. As we reported in 2008, even one delay can have a 
        domino effect, requiring the assessment process to essentially 
        be repeated to incorporate changing science.

           In April 2008, EPA issued a revised IRIS assessment process. 
        As we testified before this subcommittee in May 2008, the new 
        process was largely the same as the draft we had evaluated 
        during our review and did not respond to the recommendations in 
        our March 2008 report. Moreover, some key changes were likely 
        to further exacerbate the credibility and productivity concerns 
        we had identified. For example, EPA's revised process formally 
        defined comments on IRIS assessments from OMB and other federal 
        agencies as ``deliberative'' and excluded them from the public 
        record. As we have stated, it is critical that input from all 
        parties--particularly agencies that may be directly affected by 
        the outcome of IRIS assessments--be publicly available. In 
        addition, the estimated time frames under the revised process, 
        especially for chemicals of key concern, would have likely 
        perpetuated the cycle of delays to which the majority of 
        ongoing assessments have been subject. Instead of streamlining 
        the process, as we had recommended, EPA institutionalized a 
        process that from the outset was estimated to take six to eight 
        years for some chemicals of key concern that are both 
        widespread and likely to cause cancer or other serious health 
        effects. This was particularly problematic because of the 
        substantial rework often required to take into account changing 
        science and methodologies.

EPA's Latest IRIS Process Reforms Appear Largely Responsive to Our 
                    Recommendations, But Their Success Will Depend on 
                    Effective Management

    Overall, EPA's May 2009 IRIS assessment process reforms represent 
significant improvements and, if implemented effectively, would be 
largely responsive to the recommendations made in our March 2008 
report.

          First, the new process and the memorandum announcing 
        it indicate that the IRIS assessment process will be entirely 
        managed by EPA, including the interagency consultations 
        (formerly called OMB/interagency reviews). Under EPA's prior 
        process, these two interagency reviews were required and 
        managed by OMB--and EPA was not allowed to proceed with 
        assessments at various stages until OMB notified EPA that it 
        had sufficiently responded to comments from OMB and other 
        agencies. The independence restored to EPA under the new 
        process is critical in ensuring that EPA has the ability to 
        develop transparent, credible IRIS chemical assessments that 
        the agency and other IRIS users, such as State and local 
        environmental agencies, need to develop adequate protections 
        for human health and the environment.

          Second, the new process addresses a key transparency 
        concern highlighted in our 2008 report and testimonies. As we 
        recommended, it expressly requires that all written comments on 
        draft IRIS assessments provided during the interagency 
        consultation process by other federal agencies and White House 
        offices be part of the public record.

          Third, the new process streamlines the previous one 
        by consolidating and eliminating some steps. Importantly, EPA 
        eliminated the step under which other federal agencies could 
        have IRIS assessments suspended in order to conduct additional 
        research, thus returning to EPA's practice in the 1990s of 
        developing assessments on the basis of the best available 
        science. As we highlighted in our report, as a general rule, 
        requiring that IRIS assessments be based on the best science 
        available at the time of the assessment is a standard that best 
        supports the goal of completing assessments within reasonable 
        time periods and minimizing the need to conduct significant 
        levels of rework.\4\
---------------------------------------------------------------------------
    \4\ As also stated in our report, we understand that under 
exceptional circumstances, it may be appropriate to wait for the 
results of an important ongoing study, such as a major epidemiological 
study that will provide new, critical data for an assessment.

          Fourth, as outlined in the EPA Administrator's 
        memorandum announcing the new IRIS process, the President's 
        budget request for fiscal year 2010 includes an additional $5 
        million and 10 full-time-equivalent staff positions for the 
        IRIS program, which is responsive to our recommendation to 
        assess the level of resources that should be dedicated to the 
        IRIS program in order to meet user needs and maintain a viable 
---------------------------------------------------------------------------
        IRIS database.

    We are encouraged by the efforts EPA has made to adopt most of our 
recommendations, including those addressing EPA's ability to manage its 
IRIS assessment process, transparency practices, and streamlining the 
lengthy IRIS assessment process. The changes outlined above reflect a 
significant redirection of the IRIS process that, if implemented 
effectively, can help EPA restore the credibility and increase the 
productivity of this important program. While these broad reforms 
provide a sound general framework for conducting IRIS assessments, the 
manner in which EPA implements the new process will determine whether 
the agency will be able to overcome its long-standing productivity 
problems and complete credible and transparent assessments. 
Specifically, management attention is warranted on certain aspects of 
the new process that are incomplete or lack clarity.

          EPA's estimated time frames of about two years for 
        standard IRIS assessments--those that are not particularly 
        complex or controversial--do not include the time required to 
        complete two steps that are nonetheless included in the 
        assessment process. As a result, EPA has likely understated the 
        time required to complete an assessment. The steps lacking 
        timeframes--the scientific literature review and the request to 
        the public and other agencies to submit relevant research (the 
        data call-in)--are integral to developing an assessment. In 
        prior IRIS assessment processes, EPA provided timeframes for 
        these steps. Importantly, including the time frames for these 
        steps would likely bring the estimated overall time for 
        completing standard assessments closer to three years. We note 
        that this more realistic timeframe may be problematic because 
        when assessments take longer than two years, they can become 
        subject to substantial delays stemming from the need to redo 
        key analyses to take into account changing science and 
        assessment methodologies.

          While EPA states that some IRIS assessments may take 
        longer because of their complexity, large scientific literature 
        base, or high profile, the agency does not provide any guidance 
        on likely or expected time frames for assessments of these 
        chemicals. This is noteworthy because we found that EPA has not 
        been able to complete assessments of the most important 
        chemicals of concern, such as those likely to cause cancer or 
        other significant health effects. For example, EPA's assessment 
        of dioxin has been ongoing for 18 years. It is critical that 
        EPA establish timeframes to enable the agency to manage complex 
        assessments.

          EPA's new process does not include a discussion of 
        key planning steps. Specifically, it omits important pre-
        assessment steps included in prior processes--such as a call 
        for nominations of chemicals to be assessed and the 
        establishment of the IRIS agenda, which is list of chemicals 
        that EPA plans to assess. Accordingly, it is not clear whether 
        or when EPA will implement our recommendation that it provide 
        at least two years' notice of planned assessments. Among other 
        things, doing so would give agencies and the public more 
        advance notice of planned assessments and enable external 
        parties with an interest in a given chemical to, for example, 
        complete relevant research before the start of an IRIS 
        assessment.

          Particularly in light of the fact that EPA's 
        estimates for completing assessments are likely understated, we 
        believe that the agency should continue to look for additional 
        opportunities to streamline its process. For example, it is not 
        clear why EPA could not solicit comments from other federal 
        agencies at the same time it sends the initial draft assessment 
        to independent peer reviewers and publishes it in the Federal 
        Register for public comment. In addition to reducing overall 
        assessment time frames, this change could enhance transparency. 
        Specifically, by obtaining the first draft of the assessment at 
        the same time as the other federal agencies, the public and 
        peer reviewers could have greater assurance that the draft had 
        not been inappropriately biased by policy considerations of 
        these agencies, including ones that may be affected by the 
        assessment's outcome, such as the Departments of Defense and 
        Energy. Some of these agencies and their contractors could, for 
        example, face increased cleanup costs and other legal 
        liabilities if EPA issued an IRIS assessment for a chemical 
        that resulted in a decision to regulate the chemical to protect 
        the public.

          The new assessment process states that ``White House 
        offices'' will be involved in the interagency consultation 
        process but does not indicate which offices. Given that (1) EPA 
        will be performing the coordinating role that OMB exercised 
        under the prior process and (2) the purpose of these 
        consultations is to obtain scientific feedback, it is unclear 
        whether OMB will continue to be involved in the interagency 
        consultation process.

          EPA has specified in its new assessment process that 
        written comments provided by other federal agencies will become 
        part of the public record. However, it is silent as to the 
        purpose of the consultation meetings and, if applicable, 
        whether EPA plans to document for the public record any 
        significant oral agreements or decisions made at the 
        consultation meetings. In order to ensure transparency and 
        alleviate any concerns of potential bias in the assessments, it 
        will be important for EPA to be clear on these matters.

    In addition to addressing these issues, the viability of the IRIS 
program will depend on effective and sustained management and 
oversight. Collectively, a number of factors that can impede the 
progress of IRIS assessments present significant management challenges. 
These include the following:

          Unlike a number of other EPA programs with statutory 
        deadlines for completing various activities, no enforceable 
        deadlines apply to the IRIS program. We have stated in previous 
        testimonies on the IRIS program that if EPA is not able to 
        effectively maintain this critical program, other approaches, 
        including statutory requirements, may need to be explored. We 
        believe the absence of statutory deadlines may contribute to 
        EPA's failure to complete timely IRIS assessments. For example, 
        assessment schedules can easily be extended--and consistently 
        are. These chronic delays in completing IRIS assessments have 
        detrimental consequences for EPA's ability to develop timely 
        and scientifically sound decisions, policies, and regulations.

          Science and methodologies are constantly changing. 
        Thus, there will always be a tension between assessing the best 
        available science and waiting for more information. IRIS will 
        remain viable only if it returns to its model of using the best 
        science available at the time of its assessments and plans for 
        periodic updates of assessments to identify the need for 
        revisions.

          An overarching factor that affects EPA's ability to 
        complete IRIS assessments in a timely manner is the compounding 
        effect of delays--even one delay can have a domino effect, 
        requiring the process to essentially be repeated to incorporate 
        changing science. For example, delays often require repeating 
        reviews of the scientific literature on a chemical to take into 
        account the time that has passed since the literature review 
        was completed; this, in turn, may require detailed analyses of 
        any new studies found to be relevant.

          Long-standing difficulties in completing assessments 
        of chemicals of key concern--those that are both widespread and 
        likely to cause significant health issues--stem in part from 
        challenges by external parties, including those that may be 
        impacted by EPA regulation of chemicals should an assessment 
        lead to such action. Such challenges are to be expected and can 
        be best addressed by EPA's focusing on the best available 
        science, credible expert review, and completing the 
        assessments.

          The IRIS assessment process has been frequently 
        changed in recent years; IRIS process reforms, such as those 
        recently issued, are not established in a regulation or statute 
        and thus can easily be altered. As we have reported, EPA's 
        continual changes present a challenge to the chemical managers 
        who are undertaking the assessments, particularly in the 
        absence of current operating procedures to guide chemical 
        managers on basic procedures and program management 
        responsibilities for the development, review, and finalization 
        of IRIS assessments.

    In conclusion, EPA's most recent changes to the IRIS assessment 
process appear to represent a significant improvement over the process 
put in place in 2008. That is, if implemented effectively, the changes 
may appropriately restore to EPA its control of the IRIS process, 
increase the transparency of the process, and streamline aspects of the 
process, among other things. We believe that the agency's ability to 
produce timely, credible, and transparent assessments will also depend 
in large measure on clear implementation procedures and rigorous 
management oversight, given the numerous factors that can impede EPA's 
ability to complete timely IRIS assessments and the lack of clarity on 
some aspects of the new process. Perhaps most importantly, EPA needs to 
hold itself more accountable to the public and Congress for carrying 
out this important component of its mission, especially since the IRIS 
program is discretionary.
    Mr. Chairman, this concludes my prepared statement. I would be 
happy to respond to any questions that you or other Members of the 
Subcommittee may have at this time.

GAO Staff Acknowledgments

    Contributors to this testimony include Christine Fishkin (Assistant 
Director), Laura Gatz, Richard P. Johnson, Summer Lingard, Nancy 
Crothers, Antoinette Capaccio, and Carol Kolarik.

Related GAO Products

Scientific Integrity: EPA's Efforts to Enhance the Credibility and 
        Transparency of Its Scientific Processes. GAO-09-773T. 
        Washington, D.C.: June 9, 2009.

High-Risk Series, An Update. GAO-09-271. Washington, D.C.: January 
        2009.

EPA Science: New Assessment Process Further Limits the Credibility and 
        Timeliness of EPA's Assessments of Toxic Chemicals. GAO-08-
        1168T. Washington, D.C.: September 18, 2008.

Chemical Assessments: EPA's New Assessment Process Will Further Limit 
        the Productivity and Credibility of Its Integrated Risk 
        Information System. GAO-08-810T. Washington, D.C.: May 21, 
        2008.

Toxic Chemicals: EPA's New Assessment Process Will Increase Challenges 
        EPA Faces in Evaluating and Regulating Chemicals. GAO-08-743T. 
        Washington, D.C.: April 29, 2008.

Chemical Assessments: Low Productivity and New Interagency Review 
        Process Limit the Usefulness and Credibility of EPA's 
        Integrated Risk Information System. GAO-08-440. Washington, 
        D.C.: March 7, 2008.

                    Biography for John B. Stephenson

    Mr. Stephenson is currently the Director of Natural Resource and 
Environment issues for the U.S. Government Accountability Office--the 
independent investigative arm of the Congress. In that capacity, he has 
for the past nine years directed numerous studies and research 
projects, issued hundreds of reports, and testified on many occasions 
before several Senate and House Committees. His work has provided 
invaluable assistance to the Congress in its oversight and legislative 
role on diverse environmental protection issues such as clean air, 
clean water, safe drinking water, chemical controls, toxic substances, 
climate change, superfund, and hazardous materials spill prevention and 
cleanup, as well as critical infrastructure protection.
    Prior to his current position, he led numerous GAO studies and 
investigation in the information technology and federal acquisition and 
federal grant areas. He has extensive experience in dealing with 
Congressional Committees and Members, federal agencies, trade 
associations, special interest groups, and State and local governments. 
From April 1998-February 2000, he was Deputy Staff Director for the 
Senate Special Committee on the Year 2000 Technology Problem for the 
Chairman (Senator Robert Bennett, R-UT), and Vice Chairman (Senator 
Christopher Dodd, D-CT). In that capacity, he ran the day-to-day 
operations of the Committee including orchestrating over 35 hearings, 
preparing legislation, organizing briefings and Floor activities for 
the Full Senate, working with the White House's Year 2000 Director and 
staff, and organizing numerous press and public events. He returned to 
GAO in March 2000 where he was Executive Assistant to the U.S. 
Comptroller General (the head of GAO) until entering the Senior 
Executive Service in October 2000.
    Mr. Stephenson holds a BS degree in Industrial Management from 
Purdue University, an MBA from Xavier University, and is a graduate of 
the Harvard Kennedy School of Government's Senior Executive Fellows 
program. He lives in Fairfax Station, Virginia with his wife, 11-year-
old daughter, and 9-year-old son. He also has two grown sons who reside 
in Cincinnati, Ohio.

                               Discussion

    Chair Miller. Thank you, Mr. Stephenson.
    We will now begin our first round of questions, and I now 
recognize myself for five minutes.

                     Ensuring EPA's Program Control

    Mr. Stephenson, I want to talk about control of IRIS by 
EPA. IRIS, as Dr. Broun pointed out in his opening statement, 
has always provided for control, at least according to the 
statute, stated control by EPA. But in the last eight years 
certainly EPA's control was very much eroded by pressures from 
other agencies, that although the IRIS listing has no 
regulatory affect, it is a precursor to regulation. And there 
were agencies that liked using chemicals without restrictions 
and didn't want to have to mess with the risk management 
issues. So it was easy to stymie a risk assessment through IRIS 
and not have to worry about it.
    And there were officials at OMB who seemed to be more than 
happy to help them in that effort at OIRA. Whether it was the 
other agencies or the manufacturers of the chemicals or simply 
an anti-regulatory zeal, OIRA was more than happy to block it.
    Mr. Stephenson, in light of all that history, how can we be 
sure? Should we continue to worry that EPA will not, in effect, 
be in control, even though it may, according to the stated 
procedures, be in control?
    Mr. Stephenson. A multi-faceted question. OMB does serve a 
purpose in facilitating interagency comments. There is no 
question. The problem with the old process was that all of 
those comments were declared delivered evidence, so there was 
no honest broker, if you will, as to what comments were being 
provided and when. So we think the fact that this process 
allows for complete transparency and all of those comments, 
which are supposed to be comments on the scientific integrity 
of the assessment, be made public. So that is huge.
    Having said that, you know, EPA like every other agency 
works for the White House, and OMB is an office of the White 
House, and so the proof is going to be in the pudding as to how 
much influence OMB may or may not have in this current process. 
And now with you asking us to do so, we are going to be 
watching that closely.
    Chair Miller. Are there things for us to watch for? Are 
there going to be early indicators that will tell us that EPA 
is truly in charge or only nominally in charge, and it is still 
being run out of OIRA or by the White House?
    Mr. Stephenson. Well, the only thing you can really do is 
track individual assessments through the process, and see what 
kind of comments are made and by whom and what the reaction is 
to those comments. Interestingly, in the old OMB, while it is 
true they said that EPA was in charge, if you talked to OIRA, 
if you talked to the other part of OMB, they would--who did the 
part reviews if you are familiar with those, they clearly said 
that OMB was in charge. So even within OMB it was unclear who 
was in charge of that IRIS process.

                     The Effect of an IRIS Listing

    Chair Miller. Mr. Stephenson, the opening statements kind 
of raised the question of whether there should be more process, 
more procedures, more of a chance to challenge EPA, that EPA 
should not be the final decider, should not make the final 
decision on IRIS listings. But do IRIS listings have any 
regulatory effect? Is there anything that anybody cannot do or 
has to do because of the way a chemical is listed in IRIS?
    Mr. Stephenson. No. You correctly mentioned that it is a 
precursor to deciding how to control dangerous chemicals, if 
you need to at all, and so we view it as a purely scientific 
process that shouldn't be meddled--you shouldn't be mixed with 
science policy, which also has a legitimate role.
    Chair Miller. Well, if there is a regulatory effort after 
the--after an IRIS listing to manage the--a risk that IRIS, an 
IRIS listing identifies, does--how is the science treated 
there? Are all the same issues revisited in the regulatory 
process?
    Mr. Stephenson. Well, sure. I mean, you have an opportunity 
to question the relevance of the science for a given 
regulation, but each one is a case-by-case issue. The beauty of 
IRIS is that it is the official agency position on a given 
chemical, and therefore, the starting point to decide where you 
want to go from there. It doesn't mean anything about 
regulation purely.
    Chair Miller. But if the formaldehyde industry, for 
instance, wanted to argue that formaldehyde is actually good 
for you, they could do that in the regulatory process for risk 
management regulations. Is that correct?
    Mr. Stephenson. Well, I would think they would do it in 
both places; in the IRIS process as well as the regulatory 
process.
    Chair Miller. My time has expired.
    I now recognize Dr. Broun for five minutes.
    Mr. Broun. Thank you, Mr. Chair.

                     How IRIS Assessments Are Used

    Just to go along with what Chair Miller was just talking 
about, Mr. Stephenson, it is my understanding that a lot of 
private sector stakeholders are basically using IRIS 
assessments as a de facto regulatory statement. Is this true?
    Mr. Stephenson. I have no way of knowing that.
    Mr. Broun. Okay. What part in IRIS's process should outside 
stakeholders play?
    Mr. Stephenson. If they have--remember, IRIS is supposed to 
be a collection and a synthesis of existing research that is 
available at the time the assessment is--begins, essentially, 
and so there are good researchers and scientists throughout 
industry, throughout the other federal agencies, throughout 
academia. All of those people are allowed to contribute to an 
individual assessment once they see the draft assessment and it 
goes out for public comment. And all of those comments can be 
seen by the public and vetted by other scientists, and everyone 
in this process seemingly can see how EPA dispenses with each 
of those comments.

                          Transparency Process

    Mr. Broun. Chair Miller referred to me as Dr. Broun. I am a 
physician. There are some on this whole committee that would 
argue that I am not a scientist, but I am. There are some 
research scientists that would argue that, but I am an applied 
scientist, and I believe in the scientific process and believe 
in peer review and lots of it. The more peer review that enters 
into the process, the greater I think we have in scientific 
integrity.
    When I graduated from medical school, the things I was 
being taught at that time, to be absolutely factual, have 
subsequently been shown to not be factual, and I think we have 
a lot of things going on in public policy today such as climate 
change caused by human effects on the climate are part of that, 
but it is kind of--I don't want to go off on that tangent, but 
to get back to IRIS, so is--I am just real concerned that there 
is not enough transparency, Mr. Stephenson.
    You talked about the transparency, but is all the 
discussion within the agency or within anybody who has comments 
on the assessments being done, is all of that available for 
public peer review?
    Mr. Stephenson. It is supposed to be.
    Mr. Broun. Everything?
    Mr. Stephenson. We hope so. Like you say, it is a 
scientific process, and we would hope all of that is very 
public and vetted in the public.
    Mr. Broun. How about the oral arguments, interagency oral 
arguments, any consultation meetings, things like that? Will 
all of those things be available for public peer review?
    Mr. Stephenson. We don't know, but that is why we say more 
clarification is needed in those consultation steps within the 
process, and if there are any decisions made, our 
recommendation would be that they be made public. But EPA may 
have a better clarification on that.
    Mr. Broun. Doctor?
    Dr. Teichman. It is certainly our intention to make sure 
that all the written comments are put in the public docket, but 
we also know that there is sometimes discussions that go on 
orally. We would hope in those discussions, and what we have 
tried to do since we will be controlling the process, is to 
encourage people to provide the important points even in those 
oral discussions in writing so they are made open and 
transparent to the public. And that is just within the 
interagency discussion steps at 3, Step 3 and Step 6A in your 
chart number three, Mr. Chair, if I remember correctly.
    I think it is also important to note that when there are 
disagreements potentially between agencies, which can occur, 
that that is when it is a good time, in fact, to turn to peer 
review, Mr. Broun, just as you have identified. And so it is 
the consultations both inside of the Agency where we may have 
some scientific disagreements on a draft assessment, as well as 
when we had the interagency discussions, that those become, in 
fact, very good charge questions to the peer review panel for 
them to opine on to inform us in the federal system.
    Mr. Broun. Well, I hope that you can assure this committee 
that all opinions, particularly dissentive views, within any 
oral discussion, consultation is available for public preview, 
because I think it is absolutely critical for scientific 
integrity, first thing. Secondly is to guarantee that there is 
a correct peer review process and that there is not a quashing 
of opposing views by any entity, whether it is an agency or an 
individual scientist, what have you. I think it is absolutely 
critical for the health of this country and its science that 
those things--so please assure this committee that that is 
going to be the policy at EPA.
    Dr. Teichman. It is certainly something as I think Mr. 
Stephenson has mentioned that is a bit vague in the process as 
identified and something that requires further discussion and 
clarification to be more precise. So I would prefer to have 
that discussion before I assure this committee at this 
particular time. But it is something we will certainly have 
discussion about.
    If I may for just a brief moment, however, I want to make 
sure we are distinguishing sometimes between those comments 
that are scientific in nature and those that may be policy in 
nature, because it is, indeed, we hope with our IRIS process to 
really focus on the scientific comments, because, indeed, our 
IRIS assessments are not regulatory.
    And if I may draw attention actually to a report by the 
bipartisan policy center that you may be familiar with since it 
is co-chaired by Sherwood Boehlert, a friend, I believe, of 
this committee in the past, okay, and has esteemed Members on 
it such as Lynn Goldman and John Graham from, therefore, across 
the political spectrum.
    Chair Miller. I think the screen is actually obscuring the 
portrait of Mr. Boehlert.
    Dr. Teichman. That I can't see. I apologize. But, anyway, I 
did want to make it clear that, indeed, your--the comments 
about scientific disagreements we certainly want to make sure 
are aired, but we want to distinguish those from policy 
ramifications. These are the recommendations, in fact, from 
Sherwood Boehlert's bipartisan committee:

        L``Distinguishing between science and policy is not 
        always easy or straightforward, and scientists must 
        make choices based on values in the course of their 
        work. Nonetheless, policy debate would be clarified and 
        enhanced if a systematic effort were made to 
        distinguish between questions that can be resolved 
        through scientific judgments and those involved 
        judgments about values and other matters of policy.''

    So what we are trying to do here is to keep the focus on 
the scientific arguments that are the basis for the conclusions 
drawn in our IRIS assessments, and it is later in subsequent 
steps when regulations occur that the policy ramifications can 
be debated as well.
    Mr. Broun. Well, thank you, Doctor. My time is long up, and 
the Chair----
    Dr. Teichman. I apologize.
    Mr. Broun.--has been very long suffering, but I just want 
to make one statement from a--Mr. Chair. Policy makes a 
difference, too, and it needs to be transparent, and we need to 
make absolutely certain that any discussion, policy or 
scientific, I think is available for the public.
    Thank you, Mr. Chair.
    Chair Miller. Thank you, Mr.--Dr. Broun.
    I now recognize Ms. Dahlkemper for five minutes.
    Ms. Dahlkemper. Thank you, Mr. Chair, and I want to thank 
you and the Ranking Member for bringing forward this important 
hearing and thank the witnesses for joining us today.

                   Program Schedule and Productivity

    I want to talk a little bit about the productivity side of 
things, and as we are looking at your new process here, you 
have certain durations, Dr. Teichman, on there, and I want to 
ask you about how EPA will guarantee that these dates are met. 
Obviously, it is a good, aggressive schedule, I believe, but 
how are you going to make sure that these dates are met with 
the different processes?
    Dr. Teichman. We are going to do our absolute best. In 
terms of a guarantee, I cannot promise that every assessment 
will last only 23 months. There will, indeed, be situations, 
and we hope they are few and far between, and indeed, this is 
stated in the Administrator's testimony as well that she gave 
two days ago on the other side of the Hill, if you will, that 
most assessments we expect to try and stick to the 23 months.
    I have worked for the Administrator now for five months. I 
can tell you she is a very intelligent, very aggressive 
individual who keeps us on our toes and does everything she can 
to support our efforts.
    In that regard you also should hopefully take some solace 
in the fact that the policy was discussed. I was certainly not 
in the room, as it was, but among the Administrator and her 
staff and officials within OMB, and I don't know, other 
agencies, perhaps, too, and it was agreement across the board 
on this particular process. So I believe there will be other 
agencies who will be held to task as we try and hold to the 
schedule to commitments that they made to the Administrator in 
those initial negotiations.
    Ms. Dahlkemper. Mr. Stephenson, do you have any comments on 
this in terms of how you think this could be achieved?
    Mr. Stephenson. We have already mentioned that some of the 
early steps are missing, so you are already behind the eight 
ball on the 23 months. Most importantly it is mentioned on the 
chart here that you are going to do a comprehensive literature 
search and data call, which will be in the notice, so there is 
a process that has to be followed to do that, which will take 
some time.
    In addition, our recommendation from 2008, about the 
importance of a two-year planning window is critical here so 
that the whole research community, well in advance, will know 
which chemicals are going to be assessed two years down the 
road and can put together any research they deem appropriate 
before the process actually starts. That will completely avoid, 
you know, the development of research as the particular 
chemical is being assessed and make the whole process more 
efficient.
    We think this is really ambitious, but we are going to be 
watching.

                         Potential Improvements

    Ms. Dahlkemper. Also, as you were speaking, Mr. Stephenson, 
you were mentioning different--about five or six different 
improvements that you would like to see, and I guess I want to 
ask you, Dr. Teichman, about that, you know, about his, Mr. 
Stephenson's testimony on that.
    Mr. Stephenson. Well, some of them were just clarifications 
but yes.
    Dr. Teichman. Well, some were clarifications and some I 
have written down. I am not sure I have got them all correctly 
written, but I will state that as, hopefully, and I think I 
can--if I parrot back correctly, the statement of my co-witness 
here, that if managed effectively, the new EPA process for IRIS 
would be considered very responsive to the GAO recommendations 
of the past.
    Therefore, we are trying to demonstrate a commitment to 
seriously consider what GAO tells, and we will consider the 
recommendations that the co-witness has asked. We would like to 
have a chance to try the process as it has been agreed to, and 
I think Mr. Stephenson has said it is worth a try, but we need 
to take a look and see how we progress. I know the Chair has 
asked GAO in a year to report back, and I think we are anxious 
to follow that particular path. But we will still, nonetheless, 
consider certainly for clarification, the recommendations from 
GAO and even some of the potential changes if, indeed, they 
enhance the process in our estimation as well.
    Ms. Dahlkemper. I thank you, and I yield back.
    Chair Miller. Thank you, and I now recognize myself for a 
second round of questions.
    My--we will be called for votes in maybe 20 minutes, half 
an hour, and my intention will be just to have questions 
probably until that time and then that will be the end of our 
hearing when we get called for votes.

                          Deliberative Process

    Dr. Teichman, there were questions about written, 
everything written is going to be available. There is no 
assertion that it is deliberative. We all get to see it. 
Congress sees it, the American people sees it. It is public.
    Dr. Broun asked questions about oral discussions, telephone 
conversations, conversations at a water cooler, whatever, 
meetings. And to the extent that they produce in writing, that 
will then--the writing will be available. There is--it is 
probably not reasonable to expect that everything will be 
transcribed, but in the past when we have asked, specifically 
Ms. Dudley, about who was involved in what conversations and 
what conversations there were and what was said, she asserted a 
deliberative process privilege, which I read the cases that 
discuss deliberative process privilege, it is a very light 
privilege. It is basically--it protects anything--discussions--
if the only reason that Congress or a court is asking for it is 
out of idle curiosity, but if there is any real need for it at 
all, that it should be available.
    It--my understanding is the Administration does not--EPA 
now does not assert a deliberative process privilege for any 
oral conversations. So if Congress calls upon people involved 
in the decision to tell us who was in the discussion, what they 
had to say, that that would be--those would be questions that 
you would answer as well as you could remember them. Is that 
correct?
    Dr. Teichman. I am not a lawyer, but that is certainly my 
interpretation as well.

                         The GAO High-Risk List

    Chair Miller. Okay. All right. I think Ms. Dahlkemper asked 
around the high-risk list or came close to it. Mr. Stephenson, 
I assume that being on the GAO's high-risk list is something 
that a Federal Government agency would regard about the same 
way a bank would regard being on the FDIC's watch list. It is 
not a favorite place to be.
    How long do you expect it would take IRIS to kind of earn 
their way off that list?
    Mr. Stephenson. The high-risk designation is not only 
designated to IRIS, it has to do with TOSCA reform as well.
    Chair Miller. Uh-huh.
    Mr. Stephenson. So we need to wait and see proof that the 
problems that we have observed have been addressed, and there 
is no, you know, it is not--it is fairly subjective. It is up 
to GAO when we decide to add or remove things from that risk. 
It doesn't carry any designation other than the fact that we 
hope that the Agency and the Administration will devote greater 
attention to it, and the Congress for that matter. That is why 
we do it.
    So to get on that list we are very, very, very concerned. 
We are a conservative agency, and it doesn't get put on that 
list lightly. There were only three new additions to the list 
this year, and this was one of them.
    Chair Miller. Dr. Teichman, I assume it is a high priority 
to get off that list?
    Dr. Teichman. Most certainly, sir.

                       Royal Demolition Explosive

    Chair Miller. Okay. Thank you. Mr. Stephenson, you examined 
in the GAO report last year the IRIS process specifically for a 
chemical called Royal Demolition Explosive or RDX. What is the 
status of that?
    Mr. Stephenson. We haven't done any specific work on that. 
It was one of the chemicals we highlighted to illustrate how 
broken the process was and how long it was taking. I believe it 
had been in assessment over a decade. In updating for this 
hearing we noticed that it had been removed from EPA's list of 
chemicals undergoing assessment, and we haven't been able to 
follow up onto exactly why that happened. It was on there a 
month ago and removed as of a day ago.
    Chair Miller. Dr. Teichman, do you know why RDX has gone 
missing?
    Dr. Teichman. I can tell you what response I got when I 
posed that same question to the staff. Nonetheless, I would 
prefer to give a full response to a question for the record on 
where the chemical managers involved would be able to comment 
on the decision process that is involved with that particular 
chemical. But it was, indeed, listed for possible assessment 
under the IRIS Program, but we have identified 48 assessments 
that we think are priority chemicals, and in the second batch 
an additional 48. RDX is in the second batch, so I would 
prefer, again, for a question for the record to give the 
decision process as to why it is in the second batch.
    Chair Miller. If you would submit it on the record.
    Mr. Whittaker, in a show of bipartisanship would you like 
to--would you raise the screen so we can all see the portrait 
of Mr. Boehlert?
    I now yield back the remaining 10 seconds of my time and 
recognize Dr. Broun for another round of questions.

                         Assessment Timeliness

    Mr. Broun. Thank you, Mr. Chair. I understand there is a 
natural tension between fairness and timeliness with 
assessments. The question is, will this streamlined process 
ultimately sacrifice scientific credibility, especially 
considering the recent negative reviews of the assessments by 
the National Academy of Science? And the question I have really 
for both of you is, if EPA can't get the assessment right in 10 
years, what makes you think, each one of you, that you can 
produce better results in 23 months?
    Mr. Stephenson. I mean, we are going to--we think 23 months 
is optimistic. We are going to be looking, but the problem is 
it is like a domino effect. If the assessment takes too long, 
there is new research that becomes available. You have to 
reconsider, and it goes back to square one again. That is what 
I meant about the endless assessment and reassessment. This is 
supposed to be a process that synthesizes existing research 
that is available at the time and should be able to be done 
fairly quickly and vetted. These assessments are supposed to be 
updated routinely, you know, every 10 years. So with 540 
chemicals on the list, if you are not doing at least 54 a year, 
you are not even keeping up.
    So we think this is very ambitious. We are not sure there 
is enough resources devoted to this yet, but that is a very 
good question.
    Dr. Teichman. It is a very ambitious goal.
    Mr. Stephenson. It is an ambitious goal. I don't disagree, 
and we have certainly asked for additional resources to help us 
meet that goal in the President's budget request. There are a 
couple of things I think, though, that are different than 
perhaps the past as we look at the new process.
    The first is this new process as I mentioned earlier was 
developed in consultation with other federal agencies, and 
therefore, I believe there is a mutual commitment to try and 
meet the schedule that has been identified. This does not mean 
that it isn't aggressive and that we shouldn't take a look and 
see in a year's time if we have been able to stick to it. We 
welcome that type of a review and hope to be able to 
successfully demonstrate we were able to meet that goal of 23 
months.
    Second is the listening sessions that I referred to earlier 
are still maintained in this process. This is a chance where 
the external peer review meeting that--where there used to be 
an opportunity for somebody to speak for two or three minutes 
or perhaps as many as five or seven minutes, no longer than I 
was able to testify today, I would add, most likely, that that 
was perhaps insufficient time for real discussion and exchange. 
The listening sessions actually now are for much longer periods 
of time, more interchanged with those who have any opinions 
they wish about our draft assessments, and that listening 
session is, indeed, also shared with the external peer review 
panel and their assessment.
    So I believe that is a very positive step that will 
hopefully enable us to air for greater, longer periods of time 
potential disagreements in the scientific facts and let the 
external peer review panel tell us their position on those 
arguments.
    Mr. Broun. Has the timeframe for peer review changed at 
all?
    Dr. Teichman. I believe the time period is 60 days at this 
point. I think it might have been a little longer. I have to 
check. I apologize.
    Mr. Stephenson. I got it at 105 days.
    Mr. Broun. Mr. Chair, I am not real interested in a lot of 
conversations that go around the water fountain, but those 
conversations that do have to do with scientific integrity as 
well as the scientific process I think are very important, and 
I hope that we can, as a committee be reassured that those 
conversations will be reported and will be open and for public 
view. And it is just something that I think is absolutely 
critical for scientific integrity, and I just want--I just 
throw that out as a comment to both of you all.
    And with that I will yield back to the Chair for the next 
round, if we have one.
    Chair Miller. Thank you. Just one more brief round.
    I do want to point out that when we raised the screen to 
reveal the portrait of Mr. Boehlert, we also revealed the 
portrait of a substantially slimmer Chair Sensenbrenner, which 
is perhaps more bipartisan than I really intended to be.

                              Peer Reviews

    Dr. Teichman, Step 4 of the new process is an independent 
expert peer review, which Dr. Broun has been asking about 
already, and our staff understands that that will usually be 
done on a face-to-face basis, meetings, and perhaps that could 
be transcribed or--but in some cases it will also be done by 
the National Academy of Sciences. We understand that peer 
review can be done by mail, it can be done through the 
Internet, it can be done face to face, it can be done through 
an Academy of Sciences study.
    Can you give us a sense of what each of those different 
methods for peer review will cost and how you will decide which 
method?
    Dr. Teichman. First of all, let me since I was under oath 
correct the statement I said before about 60 days indeed as my 
co-witness has said it. Now that I have it in front of me, it 
is 105. I was confusing with a different step.
    In terms of the cost for each of the individual types of 
peer reviews, I would like to provide that as information for 
the record. However, it is important to state that we very 
carefully consider the complexity of a given assessment as to 
which form of peer review that we would use. To use a letter if 
you want an IRIS assessment would be very rare. At the other 
end of the spectrum to go the National Academy of Sciences, 
which we have done, one of the most controversial chemicals, is 
hopefully equally rare. More times than not we will convene a 
peer review panel, which would have a face-to-face meeting that 
might be the contractor choosing the panelists, or it might be 
our own science advisory board.
    And the cost for those four different options we will be 
glad to provide, but certainly they vary as from the letter 
review to the NAS, based on the complexity of the assessment.
    Chair Miller. Can you, Dr. Teichman, can you tell us who 
some of the contractors are who have been contracted with--that 
EPA contracted with to conduct the peer review?
    Dr. Teichman. I am only familiar with one and any mention 
is not considered an endorsement, but nonetheless, I think the 
Eastern Research Group has been one of the organizations that 
our National Center for Environmental Assessment has used to 
locate peer reviewers and pull together such panels.
    Chair Miller. What procedures do you have in place to make 
sure that there are no conflicts of interest with forums 
conducting the peer review process?
    Dr. Teichman. The firms themselves, again, I would prefer 
to have a better chance to put this in the record than I will 
be able to convey right now, but if you are talking about the 
choice of the firms, those are competed, and I don't know what 
confidentiality or impartiality statements they may have to be 
to be a successful bidder on the contract.
    However, the people who they hire as subcontractors, as 
panelists there, there are, indeed, statements that have to be 
provided where people state what their potential associations 
are, and they demonstrate that they are impartial.
    Chair Miller. Mr. Stephenson, are you familiar with any 
work that the GAO has done on outside contractors for peer 
reviews?
    Mr. Stephenson. Not specifically contractors but there are 
two different brands of scientific advisory committees the EPA 
uses. There is 24 of them in total, and we noted in the 
testimony in the Senate that seven of those have specific 
conflict of interest procedures for their membership, but the 
others do not. And they are--that may not be inappropriate 
because you are trying to seek points of view on a given 
chemical or giving a scientific assessment or a given 
regulation. So we just observe that EPA should not confuse the 
purpose of both of those two different kinds of scientific 
advisory committees.
    Chair Miller. Dr. Teichman, it seems that some of the most 
widely-used chemicals with perhaps the most troubling health 
consequences are the ones that are tied up for the longest time 
in--or have been in the past in IRIS: formaldehyde, TCE, Perk, 
Dioxin. How are you going to set priorities for completing 
assessments?
    Dr. Teichman. Well, indeed, we wish to tackle those 
chemicals that we think pose the greatest risk to the American 
public, and those become our priorities. It is not an issue of 
any particular stakeholder group interest one way or the other, 
anybody influencing our decision other than we believe it poses 
a high risk, and those become the chemicals that we go after.
    And we believe we do it in a rigorous fashion that 
everybody has an opportunity to comment and to tell us if we 
have gotten it right in our draft and hopefully we have done it 
correctly by the time we have the final assessment.
    Chair Miller. Okay. Are you going to include others, both 
interagency suggestions or outside----
    Dr. Teichman. We take suggestions from everybody as we 
publish our list of potential chemicals we could be working on 
and others that people wish to recommend, and that includes 
other federal agencies, it includes State and health 
organizations. It is a FR--a Federal Register notice asking for 
people's thoughts on what our agenda should be.
    Chair Miller. I yield back the remaining three seconds of 
my time.
    Dr. Broun, do you have any more questions?

                     Fairness and Time Constraints

    Mr. Broun. Going back to peer review process, Doctor, I am 
looking at the document actually here, and you were correct the 
first time, that you are supposed to announce a public comment 
period of 60 days for peer review, and again, as a physician I 
am concerned that 60 days, 105 days may or may not be enough, 
and 23 months may not be enough time to adequately evaluate 
each of these chemicals.
    How can you guarantee--but in the review process how can 
you guarantee fairness in that IRIS process if you give the 
public only 60 days to review?
    Dr. Teichman. We believe 60 days will be adequate to give 
the public fair opportunity to comment. We believe the 
combination of the listening sessions gives them even a chance 
to interact with us on the draft assessment prior to the 
external peer review panel coming together. If indeed somebody 
in a rare instance asks for an extension and indeed the 
material in front of you discusses that potentiality, we do, 
indeed, offer such an extension, but we can't promise, in fact, 
that their comments will be before the peer review committee. 
And we believe it is best for as many public comments to be 
shared with the peer review committee as they make their 
deliberations.
    Mr. Broun. Was the 60-day number just picked somewhat 
arbitrarily? Did you all just think that that is a good period 
of time, or was there a particular thought in giving enough 
time but not too much?
    Dr. Teichman. I think that is a fair way of putting it. It 
was not arbitrary in terms of we plucked it randomly, we 
plucked it out of midair. We think this is an appropriate 
amount of time. If it turns out as we have explored this that 
people feel they must have 90 days, for example, it is 
something to consider down the road.

                    More on the Transparency Process

    Mr. Broun. All right. Thank you, sir. Back to the 
transparency, will you commit to truly making the IRIS process 
transparent by creating a public docket for all materials 
received at EPA related to each IRIS assessment, including 
materials that EPA has received but which it decides will not, 
it will not allow them to make its assessment decisions?
    Dr. Teichman. Yes, indeed. All comments that we receive in 
the written form as we have discussed will be in the public 
docket. We always include all the information that has been 
given to us, whether or not it is what we use in our final 
assessment, so that people see the total record, and they can 
choose from among it as to what they think should be 
influencing our final word.
    Mr. Broun. So that it is a promise to us that that will be 
done, and I hope you can promise us at some point that all 
those oral discussions and those conversations and 
consultations that do occur orally will be provided for the 
public also.
    With that, Mr. Chair, I yield back.
    Dr. Teichman. May I just comment for a moment, Mr. Chair, 
if I can?
    Chair Miller. Dr. Teichman.
    Dr. Teichman. Again, we will be--the oral comments I wish 
to come back to the Agency and have further discussion on. On 
the written, I am not aware that we have never or that we have 
ever not put every written comment that we got from the public 
or as part of the peer review in the docket. What is 
interesting and new in this process is, in fact, now the 
written comments we get from other agencies will also be in the 
public docket.

                                Closing

    Chair Miller. I think we are now done with our questions.
    There is a phrase I have heard all my life, which I suspect 
is a southern phrase. I am sure Dr. Broun has heard it as well 
then. When we want to disassociate ourselves from someone else, 
not take full responsibility for the conduct and other, we say, 
``I didn't take him to raise.''
    But it appears that I have taken IRIS to raise, this 
subcommittee has taken IRIS to raise, GAO has taken IRIS to 
raise. So we will continue to close--to watch IRIS closely. We 
think it is important that IRIS perform its mission and produce 
the right number of very sound, credible, scientifically-sound, 
credible assessments.
    Mr. Broun. Mr. Chair, would you yield?
    Chair Miller. Mr.--Dr. Broun.
    Mr. Broun. Thank you for yielding, sir. I am very happy you 
have taken IRIS to raise and that we are having this hearing 
and that you are continuing this process because I think it is 
absolutely critical for the public to have total confidence in 
what assessments are made by IRIS and by the government across 
the board.
    I think there are many things that are being put out by the 
government that are declared scientific that aren't, and it 
does not--things in the way of determinations that aren't 
accepted by the public, and I think rightfully so. And so I am 
glad you have taken IRIS to raise, sir, and I am eager to 
continue in this process with you, so I thank you very much, 
and I congratulate you on taking IRIS to raise.
    Chair Miller. Thank you, Dr. Broun. We may not think alike, 
but we do talk alike.
    Before we bring the hearing to a close I want to thank our 
witnesses today for testifying before the Committee. We may see 
you again.
    Under the rules of the Committee the record will remain 
open for two weeks for additional statements from the Members 
and for any answers to any follow-up questions the Committee 
may have for the witnesses. Dr. Teichman, you had said you 
wanted to provide additional information.
    And with that the witnesses are excused, and the hearing is 
now adjourned.
    [Whereupon, at 2:15 p.m., the Subcommittee was adjourned.]
                              Appendix 1:

                              ----------                              


                   Answers to Post-Hearing Questions


Responses by Kevin Teichman, Deputy Assistant Administrator for 
        Science, Office of Research and Development (ORD), U.S. 
        Environmental Protection Agency (EPA)

Questions submitted by Chairman Brad Miller

Q1.  During the hearing, we discussed the status of the chemical called 
Royal Demolition Explosive (RDX), in the IRIS process. Please explain 
the decision process and process for removal of RDX from EPA's list of 
chemicals undergoing IRIS assessment.

A1. There are over 80 assessments in progress in the IRIS program, all 
at various stages of development.
    EPA made a decision to focus its resources on those assessments 
that were farthest along in the process and work as quickly as possible 
to finish up that first set and then turn its attention to the second 
set of chemicals/substances. The first set consisted of 48 assessments. 
Each of those 48 was at the internal Agency review step or further in 
the process. As assessments are completed and staff are available to 
work on the next set of assessments, focus will shift to the 
approximately 40 other assessments on the IRIS agenda, which will 
become the priority list for 2010-2011. RDX was one of the assessments 
where development of the IRIS toxicological review report had not 
progressed to the point where a draft assessment was in, or ready, for 
internal Agency review. Thus, RDX will be on the second set of IRIS 
chemical assessments.

Q2.  We also discussed the independent expert peer review step of the 
new IRIS process. Please clarify the timeframes provided for peer 
review and the anticipated costs for each method of peer review. 
Moreover, please explain EPA's plan for mitigating conflicts of 
interest during the peer review process.

A2. Part 1--Types of Reviews:

Timeframes for IRIS Peer Reviews

    The timeframe provided in the new IRIS process provides for a 105-
day peer review process. We are working on processes to be put into 
place for peer reviews conducted through a contractor convened peer 
review panel and the EPA's Science Advisory Board (SAB) peer review 
panel to meet that timeframe. We will also work with the National 
Academy of Sciences (NAS) to determine if they would be able to meet 
the 105-day timeframe. We recognize that, on occasion, there will be 
particularly complex assessments that may take longer than 105 days.

Costs for IRIS Peer Reviews

Letter Review: All independent external peer reviews for IRIS draft 
assessments are conducted at public meetings. Thus, letter reviews are 
not used for external peer review of draft IRIS human health 
assessments.

Contractor-Convened Panel: Extramural cost for these types of peer 
reviews range from $35,000 to $70,000. Cost depends on the complexity 
of the assessment, which determines the number of different types of 
expertise needed, the number reviewers required, the number of days 
scheduled for the public review meeting, and the cost of the meeting 
venue. The staff time required is around 80 hours on average. This 
includes four staff attending the day(s)-long panel meeting and 
preparing materials for presentation at the meeting. The rest of the 
staff time is spent by the work assignment manager, project officer, 
and contracting officer writing and approving Statements of Work, 
working out the details of the date and location of the meeting, making 
sure the panel members have the needed range of expertise, etc.

         Estimates:

         Extramural costs: $35,000 to $70,000

         Intramural costs: $5,000 to $7,000

Science Advisory Board (SAB) (chartered under Federal Advisory 
Committee Act [FACA]): The estimated cost of a standard peer review by 
the Agency's SAB is $200,000 to $250,000. The cost includes: contractor 
support, travel, Special Government Employee (SGE) salary, plus EPA FTE 
cost in the office of the SAB, Designated Federal Official (DFO), 
management, and personnel staff. This does not, however, include EPA 
scientist(s) or management staff time in the office requesting SAB's 
review of the draft assessment. The staff time required is around 80 
hours on average. This includes four staff attending the day(s)-long 
panel meeting and preparing materials for presentation at the meeting.

         Estimates:

         SAB's costs: $200,000 to $250,000

         Requesting office intramural costs: $5,000 to $7,000

National Academy of Sciences/National Research Council (NAS/NRC): 
External peer review by the NAS/NRC is estimated to cost $800,000-
1,000,000. This does not, however, include EPA scientist(s) or 
management staff time in the EPA office requesting NAS's review of the 
draft assessment. The staff time required is difficult to estimate 
because often times the NAS has multiple meetings; however, an estimate 
may be 120 hours on average.

         Estimates:

         Extramural costs: $800,000 to $1,000,000

         Intramural costs: $8,000 to $10,000

A2. Part 2: EPA's Plan for Mitigating Conflict of Interest (applies to 
all types of reviews)
    Since the Agency's Peer Review Policy was first affirmed in 1994, 
EPA has made tremendous strides in building a strong and well 
recognized peer review program. EPA's Science Policy Council has 
updated and improved the EPA Peer Review Handbook including clarifying 
conflict of interest and impartiality issues. This Handbook is used to 
guide and implement peer review across the Agency, including IRIS peer 
reviews. A recent report by the EPA Inspector General provided several 
suggestions for how we can improve our peer review practices. We 
welcome the opportunity for continuous improvement. EPA's Science 
Policy Council is updating the EPA Peer Review Handbook to clarify the 
definition of the ``appearance of a lack of impartiality.'' In 
addition, our Office of Research and Development is updating some of 
its procedures to enhance its use of peer review.

Q3.  Will EPA place all interagency comments in the public record?

A3. On May 21, 2009, EPA Administrator Lisa Jackson announced a new 
process for health assessment development and review for the IRIS 
Program. The new process is summarized as follows:

         Step 1--document development,

         Step 2--internal EPA review,

         Step 3--interagency science consultation,

         Step 4--external peer review and public comment,

         Step 5--document revision,

         Step 6A--final internal EPA review,

         Step 6B--interagency science discussion, and

         Step 7--posting the final assessment on the IRIS database.

    The new process affords federal agencies and White House offices 
three opportunities to comment on science issues in draft IRIS 
assessments (Steps 3, 4 and 6B). In Step 3, the Interagency Science 
Consultation, federal agencies and White House offices will be invited 
to provide written scientific comments on the draft Toxicological 
Review and draft charge to external peer reviewers before the 
assessment is released for public review and comment. Also, in Step 4, 
the External Peer Review and Public Comment, the federal agencies and 
White House offices may provide written comments on the draft 
Toxicological Review during the public comment period. All comments 
received during the announced public comment period automatically 
become part of the public docket for the assessment. Finally, in Step 
6B, the Interagency Science Discussion, federal agencies and White 
House offices will be invited to provide written scientific comments 
specifically on EPA's response to external peer review and public 
comments before the final assessment is posted on IRIS.
    As specified in the new IRIS process, all written comments received 
during the Interagency Science Consultation (Step 3) and the 
Interagency Science Discussion (Step 6B) will be documented in the 
public record. This applies to all comments received on or after May 
21, 2009. When the draft assessment is released for external peer 
review and public comment, the following documents will be posted on 
the docket at www.regulations.gov and on the National Center for 
Environmental Assessment (NCEA) and IRIS web sites:

          Interagency Science Consultation draft Toxicological 
        Review

          Interagency Science Consultation draft external peer 
        review charge

          All written comments as received from agencies as 
        part of the Interagency Science Consultation

          External Peer Review draft Toxicological Review

          Final Charge to External Peer Reviewers

    When the final assessment is posted on the IRIS database, the 
following documents will be posted on the NCEA and IRIS web sites:

          Interagency Science Discussion draft Toxicological 
        Review with summary and disposition of external peer review and 
        public comments

          Interagency Science Discussion draft IRIS Summary

          All written comments as received from federal 
        agencies and White House offices as part of the Interagency 
        Science Discussion

          Final Toxicological Review and IRIS Summary.

                              Appendix 2:

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                   Additional Material for the Record









































































































































































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