[House Hearing, 110 Congress]
[From the U.S. Government Printing Office]


 
                         THE EPA'S IRIS PROGRAM

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

                                HEARINGS

                               BEFORE THE

                   SUBCOMMITTEE ON INVESTIGATIONS AND
                               OVERSIGHT

                  COMMITTEE ON SCIENCE AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             SECOND SESSION

                               __________

                              MAY 21, 2008
                                  and
                             JUNE 12, 2008

                               __________

                           Serial No. 110-104
                                  and
                           Serial No. 110-108

                               __________

     Printed for the use of the Committee on Science and Technology


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

                                 ______


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                  COMMITTEE ON SCIENCE AND TECHNOLOGY

                 HON. BART GORDON, Tennessee, Chairman
JERRY F. COSTELLO, Illinois          RALPH M. HALL, Texas
EDDIE BERNICE JOHNSON, Texas         F. JAMES SENSENBRENNER JR., 
LYNN C. WOOLSEY, California              Wisconsin
MARK UDALL, Colorado                 LAMAR S. SMITH, Texas
DAVID WU, Oregon                     DANA ROHRABACHER, California
BRIAN BAIRD, Washington              ROSCOE G. BARTLETT, Maryland
BRAD MILLER, North Carolina          VERNON J. EHLERS, Michigan
DANIEL LIPINSKI, Illinois            FRANK D. LUCAS, Oklahoma
NICK LAMPSON, Texas                  JUDY BIGGERT, Illinois
GABRIELLE GIFFORDS, Arizona          W. TODD AKIN, Missouri
JERRY MCNERNEY, California           JO BONNER, Alabama
LAURA RICHARDSON, California         TOM FEENEY, Florida
PAUL KANJORSKI, Pennsylvania         RANDY NEUGEBAUER, Texas
DARLENE HOOLEY, Oregon               BOB INGLIS, South Carolina
STEVEN R. ROTHMAN, New Jersey        DAVID G. REICHERT, Washington
JIM MATHESON, Utah                   MICHAEL T. MCCAUL, Texas
MIKE ROSS, Arkansas                  MARIO DIAZ-BALART, Florida
BEN CHANDLER, Kentucky               PHIL GINGREY, Georgia
RUSS CARNAHAN, Missouri              BRIAN P. BILBRAY, California
CHARLIE MELANCON, Louisiana          ADRIAN SMITH, Nebraska
BARON P. HILL, Indiana               PAUL C. BROUN, Georgia
HARRY E. MITCHELL, Arizona
CHARLES A. WILSON, Ohio
                                 ------                                

              Subcommittee on Investigations and Oversight

               HON. BRAD MILLER, North Carolina, Chairman
JERRY F. COSTELLO, Illinois          F. JAMES SENSENBRENNER JR., 
EDDIE BERNICE JOHNSON, Texas             Wisconsin
DARLENE HOOLEY, Oregon               DANA ROHRABACHER, California
STEVEN R. ROTHMAN, New Jersey        DAVID G. REICHERT, Washington
BRIAN BAIRD, Washington              PAUL C. BROUN, Georgia
BART GORDON, Tennessee               RALPH M. HALL, Texas
                DAN PEARSON Subcommittee Staff Director
                  EDITH HOLLEMAN Subcommittee Counsel
            JAMES PAUL Democratic Professional Staff Member
       DOUGLAS S. PASTERNAK Democratic Professional Staff Member
           KEN JACOBSON Democratic Professional Staff Member
                    BART FORSYTH Republican Counsel
            TOM HAMMOND Republican Professional Staff Member
                    STACEY STEEP Research Assistant


                            C O N T E N T S

EPA's Restructured IRIS System: Have Polluters and Politics Overwhelmed 
                                Science?

                              May 21, 2008

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

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

                           Opening Statements

Statement by Representative Brad Miller, Chairman, Subcommittee 
  on Investigations and Oversight, Committee on Science and 
  Technology, U.S. House of Representatives......................    10
    Written Statement............................................    11

Prepared Statement by Representative F. James Sensenbrenner Jr., 
  Ranking Minority Member, Subcommittee on Investigations and 
  Oversight, Committee on Science and Technology, U.S. House of 
  Representatives................................................    13

Prepared Statement by Representative Jerry F. Costello, Member, 
  Subcommittee on Investigations and Oversight, Committee on 
  Science and Technology, U.S. House of Representatives..........    13

Prepared Statement by Representative Eddie Bernice Johnson, 
  Member, Subcommittee on Investigations and Oversight, Committee 
  on Science and Technology, U.S. House of Representatives.......    14

Statement by Representative David G. Reichert, Member, 
  Subcommittee on Investigations and Oversight, Committee on 
  Science and Technology, U.S. House of Representatives..........    12

                                Panel I:

Mr. John B. Stephenson, Director, Natural Resources and 
  Environment, Government Accountability Office
    Oral Statement...............................................    15
    Written Statement............................................    16
    Biography....................................................    35

Discussion
  The Revised IRIS Process.......................................    36
  Did OMB Review EPA's GAO Exit Conference Comments?.............    37
  The IRIS Process...............................................    42
  Delayed Risk Assessments.......................................    42
  Comparing Risk Assessments: EPA vs. FDA........................    44
  Risk Assessment vs. Risk Management............................    46
  GAO Recommendations............................................    48
  More on Risk Assessment vs. Risk Management....................    50

                               Panel II:

Dr. George M. Gray, Assistant Administrator for Research and 
  Development, U.S. Environmental Protection Agency
    Oral Statement...............................................    52
    Written Statement............................................    54
    Biography....................................................    57

Ms. Susan E. Dudley, Administrator, Office of Information and 
  Regulatory Affairs (OIRA), Office of Management and Budget
    Oral Statement...............................................    58
    Written Statement............................................    59
    Biography....................................................    62

Discussion
  More on EPA's GAO Exit Conference Comments.....................    63
  OMB's Role in Risk Assessments.................................    64
  More on the IRIS Process.......................................    64
  How Transparent Is the New IRIS Process?.......................    68
  Timelines for IRIS Assessments.................................    73

              Appendix: Additional Material for the Record

DOD Interests in Emerging Contaminants by Tom Morehouse, Program 
  Advisor, Emerging Contaminants, Office of Deputy Under 
  Secretary of Defense (Installations & Environment), October 26, 
  2006...........................................................    80

Memorandum to George Gray, Assistant Administrator, ORD, from 
  Marcus Peacock, Deputy Administrator, United States 
  Environmental Protection Agency, dated April 10, 2008..........   101

EPA's Integrated Risk Information System, Assessment Development 
  Procedures.....................................................   103

       Toxic Communities: How EPA's IRIS Program Fails the Public

                             June 12, 2008

                                                                   Page
Witness List.....................................................   116

Hearing Charter..................................................   117

                           Opening Statements

Statement by Representative Brad Miller, Chairman, Subcommittee 
  on Investigations and Oversight, Committee on Science and 
  Technology, U.S. House of Representatives......................   122
    Written Statement............................................   123

Statement by Representative F. James Sensenbrenner Jr., Ranking 
  Minority Member, Subcommittee on Investigations and Oversight, 
  Committee on Science and Technology, U.S. House of 
  Representatives................................................   124
    Written Statement............................................   125

Prepared Statement by Representative Eddie Bernice Johnson, 
  Member, Subcommittee on Investigations and Oversight, Committee 
  on Science and Technology, U.S. House of Representatives.......   128

                               Witnesses:

Mr. Jerome M. Ensminger, Master Sergeant, U.S. Marine Corps 
  (Ret.)
    Oral Statement...............................................   129
    Written Statement............................................   132

Mr. Lenny Siegel, Executive Director, The Center for Public 
  Environmental Oversight (CPEO)
    Oral Statement...............................................   165
    Written Statement............................................   167
    Biography....................................................   188

Dr. Linda E. Greer, Director, Health Program, Natural Resources 
  Defense Council
    Oral Statement...............................................   189
    Written Statement............................................   191
    Biography....................................................   199

Discussion
  Deliberative, Interagency Decision-making......................   199
  OIRA's Role in the IRIS Process................................   201
  The IRIS Process...............................................   201
  Tracking Citizen Exposure to TCE...............................   203
  Science Policy.................................................   203
  Assessing Cumulative Exposures.................................   205
  The Agency for Toxic Substances and Disease Registry (ATSDR)...   206
  The European REACH Program.....................................   209

              Appendix: Additional Material for the Record

Statement by David G. Hoel, Medical University of South Carolina, 
  Charleston.....................................................   212


EPA'S RESTRUCTURED IRIS SYSTEM: HAVE POLLUTERS AND POLITICS OVERWHELMED 
                                SCIENCE?

                              ----------                              


                        WEDNESDAY, MAY 21, 2008

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

    The Subcommittee met, pursuant to call, at 11:10 a.m., in 
Room 2318 of the Rayburn House Office Building, Hon. Brad 
Miller [Chairman of the Subcommittee] presiding.



                            hearing charter

              SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT

                  COMMITTEE ON SCIENCE AND TECHNOLOGY

                     U.S. HOUSE OF REPRESENTATIVES

                    EPA's Restructured IRIS System:

                      Have Polluters and Politics

                          Overwhelmed Science?

                        wednesday, may 21, 2008
                          11:00 a.m.-1:00 p.m.
                   2318 rayburn house office building

    The Subcommittee on Investigations and Oversight will hold the 
first of two hearings on the Integrated Risk Information System (IRIS) 
at the Environmental Protection Agency (EPA).
    We have three excellent witnesses who can place the role of IRIS in 
perspective as well as address questions regarding the Bush 
Administration's evolving system to draft and review IRIS entries:

Mr. John Stephenson, Director, Natural Resources and Environment, 
        Government Accountability Office.

Dr. George Gray, Assistant Administrator for Research and Development, 
        United States Environmental Protection Agency.

Ms. Susan Dudley, Administrator, Office of Information and Regulatory 
        Affairs, Office of Management and Budget.

What Is IRIS and Why Does It Matter?

    IRIS was established in the 1980s to provide a single source of 
information on the risks associated with exposure to chemicals. The 
IRIS database provides a hazard identification and dose-response 
analysis, scientific information that when combined with estimates of 
exposure allow regulatory agencies to produce a risk assessment. 
Historically, entries to the database were the result of extensive in-
house development by the science staff at EPA, peer review processes 
with experts from outside the agency, and opportunities for public 
input and comment. To the degree interagency communications occurred, 
they were managed by EPA (See Figure 1).




    While not a regulatory product itself, IRIS is designed to help 
regulators set priorities about what to regulate and inform regulators 
about what level of exposure workers or communities can absorb safely. 
A long-recognized principle in the U.S. approach to regulation has been 
the distinction between risk assessment--the characterization of what 
science tells us regarding a particular hazard--and risk management, or 
what you want to do about the hazard (including choosing to do 
nothing). Science can point to where regulation may be needed, but 
science may not be the sole consideration in setting a regulatory 
standard or approach. IRIS is designed to be a risk assessment tool. 
Government officials in federal agencies, in State and county 
governments and even in foreign countries, have come to rely upon IRIS 
for the most reliable, most comprehensive statements on what science 
tells us about the risk associated with a particular chemical.
    A long-standing challenge for the IRIS database is meeting the 
requests for information on the many chemicals that are manufactured 
and utilized in global commerce, and updating information on chemicals 
that have been previously evaluated. IRIS is loosing ground to the 
torrent of new chemicals introduced to the marketplace. Approximately 
700 new chemicals enter commerce each year. Those new chemicals are 
added to the over 80,000 currently reported under the Toxic Substances 
Control Act (TSCA) as being in the market. In addition, about one half 
of the assessments on approximately 480 chemicals currently in the 
database need to be updated according to EPA staff estimates. To keep 
IRIS relevant would require aggressive moves to speed the production 
and approval of entries. Congress has actually increased funding for 
IRIS staff in recent years in an effort to address this severe backlog 
(this committee supported increased funding in Chairman Boehlert's FY 
2007 Views and Estimates Report to the Committee on the Budget--see 
Figure 2 for a representation of the IRIS budget).




IRIS Slows to a Crawl

    Instead of seeing IRIS entries spike with funding and personnel 
increases, additions and updates to IRIS have slowed to a crawl (Figure 
3). Only four IRIS listings have been finalized in the past two years. 
In comparison, the State of Minnesota requested new or updated 
assessments of 52 chemicals of concern in the 2006 solicitation for the 
2007 Program.\1\
---------------------------------------------------------------------------
    \1\ Submission by the Minnesota Department of Health to the 
Integrated Risk Information System (IRIS); Request for Chemical 
Substance Nominations for the 2007 Program. Docket ID No. EPA-HQ-ORD-
2006-0950.




    This outcome appears to be tied to the intervention of OMB in the 
IRIS review and approval process. Beginning in 2004, OMB established a 
formal system of interagency review (Figure 5). This system, ostensibly 
designed to improve the quality of IRIS entries, appears to have all 
but stopped IRIS entries. On April 10 of this year, EPA announced a new 
IRIS review and approval system that is even more elaborate than its 
predecessors (Figure 4).






    It appears that any IRIS listing that is the least bit 
controversial will take six years or more to be completed. The 
interagency process allows agencies with a direct conflict of interest 
multiple opportunities to influence the development and content of IRIS 
assessments all within a process that lacks any transparency for 
Congress or the public. The Department of Defense, the Department of 
Energy and NASA all are responsible for pollution on the federal lands 
they manage and for the health and safety of the personnel that manage 
their facilities and operations. Rocket fuel, jet fuel, solvents, 
munitions, nuclear waste all contain hazardous materials that can 
become pollutants contaminating aquifers and air, and exposing workers 
and families to real harm.

IRIS Entries Become a Political Science

    EPA leadership has agreed to OMB establishing a review that gives 
polluting agencies lengthy, unmonitored opportunities to try to 
convince OMB that the risks of a particular substance should not be set 
at a particular level. It is hard to understand what special science 
expertise these other agencies bring to the table such that OMB needs 
to set up an interagency review to discuss science.
    Remember that the development of IRIS assessments and, the risk 
assessment process generally, is supposed to be separate from the risk 
management process. There you would expect interested parties, 
including other federal agencies, to discuss how to manage risks by 
weighing costs and benefits in a search for the best option given a 
particular configuration of risk and need. IRIS is supposed to be 
solely about what science says regarding health and environmental risk 
associated with the listed chemicals. With 7000 scientists, and 
mandated by law and appropriation to be the Nation's lead agency on 
environmental science, EPA really has no peers when it comes to 
understanding the science at stake in IRIS listings.
    The process established on April 10 allowing agencies to discuss a 
particular IRIS listing is closed to the public. Because that work 
represents pre-deliberative discussions, any materials from that 
process are not subject to the Freedom of Information Act. Because 
these processes are managed by OMB, it will be very difficult for 
Congress to learn of what is happening due to OMB's consistent 
assertions that all of their work should be shielded from Congress and 
the public. Whether the proposals that come out of this lengthy, 
secretive process are based solely on science, or whether other 
considerations held sway, would be very hard for anyone to ever prove.
    IRIS is withering. It is loosing its relevance due to the sweep of 
time, new science and new substances as well as its own inability to 
refresh its data. The process put in place on April 10 appears 
guaranteed not to improve this situation, but to make it worse. But 
even if the process was somehow producing more entries, more quickly, 
the integrity of the process is itself in question and that alone will 
undermine the utility of the IRIS database. If policy-makers and the 
public believe the science has been cooked to meet a polluter's agenda, 
then they will not have confidence in the science. It is a simple 
problem and one that the April 10 revision puts at center stage.
    The Subcommittee hopes to explore these issues with witnesses on 
Wednesday morning.

 The Minnesota Department of Health Submission to the Integrated Risk 
 Information System (IRIS); Request for Chemical Substance Nominations 
         for 2007 Program (Docket ID No. EPA-HQ-ORD-2006-0950)

    The Health Risk Assessment staff at the Minnesota Department of 
Health wish to nominate a list of chemicals to be included in the 
Integrated Risk Information System (IRIS); Request for Chemical 
Substance Nomination for 2007 Program. These chemicals are of concern 
to the Minnesota Department of Health because they are among 
contaminants found in Minnesota groundwater. In Minnesota, health-based 
values are derived for such contaminants. When conducting risk 
assessments, the Minnesota Department of Health has relied upon the 
IRIS summaries as a resource for the development of these health 
protective values. Therefore, it is our hope that you take our 
nominated chemicals in consideration. By obtaining IRIS summaries of 
these chemicals it will result in a more thorough and accurate risk 
assessment process.

1,2,3--Trichloropropane
1--Methylnaphtalene
1--Methylphenol
2,2--Dichloropropane
2,3,4,5--Tetrachlorophenol
2,3,5,6--Tetrachloroterephthalic acid
2,6--dinitrotoluene
2,6--diethylaniline (Alchlor degradate)
2--Nitrophenol
3,5--Dichlorophenol
4--Isopropyl toluene
Acetochlor ESA
Acetochlor OA
Alachlor ESA (degradate of Alachlor)
Alachlor OA (degradate of Alachlor)
Aluminum
Deaminated diketomethribuzin (degradate of Metribuzin)
Deaminated metribuzin (degradate of Metribuzin)
Deethylatrazine (degradate of Atrazine and Propazine)
Deisopropylatrazine (degradate of Atrazine, Cyanazine and Simazine)
Diallate
Diazion
Dichlorofluoromethane
Diketometribuzin (degradate of Metribuzin)
Dimethenamid
Dimethenamid ESA (degradate of Demethenamid)
Dimethenamid OXA (degradate of Dimethenamid)
Ethafluralin
Hydroxyatrazine
Iron
Isopropyl ether
Isoxaflutole
Lithium
Metolachlor ESA
Metsulfuron-methyl (Ally)
Monomethyl tetrachloroterephthalic acid
n-Butylbenzene
Nicosulfuron
n-Propylbenzene
Primisulfuron-methyl (Beacon)
Radionuclides (all)
Sec-Butylbenzene
Sodium
Thifensulfuron methyl
Tin
Total petroleum hydrocarbons
Tribenuron-methyl
Triclopyr
Trinitro-phenylmethylnitramine
Triphenyltin hydroxide
Vanadium

    In addition, the Minnesota Department of Health currently needs and 
uses reference concentrations and reference doses for less than chronic 
periods of exposure to assess risks from a variety of exposure 
scenarios. These scenarios include less than chronic exposures that 
commonly occur at contaminated sites resulting in the need for less 
than chronic toxicity values to assess current risks. The EPA 2002 ``A 
review of the reference dose and reference concentration processes'' 
has guided much of the practice of the Department in this area.
    The Department has found that health effects that result from less 
than chronic periods of exposure, when combined with high drinking 
water exposures associated with specific life stages (e.g., childhood), 
result in drinking water values that are lower and therefore more 
appropriate as drinking water standards for the general population than 
the value calculated using a chronic reference dose and lifetime 
average dose. As a result, the Department is very interested in recent 
efforts by IRIS to develop less than lifetime reference values, and 
urges the EPA to continue to develop and publish these analyses. The 
Department also urges the EPA to consider the potential that effects 
observed in chronic studies result from early exposures rather than 
continuous exposure. To the extent that studies are available; the 
Department urges the EPA to present acute, short-term, longer-term, and 
chronic evaluations (recommendations for critical studies for each and 
resulting reference doses) for each chemical that undergoes review in 
the future.
    Chairman Miller. Good morning. This hearing will now come 
to order.
    More than 80,000 chemicals are now in use, and another 700 
new chemicals enter the marketplace each year. Americans need 
an efficient system to evaluate the risk to public health and 
the environment of chemicals on a regular basis and to have 
ready access to that information. That is the mission of the 
Integrated Risk Information System, or IRIS, but IRIS now has 
evaluations of only about 480 chemicals.
    In recent years, IRIS's assessments have not been the open 
discussions among scientists we associate with scientific peer 
review but have become a secretive process managed by OMB. 
OMB's mission does not include scientific analysis, nor does 
OMB appear to have the expertise to perform such work. As a 
result of OMB's control of IRIS evaluation procedures, however, 
four chemicals have been listed by IRIS in the last two fiscal 
years. EPA scientists produced 15 or so assessments in each of 
those years, but the assessments disappeared into an abyss of 
elaborate, endless reviews, mostly behind closed doors. A 
weighing of the need for assessments against the productivity 
under IRIS appears to show that the system is fundamentally 
broken and in desperate need of reform.
    Instead, EPA and OMB appear intent upon choking 
productivity under IRIS further still and depriving the 
assessments of what credibility they have left. Just last 
month, EPA unveiled its new process for developing and 
reviewing IRIS assessments. The solution offered by EPA and OMB 
is to take an already-broken system and to make it more 
convoluted, more secretive, and more suspect.
    The new system establishes an interagency process that 
gives polluting agencies even more opportunity than they had 
before to slow walk the IRIS process to avoid the consequences 
of their own conduct. With the new process announced April 10, 
we may view two new entries a year as the golden era of IRIS 
assessments. As GAO will testify this morning, it is highly 
likely that no new chemical entry that is the least bit 
controversial will ever come out of this system in less than 
six years and probably more like eight years.
    If the goal of the IRIS review process is to produce new 
IRIS entries, this system, designed by OMB and dutifully 
blessed by EPA's leadership, would be judged an abysmal 
failure. However, if the goal is to avoid new IRIS entries, or 
at least troublesome, inconvenient entries, this new system 
should perform beautifully. It effectively kills IRIS without 
honestly acknowledging that intent.
    How does it kill IRIS?
    Any new entry or revision that will make it into IRIS will 
be of very dubious reliability. Any entries that make it into 
IRIS will emerge from a largely secretive process that allows 
polluters to urge EPA to shift its science so that it is 
acceptable to the polluting agencies. The public will never 
have confidence that EPA stood firm on scientific principle or 
fought off the combined forces of OMB, the Department of 
Defense, the Department of Energy, or any other agencies that 
may have a desire to avoid cleaning up their practices or their 
messes. If the science appears to have been reworked behind 
closed doors to protect the interests of polluters, at the 
instance of polluters, who can believe the science?
    The Office of Information and Regulatory Affairs, OIRA, at 
OMB say that they are just managing an interagency process. 
That is a fiction. EPA is the agency that Congress directed in 
statute to do environmental science and charged with protecting 
public health and the environment. EPA is given billions of 
dollars a year in tax funds to carry out that research and 
regulatory work.
    There is no need for the secretive interagency process that 
OMB is requiring. The Department of Defense and National 
Aeronautics and Space Administration, the Department of Energy 
have entirely different missions and entirely different areas 
of expertise. Their interest in IRIS is that of an agency using 
the very chemicals that are being evaluated, not of a 
scientific agency making decisions based upon science. OMB is 
using that interagency process to undermine IRIS's integrity 
and take it away from EPA's control.
    EPA says that this really is their process, honest. They 
control it and are happy with it, but it is headed by political 
appointees. Dr. Gray is a political appointee. His testimony 
has been vetted and approved by OMB. EPA's official response 
even to the GAO report we will hear today was vetted and 
approved by OMB. And no IRIS entry can go forward without OMB 
approval.
    The Oversight and Government Reform Committee this week, 
just yesterday, held a hearing and issued a report that 
demonstrates the degree to which the White House has controlled 
the opinions of the EPA scientists on regulatory matters. With 
IRIS, we see that even in the realm of science, before policy 
should have a role, before economic consideration should have a 
role, EPA appears to follow the dictates of OMB. Thousands of 
career scientists must answer to political appointees without 
scientific expertise not about how to manage risk, whether risk 
management measures are justified by the economic costs, but 
about what risks chemicals pose to public health and to the 
environment in the first place, a question in which political 
considerations should have no role.
    Whatever your personal views of motive or intent by the 
EPA, the political leadership of the EPA, or by OMB, I hope 
almost everyone would agree that two new entries a year when 
700 chemicals are entering the marketplace every year, is just 
not acceptable. I look forward to GAO's testimony today for 
offering advice to Congress on how to make IRIS relevant again 
and responsive to the needs of the American public again and 
not just to agencies that are using chemicals and do not want 
to be disturbed, do not want to be inconvenienced, and their 
friends at OIRA.
    [The prepared statement of Chairman Miller follows:]

               Prepared Statement of Chairman Brad Miller

    More than 80,000 chemicals are now in use, and another 700 new 
chemicals enter the marketplace each year. Americans need an efficient 
system to evaluate the risk to public health and the environment of 
chemicals on a regular basis and have ready access to that information. 
That is the mission of the Integrated Risk Information System, or IRIS, 
but IRIS now has evaluations of only about 480 chemicals.
    In recent years, IRIS' assessments have not been the open 
discussions among scientists we associate with scientific peer review, 
but has become a secretive process managed by OMB. OMB's mission does 
not include scientific analysis, nor does OMB appear be have the 
expertise to perform such work. As a result of OMB's control of IRIS 
evaluation procedures, four chemicals have been listed on IRIS in the 
last two fiscal years. EPA scientists produced 15 or so assessments in 
each of these years, but the assessments disappeared into an elaborate, 
endless series of reviews, mostly behind closed doors. A weighing of 
the need for assessments against the productivity under IRIS, appears 
to show that the system is fundamentally broken and cries out for 
reform.
    Instead, EPA and OMB appear intent upon choking productivity under 
IRIS further still, and depriving the assessments of their remaining 
credibility. Just last month, EPA unveiled its new process for 
developing and reviewing IRIS assessments. The solution offered by EPA 
and OMB is to take a broken system and to make it more convoluted, 
secretive and suspect.
    The new system establishes an interagency process that gives 
polluting agencies even more opportunity than they had before to slow 
walk the IRIS process to avoid the consequences of their own conduct. 
With the new process announced April 10, we may view two new entries a 
year as the golden era of IRIS assessments. As GAO will testify, it is 
highly likely that no new chemical entry that is the least bit 
controversial will ever come out of this system in less than six years, 
and probably eight years.
    If the goal of the IRIS review process was to produce new IRIS 
entries, this system--designed at OMB and dutifully blessed by EPA's 
leadership--would be judged an abysmal failure. However, if the goal is 
to avoid new IRIS entries, or at least troublesome entries, then this 
new system should perform beautifully. It effectively kills IRIS 
without honestly acknowledging that purpose.

How does it kill IRIS?

    Any new entries or revisions that make it into IRIS will be of 
dubious reliability. Any entries that make it into IRIS will emerge 
from a largely secretive process that allows polluters to urge EPA to 
shift its science so that it is acceptable to the polluting agencies. 
The public will never have confidence that EPA stood firm on scientific 
principle, and fought off the combined forces of OMB, the Department of 
Defense, the Department of Energy or any other agencies that may have a 
desire to avoid cleaning up their practices or their messes. If the 
science appears to have been reworked behind closed doors to protect 
the interests of polluters, who can believe the science?
    The Office of Information and Regulatory Affairs at OMB say that 
they are just managing an interagency process. That is a fiction. EPA 
is the agency that Congress directed in statute to do environmental 
science and charged with protecting public health and the environment. 
EPA is given billions of dollars to carry out that research and 
regulatory work.
    There is no need for the secret interagency process that OMB is 
mandating. The Department of Defense, the National Aeronautics and 
Space Administration and the Department of Energy have entirely 
different missions and entirely different areas of expertise. Their 
interest in IRIS is that of a polluter, not of a science agency. OMB is 
using this interagency process to subvert the IRIS process and take it 
away from EPA's control.
    EPA will say this is really their process--honest--they control it 
and are happy with it. Dr. Gray is a political appointee of the 
Administration. His testimony has been vetted and approved by OMB. 
EPA's official response to the GAO report we will hear about today was 
vetted and approved by OMB. And no IRIS entry can go forward without 
OMB approval.
    The Oversight and Government Reform Committee this week held a 
hearing and issued a report that demonstrates the degree to which the 
White House has controlled the ``opinions'' of EPA on regulatory 
matters. With IRIS, we see that even in the realm of science, EPA 
appears to follow the dictates of OMB. Thousands of career scientists 
must answer to political appointees without scientific expertise not 
about how to manage risk, whether risk management measures are 
justified by the costs, but about what risks chemicals pose to public 
health and to the environment, a question in which political 
considerations should play no part.
    Whatever your personal views of motive or intent of EPA or OMB, I 
think almost everyone would agree that just two new entries a year is 
simply not acceptable. I look forward to GAO's testimony today for 
offering advice to Congress on how to make IRIS relevant and responsive 
to the needs of the American public and not just a handful of polluters 
and their friends at OIRA.

    Chairman Miller. At this time I would like to recognize Mr. 
Reichert of Washington who is sitting in for Mr. Sensenbrenner 
of Wisconsin.
    Mr. Reichert. Thank you, Mr. Chairman. I ask unanimous 
consent to submit a statement from Ranking Member Sensenbrenner 
and a memo from the EPA into the Committee records.
    Chairman Miller. Without objection.
    Mr. Reichert. I yield back.
    [The prepared statement of Mr. Sensenbrenner follows:]

    Prepared Statement of Representative F. James Sensenbrenner Jr.

    The Integrated Risk Information System (IRIS) process was 
originally developed for a specific task. Different offices throughout 
the Environmental Protection Agency (EPA) were relying on different 
assessments of the health effects of chronic exposure to toxic 
chemicals. IRIS was intended to establish a uniform database within 
EPA.
    Over time, however, IRIS became an authoritative resource on 
chemical toxicity. Other agencies, states, the international community, 
and industries increasingly began to rely on IRIS, and the assessments 
took on increased importance. These outside groups have sought to 
impact a process that was not initially designed to handle external 
pressures. The result has been an IRIS process that has effectively 
broken down.
    The Government Accountability Office (GAO) recently issued a 
scathing condemnation of the current state of the IRIS program. The 
report's title, Low Productivity and New Interagency Review Process 
Limit the Usefulness and Credibility of EPA's Integrated Risk 
Information System, accurately sums up GAO's findings. But IRIS' actual 
production numbers are worse. EPA currently has a backlog of 70 ongoing 
assessments and has managed to complete only two assessments in each of 
the last two years. At the current pace, it will take 35 years for EPA 
to finish its current backlog.
    EPA has attempted to develop a uniform process for IRIS 
assessments. The agency argues that it can expedite the IRIS process by 
involving other agencies earlier in the process. While preventing last 
minute delays is an important reform, the ability of other agencies to 
extend the timeframe of assessments should be sharply limited. Data 
gaps in risk assessments will always exist as better science is always 
developing. EPA needs to limit the timeframe of assessments to prevent 
other agencies from indefinitely delaying the process.
    EPA must balance its need to complete assessments with the rights 
of interested parties to comment. The best way to achieve this balance 
would be to give more notice of its assessments. EPA already publishes 
an annual agenda of the chemical it intends to assess in the Federal 
Register. If EPA moves the date of that publication forward, providing 
more notice, interested parties will have a longer period to comment on 
what they deem to be insufficiencies in the scientific record. During 
this comment period, EPA can focus on its backlog. Because it offered a 
comment period, EPA can then fairly limit the ability of outside 
parties to delay assessments once they are underway. The result would 
be a more efficient process that preserves taxpayers' money and 
promotes public health.
    I urge EPA to consider these proposals, because IRIS must be fixed. 
In April, this subcommittee held a hearing on formaldehyde levels in 
trailers provided to the victims of Hurricane Katrina. In that hearing, 
we investigated how the Agency for Toxic Substances and Disease 
Registry struggled to identify the proper ``level of concern'' for 
long-term exposure to formaldehyde. EPA determined its formaldehyde 
assessment was outdated in 1997, but eleven years later, that 
assessment is still incomplete. These hurricane victims are the real 
world result of EPA's bureaucratic failures.

    [The prepared statement of Mr. Costello follows:]

         Prepared Statement of Representative Jerry F. Costello

    Mr. Chairman, I appreciate the Subcommittee's attention to this 
important matter. The role of the Environmental Protection Agency's 
(EPA) IRIS program cannot be understated. Created in the 1980s, the 
program is a primary resource for information on the risks associated 
to exposure of chemicals. Government officials, State and local 
governments and many scientists have come to rely on the comprehensive 
analysis completed by the IRIS program.
    However, the rate at which information requests have been processed 
over the years is troubling. Recent revisions to the program have 
received conflicting reviews as to whether these steps will increase 
productivity or continue to slow the process further. A March 2008 GAO 
report concluded that the IRIS database is at serious risk of becoming 
incomplete because EPA has not been able to routinely complete timely, 
credible assessments or decrease its backlog of 70 ongoing assessments. 
That a total of four assessments were completed over the course of 
fiscal years 2006 and 2007 is unacceptable.
    I look forward to hearing our witnesses' testimony today and 
working with my colleagues on the Committee to improve and increase 
efficiency within this important program. Thank you, Mr. Chairman, I 
yield back.

    [The prepared statement of Ms. Johnson follows:]

       Prepared Statement of Representative Eddie Bernice Johnson

    Thank you, Mr. Chairman. The mission of the Environmental 
Protection Agency is to protect both environmental quality and human 
health through effective regulations and other policy implementation.
    What is confounding to me, regarding the Integrated Risk 
Information System, is why only four IRIS listings have been finalized 
in the past two years.
    After all, approximately 700 new chemicals enter commerce each 
year. There are more than 80,000 chemicals reported under the Toxic 
Substances Control Act as being in the market.
    It seems implausible to me that only four chemicals should be 
investigated to completion and published in the IRIS database at E.P.A.
    The Government Accountability Office report, published in March 
2008, concluded that, ``the IRIS database is at serious risk of 
becoming obsolete because E.P.A. has not been able to routinely 
complete timely, credible assessments or decrease its backlog of 70 
ongoing assessments.''
    The statement of George M. Gray, Ph.D., who is Assistant 
Administrator for Research and Development at E.P.A., explains that 
IRIS began as ``an internal E.P.A. resource.''
    Even if that explanation is true, then why would E.P.A. compile 
only four IRIS listings in the past two years?
    It makes me question what E.P.A. is doing, when it comes to 
chemical toxicity and public health.
    Dr. Gray's statement also says that the risk assessment process 
``consists of both `science' and `science policy' components.''
    It goes on to say that, ``although there are some instances at 
E.P.A. where `pure science' is involved, . . . much of the work done at 
E.P.A. . . . involves both science and science policy. . . .Due to the 
uncertainty in IRIS assessments, judgments and choices must be made 
about the most appropriate assumptions . . . to use in deriving 
toxicity data.''
    Mr. Chairman, I chafe at this testimony.
    These statements insult the scientific community that publishes 
data on these matters. They also insult the talented scientists who are 
working at E.P.A., who are perfectly capable of interpreting peer-
reviewed literature and making public health decisions.
    This subcommittee has concerns that the IRIS system has become 
politicized, when it should be based solely on scientific facts 
regarding health and environmental risk associated with the listed 
chemicals.
    Although I understand that E.P.A. is making moves to re-evaluate 
the IRIS System, there are only so many patches that may be placed on a 
sinking ship.
    For me, what is truly sinking is the feeling I get when I consider 
the good scientists who have dedicated their entire careers to 
environmental safety at E.P.A. I suspect that those who remain must be 
frustrated at this gross politicization of science and wide scale 
destruction of our environment.
    Mr. Chairman, you will know that I have a near-perfect voting 
record with environmental groups, and I will be swift to act, should I 
see a way to rectify the situation.
    Thank you, and I yield back the remainder of my time.

                                Panel I:

    Chairman Miller. It is now my pleasure to introduce our 
witnesses today. Mr. John Stephenson is the Director of Natural 
Resources and Environment Division at the Government 
Accountability Office, which just released a report on IRIS's 
new interagency review process. Mr. Stephenson, you will have 
five minutes for your spoken testimony. Your written testimony 
will be included in the record for the hearing. When you 
complete your testimony, we will begin with questions, and each 
Member will have five minutes to question you. It is a practice 
of the Subcommittee to take testimony under oath. Do you object 
to swearing an oath?
    Mr. Stephenson. No.
    Chairman Miller. Please stand and raise your right hand. Do 
you swear to tell the truth and nothing but the truth?
    Mr. Stephenson. I do.
    Chairman Miller. Mr. Stephenson, the Committee also 
provides that you may be represented by counsel. Are you 
represented by counsel at today's hearings?
    Mr. Stephenson. I am not.
    Chairman Miller. Then Mr. Stephenson, please begin.

    TESTIMONY OF MR. JOHN B. STEPHENSON, DIRECTOR, NATURAL 
  RESOURCES AND ENVIRONMENT, GOVERNMENT ACCOUNTABILITY OFFICE

    Mr. Stephenson. Thank you, Mr. Chairman, and other Members 
of the Committee. I am here today to discuss our recently 
issued report on IRIS, a database that contains the scientific 
position on health effects of exposure to more than 540 toxic 
chemicals. IRIS is a critical component of EPA's capacity to 
support scientifically sound environmental decisions, policies, 
and regulations. Our March 2008 report concluded that the IRIS 
database is at serious risk of becoming obsolete because EPA 
has not been able to complete timely, credible assessments or 
decrease its back-load of 70 ongoing assessments. In summary, 
we found that EPA efforts to improve IRIS since 2000 have been 
thwarted by a combination of factors including OMB interagency 
reviews, EPA decisions to delay assessments to wait for new 
research or additional uncertainty analysis, and the 
compounding effect of continuous delays.
    The two new OMB interagency reviews involve other federal 
agencies in a manner that limits the credibility of IRIS 
assessment and hinders EPA's ability to manage them. In 
addition, OMB is inserting itself into the decision-making 
process by, for example, requiring EPA to terminate five 
assessments EPA's own office of theirs said that it needed to 
implement the Clean Air Act. The effect of all of these changes 
to what should be a scientific process is that chemicals remain 
in the assessment phase indefinitely, and few assessments are 
ever finalized. Indeed, EPA staff have prepared over 32 draft 
assessments of toxic chemicals in the past two years, yet only 
four have been finalized.
    Our report includes eight specific recommendations for 
streamlining the IRIS program, improving the transparency and 
credibility of the assessments, and ensuring that EPA has the 
requisite independence to achieve its goals, recommendations 
that EPA in February agreed to consider before finalizing the 
IRIS process. However, EPA released its final IRIS process on 
April 10th as you mentioned, and instead of seeking public 
comment, as OMB promised in responding to our report, made it 
effective immediately. To say that we are disappointed is a 
gross understatement. The new IRIS process is not responsive to 
our recommendations and is in many respects worse than the 
draft we reviewed. For example, the draft process would have 
made comments from other federal agencies part of the public 
record. However, the new process expressly defined such 
comments as deliberative, excluding them from the public 
record. EPA's position that the IRIS process is transparent 
because final assessments must undergo public and external peer 
review is ludicrous. Transparency at a late stage after OMB and 
other federal agencies have had multiple opportunities to 
influence the content of the assessment without any disclosure 
of their input does not compensate for its absence earlier.
    In addition, the estimated timeframes under the new process 
will likely perpetuate the cycle of delays and exacerbate the 
problems we identified in our report and sought to address with 
our recommendations, all of which were aimed at preserving the 
viability of this critical database which is integral to EPA's 
mission of protecting the public health from exposure to toxic 
chemicals. Instead of significantly streamlining IRIS, EPA has 
institutionalized an assessment process from the outset that 
will take 6 to 8 years to complete.
    We all understand that science regarding the toxicity of a 
given chemical is never perfect, but at some point EPA must 
complete assessments so that it can take the next step of 
exploring what regulatory options are appropriate for 
protecting human health. My testimony includes several examples 
of dangerous chemicals that are stuck in the endless loop of 
assessment and reassessment. I would like to summarize just one 
very quickly.
    In 1998, EPA initiated a toxic risk assessment of 
trichloroethylene, a degreasing agent used widely by the 
Department of Defense and others. Numerous studies have linked 
TCE to cancer and birth defects over the last decade. EPA 
completed a draft risk assessment in 2001 which was then peer 
reviewed by the science advisory board and released for public 
comment. During the comment process, questions were raised 
about the assessment by DOD and others that led to a request 
for the National Academies of Science to review it in 2004. In 
2006, the Academies concluded that the weight of evidence of 
cancer from TCE had actually strengthened since EPA's 2001 
assessment. Nevertheless, after more than 10 years, TCE is back 
at the draft development stage, and the public continues to be 
exposed to this dangerous chemical. EPA estimates that its 
final assessment will not be completed until 2010. In 
frustration, five Senators, spurred by the TCE contamination in 
the drinking water at Camp Lejeune, North Carolina, introduced 
a bill last year that would require EPA to complete its risk 
assessment and issue a drinking water standard within 18 
months.
    Mr. Chairman, IRIS is a critical process that is clearly 
broken and needs to be fixed. We believe that the Congress 
should consider directing EPA to suspend implementation of its 
new process and develop one that is transparent and otherwise 
responsive to our recommendations. If EPA is unable or 
unwilling to take the steps necessary to improve this critical 
program, we believe that other approaches including legislative 
action may be needed.
    That concludes my comments, and I will be happy to take 
questions.
    [The prepared statement of Mr. Stephenson follows:]

                Prepared Statement of John B. Stephenson

Mr. Chairman and Members of the Subcommittee:

    I am pleased to be here today to discuss issues associated with the 
Environmental Protection Agency's (EPA) Integrated Risk Information 
System (IRIS)--one of the most significant tools that EPA has developed 
to effectively support its mission of protecting people and the 
environment from harmful chemical exposures. IRIS contains EPA's 
scientific position on the potential human health effects that may 
result from exposure to more than 540 chemicals in the environment and 
is a critical component of EPA's capacity to support scientifically 
sound risk management decisions, policies, and regulations. IRIS is 
also relied upon by State and local environmental programs and some 
international regulatory bodies for managing their environmental 
protection programs. As shown in Figure 1, the toxicity assessments in 
the IRIS database fulfill the first two critical steps of the four-step 
risk assessment process--providing hazard identification and 
quantitative dose-response assessments. IRIS information can then be 
used with the results of exposure assessments (typically conducted by 
EPA's program or regional offices) to provide an overall 
characterization of the public health risks for a given chemical in a 
given situation. The development of health risk assessments is thus 
directly dependent on the development of toxicity assessments such as 
those developed in the IRIS program.




    Under the National Academies' risk assessment and risk management 
paradigm, policy considerations are relevant in the risk management 
phase, which occurs after the risk assessment phase.\1\ With risk 
assessment information, decision-makers can make informed risk 
management decisions on how to protect public health, reflecting other 
important data and considerations, such as the costs and benefits of 
mitigating identified risks, the technological feasibility of managing 
risks, and the concerns of various stakeholders. Examples of risk 
management decisions include deciding how much of a chemical a company 
may discharge into a river, determining the extent to which a hazardous 
waste site must be cleaned up, and setting allowable levels of 
contamination in drinking water.
---------------------------------------------------------------------------
    \1\ The National Academies comprises four organizations: the 
National Academy of Sciences, the National Academy of Engineering, the 
Institute of Medicine, and the National Research Council.
---------------------------------------------------------------------------
    Thus, although IRIS assessments are not regulatory in nature, the 
quantitative IRIS values may influence many risk management decisions 
and serve as a basis for regulatory consideration. However, EPA's 
productivity in finalizing IRIS assessments is poor, and EPA has a 
significant backlog of incomplete IRIS assessments and a growing number 
of outdated assessments. Importantly, EPA has not been able to complete 
assessments of key chemicals of concern to public health, including 
dioxin, formaldehyde, trichloroethylene (TCE), naphthalene, and 
tetrachloroethylene (perc) (see Appendix I).
    In this context, my testimony today discusses (1) highlights of our 
March 2008 report, Chemical Assessments: Low Productivity and New 
Interagency Review Process Limit the Usefulness and Credibility of 
EPA's Integrated Risk Information System\2\ and (2) key aspects of 
EPA's revised IRIS assessment process, released on April 10, 2008. For 
our March 2008 report, we examined the outcome of steps EPA has taken 
to ensure that IRIS contains current, credible chemical risk 
information; to address the backlog of ongoing assessments; and to 
respond to new requirements from the Office of Management and Budget 
(OMB). We also examined the potential effects of planned changes to the 
IRIS assessment process on EPA's ability to ensure that IRIS provides 
current, credible risk information. In conducting our work, we obtained 
and analyzed information on EPA's productivity and the resources 
provided to the program for fiscal years 2000 through 2007, user needs, 
and EPA's assessment completion goals. We also interviewed EPA's 
National Center for Environmental Assessment officials who manage the 
IRIS assessment program; officials from other EPA program offices and 
federal science and health agencies involved in the IRIS assessment 
process; and officials from the Department of Defense, the Department 
of Energy (DOE), the National Aeronautics and Space Administration 
(NASA), and OMB. For this testimony, we supplemented our report with a 
review of the IRIS assessment process that EPA released on April 10, 
2008. We conducted this work from May 7 to May 21, 2008, in accordance 
with generally accepted government auditing standards. Those standards 
require that we plan and perform the audit to obtain sufficient, 
appropriate evidence to provide a reasonable basis for our findings and 
conclusions based on our audit objectives. We believe that the evidence 
obtained provides a reasonable basis for our findings and conclusions 
based on our audit objectives.
---------------------------------------------------------------------------
    \2\ GAO-08-440 (Washington, D.C.: Mar. 7, 2008).

Background

    IRIS was created in 1985 to help EPA develop consensus opinions 
within the agency about the health effects of chronic exposure to 
chemicals. Its importance has increased over time as EPA program 
offices and the states have increasingly relied on IRIS information in 
making environmental protection decisions. Currently, the IRIS database 
contains assessments of more than 540 chemicals. According to EPA, 
national and international users access the IRIS database approximately 
nine million times a year. EPA's Assistant Administrator for the Office 
of Research and Development has described IRIS as the premier national 
and international source for qualitative and quantitative chemical risk 
information; other federal agencies have noted that IRIS data are 
widely accepted by all levels of government across the country for 
application of public health policy, providing benefits such as 
uniform, standardized methods for toxicology testing and risk 
assessment, as well as uniform toxicity values. Similarly, a private-
sector risk assessment expert has stated that the IRIS database has 
become the most important source of regulatory toxicity values for use 
across EPA's programs and is also widely used across State programs and 
internationally.
    Historically and currently, the focus of IRIS toxicity assessments 
has been on the potential health effects of long-term (chronic) 
exposure to chemicals. According to OMB, EPA is the only federal agency 
that develops qualitative and quantitative assessments of both cancer 
and non-cancer risks of exposure to chemicals, and EPA does so largely 
under the IRIS program. Other federal agencies develop quantitative 
estimates of non-cancer effects or qualitative cancer assessments of 
exposure to chemicals in the environment. While these latter 
assessments provide information on the effects of long-term exposures 
to chemicals, they provide only qualitative assessments of cancer risks 
(known human carcinogen, likely human carcinogen, etc.) and not 
quantitative estimates of cancer potency, which are required to conduct 
quantitative risk assessments.
    EPA's IRIS assessment process has undergone a number of formal and 
informal changes during the past several years. While the process used 
to develop IRIS chemical assessments includes numerous individual steps 
or activities, major assessment steps include (1) a review of the 
scientific literature; (2) preparation of a draft IRIS assessment; (3) 
internal EPA reviews of draft assessments; (4) two OMB/interagency 
reviews, managed by OMB, that provide input from OMB as well as from 
other federal agencies, including those that may be affected by the 
IRIS assessments if they lead to regulatory or other actions; (5) an 
independent peer review conducted by a panel of experts; and (6) the 
completion of a final assessment that is posted to the IRIS web site.
    Unlike many other EPA programs that have statutory requirements, 
including specific time frames for completing mandated tasks, the IRIS 
program is not subject to statutory requirements or timeframes. In 
contrast, the Department of Human Health and Services' Agency for Toxic 
Substances and Disease Registry (ATSDR), which develops quantitative 
estimates of the non-cancer effects of exposures to chemicals in the 
environment, is statutorily required to complete its assessments within 
certain timeframes.

Findings and Recommendations from Our March 2008 Report on the 
                    Productivity and Credibility of EPA's Integrated 
                    Risk Information System

    The IRIS database is at serious risk of becoming obsolete because 
the agency has not been able to routinely complete timely, credible 
assessments or decrease a backlog of 70 ongoing assessments. 
Specifically, although EPA has taken important steps to improve the 
IRIS program and productivity since 2000 and has developed a number of 
draft assessments for external review, its efforts to finalize the 
assessments have been thwarted by a combination of factors including 
the imposition of external requirements, the growing complexity and 
scope of risk assessments, and certain EPA management decisions. In 
addition, the changes to the IRIS assessment process that EPA was 
considering at the time of our review would have added to the already 
unacceptable level of delays in completing IRIS assessments and further 
limited the credibility of the assessments.

EPA's Efforts to Improve the IRIS Assessment Program Have Not Produced 
        the Desired Results
    EPA has taken a number of steps to help ensure that IRIS contains 
current, credible chemical risk information; to address its backlog of 
ongoing assessments; and to respond to new OMB requirements. However, 
to date, these changes--including increasing funding, centralizing 
staff conducting assessments, and revising the assessment process--have 
not enabled EPA to routinely complete credible IRIS assessments or 
decrease the backlog. That is, although EPA sent 32 draft assessments 
for external review in fiscal years 2006 and 2007, the agency finalized 
only four IRIS assessments during this time (see Fig. 2).




    Several key factors have contributed to EPA's inability to achieve 
a level of productivity that is needed to sustain the IRIS program and 
database: new OMB-required reviews of IRIS assessments by OMB and other 
federal agencies; the growing complexity and scope of risk assessments; 
certain EPA management decisions and issues, including delaying 
completion of some assessments to await new research or to develop 
enhanced analyses of uncertainty in the assessments; and the 
compounding effect of delays. Regarding the last factor, even a single 
delay in the assessment process can lead to the need to essentially 
repeat the assessment process to take into account changes in science 
and methodologies.
    A variety of delays have impacted the majority of the 70 
assessments being conducted as of December 2007--48 had been in process 
for more than five years, and 12 of those for more than nine years. 
These time frames are problematic because of the substantial rework 
such cases often require to take into account changing science and 
methodologies before they can be completed. For example, EPA's 
assessment of the cancer risks stemming from exposure to naphthalene--a 
chemical used in jet fuel and in the production of widely used 
commercial products such as moth balls, dyes, insecticides, and 
plasticizers--was nearing completion in 2006. However, prior to 
finalizing this assessment, which had been ongoing for over four years, 
EPA decided that the existing non-cancer assessment had become outdated 
and essentially restarted the assessment to include both cancer and 
non-cancer effects. As a result, six years after the naphthalene 
assessment began, it is now back at the drafting stage. The assessment 
now will need to reflect relevant research completed since the draft 
underwent initial external peer review in 2004, and it will have to 
undergo all of the IRIS assessment steps again, including the 
additional internal and external reviews that are now required (see 
Appendix I).
    Further, because EPA staff time continues to be dedicated to 
completing assessments in the backlog, EPA's ability to both keep the 
more than 540 existing assessments up to date and initiate new 
assessments is limited. Importantly, EPA program offices and State and 
local entities have requested assessments of hundreds of chemicals not 
yet in IRIS, and EPA data as of 2003 indicated that the assessments of 
287 chemicals in the database may be outdated--that is, new information 
could change the risk estimates currently in IRIS or enable EPA to 
develop additional risk estimates for chemicals in the database (for 
example, developing a cancer potency estimate for assessments with only 
non-cancer estimates). In addition, because EPA's 2003 data are now 
more than four years old, it is likely that more assessments may be 
outdated now.
    The consequences of not having current, credible IRIS information 
can be significant. EPA's inability to complete its assessment of 
formaldehyde, which the agency initiated in 1997 to update information 
already in IRIS on the chemical, has had a significant impact on EPA's 
air toxics program. Although in 2003 and 2004, the National Cancer 
Institute and the National Institute of Occupational Safety and Health 
(NIOSH) had released updates to major epidemiological studies of 
industrial workers that showed a relationship between formaldehyde and 
certain cancers, including leukemia, EPA did not move forward to 
finalize an IRIS assessment incorporating these important data. 
Instead, EPA opted to await the results of another update to the 
National Cancer Institute study. While this additional research was 
originally estimated to take, at most, 18 months to complete, at the 
time of our report (more than three years later) the update was not 
complete. In the absence of this information, EPA's Office of Air and 
Radiation decided to use risk information developed by an industry-
funded organization--the CIIT Centers for Health Research--for a 
national emissions standard. This decision was a factor in EPA 
exempting certain facilities with formaldehyde emissions from the 
national emissions standard. The CIIT risk estimate indicates a potency 
about 2,400 times lower than the estimate in IRIS that was being re-
evaluated and that did not yet consider the 2003 and 2004 National 
Cancer Institute and NIOSH epidemiological studies. According to an EPA 
official, an IRIS cancer risk factor based on the 2003 and 2004 
National Cancer Institute and NIOSH studies would likely be close to 
the current IRIS assessment, which EPA has been reevaluating since 
1997. The discrepancy between these two risk estimates raises concerns 
about whether the public health is adequately protected in the absence 
of current IRIS information. For example, in 1999, EPA published a 
national assessment that provided information about the types and 
amounts of air toxics to which people are exposed. The assessment, 
which also used the CIIT risk estimate for formaldehyde, concluded, for 
example, that formaldehyde did not contribute significantly to the 
overall cancer risk in the State of New Jersey. However, in carrying 
out its own risk assessment on formaldehyde, the New Jersey Department 
of Environmental Protection opted to use the risk information that is 
currently in IRIS (dating back to 1991) and found that the contribution 
from formaldehyde to overall cancer risk in New Jersey is quite 
significant, second only to diesel particulate matter. (Appendix I 
provides additional information on EPA's IRIS assessment for 
formaldehyde.)
    One of the factors that has contributed to EPA's inability to 
complete assessments in a timely manner--the new OMB-directed OMB/
interagency review process--also limits the credibility of the 
assessments because it lacks transparency. Specifically, neither the 
comments nor the changes EPA makes to the scientific IRIS assessments 
in response to the comments made by OMB and other federal agencies, 
including those whose workload and resource levels could be affected by 
the assessments, are disclosed. In addition, the OMB/interagency 
reviews have hindered EPA's ability to independently manage its IRIS 
assessments. For example, without communicating its rationale for doing 
so, OMB directed EPA to terminate five IRIS assessments that for the 
first time addressed acute, rather than chronic exposure--even though 
EPA initiated this type of assessment to help it implement the Clean 
Air Act.

The Expansion of Agencies' Roles in IRIS Assessments That EPA Was 
        Considering at the Time of Our Review Would Have Caused Further 
        Delays and Limited the Assessments' Credibility
    For our March 2008 report, we reviewed the additional assessment 
process changes EPA was planning and concluded that they would likely 
exacerbate delays in completing IRIS assessments and further affect 
their credibility. Specifically, despite the OMB/interagency review 
process that OMB required EPA to incorporate into the IRIS assessment 
process in 2005, certain federal agencies continued to believe they 
should have greater and more formal roles in EPA's development of IRIS 
assessments. Consequently, EPA had been working for several years to 
establish a formal IRIS assessment process that would further expand 
the role of federal agencies in the process--including agencies such as 
DOD, which could be affected by the outcome of IRIS assessments. For 
example, some of these agencies and their contractors could face 
increased cleanup costs and other legal liabilities if EPA issued an 
IRIS assessment for a chemical that resulted in a decision to regulate 
the chemical to protect the public. In addition, the agencies could be 
required to, for example, redesign systems and processes to eliminate 
hazardous materials; develop material substitutes; and improve personal 
protective clothing, equipment, and procedures. Under the changes that 
EPA was planning at the time of our review, these potentially affected 
agencies would have the opportunity to be involved, or provide some 
form of input, at almost every step of EPA's IRIS assessment process. 
Most significantly, the changes would have provided federal agencies, 
including those facing potential regulatory liability, with several 
opportunities during the IRIS assessment process to subject particular 
chemicals of interest to additional process steps. These additional 
process steps, which would have lengthened assessment times 
considerably, include:

          giving federal agencies and the public 45 days to 
        identify additional information on a chemical for EPA's 
        consideration in its assessment or to correct any errors on an 
        additional assessment draft that would provide qualitative 
        information;\3\
---------------------------------------------------------------------------
    \3\ This represents an additional review of a new draft product and 
comment period that had not existed previously. As shown in Appendix 
II, the assessment process EPA used at the time of our review included 
publishing its annual IRIS assessment agenda in the Federal Register 
and soliciting relevant scientific information from the public.

          giving potentially affected federal agencies 30 days 
        to review the public comments EPA received and initiate a 
        meeting with EPA if they want to discuss a particular set of 
---------------------------------------------------------------------------
        comments;

          allowing potentially affected federal agencies to 
        have assessments suspended for up to 18 months to fill a data 
        gap or eliminate an uncertainty factor that EPA plans to use in 
        its assessment; and

          allowing other federal agencies to weigh in on (1) 
        the level of independent peer review that would be sought (that 
        is, whether the peer reviews would be conducted by EPA Science 
        Advisory Board panels, National Academies' panels, or panels 
        organized by an EPA contractor); (2) the areas of scientific 
        expertise needed on the panel; and (3) the scope of the peer 
        reviews and the specific issues they would address.

    EPA estimated that assessments that undergo these additional 
process steps would take up to six years to complete. While it is 
important to ensure that assessments consider the best science, EPA has 
acknowledged that waiting for new data can result in substantial harm 
to human health, safety, and the environment. Further, although 
coordination with other federal agencies about IRIS assessments could 
enhance their quality,\4\ increasing the role of agencies that may be 
affected by IRIS assessments in the process itself reduces the 
credibility of the assessments if that expanded role is not 
transparent. In this regard, while EPA's proposed changes would have 
allowed for including federal agencies' comments in the public record, 
the implementation of this proposal was delayed for a year, in part, 
because of OMB's view that agencies' comments about IRIS assessments 
represent internal executive branch communications that may not be made 
public--a view that is inconsistent with the principle of sound 
science, which relies on, among other things, transparency. (Appendix 
II and III provide flow charts of the IRIS process that was in place at 
the time of our review and EPA's draft proposed process being 
considered at the time of our review, respectively).
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    \4\ We recommended in our 2006 report on human health risk 
assessment that EPA consistently involve stakeholders as appropriate to 
the risk assessment. We made this recommendation in the context of 
improving the overall quality, consistency, and transparency of risk 
assessments. GAO, Human Health Risk Assessment: EPA Has Taken Steps to 
Strengthen Its Process, but Improvements Needed in Planning, Data 
Development, and Training, GAO-06-595 (Washington, D.C.: May 31, 2006).

Recommendations Made in Our March 2008 Report
    To address the productivity and credibility issues we identified, 
we recommended that the EPA Administrator require the Office of 
Research and Development to re-evaluate its draft proposed changes to 
the IRIS assessment process in light of the issues raised in our report 
and ensure that any revised process, among other things, clearly 
defines and documents an IRIS assessment process that will enable the 
agency to develop the timely chemical risk information it needs to 
effectively conduct its mission. One of our recommendations--that EPA 
provide at least two years' notice of IRIS assessments that are 
planned--would, among other things, provide an efficient alternative to 
suspending assessments while waiting for new research because 
interested parties would have the opportunity to conduct research 
before assessments are started.
    In addition, we recommended that the EPA Administrator take steps 
to better ensure that EPA has the ability to develop transparent, 
credible IRIS assessments--an ability that relies in large part on 
EPA's independence in conducting these important assessments. Actions 
that are key to this ability include ensuring that EPA can (1) 
determine the types of assessments it needs to support EPA programs and 
(2) define the appropriate role of external federal agencies in EPA's 
IRIS assessment process, and (3) manage an interagency review process 
in a manner that enhances the quality, transparency, timeliness, and 
credibility of IRIS assessments. In its February 21, 2008, letter 
providing comments on our draft report, EPA said it would consider each 
of our recommendations in light of the new IRIS process the agency was 
developing.

Key Aspects of the Revised IRIS Assessment Process Implemented in April 
                    2008 Which Is Not Responsive to GAO's 
                    Recommendations

    On April 10, 2008, EPA issued a revised IRIS assessment process, 
effective immediately. Overall, EPA's revised process is not responsive 
to the recommendations made in our March 2008 report--it is largely the 
same as the draft proposed process we evaluated in our March 2008 
report (see Appendix III and IV). Moreover, changes EPA did incorporate 
into the final process are likely to further exacerbate the 
productivity and credibility issues we identified in our report.

  We recommended that EPA ensure that, among other things, any 
revised process clearly defines and documents a streamlined IRIS 
assessment process that can be conducted within time frames that 
minimize the need for wasteful rework.

    As discussed in our report, when assessments take longer than two 
years, they can become subject to substantial delays stemming from the 
need to redo key analyses to take into account changing science and 
assessment methodologies. However, EPA's revised process 
institutionalizes a process that the agency estimates will take up to 
six years to complete. Further, the estimated time frames do not factor 
in the time for peer reviews conducted by the National Academies, which 
can take two years to plan and complete.\5\ EPA typically uses reviews 
by the National Academies for highly controversial chemicals or complex 
assessments. Therefore, assessments of key chemicals of concern to 
public health that are reviewed by the National Academies are likely to 
take at least eight years to complete. These time frames must also be 
considered in light of OMB's view that health assessment values in IRIS 
are out of date if they are more than 10 years old and if new 
scientific information exists that could change the health assessment 
values. Thus, EPA's new process institutionalizes time frames that 
could essentially require the agency to start assessment updates as 
soon as two years after assessments are finalized in order to keep the 
IRIS database current. Such time frames are not consistent with our 
recommendation that EPA develop, clearly define, and document a 
streamlined IRIS process that can be conducted within time frames that 
minimize the need for wasteful rework. Further, the agency would need a 
significant increase in resources to support such an assessment cycle.
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    \5\ It is not clear whether the time frames exclude reviews 
conducted by EPA's Science Advisory Board, which can also add 
considerably more time than the most basic level of peer review used by 
the IRIS program--panels organized by an EPA contractor.
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    In addition, EPA had previously emphasized that, in suspending 
assessments to allow agencies to fill in data gaps, it would allow no 
more than 18 months to complete the studies and have them peer 
reviewed. However, under the new process, EPA states that it generally 
will allow no more than 18 months to complete the studies and have them 
peer reviewed. As we concluded in our report, we believe the ability to 
suspend assessments for up to 18 months would add to the already 
unacceptable level of delays in completing IRIS assessments. Further, 
we and several agency officials with whom we spoke believe that the 
time needed to plan, conduct, and complete research that would address 
significant data gaps, and have it peer reviewed, would likely exceed 
18 months. Therefore, the less rigid time frame EPA included in its new 
process could result in additional delays.
    Finally, the new process expands the scope of one of the additional 
steps that initially was to apply only to chemicals of particular 
interest to federal agencies.\6\ Specifically, under the draft process 
we reviewed, EPA would have provided an additional review and comment 
opportunity for federal agencies and the public for what EPA officials 
said would be a small group of chemicals. However, under EPA's new 
process, this additional step has been added to the assessment process 
for all chemicals and, therefore, will add time to the already lengthy 
assessments of all chemicals.
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    \6\ The new IRIS assessment process refers to such chemicals as 
``mission critical.'' The process defines a mission-critical chemical 
as one that ``is an integral component to the successful and safe 
conduct of an agency's mission in any or all phases of its 
operations.'' According to the process, ``impacts on the use of 
mission-critical chemicals include cessation or degradation of the 
conduct of the mission and/or unacceptable resource constraints.''

  We also recommended that the EPA Administrator take steps to 
better ensure that EPA has the ability to develop transparent, credible 
IRIS assessments--an ability that relies in large part on EPA's 
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independence in conducting these important assessments.

    Contrary to our recommendation, EPA has formalized a revised IRIS 
process that is selectively, rather than fully, transparent, limiting 
the credibility of the assessments. Specifically, while the draft 
process we reviewed provided that comments on IRIS assessments from OMB 
and other federal agencies would be part of the public record, under 
the recently implemented process, comments from federal agencies are 
expressly defined as ``deliberative'' and will not be included in the 
public record.\7\ Given the importance and sensitivity of IRIS 
assessments, we believe it is critical that input from all parties, 
particularly agencies that may be affected by the outcome of IRIS 
assessments, be publicly available. However, under EPA's new process, 
input from some IRIS assessment reviewers--representatives of federal 
agencies, including those facing potential regulatory liability, and 
private stakeholders associated with these agencies--will continue to 
receive less public scrutiny than comments from all others.
---------------------------------------------------------------------------
    \7\ Making these comments public would have been a change from the 
OMB/interagency review process that has been in place since 2004.
---------------------------------------------------------------------------
    In commenting on a draft of our March 2008 report, and in a recent 
congressional hearing, EPA's Assistant Administrator, Office of 
Research and Development, stated that the IRIS process is transparent 
because all final IRIS assessments must undergo public and external 
peer review. However, as we stated in our report, the presence of 
transparency at a later stage of IRIS assessment development does not 
explain or excuse its absence earlier. Under the new process, neither 
peer reviewers nor the public are privy to the changes EPA makes in 
response to the comments OMB and other federal agencies provide to EPA 
at several stages in the assessment process--changes to draft 
assessments or to the questions EPA poses to the peer review panels. 
Importantly, the first IRIS assessment draft that is released to peer 
reviewers and to the public includes the undisclosed input from federal 
agencies potentially subject to regulation and therefore with an 
interest in minimizing the impacts of IRIS assessments on their budgets 
and operations.
    In addition, EPA's revised process does not provide EPA with 
sufficient independence in developing IRIS assessments to ensure they 
are credible and transparent. We made several recommendations aimed at 
restoring EPA's independence. For example, we recommended that the EPA 
Administrator ensure that EPA has the ability to, among other things, 
define the appropriate role of external federal agencies in the IRIS 
assessment process and determine when interagency issues have been 
appropriately addressed. However, under the newly implemented IRIS 
assessment process, OMB continues to inform EPA when EPA has adequately 
addressed OMB's and interagency comments. This determination must be 
made both before EPA can provide draft assessments to external peer 
reviewers and to the public and before EPA can finalize and post 
assessments on the IRIS database. While EPA officials state that 
ultimately IRIS assessments reflect EPA decisions, the new process does 
not support this assertion given the clearances EPA needs to receive 
from OMB to move forward at key stages. In fact, we believe the new 
IRIS assessment process may elevate the goal of reaching interagency 
agreement above achieving IRIS program objectives. Further, as 
discussed above, because the negotiations over OMB/interagency comments 
are not disclosed, whether EPA is entirely responsible for the content 
of information on IRIS is open to question.
    In our report, we also emphasized the importance of ensuring that 
IRIS assessments be based solely on science issues and not policy 
concerns. However, under the new IRIS assessment process, EPA has 
further introduced policy considerations into the IRIS assessment 
process. That is, the newly implemented IRIS assessment process 
broadens EPA's characterization of IRIS assessments from ``the agency's 
scientific positions on human health effects that may result from 
exposure to environmental contaminants'' to ``the agency's science and 
science policy positions'' on such effects. EPA's new, broader 
characterization of IRIS raises concerns about the agency's stated 
intent to ensure that scientific assessments are appropriately based on 
the best available science and that they are not inappropriately 
impacted by policy issues and considerations. For example, in 
discussing science and science policy at a recent Senate hearing, EPA's 
Assistant Administrator of Research and Development described science 
policy considerations as including decisions about filling knowledge 
gaps (e.g., whether and to what extent to use default assumptions) and 
assessing weight-of-the-evidence approaches to make scientific 
inferences or assumptions. We believe that these are scientific 
decisions that should reflect the best judgment of EPA scientists who 
are evaluating the data, using the detailed risk assessment guidance 
the agency has developed for such purposes. We have concerns about the 
manner and extent to which other federal agencies, including those that 
may be affected by the outcome of assessments, are involved in these 
decisions as well as the lack of transparency of their input. As we 
highlighted earlier, under the National Academies' risk assessment and 
risk management paradigm, policy considerations are relevant in the 
risk management phase--which occurs after the risk assessment phase 
that encompasses IRIS assessments. The National Academies recently 
addressed this issue as follows: ``The committee believes that risk 
assessors and risk managers should talk with each other; that is, a 
`conceptual distinction' does not mean establishing a wall between risk 
assessors and risk managers. Indeed they should have constant 
interaction. However, the dialogue should not bias or otherwise color 
the risk assessment conducted, and the activities should remain 
distinct; that is, risk assessors should not be performing risk 
management activities.'' \8\
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    \8\ National Academies, Scientific Review of the Proposed Risk 
Assessment Bulletin from the Office of Management and Budget Committee 
to Review the OMB Risk Assessment Bulletin (2007).

Concluding Observations

    The new IRIS assessment process that EPA implemented in April 2008 
will not allow the agency to routinely and timely complete credible 
assessments. In fact, it will exacerbate the problems we identified in 
our March 2008 report and sought to address with our recommendations--
all of which were aimed at preserving the viability of this critical 
database, which is integral to EPA's mission of protecting the public 
and the environment from exposure to toxic chemicals. Specifically, 
under the new process, assessment time frames will be significantly 
lengthened, and the lack of transparency will further limit the 
credibility of the assessments because input from OMB and other 
agencies at all stages of the IRIS assessment process is now expressly 
defined as deliberative and therefore not subject to public disclosure. 
The position of the Assistant Administrator, Office of Research and 
Development, that the IRIS process is transparent because all final 
IRIS assessments must undergo public and external peer review is 
unconvincing. Transparency at a later stage of the IRIS assessment 
process--after OMB and other federal agencies have had multiple 
opportunities to influence the content of the assessment without any 
disclosure of their input--does not compensate for its absence earlier.
    We continue to believe that to effectively maintain IRIS EPA must 
streamline its lengthy assessment process and adopt transparency 
practices that provide assurance that IRIS assessments are 
appropriately based on the best available science and that they are not 
inappropriately biased by policy issues and considerations. As 
discussed in our April 29, 2008, testimony before the Senate 
Environment and Public Works Committee, we believe that the Congress 
should consider requiring EPA to suspend implementation of its new IRIS 
assessment process and develop a streamlined process that is 
transparent and otherwise responsive to our recommendations aimed at 
improving the timeliness and credibility of IRIS assessments.\9\ For 
example, suspending assessments to obtain additional research is 
inefficient; alternatively, with longer-term planning, EPA could 
provide agencies and the public with more advance notice of 
assessments, enabling them to complete relevant research before IRIS 
assessments are started.
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    \9\ GA0, Toxic Chemicals: EPA's New Assessment Process Will 
Increase Challenges EPA Faces in Evaluating and Regulating Chemicals, 
GAO-08-743T (Washington, D.C.: April 29, 2008).
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    In addition, as discussed in our April 2008 testimony, the Congress 
should consider requiring EPA to obtain and be responsive to input from 
the Congress and the public before finalizing a revised IRIS assessment 
process. We note that while EPA and OMB initially had planned for EPA 
to release a draft revised IRIS assessment process to the public, hold 
a public meeting to discuss EPA's proposed changes, and seek and 
incorporate public input before finalizing the process, EPA released 
its new assessment process without obtaining public input and made it 
effective immediately. This was inconsistent with assertions made in 
OMB's letter commenting on our draft report, which emphasized that EPA 
had not completed the development of the IRIS assessment process and 
stated: ``Indeed, the process will not be complete until EPA circulates 
its draft to the public for comments and then releases a final product 
that is responsive to those comments.''
    Finally, if EPA is not able to take the steps we have recommended 
to effectively maintain this critical program, other approaches, 
including statutory requirements, may need to be explored.
    Mr. Chairman, this concludes my prepared statement. I would be 
happy to respond to any questions that you or other Members of the 
Subcommittee may have at this time.

Contacts and Acknowledgments

    Contact points for our Congressional Relations and Public Affairs 
Offices may be found on the last page of this statement. Contributors 
to this testimony include Christine Fishkin (Assistant Director), Laura 
Gatz, Richard P. Johnson, and Nancy Crothers.

Appendix I:

        Examples of Key IRIS Assessments That Have Been Delayed

    Some key IRIS assessments have been in progress for a number of 
years, in part because of delays stemming from one or more of the key 
factors we identified that have hindered EPA's productivity.\10\ 
Examples include the following:
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    \10\ The factors we identified that have hindered EPA's efforts to 
improve productivity are the OMB/interagency review process managed by 
OMB, the growing complexity and scope of risk assessments, certain 
management decisions and issues regarding the IRIS program, 
congressional action that has delayed some assessments with potentially 
significant economic effects, and the compounding effect of delays.

Naphthalene. EPA started the IRIS assessment of cancer risks stemming 
from the inhalation of naphthalene in 2002. Naphthalene is used in jet 
fuel and in the production of widely used commercial products such as 
moth balls, dyes, insecticides, and plasticizers. According to a 
presentation delivered at the 2007 annual meeting of the Society for 
Risk Analysis by an Army Corps of Engineers toxicologist,\11\ ``The 
changing naphthalene regulatory environment includes a draft EPA risk 
assessment that if/when finalized, will change naphthalene's status 
from `possible' to `likely' human carcinogen.'' \12\ Thus, according to 
this presentation, one potential impact of this IRIS assessment on DOD 
is that DOD would need to provide many employees exposed to naphthalene 
with equipment measuring their exposure to the chemical. In addition, 
because many military bases are contaminated with naphthalene, a 
component of jet fuel (approximately one percent to three percent) used 
by all DOD services, DOD could face extensive cleanup costs. By 2004, 
two years after starting the assessment, EPA had drafted a chemical 
assessment that had completed internal peer reviews and was about to be 
sent to an external peer review committee. Once it returned from 
external review, the next step, at that time, would have been a formal 
review by EPA's IRIS Agency Review Committee. If approved, the 
assessment would have been completed and released. However, in part 
because of concerns raised by DOD, OMB asked to review the assessment 
and conducted an interagency review of the draft. In their 2004 reviews 
of the draft IRIS assessment, both OMB and DOD raised a number of 
concerns about the assessment and suggested to EPA that it be suspended 
until additional research could be completed to address what they 
considered to be significant uncertainties associated with the 
assessment. Although all of the issues raised by OMB and DOD were not 
resolved, EPA continued with its assessment by submitting the draft for 
external peer review, which was completed in September 2004.\13\ 
However, according to EPA, OMB continued to object to the draft IRIS 
assessment and directed EPA to convene an additional expert review 
panel on genotoxicity to obtain recommendations about short-term tests 
that OMB thought could be done quickly.\14\ According to EPA, this 
added six months to the process, and the panel, which met in April 
2005, concluded that the research that OMB was proposing could not be 
conducted in the short-term. Nonetheless, EPA officials said that the 
second expert panel review did not eliminate OMB's concerns regarding 
the assessment, which they described as reaching a stalemate. In 
September 2006, EPA decided, however, to proceed with developing the 
assessment. By this time, the naphthalene assessment had been in 
progress for over four years; EPA decided that the IRIS non-cancer 
assessment, issued in 1998, was outdated and needed to be revisited. 
Thus, EPA expanded the IRIS naphthalene assessment to include both non-
cancer and cancer assessments. As a result, six years after the 
naphthalene assessment began, it is now back at the drafting stage. The 
assessment now will need to reflect relevant research completed since 
the draft underwent initial external peer review in 2004, and it will 
have to undergo all of the IRIS assessment steps again, including 
additional internal and external reviews that are now required. This 
series of delays has limited EPA's ability to conduct its mission. For 
example, the Office of Air and Radiation has identified the naphthalene 
assessment as one of its highest-priority needs for its air toxics 
program. In addition, the Office of Solid Waste and Emergency Response 
considers the naphthalene assessment a high priority for the Superfund 
program--naphthalene has been found in at least 654 of Superfund's 
current or former National Priorities List sites.\15\ Although EPA 
currently estimates that it will complete the assessment in 2009, 
meeting this revised estimate will be challenging, given all of the 
steps that are yet to be completed and the extensive external scrutiny 
to which it will continue to be subjected.
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    \11\ Presentations at the Society for Risk Analysis meeting reflect 
the views of the authors and ``do not necessarily reflect the views of 
any other organization or agency.''
    \12\ Using its 1996 Proposed Guidelines for Carcinogen Risk 
Assessment, EPA concluded in the 1998 IRIS assessment of naphthalene 
that its human carcinogenic potential could not be determined at that 
time, but noted that there was suggestive evidence of potential human 
carcinogenicity. (EPA also noted that under its 1986 cancer guidelines, 
EPA classified naphthalene as a possible human carcinogen.) 
Subsequently, in 2002, the International Agency for Research on Cancer 
(IARC), part of the World Health Organization, concluded that 
naphthalene is possibly carcinogenic to humans; in 2004, the Department 
of Human Health and Services' National Toxicology Program concluded 
that naphthalene can reasonably be anticipated to be a human 
carcinogen. EPA's current assessment will be subject to the agency's 
2005 cancer guidelines.
    \13\ According to DOD, EPA did not specifically ask the peer 
reviewers to address some of the technical questions DOD had raised and 
wanted the peer review to address.
    \14\ Genotoxic substances are a type of carcinogen, specifically 
those capable of causing genetic mutation and of contributing to the 
development of tumors. This includes both certain chemical compounds 
and certain types of radiation.
    \15\ The National Priorities List is EPA's list of seriously 
contaminated sites.

Royal Demolition Explosive. This chemical, also called RDX or 
hexahydro-1,3,5-trinitrotriazine, is a highly powerful explosive used 
by the U.S. military in thousands of munitions. Currently classified by 
EPA as a possible human carcinogen, this chemical is known to leach 
from soil to groundwater. Royal Demolition Explosive can cause seizures 
in humans and animals when large amounts are inhaled or ingested, but 
the effects of long-term, low-level exposure on the nervous system are 
unknown. As is the case with naphthalene, the IRIS assessment could 
potentially require DOD to undertake a number of actions, including 
steps to protect its employees from the effects of this chemical and to 
clean up many contaminated sites. Although EPA started an IRIS 
assessment of Royal Demolition Explosive in 2000, it has made minimal 
progress on the assessment because EPA agreed to a request by DOD to 
wait for the results of DOD-sponsored research on this chemical. In 
2007, EPA began to actively work on this assessment, although some of 
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the DOD-sponsored research is still outstanding.

Formaldehyde. EPA began an IRIS assessment of formaldehyde in 1997 
because the existing assessment was determined to be outdated.\16\ 
Formaldehyde is a colorless, flammable, strong-smelling gas used to 
manufacture building materials, such as pressed wood products, and used 
in many household products, including paper, pharmaceuticals, and 
leather goods. While EPA currently classifies formaldehyde as a 
probable human carcinogen, the International Agency for Research on 
Cancer (IARC), part of the World Health Organization, classifies 
formaldehyde as a known human carcinogen. Since 1986, studies of 
industrial of workers have suggested that formaldehyde exposure is 
associated with nasopharyngeal cancer, and possibly with leukemia. For 
example, in 2003 and 2004, the National Cancer Institute (NCI) and the 
National Institute of Occupational Safety and Health (NIOSH) released 
epidemiological studies following up on earlier studies tracking about 
26,000 and 11,000 industrial workers, respectively, exposed to 
formaldehyde; the updates showed exposure to formaldehyde might also 
cause leukemia in humans, in addition to the cancer types previously 
identified. According to NCI officials, the key findings in their 
follow-up study were an increase in leukemia deaths and, more 
significantly, an exposure/response relationship between formaldehyde 
and leukemia--as exposure increased, the incidence of leukemia also 
rose. As with the earlier study, NCI found more cases of a rare form of 
cancer, nasopharyngeal cancer, than would usually be expected. The 
studies from NCI and NIOSH were published in 2003 and 2004,\17\ around 
the time that EPA was still drafting its IRIS assessment. In November 
2004, the Chairman of the Senate Environment and Public Works Committee 
requested that EPA delay completion of its IRIS assessment until an 
update to the just-released NCI study could be conducted, indicating 
that the effort would take, at most, 18 months. EPA agreed to wait--and 
more than three years later, the NCI update is not yet complete. As of 
December 2007, NCI estimates that the study will be completed in two 
stages, one in mid-2008 and the second one later that year. An NCI 
official said that the additional leukemia deaths identified in the 
update provide ``greater power'' to detect associations between 
exposure to formaldehyde and cancer. EPA's inability to complete the 
IRIS assessment it started more than 10 years ago in a timely manner 
has had a significant impact on EPA's air toxics program. Specifically, 
when EPA promulgated a national emissions standard for hazardous air 
pollutants covering facilities in the plywood and composite wood 
industries in 2004, EPA's Office of Air and Radiation took the unusual 
step of not using the existing IRIS estimate but rather decided to use 
a cancer risk estimate developed by an industry-funded organization, 
the CIIT Centers for Health Research (formerly, the Chemical Industry 
Institute of Toxicology) that had been used by the Canadian health 
protection agency. The IRIS cancer risk factor had been subject to 
criticism because it was last revised in 1991 and was based on data 
from the 1980s. In its final rule, EPA stated that ``the dose-response 
value in IRIS is based on a 1987 study, and no longer represents the 
best available science in the peer-reviewed literature.'' The CIIT 
quantitative cancer risk estimate that EPA used in its health risk 
assessment in the plywood and composite wood national emissions 
standard indicates a potency about 2,400 times lower than the estimate 
in IRIS that was being re-evaluated and that did not yet consider the 
2003 and 2004 NCI and NIOSH epidemiological studies. According to an 
EPA official, an IRIS cancer risk factor based on the 2003 and 2004 NCI 
and NIOSH studies would likely be close to the current IRIS assessment, 
which EPA has been attempting to update since 1997. The decision to use 
the CIIT assessment in the plywood national emissions standard was 
controversial, and officials in EPA's National Center for Environmental 
Assessment said the center identified numerous problems with the CIIT 
estimate. Nonetheless, the Office of Air and Radiation used the CIIT 
value, and that decision was a factor in EPA exempting certain 
facilities with formaldehyde emissions from the national emissions 
standard. In June 2007, a federal appellate court struck down the rule, 
holding that EPA's decision to exempt certain facilities that EPA 
asserted presented a low health risk exceeded the agency's authority 
under the Clean Air Act.\18\ Further, the continued delays of the IRIS 
assessment of formaldehyde--currently estimated to be completed in 2010 
but after almost 11 years still in the draft development stage--will 
impact the quality of other EPA regulatory actions, including other air 
toxics rules and requirements.
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    \16\ The cancer portion of the formaldehyde assessment was 
originally issued in 1989 and updated in 1991; the non-cancer 
assessment was added in 1990.
    \17\ NCI published the results of its study in two publications. 
The first study, published in November 2003, focused on the association 
between formaldehyde exposure and leukemia. M. Hauptmann, J.H. Lubin, 
P.A. Stewart, R.B. Hayes, A. Blair, ``Mortality from 
Lymphohematopoietic Malignancies among Workers in Formaldehyde 
Industries,'' Journal of the National Cancer Institute (2003). The 
second study, published in June 2004, evaluated the association between 
formaldehyde exposure and other cancers--including nasopharyngeal 
cancer. M. Hauptmann, J.H. Lubin, P.A. Stewart, R.B. Hayes, A. Blair, 
``Mortality from Solid Cancers among Workers in Formaldehyde 
Industries,'' American Journal of Epidemiology (2004). The results of 
the NIOSH study were described in one publication, dated March 2004, 
which assessed mortality from all causes and all cancers. L.E. 
Pinkerton, M.J. Hein, L.T. Stayner, ``Mortality among a Cohort of 
Garment Workers Exposed to Formaldehyde: an Update,'' Occupational and 
Environmental Medicine (2004).
    \18\ Natural Resources Defense Council v. E.P.A., 489 F.3d 1364, 
1372-73 (D.C. Cir, 2007). The court did not specifically address EPA's 
reliance on the CIIT study, holding instead that the Clean Air Act 
prohibited establishment of the exemptions at issue.

Trichloroethylene. Also known as TCE, this chemical is a solvent widely 
used as a degreasing agent in industrial and manufacturing settings; it 
is a common environmental contaminant in air, soil, surface water, and 
groundwater. TCE has been linked to cancer, including childhood cancer, 
and other significant health hazards, such as birth defects. TCE is the 
most frequently reported organic contaminant in groundwater, and 
contaminated drinking water has been found at Camp Lejeune, a large 
Marine Corps base in North Carolina. TCE has also been found at 
Superfund sites and at many industrial and government facilities, 
including aircraft and spacecraft manufacturing operations. In 1995, 
the International Agency for Research on Cancer classified TCE as a 
probable human carcinogen, and in 2000, the Department of Health and 
Human Services' National Toxicology Program concluded that it is 
reasonably anticipated to be a human carcinogen. Because of questions 
raised by peer reviewers about the IRIS cancer assessment for TCE, EPA 
withdrew it from IRIS in 1989 but did not initiate a new TCE cancer 
assessment until 1998. In 2001, EPA issued a draft IRIS assessment for 
TCE that proposed a range of toxicity values indicating a higher 
potency than in the prior IRIS values and characterizing TCE as 
``highly likely to produce cancer in humans.'' The draft assessment, 
which became controversial, was peer reviewed by EPA's Scientific 
Advisory Board and released for public comment. A number of scientific 
issues were raised during the course of these reviews, including how 
EPA had applied emerging risk assessment methods--such as assessing 
cumulative effects (of TCE and its metabolites) and using a 
physiologically based pharmacokinetic model--and the uncertainty 
associated with the new methods themselves.\19\ To help address these 
issues, EPA, DOD, DOE, and NASA sponsored a National Academies review 
to provide guidance. The National Academies report, which was issued in 
2006, concluded that the weight of evidence of cancer and other health 
risks from TCE exposure had strengthened since 2001 and recommended 
that the risk assessment be finalized with currently available data so 
that risk management decisions could be made expeditiously. The report 
specifically noted that while some additional information would allow 
for more precise estimates of risk, this information was not necessary 
for developing a credible risk assessment. Nonetheless, 10 years after 
EPA started its IRIS assessment, the TCE assessment is back at the 
draft development stage. EPA estimates this assessment will be 
finalized in 2010. More in line with the National Academies' 
recommendation to act expeditiously, five senators introduced a bill in 
August 2007 that, among other things, would require EPA to both 
establish IRIS values for TCE and issue final drinking water standards 
for this contaminant within 18 months.
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    \19\ Physiologically based pharmacokinetic models are a class of 
dosimetry models that are useful for predicting internal doses to 
target organs. With the appropriate data, these models can be used to 
extrapolate across species and exposure scenarios and address various 
sources of uncertainty in risk assessments.

Tetrachloroethylene. EPA started an IRIS assessment of 
tetrachloroethylene--also called perchloroethylene or ``perc''--in 
1998. Tetrachloroethylene is a manufactured chemical widely used for 
dry cleaning of fabrics, metal degreasing, and making some consumer 
products and other chemicals. Tetrachloroethylene is a widespread 
groundwater contaminant, and the Department of Health and Human 
Services' National Toxicology Program has determined that it is 
reasonably anticipated to be a carcinogen. The IRIS database currently 
contains a 1988 non-cancer assessment based on oral exposure that will 
be updated in the ongoing assessment. Importantly, the ongoing 
assessment will also provide a non-cancer inhalation risk and a cancer 
assessment. The IRIS agency review of the draft assessment was 
completed in February 2005, the draft assessment was sent to OMB for 
OMB/interagency review in September 2005, and the OMB/interagency 
review was completed in March 2006. EPA had determined to have the next 
step, external peer review, conducted by the National Academies--the 
peer review choice reserved for chemical assessments that are 
particularly significant or controversial. EPA contracted with the 
National Academies for a review by an expert panel, and the review was 
scheduled to start in June 2006 and be completed in 15 months. However, 
as of December 2007, the draft assessment had not yet been provided to 
the National Academies. After verbally agreeing with both the non-
cancer and cancer assessments following briefings on the assessments, 
the Assistant Administrator, Office of Research and Development, 
subsequently requested that additional uncertainty analyses--including 
some quantitative analyses--be conducted and included in the assessment 
before the draft was released to the National Academies for peer 
review. As discussed in our March 2008 report on IRIS (GAO-08-440), 
quantitative uncertainty analysis is a risk assessment tool that is 
currently being developed, and although the agency is working on 
developing policies and procedures for uncertainty analysis, such 
guidance currently does not exist. The draft tetrachloroethylene 
assessment has been delayed since early 2006 as EPA staff have gone 
back and forth with the Assistant Administrator trying to reach 
agreement on key issues such as whether a linear or nonlinear model is 
most appropriate for the cancer assessment and how uncertainty should 
be qualitatively and quantitatively characterized. EPA officials and 
staff noted that some of the most experienced staff are being used for 
these efforts, limiting their ability to work on other IRIS 
assessments. In addition, the significant delay has impacted the 
planned National Academies peer review because the current contract, 
which has already been extended once, cannot be extended beyond 
December 2008. The peer review was initially estimated to take 15 
months. As a result, a new contract and the appointment of another 
---------------------------------------------------------------------------
panel may be required.

Dioxin. The dioxin assessment is an example of an IRIS assessment that 
has been, and will likely continue to be, a political as well as a 
scientific issue. Often the byproducts of combustion and other 
industrial processes, complex mixtures of dioxins enter the food chain 
and human diet through emissions into the air that settle on soil, 
plants, and water. EPA's initial dioxin assessment, published in 1985, 
focused on the dioxin TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin) 
because animal studies in the 1970s showed it to be the most potent 
cancer-causing chemical studied to date. Several years later, EPA 
decided to conduct a reassessment of dioxin because of major advances 
that had occurred in the scientific understanding of dioxin toxicity 
and significant new studies on dioxins' potential adverse health 
effects. Initially started in 1991, this assessment has involved 
repeated literature searches and peer reviews. For example, a draft of 
the updated assessment was reviewed by a scientific peer review panel 
in 1995, and three panels reviewed key segments of later versions of 
the draft in 1997 and 2000. In 2002, EPA officials said that the 
assessment would conclude that dioxin may adversely affect human health 
at lower exposure levels than had previously been thought and that most 
exposure to dioxins occurs from eating such American dietary staples as 
meats, fish, and dairy products, which contain minute traces of 
dioxins. These foods contain dioxins because animals eat plants and 
commercial feed and drink water contaminated with dioxins, which then 
accumulate in animals' fatty tissue. It is clear that EPA's dioxin risk 
assessment could have a potentially significant impact on consumers and 
on the food and agriculture industries. As EPA moved closer to 
finalizing the assessment, in 2003 the agency was directed in a 
congressional appropriations conference committee report to not issue 
the assessment until it had been reviewed by the National Academies. 
The National Academies provided EPA with a report in July 2006. In 
developing a response to the report, which the agency is currently 
doing, EPA must include new studies and risk assessment approaches that 
did not exist when the assessment was drafted. EPA officials said the 
assessment will be subject to the IRIS review process once its response 
to the National Academies' report is drafted. As of 2008, EPA has been 
developing the dioxin assessment, which has potentially significant 
health implications for all Americans, for 17 years.












                    Biography for John B. Stephenson
    John Stephenson has been the Director of Environmental Protection 
Issues within GAO's Natural Resources and Environment team since 
October 2000. He began his GAO career with the Dayton Field Office 
(formerly Cincinnati Regional Office) where he focused primarily on 
acquisition management, defense capabilities, and information 
technology issues. In 1987, he transferred to Headquarters as an 
Assistant Director in the Accounting and Information Management 
Division (the forerunner of the IT, SI, and FMA teams). In that 
capacity he directed numerous projects, assisted in several 
testimonies, and issued over 100 reports on information technology 
issues. From April 1998-February 2000, he was detailed to the Senate 
Special Committee on the Year 2000 Technology Problem where he was the 
Deputy Staff Director. In that capacity, he ran the day-to-day 
operations of the Committee including establishing strategy and 
agendas, managing the staff, overseeing investigations, conducting over 
35 hearings, and representing the Chairman (Senator Bennett, R-UT) and 
the Vice Chairman (Senator Dodd, D-CT) in a variety of forums. He was 
appointed to GAO's Executive Candidate Program in June 1999. From 
March-October 2000, he worked in the Office of the Comptroller General 
and directed GAO's mission support reorganization and realignment 
project for the Chief Mission Support Officer. John holds a BS degree 
in Industrial Management from Purdue University, an MBA from Xavier 
University, and is a graduate of the Harvard Kennedy School of 
Government's Senior Executive Fellows program.

                               Discussion

                        The Revised IRIS Process

    Chairman Miller. Thank you. At this point, we will have our 
first round of questions. The Chair now recognizes himself for 
five minutes.
    I would like to ask Mr. Whittaker to display a chart, 
Figure 1, if you would, please.




    Chairman Miller. Mr. Stephenson, displayed there is I 
believe an EPA-prepared chart that describes the IRIS process 
that existed before 2004. Is that--before OMB made helpful 
changes, helpful suggestions, about what the process should be 
instead. Is that correct?
    Mr. Stephenson. That looks like a reasonable 
representation. We have a little bit different one in our 
testimony but----
    Chairman Miller. Okay. Now, if Mr. Whittaker could then 
display Figure 3.




    Chairman Miller. All right. Is that the current process? 
That also is an EPA-prepared document to show their process.
    Mr. Stephenson. Yes. That looks like some of the new steps 
that have been inserted in the new process.
    Chairman Miller. Okay. It will be the testimony of the 
later witnesses today that that process is the streamlined 
version of the earlier process and that we should not believe 
our own lying eyes that this really is more streamlined than 
the previous process. Is it your testimony or your belief that 
it is in fact a more complicated, convoluted process, not a 
streamlined process?
    Mr. Stephenson. It appears to be more complicated, but if 
you put the individual timeframes associated with each of those 
steps, we didn't invent the six to eight years, it is based on 
adding up the amount of time that could be taken for each of 
those steps and two years additional for any chemical that is 
deemed mission critical.
    Chairman Miller. But just if our eyes tell us that this 
looks a lot more complicated, our eyes did not lie?
    Mr. Stephenson. Not in our opinion.

           Did OMB Review EPA's GAO Exit Conference Comments?

    Chairman Miller. All right. Thank you. Mr. Stephenson, one 
of your findings was that the EPA needed to be more independent 
and that the lack of independence was undermining the 
credibility of IRIS assessments. Is it your typical procedure 
to show proposed findings to the agency that you have been 
examining?
    Mr. Stephenson. Yes, there is a two-step process. Whenever 
GAO completes a review, we hold what we call an exit conference 
with the affected agency, usually at the program level; and it 
is really a fact check, if you will, to make sure that we have 
characterized the facts correctly. We did that and then when we 
go back and consider those comments, and we publish a draft 
report which we then pass by the agency for official review. In 
this case, we passed the final report by both EPA and OMB since 
both were affected.
    Chairman Miller. And what was the result of that review?
    Mr. Stephenson. Well, the first process is not considered 
official agency comments because it isn't blessed all the way 
up the chain. Nevertheless, it represents the views of the 
program office people who run IRIS, and in that case they felt 
like the interagency review process that was being levied on 
them was indeed adding time to the process. And not only that, 
they felt like they could not move forward without an OMB 
blessing at several points along the way when they had 
adequately responded to concerns of the other agencies and OMB.
    So in that sense, this science agency that, as you 
mentioned, is set up in statute to be a science agency was kind 
of, in our view, being obstructed by other agencies that don't 
have that as their primary mission.
    Chairman Miller. And in their own view based on what they 
said to you.
    Mr. Stephenson. Yes. I mean, OMB will tell you that EPA 
owns the IRIS process, but it depends upon which part of OMB 
you talk to. The management agenda part of OMB says that EPA 
loses control of the process when they send a draft assessment 
to OMB, yet the OIRA part of OMB will tell you that EPA still 
owns the process, and they are only serving to coordinate the 
federal family of comments.
    Chairman Miller. Have they stuck with that initial response 
to the GAO's facts?
    Mr. Stephenson. They asked that we not consider the exit 
conference comments of the program office officials and instead 
consider the official agency comments which no longer 
considered the interagency process as obstructive or taking 
additional time, rather that the real thing that took time was 
the complexity of IRIS assessments.
    Chairman Miller. Okay. So OMB told them that they were in 
fact independent? They misapprehended the facts when they said 
that they were not independent, OMB advised them that they 
were, and now it is their view that they are?
    Mr. Stephenson. They are the decision-makers according to 
OMB.
    Chairman Miller. My time is almost expired, but I have two 
documents that have been provided to the Minority which I 
believe are the initial response of the staff of IRIS, and then 
the official response. And I now enter both of these into the 
record.
    [The information follows:]

    
    
    
    
    
    
    
    

    Chairman Miller. My time is now expired. Mr. Reichert for 
five minutes.

                            The IRIS Process

    Mr. Reichert. Thank you, Mr. Chairman. Thank you for being 
here with us this morning, sir. I have a question about 
balancing priorities. How do you balance the competing 
priorities of timeliness and thoroughness?
    Mr. Stephenson. In science, that is always an issue. As I 
said in my statement, the science is never going to be 
absolutely certain on a given chemical, but in the judgment of 
the scientific community, they have to decide when protecting 
human health should be undertaken. You have to get into a cycle 
of risk assessments that takes about two to four years. To have 
it take 10 years, you will never finish anything. Chemicals 
should be reassessed after 10 years, so it is obvious that you 
won't make any progress at two per year. You need more like 50 
a year.
    Mr. Reichert. But to follow up on that, until this new 
process was released, were there any schedules imposed at any 
point in this process?
    Mr. Stephenson. That was part of the problem. There were no 
schedules imposed. So now there is a schedule imposed on that 
complex flow chart you just saw, and if you add all those up, 
the minimum you can complete an assessment in is six years. In 
other words, that is an unacceptable schedule.
    Mr. Reichert. Mr. Chairman, I will yield back.
    Chairman Miller. Thank you. Mr. Baird for five minutes.

                        Delayed Risk Assessments

    Mr. Baird. Have you got any insights into what the costs of 
the current situation is in terms of the relatively slow pace 
and some bias of information?
    Mr. Stephenson. Well, I mean, if you don't have a credible 
risk assessment, you can't move from the risk assessment 
process to the risk management process. The risk management 
process is where you start determining what regulatory options 
are appropriate. So the cost and lack of protection to human 
health, I don't know how you would measure that, but it has got 
to be enormous if you are not getting these risk assessments 
completed in time. Now, you know, they can use other sources of 
science. They don't have to use IRIS, and they have in some 
cases done that. Nevertheless, IRIS was put in place to 
streamline the scientific process so that we get on with the 
business of determining which regulatory options were 
appropriate for a given chemical.
    Mr. Baird. You know, I have witnessed a pattern in the 
past. I spent a fair bit of time doing research on the area of 
risk analysis, and a rhetorical pattern which is, well, of 
course we need to protect the public, but we must make that 
protection based on the best available science. And if the 
corollary is that you make interventions to slow down or 
obstruct or obfuscate the best available science, you then 
allow the prior argument to occur. Is there any of that going 
on where people are saying, well, we can't regulate because we 
don't have the information but then obstructing the access to 
the information?
    Mr. Stephenson. I mean, we are not trying to say that there 
is intentional obstruction going on. We didn't try to find 
that. But that is why we do believe transparency in the entire 
process is so critical. It removes the perception of a conflict 
of interest. We encourage DOD and DOE and any agency to provide 
comments on risk assessments, but it should be in the sunlight, 
it should be available to the scientific community for 
scrutiny, the same as any other comments from any other 
organization is.
    Mr. Baird. What recourse exists? If you are a scientist 
working for an agency, and you have in your best scientific 
judgment made a case in a certain direction, and it heads to 
another entity and comes back in some way different than what 
you had put forward, what options exist right now?
    Mr. Stephenson. Well, I mean, that is why independence of 
EPA is so important. They have to own the process. You have to 
hope that the credibility of the science will rule and that 
they will consider legitimate comments appropriately and 
address those kinds of concerns appropriately. But to keep all 
that from public view is not a good thing.
    Mr. Baird. Yeah, that is my question. So do we believe it 
has happened that someone has put forward a report that went to 
a different entity, let us say OMB, the scientific judgment in 
the initial report is in some way altered, influenced, 
undermined, blocked, and then it comes back and is disseminated 
in a fashion different than the initial input?
    Mr. Stephenson. I don't know that, but OMB, DOD, anybody 
can challenge the assumptions within the assessment, the 
uncertainty analysis, exposure characteristics. And so they can 
ask for additional research if they think there are gaps in the 
research which can take up to two years. There is a certain 
amount of ad hocness to the whole process that is secretive 
right now, and you just can't tell what is going on. And to say 
again that there is transparency in the final assessment does 
not excuse its absence early in the process when you need to 
see what is going on with these decisions.
    Mr. Baird. Right. And let me ask this question. If someone 
were to ask for--in the IRIS process, if someone says, okay, so 
this is our best available science at the present moment 
regarding risk of exposure at certain levels----
    Mr. Stephenson. Right.
    Mr. Baird.--we don't ever expect to have the final answer 
on all these chemicals. What IRIS I thought was to get the best 
available evidence out there.
    Mr. Stephenson. That is what we are suggesting, that you 
should take available research, do the best assessment you can, 
put it into the database, and the intention is to revisit it at 
least every 10 years or when new science becomes available. So 
it should be a moving database that is the repository for the 
best available science on any chemical.
    Mr. Baird. If that is the case then, requests for 
additional information that are delaying should not necessarily 
delay publication of a position, they should be included as a 
corollary opinion or a statement, an explicit statement; but 
here is a question that is unresolved, but you don't 
necessarily delay moving forward with the information, right?
    Mr. Stephenson. But all of that rationale for moving 
forward or considering that science later and the next 
reassessment of that chemical should be open to the science 
community for scrutiny.
    Mr. Baird. Right. Right. I think that is right. But I think 
there is a difference between saying we are not going to move 
forward with something----
    Mr. Stephenson. Right.
    Mr. Baird.--until we get the additional information versus 
move forward with what you have got with the caveat explicitly 
stated that while we put this forward, there are these 
additional questions. What you are saying right now is that the 
additional questions can block moving forward.
    Mr. Stephenson. Exactly. If you wait until the science is 
perfect, you will never regulate, you will never complete a 
toxicity assessment. So it is always a judgment call, and it is 
only the first step to deciding whether you need to regulate or 
not. It doesn't mean anything. It is just the best available 
science on that chemical at the time.
    Mr. Baird. Thank you.
    Chairman Miller. Thank you, Mr. Baird. Mr. Rohrabacher for 
five minutes.

                Comparing Risk Assessments: EPA vs. FDA

    Mr. Rohrabacher. I have been trying to put into perspective 
the discussions on this particular issue compared to some of 
the other issues that we face. You seem to be telling us we 
need to speed up assessments in the process. Certainly I 
wouldn't disagree with the concept about transparency and 
openness. In terms of speed, now let me note that in other 
areas where we have people taking the----
    Chairman Miller. Mr. Rohrabacher, it is very hard to hear 
you. Your mic----
    Mr. Rohrabacher. Excuse me. I will get a little--have to 
lean down a little closer. The assessment time that, for 
example, that the FDA takes in approving a new drug or 
approving a new medical process that could be sold on the 
market, would you think that we should be speeding up those 
type of assessments?
    Mr. Stephenson. Well, I think they should all be made 
efficient. This is entirely different. This is toxic chemicals. 
They are not things that you consume, not things that you eat.
    Mr. Rohrabacher. Well, but----
    Mr. Stephenson. And we----
    Mr. Rohrabacher. Actually it is something you consume.
    Mr. Stephenson. Well, IRIS----
    Mr. Rohrabacher. Something that will affect people's health 
and it will affect in a big way whether or not certain people 
live or die, and frankly with the FDA approval, we have the 
same situation. There are people who wait for years and are 
told, oh, boy, the FDA has approved this and it is going to 
save 100,000 people a year but it has taken them 10 years to 
get it on the market, and it hasn't changed a bit in 10 years. 
And so we have to assume that 100,000 people a year have been 
negatively affected by not having it available to them. So why 
is there a dichotomy then between speeding up the assessment 
now but not wanting to speed up the FDA assessments?
    Mr. Stephenson. Let me just say that IRIS, you don't start 
from scratch in researching the chemical. It is based on a body 
of research that is already available. So you are not starting 
from ground zero. It is not a new drug that has been 
introduced, it is not consumed. You may be exposed to it in a 
variety of ways, airborne ways. You are not ingesting it like a 
food product or a drug. So the standards are completely 
different. Speeding up to me means you start with the available 
assignments right now and you create a system where you can 
complete the synopsis of a summary of that scientific 
information on a given chemical in about two years. Then you 
are going to revisit it as new research becomes available. But 
if you never finish the risk assessment in the first place, 
then EPA can't move to the next step of determining what is 
appropriate in terms of regulating or not a given chemical. 
This is the first step to regulating or deciding what you need 
to regulate a dangerous chemical. This is deciding how 
dangerous it is. It is based on existing research, not new 
research necessarily.
    Mr. Rohrabacher. Well, I think in both situations you have 
people's lives at stake or at least their health at stake. And 
it seems to me that there is a sort of predetermined reaction 
with certain people that some are trying to basically protect 
the public to the point that the public is sometimes damaged by 
that and sometimes it is not. Sometimes you can be overly 
protected and find that the person who is trying to actually 
end up helping you is doing something that prevents you from 
improving your situation.
    Mr. Stephenson. In your example, you are denying a drug 
that may save lives in the future. In my example, you are not 
moving forward with regulations on a chemical that may protect 
human health until you wait for the science to be perfect. It 
is a judgment call in both cases. You are absolutely right. But 
we are suggesting that if you wait until the science is 
perfect, then there is many more years of a potentially 
dangerous chemical that could affect public health.
    Mr. Rohrabacher. As could public health be affected by 
people who take too long in assessing something that could have 
a dramatic impact on cancer or some other malady.
    Thank you very much. I appreciate your testimony.

                  Risk Assessment vs. Risk Management

    Chairman Miller. Thank you. Mr. Stephenson, if I could get 
Mr. Whittaker again to put up the streamlined process, Figure 
3.
    While it is coming up, Mr. Stephenson, quickly, explain 
again in a sentence or two the difference between risk 
assessment and risk management.
    Mr. Stephenson. Risk assessment is when you are really 
synthesizing the best available research on a given chemical to 
determine the toxicity of that chemical.
    Chairman Miller. What danger does this chemical pose.
    Mr. Stephenson. What danger does it potentially pose.
    Chairman Miller. What is risk management?
    Mr. Stephenson. Risk management is when you take that 
information and you decide how serious it is, how many people 
are affected, what regulatory options might be available, what 
would be the cost benefit of instituting those regulations, and 
it is a whole separate process that starts after the risk 
assessment is complete.
    Chairman Miller. Mr. Rohrabacher talked about some people--
I thought he was probably calling my name--who thought we 
should be doing, you know, a good deal more to protect people 
from risk. Is that not risk management rather than risk 
assessment?
    Mr. Stephenson. It is.
    Chairman Miller. Okay. So this is simply trying to decide 
what danger to the public health and to the environment a 
chemical may pose.
    Mr. Stephenson. And until you know that you don't know 
what----
    Chairman Miller. You don't know what to do about it.
    Mr. Stephenson. Right.
    Chairman Miller. Or whether you need to do anything about 
it.
    Mr. Stephenson. That is right.

    
    

    Chairman Miller. Or how to proceed with any kind of risk or 
cost benefit analysis, is that correct? Okay. Now, you talked 
about transparency. Again, looking at Figure 3, and I assume 
that you have got it before you which may be easier on your 
neck to look down, but could you kind of walk through the 
various steps where there is no public participation, there is 
no transparency?
    Mr. Stephenson. I don't have it in front of me 
unfortunately but----
    Chairman Miller. Can you turn so you can see it?
    Mr. Stephenson. Where there is no public participation is 
when EPA is starting its draft assessment process and other 
agencies can comment on the approach and on what things should 
be considered on, if they have research they can bring it 
forward. With glasses on I can't see that.
    Chairman Miller. This is the Science Committee, and the 
Science and Technology Committee doesn't mean that we are all 
adept at technology.
    Mr. Stephenson. Well, I think it is probably, it is hard to 
tell. I mean, this is a very confusing process, but in general, 
it is the part where they look at the draft assessment, 
determine if additional research is needed, what default 
assumptions might be appropriate, what toxicity assessments 
might be appropriate.
    Chairman Miller. And the agencies that are using the 
chemical presumably would have a chance to comment at that 
point?
    Mr. Stephenson. Exactly. Like I say, I disagree with this 
in your risk assessment. You may need to do this additional 
research or you need to consider that.
    Chairman Miller. We are using again the example of TCE. Is 
it your impression that the DOD's toxicologist would be 
participating or someone else or do you know?
    Mr. Stephenson. I don't know.
    Chairman Miller. Just someone at Department of Defense 
would presumably be participating. How about TCE manufacturers?
    Mr. Stephenson. I don't know.
    Chairman Miller. You don't know if they would be given an 
opportunity to comment privately or publicly? Well, we know 
they could comment publicly.
    Mr. Stephenson. TCE is a degreaser that is widely used in 
motor pools and in gas stations across the country. It is used 
everywhere.
    Chairman Miller. If the Department of Defense's point is, 
we really need to use this or our stuff isn't going to work 
right, that is really more risk management than risk 
assessment?
    Mr. Stephenson. It is. If they have concerns about the cost 
of cleaning up TCE based on a given standard, that is all risk 
management decisions.
    Chairman Miller. And if they are saying this TCE is just 
not going to hurt you, it doesn't pose any kind of 
environmental risk, it doesn't pose any kind of health risk, 
that is risk assessment.
    Mr. Stephenson. Exactly.
    Chairman Miller. Okay. And wouldn't you expect scientists 
to be involved in risk assessment?
    Mr. Stephenson. That is our assertion.
    Chairman Miller. Is there any reason that if their 
toxicologists are participating in this it wouldn't be an open, 
transparent process, it wouldn't be peer reviewed, it wouldn't 
be an open, transparent discussion, argument, disputation, 
asserting facts in public for them to be questioned by other 
scientists, other peers, expert in the field? Is there any 
reason that kind of debate should be private?
    Mr. Stephenson. We can't imagine a scientific concern that 
shouldn't be made public.
    Chairman Miller. All right. And what expertise in science 
does OMB have?
    Mr. Stephenson. I don't know.
    Chairman Miller. Is that part of their mission to your 
knowledge?
    Mr. Stephenson. There is no ``s'' in OMB so I don't know.
    Chairman Miller. There is no public health, there is no 
environment, it is all management and budget. Okay. Mr. Baird, 
four or five minutes.

                          GAO Recommendations

    Mr. Baird. Mr. Stephenson, if there would be an ``s'' it 
would be OMBS.
    Mr. Stephenson. You said that, I didn't.
    Chairman Miller. That is the line of questioning I was 
pursuing earlier. Can you talk a little bit about what it would 
take to change the current situation. Is this something we need 
to deal with statutorily or do we need to just say to those who 
would meddle inappropriately, knock it off or what do we do?
    Mr. Stephenson. Again, we had eight specific 
recommendations that EPA said it would consider in our report, 
and it did not. Other than loosely assigning some timeframes to 
this cumbersome process, I can't imagine what recommendations 
they did consider. So that is why we suggest in our testimony--
you have got to remember that the report was written before 
this new process was unveiled on April the 10th. Our report was 
in March. And so we were frankly very surprised when this 
process came out, and we mentioned there may be a need for 
legislation. Certainly we would recommend stopping this 
process, but there may be--if EPA is unable to make the changes 
we suggest in our report, then legislative action may be needed 
to establish timeframes and establish a process for them. That 
is not the desired approach, but I am not sure what else can be 
done.
    Mr. Baird. And you don't seem to have seen much evidence 
that they are going to follow these recommendations?
    Mr. Stephenson. To the contrary. I think this process is 
worse than the draft we reviewed because of the transparency 
issue, because of the many bites at the apple that agencies 
with a conflict of interest like DOD have that is now secretive 
and not public. And all this is new from the draft proposal. 
But we are encouraging agencies to participate in the process 
early, it just should be done in the sunlight and with better 
planning and advanced notice of when you are going to do 
assessment. There is no reason why this process can't be 
shortened and still be very, very credible.
    Mr. Baird. Have any cogent arguments been made or what are 
the arguments that are made for keeping the shades drawn and 
not letting the sunlight in?
    Mr. Stephenson. The only thing that came up was the quality 
of the assessments. If you take 10 years, the quality doesn't 
make much difference because it is obsolete the day it is 
finished. So there have been no good arguments that I can see 
why this process can't be streamlined and improved, and it is 
so, so critical to the protection of human health that we just 
have to get it fixed.
    Mr. Baird. In science there are some occasions where things 
are confidential, identity of peer reviewers and peer review. I 
think it is actually an error to do that myself. But certainly 
the data are supposed to be made available.
    Mr. Stephenson. The data, the assumptions, the process----
    Mr. Baird. Methodology.
    Mr. Stephenson.--the methodology. Everything should be 
totally open. How are you going to assure that the best science 
is considered and is in there if it is not an open process?
    Mr. Baird. This is admittedly a little bit extreme but 
under the current situation, risk analysis, risk assessment 
could be sent up. Somebody with OMB or some other agency could 
say, yes, but you haven't studied this impact in the strain of 
Norwegian rats R24A6. You haven't done this with R24A2, and we 
won't let you go forward until you do R24A6 and just sort of 
throw that out there, whether or not it is relevant but 
nevertheless results in a significant delay. Is that----
    Mr. Stephenson. It could happen. I mean, we have no 
evidence of that, but if it is not open to scrutiny by the 
scientific community, things like that could happen. It could 
be continually be assessed. If it is continually assessed, it 
is never regulated.
    Mr. Baird. But if it were made available, then people would 
have transparency and say possibly, thank goodness for this 
agency doing their job. It turns out that the assessment had 
not looked at something important, and then the people who 
asked that more be looked at were doing a good job and a good 
public service. Or conversely, the publicity or the 
transparency could lead some to say they are asking tangential, 
ridiculous, and unjustified questions which are not 
scientifically defensible. It could go either way, right?
    Mr. Stephenson. Exactly. Very well said.
    Mr. Baird. Thank you. I would yield back.
    Chairman Miller. Mr. Rohrabacher for five minutes.

              More on Risk Assessment vs. Risk Management

    Mr. Rohrabacher. Yes, I am not sure if I agree with the 
Chairman on his emphasis of differentiating risk management 
from risk assessment. Obviously, we live in a real world. What 
we have to do is make sure the activities that are being 
conducted relate to exactly what the impacts will be and not 
just state theoretical standard not associated with the way 
things happen in our lives. Is it possible for the OMB to come 
in earlier? Scientists, I have a great deal of respect for 
scientists, but I also know that sometimes scientists become 
too focused and do not fully appreciate the magnitude of what 
they are doing to other people and other things outside of the 
laboratory. And sometimes perhaps--and I am a journalist by 
profession, by the way. So I realize that I do not know this 
much about anything but I do know this much about that much. 
And sometimes it helps science authorities to have their 
perspective come in and talk to them about putting their 
science in perspective, rather than having it be a purely 
scientific laboratory endeavor, does it not?
    Mr. Stephenson. Well, yes, but I mean the toxicity of a 
chemical is the toxicity of a chemical. It is not subject to 
the implications of whatever that assessment shows. That is 
risk management. That is when you decide whether it needs to be 
regulated or not.
    Mr. Rohrabacher. But there are certain----
    Mr. Stephenson. Is it a big risk?
    Mr. Rohrabacher. Yeah, but there are certain areas that--
for example, if a certain chemical is needed to complete a 
mission that is important for the security or safety or even 
health of the public, that should be taken into consideration 
in terms of the risks that people take in order to achieve that 
other goal.
    Mr. Stephenson. Under either risk management phase. That is 
when cost becomes an option. Toxicity should have no bearing on 
the cost of that toxicity assessment.
    Mr. Rohrabacher. But the importance of that should not be 
part of a determinant factor by those scientists at all?
    Mr. Stephenson. I mean, we are not suggesting that----
    Mr. Rohrabacher. That should----
    Mr. Stephenson. We are not suggesting that the EPA 
scientists go into a vacuum in a closed room and do their 
analysis. We are suggesting that everybody should have an 
opportunity to comment on that. We just think that all the 
comments should be treated openly, that the whole science 
community----
    Mr. Rohrabacher. There is no question about whatever 
communication happens, and I would certainly look into that, 
within government, people should be held accountable and it 
should be transparent. I mean I certainly am not suggesting 
that. I am suggesting that maybe what you are suggesting is 
that it be a lack of communication.
    Mr. Stephenson. No. No. The cost of cleaning up a given 
chemical--let us use TCE again. Let us say that it is 
determined and it has been by the National Academy and EPA and 
everybody else who has looked at it to be a very toxic chemical 
that likely causes cancer. Now we should move to the risk 
management phase and decide--that is when we decide, okay, DOD 
uses a lot of this stuff and if we set the cleanup standard at 
this level, it is going to cost them hundreds of millions of 
dollars to clean it up. That is a risk management decision. 
Those factors, those cost benefit analysis of the regulation--
--
    Mr. Rohrabacher. Or let me put----
    Mr. Stephenson.--are appropriate but not in the scientific 
phase.
    Mr. Rohrabacher. Let me put it in a different way. You have 
got a chemical that is an important part of a process that is 
used to save lives rather than just put things at risk. Maybe 
there is a chemical that is needed in the process of a certain 
kind of food that is necessary to prevent starvation or to take 
care of certain types of diseases in Africa or such. Yeah, we 
need to know that that is important----
    Mr. Stephenson. I agree.
    Mr. Rohrabacher.--that if there is going to be no way to 
control the mosquitoes in Africa if this decision goes the 
wrong way.
    Mr. Stephenson. I agree, and those decisions are made all 
the time. When you consider how expensive it would be for the 
regulated community to impose a regulation, all those are fair 
game and appropriate discussions, but they are part of the risk 
management phase, not the scientifically based risk assessment 
phase of a chemical.
    Mr. Rohrabacher. I am thinking that what we are talking 
about is--again, you are much more an expert. That is why you 
are testifying and I am listening. But it just seems to me that 
we have--the process isn't as defined as all of these boxes 
that we have seen and that people realize that within a period 
of time perhaps more science examination can come into the 
process rather than in the first box it could also come in the 
last box unless we have a totally closed system. Does that make 
sense?
    Mr. Stephenson. Yeah, and we are not suggesting a closed 
system. We are suggesting that it is appropriate for all 
commenters to comment on a scientific risk assessment.
    Mr. Rohrabacher. I am certainly not in favor of anything 
that would hinder transparency or making people accountable.
    Mr. Stephenson. Nor are we.
    Mr. Rohrabacher. Thank you very much.
    Chairman Miller. That was the last round of questions. I 
would, just to summarize, if I understand correctly your 
testimony in response to Mr. Rohrabacher's question, you see no 
virtue in consciously not knowing and not consciously not 
learning the potential risk to public health or to the 
environment of a chemical?
    Mr. Stephenson. None whatsoever.
    Chairman Miller. Okay. Thank you very much. If we will now 
have a short break, and the next set of witnesses, the next 
panel.
    [Recess.]
    Chairman Miller. Welcome back. We do have a couple of 
housekeeping matters that I neglected earlier. One is I now ask 
unanimous consent that all Members have two weeks to enter 
statements for the record. Without objection.
    I also ask unanimous consent to enter materials in the 
record. All the materials have been shared with the Minority 
already. Again, without objection.

                               Panel II:

    I would now like introduce our second panel. Dr. George 
Gray is the Assistant Administrator for Research and 
Development of the United States Environmental Protection 
Agency. Ms. Susan Dudley is the Administrator for the Office of 
Information and Regulatory Affairs of the Office of Management 
and Budget, OIRA. As our witnesses should know, taking 
testimony is limited to five minutes after which the Members of 
the Committee will have five minutes to ask questions in at 
least one round and perhaps a series of rounds. It is the 
practice of the Subcommittee to take testimony under oath. Do 
either of you have any objections to being sworn in? The 
Committee also provides that you may be represented by counsel. 
Are either of you represented by counsel today? You are not? 
Okay. If you would please stand and raise your right hand? Do 
you swear to tell the truth and nothing but the truth? Let the 
record reflect that both the witnesses answered yes that they 
do so swear.
    At this point, we will now open our first--I am sorry. Dr. 
Gray, you may begin.

 STATEMENT OF DR. GEORGE M. GRAY, ASSISTANT ADMINISTRATOR FOR 
 RESEARCH AND DEVELOPMENT, U.S. ENVIRONMENTAL PROTECTION AGENCY

    Dr. Gray. Thank you, Chairman Miller, Members of the 
Committee. Thank you for the opportunity to appear before this 
subcommittee to discuss EPA's highly regarded IRIS, Integrated 
Risk Information System. As you know, IRIS is a repository of 
information on potential adverse effects of long-term exposure 
to over 540 potential environmental contaminants.
    The IRIS program began in the mid-1980s. At that time, it 
was clear that the toxicity values that were being used and 
developed by EPA were not internally consistent across the 
Agency, even when based on the same data. That was due to 
different assumptions, different science, different choices of 
defaults. IRIS was therefore formed as an internal database in 
response to the critical need to have Agency-wide toxicity 
values in one place.
    Word quickly spread about the existence of IRIS, and State 
and local, public health and environmental agencies as well as 
the regulated community asked us to make it publicly available. 
So in the late 1980's IRIS was made available to the public. I 
have actually been interested in and using IRIS for many years 
as part of my research and my teaching at the Harvard School of 
Public Health. I have had a very longstanding interest in IRIS.
    Now the IRIS website gets more than 20,000 hits a day with 
inquiries coming from over 100 countries. The IRIS assessments 
contain only part of the information that is needed to 
characterize public health risks of chemical substances in 
support of risk management decisions.
    It is important to understand not only how risk assessment 
differs from risk management but also to recognize that risk 
assessments, including our IRIS assessments, include both 
science and science policy components. This is often a source 
of confusion.
    Now like all living processes, the IRIS process has evolved 
over time. For example, efforts have been made to enhance our 
peer review process and to address the longstanding issue of 
the timeliness of our IRIS reviews. Because it began as an 
internal EPA resource, the agenda for developing IRIS 
assessments first focused on those chemical assessments that 
were needed for EPA. But now each year EPA develops an annual 
agenda for the IRIS program and announces the new assessments 
under review in the Federal Register. In recent years the IRIS 
program has also sought nominations for IRIS chemical reviews 
from the public and from other federal agencies.
    Some of these recent changes in the IRIS process include: 
development of our IRIS track web system so people can see the 
status of a chemical; new opportunities for the public and 
other agencies to review and comment on IRIS assessments; and 
enhanced independent external peer review of our draft IRIS 
assessments.
    In 2005, a formal process for documenting all the existing 
steps in the IRIS process, including formalizing some of these 
and some new recent changes to the process, was initiated. And 
on April 10, 2008, this revised IRIS process was announced by 
EPA.
    The release of this is noteworthy because this is the first 
time that the IRIS process has been transparently documented 
and made available to the public. The new IRIS process has been 
designed to provide greater transparency, objectivity, balance, 
rigor, and predictability in our IRIS assessments. For example, 
improvements in the IRIS process helped define critical and 
appropriate roles for public and interagency comments and for 
interactions that promote greater communication, sharing 
information, between all interested parties in EPA. Yearly 
involvement of various stakeholders is consistent with 
recommendations we received from our own science advisory board 
and from the GAO. Remember that along with the increased 
opportunities for public and other agency involvement, all 
draft IRIS toxicological reviews will ultimately undergo 
independent external peer review, and all final decisions on 
IRIS content remain with EPA.
    It is worth noting that the revised IRIS process also meets 
many of the recommendations of the recently-issued 2008 GAO 
report. Specifically, we believe that the new process clearly 
defines and documents a streamlined IRIS process, it defines 
the critical and appropriate roles for the public and other 
agencies, and importantly, it sets time limits for all parties 
including EPA. So though the revised process is expected to 
improve the timeliness of IRIS assessments, it is important to 
recognize that many assessments today are more complex than 
ever, and some assessments will take longer than others to 
complete.
    For example, recent NAS and Science Advisory Board 
reviewers have recommended EPA do a better job of incorporating 
quantitative uncertainty analysis in IRIS assessments.
    Right now, EPA needs time to implement and evaluate this 
new process, recognizing that additional changes to the process 
may be needed in the future because it really is intended to be 
a living database and a living process.
    So thank you, Chairman Miller and Members of the 
Subcommittee for the opportunity to describe the scope, the 
purpose, and the future of EPA's IRIS program. I look forward 
to answering any questions you may have.
    [The prepared statement of Dr. Gray follows:]

                  Prepared Statement of George M. Gray

    Good morning, Chairman Miller and Members of the Committee. My name 
is Dr. George Gray, and I am the Assistant Administrator for Research 
and Development (ORD) at the U.S. Environmental Protection Agency 
(EPA). I also serve as the Agency's Science Advisor. Thank you for this 
opportunity to appear before the Subcommittee to discuss EPA's highly 
regarded Integrated Risk Information System (IRIS), which is managed by 
EPA's National Center for Environmental Assessment (NCEA) within ORD.
    As you may know, IRIS is a repository of human health risk 
information on the potential adverse effects of long-term, or chronic, 
exposure to over 540 potential environmental contaminants. The risk 
information in IRIS can include quantitative risk estimates for both 
non-cancer and cancer effects, as well as a detailed narrative that 
accompanies the risk estimates. The narratives, or qualitative risk 
information, include a full discussion of the peer reviewed scientific 
literature used in the assessment, the EPA confidence in the IRIS risk 
estimates, and an explanation of the judgments (including application 
of default approaches and uncertainty factors) that the Agency must 
make in the face of inadequate data.
    A significant part of EPA's efforts to fulfill its mission to 
protect public health and the environment is to regulate, when 
necessary, the release of contaminants into the Nation's air, water, 
and soil. As first outlined by the National Academy of Sciences (NAS) 
in its seminal 1983 report (``Risk Assessment in the Federal 
Government: Managing the Process,'' National Academies Press, 
ISBN:0309033497, commonly called the ``Red Book''), there are two 
distinct steps that should be used in the Federal Government to assess 
and manage risks. These steps are called risk assessment and risk 
management. Risk assessment, as defined by the NAS, is ``the 
characterization of the potential adverse health effects of human 
exposures to environmental hazards'' (p. 18). Risk assessments can 
entail either quantitative or qualitative expressions of risk, and 
should include characterization of the uncertainties inherent in the 
process of inferring risk. The risk assessment process has four 
components: hazard identification, dose-response evaluation, exposure 
assessment, and risk characterization. Risk management is defined by 
the NAS as ``the process of evaluating alternative regulatory options 
and selecting among them'' (p. 18). A risk assessment may serve as one 
of the bases of risk management.
    IRIS assessments fall into the first step (risk assessment); 
however they only include information on hazard identification and 
dose-response evaluation. Combined with exposure information, 
government and private entities use IRIS to help characterize the 
public health risks of chemical substances and thereby support risk 
management decisions. Thus, it is important to note that an IRIS health 
assessment is not a complete risk assessment. It provides part of the 
foundation for EPA's decision-making and regulatory processes. In 
addition, risk managers consider other important factors in a risk 
management decision such as exposures, statutory and legal 
considerations, social considerations, public health considerations, 
economic factors, and political considerations.
    It is important to recognize that although risk assessment is 
distinct from risk management, the risk assessment process consists of 
both ``science'' and ``science policy'' components. That is, although 
there are some instances at EPA where ``pure science'' is involved 
(e.g., conducting bench or lab research on animals in toxicity 
studies), much of the work done at EPA (including IRIS assessments) 
involves both science and science policy. For example, due to the 
uncertainty in IRIS assessments, judgments and choices must be made 
about the most appropriate assumptions, data sets, health endpoints, 
models, etc. to use in deriving toxicity values. These are science 
policy choices because the science is not precise enough to provide 
definitive answers. For this reason, guidance documents such as EPA's 
``Guidelines for Carcinogen Risk Assessment'' were developed and 
approved through the Agency's Science Policy Council to inform the many 
choices in the risk assessment process. This is an important 
distinction that is often overlooked or confused by the public, yet the 
NAS Red Book (1983) recognized and commented on this issue in the very 
first chapter and its section on ``Scientific and Policy Judgments in 
Risk Assessment'' (p. 28).
    The IRIS program began in the mid-1980s. At that time, it was clear 
that the toxicity values that were being developed by EPA were not 
internally consistent across the Agency. For example, EPA's Program 
Offices were publishing toxicity values for a particular chemical in 
their rule-makings and in other policy documents that were based on the 
same set of available scientific data--but these values could be orders 
of magnitude different and based on different human health endpoints or 
default uncertainty factors. This example illustrates how important it 
is to acknowledge where the science stops and science policy begins, as 
credible scientists can (and often do) reach different conclusions 
based on their interpretation of the science or make different choices 
when confronted with several scientifically plausible options. IRIS was 
therefore formed in response to a critical need to have Agency-wide 
toxicity values in one place--including accompanying narratives 
detailing the supporting studies, key assumptions and choices, and text 
on confidence--that were developed through reviews by Agency health 
scientists.
    IRIS was originally intended to be an internal system that provided 
EPA risk assessors and managers with an EPA consensus position on the 
potential human health hazard and dose-response information for 
environmental contaminants of interest to Agency programs and regions. 
Word spread quickly about the existence of IRIS and many asked to make 
it a publicly available system. State and local public health and 
environmental agencies, as well as the regulated community, requested 
access to the IRIS information. Therefore, in the late 1980's, IRIS 
access was made available to the public. EPA was pleased to share this 
information resource with a large, external user community. IRIS first 
became available on a dial-up service and later through the National 
Library of Medicine's TOXNET family of information resources, and then 
on the Internet. The IRIS web site is accessed over 20,000 times per 
day with inquiries coming from well over 100 other countries.
    The IRIS process has evolved over time including in areas such as 
setting the annual IRIS agenda, level of independent external peer 
review, and opportunities for public and other federal agency review 
and comments. Because IRIS began as an internal EPA resource, the 
agenda for developing IRIS assessments focused on those chemical 
assessments of interest to EPA's program offices and regions. It was an 
informal process where only Agency needs were addressed. Now each year, 
EPA develops an annual agenda for the IRIS program and announces new 
assessments under review in the Federal Register. EPA uses five general 
criteria to determine which new chemicals to assess: (1) potential 
public health impact; (2) EPA statutory, regulatory, or program/
regional-specific implementation needs; (3) availability of new 
scientific information or methodology that might significantly change 
the current IRIS information; (4) interest to other governmental 
agencies or the public; and (5) availability of other scientific 
assessment documents that could serve as a basis for an IRIS 
assessment.
    In recent years, the IRIS Program has also sought nominations for 
IRIS chemical reviews from the public and other federal agencies. The 
list of new or updated assessments chosen for potential development is 
published in the Federal Register (FR) as part of the IRIS annual 
agenda. The Agency is also working to improve the prioritization 
process to more appropriately capture relative priorities of individual 
chemical assessments under development. For each of the assessments 
added to the IRIS agenda, an initial literature search is conducted. As 
literature searches are completed, the results are posted on the IRIS 
web site (www.epa.gov/iris) and the public and other agencies are 
invited to review the literature search results and submit additional 
information to EPA. Other recent changes to the IRIS process include 
creation of a chemical assessment tracking system (IRISTrack) on the 
IRIS web site to inform the public and stakeholders of the status of 
the IRIS assessments that are underway, new opportunities for the 
public and other agencies to review and comment on the qualitative and 
draft IRIS assessments (including the ability to participate in 
``listening sessions'' held during the public comment period), and 
enhanced independent external peer reviews of draft IRIS assessments. 
The IRIS program has also experienced an expansion of scientific staff 
and a significantly increased budget over the last few years. For 
example, based on the enacted FY 2003 resources, EPA has since nearly 
tripled the number of IRIS staff and have quadrupled the IRIS budget 
through the FY 2009 request to 37.0 FTE and $9.4 million, respectively.
    In 2005, a formal process for documenting all of the existing steps 
in the IRIS process, including formalizing recent changes to the 
process, was initiated, and on April 10, 2008, the revised IRIS process 
was announced by EPA. The public release of the revised IRIS process is 
especially noteworthy because the IRIS process has never before been 
transparently documented and made available to the public. 
Consequently, the IRIS process had often been viewed as a ``black box'' 
both within and outside of the Agency, as it was unclear what steps 
comprised the process, what the timing was for each step, or where 
opportunities existed for internal and external Agency involvement. The 
new IRIS process has been designed to provide greater transparency, 
objectivity, balance, rigor and predictability in IRIS assessments. 
Specifically, improvements to the IRIS process help define critical and 
appropriate roles for public and interagency comments and interactions, 
and promote greater communication and sharing of information between 
all interested parties and EPA. The outcome of these improvements are 
expected to result in a more predictable, streamlined, and transparent 
process for conducting IRIS assessments, which will ultimately lead to 
assessments that are of the highest quality and rigor.
    Delays in the completion of IRIS assessments have been a long-
standing problem at EPA. For example, prior IRIS assessments took an 
average of five years to complete, and EPA has been working on some 
assessments for a decade or longer. The revised process was designed to 
help address these delays, in part, by allowing for input from various 
stakeholders (e.g., EPA program and regional offices, other agencies, 
scientific organizations, NGOs, and the public) early in the process 
and providing clear descriptions and timeframes for each step. The 
early involvement of various stakeholders is consistent with 
recommendations from EPA's Science Advisory Board (SAB) as well as a 
prior report by the General Accounting Office (GAO). For example, in a 
September 26, 2000, letter from EPA's SAB to Administrator Carol 
Browner, it was noted that ``critical data'' were often missing from 
IRIS risk assessment discussions and it was suggested that one way to 
enhance the quality of toxicologic evaluations was to ``make the IRIS 
process open to public stakeholder review in a more formal manner.'' A 
2006 report by GAO (GAO-06-595) entitled ``Human Health Risk 
Assessment: EPA Has Taken Steps to Strengthen Its Process but 
Improvements Needed in Planning, Data Development, and Training'' also 
noted that ``. . . several experts said that increased involvement with 
a broad range of stakeholders early in the planning process would help 
identify alternative methods and models and obtain stakeholder 
concurrence with the agency's approach.'' The new process therefore 
allows the EPA access to a wide range of scientific data, expertise, 
and knowledge that can be used to produce timely and high quality IRIS 
assessments. However, it should be noted that all draft IRIS 
assessments are peer reviewed by outside experts, and all final 
decisions on IRIS content remain with EPA.
    It is important to recognize that many of the assessments today are 
more complex than ever before. For example, some chemicals have 
extensive toxicity testing data that must be reviewed and analyzed, new 
data are now available for assessing the mode of action of many 
chemicals, and more sophisticated statistical and modeling techniques 
(e.g., physiologically-based pharmacokinetic or PBPK models) are now 
available for evaluating intra-species and inter-species differences. 
Recent peer reviews of IRIS assessments by the NAS and EPA's SAB have 
also recommended that EPA do a better job of incorporating quantitative 
uncertainty analyses into IRIS assessments. The timelines in the new 
IRIS process balance the need for careful consideration of science and 
science policy in assessments with the Agency's need for information.
    An important aspect of the revised process includes ``mission 
critical'' chemicals that will be determined by a sponsoring agency 
together with EPA. A ``mission critical'' chemical is one that is an 
integral component to the successful and safe conduct of an agency's 
mission in any or all phases of its operations. Impacts on use of 
mission critical chemicals include cessation or degradation of the 
conduct of the mission and/or unacceptable resource constraints. 
Agencies must identify to ORD those chemicals on the IRIS Program 
Annual Agenda that they determine meet this definition, and generate a 
detailed report documenting what types of new research will address 
significant data gaps and whether such research can be conducted within 
the allotted time frame (but it is ultimately up to EPA to agree to 
allow new research to be conducted). Although we do not anticipate that 
many chemicals will receive this designation each year or that 
additional studies will be requested for all mission critical 
chemicals, any such new studies will help fill important data gaps to 
ensure assessments of the highest quality.
    Independent external peer reviews are also a hallmark of EPA's 
commitment to ensuring we have high-quality science that has been 
vetted by a panel of outside experts. Consistent with past practices, 
the revised process specifies that all draft IRIS Toxicological Reviews 
will undergo independent external peer review. Most reviews will be 
conducted by external peer review panels at public meetings, although a 
small number of complex or high profile chemicals may undergo more in-
depth SAB or NAS peer reviews. As part of the revised IRIS process, 
external peer reviewers will also for the first time have an 
opportunity to review the revised IRIS Toxicological Review and comment 
on ORD's responses to the peer reviewers and public comments. This is 
an important step that is consistent with other peer review practices, 
such as publishing in the peer-reviewed literature, to ensure that peer 
reviewer comments are adequately addressed or sufficient rationale is 
provided for not addressing such comments.
    It is noteworthy that the revised IRIS process meets many of the 
recommendations of the recently issued 2008 GAO report entitled ``Toxic 
Chemicals: EPA's New Assessment Process Will Increase Challenges EPA 
Faces in Evaluating and Regulating Chemicals'' (GAO-08-743T). 
Specifically, the revised process (1) clearly defines and documents a 
streamlined IRIS assessment process; (2) sets time limits for all 
parties, including OMB and other federal agencies, to provide comments 
to EPA on draft IRIS assessments; (3) defines the appropriate role of 
external federal agencies in EPA's IRIS assessment process; and (4) 
determines the types of IRIS assessments to conduct on the basis of the 
needs of EPA's program offices and other users. The GAO (2008) report 
also lacks an appropriate characterization of several key issues. For 
example, the GAO report erroneously suggests that only pure science is 
involved in the risk assessment process. In reality, all risk 
assessments (including IRIS assessments) have always included a mix of 
science and science policy, as acknowledged in the NAS (1983) Red Book. 
The GAO report also mischaracterizes the interagency review process at 
EPA. Specifically, to ensure that scientists and policy-makers are able 
to have full and frank discussions without being concerned about how 
these discussions may be viewed or misrepresented, all internal EPA 
comments and interagency comments and disposition documents on draft 
IRIS assessments are considered ``deliberative'' and do not become a 
part of the public record. This is not a new or unique process, as this 
protection is the same as that afforded any other policy-making setting 
at EPA (and other federal agencies follow similar processes). 
Additionally, once EPA comes to a conclusion and releases its external 
review draft, there is a transparent public comment and external peer 
review process. The GAO report also incorrectly suggests that EPA will 
not have the final say on the content of IRIS assessments under the 
revised process. However, despite increased opportunities for public 
and other agency involvement, the revised process makes it clear that 
all final decisions on content will remain within EPA.
    EPA now needs time to implement and evaluate the new process, 
recognizing that additional changes to the process may be needed in the 
future (i.e., it is intended to be a ``living'' document). Because the 
revised process attempts to streamline and set specific time frames for 
each step, it is expected to reduce the amount of time to complete 
future IRIS assessments.
    Thank you, Chairman Miller and Members of the Subcommittee for this 
opportunity to describe the scope, the purpose and the future of EPA's 
IRIS program. I look forward to answering any questions you may have.

                      Biography for George M. Gray

    On November 1, 2005, Dr. Gray was sworn in to serve as the 
Assistant Administrator for the Office of Research and Development, 
which is the 1,900-person, $600 million science and technology arm of 
the Environmental Protection Agency. Dr. Gray was appointed to this 
position by President George W. Bush and confirmed--by unanimous 
consent--by the U.S. Senate.
    Prior to joining EPA, Dr. Gray was Executive Director of the 
Harvard Center for Risk Analysis and a Lecturer in Risk Analysis at the 
Harvard School of Public Health (HSPH). In 16 years at HSPH, his 
research focused on scientific bases of human health risk assessment 
and its application to risk policy with a focus on tradeoffs in risk 
management. Dr. Gray taught toxicology and risk assessment to both 
graduate students and participants in the School's Continuing 
Professional Education program.
    Dr. Gray holds a B.S. degree in biology from the University of 
Michigan, and M.S. and Ph.D. degrees in toxicology from the University 
of Rochester. He and his wife, Ann, and their two children make their 
home in McLean, Virginia.

    Chairman Miller. Thank you, Dr. Gray. Ms. Dudley for five 
minutes.

  STATEMENT OF MS. SUSAN E. DUDLEY, ADMINISTRATOR, OFFICE OF 
INFORMATION AND REGULATORY AFFAIRS (OIRA), OFFICE OF MANAGEMENT 
                           AND BUDGET

    Ms. Dudley. Thank you, Chairman Miller and distinguished 
Members of the Committee. As administrator of the Office of 
Information and Regulatory Affairs, or OIRA, I am pleased to be 
here today to talk with you about OIRA's role in ensuring that 
the highest quality of information, including scientific 
information, is used and disseminated by federal agencies.
    OIRA was created as part of the Office of Management and 
Budget by the Paperwork Reduction Act of 1980. Staffed almost 
exclusively by career civil servants, OIRA has served 
Administrations, both Democratic and Republican, for decades by 
providing centralized oversight and interagency coordination of 
federal information, as well as regulatory and statistical 
policy.
    In recognition of the increasing importance of science-
based regulation at federal agencies, OIRA's staffing has 
evolved over the last 8 years to include scientific and 
engineering expertise to accompany a well-established team of 
economists, statisticians, lawyers, and information policy 
specialists. This more diversified pool of expertise enables us 
to engage with federal experts throughout the government on 
issues relevant to policy development.
    Since the fall of 2005, OMB has coordinated interagency 
review of the Environmental Protection Agency's IRIS. IRIS is 
an important online database containing science and science 
policy information on chronic human health effects. It supports 
risk-based decision-making not only by EPA but by other federal 
agencies, State and local environmental programs, international 
regulatory bodies, academia, industry and others.
    Interagency coordination allows EPA to take advantage of 
the broad scientific expertise that exists throughout the 
government. The science in IRIS assessments is growing more and 
more complex, and vigorous discussion among a diverse set of 
governmental experts helps EPA ensure that the IRIS assessments 
reflect the consensus on the best science and science policy 
judgments. OMB has continually supported changes that will 
improve the quality and efficiency of the IRIS program.
    Since 2000, OMB has supported funding increases of over 450 
percent, and IRIS's program budget has increased from $1.7 
million in fiscal year 2000 to $9.6 million in fiscal year 
2007. Despite this increased funding, concerns remain with the 
pace of development of IRIS assessments. EPA observes that 
assessments take an average of five years to complete, with 
some taking as long as 10 years. In response to concerns both 
with delays in implementing IRIS assessments and lack of 
transparency in the IRIS process, EPA has recently revised the 
process to clarify the role of the public and interagency 
reviewers and promote greater communication and sharing of 
information between all interested parties and EPA. The new 
process is expected to reduce the time to complete an IRIS 
assessment from the historical average of over five years down 
to three to four and one-half years. EPA expects these changes 
will result in a more predictable, streamlined, and transparent 
process for conducting IRIS assessments, which will ultimately 
lead to assessments that are of the highest quality and rigor.
    So in conclusion, let me reiterate a few key points. EPA's 
IRIS database is a highly regarded database of potential 
chronic effects of environmental contaminants on human health. 
It is widely used within EPA, by other federal, State, and 
local agencies and elsewhere to support policies to protect 
human health. It includes science policies as well as pure 
science, quantitative risk estimates, and qualitative 
narratives. Scientists at other federal agencies and the public 
have an appropriate role in the development of IRIS 
assessments. EPA's recent clarifications to the process for 
developing IRIS assessments should improve both the quality and 
efficiency of assessments by engaging the public as well as 
experts within and outside the government earlier in the 
process and providing streamlined opportunity for review and 
comment.
    I have a few seconds left on my clock. I would like to 
correct a misimpression that may have been left from the last 
panel. OMB did not review EPA's response to the GAO report as 
was suggested.
    Thank you.
    [The prepared statement of Ms. Dudley follows:]

                 Prepared Statement of Susan E. Dudley

    Chairman Miller, Ranking Member Sensenbrenner, and distinguished 
Members of the Committee, thank you for inviting me to testify at 
today's hearing about the Environmental Protection Agency's Integrated 
Risk Information System (IRIS) database policy.
    As the Administrator of the Office of Information and Regulatory 
Affairs (OIRA), I am pleased to be here today to talk with you about 
OIRA's role in ensuring that the highest quality of information, 
including scientific information, is used and disseminated by federal 
agencies.
    OIRA was created as part of the Office of Management and Budget 
(OMB) by the Paperwork Reduction Act of 1980. Staffed almost 
exclusively by career civil servants, OIRA has served Administrations, 
both Democratic and Republican, for decades by providing centralized 
oversight and interagency coordination of federal information, as well 
as regulatory and statistical policy.
    Over the last 27 years, OIRA's interagency coordination role has 
been an integral part of government accountability--a non-partisan tool 
for understanding the likely effects of government policy. In 
recognition of the increasing importance of science-based regulation at 
federal agencies, OIRA's staffing has evolved over the last eight years 
to include scientific and engineering expertise to accompany a well 
established team of economists, statisticians, and information 
technology specialists. This more diversified pool of expertise enables 
us to engage with experts throughout the Federal Government on issues 
relevant to policy development.

EPA's Updated IRIS Process

    The Environmental Protection Agency (EPA)'s Integrated Risk 
Information System (IRIS) is an online database prepared and maintained 
by the EPA's National Center for Environmental Assessment (NCEA) within 
the Office of Research and Development (ORD). IRIS contains science and 
science policy information on chronic human health effects.\1\ The 
hazard identification and dose-response assessment information in IRIS 
can be used in combination with exposure information to characterize 
the public health risks of a given substance in a given situation. 
These risk characterizations can form the basis for risk-based 
decision-making, regulatory activities, and other risk management 
decisions designed to characterize and protect public health. The IRIS 
database supports risk-based decision-making not only by EPA, but by 
other federal agencies, State and local environmental programs, 
international regulatory bodies, academia, industry, and others. 
According to EPA, national and international users access the IRIS 
database approximately nine million times a year.\2\
---------------------------------------------------------------------------
    \1\ See EPA, ``Revised IRIS Process Q&A's,'' (EPA Q&A) question 1, 
available at http://oaspub.epa.gov/eims/
eimscomm.getfile?p-download-id=472643
    \2\ See U.S. Government Accountability Office, Report to Chairman, 
Committee on Environment and Public Works, U.S. Senate, ``Chemical 
Assessments: Low Productivity and New Interagency Review Process Limit 
the Usefulness and Credibility of EPA's Integrated Risk Information 
System,'' (March 2008), p. 6.
---------------------------------------------------------------------------
    OMB recognizes the importance of IRIS assessments for making sound, 
science-based decisions across the government, throughout the country, 
and internationally as well. OMB has continually supported changes that 
will improve the quality and efficiency of the IRIS program.
    Since 2000, OMB has supported funding increases for the IRIS 
program of over 450 percent; as evidenced in the President's annual 
budgets, the funding requested has increased from $1.7 million in FY 
2000 to $9.6 million in FY 2007.\3\
---------------------------------------------------------------------------
    \3\ Id. at 14.
---------------------------------------------------------------------------
    Despite these funding increases, concerns remain with the pace of 
development of IRIS assessments. EPA observes that prior assessments 
took an average of five years to complete, with some taking as long as 
10 years.\4\ In response to concerns both with delays in completion of 
IRIS assessments, and lack of transparency in the IRIS process, EPA has 
recently revised the process to provide greater transparency, 
objectivity, balance, rigor and predictability in IRIS assessments. The 
revised process clarifies the role of the public and interagency 
reviewers, and promotes greater communication and sharing of 
information between all interested parties and EPA. EPA expects these 
changes to result in a more predictable, streamlined, and transparent 
process for conducting IRIS assessments, which will ultimately lead to 
assessments that are of the highest quality and rigor.\5\
---------------------------------------------------------------------------
    \4\ See EPA Q&A, supra note 1, at question 13.
    \5\ Memorandum from EPA Deputy Administrator Marcus Peacock to EPA 
Assistant Administrator George Gray (Peacock Memo), ``Implementation of 
Revised IRIS Process,'' (April 10, 2008), available at http://
oaspub.epa.gov/eims/
eimscomm.getfile?p-download-id=472651
---------------------------------------------------------------------------
    The nomination process for chemicals to be included in IRIS is 
transparent and open. ORD initiates the process through a Federal 
Register notice which invites nominations from the public and at the 
same time reaches out to the EPA Program and Regional Offices and other 
agencies for their nominations. After receiving the nominations and 
discussing them with other agencies and EPA Program and Regional 
Offices, EPA determines its IRIS agenda for the coming year, and 
publishes that in the Federal Register. EPA's determination is based on 
its published selection criteria, as well as its available work force 
and areas of expertise.
    EPA then begins the process of developing chemical health 
assessments that ultimately are posted to the IRIS database.\6\ This 
assessment process consists of 13 steps:
---------------------------------------------------------------------------
    \6\ Id.

---------------------------------------------------------------------------
         1.  A scientific literature search for each chemical;

         2.  A Federal Register notice seeking scientific information 
        on selected chemical substances;

         3.  EPA development of draft qualitative IRIS health 
        assessment;

         4.  Review of the draft qualitative assessment within EPA, by 
        other agencies, and by the public, announced in the Federal 
        Register;

         5.  EPA review of public and agency comments;

         6.  EPA evaluation of interagency interest in closing data 
        gaps for mission critical chemicals;\7\
---------------------------------------------------------------------------
    \7\ EPA defines a ``mission critical chemical'' as one that is an 
integral component to the successful and safe conduct of an Agency's 
mission in any or all phases of its operation. Id. at n. 1.

         7.  Design and implementation of new studies for mission 
---------------------------------------------------------------------------
        critical chemicals, if needed;

         8.  EPA completion of its draft IRIS review, including 
        quantitative values;

         9.  EPA initiation of interagency review (and revision of 
        draft assessment documents as appropriate);

        10.  EPA initiation of independent external peer review and 
        release of the draft IRIS assessment to the public;

        11.  EPA revision to the IRIS assessment and development of an 
        IRIS summary based on expert review and public comment;

        12.  EPA initiation of final intra-agency and interagency 
        review; and

        13.  EPA completion of the IRIS assessment and IRIS summary and 
        posting of completed IRIS assessments on to the database.

OMB Role in the IRIS Process

    Since the fall of 2005, OMB has coordinated review of IRIS 
assessments (steps 9 and 12 in the new process). Interagency 
coordination allows EPA to take advantage of the broad scientific 
expertise that exists throughout the government. The science in IRIS 
assessments is growing more and more complex, and vigorous discussion 
that involves a diverse set of governmental experts helps EPA ensure 
that the IRIS assessments represent the consensus opinions of the 
government's leading scientists. In addition, risk assessment involves 
science policy judgments which help to shape the risk assessment 
process. As many accepted `default' positions are based on scientific 
consensus opinions, a frank and broad discussion among interagency 
experts helps to inform EPA's choices.\8\ The agencies involved in any 
interagency review process will vary depending on the chemical in 
question, agencies' expertise, and agencies' interest in it. The 
interagency group may consist of representatives from the following 
offices and departments:
---------------------------------------------------------------------------
    \8\ See EPA, Office of the Science Advisor, Staff Paper, ``Risk 
Assessment Principles and Practices,'' (March 2004), available at 
http://www.epa.gov/OSA/pdfs/ratf-final.pdf. Sections 2.1.3 and 4.1.2 
discuss the science policy used in risk assessment and in determining 
default assumptions.

---------------------------------------------------------------------------
          Office of Management and Budget (OMB),

          Office of Science and Technology Policy (OSTP),

          Council on Environmental Quality,

          Department of Health and Human Services (HHS) 
        [including representation from the Agency for Toxic Substances 
        and Disease Registry (ATSDR), Centers for Disease Control and 
        Prevention (CDC), National Institutes of Health (NIH), National 
        Institute for Environmental Health Sciences (NIEHS), National 
        Institute for Occupational Safety and Health (NIOSH) and Food 
        and Drug Administration (FDA)],

          Department of Defense (DOD),

          Department of the Interior (DOI),

          Department of Labor (DOL),

          National Air and Space Administration (NASA),

          Department of Energy (DOE),

          Department of Transportation (DOT),

          Department of Agriculture (USDA), and

          the Consumer Product Safety Commission (CPSC).

    In step 9 noted above, EPA provides OMB the draft health assessment 
and the draft charge to the external peer reviewers. OMB distributes 
these draft documents to the others in the interagency group for review 
and comment. EPA then revises the draft health assessment and charge, 
as appropriate, to respond to the interagency comments. After 
completing interagency review, EPA publishes the draft assessment in 
the Federal Register for public comment and begins independent peer 
review. After revising the IRIS assessment based on peer review and 
public comment, EPA again shares the assessment with OMB and other 
federal agencies (step 12 listed above).
    Under EPA's revised system, OMB will continue to coordinate 
interagency review to help assure timely responses from agencies within 
designated review periods. For step 9, interagency review comments are 
due within 30 to 60 days, depending on the complexity of draft 
assessment documents.\9\ EPA will respond, as appropriate, in 15-30 
days.\10\ At step 12, interagency and intra-agency review comments are 
provided to ORD within 30 days\11\ and ORD addresses any remaining 
issues within 15 days.\12\ In addition, the EPA web page allows the 
public to track the progress of each chemical as it moves through the 
IRIS assessment process.\13\
---------------------------------------------------------------------------
    \9\ See Peacock Memo, supra note 5, at step 9(C)(a).
    \10\ Id. at step 9(E).
    \11\ Id. at step 12(D)(a).
    \12\ Id. at step 12(E).
    \13\ See www.epa.gov/iris
---------------------------------------------------------------------------
    OMB supports the new EPA IRIS process and EPA's efforts to provide 
greater transparency, and opportunities for the public to share 
information and comment on EPA's assessment. For example, the public 
has an opportunity to comment on EPA's initial literature review and to 
present additional information on a chemical. The public can also 
comment on the draft qualitative assessment and participate in an EPA-
sponsored ``listening session.'' This ``listening session'' will allow 
for broad public participation earlier in the assessment process. The 
new process also defines appropriate roles for the public and 
interagency interactions with ORD and also allows the interagency 
group, as well as the EPA Program and Regional Offices, in addition to 
the public, opportunities to share information and comment on EPA's 
draft assessments.\14\ All of these steps will also help to ensure the 
high quality of IRIS assessments. OMB also believes that the new 
process will increase efficiencies in the IRIS program. EPA estimates 
that the new process will reduce the time to complete an IRIS 
assessment from the historical average of over five years to three to 
four and one-half years, with perhaps an additional one to two and one-
half years for the smaller number of mission critical chemicals.\15\ 
Thus this revised process not only allows for earlier public and agency 
involvement, but also streamlines the process such that EPA will be 
able to release IRIS assessments in a more timely manner.
---------------------------------------------------------------------------
    \14\ See EPA Q&A, supra note 4, at questions 6 and 12.
    \15\ Id. at question 13.

Conclusion

    Thank you for the opportunity to testify in today's hearing. EPA's 
IRIS database is highly regarded and widely used. EPA's recent 
clarifications to the process for developing IRIS assessments should 
improve both the quality and efficiency of the assessments by engaging 
the public as well as experts within and outside the government earlier 
in the process and providing streamlined opportunity for review. I 
would be happy to answer any questions you may have.

                     Biography for Susan E. Dudley
    Susan Dudley was nominated by the President on July 31, 2006, and 
appointed on April 4, 2007, to serve as the Administrator of the Office 
of Information and Regulatory Affairs (OIRA) of the Office of 
Management and Budget.
    Prior to her service at OIRA, from 1998 through January 2007, Ms. 
Dudley served at the non-profit Mercatus Center at George Mason 
University, where she directed the Regulatory Studies Program from 2003 
to 2006. As an Adjunct professor at the George Mason University School 
of Law from 2002 to 2006, she designed and taught courses on 
regulations and led regulatory clinics.
    Earlier in her career, Ms. Dudley served as a career civil servant, 
working as a policy analyst at the Environmental Protection Agency 
(1984-1985), an economist at OIRA (1985-1989), and an economist advisor 
to the Commodity Futures Trading Commission (1989-1991). From 1991 
until 1998, she was a consultant to government and private clients at 
Economists Incorporated.
    Ms. Dudley has authored more than 25 scholarly publications on 
regulatory matters ranging from e-rule-making, to electricity, health 
care, the environment, and occupational safety. Before joining the 
Administration, she served on the boards of the Association of Private 
Enterprise Education and the International Foundation for Research in 
Experimental Economics, which was founded by Nobel Prize winning 
economist Vernon Smith. She has also served as a citizen member of 
several committees and boards in the Commonwealth of Virginia, 
including the Virginia Environmental Education Advisory Committee 
(2000-2002), the Administrative Law Advisory Committee (2000-2003), and 
the Virginia Waste Management Board (1996-2001).
    Ms. Dudley holds a Master of Science degree from the Sloan School 
of Management at the Massachusetts Institute of Technology (1981) and a 
Bachelor of Science degree (summa cum laude) in Resource Economics from 
the University of Massachusetts, Amherst (1977). She lives in Virginia 
with her husband and two sons.

                               Discussion

    Chairman Miller. Thank you, Ms. Dudley. There are only 
three witnesses today. Mr. Stephenson, would you mind rejoining 
the panel so you might be able to respond to questions that 
were directed to all of us because your testimony has been very 
different from the testimony of that we have heard from others 
today.
    Mr. Stephenson. Yes, it has.
    Chairman Miller. Again, if Mr. Whittaker could put up 
Figure 1.




    Mr. Rohrabacher. Mr. Chairman, I might note that we didn't 
have these witnesses available to comment on his testimony----
    Chairman Miller. Well, they certainly----
    Mr. Rohrabacher.--to have the time when he was testifying. 
It seems to be not quite a balanced decision on your part.

               More on EPA's GAO Exit Conference Comments

    Chairman Miller. Dr. Gray, do you have anything to say in 
response to anything Mr. Stephenson said?
    Dr. Gray. There are areas where I think there is some 
misperceptions in some of Mr. Stephenson's testimony.
    Chairman Miller. Perhaps we can elaborate on those as we go 
along. Ms. Dudley? Okay, could you----
    Ms. Dudley. Yes, I do, too.
    Chairman Miller. Can you just tell me the topics quickly 
and perhaps we can try to hit those as we ask questions, Mr. 
Rohrabacher and I.
    Ms. Dudley. I don't have notes on all the topics. One was 
the notion that OMB reviewed EPA's response to the GAO report, 
which is not true. OMB did not review that.
    Chairman Miller. You have already said that that was simply 
not true.
    Ms. Dudley. Just the----
    Chairman Miller. Is there anything that you want to 
elaborate besides that it is not true?
    Ms. Dudley. Yeah, the suggestion that OMB doesn't have 
scientific expertise. You know, Mr. Stephenson's response was 
that there is no ``s'' in OMB but there is no ``s'' in GAO, 
either.
    Chairman Miller. Okay.
    Mr. Stephenson. Or EPA.
    Ms. Dudley. That is right. So I don't think whether there 
is an ``s'' in the title of an agency qualifies.
    Mr. Stephenson. Well, I didn't mean that literally.

                     OMB's Role in Risk Assessments

    Chairman Miller. Well, we haven't really begun our line--
well, I guess I will now recognize myself for five minutes. 
Following that, Ms. Dudley, do you think it is part of the role 
of OMB or allow it to review scientific assessments prepared by 
other agencies of government?
    Ms. Dudley. OMB serves a coordinating function. We 
coordinate interagency review of various things, so OMB's role 
I think is a legitimate role. We have scientists that engage 
other scientists throughout the Federal Government in reviewing 
IRIS assessments.
    Chairman Miller. Well, I understand that there is one 
toxicologist that works for OIRA, is that correct?
    Ms. Dudley. You know, I am not sure exactly their 
credentials. We have toxicologists, risk assessors, 
statisticians.
    Chairman Miller. Well, they are remarkably productive, 
because they respond point by point in great detail at great 
length to the assessments that come up from the scientific 
agencies of government. Is that all done in-house or are there 
others who are invited to participate in OIRA's work or OMB's 
work?
    Ms. Dudley. No, it is certainly an interagency effort. So 
OMB doesn't provide the--we don't do the analysis, we 
coordinate it with other agencies. So we take advantage of the 
expertise throughout the Federal Government. So at the----
    Chairman Miller. Do you take advantage of expertise outside 
of the Federal Government?
    Ms. Dudley. No, as a rule, OIRA does not do that. Our role 
is coordinating within the government.

                        More on the IRIS Process

    Chairman Miller. Okay. If we could turn back our attention 
to Figure 1. This is the IRIS process that existed before OMB, 
OIRA, made helpful suggestions to make sure, to try to make 
this a more productive transparent system, is that correct?
    Ms. Dudley. I have to defer to Dr. Gray on that.
    Dr. Gray. The first thing I would have to say is that these 
diagrams, I don't necessarily--I am not able to endorse these 
because I was not involved in preparing them. In fact, I will 
say----
    Chairman Miller. Actually it says--these are not diagrams 
prepared by critics of OMB----
    Dr. Gray. No.
    Chairman Miller.--or EPA to belittle or make a mockery of 
the complexity of the process. These are actually EPA 
documents.
    Dr. Gray. Yes, they are. And the only reason I am unable to 
completely verify things is that the process that we use in 
IRIS prior to April 10th was never written down and made 
publicly available.
    Chairman Miller. Okay. But if we could now look at Figure 
3.



    Ms. Dudley. May I ask, do you have hard copies of those? It 
is hard for us to see them on the screens.
    Chairman Miller. Okay. Is your need now satisfied? Okay. 
This is the streamlined version, the streamlined transparent 
version of the earlier, slow, opaque process, is that correct?
    Dr. Gray. This is----
    Chairman Miller. This is what is recently adopted.
    Dr. Gray. This is our process, yes, that is how to find 
many of those enhancements that I had mentioned that have been 
going on in the IRIS process for many years. They are designed 
to enhance the transparency and the timeliness of the process 
and in fact putting timelines on this, which are not on this 
diagram I notice, is very helpful in that it reminds both EPA 
of its responsibilities and the others who are involved in the 
responsibilities. It also indicates all of the various places 
where the EPA, its regions and program offices, the public, 
non-governmental organizations, anyone in the scientific 
community, and other agencies can come together to provide 
input to our process.
    Chairman Miller. That is a yes. Let me ask the same 
question that I asked of Mr. Stephenson to clarify or to 
summarize his testimony response to Mr. Rohrabacher's 
questions. Do either of you see a virtue in consciously not 
knowing and consciously not learning the environmental or 
public health risk posed by a chemical? That is a yes or no 
answer.
    Ms. Dudley. No.
    Dr. Gray. Not at all. Not at all.
    Chairman Miller. None. And the purpose of IRIS is that, to 
assess what the risk is.
    Dr. Gray. IRIS is an input to the risk assessment process. 
It is not a complete risk assessment.
    Chairman Miller. Okay. But it is not risk management?
    Dr. Gray. That is correct.
    Chairman Miller. Ms. Dudley, it is not risk management, 
correct?
    Ms. Dudley. IRIS is not risk management. It is a component 
of the risk----
    Chairman Miller. If there is a later decision about what to 
do about it, if a chemical poses a risk but the IRIS decision, 
the IRIS listing is the best available science at the time of 
what risk a chemical poses, isn't that right?
    Ms. Dudley. It is science and science policy because 
science doesn't give you the full answer, so there are policy 
judgments involved.
    Chairman Miller. Well, the policy is what scientific 
assumptions to make if the data is incomplete.
    Ms. Dudley. That is correct. It deals with uncertainty.
    Chairman Miller. It is still science. A policy might be, do 
we really need to use TCE, even if it is toxic, because our 
machines, our Bradley fighting vehicles, work better, and it is 
important that our Bradley fighting vehicles work better. That 
is policy, right?
    Dr. Gray. Sir, could I make a statement? I know----
    Chairman Miller. That is risk management.
    Dr. Gray. That is management. Risk policy--I notice there 
is a copy of the NAS Red Book next to you. Chapter 1, the very 
first thing after defining terminology says science and policy 
and risk assessment. That is the kind of policy we are talking 
about.
    Chairman Miller. All right. Well, my time is expired. There 
will be other opportunities. Mr. Rohrabacher for five minutes.
    Mr. Rohrabacher. Thank you very much, Mr. Chairman. So, Dr. 
Gray, you were mentioning these charts that have been shown a 
number of times in this hearing. So you are suggesting that the 
chart that has been given to us during this hearing is not an 
officially approved chart from your agency?
    Dr. Gray. I am just saying that I was not involved in 
drafting them, and it is--there are questions about defining 
the previous versions of the process simply because they were 
not written down in the same way as we have now done.
    Mr. Rohrabacher. I am not quite understanding the answer, 
whether that was--it seems that you are saying that this chart 
then was developed by somebody in your agency, that it was not 
officially entitled to have the final word on what the flow 
chart would----
    Dr. Gray. No, I don't think that is quite it. It is my 
understanding that those were put together in an effort for our 
staff to come up here and brief the Committee, and we use those 
to brief some other committees. What I am saying is I didn't--I 
was not involved in putting those together. The only one of 
those that I can say accurately, to the best of my knowledge, 
completely and accurately reflects the way things are done is 
the last one that does reflect the new process that we have 
released.
    Mr. Rohrabacher. So the complicated flow chart that we see 
does not reflect or does reflect----
    Dr. Gray. It does reflect the process as it is currently 
defined.
    Mr. Rohrabacher. And what is your disagreement then with 
the Chairman on the flow chart? I was not quite understanding 
why----
    Dr. Gray. Oh, simply----
    Mr. Rohrabacher.--you brought up that point.
    Dr. Gray. Well, because it is very difficult I think to 
accurately compare these because in the past this process has 
not been written down as explicitly and transparently as it is 
now so that knowing exactly what the process was in each of 
those steps is a little harder.
    Mr. Rohrabacher. So, the other flow chart, the original one 
that has been presented to us as the formerly streamlined 
process now has been made more complicated actually does not 
reflect the complication of what it was before?
    Dr. Gray. Well, to me, complication is not what this is 
about. This is about making sure we are doing the right 
science. Those processes that we were looking at in, I believe 
it was Chart 1 and maybe Chart 2, are the ones that have us in 
the place today where we have assessments that are taking over 
10 years to do. That is not what I want, that is not what EPA 
needs. The new process is designed with timelines and 
milestones to help us move that process along, and actually 
though it may look more complicated, I believe it is both more 
streamlined and will be more efficient.
    Mr. Rohrabacher. Okay. So what you are suggesting then is 
that because something looks more complicated, it doesn't 
necessarily mean that it is more time consuming and 
complicated?
    Dr. Gray. No, I would--that is exactly true.
    Mr. Rohrabacher. Well, I think that is a disagreement you 
have with our Chairman, but I will follow through on that.
    Dr. Gray. Thank you.
    Mr. Rohrabacher. I think that sometimes, yes, I really 
understand that you sometimes cannot believe your eyes. Thank 
you.
    Chairman Miller. Well, as I said in the opening that we 
should--apparently it is you testimony that we should not 
believe our lying eyes, that the flow chart that was prepared 
by IRIS staff--I am advised by our Committee staff that all the 
charts were prepared by IRIS committee staff and prepared to 
our staff as part of our preparation for this hearing. Isn't 
that correct?
    Dr. Gray. I believe that is what I said.
    Chairman Miller. You may not have done it, but it was IRIS 
staff that prepared the charts that describe the process as it 
has existed along the way before 2004, before OMB and OIRA 
began making helpful suggestions about how it might be 
different, how it existed from 2004 to April 2008 and how it 
exists since April 10, 2008, isn't that right?
    Dr. Gray. That is correct.

                How Transparent Is the New IRIS Process?

    Chairman Miller. All right. There has been discussion of 
transparency. Well, it is not really possible to describe how 
many steps there are because there are so many kind of sub-
numbers. But say for instance looking at 2F, Step 2F, federal 
agencies identify mission critical chemicals. Is that step 
transparent? Does the public know what the agencies have had to 
say about what chemicals are mission critical?
    Dr. Gray. The designation mission critical is something we 
expect to happen very, very infrequently. When it does, it 
happens in consultation with and with the agreement of the EPA. 
If that in fact is something that is--if that designation is 
made and agreed to by the Agency, it would be certainly made 
known publicly.
    Chairman Miller. The final decision or the viewpoints that 
went into the decision?
    Dr. Gray. The decision that this has been chosen to be 
mission critical and that the Agency had agreed that in fact 
there were specific areas of research that could be conducted 
in a short amount of time that would provide additional 
information to improve the----
    Chairman Miller. How about Step 8B, internal Agency review 
of draft assessment?
    Dr. Gray. It has always been the practice that our 
discussions that we have within our Agency where I can tell you 
there is rarely scientific agreement, those are always kept 
deliberative within the Agency.
    Chairman Miller. So if it was a chemical that was being 
used by the Department of Defense, the Department of Defense--
that would be the step at which, or a step at which the 
Department of Defense would say whatever they had to say about 
TCE being on the IRIS list? Now, whether it should be on the 
list of chemicals that we know something about the risk--what 
we know about the risk, is that right?
    Dr. Gray. I am sorry, could you--I wasn't sure what your 
question was.
    Chairman Miller. 8B. Internal agency review. Is that all 
your agency or is that----
    Dr. Gray. Yeah, no, that is EPA. As I said, our remarks in 
EPA have always been kept deliberative, if it is something 
that--and are not released publicly.
    Chairman Miller. All right. How about nine? OMB interagency 
review of draft assessment and peer review charge? Is that 
public?
    Dr. Gray. No, that is interagency.
    Chairman Miller. Okay. And what would happen at that step?
    Dr. Gray. This is when the Office of Management and Budget 
would coordinate a review of the document by other federal 
agencies. Comments would come in to EPA, they would be combined 
with our comments that we had from within our agency and would 
be considered in ultimately revising the document that would 
then go very importantly to step 10A, external peer review, so 
that any scientific choices, any scientific decisions that are 
made in that document have to pass independent external peer 
review.
    Chairman Miller. Well, who would be commenting at that 
point? Would the Department of Defense--if you are talking 
about a chemical used by the Department of Defense, would the 
Department of Defense, would that be where they would have 
something to say?
    Dr. Gray. This process opens up the ability for comment 
much more broadly for the----
    Chairman Miller. Was that a yes?
    Dr. Gray.--for the agencies, for the public, and other 
interested parties.
    Chairman Miller. I am talking about nine, interagency 
review of draft assessment peer. Is that where the Department 
of Defense would have something to say?
    Dr. Gray. It is my understanding, and I don't know how OMB 
does the formal process for reviewing these, but this would go 
out to all of the federal agencies to have an opportunity to 
comment.
    Chairman Miller. And that would be----
    Dr. Gray. And as the GAO has recognized--we often get very 
useful comments back from that interagency process.
    Chairman Miller. Okay. And that is public or private?
    Dr. Gray. Those are deliberative, within the executive 
branch.
    Chairman Miller. That means it is not public.
    Dr. Gray. That is correct.
    Chairman Miller. Okay. Now, if this is all about what risk 
a chemical poses, not what to do about it, what risk it poses, 
isn't that entirely a scientific decision?
    Dr. Gray. No----
    Chairman Miller. Are toxicologists at DOD commenting? Who 
are you getting from DOD?
    Dr. Gray. I don't know who all of the commenters are, but 
again, as GAO has recognized, EPA says those comments that come 
in are useful. But again, they can be comments on science and 
on the science policy decisions and choices that are made----
    Chairman Miller. Which is also science. Which is also 
science.
    Dr. Gray. No, we have----
    Chairman Miller. Of course it is.
    Dr. Gray. We have a separate process in our Agency for 
example for dealing with science policy. We develop guidelines 
for those choices. They are vetted through our Science Policy 
Council.
    Chairman Miller. What would be the----
    Dr. Gray. We keep these two things separate.
    Chairman Miller. What would be the purpose of having this 
be a deliberative process, rather than open, transparent, 
having everyone who had anything to say, say it right out loud 
in front of God and everybody? So everybody else who has 
expertise can comment on what they had to say, whether their 
factual assumptions are correct, whether their analysis is 
correct or flawed, whatever. Isn't that the whole nature of 
peer review? Isn't scientific analysis open? Ms. Dudley?
    Ms. Dudley. Mind if I comment on that? I think the purpose 
is that healthy skepticism and frank discussions or candid 
discussions among scientists throughout the government actually 
makes for better results. And let me just read to you from the 
National Academies--they frequently ask questions. 
``Deliberative portions of meetings''--and this is the National 
Academy of Sciences--``deliberative portions of meetings are 
closed to allow the discussions and consensus process to 
proceed frankly and without public posturing so that Committee 
Members are free to change their positions in the face of 
evidence or argument.'' That is the same nature, the same 
reason as Dr. Gray said the discussions among EPA scientists 
who don't always agree, the discussions among interagency 
scientists. Providing that opportunity for candid, frank 
discussion is valuable.
    Chairman Miller. Mr. Stephenson, do you have anything to 
say on this point?
    Mr. Stephenson. Well, any time you want to question a risk 
assessment, whether it is what Dr. Gray is referring to as 
science policy or not, I still see no problem with the 
toxicologist at DOD suggesting that you don't have a good 
enough uncertainty analysis. Why can't that be made public, the 
basis for that statement? It is not to say that individual 
scientists within DOD statements would be available, but at 
least the DOD position on that particular risk assessment or 
why they are concerned with the science would be publicly 
available. I can't understand the scenario in which 
deliberative--if it encourages more frank and open 
conversations with the federal family, why doesn't it encourage 
more frank and open conversations with other public commenters? 
I mean, the logic defies me.
    Chairman Miller. I now recognize myself for another--well, 
do you wish, Dr. Gray, before I recognize myself for another 
five minutes, do you wish to comment on what Mr. Stephenson had 
to say?
    Dr. Gray. I did want to say that I think it is important 
for these discussions to take place. One of the new 
enhancements in the IRIS process that is here is something that 
we call listening sessions in which we open up and invite 
scientists from the public, from industry, from environmental 
organizations to all come in and to have a discussion about the 
science of a particular assessment at two different points here 
to make sure that we are hearing a wide range of views and we 
are getting that kind of input. We think that is very 
important.
    Chairman Miller. Now I recognize myself for five more 
minutes. Is there any stage at which a TCE manufacturer would 
have a say? Would a TCE manufacturer be able to talk to OMB? 
Would a TCE manufacturer fit in any of these boxes? Would 
someone outside a Federal Government agency have any chance to 
comment other than the public comment?
    Dr. Gray. Can I say right here, this goes back to my 
previous point of these listening sessions. Previously, there 
are contacts that come from various affected parties. It may be 
an industry or a manufacturer or use----
    Chairman Miller. Right. You have to have public comment.
    Dr. Gray. No.
    Chairman Miller. That is not public, that is private.
    Dr. Gray. Now in the new process, that will be happening in 
these open public listening sessions.
    Chairman Miller. Okay. Is there an opportunity for a 
manufacturer other than a public open listening sessions to 
have a say? Do they fit in any of these boxes or do they talk 
to OMB, to OIRA?
    Dr. Gray. I cannot speak for that. In our case, the 
intention now is to have these listening sessions which are 
open, publicly available as the----
    Chairman Miller. Right.
    Dr. Gray.--way that anyone who wants to bring----
    Chairman Miller. Any chance----
    Dr. Gray.--information brings it in.
    Chairman Miller. Any chance to do it in a deliberative way, 
not a public way, but deliberative way?
    Dr. Gray. No.
    Chairman Miller. Okay.
    Mr. Stephenson. Mr. Chairman----
    Chairman Miller. Ms. Dudley, is there any opportunity for 
deliberative----
    Ms. Dudley. No, not to my knowledge.
    Chairman Miller. OMB doesn't talk to manufacturers or no--
--
    Ms. Dudley. We talk to other federal scientists. Our role 
is coordinating scientific dialogue between scientists within 
the Federal Government.
    Mr. Stephenson. Mr. Chairman, could I add a comment here?
    Chairman Miller. Mr. Stephenson.
    Mr. Stephenson. In the course of doing our work and having 
discussions with DOD, DOE, and NASA, none of them really had 
objections to their comments on the scientific risk assessment 
being made public. So I am not sure where this need for 
deliberation comes from.
    Chairman Miller. All right. I am sorry, Dr. Gray and Ms. 
Dudley, you are both testifying that there is no step in this 
whole process, there is no procedure by which a private party, 
not a government agency, a private party can participate 
formally or informally in a deliberative way, not in a public 
way, but privately? Ms. Dudley, is that correct?
    Ms. Dudley. I am not familiar with the entire process. I 
know that the two steps that OMB manages--interagency review--
that is not an opportunity for people outside the government to 
weigh in.
    Chairman Miller. Okay. Now, both the EPA and OMB have 
recently asserted in Congressional testimony and refused to 
answer questions based upon the deliberative process privilege, 
that internal government discussions are not subject to--I 
don't agree with it, I am stating that--the assertion the 
privilege that EPA and OMB has asserted. Do you contend that if 
there were private conversations with those outside of 
government that they would be subject to any privilege?
    Ms. Dudley. I am not a lawyer. I know that our process is 
that in our regulatory review as well as the IRIS review, we do 
not talk to people outside the government. In our regulatory 
review, we operate under Executive Order 12866, and under that 
when we have a regulation under review, if we are to meet with 
people outside the government, we post that on our website, we 
post the attendees to that meeting and we also invite the 
agency.
    There is a balance to be struck, and I understand where you 
are going. There is a balance to be struck between a 
deliberative process to allow for that frank and candid 
discussion and also for the public's need for transparency and 
need to know. And I think we try to strike that balance. In the 
IRIS process, it is through this new procedure, and in the 
regulatory process it is through our transparent posting of 
meetings with people outside the government.
    Chairman Miller. Dr. Gray, the head of your agency asserted 
that privilege yesterday and refused to answer a direct 
question in another committee.
    Ms. Dudley. Actually, if I could just quickly correct that. 
I was sitting next to him, and he did not assert that 
privilege.
    Chairman Miller. I am sorry. He didn't actually say those 
words, he just said he wasn't going to answer. So do you 
intend, assert that I-don't-feel-like-telling-you privilege?
    Ms. Dudley. Only the President can assert Executive 
Privilege, and to my knowledge he has not done that in the 
issue of the testimony yesterday nor today.
    Chairman Miller. Do you have any idea of the nature of the 
privilege upon which the head of the EPA was lying in refusing 
to answer direct questions in a committee?
    Ms. Dudley. Are we discussing yesterday or on IRIS?
    Chairman Miller. Well, I am trying to figure out which one 
of these is going to be available to a Congressional oversight 
committee.
    Ms. Dudley. On this issue, actually, Dr. Gray is probably 
better to answer. But after the assessments have gone through 
interagency review, they are available for public peer review, 
and all the information on which those assessments rely is 
available for scientists outside the government or the general 
public outside the government to evaluate.
    Chairman Miller. Okay. Dr. Gray, did you have an answer to 
that question?
    Dr. Gray. I would agree completely with what Ms. Dudley has 
just said. No, there is--here the only things--there is a 
deliberative process with the discussions that we have within 
the EPA and the discussions that we have with the other federal 
agencies. When the ultimate decisions are made, the choices, 
the data, the endpoints in an IRIS assessment, those are put 
forth in a transparent way and go out for independent, external 
peer review to make sure that the science choices, the science 
assumptions, the data choices we have made are scientifically 
appropriate.
    Chairman Miller. Dr. Gray, Mr. Stephenson said a minute ago 
that--he listed three agencies, NASA and who else?
    Mr. Stephenson. DOE and DOD.
    Chairman Miller. They say they don't mind commenting right 
out loud in front of God and everybody. They don't need for it 
to be privileged or private, deliberative. They are willing to 
say what they have to say publicly. Are there agencies that 
have objected to having their comments be public?
    Dr. Gray. The deliberative steps here were decisions that 
were taken by the EPA to make these steps deliberative as they 
have been in the past and as is done with other kinds of 
reviews that we have.
    Ms. Dudley. Excuse me sir, do you mind if I comment on 
that?
    Chairman Miller. Sure.
    Ms. Dudley. Any agency that wants to make that information 
public certainly can do that during the comment period. So 
there is nothing in this process that would bar them from 
making that information public.

                     Timelines for IRIS Assessments

    Chairman Miller. I understand this has only been in effect 
since April 10, 2008, and it is designed to streamline the 
process so that it would be more productive and that more 
chemicals will be assessed. We won't still be waiting 11 years 
after formaldehyde was submitted for re-evaluation, and 
formaldehyde is--we have had another Subcommittee hearing on 
formaldehyde. It would have been nice to have for the EPA and 
FEMA and for the Centers for Disease Control to have a picture 
of formaldehyde's likely toxicity, likely risk, based on the 
current science. But it still hasn't happened. When are we 
going to know that this is actually producing more assessments? 
Four in the last two years does not seem like the changes made 
in 2004 resulted in a leap in productivity. When are we doing 
to know if this is now going to fix whatever errors there are? 
Mr. Stephenson thinks that it will not but it will make it 
worse. When are we going to decide who is correct?
    Dr. Gray. Well, I would say that we agree, that there are 
real issues with the development of IRIS assessments and their 
timeliness. These delays have been a longstanding issue, and it 
is very clear the fact that we have a significant number that 
have taken 10 years or more, that a lot of the delays predate 
any changes in this process. Our goal is to have a process that 
will increase the rigor and the timeliness with these timelines 
that will provide strict milestones for EPA and for the other 
parties in this entire process to move this along. I think what 
we need now is time to implement this process, to evaluate it. 
It is intended to be a living document, recognizing it may need 
future revisions, but I think that the process that we have 
been using certainly hasn't gotten us to the place we want to 
be.
    Chairman Miller. Ms. Dudley.
    Ms. Dudley. You know, I wasn't involved in developing the 
new IRIS process, but the fact that it has timelines for every 
step along the way, including interagency comment and EPA 
response to that, I think will both streamline the process and 
improve the quality and rigor of the resulting assessments.
    Chairman Miller. What are the consequences of not meeting 
the timelines?
    Ms. Dudley. I don't know that there are any consequences.
    Dr. Gray. No, but these are intended as part of a 
management system that we are implementing so that people know 
on our side how we expect them to do their work and when we 
expect them to do their work when we deal with the other 
agencies how things go. For example, one of the things that is 
commonly done is to suggest to an agency, if we don't hear from 
you in some amount of time, we assume you have no comments. 
Those sorts of things may well be the way in which this would 
work to help make sure that things keep to the timelines.
    Chairman Miller. Mr. Stephenson, when do you have a sense 
of how well this is working?
    Mr. Stephenson. If you look at the timeframes that are 
missing from your chart with this system, we already know that 
it is not going to work.
    Chairman Miller. And how is that?
    Mr. Stephenson. All we did was add up the timeframes which, 
as you just heard, may or may not have consequences. We added 
them up through this flow chart, and they total six years. And 
if it is a mission critical system, the DOD commenter or 
whomever, has the ability to ask for additional research, which 
can take up to 18 more months. It is already broken.
    Dr. Gray. I would like to suggest that in fact this process 
I believe can help us get done in less time than our current 
five and one-half year per assessment average; if you add up 
the timelines and remove those small fraction of chemicals that 
might be considered mission critical, this is something that 
will take less time than our current process and will be more 
responsive, more rigorous, and more transparent.
    Mr. Stephenson. We are not thrilled with the current 
process.
    Chairman Miller. Are there no milestones at all in the 
current process, in the previous process?
    Dr. Gray. There are none that are written down and publicly 
available.
    Chairman Miller. Okay.
    Mr. Stephenson. That is the improvement. It is no longer ad 
hoc. Now you know what the process is.
    Ms. Dudley. Sir, I actually have a chart that I don't 
know--did you get this just before the hearing? I am sorry that 
we don't have it so that you can put it up.
    Chairman Miller. I haven't seen it but perhaps the staff 
has.
    Ms. Dudley. What it does is it takes a look--EPA has data 
on the number of IRIS assessments completed going back to 1997. 
The GAO reports--I am not sure what day it starts, but it 
doesn't go back as far as we have data. And that suggests that 
there are increases--that you see increases and decreases in 
the assessments but that on average in the last three years of 
the previous administration, there were four assessments per 
year, whereas the average between 2000 and 2007 has been 4.6. 
So I think we all agree that the process, that it is too slow 
and we need to speed that up, but I think it is not fair to 
characterize the previous way as the golden age and the future 
as a slowing of the process.






    Mr. Stephenson. I agree with that.
    Chairman Miller. I am advised by our staff that we do have 
this but we got it 15 minutes before the hearing. So there has 
not exactly been an ample opportunity to look at it closely.
    That is the end of the hearing today. Thank you all for 
appearing. We did have an earlier hearing on the issue of 
formaldehyde in trailers provided by FEMA. And an effort began 
in 1997 to update the listing for formaldehyde. The equivalent 
agencies through the EPA and other developed countries list 
formaldehyde as a known carcinogen. It is still listed as a 
suspected carcinogen, and since 1997, there has not been a 
completed revision of formaldehyde's risk to the public, risk 
to health, risk to the environment. There were hundreds and 
thousands of people who were living in trailers provided by 
FEMA that used particle board made with formaldehyde with high 
levels of formaldehyde in the air inside the trailers, with 
families who were displaced by Katrina and by Rita breathing 
that air every day. It would have been nice to have a current 
assessment of the health consequences for formaldehyde that 
FEMA could have relied upon, that the Centers for Disease 
Control could have relied upon, and that the Agency for Toxic 
Substances and Disease Registry, ATSDR, could have relied upon 
instead of saying, well, just open the windows and doors. If in 
fact formaldehyde is a substantially greater health risk than 
the now more than decade old assessment, that is a current 
science. There is no virtue--and I agree with all of the 
witnesses today--there is no virtue in not knowing. There is no 
virtue in not finding out. This is not a process about--ours is 
not intended to be health or risk management. It is not what to 
do about the fact that there is a risk, it is what is the risk? 
And there is no virtue in not knowing. But it is hard to look 
at EPA's performance and not conclude that we are not doing a 
sufficient job in determining which of the 80,000 chemicals 
present a hazard and what the hazard is.
    So I thank all of you for appearing today, and we will 
pursue this further. Thank you. The hearing is adjourned.
    [Whereupon, at 12:50 p.m., the Subcommittee was adjourned.]

                               Appendix:

                              ----------                              


                   Additional Material for the Record










































































       TOXIC COMMUNITIES: HOW EPA'S IRIS PROGRAM FAILS THE PUBLIC

                              ----------                              


                        THURSDAY, JUNE 12, 2008

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

    The Subcommittee met, pursuant to call, at 10:00 a.m., in 
Room 2318 of the Rayburn House Office Building, Hon. Brad 
Miller [Chairman of the Subcommittee] presiding.


                            hearing charter

              SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT

                  COMMITTEE ON SCIENCE AND TECHNOLOGY

                     U.S. HOUSE OF REPRESENTATIVES

               Toxic Communities: How EPA's IRIS Program

                            Fails the Public

                        thursday, june 12, 2008
                         10:00 a.m.-12:00 p.m.
                   2318 rayburn house office building

    The Subcommittee on Investigations and Oversight will hold the 
second hearing on the Integrated Risk Information System (IRIS) at the 
Environmental Protection Agency (EPA).
    On May 21, 2008, the Subcommittee heard the Government 
Accountability Office's (GAO) evaluation of the Administration's new 
process for reviewing and approving chemical assessments for inclusion 
in the IRIS database. In their March 2008 review of EPA's IRIS program 
GAO found that the IRIS database was at serious risk of becoming 
obsolete because the Agency has not been able to complete credible 
assessments in a timely manner or to reduce the backlog of 70 
assessments that were in the development, review or approval 
process.\1\ In their subsequent examination of the process implemented 
by the Administration on April 10, 2008, GAO testified that the recent 
assessment process changes arid the other process changes being 
implemented by EPA were likely to increase the time needed to finalize 
IRIS assessments and to further reduce the credibility of IRIS 
assessments.\2\
---------------------------------------------------------------------------
    \1\ U.S. Government Accountability Office (GAO). 2008. Chemical 
Assessments Low Productivity and New Interagency Process Limit the 
Usefulness of EPA's Integrated Risk Information System. GAO-08-440.
    \2\ U.S. Government Accountability Office (GAO). 2008. Chemical 
Assessments EPA's New Assessment Process Will Further Limit the 
Productivity and Credibility of Its Integrated Risk Information System. 
Testimony before the Subcommittee on Investigations and Oversight, 
Committee on Science and Technology, House of Representatives.
---------------------------------------------------------------------------
    The witnesses will address the role of IRIS assessments in the 
regulatory process for implementing environmental statutes administered 
by EPA and by State, territorial, and tribal governments and the 
consequences of extended delay in the IRIS assessment process for 
public health. They will also address questions regarding the Bush 
Administration's evolving system to draft and review IRIS entries. 
Witnesses include:

          Mr. Jerome Ensminger, Master Sergeant U.S. Marine 
        Corps (ret.)

          Mr. Lenny Seigel, Center for Public Environmental 
        Oversight

          Dr. Linda Greer, Senior Scientist, Natural Resources 
        Defense Council

          Dr. David G. Hoel, Professor, Medical University of 
        South Carolina

What Is the Role of an IRIS Assessment in the Regulatory Process?

    Federal and State governments adopt environmental and public health 
laws to protect natural resources and the public. EPA, State, 
territorial, anal tribal governments implement environmental statutes 
through the issuance of regulations that set standards for air and 
water quality and for clean-up of contaminated areas. Regulations also 
set deadlines for achieving the standards. At the federal level, EPA 
administers environmental statutes to protect public health and the 
environment, to establish criteria for the handling and disposal of 
hazardous materials, and that govern the clean-up of contaminated land 
and water. The preparation of a regulation requires assembling a wide 
variety of information to define risk and justify the risk management 
approach mandated by the regulation. In addition to the information and 
procedural requirements imposed by individual statutes, there are 
general statutes governing the issuance of regulations by federal 
agencies that also impose procedural and information requirements 
(e.g., Administrative Procedures Act, Paperwork Reduction Act, Unfunded 
Mandates Reform Act) and there are Executive Orders and guidance from 
the Office of Management and Budget (OMB) that also require procedures 
and analyses to be done in support of a regulation.
    Two of the most commonly required analyses are risk assessments and 
cost-benefit analyses. While not a regulatory product itself, IRIS is 
designed to help regulators set priorities about what to regulate and 
inform regulators on a safe exposure level for workers or communities. 
An IRIS assessment provides a hazard identification and dose-response 
analysis, scientific information that when combined with estimates of 
exposure allow regulatory agencies to produce a risk assessment. Delay 
in the production of the IRIS assessment translates into delay in 
implementation of environmental statutes and in establishment of 
standards to protect public health.
    While some State governments have environmental programs that 
independently establish standards (e.g., California), many State 
governments and virtually all territorial and tribal governments rely 
upon the Federal Government to develop and evaluate the scientific 
information that will determine safe levels of exposure and allow 
regulatory agencies to set standards for air and water quality to 
protect public health and the environment. For example, in response to 
EPA's solicitation to set priorities for developing IRIS assessments, 
the State of Minnesota submitted a list of 52 chemicals of concern.\3\
---------------------------------------------------------------------------
    \3\ Submission by the Minnesota Department of Health to the 
Integrated Risk Information System (IRIS); Request for Chemical 
Substance Nominations for the 2007 Program. Docket ID No. EPA-HQ-ORD-
2006-0950.

The Case of Trichloroethylene: How Long Does a Controversial IRIS 
                    Assessment Take to Complete?

    In its March 2008 report on EPA's IRIS program GAO examined six 
specific IRIS assessments that are in process.\4\ One of the six 
assessments was of trichloroethylene or TCE. GAO's report provided the 
following timeline for the development of a cancer assessment of TCE 
for inclusion in the IRIS database: EPA developed a cancer assessment 
of TCE for inclusion in the IRIS database, but withdrew it in response 
to peer reviewers' comments in 1989. EPA initiated a new TCE cancer 
assessment in 1998 and issued a new draft assessment in 2001. This 
draft and its findings were controversial. It was reviewed by EPA's 
Science Advisory Board and released for public comment. The National 
Academy of Sciences (NAS) was asked to review the draft and to resolve 
issues raised in the SAB review and through the public comment process 
about methods EPA used to assess the risk of TCE. In 2006, the NAS 
panel released their report. The panel stated:
---------------------------------------------------------------------------
    \4\ U.S. Government Accountability Office (GAO). 2008. Chemical 
Assessments Low Productivity and New Interagency Process Limit the 
Usefulness of EPA's Integrated Risk Information System. GAO-08-440.

         The committee found that the evidence on carcinogenic risk and 
        other health hazards from exposure to trichloroethylene has 
        strengthened since 2001. Hundreds of waste sites in the United 
        States are contaminated with trichloroethylene, and it is well 
        documented that individuals in many communities are exposed to 
        the chemical, with associated health risks. Thus, the committee 
        recommends that federal agencies finalize their risk assessment 
        with currently available data so that risk management decisions 
        can be made expeditiously.\5\
---------------------------------------------------------------------------
    \5\ National Research Council. 2006. Assessing the Human Health 
Risks of Trichloroethylene: Key Scientific Issues. The National Academy 
Press. Washington, DC. p. 2.

    Despite this direction from the NAS to move forward, EPA has not 
yet released its assessment of TCE. According to GAO, the assessment is 
back at the draft development stage and will not be finalized until 
---------------------------------------------------------------------------
2010.

What Are the Consequences for Public Health When IRIS Assessments Are 
                    Delayed?

    TCE is a solvent that has been in commerce since the 1920s. TCE is 
a degreasing agent and has been widely used in manufacturing and 
industrial settings. It is one of the most commonly identified 
contaminants at sites included on EPA's National Priority List (NPL) 
under the Superfund program. It is a found in air, water, and soils. A 
number of different cancers, reproductive and developmental problems, 
neurotoxic effects, and auto-immune disease have all been associated 
with exposures to TCE.
    Since TCE is a contaminant of air, water, and soils its clean-up is 
determined through various statutes administered by EPA including: the 
Safe Drinking Water Act, the Clean Air Act, and the Comprehensive 
Environmental Response, Compensation, and Liability Act (CERCLA) or 
Superfund. Under each of these statutes, EPA has the authority to set 
maximum contaminant levels that define safe drinking water, set air 
quality standards that define clean air, and that set standards for 
clean-up of contaminated soil and water at Superfund sites. These 
standards cannot be strengthened, until EPA has completed the IRIS 
assessment, a risk assessment, and other supporting studies and 
information requirements (e.g., cost-benefit analysis, regulatory 
impact analyses, etc.) needed to support a regulation. Many people 
believe the TCE standards currently in place are inadequate to protect 
human health especially that of children and other sensitive sub-
populations.
    The Subcommittee will hear from two witnesses whose family or 
communities have experienced serious health impacts that are associated 
with exposure to TCE. One of the sites listed on the Superfund NPL is 
Camp Lejeune, the Marine Corps base in North Carolina. The drinking 
water source for the base is contaminated with TCE and 
tetrachloroethylene (PCE or perc): The Marine Corps closed contaminated 
drinking water wells in 1985, and the site was listed in 1989. The 
Agency for Toxic Substances and Disease Registry estimated that up to 
one million people were exposed to these toxic contaminants before the 
contaminated wells were closed in 1985.
    The community of Mountain View, California has several TCE clean-up 
sites. Several of the contaminated sites are located on federal lands 
including the Orion Park Military Housing Area (U.S. Army). These areas 
are still undergoing clean-up and remediation and residents of the area 
are still exposed to TCE through a process known as vapor intrusion.
    Mr. Ensminger and Mr. Seigel will discuss the experiences of their 
family and community, respectively and why they believe EPA's IRIS 
program needs reform.

Attachment

 The Minnesota Department of Health Submission to the Integrated Risk 
 Information System (IRIS); Request for Chemical Substance Nominations 
                            for 2007 Program

                  (Docket ID No. EPA-HQ-ORD-2006-0950)
    The Health Risk Assessment staff at the Minnesota Department of 
Health wish to nominate a list of chemicals to be included in the 
Integrated Risk Information System (IRIS); Request for Chemical 
Substance Nomination for 2007 Program. These chemicals are of concern 
to the Minnesota Department of Health because they are among 
contaminants found in Minnesota groundwater. In Minnesota, health based 
values are derived for such contaminants. When conducting risk. 
assessments, the Minnesota Department of Health has relied upon the 
IRIS summaries as a resource for the development of these health 
protective values. Therefore, it is our hope that you take our 
nominated chemicals in consideration. By obtaining IRIS summaries of 
these chemicals it will result in a more thorough and accurate risk 
assessment process.

1,2,3--Trichloropropane
1-Methylnaphtalene
1-Methylphenol
2,2--Dichloropropane
2,3,4,5--Tetrachlorophenol
2,3,5,6-Tetrachloroterephthalic acid
2,6-dinitrotoluene
2,6-diethylaniline (Alchlor degradate)
2-Nitrophenol
3,5-Dichlorophenol
4-Isopropyltoluene
Acetochlor ESA
Acetochlor OA
Alachlor ESA (degradate of Alachlor)
Alachlor OA (degradate of Alachlor)
Aluminum
Deaminated diketomethribuzin (degradate of Metribuzin)
Deaminated metribuzin (degradate of Metribuzin)
Deethylatrazine (degradate of Atrazine and Propazine)
Deisopropylatrazine (degradate of Atrazine, Cyanazine and Simazine)
Diallate
Diazion
Dichlorofluoromethane
Diketometribuzin (degradate of metribuzin)
Dimethenamid
Dimethenamid ESA (degradate of Demethenamid)
Dimethenamid OXA (degradate of Dimethenamid)
Ethafluralin
Hydroxyatrazine
Iron
Isopropyl ether
Isoxaflutole
Lithium
Metolachlor ESA
Metolachlor ESA
Metsulfuron-methyl (Ally)
Monomethyl tetrachloroterephthalic acid
n-Butylbenzene
Nicosulfuron
n-Propylbenzene
Primisulfuron-methyl (Beacon)
Radionuclides (all)
Sec-Butylbenzene
Sodium
Thifensulfuron methyl
Tin
Total petroleum hydrocarbons
Tribenuron-methyl
Triclopyr
Trinitro-phenylmethylnitramine
Triphenyltin hydroxide
Vanadium

    In addition, the Minnesota Department of Health currently needs and 
uses reference concentrations and reference doses for less than chronic 
periods of exposure to assess risks from a variety of exposure 
scenarios. These scenarios include less than chronic exposures that 
commonly occur at contaminated sites resulting in the need for less 
than chronic toxicity values to assess current risks. The EPA 2002 ``A 
review of the reference dose and reference concentration processes'' 
has guided much of the practice of the Department in this area.
    The Department has found that health effects that result from less 
than chronic periods of exposure, when combined with high drinking 
water exposures associated with specific life stages (e.g., childhood), 
result in drinking water values that are lower and therefore more 
appropriate as drinking water standards for the general population than 
the value calculated using a chronic reference dose and lifetime 
average dose. As a result, the Department is very interested in recent 
efforts by IRIS to develop less than lifetime reference values, and 
urges the EPA to continue to develop and publish these analyses. The 
Department also urges the EPA to consider the potential that effects 
observed in chronic studies result from early exposures rather than 
continuous exposure. To the extent that studies are available, the 
Department urges the EPA to present acute, short-term, longer-term, and 
chronic evaluations (recommendations for critical studies for each and 
resulting reference doses) for each chemical that undergoes review in 
the future.
    Chairman Miller. The hearing will come to order. Good 
morning, and welcome to our second hearing on EPA's Integrated 
Risk Assessment System, IRIS.
    The glacial pace at which EPA is completing assessments of 
chemicals has real consequences for public health, and tragic 
consequences for human beings and their families. Completion of 
an IRIS assessment is just the first step in the process of 
protecting people from dangerous exposures to toxic chemicals. 
With an IRIS assessment in place, it is easier to deal with the 
clean-up of chemical contamination of the air or water, to 
adopt safer practices in the workplace, and to consider steps 
to regulate toxic substances that can harm our children and our 
communities.
    The Government Accountability Office's recent report on 
IRIS concluded that EPA's process for initiating and completing 
IRIS assessments resulted in proposals that are now in 
preparation for more than five years, with some assessments 
taking more than a decade. The new process that EPA and OMB 
instituted just in April will add additional years to our 
assessments, according to the GAO conclusions.
    The years of study and discussion regarding IRIS 
assessments comes on top of a regulatory process that is 
burdened with time-consuming steps for complete risk 
assessment, cost benefit analysis, and internal and external 
reviews, all as laid out in Executive Orders and in statute. 
Even after a regulation is finalized, it can be challenged in 
court and sent back to the Agency for revision. When finally 
established, a new regulation usually includes some time, often 
many years, for the affected parties to transition away from 
the practices that are being regulated.
    During this entire process, exposures continue, toxic 
substances remain unregulated or under-regulated in commerce, 
and contamination is not cleaned up, or not cleaned up to a 
level that we think is actually safe.
    Today, we will hear from people who have lived and are 
living with those consequences. These people will describe what 
their families and communities have endured for years, 
situations that no one would wish to endure for a day.
    While the failures of the IRIS database are not responsible 
for these experiences, the gaps in IRIS and the improper 
intrusion of politics into database entries have likely 
contributed to the situations that these people and their 
communities have had to deal with. When State and local 
authorities get poor information or no information regarding 
the health hazards of a particular pollutant, their response to 
pollution in a community is likely to be confused and 
confusing. When citizens can't turn to IRIS for information--
and the database gets 20,000 web hits a year--then it is hard 
for them to know what they are fighting in terms of clean-ups 
and health risks.
    The worst thing about these families' experiences is that 
they are likely to be repeated because exposures that led to 
the chemical that led to the problems continue. TCE was 
discovered in the early 1900s and has been on the market and 
widely used since the 1920s as a degreaser. Discovery of its 
toxic properties eliminated its use as an analgesic in the 
1930s, and by the 1970s, evidence in animal experiments showed 
that it might cause cancer. It is one of the most frequently 
occurring contaminants in Superfund sites, and it is present in 
air, drinking water, and soils.
    EPA has been working on a revised TCE assessment since 
1989. Two years ago, following interventions by NASA, the 
Department of Energy, the Department of Defense, and OMB, the 
National Academy reviewed EPA's draft IRIS assessment and the 
science available on TCE, and said that ``evidence on 
carcinogenic risk and other health hazards from exposure to TCE 
has strengthened since 2001. Priority should be given to 
finalizing the risk assessment so that risk management 
decisions can be made expeditiously.''
    Expeditious is not a word that describes this situation. 
GAO estimates that EPA will not complete their TCE assessment 
until 2010. That is 21 years from the start date. If they 
completed their assessment in 2010, we will still be years away 
from real regulatory action. People have been exposed to a 
known toxic substance for decades for a generation while their 
government has engaged in one study after another. Have we 
become so obsessed with getting the science exactly right that 
we have lost sight of our real goal, protecting public health? 
Or is getting the science exactly right a pretext for 
obstruction of any real protection of the public.
    This system defies common sense. It is broken. It is 
condemning people to future health problems.
    I now yield to my distinguished colleague, the Ranking 
Member of the Subcommittee, Mr. Sensenbrenner, for an opening 
statement.
    [The prepared statement of Chairman Miller follows:]
               Prepared Statement of Chairman Brad Miller
    Good morning and welcome to our second hearing on EPA's Integrated 
Risk Assessment System (IRIS).
    The glacial pace at which EPA is completing assessments of 
chemicals has real consequences for public health and tragic 
consequences for individuals and their families.
    Completion of an IRIS assessment is just the first step in the 
process protecting people from dangerous exposures to toxic chemicals. 
With an IRIS assessment in place, it is easier to deal with the clean-
up of chemical contamination of the air or water, to adopt safer 
practices in the workplace and to consider steps to regulate toxic 
substances that can harm our children and our communities.
    The Government Accountability Office's recent report on IRIS 
concluded that EPA's process for initiating and completing IRIS 
assessments resulted in proposals that are in preparation for more than 
five years, with some assessments taking more than a decade. The new 
process that EPA and OMB instituted just this past April will add 
additional years to IRIS assessments.
    The years of added study and discussion regarding IRIS assessments 
come on top of a regulatory process that is burdened with very time 
consuming steps for a complete risk assessment, cost-benefit analyses, 
and internal and external reviews as laid down in Executive Orders and 
statute. Even after a regulation is finalized, it can be challenged in 
court and sent back to the Agency for revision. When finally 
established a new regulation usually includes some time, often many 
years, for the affected parties to ``transition'' away from the 
practices that are being regulated.
    During this entire process, exposures continue, toxic substances 
remain unregulated or under-regulated in commerce, and contamination is 
not cleaned up or not cleaned up to a level that we think is actually 
safe.
    Today we will hear from people who have lived, and ore living with, 
these consequences. These people will describe what their families and 
communities have endured for years--situations that no one would wish 
to experience for even one day.
    While the failures of the IRIS database are not responsible for 
these experiences, the gaps in IRIS, and the improper intrusion of 
politics into database entries have likely contributed to the 
situations that these people and their communities have had to deal 
with. When State and local authorities get poor information, or no 
information, from IRIS regarding the health hazards of a particular 
pollutant, their response to pollution in a community is likely to be 
confused and confusing. When citizens can't turn to IRIS for 
information--and the database gets 20,000 web hits a year--then it is 
hard for them to know what they are fighting for in terms of clean-ups 
and health risks.
    The worst thing about these families' experiences is that they are 
likely to be repeated because exposures to the chemical that led to 
their problems continue. Trichloroethylene or TCE was discovered in the 
early 1900s and has been on the market and widely used since the 1920s 
as a degreaser. Discovery of its toxic properties eliminated its use as 
an analgesic in the 1930s and by the 1970s evidence in animal 
experiments indicated it might cause cancer. It is one of the most 
frequently occurring contaminants in Superfund sites and it is present 
in air, drinking water, and soils.
    EPA has been working on a revised TCE assessment since 1989. Two 
years ago, following interventions by NASA, the Department of Energy, 
the Department of Defense and OMB, the National Academy reviewed EPA's 
draft IRIS assessment and the science available on TCE and said that: 
``evidence on carcinogenic risk and other health hazards from exposure 
to trichloroethylene has strengthened since 2001 . . .. Priority should 
be given to finalizing the risk assessment so that risk management 
decisions can be made expeditiously.''
    Expeditiously? Expeditious is not a word that describes this 
situation. GAO estimates that EPA will not complete their TCE 
assessment until 2010--that's twenty-one years from their original 
start date.
    If they complete the assessment in 2010, we will still be years 
away from regulatory action. People will have been exposed to a known 
toxic substance for decades, for a generation, while the government 
engages in study after study. Have we become so obsessed with getting 
the science right that we have lost sight of our real goal protecting 
public health? Or, is getting the science right a pretext for 
obstruction?
    This system defies common sense. It is broken, and it is condemning 
people to future health problems.
    I now yield to my distinguished colleague, the Ranking Member of 
the Subcommittee, Representative Sensenbrenner for an opening 
statement.

    Mr. Sensenbrenner. Thank you very much, Mr. Chairman. 
Before making my statement, let me say that Dr. David Hoel, who 
is the Minority witness at today's hearing, got stuck in the 
Atlanta airport last night because of bad weather. We kind of 
know about that the last couple of weeks in Wisconsin where I 
come from. I would like to ask unanimous consent that Dr. 
Hoel's testimony be placed in the record, and that he be 
instructed to respond to certain written questions by Members 
of the Committee and their staff, and that the responses to 
those questions also be placed into the record.
    Chairman Miller. Without objection, that is so ordered.
    [The statement of Mr. Hoel appears in Appendix: Additional 
Material for the Record.]
    Mr. Sensenbrenner. Mr. Chairman, the Integrated Risk 
Information System, IRIS, process was originally developed for 
a specific task. Different offices throughout the EPA were 
relying on different assessments of the health effects of 
chronic exposure to toxic chemicals. IRIS was intended to 
establish a uniform database within the EPA.
    However, over time, IRIS has become an authoritative 
resource on chemical toxicity. Other agencies, states, the 
international community, and the industries have been becoming 
increasingly reliant on IRIS and the assessments took on 
increased importance. These outside groups have sought to 
impact a process that was not initially designed to handle 
external pressures. The result has been an IRIS process that 
has effectively broken down.
    The GAO recently issued a scathing condemnation of the 
current state of the IRIS program. The report is titled ``Low 
Productivity and New Interagency Review Process Limit the 
Usefulness and Credibility of EPA's Integrated Risk Information 
System.'' Now, that is a mouthful, but I think it says where we 
are at now. In my opinion, it accurately sums up the GAO's 
findings. But IRIS' actual production numbers are even worse. 
EPA currently has a backlog of 70 ongoing assessments, and has 
managed to complete only two assessments in each of the last 
two years. Talk about a snail's pace. At the current pace, it 
will take 35 years for the EPA to finish its current backlog, 
and that is assuming it takes on no further tasks.
    The EPA has attempted to develop uniform process for IRIS 
assessments. The Agency argues that it can expedite the IRIS 
process by involving other agencies earlier in the process. 
While preventing last-minute delays is an important reform, the 
ability of other agencies to extend the timeframe of 
assessments should be sharply limited. Data gaps in risk 
assessments will always exist as better science is always 
developing. EPA needs to limit the timeframe of assessments to 
prevent other agencies from indefinitely delaying the process.
    EPA must also balance its need to complete assessments with 
the rights of interested parties to comment. The best way to 
achieve this balance would be to give more notice of its 
assessments. The EPA already publishes an annual agenda of the 
chemical it intends to assess in the Federal Register. If the 
EPA moves the date of that publication forward, thus providing 
more notice, the interested parties will have a longer period 
to comment on what they deem to be insufficiencies in the 
scientific record. During this comment period, EPA can focus on 
its backlog. Because it offered a comment period, EPA can then 
fairly limit the ability of outside parties to delay 
assessments once they are underway. The result would be a more 
efficient process that preserves taxpayers' money and promotes 
public health. In my opinion, that is a win-win.
    I urge the EPA to consider these proposals, because IRIS 
must be fixed. In April, this subcommittee held a hearing on 
formaldehyde levels in trailers provided to the victims of 
Hurricane Katrina. In that hearing, we investigated how the 
Agency for Toxic Substances and Disease Registry struggled to 
identify the proper level of concern for long-term exposure to 
formaldehyde. EPA determined its formaldehyde assessment was 
outdated in 1997, but 11 years later, the assessment is still 
incomplete. These hurricane victims are the real world result 
of EPA's bureaucratic failures.
    I yield back the balance of my time.
    [The prepared statement of Mr. Sensenbrenner follows:]

    Prepared Statement of Representative F. James Sensenbrenner Jr.

    The Integrated Risk Information System (IRIS) process was 
originally developed for a specific task. Different offices throughout 
the Environmental Protection Agency (EPA) were relying on different 
assessments of the health effects of chronic exposure to toxic 
chemicals. IRIS was intended to establish a uniform database within 
EPA.
    Over time, however, IRIS became an authoritative resource on 
chemical toxicity. Other agencies, states, the international community, 
and industries increasingly began to rely on IRIS, and the assessments 
took on increased importance. These outside groups have sought to 
impact a process that was not initially designed to handle external 
pressures. The result has been an IRIS process that has effectively 
broken down.
    The Government Accountability Office (GAO) recently issued a 
scathing condemnation of the current state of the IRIS program. The 
report's title, Low Productivity and New Interagency Review Process 
Limit the Usefulness and Credibility of EPA's Integrated Risk 
Information System, accurately sums up GAO's findings. But IRIS' actual 
production numbers are worse. EPA currently has a backlog of 70 ongoing 
assessments and has managed to complete only two assessments in each of 
the last two years. At the current pace, it will take 35 years for EPA 
to finish its current backlog.
    EPA has attempted to develop a uniform process for IRIS 
assessments. The agency argues that it can expedite the IRIS process by 
involving other agencies earlier in the process. While preventing last 
minute delays is an important reform, the ability of other agencies to 
extend the timeframe of assessments should be sharply limited. Data 
gaps in risk assessments will always exist as better science is always 
developing. EPA needs to limit the timeframe of assessments to prevent 
other agencies from indefinitely delaying the process.
    EPA must balance its need to complete assessments with the rights 
of interested parties to comment. The best way to achieve this balance 
would be to give more notice of its assessments. EPA already publishes 
an annual agenda of the chemical it intends to assess in the Federal 
Register. If EPA moves the date of that publication forward, providing 
more notice, interested parties will have a longer period to comment on 
what they deem to be insufficiencies in the scientific record. During 
this comment period, EPA can focus on its backlog. Because it offered a 
comment period, EPA can then fairly limit the ability of outside 
parties to delay assessments once they are underway. The result would 
be a more efficient process that preserves taxpayers' money and 
promotes public health.
    I urge EPA to consider these proposals, because IRIS must be fixed. 
In April, this subcommittee held a hearing on formaldehyde levels in 
trailers provided to the victims of Hurricane Katrina. In that hearing, 
we investigated how the Agency for Toxic Substances and Disease 
Registry struggled to identify the proper ``level of concern'' for 
long-term exposure to formaldehyde. EPA determined its formaldehyde 
assessment was outdated in 1997, but eleven years later, that 
assessment is still incomplete. These hurricane victims are the real 
world result of EPA's bureaucratic failures.

    Chairman Miller. Thank you, Mr. Sensenbrenner. Mr. 
Sensenbrenner spoke of the backlog and said that there was no 
further work for EPA to do, and an IRIS list that would take 35 
years. Since 600 new chemicals enter the marketplace a year, it 
is reasonable to assume that there will be more for EPA to do.
    I ask unanimous consent to enter documents for the record 
that had been provided to the minority. Without objection, it 
is so ordered.
    [The information follows:]

    
    
    
    
    
    

    Chairman Miller. I also ask unanimous consent that any 
additional statements submitted by Members be included in the 
record. Without objection, so ordered.
    [The prepared statement of Ms. Johnson follows:]
       Prepared Statement of Representative Eddie Bernice Johnson
    Thank you, Mr. Chairman. This is the second hearing in one month on 
the Integrated Risk Information System within the Environmental 
Protection Agency.
    This system is intended to protect both environmental quality and 
human health through effective regulations and other policy 
implementation.
    However, today's witnesses will make clear that environmental 
contamination has impacted their lives in the most severe ways.
    It is my hope that this subcommittee can learn what influence the 
current Administration has had on IRIS, and how IRIS' functions have 
changed since the commencement of the current Administration.
    Some of the problems with that process were the subject of this 
subcommittee's hearing two weeks ago.
    Oversights as glaring and irresponsible have major consequences.
    Today, we will hear true stories from Americans whose lives are 
forever changed as a result of needless, reckless pollution.
    It is our duty to hear them, and to work out policies to prevent 
tragedies of this nature from ever occurring.
    This subcommittee is aware that within the IRIS system, only four 
chemical listings have been finalized in the past two years.
    While approximately 700 new chemicals enter commerce each year, and 
more than 80,000 chemicals reported under the Toxic Substances Control 
Act, it is beyond my comprehension that the E.P.A. is taking no action 
to inform the public on the health risks of no more than four 
chemicals.
    This subcommittee seeks to closely evaluate the work--or lack 
thereof--of the E.P.A. when it comes to chemical toxicity and public 
health.
    My condolences go to Ms. Holt-Orsted and Mr. Ensminger, who have 
seen loss of life as a result of environmental contamination.
    My own constituents, in Dallas, have struggled with lead 
contamination in the past, and they continue to deal with long-term 
health effects.
    This issue of the politicization of science--particularly 
environmental protection--is of gravest concern to me.
    Congress is right to provide vigorous oversight in situations where 
the Federal Government may be guilty of failing its citizens in such an 
egregious manner.
    Thank you, Mr. Chairman. I yield back the balance of my time.

    Chairman Miller. And now, it is my pleasure to introduce 
our witnesses today. The first is a North Carolinian--at least, 
an adopted North Carolinian, Mr. Jerome Ensminger, retired 
Master Sergeant with United States Marine Corps. Second, Mr. 
Lenny Siegel, Executive Director of the Center for Public 
Environmental Oversight; and Dr. Linda Greer is the Director of 
the Natural Resources Defense Council's Health Program.
    You will have five minutes for your spoken testimony, and 
your written testimony will be included in the record for the 
hearing. When you have completed your testimony, we will begin 
with questions. Each Member will have five minutes to question 
the panel.
    It is the practice of the Subcommittee to take testimony 
under oath. Do any of you have any objection to being sworn in? 
The Committee also provides that you may be represented by 
counsel. Are you represented by counsel at today's hearing?
    If you now would please stand and raise your right hand? Do 
you swear to tell the truth and nothing but the truth? All of 
the witnesses have responded in the affirmative.
    Mr. Ensminger, you may begin.

  STATEMENT OF MR. JEROME M. ENSMINGER, MASTER SERGEANT, U.S. 
                      MARINE CORPS (RET.)

    Master Sergeant Ensminger. Good morning. My name is Jerry 
Ensminger, and I served my country faithfully for more than 24 
years in the United States Marine Corp. I would like to thank 
the Chairman, the Committee Members, and their staff for all of 
the hard work that went into making these hearing possible. I 
must say that since 3 January 2007, I have been heartened and 
inspired by the oversight activities by this Congress. You have 
been taking on the important issues that matter to the majority 
of our citizens, not just the issues that reflect the benefit 
of special-interest groups and big business. I am appearing 
here today as a tragic example of the consequences of a system 
that ignores our environment and the inevitable health effects 
that result from it.
    Marine Corp Base Camp Lejeune, North Carolina is quite 
possibly one of, if not the worst, water-contamination 
incidents in modern world history. The Agency for Toxic 
Substances and Disease Registry, or ATSDR, estimates that 
between 750,000 and one million people were potentially exposed 
to horrendous levels of toxins through their drinking water 
while stationed at Camp Lejeune. My daughter Janey was 
conceived while her mother and I lived in one of the base-
family housing areas where the drinking water was affected by 
the contamination at the base. Just like our other children, 
Janey was born seemingly normal. That is until she was 
diagnosed with Acute Lymphocytic Leukemia, ALL, at the age of 
six.
    In 1997, the ATSDR proposed a childhood leukemia and non-
Hodgkin's lymphoma study for Camp Lejeune children who had been 
exposed to volatile organic chemicals, or VOCs, cleaning 
solvents, in utero, while their parents lived at the base, 
between the years of 1968 through 1985. The protocol and 
proposal for this study outlines that the expected occurrences 
of the target illnesses in a cohort of 10,000 to 12,000 births 
for that time period would be 7.2 cases. The ATSDR has 
confirmed 14 cases of leukemia and two cases of non-Hodgkin's 
lymphoma. This more than 100-percent increase in the incidence 
of these childhood cancers.
    Mr. Chairman, let me lay out some of the facts and figures 
relating to the Camp Lejeune water-contamination situation. The 
documented levels of contaminants in the finished drinking 
water, at the tap, were some 280 times higher than what is 
considered safe for these very same chemicals. The Navy Bureau 
of Medicine and Surgery issued strict regulations in their 
BUMED instructions 6240.3(b), in 1963, governing potable water-
distribution systems on Naval Shore Facilities. Included in 
these regulations were preemptive measures to ensure that 
existing and future water supplies were not contaminated by 
extraneous sources. The Camp Lejeune family-area water-supply 
wells were located on the virtual property line, down gradient, 
and directly across the street from potential civilian 
contamination sources, gasoline stations, auto-repair 
facilities, dry-cleaning establishments, and known septic 
systems.
    In 1971, the Naval Facilities Engineering Command from 
Norfolk, Virginia, came to Camp Lejeune and selected multiple 
sites for new drinking-water supply wells. One of these new 
wells was HP-651, which began producing well water for the Camp 
Lejeune Point Water Distribution Plan in January of 1972. The 
site which had been selected by the Navy engineers for the 
placement of HP-651 was at the back corner of the base disposal 
yard, the junk yard. The disposal yard had been in operation 
for decades by the time they selected for a water-supply well. 
In February of 1985, HP-651 tested positive for some 26,000 
parts-per-billion of volatile organic chemicals. There is 
little doubt that this water-supply well was contaminated 
immediately upon or shortly after its construction.
    The irony of all of this is the fact that many of the human 
exposures that took place at Camp Lejeune would have been 
avoided, had Navy and Marine Corp officials followed their own 
regulations. The most audacious and blasphemous truth to this 
entire water-contamination incident at Camp Lejeune is the fact 
that Navy and Marine Corp officials knew of the existence of 
this contamination in their drinking water for five years 
before they took any action to rectify the problem. Navy and 
Marine Corp officials were knowingly poisoning their own 
people. That is correct. All of this was known and taking place 
behind the scenes at the very same time that my daughter, 
Janey, was suffering through her fight with leukemia, and they 
said absolutely nothing.
    Not only did they say nothing, they went as far as to 
return two of the three contaminated wells for the Tarawa 
Terrace Housing Area back online for two more years. They had 
the opportunity of tapping into the local community water 
lines, which were located just a few feet from the property 
line. Instead, Navy and Marine Corp officials opted against 
this idea because they did not want to owe the local government 
any reciprocating favors.
    Since the ATSDR entered the gates of Camp Lejeune to 
execute their Congressionally mandated mission, representatives 
of the Department of the Navy have done all they could to 
obstruct their efforts. I can make this statement with 
confidence, because I possess the documentation to back it up. 
As recently as the week before last, DOD and Department of the 
Navy officials were threatening to thwart the ATSDR initiatives 
at Camp Lejeune by withholding the funding.
    I spoke earlier about my daughter Janey. My daughter 
Janey--and I do not know if anybody else in this room ever had 
a child that was diagnosed with a catastrophic illness, but I 
can assure you, when Janey was diagnosed, and they told me that 
she had leukemia, it took me to my very knees, in the hallway 
at the Naval hospital at Camp Lejeune. And my forehead went 
down on the deck, and I broke out in a sweat, and I could not 
move. Janey went through hell, and all of us that loved her 
went through hell with her. A six-year-old child, naturally, 
they have had their normal inoculations; but a child with 
leukemia is poked and prodded. You just cannot believe what 
they go through. I held my daughter in the treatment rooms when 
they took needles and broke through her hip to extract bone 
marrow to test, and she screamed in my ear, ``Daddy, Daddy do 
not let them hurt me.'' And the only response that I could give 
her was, ``Janey, the only reason I am letting them hurt you is 
because they have to hurt you. They are trying to help you.''
    When she got hit with chemotherapy, I would make it a few 
miles down the road, and she would get so sick, I would have to 
stop, and pull over, and hold her and rub her back while she 
threw her guts up, wishing that I could take that off of my 
child and put it on myself, but God would not do it.
    Throughout Janey's treatment, when she was allowed to go 
back to school, her treatments made her look like a freak. She 
lost her hair. She gained more than 30 pounds at a time when 
she was on steroids. Her schoolmates would pick on her and call 
her Cabbage Patch Kid. She would come home from school crying. 
I do not know how many times I had to take Janey in the 
evenings and just go out to the beach and walk to try to make 
sense out of what was happening to her.
    At Duke University Medical Center where Janey died, and 
where Janey was receiving a lot of her treatments, in the 
pediatric ward, the majority of the rooms up there have soft 
walls. They fold. There's two rooms at the corners, directly 
across from the nurses' station that have two solid walls. They 
are referred to by the parents as the dying rooms, and the 
closer your child comes to dying, the closer you are to those 
two rooms. When you get moved into one of them, you know you 
are next. It is like watching mortar rounds walking towards 
your bunker.
    Nights in the hospital, I spend countless nights in a cot 
that folded down from the wall. And you lay in that hospital 
all hours of the night, listening to the kids that they got in 
the treatment rooms screaming bloody murder. I never cried in 
front of Janey the whole time she was being treated, which was 
nearly two-and-a-half years. That morning, that day, I started 
crying, and she looked up at me, and she had pneumonia, and she 
could hardly talk. And she looked at me, and she said, ``Stop 
it.'' And I said, ``Stop what?'' And she said, ``Stop crying, 
Daddy.'' She said, ``I love you.'' And I said, ``Janey, I know 
that.'' I said, ``I love you.'' And she said, ``I know.'' Those 
were the last words my daughter spoke to me. She went into a 
coma. Thirty-five minutes later, she was dead.
    Janey is dead now. Nothing is going to bring her back. But 
there were people who were exposed at Camp Lejeune, adults, the 
siblings of these in utero children, that are just now reaching 
the latency period for their exposures. They are, right now, 
developing cancers, adult leukemia, non-Hodgkin's lymphomas, 
male breast cancers--six cases of it that we found--renal 
failures. Those people need help. We do not need any more 
delays from DOD and the Department of the Navy and the United 
States Marine Corp.
    It is a known fact that the United States Department of 
Defense is our nation's largest polluter. It is beyond my 
comprehension why an entity with that type of reputation and 
who has a vested interest in seeing little to no environmental 
oversight would be included in the scientific process. Not only 
are they obstructing science, they are also jeopardizing the 
public health for millions of people all around the world. It 
is quite obvious by their activities to thwart science that 
they have something to fear. What they fear is that past 
negligence and the liability that comes along with it. There is 
little wonder why DOD has been seeking immunities from 
environmental regulations for the last seven years running, and 
yet this Administration and past Congresses have allowed DOD's 
tentacles to infiltrate the realm of science.
    We all need to just back off a little bit and allow science 
to speak for itself and let the chips fall where they may. 
Thank you, Mr. Chairman.
    [The prepared statement of Mr. Ensminger follows:]

               Prepared Statement of Jerome M. Ensminger

    Good morning, my name is Jerry Ensminger and I served my country 
faithfully for more than 24 years in the United States Marine Corps. I 
would like to thank the Chairman, the Committee Members and their 
staffs for all of the hard work that went into making these hearings 
possible. I must say that since 3 January 2007, I have been heartened 
and inspired by the oversight activities of this Congress. You have 
been taking on the important issues that matter to the majority of our 
citizens, not just the issues that affect/benefit special interest 
groups and big business!
    I am appearing here today as a tragic example of the consequences 
of a system that ignores our environment and the inevitable health 
effects that result from it. Marine Corps Base, Camp Lejeune, North 
Carolina is quite possibly one of, if not the worst drinking water 
contamination incidents in modern world history! The Agency for Toxic 
Substances and Disease Registry (ATSDR) estimates that between 750,000 
and 1,000,000 people were potentially exposed to horrendous levels of 
toxins through their drinking water while stationed at Camp Lejeune.
    My daughter Janey was conceived while her mother and I lived in one 
of the base family housing areas where the drinking water was affected 
by the contamination at the base. Just like our other children, Janey 
was born seemingly normal, that is until she was diagnosed with Acute 
Lymphosytic Leukemia (A.L.L.) at the age of six. In 1997, the ATSDR 
proposed a childhood leukemia/non-Hodgkins lymphoma study for Camp 
Lejeune children who had been exposed to Volatile Organic Chemicals 
(V.O.C.'s, cleaning solvents!) in utero while their parents lived at 
the base between the years of 1968-1985. (Note: The start date of this 
study was based upon the beginning date for the computerization of 
birth records in North Carolina, not on potential exposure.) The 
protocol/proposal for this study outlined that the expected occurrences 
of the targeted illnesses in a cohort of 10,000-12,000 births for that 
time period would be 7.2 cases. The ATSDR has confirmed 14 cases of 
leukemia and two cases of non-Hodgkins lymphoma, this is more than a 
100 percent increase in the incidence of these childhood cancers!
    Mr. Chairman, let me layout some of the facts and figures relating 
to the Camp Lejeune water contamination situation. The documented 
levels of contaminates in the finished drinking water (at the tap) were 
some 280 times higher than what is currently considered safe for these 
very same chemicals! The Navy Bureau of Medicine and Surgery issued 
strict regulations (BUMED INST 6240.3B [CLW 0144]) in 1963 governing 
potable water distribution systems on Naval Shore Facilities. Included 
in these regulations were preemptive measures to ensure that existing 
and future water supplies were not contaminated by extraneous sources.
    The Camp Lejeune, Tarawa Terrace family housing area water supply 
wells were located on the virtual property line, down gradient, and 
directly across the street from multiple potential civilian 
contamination sources! (Gasoline stations, auto repair facilities, dry 
cleaning establishments, and known septic systems.) In 1971, the Naval 
Facilities Engineering Command from Norfolk, Va. came to Camp Lejeune 
and selected multiple sites for the construction of new drinking water 
supply wells for the base.
    One of these new wells was HP-651, which began producing raw water 
for the Camp Lejeune Hadnot Point water distribution plant in January 
of 1972. The site which had been selected by the Navy engineers for the 
placement of HP-651 was at the back corner of the base disposal yard! 
(junk yard!) The disposal yard had been in operation for decades by the 
time this site was selected for a drinking water supply well. In 
February 1985, HP-651 tested positive for some 26,000 ppb of Volatile 
Organic Chemicals (CLW 5260)! There is little doubt that this water 
supply well was contaminated immediately upon, or very shortly after 
its construction! (Note: The ATSDR's on-going water modeling for the 
Camp Lejeune, Hadnot Point and Holcomb Blvd. water systems will verify 
this fact once it is completed.) The irony of all this is the fact that 
many of the human exposures that took place at Camp Lejeune would have 
been avoided had Navy and Marine Corps officials followed their own 
regulations!
    The most audacious and blasphemous truth in this entire water 
contamination incident at Camp Lejeune is the fact that Navy and Marine 
Corps officials knew of the existence of this contamination in the 
drinking water for five years before they took any action to rectify 
the problem (CLW 0430-0432, 0436, 0438, 0441, 0443, 0592, 0593)! (Navy 
and Marine Corps officials were knowingly poisoning their own people!) 
That is correct, all of this was known and taking place behind the 
scenes at the very same time that my daughter Janey was suffering 
through her fight with leukemia and they said absolutely nothing! Not 
only did they say nothing, they went as far as to return two of the 
three known contaminated wells for the Tarawa Terrace housing area back 
on-line for two more years! They had the option of tapping into the 
local community water lines which were located just a few feet from the 
property line. Instead, Navy and Marine Corps officials opted against 
this idea because they didn't want to owe any reciprocating favors to 
the local community government! (CLW 1129-1131)
    Since the ATSDR entered the gates of Camp Lejeune to execute their 
Congressionally-mandated mission, representatives of the Department of 
the Navy (DON) have done all they could to obstruct their efforts. I 
can make this statement with confidence because I possess the 
documentation to back it up! As recently as the week before last, DOD 
and DON officials were threatening to thwart the ATSDR's initiatives at 
Camp Lejeune by withholding funding! (CLW 2407, 0000, 0000 (A), 2995, 
2999, 3243, 3307, 4925, 4926)
    It is a known fact that the United States Department of Defense is 
our nation's largest polluter. It is beyond my comprehension why an 
entity with that type of reputation and who has a vested interest in 
seeing little to no environmental oversight would be included in the 
scientific process. Not only are they (DOD) obstructing science, they 
are also jeopardizing the public health for millions of people all 
around the world. It is quite obvious by their activities to thwart 
science that they have something to fear. What they fear is their past 
negligence and the liability that comes along with it! There is little 
wonder why the DOD has been seeking immunities from environmental 
regulations for the last seven years and yet this administration and 
past Congress' have allowed their (DOD's) tentacles to infiltrate the 
realm of science. We all need to allow science to speak for itself and 
let the chips fall where they may!































































    Chairman. Miller. Mr. Ensminger, I know that Mr. 
Sensenbrenner joins me in extending our condolences for the 
loss of your daughter and all that you and your family have 
gone through.
    Mr. Siegel.

 STATEMENT OF MR. LENNY SIEGEL, EXECUTIVE DIRECTOR, THE CENTER 
           FOR PUBLIC ENVIRONMENTAL OVERSIGHT (CPEO)

    Mr. Siegel. Good morning. I am from the town of Mountain 
View, California. We have about seven or eight Superfund sites 
and numerous other contamination sites. I work with communities 
all over the country. I visit communities, folks from Camp 
Lejeune, and lots of places, and I hear lots of stories like 
Jerry's.
    The Environmental Protection Agency's integrated risk 
information system is the foundation of most of the federal, 
State, and tribal risk-management decisions that determine the 
safety of the air that we breathe, the water we drink and the 
soil under our feet. Quantitative judgments embedded in IRIS 
may read like a foreign language or quantum physics to most 
Americans. People do not understand it. But those judgments 
affect our health, our environment, and our property.
    Unfortunately, over the past several years, the White House 
and federal agencies that are among the world's greatest 
polluters, Department of Energy, Department of Defense, and 
NASA, have essentially hijacked EPA's authority to conduct 
human health-risk assessments. EPA's announcement in April of 
the new process for IRIS simply institutionalizes an approach 
that has been used, at least for perchlorate and 
trichloroethylene. This is an approach that unnecessarily puts 
Americans at risk. In lay terms, the fox is now managing the 
hen house.
    In my prepared testimony, I tell the story of 
trichloroethylene. I could tell perchlorate because I have 
worked on that as well. Federal agencies have delayed and 
perhaps prevented, in the long run, the establishment of more 
protective health standards for TCE. The process they use for 
that is apparently the precedent for the new IRIS process that 
EPA announced in April.
    In 2001, EPA issued a draft human health-risk assessment 
for TCE. Though its Science Advisory Board generally endorsed 
the study, EPA, under pressure from the White House and federal 
polluting agencies, withdrew its 2001 findings, and it turned 
the issue of TCE toxicity over to what was called the 
interagency working group, and that working group sent it to 
the National Academy of Sciences for re-review.
    In early 2003, January 2003, EPA scientists came to my 
community of Mountain View to discuss the migration of TCE 
vapors into homes and businesses at, at least, four 
contamination sites. One of them was not Superfund. The others 
were Superfund. Over 400 people attended that meeting. The 
picture is up there.



    EPA told us that, based on the 2001 risk assessment, that 
TCE was five to 65 times as toxic as previously believed. I 
learned about a year later from a friend in the Navy that that 
provisional risk assessment would never be implemented, that 
the EPA was going to withdraw it and go through the process I 
just mentioned.
    They weakened the standards, and those weakened standards 
have led to less protection for the people in my community and 
communities throughout the country, even though, as Chairman 
Miller read, the Academy of Science's review committee found 
that the evidence that TCE caused cancer was even stronger than 
EPA believed in 2001. Still, EPA has really done almost nothing 
to move forward to establish new standards for TCE.
    The key point of my testimony is that these numbers in IRIS 
actually make a difference in people's lives and their health 
and what happens to their property. This is a picture of my 
friend Jane's house, about a half-mile from my house.



    She lives across the street from the birthplace of the 
semiconductor industry, and they originally thought that the 
plume boundary from TCE was in the middle of the street in 
front her house. It turns out the plume goes under her house, 
because when they tested her son's bedroom, they found 0.8 
micrograms per cubic meter of TCE in the air. According to the 
initial standard that the EPA science brought based on the 2001 
health-risk assessment, that was almost two orders of magnitude 
higher than what the standard should be, what was considered a 
legally safe cancer risk. With the standard that was in place 
before the 2001 health-risk assessment, he was considered safe, 
so it made it a difference.
    Now, fortunately, and it is really not fortunate at all, 
but the measurements in the basement of the house were higher, 
and so they installed a fan to ventilate the house and lower 
the contamination. After age 11, her son's exposures went down 
because we did something about it. We do not know whether he 
will get sick as a result. Jane does know that she is going to 
have a lot of trouble selling her house because it has the 
mitigation system there.
    This is a picture of where Shirley lived in Bayport, 
Minnesota.



    She had contamination in her private drinking water supply, 
between the five parts per billion, which is the longstanding 
standard for TCE in drinking water, and one which is where 
everybody expected the number to go if the 2001 human health-
risk assessment had been implemented. Her nephew wrote me. 
Because the rule was for this Superfund site in Bayport, 
Minnesota is that people who had contamination above five would 
have treatment systems on their private wells. She did not get 
it, and she died of cancer a couple of years ago. And her son 
asked me, you know, why is it that she did not get the 
protection? I cannot say. I am not a scientist, and I am not 
sure scientists can tell you she got sick because of that 
exposure or to what degree it added to the risk she faced, 
because we drink this stuff, breathe this stuff all over the 
place. But I do know that that number made a difference as to 
whether her water was treated for the trichloroethylene that 
she was drinking and was showering in and was being exposed to.
    The numbers also make a difference to these polluting 
agencies. We found on the Web an Air Force presentation a few 
years back, around the time that this was all happening, that 
figured out that it would cost the Department of Defense $5 
billion extra to clean up TCE if the standard went from five 
parts per billion to one part per billion for drinking water. I 
do not know if that is really true. There are reasons why it 
might not have been as high, but it might have been higher. The 
point is that the Defense Department's interest in this is 
primarily one that they are a responsible party, rather than 
their mission is to protect human health and the environment.
    So the people that I work with, the people who are 
impacted, the people who are breathing and drinking the 
contamination of these sites are calling on EPA to withdraw the 
revision that it made in the IRIS process in April because they 
are basically institutionalizing something that has been 
putting people at risk already.
    And we have come up with three principles that we think the 
IRIS process should involve. The IRIS process is not the entire 
process, but it is the foundation of it. First, all 
stakeholders, including the affected public, private polluters, 
federal polluting agencies, including the Defense Department, 
should have the same access to the decision-making process for 
the assessment of hazardous substances. This notion of a 
deliberative process in which the federal polluters meet 
privately with EPA to design the studies is unacceptable.
    Secondly, federally funded risk-relevant research should be 
managed by agencies that do not have conflicts of interest. 
What happened with perchlorate is that the Defense Department 
sponsored some research and did not like the results, so they 
sponsored more research to disprove it. I'm much more 
comfortable when the Centers for Disease Control does studies 
because they are not encumbered by the conflict of interest.
    The third one, the entire process of assessing hazardous 
substances should be carried out in the sunshine, with 
oversight by the public, the press, and by Congress. I'm not a 
toxicologist or an epidemiologist. I assume that Members of 
this committee are not, the same, as well. We are not in a 
position to determine whether it should be 1, 5, or 50 for TCE, 
but we are calling upon you.
    This is the people who are living and breathing this stuff. 
We are calling upon you to ensure that we have a fair, open, 
and timely process to evaluate not only the chemicals that we 
are discussing today, but the many more than impact our lives. 
Thank you.
    [The prepared statement of Mr. Siegel follows:]

                   Prepared Statement of Lenny Siegel

 Getting the Fox out of the Henhouse: Restoring the Integrity of EPA's 
    Process for Determining the Toxicity of Industrial and Military 
                               Chemicals

Executive Summary

    The Environmental Protection Agency's Integrated Risk Information 
System (IRIS) is the foundation of most of the federal, State, and 
tribal risk management decisions that determine the safety of the air 
we breathe, the water we drink, and soil under our feet. The 
quantitative judgments embedded in IRIS may read like a foreign 
language or quantum physics to most Americans, but they affect our 
health, our environment, and our property.
    Unfortunately, over the past several years, the White House and 
federal agencies that are among the world's greatest polluters have 
hijacked EPA's authority to conduct human health risk assessments. 
EPA's April announcement of a new IRIS process simply institutionalizes 
an approach--used for perchlorate and trichloroethylene (TCE)--that 
unnecessarily puts Americans at risk. In lay terms, the fox is now 
managing the henhouse.
    In my prepared testimony I tell the story of trichloroethylene. 
Federal agencies have delayed and perhaps prevented the establishment 
of more protective health standards for TCE, following a pattern that 
appears to be a precedent for the new IRIS process. In 2001 EPA issued 
a Draft Human Health Risk Assessment for TCE. Though its Science 
Advisory Board generally endorsed that study, EPA--under pressure from 
the White House and federal polluting agencies--withdrew the 2001 
findings. It turned the issue of TCE toxicity over to the Interagency 
Working Group and sent it to the National Academies of Sciences for re-
review. Meanwhile, EPA scientists significantly weakened the standards 
they were using to guide vapor intrusion investigations in my community 
of Mountain View, California. Though in July 2006 the Academies of 
Sciences told EPA and the other agencies to move quickly to promulgate 
a TCE standard, EPA has done little.
    EPA risk findings make a difference. It's the difference between 
response and inaction in the bedroom of Jane's son in Mountain View, 
California. It's the difference between water treatment and inaction in 
Shirley's former home in Bayport, Minnesota. According to an Air Force 
scientist, it's a difference of $5 billion in the cost of groundwater 
treatment at 1400 Defense Department sites.
    People impacted by TCE, perchlorate, and other toxic substances 
have called upon EPA to withdraw its recent IRIS changes and instead 
create a process based upon the three following principles:

        1.  All stakeholders, including the affected public, private 
        polluters, and federal polluting agencies, should have the same 
        access to the decision-making process for the assessment of 
        hazardous substances.

        2.  Federally funded risk-relevant research should be managed 
        by agencies that do not have conflicts of interest--that is, 
        agencies that will incur significant costs or encumbrances 
        associated with more protective health and environmental 
        standards should not control these research activities.

        3.  The entire process of assessing hazardous substances should 
        be carried out in the sunshine, with oversight by the public, 
        the press, and by Congress.

The TCE Risk Assessment

    The Environmental Protection Agency's Integrated Risk Information 
System (IRIS) is the foundation of most of the federal, State, and 
tribal risk management decisions that determine the safety of the air 
we breathe, the water we drink, and soil under our feet. The 
quantitative judgments embedded in IRIS may read like a foreign 
language or quantum physics to most Americans, but they affect our 
health, our environment, and our property.
    Unfortunately, over the past several years, the White House and 
federal agencies that are among the world's greatest polluters have 
hijacked EPA's authority to conduct human health risk assessments. 
EPA's April announcement of a new IRIS process simply institutionalizes 
an approach that unnecessarily puts Americans at risk. In lay terms, 
the fox is now managing the henhouse.
    Today I am going to tell the story of trichloroethylene (TCE), the 
once-universal solvent that is one of the most common contaminants at 
both federal and private hazardous waste sites across the country. 
Federal agencies have delayed and perhaps prevented the establishment 
of more protective health standards for TCE, following a pattern that 
appears to be a precedent for the new IRIS process.
    In August 2001 EPA issued a Draft Human Health Risk Assessment for 
Trichloroethylene. In considering the impact of the compound on young 
children, as well as cumulative exposures, it found that TCE was much 
more toxic than previously believed. In December 2002, EPA's Science 
Advisory Board peer review praised the ``ground-breaking'' assessment, 
finding:

         The Board advises the Agency to move ahead to revise and 
        complete this important assessment. The assessment addresses a 
        chemical, trichloroethylene (TCE), significant for being a 
        nearly ubiquitous environmental contaminant in both air and 
        water, being a common contaminant at Superfund sites, and 
        because it is ``listed'' in many federal statutes and 
        regulations. The draft assessment is also important because it 
        sets new precedents for risk assessment at EPA. We believe the 
        draft assessment is a good starting point for completing the 
        risk assessment of TCE. The Panel commends the Agency for its 
        effort and advises it to proceed to revise and finalize the 
        draft assessment as quickly as it can address the advice 
        provided in this report.

    Meanwhile, in November 2002, EPA issued tables along with its Draft 
Vapor Intrusion Guidance. Vapor intrusion is the migration of volatile 
compounds such as TCE from the subsurface into homes, schools, offices, 
and other structures. Those tables included target indoor air, soil 
gas, and groundwater concentrations for TCE based upon the 2001 draft 
Risk Assessment. That Draft Vapor Intrusion Guidance remains in limbo; 
EPA has no plans to finalize it.
    In January 2003, EPA scientists convened a public meeting in my 
community of Mountain View, California to discuss the emerging pathway 
of vapor intrusion at a number of local TCE cleanup sites. Over 400 
people attended. EPA scientists explained that TCE was now considered 
five to 65 times as toxic as previously believed, and they introduced a 
screening level for TCE in indoor air, .017 micrograms per cubic meter 
(mg/m3), corresponding to a one-in-a-million (``ten to the 
minus six'') excess lifetime cancer risk. In fact, most EPA regions 
adopted that number as a provisional goal.



    EPA and the Mountain View responsible parties (polluters), 
including the Navy and NASA, continued their vapor intrusion 
investigations. Testing, using the provisional screening level, showed 
that most of the homes at an award-winning new housing development were 
safe after all. However, despite the Navy's misinterpretation of site 
data, we were eventually able to show that military families were being 
exposed to unsafe levels of intruding TCE vapors in the Army-run Orion 
Park Military Housing Area, formerly part of Moffett (Field) Naval Air 
Station.
    In March 2004 I attended an EPA-sponsored workshop on vapor 
intrusion in San Diego. I was surprised to hear there, from a Navy 
friend, that I shouldn't worry about the vapor levels in Mountain View. 
EPA--the Navy had been assured--was going to withdraw the 2001 draft 
Risk Assessment. And indeed, that's what happened.
    Back home in Mountain View, EPA adopted an interim action level of 
1.0 mg/m3 for TCE in indoor air. EPA explained the status of 
the health standard in its June 2004 Draft First Five-Year Review 
Report for the Middlefield-Ellis-Whisman (MEW) Superfund Study Area, 
Mountain View, California:

         EPA's ORD [Office of Research and Development] and OSWER 
        [Office of Solid Waste and Emergency Response] have requested 
        additional external peer review of the draft TCE Health Risk 
        Assessment by the National Academy of Sciences. Consequently, 
        review of the toxicity value for TCE may continue for a number 
        of years. In the interim, because of the uncertainties 
        associated with the draft TCE Health Risk Assessment, EPA 
        Region 9 is considering both the draft TCE Health Risk 
        Assessment toxicity values, as well as the California TCE 
        toxicity value (similar to EPA's previously listed TCE toxicity 
        value from 1987), in evaluating potential health risks from 
        exposure, and in making protectiveness determinations.

    That October a high EPA official told U.S. Today that the agency 
was ``not forced to go to the National Academy of Sciences.'' I told 
the same reporter that EPA's action was like ``voluntarily'' jumping 
off the railroad tracks as a speeding train approached.

The National Academies Review

    EPA actually moved the TCE issue to the same Interagency Working 
Group that weakened EPA's drinking water guideline for perchlorate--an 
essential component of solid rocket fuel--from an expected 1 ppb to 
24.5 ppb. I actually learned that EPA, the White House, NASA, and the 
Departments of Energy and Defense were following the perchlorate game 
plan for TCE over dinner at a perchlorate meeting in Las Vegas in 
September 2004. Making conversation with a gentleman sitting across the 
table, I found that he too had an interest in TCE. In fact, as a 
Department of Energy--not EPA--official, he was awarding the study 
contract to the National Academies of Sciences for its TCE review, just 
as he had done with perchlorate.
    I had been at one of the Academy meetings about perchlorate, and I 
knew what a juggernaut of federal agencies and their contractors had 
weighed in calling for weaker perchlorate standards. So I encouraged 
people from TCE-impacted communities to attend Academy TCE Committee 
meetings and testify, and I was impressed by their response. For 
example, in March 2005 a carload of people from Endicott, New York took 
the day off work and drove down to DC on their own dime, and then drove 
back the same day, only to be caught in a Pennsylvania blizzard. In 
June, West Coast activists attended and spoke at the TCE Committee 
meeting in Irvine, California, displaying the photos of workers who 
died following exposure to TCE at the View-master plant in Beaverton, 
Oregon. People from impacted communities did not pretend to have 
toxicological or epidemiological expertise. They simple reported that 
they and their neighbors of family members had been exposed to TCE. 
Many had contracted serious illnesses. And they wanted the experts on 
the Committee to think about them, not just the well-funded testimony 
of polluters, when it continued its deliberations.
    It was at the first Academy TCE Committee meeting that the 
Interagency Working Group went public--at least about TCE. A White 
House official introduced a panel that not only included an EPA 
official, but also representatives of three federal polluting agencies: 
NASA, the Department of Energy, and the Department of Defense. What I 
had known for some time was finally out in the open: Federal agencies 
whose primary concern about TCE was the hundreds, maybe thousands of 
sites for which they were responsible for cleanup, were overseeing the 
government's efforts to update the health risk data that would be 
incorporated into IRIS. That is, the foxes had been given the keys to 
the henhouse.
    In July 2006 the Academy TCE committee issued its report. It was 
long and complicated, and it provided detailed advice on how to conduct 
additional studies. But its overall conclusion was clear:

         The committee found that the evidence on carcinogenic risk and 
        other health hazards from exposure to trichloroethylene has 
        strengthened since 2001. Hundreds of waste sites in the United 
        States are contaminated with trichloroethylene, and it is well 
        documented that individuals in many communities are exposed to 
        the chemical, with associated health risks. Thus, the committee 
        recommends that federal agencies finalize their risk assessment 
        with currently available data so that risk management decisions 
        can be made expeditiously.

    So what did EPA and the Interagency Working Group do? While in 
early 2005 they spent only a month implementing Academy recommendations 
for a weaker perchlorate standard, they moved slowly on TCE, even in 
the face of the strong Academy recommendation. They moved so slowly 
that one year later Senator Clinton, Senator Dole, and three other 
Senators introduced legislation designed to accelerate the development 
of new risk data and to create an interim vapor intrusion standard for 
TCE. Still EPA stalled, and EPA officials told Congress that the 
necessarily slow process could actually lead to a less protective 
standard.
    Finally, in April 2008 EPA announced its new IRIS process, 
essentially institutionalizing the informal process that it had applied 
to TCE, as well as perchlorate. Activists from throughout the country 
responded by sending the attached ``Grassroots Letter'' to EPA, calling 
EPA's action ``an attempt to cement a privileged position for federal 
polluting agencies, in which they would have recurring, generally 
secret (`deliberative') input into EPA's findings.'' Ironically, one 
key provision in the new process will not apply to TCE because it 
cannot be a ``mission-critical chemical substance.'' In general, 
federal agencies no longer use TCE, though some contractors apparently 
do.

It Makes a Difference

    The risk data for TCE is not just an abstract principle. It makes a 
difference in the real world.

  My neighbor, Jane, in Mountain View, California lives across 
Whisman Avenue from the birthplace of the American commercial 
semiconductor area, now known as the Middlefield-Ellis-Whisman (MEW) 
Superfund Study Area. Historically, official maps showed her home just 
outside the five parts per billion (ppb) contour line that defined the 
edge of the regional TCE groundwater plume. In March 2004, she finally 
got EPA and the MEW Responsible Parties to test the air in her house. 
They found that TCE from the MEW plume was intruding into her home. TCE 
levels in her 11-year-old (at the time) son's bedroom was .8 mg/
m3, above the screening level EPA had originally presented 
to the community, but below the interim action level. Only because 
levels in her basement were about 4 mg/m3, above that action 
level, did EPA and the companies install a ventilation system.




  In Bayport, Minnesota, Shirley lived down gradient of a 
metal-plating shop that released enough TCE to place much of the town 
on the Superfund National Priorities List (NPL). Shirley's private 
drinking water well tested TCE at 2.5 ppb in 1988. In 1999, just before 
she moved, her well tested at 4 ppb of TCE. In 2002, she was diagnosed 
with cancer. In 2005 she died. Her family wants to know, ``If Shirley's 
well never got over 4 ppb of TCE, and she died of cancer, why is the 
minimum for installing wellhead treatment systems 5 ppb?'' I have no 
way of knowing whether the TCE in Shirley's well was a primary cause of 
her illness. The point is that the risk management decision is a 
function of the Maximum Contaminant Level (MCL), which in turn is based 
upon IRIS data.

  In April 2003, an Air Force scientist estimated that if EPA 
were to lower the MCL for TCE to 1 ppb (from 5 ppb), it would cost the 
Defense Department an additional $5 billion in current dollars to 
address groundwater contamination alone at its estimated 1400 TCE 
sites. I'm not convinced by the Air Force calculations, but it's clear 
that Defense environmental officials believed that the adoption and 
implementation of standards based upon EPA's 2001 draft Human Health 
Risk Assessment would be very costly.




Three Principles

    Neither I nor the people with whom I work, people who have been 
exposed to significant levels of TCE and other toxic compounds, have 
the expertise to determine exactly what is safe. We count upon our 
government, directed by you, our elected officials, to establish a 
fair, open process to develop risk data. We ask you to direct EPA to 
reverse its recent IRIS pronouncements and instead to create a new 
process based upon the following three principles from the ``Grassroots 
Letter.''

        1.  All stakeholders, including the affected public, private 
        polluters, and federal polluting agencies, should have the same 
        access to the decision-making process for the assessment of 
        hazardous substances.

        2.  Federally funded risk-relevant research should be managed 
        by agencies that do not have conflicts of interest--that is, 
        agencies that will incur significant costs or encumbrances 
        associated with more protective health and environmental 
        standards should not control these research activities.

        3.  The entire process of assessing hazardous substances should 
        be carried out in the sunshine, with oversight by the public, 
        the press, and by Congress.

    To protect our health and the health of future generations, 
Congress must guarantee the integrity of the IRIS process.

Grassroots Letter Attachment



























                       Biography for Lenny Siegel

Education:

Valedictorian, Culver City High School, Culver City, California, 1966

Stanford University (Physics), 1966-1969

Employment:

Pacific Studies Center, Mountain View, Director, 1970-present

Center for Public Environmental Oversight (CPEO), Executive Director, 
        July, 1994-present

Teaching Experience:

UCLA Department of Urban Planning, Guest Professor, Spring, 1995 and 
        Winter, 1997

UC-Berkeley Extension, Guest Lecturer, ``Strategies for Site 
        Remediation: A Case Studies Approach,'' Winter, 1995, 1996, and 
        1997; Fall, 1998

Council of Energy Resource Tribes, Guest Lecturer, ``Mitigation of 
        Environmental Impacts to Indian Lands due to Department of 
        Defense Activities,'' Summer, 1994 and 1995

Award:

    U.S. Environmental Protection Agency, Region 9, Environmental 
Achievement Award, November, 2001

Sample Publications:

    ``Independent Review of the Draft Site Management Plan for the Mott 
Haven Schools Complex Bronx, New York,'' March, 2008; ``Community 
Perspectives on VOC Response at Department of Defense Installations,'' 
September, 2007; ``Independent Review of the Cleanup of the Mott Haven 
Schools Complex, Bronx, New York,'' January, 2007; ``Homes, Schools, 
and Parks: Where, When, and How to Build on Contaminated Sites,'' 
December, 2006; ``Gulf Coast Reconstruction: The Biggest `Brownfield,' 
'' October, 2005: ``A Stakeholder's Guide to `All Appropriate 
Inquiries,' '' August, 2005.

    ``Vapor Intrusion: The New Frontier of Toxic Cleanup,'' (BNA, 
September, 2004); Stakeholders' Guide to Munitions Response (Spring, 
2004); Stakeholders' Guide to Federal Facilities Cleanup (Summer, 
1997); Military Contamination and Cleanup Atlas for the United States--
1995 (September, 1995); Covering The Map: A Survey of Military 
Pollution in the United States (May, 1993); Citizens' Guide to Military 
Base Clean-Up and Conversion (September, 1993). He is also a 
contributor to Community Risk Profiles: A Tool to Improve Environment 
and Community Health (Rockefeller University, April, 1995). For 
additional publications, see http://www.cpeo.org/pubs/pub.html

Consulting Experience

Council of Energy Resource Tribes

Kaho'olawe Island Reserve Commission

Military Toxics Project

New York Lawyers for the Public Interest

Physicians for Social Responsibility-Los Angeles Office

RAND Corporation

Rockefeller University Program on the Human Environment

Silicon Valley Toxics Coalition

Committees (italicized are current):

Air Combat Command Project on Streamlined Oversight, External Review 
        Group

ASTM/ISR Brownfields Steering Committee

California Base Closure Environmental Advisory Group

California Brownfields Reuse Advisory Group (Co-Chair)

California CLEAN Loan Committee

California Site Mitigation Update advisory group

California Superfund Working Group

Clean Sites Independent Review of Program Performance, Defense 
        Environmental Restoration Program, Blue Ribbon Review Panel

Community Environmental Health Assessment Project Steering Committee, 
        National Association of City and County Health Officials

Compliance Assistance Advisory Committee (U.S. EPA)

Defense Science Board Task Force on Unexploded Ordnance Clearance 
        Operations

Department of Toxic Substances Control (California) External Advisory 
        Group

Federal Facilities Environmental Restoration Dialogue Committee

Interstate Technology & Regulatory Council Perchlorate Work Team

Interstate Technology & Regulatory Council Vapor Intrusion Work Team

Moffett Naval Air Station Restoration Advisory Board

National Environmental Justice Advisory Council Subcommittee on Waste 
        and Facility Siting

National Environmental Justice Advisory Council Federal Facilities 
        Working Group

National Policy Dialogue on Military Munitions

National Research Council Committee on ACWA Secondary Wastes

National Research Council Committee on Army Non-Stockpile Chemical 
        Demilitarization Program (three iterations)

National Research Council Committee on Environmental Remediation at 
        Naval Facilities (two iterations)

Northeast Mountain View Advisory Council (Board member)

Peer Review Panel for the VOC Historical Case Initiative

Range Rule Partnering Team

Range Rule Risk Methodology Partnering Team

Western Region Hazardous Substance Research Center Outreach Advisory 
        Committee

    Chairman Miller. Thank you, Mr. Siegel. Not only am I not a 
toxicologist, I could not pronounce the chemical.
    Dr. Greer.

  STATEMENT OF DR. LINDA E. GREER, DIRECTOR, HEALTH PROGRAM, 
               NATURAL RESOURCES DEFENSE COUNCIL

    Dr. Greer. Good morning, and thanks for the opportunity to 
testify. I am a toxicologist. I direct the health program at 
the Natural Resources Defense Council, where I have been for 15 
years, and I have watched the EPA's evaluation of toxic 
chemicals for many years, both in my capacity as the director 
of the health program at NRDC, as a member of the executive 
committee of EPA's Science Advisory Board, where I served for 
six years, and on many committees at the National Academy of 
Sciences, including, most recently, the Committee on Emerging 
Issues in Toxic Chemicals. I commend you, Mr. Miller, for your 
interest in the IRIS review process, and more specifically, in 
your concern in the Committee's concern about the recent 
changes that have been made to this program.
    IRIS is, as you have said, as cornerstone program at EPA, 
which provides the scientific information necessary to develop 
our nation's air and drinking-water standards as well as 
hazardous-waste clean-up levels. The changes that are the 
subject of today's hearing are yet another escalation of the 
Administration's war on science and public health that has gone 
on for nearly eight years. It's a record of political 
interference with the work of government scientists across a 
range of environmental issues, including global warming or even 
endangered species, has been well established. Things are no 
better in the case of analyzing and regulating toxic chemicals 
that pose a risk to health. In this area, the Administration 
has attempted and in some cases succeeded in blocking, 
weakening, and delaying health standards for a very long list 
of pollutants, including arsenic, mercury, lead, benzene, 
perchlorate, formaldehyde, particulates and ozone, and of 
course, trichloroethylene. In addition, the Administration has 
weakened the public's right to know about the release of toxic 
chemicals into their community.
    Thus, the recent changes to the IRIS program that are the 
subject of today's hearing are properly viewed as one part of a 
much broader agenda to sacrifice public health protections and 
limit public understanding of the risk of toxic chemicals in a 
manner that benefits a host of polluting industries and federal 
agencies.
    For many years, IRIS assessments were developed by EPA 
scientists. Drafts were released simultaneously for public 
comment and external independent peer review. OMB and 
government agencies, such as DOD or DOE, who sometimes had a 
stake in the outcome of the evaluation because of their 
obligation to address contamination at their facilities, had an 
opportunity to review and comment on the draft when it was 
released for public comment. These procedures allowed EPA 
scientific experts to create and own the assessment and kept 
influence by government agencies with polluter profiles to a 
minimum. The new process established by the White House turns 
this process on its head. It invites interference by OMB and 
other agencies, both at the onset of the process, in the 
middle, and at the bitter end--a license-to-kill, so to speak--
if the process did not end as they wished.
    Importantly, these newly introduced intervention points are 
considered deliberative, and hence shielded from public view, 
forcing EPA to respond to concern behind closed doors, and 
alarmingly the new opportunities are not limited to data 
critiques. One particularly misguided new feature offers 
agencies outside of EPA up to two years to undertake their own 
additional studies of ``mission critical'' chemicals, 
suspending EPA's evaluation of these contaminants for a very 
substantial period of time while they take advantage of this 
opportunity to delay a potential day of reckoning.
    Although current EPA leadership argues that the new process 
was developed in order to provide ``greater transparency, 
objectivity, balance, rigor, and predictability'' to the IRIS 
assessment, we would characterize these changes quite 
differently. In our view, the new process is designed precisely 
to give the polluting agencies more access, more opportunity 
for delay, and more influence to what has historically been an 
objective scientific evaluation process and to allow these 
opportunities to occur behind closed doors, hiding the exercise 
of that influence from public view.
    In fact, if one's intention was to design a new system that 
would deliver greater influence to government agencies with 
pollution problems over EPA rules, it would be hard to think of 
a system that would be better than this one. The claim that the 
new process will result in a more balanced and objective result 
simply does not pass the laugh test.
    Before closing, I would like to turn briefly to the issue 
of timeliness, which as we have seen from our other witnesses, 
is a real problem in the IRIS program. The IRIS program has 
always struggled to keep pace with EPA's regulatory needs and 
many environmental contaminants lacking IRIS assessments are 
quite important to public health, TCE, for one, perchlorate for 
another. There is no IRIS risk assessments for nearly one-third 
of the 189 hazardous air pollutants, for example. Furthermore, 
even where important chemicals are in the IRIS database, the 
risk assessments available for many of these chemicals are 
outdated. The average assessment on IRIS is over 13 years old 
with the oldest having not been significantly revised since the 
mid-1980's, and, as has been mentioned, these problems greatly 
exacerbate the already long period of time required for EPA 
standard-setting procedures, up to a decade in some cases, and 
have been the focus of criticism for some time.
    Clearly, constructive reform of the IRIS program is needed 
and constructive reform would focus on increasing resources 
available to undertake IRIS reviews as well as policy changes 
that would streamline the difficult decision-making inherent in 
the process. The new procedures run completely counter to these 
goals and will only exacerbate the backlog. Properly 
implemented, the EPA IRIS program provides a crucial scientific 
service to the public, and I emphasize speed is important but 
scientific integrity is paramount. These changes hit IRIS on 
both fronts in a terrible way, slowing the process further and 
compromising its content. We request that the Science Committee 
and the Subcommittee work with other House colleagues to ensure 
that the new IRIS process is overturned or withdrawn and that 
you require IRIS health assessments to be reviewed in an open 
process without inappropriate political interference. Thank you 
very much for this opportunity to testify.
    [The prepared statement of Dr. Greer follows:]

                  Prepared Statement of Linda E. Greer

    Good morning and thank you for this opportunity to testify on the 
failure of the EPA IRIS program to serve the needs of the public.
    My name is Linda Greer, and I direct the Health Program at the 
Natural Resources Defense Council, where I have worked for more than 
fifteen years. I have a Master's degree in public health and a Ph.D., 
in environmental toxicology. I have watch-dogged EPA's evaluation of 
toxic chemical hazards and risks for many years, both in my capacity as 
the Health Program Director at NRDC and as a member of the Executive 
Committee of EPA's Science Advisory Board, where I served for six 
years. I have also served on many committees of the National Academy of 
Sciences, including most recently the Committee on Emerging Issues in 
toxic chemicals and served on the NAS Board on Life Sciences from 2001-
2004. The Natural Resources Defense Council (NRDC) is a national, 
nonprofit organization of scientists, lawyers and environmental 
specialists dedicated to protecting public health and the environment. 
Founded in 1970, NRDC has 1.2 million members and online activists, 
served from offices in New York, Washington, Chicago, Los Angeles, San 
Francisco and Beijing.
    NRDC's Health program focuses on toxic chemical pollutants in air, 
water, food, and shelter. Over the years, we have focused our 
particular attention on the ``biggest pollutants'' in these media, the 
ones disproportionately responsible for the biggest threats to human 
health. This has led to successful efforts to substantially reduce 
diesel air emissions from trucks and buses, for example, and to take a 
number of dangerous and outdated pesticides off the market. There are 
more than 70,000 chemicals in commerce, but some are much more toxic 
than others, and we can make great progress in environmental health 
protection if eve focus on the chemicals pollutants that pose the 
greatest threat to human and ecological health.
    We commend the Science and Technology Committee and this 
subcommittee for its interest in the EPA Integrated Risk Information 
System (IRIS) chemical review process and its oversight of recent 
changes made by EPA and the Bush Administration. These changes are yet 
another escalation of the Administration's war on science and public 
health that has gone on for nearly eight years. Its record of political 
interference with the work of government scientists across a range of 
environmental issues including global warming and endangered species 
has been well-established. Things are no better in the case of 
analyzing and regulating toxic chemicals that pose a risk to public 
health. In this area, the Administration has attempted (and in some 
instances succeeded) to block, weaken, or delay health standards for a 
long list of dangerous pollutants including arsenic, mercury, lead, 
benzene, perchlorate, formaldehyde, particulates and ozone. In 
addition, the Administration has weakened the public's right to know 
about the release of toxic chemicals into their communities.
    Thus, the recent changes to the IRIS process that are the subject 
of today's hearing should properly be viewed as one part of a much 
broader agenda to sacrifice public health protections and limit public 
understanding of the risk of toxic chemicals, in a manner that benefits 
a host of polluting industries and federal agencies. Indeed, by 
attempting to weaken the IRIS process, the Administration has zeroed in 
on one of the earliest and most fundamental steps in the process of 
protecting public health, that in which EPA's scientists identify the 
health risks posed by exposure to certain chemicals. The Committee's 
hearings should preface Congressional action to reverse the recent 
changes to the IRIS process and ensure the integrity and effectiveness 
of the program is restored.

The importance of the IRIS database

    The IRIS database is a publicly available database which contains 
EPA's evaluation of potential human health effects from exposure to 
more than 540 chemicals, including highly hazardous chemicals such as 
vinyl chloride, butadiene, benzene, lead, mercury, and asbestos.\1\ 
While these evaluations are not regulations per se, they are used by 
both State and federal regulators and by the international community 
for a range of environmental health regulation and management purposes. 
For example, the information can be used in combination with exposure 
data to set cleanup levels at hazardous waste sites, or to set exposure 
standards for air, water, soil, and food. Thus, the accuracy, 
credibility, and timeliness of IRIS assessments have real world 
consequences for human health.
---------------------------------------------------------------------------
    \1\ Integrated Risk Information System (IRIS) http://cfpub.epa.gov/
ncea/iris/index.cfm
---------------------------------------------------------------------------
    The global importance of this database cannot be overstated. For 
example, in May, 2008 alone, the IRIS website received almost 25,000 
requests (an average of over 800 per day), from over 2,000 separate 
computer sources and from over 60 different countries.\2\
---------------------------------------------------------------------------
    \2\ IRIS (Integrated Risk Information System). Web Statistics for 
iriswebp. Washington, DC: U.S. Environmental Protection Agency. 
Available: http://www.epa.gov/reports/objects/iriswebp/iriswebp/
iriswebp

IRIS conducts scientific assessments, not policy documents

    Risk assessments involve the integration of hazard identification, 
dose-response assessment, and exposure assessment to estimate the 
probability (likelihood) of harm. Rather than conducting entire risk 
assessments, the IRIS program is limited to conducting hazard 
identification and assessing dose-response relationships for 
environmental chemicals; EPA factors in exposure scenarios and risks 
under its regulatory programs.
    Hazard identification, the first step in a risk analysis, 
determines whether or not the substance of concern is likely to have 
adverse health effects. This step requires a thorough review of 
relevant toxicologic data and may include human epidemiology, whole 
animal studies, non-animal data, and field data. The result is a 
scientific determination of whether or not a substance causes adverse 
health outcomes such as cancer, neurological disease, birth defects, or 
death. Since reliable human data is often not available, hazard 
evaluations generally rely heavily on identifying whether the substance 
is toxic in animals or other test systems.
    The dose-response assessment follows hazard identification and is 
designed to identify safe levels of exposure for chemicals that pose 
harm. This assessment consists of scientifically characterizing the 
relationship between the amount of exposure (dose) and the incidence of 
an adverse health endpoint. Methodologies for dose-response assessment 
often differ between cancer and non-cancer effects and between acute 
and chronic exposure scenarios. They are often scientifically 
controversial, because they must extrapolate from high experimental 
doses to more typical ambient exposure levels.
    Ideally, epidemiological data would be available that clearly 
illuminate the hazards and the dose-response relationships for 
chemicals of concern in human populations. Unfortunately, this is 
nearly never the case. Most chemicals lack key studies of effects in 
humans as well as studies of effects in animals at ambient levels. As a 
result, IRIS assessors are called upon to make informed judgments 
regarding the relevance of the animal data to humans, and to select the 
most appropriate extrapolation method. Further, the IRIS assessments 
require independent expert judgment to decide whether various safety 
factors should be applied to assessment data to ensure public health 
protection. For example. EPA often decides to include margins of safety 
to protect vulnerable populations, relevant genetic variations, 
vulnerable life stages, disease states, concomitant exposure to complex 
mixtures, and other relevant factors that may influence the probability 
of an effect caused by exposure to the substance of concern.
    Importantly, decisions made in the IRIS program are informed by 
various EPA guidance documents that are publicly-available and 
publicly-documented, and have been publicly-vetted. Reliance on these 
important guidance documents is crucial to ensure that evaluations are 
consistent across substances and as objective as possible.
    The new process established by the White House turns this process 
on its head: it invites the injection of non-scientific considerations 
into the IRIS assessments, and further, it shields from public scrutiny 
the input from other parts of the government with a potential financial 
or political interest in the outcome of a particular assessment. When 
political appointees, perhaps acting on behalf of regulated industries, 
and polluting agencies are able to interfere in a non-transparent and 
inappropriate manner, the whole process is severely compromised.

Summary of the new process

    The new 2008 IRIS process introduces three new opportunities for 
OMB and other non-health agencies to weigh in on EPA's health 
assessments, where previously there was only one. Importantly, 
interagency comments and OMB comments for all three of the new 
intervention points are shielded from public view: the first two bites 
at the apple, and the last one. Thus, whereas the pre-2004 IRIS process 
provided the agencies and OMB with the draft assessment at the same 
time as it was provided to the public, the new process injects 
polluting agencies such as DOD and DOE into the assessment process at 
an earlier stage, and forces the IRIS staff to address the interests of 
the agencies and OMB, whether they are consistent with health-
protective policies or not. These exchanges take place out of the 
public eye. Following this negotiation, the draft review is publicly 
noticed. But then there is a final intervention point provided to OMB 
and the other agencies that require that the IRIS staff to resolve any 
outstanding concerns by OMB and the other agencies, including polluting 
agencies, before the assessment can be finalized. While the 2008 
process boils down to `death by a thousand cuts,' this ability to have 
the last word--and to axe an assessment at the bitter end--may be the 
deepest cut of all.
    The U.S. Government Accountability Office (GAO) recently released 
its review of the new process, in a report entitled: Low Productivity 
and New Interagency Review Process Limit the Usefulness and Credibility 
of EPA's Integrated Risk Information System.\3\ This report provided a 
detailed and highly critical assessment of the failures of the IRIS 
program to meet its deadlines and requirements, blaming in large part 
the interference by polluting agencies and political appointees. The 
GAO report predicts that the new process will produce IRIS assessments 
that lack credibility, and will worsen what is already a critical 
backlog of new and updated assessments. NRDC agrees with the GAO 
evaluation, whose many findings validate our years of work to right 
this cornerstone program for public health protection.
---------------------------------------------------------------------------
    \3\ United States Government Accountability Office. Low 
Productivity and New Interagency Review Process Limit the Usefulness 
and Credibility of EPA's Integrated Risk Information System. Report to 
the Chairman, Committee on Environment and Public Works, U.S. Senate. 
Report No. GAO-08-440; March 2008. Available at http://www.gao.gov/
new.items/d08440.pdf

A summary of the report is also available online at: Toxic Chemicals: 
EPA's New Assessment Process Will Increase Challenges EPA Faces in 
Evaluating and Regulating Chemicals, GAO-08-743T, April 29, 2008. 
Summary at http://www.gao.gov/docsearch/abstract.php?rptno=GAO-08-743T
    For many years, IRIS assessments were developed by EPA scientists. 
Drafts were released simultaneously for public comment and external 
(independent expert) peer review. OMB and government agencies such as 
DOD or DOE, who sometimes had a stake in the outcome of the evaluation 
because of their obligations to address contamination at federal 
facilities, had an opportunity to review and comment on the draft when 
it was released for public review and comment.



    The new IRIS process introduces significant new steps that are both 
time-consuming and undermine the objectivity and transparency necessary 
for credible and valid assessments (see Table 1). Significant aspects 
of the new process are as follows:

        1.  In the 2008 process, IRIS staff is now required to develop 
        a qualitative draft assessment, prior to the quantitative 
        assessment, which must undergo both public and interagency 
        review. This qualitative draft serves as a summary of the 
        scientific literature that the staff intends to rely on to 
        supports its assessment. Although this procedure sounds benign, 
        it seriously compromises the timeliness and transparency of the 
        IRIS program. First, it allows other government agencies to 
        delay an assessment far nearly two years to do additional 
        research on any chemicals that an agency deems to be ``mission 
        critical,'' thereby significantly stalling the start of the 
        formal IRIS evaluation. Even more alarming, the comments and 
        submissions of the other agencies to the qualitative draft are 
        considered `deliberative' which, if unchallenged or upheld by 
        the courts, would shield the comments from public scrutiny.

        2.  In the new 2008 process, agencies outside of EPA are 
        invited to designate chemicals as `mission critical' and to 
        intervene in the IRIS assessment of these chemicals. Mission 
        critical chemicals are defined as those that are, ``an integral 
        component to the successful and safe conduct of an Agency's 
        mission in any or all phases of its operations. Impacts on use 
        of mission critical chemicals include cessation car degradation 
        of the conduct of the mission and/or unacceptable resource 
        constraints.'' [emphasis added] In other words, ``mission 
        critical'' chemicals includes not only those that are vital and 
        have no viable substitute, but also those where the potential 
        cost to an agency of cleaning up a pollution mess it (or its 
        contractors) have created is ``unacceptable'' or where 
        potential future limitations on use (such as stricter exposure 
        standards) are deemed too expensive by the agency. These are 
        exactly the kinds of policy considerations that should not be 
        allowed to intrude on the IRIS assessment process.

        3.  Following the quantitative draft, the IRIS staff develops 
        the draft quantitative assessment (the Toxicological Review). 
        This is subjected to public and interagency review, followed by 
        external (independent expert) peer review. The important 
        difference is that prior to 2004, this represented the first 
        and simultaneous opportunity for both the public and the other 
        agencies to comment, with all comments publicly accessible. By 
        contrast, with the 2008 process this is now the second public 
        comment. opportunity, and the third OMB/interagency 
        intervention point, but the first where the OMB/interagency 
        comments would be publicly accessible.

        4.  Finally, before the IRIS assessment can be finalized and 
        publicly released, the 2008 process requires OMB and 
        interagency approval. The pre-2004 process had only required 
        internal agency review. This 2008 process invites the fourth 
        and final opportunity for OMB/interagency interference with the 
        evaluation. Although the new process says that EPA has the 
        power to make the final decision, it is clear that the other 
        agencies and OMB will have significant access and influence 
        over the final editing choices.

    Although current EPA leadership argues that the new process was 
developed in order to provide ``greater transparency, objectivity, 
balance, rigor and predictability'' \4\ to the IRIS assessments, we 
strongly disagree. In fact, the administration's claims are Orwellian. 
This new process is designed precisely to give the polluting agencies 
more access and more influence to what has historically been an 
objective scientific evaluation process--and to add at least two or 
more years to the review of mission critical chemicals.
---------------------------------------------------------------------------
    \4\ Revised IRIS Process Question & Answers (pdf). http://
cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=190045

EPA announces improvements to IRIS process. EPA press release, 04/10/
2008.
http://yosemite.epa.gov/opa/admpress.nsf/
03dd877d6f1726c28525735900404443/
1365469639099e6585257427005bb22a!OpenDocument
    To put it plainly, in this new proposal, the Administration is 
attempting to provide those agencies with the most at stake in the 
degree of protection established for a particular chemical multiple 
opportunities to weigh-in and influence the outcome of EPA's decisions, 
while hiding the exercise of that influence from the public. The 
Administration's claim that, for example, providing the Department of 
Defense multiple opportunities to weaken or delay setting a health 
standard for TCE--a chemical for which DOD is responsible of widespread 
contamination of drinking water--completely outside of public view, 
will result in a more balanced and objective result, doesn't pass the 
laugh test.
    The EPA leadership further claims that the outcome of the new 
process is expected to `streamline' the IRIS process and make it more 
`transparent.' Again, we strongly disagree. The new process allows 
public review at only one stage, which is review of the qualitative 
draft. All other evaluation steps occur behind closed doors, shielded 
from accountability to the public or other more objective, outside 
scientific experts.
    It is indicative of the Administration's disregard for public input 
on its changes to the IRIS process, and its eagerness to put them in 
place, that OMB admonished GAO for being so critical of a draft 
proposal, and assured the GAO that ``[i]ndeed, the process will not be 
complete until EPA circulates its draft to the public for comments and 
then releases a final product that is responsive to those comments.'' 
Assurances notwithstanding, some six weeks later the Administration 
finalized this deeply flawed proposal without any opportunity for 
public review or comment. This short-circuiting of the public comment 
process does not square with the principles of public right-to-know, or 
EPA's lip service in support of an open and transparent process.

Backlog at IRIS: Timeliness is already a terrible problem that cannot 
                    bear to be compounded by further delay

    In the U.S., there are about 8,000 chemicals in commerce deemed 
``economically significant'' (i.e., produced or imported at a rate 
greater than 10,000 pounds per site annually). Unfortunately, only 
about 550 chemicals in total have been evaluated in the IRIS program. 
Even when compared just to the universe of chemicals regulated by EPA, 
IRIS is obviously failing to adequately serve the public's needs. For 
instance, the EPA is responsible for regulating the emissions of 188 
hazardous air pollutants (HAPs) under the Clean Air Act, but only 129 
of them appear in the IRIS database. In other words, in almost 20 years 
since. IRIS was created, the EPA has been unable to complete 
Toxicological Reviews for nearly one-third of these dangerous 
pollutants.
    Furthermore, even when important chemicals are in the IRIS 
database, the risk assessments available for many of these chemicals 
are outdated: the average assessment on IRIS is over 13 years old, with 
the oldest having not been significantly revised since the mid-1980s. 
Considerable new evidence of toxicity has emerged for many of these 
chemicals since their last assessment, which renders tile conclusions 
potentially obsolete and limits their usefulness and credibility with 
regulatory agencies.
    According to the IRIS website, the program has finalized only 
thirteen assessments since 2004. As GAO notes ``[t]he IRIS database is 
at serious risk of becoming obsolete because EPA has not been able to 
routinely complete timely, credible assessments or decrease its backlog 
of 70 ongoing assessments.'' \5\
---------------------------------------------------------------------------
    \5\ Toxic Chemicals: EPA's New Assessment Process Will Increase 
Challenges EPA Faces in Evaluating and Regulating Chemicals, GAO-08-
743T, April 29, 2008. Summary at http://www.gao.gov/docsearch/
abstract.php?rptno=GAO-08-743T
---------------------------------------------------------------------------
    Consider for example Trichloroethylene (TCE), a solvent used as a 
degreasing agent. TCE is one of the roost common contaminants of 
Superfund sites across the Nation, primarily from military uses, and is 
linked to cancer, including childhood cancer, and birth defects.\6\ The 
IRIS draft was initiated a decade ago, in 1998. In 2001, EPA concluded 
that TCE was ``highly likely'' to cause cancer and specifically noted 
the added health risks when exposures took place during childhood. 
Finalization of that assessment has been held up after repeated 
objections from military contractors and the Department of Defense. 
Finally it was reviewed by the National Academies, which issued their 
report in July 2006, finding that the data linking TCE with cancer was 
even stronger than EPA IRIS staff had determined, and recommending that 
the IRIS assessment be finalized as soon as possible. Nonetheless, the 
Defense Department continued to insist that it not be finalized until 
more data was available, and today the assessment has still not been 
finalized.
---------------------------------------------------------------------------
    \6\ ATSDR ToxFAQs for trichloroethylene. http://www.atsdr.cdc.gov/
tfacts19.html
---------------------------------------------------------------------------
    Clearly, constructive reform for the IRIS program would focus on 
increasing resources available to undertake IRIS reviews as well as 
policy changes that would streamline the difficult decision-making 
inherent in the process. The new procedures run completely counter to 
these goals and will only exacerbate this backlog.

Delays to IRIS assessments result in continued unsafe exposures to 
                    humans and wildlife

    Setting a health assessment standard under IRIS is only the first 
step in a long regulatory process. For example, for the EPA to 
establish a national drinking water standard, the Agency would 
typically reach out to stakeholders for input and perhaps even convene 
a Federal Advisory Committee, which could take over a year. 
Additionally, the docket for a proposed rule could remain open for at 
least a few months to collect comments from the public. Depending on 
the extent of the comments received, the Agency could again take up to 
a year or more to address and respond to those comments. In the end, it 
could take the Agency years, even decades, to finalize a drinking water 
regulation.
    As new or updated IRIS assessments continue to languish, or get 
weakened to satisfy the demands of OMB and federal agencies including 
the Department of Defense and Department of Energy, the process of 
setting health standards becomes unspeakably prolonged. And the public 
continues to suffer due to lack of adequate public health protections.
    For example. the Administration has successfully blocked a much 
needed update of the IRIS assessment for formaldehyde. An updated 
assessment reflecting recent science that shows greater health hazards 
posed by formaldehyde could ultimately be the basis of establishing 
stricter emissions or exposure limits from building materials and other 
sources. Meanwhile, people living in temporary trailers provided by 
FEMA after Hurricane Katrina have complained of a host of illnesses 
they believe are related to the high levels of formaldehyde which they 
have been exposed to in those trailers.
    Similarly, delay in IRIS has contributed to an inexcusable failure 
to develop a national health-protective standard for perchlorate, a 
component of rocket fuel and other explosives, in drinking water. 
Scientific evidence is overwhelming that exposure to perchlorate, an 
iodine uptake inhibitor in the thyroid gland, can cause significant 
development problems for developing infants. Subtle alterations of 
thyroid hormones during pregnancy--even within the normal range--have 
been associated with decreased intellectual and learning capacity in 
childhood.
    Approximately 350 public water systems serving over 41 million have 
reported perchlorate detections.\7\ The source of the contamination at 
many of these sites is defense and aerospace facilities and military 
installations.\8\ The Defense Department mounted a years-long battle, 
and elicited White House support, against IRIS draft assessments in 
1998 and in 2002 that had determined that even low doses of perchlorate 
may be harmful to early development of the human brain.\9\ The final 
IRIS assessment was not completed until 2005. Due to the year's long 
delay in assessing and quantifying the harm posed by perchlorate in the 
IRIS program, the public remains years away from a national drinking 
water standard that will protect their health.
---------------------------------------------------------------------------
    \7\ U.S. EPA Unregulated Contaminant Monitoring Rule (UCMR) 
database, January 2005 data release, and data collected by State 
agencies in Arizona, California. Texas, and Massachusetts.
    \8\ Wall Street Journal online. Inside Pentagon's Fight to Limit 
Regulation of Military Pollutant. Peter Waldman. December 29, 2005.
    \9\ Wall Street Journal online. Inside Pentagon's Fight to Limit 
Regulation of Military Pollutant. Peter Waldman. December 29, 2005.

Objectivity and transparency of IRIS review is paramount

    IRIS assessments must be shielded from political interference and 
be open to public scrutiny to ensure their scientific rigor and 
adherence to public health protective policies.
    Under the new IRIS process, polluting federal agencies are provided 
excessive and redundant opportunities to intervene in the development 
of the IRIS assessments, shielded from scrutiny by the scientific 
community and the public. This is indefensible. The IRIS assessments 
and the comments provided by federal agencies, academics, industry, 
public interest groups, the general public, and others regarding drafts 
are supposed to be about science. The Administration has no reason for 
insisting upon secrecy other than to shield injection of politics and 
policy into the scientific debate, and avoid public airing of 
scientific arguments that won't stand up to public scrutiny.

Political appointees in the EPA undermine EPA's mandate to protect 
                    human health and the environment

    The Director of the IRIS program, George Gray, is clearly 
subverting the mission of the EPA in the development of the new IRIS 
process, essentially carrying out the mission of the OMB instead. Gray, 
who is EPA Assistant Administrator for the Office of Research and 
Development, was previously the Director of the Harvard Center for Risk 
Analysis, a seemingly prestigious academic center but one quite 
notorious for its extensive support from with corporate money and its 
tendency to promote industry perspectives in environmental health 
policy deliberations. With Gray holding direct management power over 
the IRIS program, the Administration has ensured that EPA resistance to 
the agenda of undermining public health protections will be minimal, 
and, more often, will be aided by its political appointee.
    A documented example of Gray's role in blocking the work of his own 
IRIS staff is the case of the Toxicological Review of 
tetrachloroethylene also known as perchloroethylene (perc), a dry 
cleaning and degreasing chemical and widespread groundwater 
contaminant. The IRIS assessment was initiated in 1998. In 2006 Risk 
Policy Report revealed that George Gray was insisting that his staff 
re-analyze the cancer risks of the chemical to try to fit the data to a 
model that would have assumed (without scientific evidence) that low 
doses were safe, whereas the staff's careful review of all available 
data did not support this assumption.\10\ In addition, Gray's directive 
contradicts EPA's established, peer-reviewed cancer guidelines. Had the 
IRIS staff complied with Gray's directive, it would have resulted in a 
less-protective assessment. This assessment has still not been 
updated.\11\
---------------------------------------------------------------------------
    \10\ Clean Air Report via InsideEPA.com. Staff rebuff ORD Chief's 
bid for new risk study for key solvent. Inside Washington Publishers. 
Vol. 17, No. 20. October 5, 2006. Originally reported in Risk Policy 
Report, September 26, 2006, p. 1.
    \11\ On January 25, 2007, the California Air Resources Board 
ordered the phase-out of the use of perchloroethylene, from dry 
cleaning, with a complete ban by 2023. See details in news release at: 
http://www.arb.ca.gov/newsrel/nr012607b.htm
---------------------------------------------------------------------------
    In short, the political appointee currently in charge of the IRIS 
program, and defending the Administration's new reforms to Congress and 
the public, has blocked an updated assessment of a chemical polluting 
groundwater across the Nation, and is insisting EPA scientists use 
unsupported and unprotective assumptions in a model intended to 
downplay the potential harm posed to the public by the chemical.
    According to NRDC discussions with IRIS staff, additional instances 
of interference by George Gray to delay or weaken assessments include:

          blocking IRIS from posting acute (less than 24 hour) 
        risk values.\12\ Acute risk values are relevant to communities 
        that are exposed to chemicals by burst releases of toxics 
        (smokestacks, etc.) that may not exceed short-term (days-weeks) 
        or long-term (months-years) regulatory standards, but may still 
        pose a hazard to acutely exposed individuals.
---------------------------------------------------------------------------
    \12\ EPA Eyes Expanded Risk Database Used in Toxic Regulation, 
Clean-ups. ``The managers of an EPA chemical risk database are 
considering adding short-term and acute exposure categories on several 
chemicals to gauge the resources needed to add the broader risk data to 
the system.'' January 27, 2003. Inside Washington Publishers.

          blocking IRIS from posting summaries of its 
        assessments online, arguing that the summaries give a naive 
        public and regulators inaccurate impressions, contribute to 
---------------------------------------------------------------------------
        misunderstandings, and are misused.

          blocking the IRIS staff recommendations to apply a 
        10-fold safety factor to site-specific assessments where 
        children may be exposed to ethylene oxide, a potent human 
        carcinogen with evidence that exposures during early life 
        significantly increase the risk of developing cancer. Use of 
        such a safety factor under precisely these conditions is 
        specifically recommended in the EPA Supplemental Cancer 
        Guidelines on Children's Exposure.

    These examples should be alarming to any Member of Congress, and 
any member of the public, who cares about ensuring that the best 
science is used by EPA to determine the risks posed by dangerous 
chemicals and who cares about fully informing the public about the 
risks posed by exposure to toxic chemicals. It also illustrates why 
NRDC and other environmental and public health groups, as well as the 
GAO, are so concerned about the changes to the IRIS process that will 
allow more of the decision-making to take place behind closed doors, 
where political appointees can make demands on career employees, 
without having to defend the merits of their scientific arguments (or 
the injection of policy and political preferences in a scientific 
process) before the public.

Conclusion

    Properly implemented, the EPA IRIS program provides a critical 
scientific service to the public. Like other vital EPA programs, it 
must be preserved and protected so that EPA's scientists can conduct 
their work without political interference. The EPA's authority to 
determine the risks posed by hazardous chemicals should not be 
sacrificed to the desire of other federal agencies' or industry 
interests in avoiding clean-up costs or requirements for additional 
controls on emissions and exposures.
    We request that the Science Committee work with other House 
colleagues to ensure that the new IRIS process is overturned or 
withdrawn and require IRIS health assessments to be reviewed in an open 
process, without inappropriate political interference.
    There are hundreds of potentially dangerous chemicals that are 
either already in the IRIS database but need to be updated, or that 
have not yet been added. Without an open, credible, effective, science-
based, fully-funded program to develop these assessments without 
political interference from the White House or other federal agencies, 
EPA will continue to fall further behind in a fundamental program that 
serves as the foundation for fulfilling its mission: protecting the 
environment and public health.
    Thank you for the opportunity to testify today.

                      Biography for Linda E. Greer

    Linda E. Greer joined the Natural Resources Defense Council (NRDC) 
in 1990 as a Senior Scientist specializing in public health issues, 
especially toxic chemicals and hazardous waste. She now is the Director 
of the Environment and Health Program. Linda is currently focusing on 
the scientific controversies in determining toxicity of chemicals in 
regulation and on mercury pollution. Prior initiatives have most 
notably included pollution prevention opportunities at large chemical 
manufacturing facilities, where she directed a large and successful 
collaborative project to reduce toxic wastes and releases with the Dow 
Chemical Company. Linda has been appointed to the Board of Life 
Sciences for the National Academy of Sciences as well as the U.S. EPA 
Science Advisory Board Executive Committee, and she serves several 
other technical and policy advisory groups.
    Dr. Greer teaches an intensive summer course, ``Scientific 
Fundamentals of Risk Assessment'' for law students and practicing 
lawyers, which she has done for ten years, and she has taught a 
graduate-level class to scientists in toxic chemical impact and 
regulation.
    She received her Ph.D. in Environmental Toxicology from the 
University of Maryland in 1989, M.S.P.H. in Environmental Sciences and 
Engineering from UNC-Chapel Hill, and B.S. in Biology from Tufts 
University.
    Dr. Greer is the author of over a dozen technical and policy 
articles on environmental matters, and has frequently testified before 
Congress.

                               Discussion

               Deliberative, Interagency Decision-making

    Chairman Miller. Thank you, Dr. Greer.
    At this point we will have our first round of questions, 
and the Chair now recognizes himself for five minutes. Mr. 
Ensminger, as you know, as other witnesses have testified, the 
current IRIS process allows repeated interagency, 
intragovernmental discussions about the health risk 
assessments. Those discussions, to use the word that Dr. Greer 
quoted, are deliberative. You would probably call those secret. 
The doors are closed. We are not entirely sure what happens in 
there. But your testimony made it pretty clear that you do not 
believe that your former employer, the Department of Defense, 
talks about public health or expresses concern for public 
health. They are more concerned about potential clean-up costs, 
Mr. Siegel said perhaps as much as $5 billion. What they are 
not doing is talking about the public good. I have always 
thought that democracy dies behind closed doors. To use Justice 
Brandeis's phrase, sunlight is the best disinfectant and the 
electric light the most efficient policeman, but last week in 
our hearings, Susan Dudley, the head of OIRA, the Office of 
Information and Regulatory Affairs at OMB, the office within 
OMB that supervises this interagency, intragovernmental 
process, extolled the virtues of closed-door meetings. She said 
that it encouraged candor, that people could say exactly what 
was on their mind and not worry about the consequences of it 
because they knew that what they had to say would go no further 
and therefore they could say exactly what they thought and that 
the process was better as a result. Do you have any thoughts on 
her view of the virtues of closed-door meetings and a 
deliberative process to decide?
    Master Sergeant Ensminger. Mr. Chairman, it is my opinion 
that if somebody has to go behind closed doors to say 
something, they have something to hide, and why else wouldn't 
they want to say it out in the open. If you can't say it out in 
front of everybody, maybe you better keep your mouth shut.
    Chairman Miller. Right out in front of God and everybody, 
as we would say in North Carolina.
    Mr. Siegel, do you have a----
    Mr. Siegel. I have a slightly different perspective. I have 
served on a number of National Academy of Science's committees 
dealing with various contaminations at Department of Defense 
facilities, and those meetings, they exclude DOD and we have a 
number of scientists talking frankly, and that works because I 
am in the room, because they have a representative of the 
public interest in the room to make sure that it is not just a 
few people trying to pull the wool over everybody else's eyes. 
There are stages and various processes where, you know, private 
discussions may make sense but not if a major interest group is 
excluded.
    Chairman Miller. And I am sorry, who would you include as a 
major interest group?
    Mr. Siegel. Well, I am basically there representing the 
impacted public from the sites.
    Chairman Miller. You are considering yourself or the public 
as an interest group?
    Mr. Siegel. Yeah, and I strongly believe that my presence 
affects what other people in the room say because, you know, 
not that I am going to run to the press and leak something but 
they have to treat things differently when they know that there 
is somebody who is asking real questions.
    Chairman Miller. You think perhaps the candor that Susan 
Dudley thought was a virtue of being able to say whatever you 
thought was actually not such a virtue and----
    Mr. Siegel. I mean, this is almost like a brainstorming 
session where people are saying I think this but I am not 
really sure, and so in the privacy of that environment, people 
will say things they aren't sure of and then say oh, I see, you 
are right, and they aren't quoted in the press and the thing 
isn't taken too far, but that only works if it is open to other 
people with other interests, and that is a scientific 
discussion. That is not a political discussion.
    Chairman Miller. Dr. Greer.
    Dr. Greer. Well, I think the important principle here is 
transparency and accountability of the decision-making process, 
and what we have seen through the IRIS experiences is that 
behind closed doors, arguments are made, data is hidden, and 
the decision that comes out in the end is not transparent and 
is not accountable, so although there may be a minor role for 
informal conversations to try to get your act together, the 
general principle for all EPA rule-making is one of 
transparency and accountability to the public and to all 
affected parties, and that is what we lose with these closed-
door deliberations, which are decision-making deliberations.

                    OIRA's Role in the IRIS Process

    Chairman Miller. The current interagency process, the IRIS 
listing process, the one--actually the one that preceded the 
one that was adopted in April seemed to have the OIRA, OMB 
really in control because it was interagency and now it seems 
to be more clearly in control in a process that statutes seem 
to contemplate the EPA would run. Do you think the EPA is 
capable of conducting an interagency discussion on its own or 
they need OMB standing over their shoulder or actually being 
the ones themselves to decide, Dr. Greer?
    Dr. Greer. Well, EPA is absolutely capable of doing that. I 
mean, this is really at the core of scientific deliberation. 
They have guidance documents on principles of how to make these 
decisions and they have decades of experience in making these 
decisions. I would contrast that against any of the scientific 
experts in any of these agencies who are really in a much less 
expertise, less experience and this is really EPA's arena.
    Chairman Miller. Mr. Siegel.
    Mr. Siegel. I think that not only does EPA have the 
capacity but I think that the other agencies--there are a lot 
of good people at the Department of Defense who are trying to 
do good science too and they are capable of communicating with 
EPA and EPA is capable of communicating back, and the OIRA 
involvement to me smacks of a political involvement, that you 
have people who are involved not primarily because of their 
scientific expertise but because of their political 
obligations.

                            The IRIS Process

    Chairman Miller. My time is expired, but Mr. Sensenbrenner 
is not here so I will recognize myself for a second round of 
questions.
    Mr. Whittaker, I think you are the audiovisual guy. There 
were two charts in the hearing last week. Chart 3, that is--
actually could I see Chart 1 first? All right. That chart based 
on Susan Dudley's testimony last week is the very complicated 
process. That is actually prepared by the EPA and it is the 
flow chart to show the IRIS process, which she--before 2004, 
and then there was an interim one and then Chart 3, Mr. 
Whittaker, that is the chart that she said streamlined the IRIS 
process. Mr. Siegel, does that--is it your impression like 
GAO's that that actually will further complicate, not 
streamline it? It does not look just to my own lying eyes to be 
a simplification of the earlier chart.
    Mr. Siegel. As I said, you know, there are a lot of good 
people at EPA and career people I talk to, you know, are very 
concerned about this sort of thing, and I tease them. I say it 
takes the EPA 30 days to put in a light bulb, and basically you 
have that not just with IRIS but with a large number of 
processes, things just drag on and on while people are already 
exposed. It is one thing if there is a delay and nobody is 
being exposed but you basically have people like Shirley, like 
Janey Ensminger, people who are being exposed while this is 
being--this process goes on. So again, things that take a long 
time that are complicated are okay if people are safe, but if 
you don't know that they are safe, you need to act quickly, and 
when we have tried to accelerate some of these studies like on 
perchlorate, they say, we can't possibly do it by such and such 
a date. Well, I guess that is because they don't really care 
about the exposures that are going on. That is all I can think 
of.
    Chairman Miller. Mr. Ensminger, you appear to want to 
comment.
    Master Sergeant Ensminger. I had a researcher make the 
comment to me the other day exactly about OMB overruling the 
EPA. I believe the OMB has one toxicologist on their staff.
    Chairman Miller. I asked Susan Dudley that last week and I 
did not get a clear answer.
    Master Sergeant Ensminger. They have one toxicologist on 
their staff who overruled the thousands that work at EPA. Boy, 
isn't that something?
    Chairman Miller. Well, again, what you just said is 
consistent with what I had heard. When I asked Susan Dudley 
that, the head of OIRA, I did not seem to get a clear answer 
and she said that they had access to other expertise that they 
employed.
    Master Sergeant Ensminger. And Mr. Siegel made a comment a 
while ago about the DOD had good researchers on their staff as 
well. Why are we duplicating these efforts? Why is DOD 
authorized to use taxpayers' money to do research on these 
chemicals when we are already funding somebody else to do it, 
the EPA? I mean, this is ludicrous. Is it the Department of 
Defense or is it the Department of Legal Defense?
    Chairman Miller. When Susan Dudley testified last week, I 
asked her if in any of these old mini blocks, I haven't 
actually counted how many blocks there are, other than the 
public comment section periods, whether there was an 
opportunity for anyone in the private sector to be part of 
deliberative discussions and obviously public comment is not a 
deliberative discussion or secretive, as I am sure you would 
say, and I would too, and she said no, that actually all the 
participation by the private sector would be through public 
comment. There was no opportunity for them to have any say, any 
opportunity to influence an IRIS decision, an IRIS assessment, 
not TCE manufacturers, not any private sector companies that 
might face clean-up costs, no opportunity except during public 
comment. Mr. Siegel, is that consistent with your own 
observations of the process?
    Mr. Siegel. It is my understanding that through the 
perchlorate study group, and you may have the documents, that 
the contractors for these federal polluting agencies have a 
direct line to the Defense Department, NASA participants 
because these agencies end up in many cases paying for the 
clean-up of the contractor obligations. I mean, it is little 
known, when Congress looked at this over 10 years ago, that 
companies like Lockheed and Aerojet charged the costs of their 
clean-up off as overhead on their government contracts and the 
people in the Defense Department who are in charge of dealing 
with it, know it so they are very open to input from these 
companies when they go to EPA. I don't know that the companies 
are actually in the room in the meetings with EPA, but their 
information is.
    Chairman Miller. Dr. Greer.
    Dr. Greer. Yes, that is right. I was going to say the same 
thing, that the perchlorate study group is a great example of 
how that is really not the case, that what Susan Dudley was 
talking about, there is plenty of precedent for that not being 
true. You know, in this case, that was a group set up by the 
military. They were present in the so-called interagency 
deliberations, and Aerojet was actually the chair of the 
deliberations in many of the meeting notes that NRDC has. So 
they were running the deliberation, let alone not present.
    Chairman Miller. Dr. Greer, if there were not this 
streamlined process, interagency IRIS process, could federal 
agencies still weigh in on an IRIS assessment and how would 
they go about that?
    Dr. Greer. Well, you know, federal agencies have always had 
an opportunity to comment and weigh in on these assessments. 
That has been the case all the time. They have weighed in 
during the public comment period but not in secret and, you 
know, not with a license to kill. That is the big difference 
between what we are looking at today and the normal procedures. 
We certainly would not object to having these agencies weigh in 
with the public, you know, on the record, so to speak.
    Mr. Siegel. You know, one of the things that I wonder is 
what these agencies, polluting agencies say in private versus 
what they are actually saying in public, that we have no way of 
knowing that.

                    Tracking Citizen Exposure to TCE

    Chairman Miller. Mr. Ensminger, obviously a lot of folks 
have lived on Camp Lejeune. The military is transient by 
nature. I grew up in Fayetteville. As you pointed out when we 
talked yesterday, I know you have less than warm feelings for 
Fayetteville since you see it as an Army town. I know that 
people are on and off of military bases, their families are on 
and off military bases all the time, and keeping track of all 
the people who have been exposed is no small task. How is the 
government doing in identifying the people who have been 
exposed and trying to see what health outcomes they have had, 
whether they have had health consequences that are consistent 
with the TCE exposure risk?
    Master Sergeant Ensminger. To answer your question, Mr. 
Chairman, to date, to date, there have been no studies done on 
any population groups at Camp Lejeune other than the in utero 
population. In other words, the siblings of those in utero 
children, their parents, the men and women who were stationed 
at Camp Lejeune, the Marines and sailors, and the civilian 
employees that work aboard the base, to date, no studies have 
been done on them. Trying to get the Department of Defense, 
Department of the Navy and the United States Marine Corps to 
execute a notification process, actually had to go to the 
extreme of getting an amendment to the Defense Authorization 
bill through the Senate last year to force them to live up to 
their own motto, which is semper fidelis, always faithful.

                             Science Policy

    Chairman Miller. When Dr. Gray of the EPA, the official who 
seems to be in charge of IRIS, and Ms. Dudley from OMB, from 
OIRA appeared last week, they, particularly Dr. Gray, used the 
phrase that IRIS includes both science and science policy. I 
pushed him some on exactly what he meant by science policy and 
I think most people would think that science policy was just 
part of science. Occam's razor, for instance, appears to be 
science policy rather than strictly science. Dr. Greer, can you 
give us some idea of what elements of a policy might be in an 
IRIS listing?
    Dr. Greer. Yes. So, you know, there is a mixture of science 
and some decisions that I would call policy decisions in an 
IRIS assessment. For example, deciding whether the data has 
enough certainty to negate the need for a safety factor or 
deciding whether or not a certain study shows that there really 
is disproportionate vulnerability in a certain type of 
population. I think the key thing here though to focus on is 
that those policy decisions are best made by relying on 
existing EPA guidance documents because the key here is 
consistency. The key here is consistency and how you make those 
decisions so that you get objective, clear and health-
protective decisions, and those guidance documents are publicly 
vetted, publicly commented on and open, and so what I get 
worried about in this distinction between science and policy is 
that we lose the plot here, that the plot here is how to make 
consistent decisions that err on the side of protecting public 
health and that is not about individual analysts or even the 
boss, George Gray, inserting his own personal opinion on how he 
thinks something ought to go. That is about following the rules 
of the road that EPA has in those longstanding documents.
    Mr. Siegel. May I add something?
    Chairman Miller. Mr. Siegel.
    Mr. Siegel. One of the innovative things in the TCE human 
health risk assessment, the draft for 2001, is that it 
incorporated cumulative exposures because as you are exposed to 
other similar chemicals to TCE or even alcohol can enhance the 
impact of the exposure and the scientists who led that study 
explained it to me with an analogy of taxes. If you make zero 
dollars a year and then all of a sudden you make $5,000 more, 
your taxes don't really go up. You barely pay any taxes anyhow. 
But if you start out at $100,000 and you go to $105,000, your 
taxes might go up a couple thousand dollars, and the same is 
true with the body. If you already have a load of exposure to 
chemicals that affect the kidney or affect the liver or various 
parts of the body and it goes up, it has an impact. The 2001 
human health risk assessment incorporated that. That is a 
policy decision. Some people argue the other side and say no, 
we should address that at the risk management stage when we 
decide whether or not to treat the well, to treat the air, 
something like that. That is a viable argument. It is a policy 
debate. Unfortunately, I don't know of any place where that 
cumulative exposure is addressed at the risk management stage. 
So I think I would go with the 2001 health risk assessment and 
say yes, we should do it in the risk assessment phase and that 
should be part of IRIS. But that is a policy decision that 
affects how the science comes out.
    Chairman Miller. Mr. Ensminger, you seem to want to answer 
this.
    Master Sergeant Ensminger. No, I wanted to go back to that 
thing about the studies. Now, there are some feasibility 
studies that have been proposed by ATSDR for some of these 
other population groups. The protocols have just been written 
for them. They are in the peer review process now and approval 
process but like I said in my testimony, just the week before 
last, the Department of Defense and Department of the Navy were 
balking at $1.6 million and ATSDR is estimating that next 
year's feasibility studies and their water modeling at Camp 
Lejeune is going to come somewhere close to $12 million. I can 
just hear them now, that, you know, they are doing everything 
they can to kill the Camp Lejeune efforts and they are going to 
use every excuse in this world to make that possible, but I 
will be here fighting them.

                     Assessing Cumulative Exposures

    Chairman Miller. Mr. Ensminger, I want to come back to you 
in just a second on your experience with ATSDR, which has also 
gotten the Subcommittee's attention. But Mr. Siegel and I think 
Dr. Greer, Mr. Ensminger has obviously done a good deal of 
research and it is obvious what his motivation is from having 
heard his testimony, that the typical expectation for a 
population the size of the children who were exposed in utero 
would have been 7.2 cases, and ATSDR has now confirmed 14 to 
this point of childhood leukemia, two cases of non-Hodgkin's 
lymphoma. That is more than twice what would be expected, but 
Mr. Siegel, your discussion of the cumulative effect, is that--
is it likely that that baseline does include a fair number of 
folks whose leukemia is a result of environmental exposures? 
Did that question make sense?
    Mr. Siegel. Yes. I mean, basically it is very difficult to 
show, unless you have a specific disease like mesothelioma--I 
can't pronounce that one.
    Chairman Miller. We have Dr. Greer here to pronounce 
everything for us.
    Mr. Siegel. There are some specific diseases that have 
fingerprints. Most diseases are not caused by a single exposure 
to a single chemical and so it is very difficult to show that 
the particular--even in Janey's case, it is difficult to show 
that that particular exposure caused the disease but we know 
that if we know something about the exposures, that it was 
probably a very major percentage of the cause, not just--you 
know, but if there were other exposures, that would have also 
increased it, and the problem--we have a problem, a burden of 
proof in this country, and I will give you an example. A man I 
met in Kentucky earlier this year where he was one of the key 
subjects in a study by the University of Kentucky which showed 
that there is a relationship between TCE and Parkinsonism, and 
he was obviously very sick and the woman who was with him 
wasn't exposed as much and she wasn't quite as sick and they 
used this for this very well, you know, regarded published 
scientific study, and that is great, you know, that they can 
show that there is--that TCE is a factor in Parkinsonism. They 
told me that the doctor who did the study on him, that included 
him, would not certify for his purpose of workers' compensation 
that he was sick because of that exposure and so with all the 
studying that is going on and a lot of scientists are, you 
know, getting awards and degrees and all kinds of stuff for 
doing it, but the problem I have is that the studies go on and 
they don't end up helping people and that is something that 
needs to be addressed.
    Chairman Miller. Dr. Greer, I guess my question was, is 
there reason to think that the baseline is not actually a clean 
baseline that assumes no environment exposures but may in fact 
the baseline be the result of, in some part, to some extent of 
environmental exposures?
    Dr. Greer. Yeah, I mean to some extent, you know what they 
try to do is compare against a control population that looks 
the same about everything except the exposure of concern, but I 
will tell you that an environmental epi study that shows twice 
as high as expected is very alarming. I mean, two times as high 
is a high rate for an environmental epi study, and the reason 
for that is because unlike laboratory animals that you control 
every single thing that they are exposed to, people are exposed 
to a lot of things. People smoke and people have other 
diseases, et cetera, et cetera. So when you are comparing a 
disease caused by an environmental exposure with a baseline of 
disease, it is sort of muddy and you have a hard time seeing 
trends. Two times is high for an environmental study and would 
certainly be a red flag for most environmental epidemiologists 
as, you know, something that looks like a real concern.

      The Agency for Toxic Substances and Disease Registry (ATSDR)

    Chairman Miller. Mr. Ensminger, you mentioned ATSDR is 
involved in this. ATSDR is an agency of the Federal Government 
I had never heard of a year ago. The Agency for Toxic 
Substances and Disease Registry is part of the CDC, the Centers 
for Disease Control. They were involved in the FEMA trailers, 
the, I guess, hundreds of thousands of people who were living 
in trailers provided by FEMA as a result of being victims of 
Katrina, being displaced by Katrina and Rita. Mr. Sensenbrenner 
mentioned that in his opening remarks, that we had had a 
hearing on FEMA trailers and formaldehyde exposure. The 
formaldehyde was used in those trailers as a very cheap 
building material, an adhesive that held together particleboard 
that was used for walls and flooring and cabinets and that 
since 1997 the IRIS assessment process has had before them a 
reassessment of formaldehyde that EPA has yet to act upon. With 
a fairly active effort to influence the process by the 
industry, our impression of ATSDR was that they were entirely 
too eager to please FEMA. FEMA asked ATSDR for a health 
assessment. It obviously would not have done them a lot of good 
to go to IRIS to find out what the effect of formaldehyde was, 
and ATSDR provided a health assessment that they knew was not 
appropriate to the circumstances because they were trying to 
please FEMA, give FEMA what they wanted. What has been your own 
impression of ATSDR from your dealing with them?
    Master Sergeant Ensminger. Well, specifically--and ATSDR is 
many, many different departments, several different 
departments. Their largest department is the Department of 
Health Assessments and Consultations. For lack of a better 
term, the public health assessment for Camp Lejeune is a piece 
of crap, okay.
    Chairman Miller. Could you put that in lay terms?
    Master Sergeant Ensminger. They--and there are so many 
errors in that public health assessment, and every one of those 
errors have been pointed out to those people. And they 
absolutely refused to pull that health assessment down and 
correct it.
    Last year, there was a hearing held specifically about Camp 
Lejeune, and we almost had to beat them into submission just to 
get them to put a disclaimer up at the beginning of that public 
health assessment so people weren't looking at that thing and 
relying on the erroneous information that they have on their 
website.
    Now, public health assessments and consultations with 
ATSDR, when we discussed this yesterday with some of your 
staff, ATSDR was given an exception when they were created back 
in the early '80s to bypass the peer review process because of 
the backlog in Superfund sites that they needed to do 
assessments on. So Congress gave them a pass on the peer review 
process for public health assessments. That backlog is done. 
There is no backlog for Superfund sites anymore. ATSDR needs to 
be held to the same standard as everybody else and those public 
health assessments need to go through a peer review process. 
And I will guarantee you, if this is instituted, you will see a 
much better product coming out of ATSDR than you see now.
    Matter of fact, I would make the--I would bet you that 
there are a lot of people working at ATSDR who are so used to 
pulling out their little tray in their desk that got all their 
little standard quotes that they can just slip in there and 
nobody ever questions. I bet you if you make them go through 
the peer review process you will see a lot of people that work 
at ATSDR that won't be working there later.
    Chairman Miller. Mr. Siegel or Dr. Greer, do you have any 
experience with ATSDR?
    Mr. Siegel. Well, you know, when I visit a community that 
has just found out about contamination in their water there, 
everybody wants a health study. Often that means bringing in 
ATSDR. But ATSDR's batting average is very low. They almost 
never find, with their methodology, with the burden of proof, 
that people are sick as a result of environmental exposures.
    I would ask them, you know, how many times out of all the 
health assessments that you have done, have you found that 
there is a direct link between the exposure and disease? And 
the problem is, to me, with their methodology, and their 
methodology may be good for some purposes, but not for the 
purpose that they have been assigned, you know, to help guide 
risk management decisions at these sites.
    Unless you believe that people really don't get sick as a 
result of exposures to these chemicals, and there are people 
who believe that, in which case, ATSDR's batting average is 
very good. But almost--friends of mine wrote a report, 
``Inconclusive by Design,'' 20 years ago about ATSDR, and the 
same is true today.
    Chairman Miller. Dr. Greer, anything?
    Dr. Greer. Well, as I said in my oral statement, you know, 
the changes to the IRIS program that we were talking about are 
just part of what we regard as the Administration's war on 
science and public health protection, and I think ATSDR is 
another--is an area which shows the influence of the 
Administration on some of their deliberations.
    It is true, actually, that ATSDR is sometimes inconclusive 
by design. What we urge them strongly to do is if they are 
going into a community where they know that it is a small 
community and statistics will not allow them to ever find 
something significant, because there just are not enough people 
to study, that they should say that it is scientifically not 
possible to do a study, rather than going in and doing a study 
and saying we didn't find anything statistically significant, 
which sounds like there is nothing wrong here.
    So they really need to develop a bright line threshold that 
they make an evaluation at the outset to say is there enough 
people or enough type of disease here that we could actually 
study this scientifically, or this doesn't lend itself to a 
scientific study and we need to make a decision to move 
forward, erring on the side of protecting human health, to do 
it without the study. And that is what we have urged upon them 
many times without success.
    Chairman Miller. Mr. Ensminger.
    Master Sergeant Ensminger. Also, the researchers at ATSDR--
now, I am going to take their side for a minute here, which is 
unusual, but ATSDR's researchers, when they go to a DOD site 
specifically, all the information gathering for their health 
assessment--DOD Superfund sites are placed on an honor system. 
They are on an honor system. These people are the keepers of 
all the records on that--for that base, and these researchers 
are literally thrown to these wolves when they go to these 
bases and have to rely on these people. These people withhold--
I mean, I have got letters that I provided with my testimony 
back in 1994 where ATSDR was complaining that the people at 
Camp Lejeune weren't providing them with the documents they 
needed to do their required mission. And when they did provide 
them with data, there was no supporting documentation to back 
up what they were giving them.
    I mean, how can you place a polluter on an honor system? 
They have already shown they don't have any honor, and they 
have proven it time and time again in the Camp Lejeune 
situation, dragging their feet, putting up road blocks, 
stalling, giving incorrect data. And I have documented 
situations at Camp Lejeune where they knowingly provided 
incorrect data to ATSDR, which skewed one of their studies, and 
never corrected. They relied on us to correct it.
    Chairman Miller. We are getting short on time, and Mr. 
Siegel?
    Mr. Siegel. This is a systemic problem. ATSDR does not do 
studies. They take data that is provided to them by the 
polluter, sometimes by the regulator which really doesn't do 
its own studies, and they do an assessment. But they do not 
generate any new data. They don't go out and do sampling, they 
don't go out and interview people like a university study would 
do. They just take the existing data and make a judgment based 
upon it, which in my experience--that is what I have seen. 
Somebody may know more about it, but that is generally the way 
they operate when they are asked to conduct a public health 
assessment.

                       The European REACH Program

    Chairman Miller. This probably needs to be a final 
question, but this morning when I rolled out of bed and walked 
down to the corner to get the Washington Post thinking of 
today's hearing, there was an article on the front page on a 
decision by the European Union that has been adamantly opposed 
by the Bush Administration and the chemical industry that would 
take a fundamentally different approach to regulating chemicals 
that may be toxic.
    What we have been talking about today is just the very 
initial stages of a regulatory process before cost benefit 
analysis, for instance, is supposed to be taken into effect. 
Just assessing which chemicals have what toxic effect, and in 
this case, we can see that two assessments are coming out when 
600 new chemicals enter the marketplace a year. TCE, which 
appears to cause a great deal of damage, has taken 20 years, 
formaldehyde, 11 years and counting.
    This hearing has been about how to fix that IRIS assessment 
process, but Mr. Siegel, Dr. Greer, do you think maybe our 
fundamental approach should be different? EU, by the way, is 
500 million people in developed economies. We are 300 million 
people in a developed economy. It is hard to imagine that 
industry will simply stop producing goods from the European 
market, which is significantly two-thirds, again, the size of 
our economy.
    Mr. Siegel.
    Mr. Siegel. The short answer is yes. I mean, I have 
actually been to a Defense Department-sponsored meeting with 
their contractors where the European approach, the REACH 
program has been presented. And very clearly, with the Defense 
contractors, they are already finding that they are changing 
their practices, phasing out certain uses of chemicals like 
chromium, because of their need to market globally. American 
companies are at a competitive disadvantage if they do not 
recognize this new approach. But unless, you know, the American 
Defense Department adjusts its specifications, which would 
actually require the use of toxic substances, it will be 
limited.
    But this is definitely--you know, it is being heard, it is 
being felt, and it would be so easy for the U.S.--I mean, the 
implementing would be hard, would take a while, but it would be 
so easy, so helpful to put the burden of proof on the people 
who are using these toxic substances, rather than on the people 
who are the victims, that there is a problem.
    Chairman Miller. Dr. Greer.
    Dr. Greer. Well, you know, we Americans really like to 
think of ourselves as number one, and at the head of the pack 
globally on so many things, but I have to tell you that Europe 
is far ahead of us on these issues of public health protection 
and environmental contaminants. And the REACH program really 
has a tremendous amount of promise. I mean, it sort of takes--
you know, here a chemical is innocent until proven guilty, and 
you see how long it takes to get proven one way or the other. 
Under their new system, a chemical is going to be guilty until 
proven innocent; that is, data is going to be required before a 
chemical can get on the market so that we don't get this big 
bad backlog. And of course, the incentive will be to get that 
information forward, because they want to put it on the market.
    So it is a really smart idea. I think because we are in 
such a global economy, we may be the accidental beneficiaries 
of a lot of that work because when global companies need to 
make certain products, the European standards are going to be 
higher than the American standards, and they probably will 
benefit from that. But you know, we have had our feet in cement 
shoes for almost a decade now on these toxic chemical issues, 
and we have got our work cut out for us to get back to where 
some of these colleagues in the other developed countries have 
really been on this scientifically.
    Chairman Miller. It seems unlikely they will produce two 
versions of their product----
    Dr. Greer. Exactly.
    Chairman Miller.--so the safe European version and the 
toxic American version.
    Mr. Ensminger, do you have any thoughts on it? You don't 
have to have any thoughts on this, you have had thoughts on a 
lot of things.
    Master Sergeant Ensminger. I do. Well, basically the 
European Union is concerned about their people. It makes you 
wonder what our government is concerned about. Is it people or 
money?
    Chairman Miller. That is a pretty good valedictory 
statement from the witnesses.
    I want to thank all of you for appearing today for this 
hearing. Under the rules of the Committee--the Subcommittee, 
the record will be open for an additional two weeks for any 
Member to submit additional statements and any additional 
questions that could go to you for written response.
    The hearing is now adjourned. Thank you.
    [Whereupon, at 11:28 a.m., the Subcommittee was adjourned.]
                               Appendix:

                              ----------                              


                   Additional Material for the Record


                       Statement of David G. Hoel
                  Medical University of South Carolina
                       Charleston, South Carolina

  Discussion of EPA's IRIS and the Health Effects of Trichloroethylene

    I am a University Distinguished Professor in the Department of 
Biostatistics, Bioinformatics and Epidemiology at the Medical 
University of South Carolina in Charleston. Prior to joining the 
University, I was employed for over twenty years at the National 
Institute of Environmental Health Sciences of the National Institutes 
of Health.
    There I was Director of the Division of Risk Assessment, and served 
for a time as Acting Scientific Director of the Intramural Research 
Program. I was a member of the Environmental Protection Agency's 
scientific panels for perchlorate and for trichloroethylene (TCE). I 
was a peer reviewer of the National Research Council's report on TCE.
    The opinions I state today are my own.
    I will comment on the general process used by EPA (e.g., IRIS) for 
calculating permissible dose levels of environmental carcinogens with a 
focus on the example of TCE. I will conclude with a few 
recommendations.

  EPA 2001 TCE Report

    The EPA 2001 TCE risk assessment had a number of shortcomings that 
were pointed out by individual scientists and EPA's Scientific Advisory 
Board's TCE Advisory Panel. Although there were several health 
endpoints under consideration, cancer is the predominant outcome used 
for exposure standard setting. This is due in part to the target of one 
in a million lifetime cancer risk, and the assumption of a linear no 
threshold dose-response for carcinogens. It should be noted that the 
NRC report discussed this assumption and the need to validate it. The 
usual method for estimating cancer risk was applied to TCE. Basically, 
a few selected epidemiological studies and a few high dose rodent 
studies were individually fit to a linear dose response function in 
order to estimate the dose which would correspond to a lifetime risk of 
one in a million. Figure 1 is a reproduction of a graph of the results 
of this process taken from the EPA draft report, with Table 1 giving 
the numbers used in Figure 1.
    First there is a question of the selection of epidemiological 
studies used for this process.
    EPA used three studies: Henschler (1995) kidney cancers among 
workers in a German cardboard factory, Anttila (1995) Finnish workers 
who were monitored for TSE (kidney, liver and NHL) and an ecological 
study of drinking water in New Jersey (NHL).
    The data from animal studies was also treated in a manner similar 
to human studies. Using kidney cancer as the primary example, EPA gave 
three dose estimates. They were derived from the rat study, the German 
worker study and the Finnish worker study. EPA calculated the dose 
estimates to be (see Table 1).



    This represents a range in estimated dose by a factor of almost 
10,000, suggesting that the process is so variable as to be 
meaningless. It should be noted that the most extreme result produced 
by EPA was from the Finnish study, which was not statistically 
significant, and the workers had fewer kidney tumors than were 
expected. It is not clear why this study was included in the analysis.
    Multiple studies are often quantitatively combined using meta 
analysis or joint data analysis techniques. A meta-analysis was carried 
out by EPA (Wartenberg et al., 2000), but not used in the calculating 
cancer risk. The specific TCE application has been criticized in the 
scientific literature and most recently by the NRC 2006 report. If done 
correctly, with consideration of exposure, as has been done with 
radiation and cancer (e.g., Lubin and Boice, 1997), one could avoid 
using selected studies and their less stable risk estimates. Further 
Bayesian statistical methods can adjust for exposure uncertainties 
which vary among studies. The NRC report gives very detailed 
recommendations concerning the meta analysis process.
    I feel that without a considerably more sophisticated analysis, 
which does not selectively choose individual studies and treat them 
independently, the low-exposure cancer risk estimates in EPA 2001 are 
unreliable and should not be used to set environmental standards.

  NRC 2006 TCE Report

    The NRC (2006) report on TCE recommended that low dose cancer risk 
estimates be based on rodent bioassays and human data be used as 
validation of the rodent studies. This is a reasonable approach, which 
I support. The human epidemiological data is thought to be preferable 
but the very large uncertainty of exposures plus the confounding of 
other chemical exposures, as well as lifestyle issues, greatly 
decreases the value of the data for quantitative risk estimation.
    Basic toxicological research focuses on a compound's mode of action 
(MOA); that is, how it and its metabolites affect the carcinogenesis 
process. Also, the use of physiologically based pharmacokinetic models 
(PBPK) to evaluate the relationship between routes of exposure and the 
formation of reactive metabolites of interest is critical to 
quantitative risk estimation. This information, although discussed, was 
not incorporated into the EPA cancer risk models. This PBPK model 
information, along with MOA understanding, is key to evaluating the 
validity of the predictability of rodent cancer effects to man. The NRC 
report discusses these important issues and makes specific research 
recommendations for improved TCE risk estimation.
    An issue of increasing concern is the variability in response by 
various susceptible human subgroups. This is frequently discussed but 
rarely employed in evaluating the degree of sensitivity in subgroups. 
These subgroups include age, medical conditions and genetic 
variability. For example, Bronley-Delancey et al. (2007) measured the 
variability of TCE metabolism by genetic subgroups by using human 
hepatocytes. This basic type of human data provides guidance on 
possible adjustments of environmental exposure levels for genetic 
subgroups in the population.
    All of this is important applied science which is essential to 
quality risk estimation, but it suffers from two problems.
    First, the risk assessors are not integrating enough scientific 
information into their actual cancer risk estimates. There are modern 
statistical methods for accomplishing this. The ongoing effort in 
radiation carcinogenesis is one area where re-analysis is performed as 
new, better methods are developed, and it is a good example of 
scientific responsiveness to innovation.
    The second issue is that there are no longer effective government 
programs directed at solving these issues through academic research. 
This work is too applied for NIH (i.e., NIH's toxicology grant study 
section no longer exists) and other agencies are not focused on these 
issues. Considering the cost of inappropriate risk estimates, in either 
dollars or health effects, this seems foolish from a societal 
viewpoint.
    Finally, EPA's IRIS process involves both risk estimation and risk 
management. EPA should consider using outside scientific experts to 
carry-out the risk estimation. This is done successfully by WHO's IARC 
for qualitative risk assessment of chemical carcinogens and by the NRC 
for quantitative risk estimation of various radiation types. Through 
the use of independent scientific experts and a rigorous peer review 
process these risk estimates are considered authoritative. Some 30 
years ago EPA had the NRC develop quantitative cancer risk estimates 
for chemical contaminants in drinking water. The Agency could then use 
exposure levels and the NRC risk estimates to establish standards based 
upon risks and benefits.

Conclusions and Recommendations

          EPA must develop cancer risk estimates for TCE using 
        an integrated approach following the advice of the SAB Panel 
        and the NRC Committee. Further, it should focus on the best 
        estimate of risk, including an estimated uncertainty. EPA 
        should also seriously consider the NRC's recommendation of 
        developing the risk estimates based upon the animal and 
        laboratory studies and using the human studies as validation of 
        their risk models.

          While developing risk estimates, EPA should consider 
        obtaining quality outside scientific advice before and during 
        the process, instead of waiting until the document is 
        completed. EPA should consider having risk assessment, but not 
        risk management, for the more important chemicals carried out 
        by a committee of outside experts. The National Academies' NRC 
        is well suited for this purpose.

          EPA and other governmental agencies should sponsor 
        extramurally the development and refinement of risk assessment 
        methodology in general. Also, they should support key 
        laboratory and human studies directed at specific problems 
        associated with any major chemical problem, such as TCE.

          Greater attention must be given to potentially 
        sensitive subgroups and to adverse health outcomes other than 
        cancer.
        
        
        
        

References

Bronley-Delancey, A. et al. Env Health Persp 114: 1237-42, (2006).

Hoel, D. in The Scientific Basis of Trichloroethylene Risk Assessment, 
        ISBN 0-9657650-0-8, (2004).

Lubin, J.H. and Boice, Jr., J.D. JNCI 89: 49-57, (1997).

National Research Council, Assessing the Human Health Risks of 
        Trichloroethylene: Key Scientific Issues. The National 
        Academies Press, (2006).

Wartenberg, D. et al. Env Health Persp 108 (Suppl 2): 161-176.

                      Biography for David G. Hoel

Education:

1961--A.B. (Mathematics and Statistics) with highest honors, University 
        of California at Berkeley

1966--Ph.D. (Statistics) University of North Carolina at Chapel Hill

1966-1967--U.S. Public Health Service Postdoctoral Traineeship in 
        Preventative Medicine, Stanford University

Brief Chronology of Employment:

1997-date--Distinguished University Professor, Medical University of 
        South Carolina, Charleston, South Carolina

2000-date--Clinical Professor, Department of Radiology, University of 
        South Carolina, School of Medicine, Columbia, South Carolina

1993-1997--Professor and Chairman, Department of Biometry and 
        Epidemiology and Associate Director for Epidemiology, Hollings 
        Cancer Center, Medical University of South Carolina, 
        Charleston, South Carolina

1981-1993--Director, Division of Biometry and Risk Assessment, National 
        Institute of Environmental Health Sciences, Research Triangle 
        Park, North Carolina

1990-1991--Acting Director, National Institute of Environmental Health 
        Sciences and also the National Toxicology Program, Research 
        Triangle Park, North Carolina

1984-1986--Associate Director, Radiation Effects Research Foundation, 
        Hiroshima, Japan

1979-1980--Visiting Scientist, Epidemiology Department, Radiation 
        Effects Research Foundation, Hiroshima, Japan

1977-1979--Acting Scientific Director, National Institute of 
        Environmental Health Sciences, Research Triangle Park, North 
        Carolina

1973-1981--Chief, Biometry Branch, National Institute of Environmental 
        Health Sciences, Research Triangle Park, North Carolina

1970-1973--Mathematical Statistician, National Institute of 
        Environmental Health Sciences, Research Triangle Park, North 
        Carolina

1970-date--Adjunct Professor, Department of Biostatistics, University 
        of North Carolina, Chapel Hill

1968-1970--Statistician, Oak Ridge National Laboratory, Oak Ridge, 
        Tennessee

1967-1968--Senior Mathematician, Westinghouse Research Laboratories, 
        Pittsburgh, Pennsylvania

Honors and Other Scientific Recognition:

Fellow, American Statistical Association, 1974

NIH Director's Award, 1977

Mortimer Spiegelman Gold Medal Award, American Public Health 
        Association, 1977

Public Health Service Superior Service Award, 1980

Senior Executive Service Award, 1983, 1987-1991

Citation Classic, Institute for Scientific Information (Hoel et al. 
        ``Estimation of risks of irreversible delayed toxicity'' J. 
        Toxicol. Env. Health 1:133-51, 1975).

Member, Council of Fellows, Collegium Ramazzini, 1987

Member, Institute of Medicine, National Academy of Sciences, 1988

Council Member, National Council on Radiation Protection and 
        Measurements (NCRP), 1992-1998 and 1999-2005

Westinghouse Distinguished Scientist, 1993-2004

Ramazzini 1994 Award Recipient for ``Contributions to scientific 
        knowledge on the oncogenic effects of nuclear radiation''

Fellow, American Association for the Advancement of Science, 1997

National Associate, National Academy of Sciences and National Research 
        Council, 2001

Editorial--Books:

Methods for Estimating Risk of Chemical Injury: Human and Nonhuman 
        Biota and Ecosystems, SCOPE /SGOMSEC 2, Proceedings of Workshop 
        on Quantitative Estimation of Risk to Human Health from 
        Chemicals, Rome, Italy, 1982 (co-editor with VB Vouk, GC Butler 
        and DB Pekall).

Banbury Report 19: Risk Quantitation and Regulatory Policy, Proceedings 
        of the Banbury Conference on Risk Quantitation and Regulatory 
        Policy, (co-editor with R Merrill and F Perera). Cold Spring 
        Harbor Laboratory, 1985.

Statistical Methods in Cancer Epidemiology, Proceedings of a Conference 
        of the U.S.-Japan Cooperative Cancer Research Program, 1985 
        (co-editor with W Blot and T Hirayama).

Environmental and Occupational Health Sciences: A Series, Member, 
        Editorial Advisory Board, 1986-date.

Trends in Cancer Mortality in Industrial Countries, (co-editor with D 
        Davis), New York Academy of Sciences, 1990.

Biostatistics in Cancer Risk Assessment, (co-editor with T Yanagawa), 
        Scientist, Inc., Tokyo, 1991.

2-Amino-N6-hydroxyadenine: A collaborative study on the 
        genetic toxicology of 2-amino-N6-hydroxyadenine, 
        (co-editor with FJ de Serres), Mutation Research, Vol. 253, 
        1991.

International Case Studies in Risk Assessment and Management, (co-
        editor with L Mohr and W Nixon), The Medical University of 
        South Carolina Press, 1998.

Multimedia Modeling and Risk Assessment, (co-editor with J Regens and C 
        Travis), The Medical University of South Carolina Press 1999.

Extrapolation of Radiation-Induced Cancer Risks from Non-human 
        Experimental Systems to Human, (Chairman) Members include B 
        Carnes, R Dedrick, RJM Fry, D Grahn, W Griffith, P Groer, RJ 
        Preston) National Council on Radiation Protection and 
        Measurements, NCRP Report No. 150, 2005.

Editorial--Journals:

Associate Editor, Journal of Statistical Computation and Simulation, 
        1972-1978

Associate Editor, Journal of the American Statistical Association, 
        1973-1979

Member, Editorial Board of the Journal of Toxicology and Environmental 
        Health, 1975-1979

Member, Editorial Board of Communications in Statistics, Part B--
        Simulation and Computation, 1977-1979

Member, Editorial Board of the Journal of Environmental Pathology and 
        Toxicology, 1979-1980

Member, Editorial Board of Fundamental and Applied Toxicology, 1981-
        1986

Member, Editorial Board of Environmental Health Perspectives, 1973-2000

Member, Editorial Advisory Board of Journal of Statistical Computation 
        and Simulation, 1978-date

Member, Editorial Board of the IMA Journal of Mathematics Applied in 
        Medicine and Biology, 1983-1988

Section Editor, Journal of Environmental Pathology, Toxicology and 
        Oncology, 1986-date

Contributing Editor, American Journal of Industrial Medicine, 1987-date

Associate Editor, Environmental Research, 1987-date

Member, Editorial Board of Risk Analysis, 1987-1990

Associate Editor, Journal of Communications in Statistics, 1987-date

Associate Editor, Biological Monitoring: An International Journal, 
        1988-1990

Member, International Advisory Board, Journal of Environmental 
        Statistics, 1992-1995

Section Editor, Encyclopaedia of Biostatistics, 1996-1997

Editorial Board, Environmental and Ecological Statistics, 2004-

Societies:

American Statistical Association

Biometric Society

Society for Risk Analysis

Collegium Ramazzini

American Association for the Advancement of Science

Radiation Research Society

Health Physics Society

Society for Epidemiological Research

Society Appointments:

Member, Regional Committee of the Biometric Society (ENAR), 1973-1975, 
        1978-1980

Biometrics Section Representative on the Council of the American 
        Statistical Association, 1975-1976

Secretary, Biometrics Section, American Statistical Association, 1979

Representative of the Institute of Mathematical Statistics to the 
        Biology Section of the AAAS, 1978-1981

Program Chairman, Biometric Society Spring Meetings, 1977

Member, Council of the Society for Risk Analysis, 1982-1985

Member/Chairman, American Statistical Association Awards Committee, 
        1991-1993

National Academy of Sciences Committees:

Member, Subcommittee on Margin of Safety and Extrapolation of the Safe 
        Drinking Water Committee, 1976-1977

Member, Panel on Low Molecular Weight Halogenated Hydrocarbons of the 
        Coordinating Committee for Scientific and Technical Assessments 
        of Environmental Pollutants, 1976-1977

Chairman, Risk Assessment Subcommittee, Safe Drinking Water Committee, 
        1978-1979

Member, Committee on Chemical Environmental Mutagens, 1980-1983

Member, Board on Toxicology and Environmental Health Hazards, 1982-1985

Member, Committee on the Biological Effects of Ionizing Radiation (BEIR 
        V), 1986-1989

Member, Committee to Provide Interim Oversight of the DOE Nuclear 
        Weapons Complex, 1988-1990

Member, Committee on Environmental Epidemiology, 1990-1992

Member, Committee on Epidemiology and Veterans Follow-up Studies, 1990-

Member, Committee on Applied and Theoretical Statistics, 1991-1994

Member, Committee on The Health Effects of Mustard Gas and Lewisite, 
        1991-1992

Chairman, Committee to Study the Mortality of Military Personnel 
        Present at Atmospheric Tests of Nuclear Weapons, 1993-1994

Member, National Toxicology Program's Science Advisory Board 1994-1996

Chairman, Committee on the Assessment of Wartime Exposure to Herbicides 
        in Vietnam, 1996-2002

Member, Committee to Review the Health Effects in Vietnam Veterans of 
        Exposure to Herbicides, 1997-2003

Chairman, Board of the Medical Follow-up Agency, 1996-2001

Member, Commission on Life Sciences, 1999-2000

Advisor, Division on Earth and Life Studies (DELS), 2001-

Chairman, Medical Follow-up Agency, Patterns of Illness and Care before 
        Deployment to the Persian Gulf War, 2001-2003

Member, Defense Threat Reduction Agency (DTRA), Committee to Review the 
        Dose Reconstruction Program, 2002-2003

Member, National Research Council, National Academy of Sciences, 
        Committee on California Agriculture Research Priorities--
        Pierce's Disease, 2003-2004

World Health Organization and Other International Activities:

Member, International Agency for Research on Cancer Working Group on 
        the Evaluation of the Carcinogenic Risk of Chemicals to Man, 
        1977, 1981, 1982

Consultant, Subcommittee of International Commission for Protection 
        against Environmental Mutagens and Carcinogens (ICPEMC) 
        October, 1977-1982

Member, Environmental Mutagenesis and Carcinogenesis Panel, U.S.-Japan 
        Cooperative Medical Science Program, NCI; 1987-1992

Member, Advisory Committee on The Radiation Protection of the Public 
        from Radioactive Residues in Kazakhstan, International Atomic 
        Energy Agency United Nations, 2003-2005

U.S. Government Advisory Committees:

Member, International Agency for Research on Cancer Working Group on 
        the Use of Mechanistic Data to Evaluate the Carcinogenicity of 
        Chemicals to Humans, 1991

Ex-officio member, Administrator's Pesticide Policy Advisory Committee, 
        EPA, 1976

Chairman, Subcommittee on Estimation of Risks of Irreversible, Delayed 
        Toxicity of the DHEW Committee to Coordinate Toxicology and 
        Related Programs, 1975

Advisor, Carcinogen Assessment Group, EPA, 1977

Member, Scientific Advisory Board of the National Center for 
        Toxicological Research, 1977-1980

Member, Ad Hoc Working Group to Develop Radioepidemiological Tables, 
        NIH, 1984-1985

Member, Work Group on Health Effects Risks of the EPA Science Advisory 
        Board's Committee on Research Strategies, 1987-1988

Chairman, Research Needs Subcommittee of the Committee to Coordinate 
        the Environment and Related Programs, U.S. Public Health 
        Service, 1990-1991

Member, Office of Technology Assessment Advisory Panel on Aging Nuclear 
        Power Plants: Life Attainment, License Renewal, and 
        Decommissioning. Congress of the United States, 1992

Member, EPA's FIFRA (pesticide) Science Advisory Panel, 1993-

Member, Interagency Staff Group for Development of OSTP Carcinogen 
        Document, Office of Science and Technology Policy, 1983-1984 
        (Report: Chemical Carcinogens: A Review of Science and Its 
        Associated Principles, Environmental Health Perspectives, Vol. 
        67, pp 201-282, 1986.)

Member, EPA's Science Advisory Board's Radiation Advisory Committee, 
        1993-1995

Member, DOD's Breast Cancer Research Program Integration Panel, 1995-
        1996

Panel Member, NIH Consensus Development Conference on Breast Cancer 
        Screening in Women Ages 40-49, 1997

Member, FDA, Transmissible Spongiform Encephalopathies Advisory 
        Committee, 1997-2000

Consultant, FDA's Center for Biologics Evaluation and Research (CBER), 
        2004-2008

Chairman, EPA's Expert Panel Review of Benzene Risk Assessment, 1997

Consultant, EPA's Science Advisory Board's Radiation Advisory 
        Committee, 1996-

Member, EPA's Science Advisory Board's Environmental Health Committee, 
        1997-2004

Member, U.S. Consumer Product Safety Commission's Chronic Hazard 
        Advisory Panel (CHAP), 1999-

Member, EPA's Science Advisory Board's Environmental Health Committee, 
        TCE Health Risk Assessment: Synthesis and Characterization 
        Review Panel, 2002

Member, EPA's Expert Panel Review of Perchlorate, 2002

Member, EPA's Expert Panel Review of Asbestos, 2003

Member, EPA's Expert Panel Review, Supplemental Guidance for Assessing 
        Cancer Susceptibility from early-life Exposure to Carcinogens'' 
        (SGACS), 2003

Chairman, Committee to Study the Extrapolation of Radiation Risks from 
        Animals to Humans, National Council on Radiation Protection and 
        Measurements (NCRP), 1991-2005

Member, Scientific Advisory Committee of the Electric Power Research 
        Institute's (EPRI) Environmental Risk Analysis Program, 1994-
        1995

Member, Scientific Committee 89 (non-ionizing radiation), National 
        Council on Radiation Protection and Measurements (NCRP), 1994-
        1995

Member, Scientific Advisory Board, Environmental Health Foundation 
        (EHF), 1994-1998

Member, Health Effects Institute (HEI) Diesel Epidemiology Project, 
        1998-1999

International Conferences Organized:

``Methods for Estimating Risk of Chemical Injury: Human and Non-Human 
        Biota and Ecosystems'' in Rome, Italy, July 12-16, 1982 (with 
        G. Butler, D. Peakall, and N. Nelson)

``Conference on Risk Assessment and Statistical Methods'' in Kyoto, 
        Japan, August 30-31, 1984 (with A. Kudo and K. Wakimoto)

``The Third Japan-U.S. Conference on Biostatistics in the Study of 
        Human Cancer'' in Hiroshima, Japan, November 11-13, 1988 (with 
        K. Aoki and T. Yanagawa)

``Trends in Cancer Mortality in Industrial Countries'' in Carpi, Italy, 
        October 21-22, 1989 (with D. Davis, J. Fox, and A. Lopez)

``International Biostatistics Conference in the Study of Toxicology'' 
        in Tokyo, Japan, May 23-25, 1992 (with A. Sakuma and T. 
        Yanagawa)

``The Fourth Japan-U.S. Biostatistics Conference in the Study of Human 
        Cancer'' in Tokyo, Japan, November 9-11, 1992 (with R. Miller, 
        H. Sugano, and T. Yanagawa)

``The Role of Environmental Factors in Breast Cancer: Collaborative 
        Workshop'' in Washington, DC, December 6-8, 1992 (with D. 
        Davis)

``International Conference in Immunogenetic Risk Assessment in Human 
        Disease'' (MUSC) in Charleston, March 6-8, 1994 (with J. 
        Pandey)

``The International Forum on Risk Assessment and Risk Management'' 
        (MUSC) in Charleston, March 5-7, 1996 (with L. Mohr and W. 
        Nixon)

Congressional Testimony:

Senate Committee on Appropriations: Subcommittee on Labor, Health and 
        Human Services, Education, and Related Agencies (Sen. Harkin)--
        March 14, 1991

House Committee on Appropriations: Subcommittee on Labor, Health and 
        Human Services, Education, and Related Agencies (Cong. 
        Natcher)--April 16, 1991

House Committee on Energy and Commerce: Subcommittee on Oversight and 
        Investigations (Cong. Dingell)--May 8, 1991

Senate Committee on Appropriations: Subcommittee on Labor, Health and 
        Human Services, Education, and Related Agencies (Sen. 
        Specter)--February 5, 1997

Senate Committee on Environment and Public Safety (Sen. Boxer)--May 6, 
        2008

Bibliography:

Hoel DG: The number of k-simplices in the mth barycentric subdivision 
        of an r-simplex. American Mathematical Monthly 74:819-820, 
        1967.

Hoel DG: Sequential testing of sample size. Technometrics 10:331-341, 
        1968.

Hoel DG: Closed sequential tests of an exponential parameter. 
        Biometrika 55:387-391, 1968.

Hoel DG and Mazumdar M: An extension of Paulson's selection procedure. 
        Annals of Mathematical Statistics 39:2067-2074, 1968.

Hoel DG: Discussion of engineering analysis of experimental data by 
        Robert P. Benedict. ASME Trans. 91:130, 1969.

Hoel DG and Mazumdar M: A class of sequential tests for an exponential 
        parameter. Journal of American Statistical Association 64:1549-
        1559, 1969.

Crump KS and Hoel DG: Some applications of renewal theory on the whole 
        line. Journal of Applied Probabilty 7:734-746, 1970.

Gaver Jr. DP and Hoel DG: Comparison of certain small-sample Poisson 
        probability estimates. Technometrics 12:835-850, 1970.

Hoel DG: On the Monotonicity of the OC of an SPRT. Annals of 
        Mathematical Statistics 41:310-314, 1970.

Hoel DG: A simple two-compartmental model applicable to enzyme 
        regulation. Journal of Biological Chemistry 245:5811-5812, 
        1970.

Hoel DG: Some modifications and applications of Wald's OC formula. 
        Annals of the Institute of Statistical Mathematics 22:65-75, 
        1970.

Kastenbaum MA, Hoel DG and Bowman KO: Sample size requirements: One-way 
        analysis of variance. Biometrika 57:421-430, 1970.

Kastenbaum MA, Hoel DG and Bowman KO: Sample size requirements: 
        Randomized block designs. Biometrika 57:573-577, 1970.

Hoel DG: A method for the construction of sequential selection 
        procedures. Annals of Mathematical Statistics 42:630-642, 1971.

Hoel DG and Mitchell TJ: The simulation, fitting, and testing of a 
        stochastic cellular proliferation model. Biometrics 27:191-199, 
        1971.

Hoel DG and Sobel M: Comparisons of sequential procedures for selecting 
        the best binomial population. Proceedings of the Sixth Berkeley 
        Symposium on Probability and Statistics 4:53-69, 1971.

Hoel DG: A representation of mortality data by competing risks. 
        Biometrics 28:475-488, 1972.

Hoel DG: An inverse stopping rule for play-the-winner sampling. Journal 
        of American Statistical Association 67:148-151, 1972.

Hoel DG, Sobel M and Weiss GH: A two-stage procedure for choosing the 
        better of two binomial populations. Biometrika 59:317-322, 
        1972.

Hoel DG and Walburg Jr. HE: Statistical analysis of survival 
        experiments. Journal of the National Cancer Institute 49:361-
        372, 1972.

Hook GER, Bend JR, Hoel DG, Fouts JR and Gram,TE: Preparation of lung 
        microsomes and a comparison of the distribution of enzymes 
        between subcellular fractions of rabbit lung and liver. Journal 
        of the Pharmocology Experimental Therapeutics 182:474-490, 
        1972.

Beauchamp JJ and Hoel DG: Some investigations and simulation studies of 
        canonical analysis. J. Stat. Comput. Simul. 2:197-209, 1973.

Hoel DG and Crump KS: Estimating the generation time distribution of an 
        age-dependent branching process. Biometrics 30:125-135, 1973.

Patel KM and Hoel DG: A generalized Jonckheere K-sample test against 
        ordered alternatives when observations are subject to arbitrary 
        right censorship. Communication in Statistics 2:373-380, 1973.

Patel KM and Hoel DG: A nonparametric test for interaction in factorial 
        experiments. Journal of American Statistical Association 
        68:615-620, 1973.

Chand N and Hoel DG: A comparison of models for determining safe levels 
        of environmental agents. In Proschan F and Serfling RJ (Eds.): 
        Reliability and Biometry. Philadelphia, SIAM, 1974, pp. 681-
        700.

Crump KS and Hoel DG: Mathematical models for estimating mutation rates 
        in cell populations. Biometrika 61:237-252, 1974.

Haseman JK and Hoel DG: Tables of Gehan's generalized Wilcoxon test 
        with fixed point censoring. Journal of Statistics Comput. 
        Simul. 3:117-135, 1974.

Hoel DG: Some statistical aspects of experiments for determining the 
        teratogenic effects of chemicals. In Pratt J (Ed.): Statistical 
        and Mathematical Aspects of Pollution Problems. New York Marcel 
        Dekker, Inc., 1974, pp. 375-381.

Hoel DG: Statistical models for estimating carcinogenic risks from 
        animal data. In Proceedings of the Fifth Annual Conference on 
        Environmental Toxicology. AMRL-TR-74-125 Washington, D.C., GPO, 
        1974, pp. 285-291.

Hoel DG and Weiss GH: A comparison of methods for choosing the better 
        of two negative exponential lifetime distributions. In 
        Proschan, F. and Serfling, R.J. (Eds.): Reliability and 
        Biometry. Philadelphia, SIAM, 1974, pp. 619-636.

Chase GR and Hoel DG: Serial dilutions: Error effects and optimal 
        designs. Biometrika 62:329-334, 1975.

Hoel DG: Human risk assessment based on laboratory animal studies. In 
        Second Joint U.S./USSR Symposium on the Comprehensive Analysis 
        of the Environment. U.S. Environmental Protection Agency, 
        Washington, D.C., 1975, pp. 22-24.

Hoel DG, Gaylor DW, Kirschstein RL, Saffiotti U and Schneiderman MA: 
        Estimation of risks of irreversible, delayed toxicity. Journal 
        of Toxicology Environmental Health 1:133-151, 1975.

Hoel DG, Sobel M and Weiss GH: A survey of adaptive sampling for 
        clinical trials. In Elashoff RM (Ed.): Perspectives in 
        Biometrics. New York, Academic Press, 1975, pp. 29-61.

Hoel DG, Sobel M and Weiss GH: Comparisons of sampling methods for 
        choosing the best binomial population with delayed 
        observations. J. Stat. Comput. Simul. 3:299-313, 1975.

Hoel DG and Weiss GH: A clinical trial design with a fixed maximum 
        number of failures. Communication in Statistics 4:429-436, 
        1975.

Simon R, Weiss GH and Hoel DG: Sequential analysis of binomial clinical 
        trials. Biometrika 62:195-200, 1975.

Crump KS, Hoel DG, Langley CH and Peto R: Fundamental carcinogenic 
        processes and their implications for low dose risk assessment. 
        Cancer Research 36:2973-2979, 1976.

Hoel DG: Statistical extrapolation methods for estimating risks from 
        animal data. Annals of New York Academy Sciences 271:418-420, 
        1976.

Hoel DG, Weiss GH and Simon R: Sequential tests for composite 
        hypotheses with two binomial populations. Royal Statistical 
        Society 38:302-308, 1976.

Guess HA and Hoel DG: The effect of dose on cancer latency period. 
        Journal of Environmental Toxicology 1:279-286, 1977.

Hoel DG: Some problems in low dose extrapolation. In Hiatt HH, Watson 
        JD and Winsten JA (Eds.): Origins of Human Cancer, Vol. 4, Book 
        C. Cold Spring Harbor, NY, Cold Spring Harbor Laboratory, 1977, 
        pp. 1391-1396.

Hoel DG and Weiss GH: Properties of noise emitted by vehicular queues. 
        Transportation Research 11:39-44, 1977.

Simon R, Hoel DG and Weiss GH: The use of covariate information in the 
        sequential analysis of dichotomous response experiments. 
        Communication in Statistics (A-Theory and Methods) 6:777-788, 
        1977.

Haseman JK and Hoel DG: Statistical design of toxicity assays: Role of 
        genetic structure of test animal population. Journal of 
        Toxicology Environmental Health 5:89-101, 1979.

Hogan MD, Chi P, Hoel DG and Mitchell TJ: Association between 
        chloroform levels in finished drinking water supplies and 
        various site-specific cancer mortality rates. Journal of 
        Environmental Pathology and Toxicology 2:873-887, 1979.

Hoel DG: Animal experimentation and its relevance to man. Proceedings 
        from U.S.-Japan Conference on Biostatistics in the Study of 
        Human Cancer, May 1978. Environmental Health Perspective 32:25-
        30, 1979.

Hoel DG: Low-dose and species-to-species extrapolation for chemically 
        induced carcinogenesis. In McElheny VK and Abrahamson S (Eds): 
        Banbury Report 1: Assessing Chemical Mutagens: The Risk to 
        Humans. Cold Spring Harbor, NY, Cold Spring Harbor Laboratory, 
        1979, pp. 135-145.

Hoel DG: Sequential methods in genetic risk assessment. Genetics 92: 
        s195-s198, 1979.

Hoel DG: Statistical approaches to toxicological data. Proceedings, 5th 
        Symposium on Statistics and the Environment, NAS. Environmental 
        Health Perspective 32:267-271, 1979.

Schoenfelder CA and Hoel DG: Properties of the Neyman-Scott 
        carcinogenesis model at low dose rates. Mathematical 
        Biosciences 45:227-246, 1979.

Anderson AW, Hoel DG and Kaplan NL: A general scheme for the 
        incorporation of pharmacokinetics in low dose risk estimation 
        for chemical carcinogenesis: Example--vinyl chloride. 
        Toxicology Applied Pharmacology 55:154-161, 1980.

Hoel DG: Incorporation of background in dose-response models. 
        Proceedings, Symposium on Extrapolation of Laboratory Toxicity 
        Data to Man: Factors Influencing the Dose-Toxic Response 
        Relationship, April 1979. Federation Proceedings 39:73-75, 
        1980.

Yanagimoto T and Hoel DG: Comparisons of models for estimation of safe 
        doses using measures of the heaviness of tail of a 
        distribution. Annals of the Institute of Statistical 
        Mathematics, Part B, 32:465-480, 1980.

Yanagimoto T and Hoel DG: Measures of the heaviness of tail of 
        estimation of safe doses. In Matusita K (Ed.): Recent 
        Developments in Statistical Inference and Data Analysis. New 
        York, North Holland Publishing Company, 1980, pp. 347-357.

Gaylor DW and Hoel DG: Statistical analysis of carcinogenesis data from 
        chronic animal studies. In Sontag JM (Ed.): Carcinogens in 
        Industry and Environment. New York, Marcel Dekker, 1981, pp. 
        97-111.

Haseman JK, Hoel DG and Jennrich RI: Some practical problems arising 
        from the use of the gamma multi-hit model for risk estimation. 
        Journal of Toxicology Environmental Health 8:379-386, 1981.

Hogan MD and Hoel DG: Estimated cancer risk associated with 
        occupational asbestos exposure. Risk Analysis l:67-76, 1981.

Hoel DG: Carcinogenic Risk. Risk Analysis l:63-64, 1981.

Hoel DG: Extrapolation models of animal toxicity data to man. In Hoch 
        RJ (Ed.): Conference Proceedings: Environmental Risk 
        Assessment: How New Regulations Will Affect the Utility 
        Industry. Palo Alto, Calif., Electric Power Research Institute, 
        1981, pp. 4-95 to 4-103.

Hoel DG: Statistical issues in toxicology. Selected Papers, Society for 
        Industrial & Applied Mathematics. Environmetrics 81:248-257, 
        1981.

Hoel DG and Crump KS: Waterbourne Carcinogens: A Scientist's View. In 
        Crandell R and Lave L (Ed.): The Scientific Basis of Health in 
        Safety Regulations. The Brookings Institute, 173-195, 1981.

Hoel DG: Extrapolation of laboratory data to human health effects. 
        Environmental Science Research 25:521-526, 1982.

Hoel DG: Statistical measures of risk. Drug Metabolic Reviews 13:829-
        838, 1982.

Hogan MD and Hoel DG: Extrapolation to man. In Hayes AW (Ed.): 
        Principles and Methods of Toxicology. New York, Raven Press, 
        1982, pp. 711-731.

Kato H, Brown CC, Hoel DG and Schull WJ: Studies of the mortality of A-
        Bomb survivors. Report 7. Mortality, 1950-1978: Part II. 
        Mortality from causes other than cancer and mortality in early 
        entrants. Radiation Research 91:243-264, 1982.

Brown KG and Hoel DG: Modeling time-to-tumor data: Analysis of the ED01 
        Study. Fundamental Applied Toxicology 3:458-469, 1983.

Brown KG and Hoel DG: Multistage prediction of cancer in serially dosed 
        animals with application to the ED01 study. Fundamental Applied 
        Toxicology 3:470-477, 1983.

Hoel DG: Conditional two sample tests with historical controls. In Sen 
        PK (Ed.): Contributions to Statistics: Essays in Honour of 
        Norman L. Johnson. Amsterdam, North Holland Publishing Company, 
        1983, pp. 229-236.

Hoel DG, Kaplan N and Anderson MW: Implication of nonlinear kinetics on 
        risk estimation in carcinogenesis. Science 219:1032-1037, 1983.

Hoel DG, Wakabayashi T and Pike MC: Secular trends in the distributions 
        of the breast cancer risk factors--menarche, first birth, 
        menopause, and weight--in Hiroshima and Nagasaki, Japan. 
        American Journal of Epidemiology 118:78-89, 1983.

Pike MC, Krailo MD, Henderson BE, Casagrande JT and Hoel DG: `Hormonal' 
        risk factors, `breast tissue age' and the age-incidence of 
        breast cancer. Nature 303:767-770, 1983.

Portier C and Hoel DG: Optimal bioassay design under the Armitage-Doll 
        multistage model. Journal of Toxicology Environmental Health 
        12:1-19, 1983.

Portier C and Hoel DG: Low-dose rate extrapolation using the multistage 
        model. Biometrics 39:897-906, 1983.

Poon AH and Hoel DG: Nonparametric estimation of the survival function 
        when cause of death is uncertain. Biometrics 40:1151-1158, 
        1984.

Portier C and Hoel DG: Design of animal carcinogenicity studies for 
        goodness-of-fit to multistage models. Fundamental Applied 
        Toxicology 4:949-959, 1984.

Portier C and Hoel DG: Type 1 error of trend tests in proportions and 
        the design of cancer screens. Communication in Statistics (A-
        Theory and Methods) 13:1-16, 1984.

Portier CJ, Hoel DG and Van Ryzin J: Statistical analysis of the 
        carcinogenesis bioassay data relating to the risks from 
        exposure to 2,3,7,8-tetrachlorodibenzo-p-dioxin. In Lowrance WW 
        (Ed.): Public Health Risks of the Dioxins. New York, 
        Rockefeller University, 1984, pp. 99-119.

Hoel DG: Epidemiology and the inference of cancer mechanisms. National 
        Cancer Institute Monograph 67:199-203, 1985.

Hoel DG: Mathematical dose-response models and their application to 
        risk estimation. In Vouk VB, Butler GC, Hoel DG and Pekall DB 
        (Eds.): Methods for Estimating Risk of Chemical Injury: Human 
        and Nonhuman Biota and Ecosystems, Scope 1985/SGOMSEC 2. New 
        York, J. Wiley and Sons, 1985, pp. 347-359.

Hoel DG and Jennrich RI: Life table analysis with small numbers of 
        cases: An example--multiple myeloma in Hiroshima and Nagasaki. 
        Journal of Statistics Comput. Simul. 20:311-322, 1985.

Bernstein L, Gold LS, Ames BN, Pike MC and Hoel DG: Some tautologous 
        aspects of the comparison of carcinogenic potency in rats and 
        mice. Fundamental Applied Toxicology 5:79-86, 1985.

Hoel DG: The impact of occupational exposure patterns on quantitative 
        risk estimation. In Hoel DG, Merrill RA and Perera FP (Eds.): 
        Risk Quantitation and Regulatory Policy, Banbury Report 19, 
        1984. Cold Spring Harbor, NY, Cold Spring Harbor Laboratory, 
        1985, pp. 105-118.

Hoel DG: Dose-response in radiation carcinogenesis: Animal studies. In 
        Castellani A (Ed.): Epidemiology and Quantitation of 
        Environmental Risk in Humans from Radiation and Other Agents: 
        Potential and Limitations. London, Plenum Press, pp. 93-103, 
        1985.

Hoel DG and Preston DL: Dose-response in radiation carcinogenesis: 
        Human studies. In Castellani A (Ed.): Epidemiology and 
        Quantitation of Environmental Risk in Humans from Radiation and 
        Other Agents: Potential and Limitations. London, Plenum Press, 
        pp. 105-122, 1985.

Yanagawa T and Hoel DG: Use of historical controls for animal 
        experiments. Environmental Health Perspective 63:217-224, 1985.

Hoel DG: The incorporation of pharmacokinetics in low-dose risk 
        estimation. In Clayton D, Krewski D and Munro I (Eds.): 
        Toxicological Risk Assessment (Volume I). Boca Raton, Fla., CRC 
        Press, 1985, pp. 205-214.

Bernstein L, Gold LS, Ames BN, Pike MC and Hoel DG: Toxicity and 
        carcinogenic potency. Risk Analysis 5:263-264, 1985.

Gold LS, Bernstein L, Kaldor J, Backman G and Hoel DG: An empirical 
        comparison of methods used to estimate carcinogenic potency in 
        long-term animal bioassays: Lifetable vs. summary incidence 
        data. Fundamental Applied Toxicology 6:263-269, 1986.

Brown KG and Hoel DG: Statistical modeling of animal bioassay data with 
        variable dosing regimens: Example--vinyl chloride. Risk 
        Analysis 6:155-166, 1986.

Hoel DG and Yanagawa T: Incorporating historical controls in testing 
        for a trend in proportions. Journal of American Statistical 
        Association 81:1095-1099, 1986.

Portier CJ, Hedges JC and Hoel DG: Age-specific models of mortality and 
        tumor onset for historical control animals in the National 
        Toxicology Program's carcinogenicity experiments. Cancer 
        Research 46:4372-4378, 1986.

Hogan M and Hoel DG: Utilizing scientific data in assessing human 
        cancer risk associated with chemical exposure. In Report: 
        Chemical Carcinogens: A Review of the Science and Its 
        Associated Principles by U.S. Intergency Staff Group on 
        Carcinogens, Environmental Health Perspectives, Vol. 67, pp. 
        253-258, 1986.

Hoel DG: Statistical aspects of chemical mixtures. In Vouk VB, Butler 
        GC, Upton AC, Parke DV and Asher SC (Eds.): Methods for 
        Assessing the Effects of Mixtures of Chemicals, SGOMSEC3. New 
        York, J. Wiley & Sons Limited, 1987, pp. 369-377.

Hoel DG and Landrigan PJ: Comprehensive evaluation of human data. In 
        Tardiff RG and Rodricks JV (Eds.): Toxic Substances and Human 
        Risk, Principles of Data Interpretation. New York, Plenum 
        Press, 1987, pp. 121-129.

Portier CJ and Hoel DG: Issues concerning the estimation of the TD50. 
        Risk Analysis 7:437-447, 1987.

Kaplan N, Hoel DG, Portier CJ and Hogan MD: An evaluation of the safety 
        factor approach in risk assessment. In Pratt RM, McLachlan JA 
        and Markert CL (Eds.): Developmental Toxicology: Mechanisms and 
        Risk, Banbury Report 26. Cold Spring Harbor, NY, Cold Spring 
        Harbor Laboratory, 1987, pp. 335-346.

Hoel DG: Radiation risk estimation models. Environmental Health 
        Perspective 75:105-107, 1987.

Weinberg CR, Brown KG and Hoel DG: Altitude, radiation, and mortality 
        from cancer and heart disease. Radiation Research 112:381-390, 
        1987.

Hoel DG: Cancer risk models for ionizing radiation. Environmental 
        Health Perspective 76:121-124, 1987.

Hoel DG, Haseman JK, Hogan MD, Huff JE and McConnell EE. The impact of 
        toxicity on carcinogenicity studies: Implications for risk 
        assessment. Carcinogenesis 9:2045-2052, 1988.

Pedersen LG, Darden TA, Deerfield DW, Anderson MW and Hoel DG: A 
        theoretical study of the effect of methylation or ethylation at 
        06-guanine on the structure and energy of DNA double strands. 
        Carcinogenesis 9:1553-1562, 1988.

Piegorsch WW and Hoel DG: Exploring relationships between mutagenic and 
        carcinogenic potencies. Mutation Research 196:161-175, 1988.

Bailer AJ and Hoel DG: Metabolite-based internal doses used in a risk 
        assessment of benzene. Environmental Health Perspective 82:177-
        184, 1989.

Bailer AJ and Hoel DG: Benzene risk assessments: Review and update. In 
        Mehlman MA (Ed.): Benzene: Occupational and Environmental 
        Hazards Scientific Update (Vol. 16, Advances in Modern 
        Environmental Toxicology). Princeton, NJ, Princeton Scientific 
        Publishing Co., Inc., 1989, 131-140. and Cell Biology and 
        Toxicology 5(3):287-295, 1989.

Yanagawa T, Hoel DG and Brooks G: A conservative use of historical data 
        for a trend test in proportions. Journal of Japan Statistical 
        Society 19(1):83-94, 1989.

Hoel DG and Dinse GE: Using Mortality Data to Estimate Radiation 
        Effects on Breast Cancer Incidence. Environmental Health 
        Perspective 87:123-129, 1990.

Portier CJ, Hoel DG, Kaplan NL and Koop A: Biologically Based Models 
        for Risk Assessment. In Vannio H, Sora M, and McMichael AJ 
        (Eds.): Complex Mixtures and Cancer Risk. Lyon, France, 
        International Agency for Research on Cancer Scientific 
        Publications, 1990, No. 104.

Hoel DG: An Overview of the Probable Consequences of Prolonged 
        Inhibition of Gastric Acid Secretion. In Elder J (Ed.): 
        Profound Gastric Acid Suppression: Long-Term Safety Risk? 
        Research and Clinical Forums 12(1):169-176, 1990.

Davis DL, Hoel DG, Fox J and Lopez A: International Trends in Cancer 
        Mortality in the France, West Germany, Italy, Japan, England 
        and Wales, and the USA. Lancet 336:474-481, 1990.

Davis DL, Hoel DG, Fox J and Lopez A: International Trends in Cancer in 
        France, West Germany, Italy, Japan, England and Wales, and the 
        United States. Annals of the New York Academy of Sciences 
        609:5-48, 1990.

Hoel DG: Assumptions of the HERP Index. Risk Analysis 10:623-624, 1990.

Ellett WH, Hoel DG and Cooper RD: BEIR V Estimates of Excess Cancer 
        Mortality. Conference Proceedings: Statistics of Human Exposure 
        to Ionizing Radiation Workshop. Oxford, England, 1990 Radiation 
        Protection Dosimetry 36:309-314, 1991.

Hoel DG: A Balanced Approach to Risk Assessment. In Tsuchiya K, Lee SD, 
        Grant LD and Mehlman MA (Eds.): Conference Proceedings: 
        Toxicology and Industrial Health, Vol. 7, Number 5/6, IXth UOEH 
        International Symposium and First Pan Pacific Cooperative 
        Symposium. Kitakyushu, Japan, 1991, pp. 305-311.

deSerres FJ and Hoel DG: Collaborative Study on the Genetic Toxicology 
        of 2-Amino-N6-Hydroxadenine (AHA): An Exercise in Genetic Risk 
        Assessment. Mutation Research 253:1-3, 1991.

Swenberg JA, Hoel DG and Magee PN: Mechanistic and Statistical Insight 
        into the Large Carcinogenesis Bioassays on DEN and DMN. Cancer 
        Research 51:6409-6414, 1991.

Davis DL, Ahlbom A, Hoel DG and Percy C: Is Brain Cancer Mortality 
        Increasing in Industrial Countries? American Journal of 
        Industrial Medicine 19:421-431, 1991.

Hoel DG, Davis DL, Miller AB, Sondik EJ and Swerdlow AJ: Trends in 
        Cancer Mortality in 15 Industrial Countries 1969-1986. Journal 
        of the National Cancer Institute 84:313-320, 1992.

Huff J and Hoel DG: Perspective and Overview of the Concepts and Value 
        of Hazard Identification as the Initial Phase of Risk 
        Assessment for Cancer and Human Health. Scandinavian Journal of 
        Work Environmental Health 18(1):83-89, 1992.

Piegorsch WW, Carr GJ, Portier CJ and Hoel DG: Concordance of 
        Carcinogenic Response between Rodent Species: Potency 
        Dependence and Potential Underestimation. Risk Analysis 12:115-
        121, 1992.

Hoel DG: Multistage Models of Carcinogenesis and Their Implications for 
        Dose-Response Models and Risk Projections. Conference 
        Proceedings: International Conference on Radiation Effects and 
        Protection. Mito, Japan, March 18-20, pp 123-126, 1992.

Shimizu Y, Kato H, Schull WJ and Hoel DG: Studies of the Mortality of 
        A-Bomb Survivors. Mortality, 1950-8: Part 3. Non-cancer 
        mortality in the years 1950-85 based on the recently revised 
        doses (DS86). Radiation Research 130:249-266, 1992.

Dinse GE and Hoel DG: Exploring Time Trends in Cancer Incidence. Cancer 
        Causes and Control 3:409-417 1992.

Davis DL and Hoel DG: Figuring Out Cancer. International Journal of 
        Health Services 22(3):447-453, 1992.

Davis DL, Blair A, and Hoel DG: Agricultural Exposures and Cancer 
        Trends in Developed Countries. Environmental Health Perspective 
        100:39-44, 1992.

Fung VA, Huff JE, Weisburger EK and Hoel DG. Predictive Strategies for 
        Selecting 379 NCI/NTP Chemicals Evaluated for Carcinogenic 
        Potential: Scientific and Public Health Impact. Fundamentals 
        and Applied Toxicology 20:413-436, 1993.

Portier C, Clark G, Edler L, Greenlee W, Hoel D, Tritscher A and Lucier 
        G: Ligand/Receptor Binding for 2,3,7,8-TCDD: Implication for 
        Risk Assessment. Fundamentals and Applied Toxicology 12:48-56, 
        1993.

Hoel DG, Carter R, Ron E and Mabuchi K: The Influence of Death 
        Certificate Errors on Cancer Mortality Trends. Journal of the 
        National Cancer Institute 85:1063-1068, 1993.

Hoel DG: Questions about Radiation and Risk Estimates that Remain After 
        BEIR-V. Radiation Research 136:137-139, 1993.

Davis DL, Bradlow HL, Wolff M, Woodruff T, and Hoel DG, Anton-Culver H: 
        Medical Hypothesis: Xeno-estrogens as Preventable Causes of 
        Breast Cancer. Environmental Health Perspectives 101:372-377, 
        1993.

Yanagawa T and Hoel DG: Incorporating Geographic Distribution into the 
        Expected Number of Deaths in a Comparative Study. Statistical 
        Science and Data Analysis, Matsusita K et al., Eds. 25-32, 
        1993.

Hoel DG and Portier CJ: Nonlinearity of Carcinogenesis Dose. 
        Environmental Health Perspective 102:109-113, 1994.

Davis DL, Dinse GE, and Hoel DG: Decreasing Cardiovascular Disease and 
        Increasing Cancer Among Whites in the United States from 1973 
        to 1987. JAMA 271:431-437, 1994.

Mori H, Nakamura T, Mine M, Kondo H, Okumura Y, and Hoel DG: Early 
        Mortality of Atomic Bomb Survivors based on House 
        Reconstruction Survey. International Journal of Radiation 
        Biology 65: No. 2, 267-275, 1994.

Hoel DG: Ionizing Radiation and Cancer Prevention. Environmental Health 
        Perspective 103 (Suppl 8):241-243, 1995.

Daniel DM, Lackland DT, Baron LF, Nixon DW, Garr DR, Gross AJ, O'Brien 
        and Hoel DG. Comparison of White and African-American Barriers 
        to Mammography: A Need for a Barrier-Specific Approach to Care. 
        Cancer Prevention International 2:3-21, 1995.

Gordis L, Berry DA, Chu SY, Fajardo LL, Hoel DG, Laufman LR, 
        Rufenbarger CA, Scott, JR, Sullivan DC, Wasson JH, Westhoff CL 
        and Zern RT. National Institutes of Health Consensus 
        Development Conference Statement: Breast Cancer Screening for 
        Women Ages 40-49, January 21-23, 1997. (Special Article) 
        Journal of National Cancer Institute 89(14):1015-1026, 1997.

Radivoyevitch T, Hoel DG, Hahnfeldt PJ, Rydberg B and Sachs RK. Recent 
        Pulsed Fields Gel Electrophoresis Data Suggest Two Types of 
        DSBs [4409-R]. Radiation Research 149:52-58, 1998.

Radivoyevitch T, Hoel DG, Chen AM, Sachs RK. Double-Strand Break 
        Misrejoining After X-Irradiation: Relating Moderate to Very 
        High Doses by a Markov Model [4437-R]. Radiation Research 
        149:59-67, 1998.

Nietert P, Sutherland SE, Silver RM, Pandey JP, Knapp R, Hoel DG and 
        Dosemeci, M. Is Occupational Organic Solvent Exposure a Risk 
        Factor for Scleroderma? Arthritis and Rheumatism 41:1111-1118, 
        1998.

Radivoyevitch T, Hoel, DG, Hahnfeldt, Sachs RK. Size Distribution of 
        Misrejoining DNA Fragments in Irradiation Cells. Mathematical 
        Biosciences 149:107-136, 1998.

Hoel DG and Li P. Threshold Models in Radiation Carcinogenesis. Health 
        Physics 75(3):241-250, 1998.

Nicholas JS, Lackland DT, Dosemeci M, Mohr L, Dunbar JB, Grosche B and 
        Hoel DG. Mortality among United States Commercial Pilots and 
        Navigators. Journal of Occupational and Environmental Medicine 
        40:980-985, 1998.

Nicholas JS, Lackland DT, Butler GC, Mohr LC, Dunbar JB, Kaune WT, 
        Grosche B and Hoel DG. Cosmic Radiation and Magnetic Field 
        Exposure to Airline Flight Crews. American Journal of 
        Industrial Medicine 34:574-580, 1998.

Dinse GE, Umbach DM, Sasco AJ, Hoel DG and Davis DL. Unexplained 
        Increase in Cancer Incidence in the United States from 1975 to 
        1994: Possible Sentinel Health Indicators? Annual Review of 
        Public Health Vol. 20, 1999.

Grosche B, Lackland D, Mohr L, Dunbar J, Nicholas J, Burkart W and Hoel 
        D. Leukemia in the vicinity of two Tritium releasing nuclear 
        facilities: a comparison of the Kruemmel Site, Germany, and the 
        Savannah River Site, South Carolina, USA. Journal of 
        Radiological Protection 19:243-252, 1999.

Radivoyevitch T and Hoel, DG. Modeling the Low-LET Dose-Response of 
        BCR-ABL Formation: Predicting Stem Cell Numbers from A-bomb 
        Data. Mathematical Biosciences 162:85-101, 1999.

Radivoyevitch T and Hoel D. Biologically-Based Risk Estimation for 
        Radiation-Induced Chronic Myeloid Leukemia. Radiation & 
        Environmental Biophysics 39(3):153-159, 2000.

Nicholas JS, Butler GC, Lackland DT, Hood WC, Hoel DG and Mohr LC. 
        Flight deck magnetic fields in Commercial Aircraft. American 
        Journal of Industrial Medicine 38(5):548-554, 2000.

Nicholas JS, Butler GC, Lackland DT, Tessier GS, Mohr LC and Hoel DG. 
        Health among commercial airline pilots. Aviation, Space, and 
        Environmental Medicine 72(9);821-826, 2001.

Tessier GS, Lam C, Nakamura T and Hoel DG, Two-Stage Cancer Models 
        Applied to Gamma and Neutron Exposed Mice. European J. of 
        Oncology 6(3):297-301, 2001.

Schubauer-Berigan MK, Frey GD, Baron L andHoel DG. Mammography Dose in 
        Relation to Body Mass Index, Race, and Menopausal Status. 
        Radiation Protection Dosimetry 98(4):425-432, 2002.

McGreevy KM, Baron LF and Hoel DG. Clinical Breast Examination 
        Practices Among Women Undergoing Screening Mammography. 
        Radiology 224(2):555-559, 2002.

Schubauer-Berigan MK, Baron L, Frey GD and Hoel DG. Breast Dose 
        Variability in a Biracial Population Undergoing Screening 
        Mammography. Radiation Protection Dosimetry 98(4):417-424, 
        2002.

Baker GS and Hoel DG. Corrections in the Atomic bomb Data to Examine 
        Low Dose Risk. Health Physics 85(6):709-720, 2003.

Carnes BA, Grahn D, Hoel D. Mortality of Atomic Bomb Survivors 
        Predicted from Laboratory Animals. Radiation Research, 160:159-
        167, 2003.

Nicholas J, Butler G, Davis S, Bryant E, Hoel D and Mohr L. Stable 
        Chromosome Aberrations and Ionizing Radiation in Airline 
        Pilots. Aviation, Space and Environmental Medicine 74:953-956, 
        2003.

Nakamura T and Hoel DG. Comparing Risks between Radiation and Dioxin 
        Exposure Based on Two-Stage Model. Environmetrics 14:203-211, 
        2003.

Creasman WT, Hoel DG and DiSaia PJ. WHI: Now that the Dust has settled. 
        A Commentary. American Journal of Obstetrics and Gynecology 
        189:621-626, 2003.

Heath, Jr. CW, Bond PD, Hoel DG and Meinhold CB. Residential Radon 
        Exposure and Lung Cancer Risk: Commentary on Cohen's County-
        based Study. Health Physics 87(7):647-655, 2004.

McGreevy KM, Hoel B, Lipsitz SR, Bissada, NK and Hoel DG. Racial and 
        Anthropometric Differences in Insulin-Like Growth Factor I 
        (IGF-I) and Insulin-Like Growth Factor Binding Protein-3 
        (IGFBP-3) Levels. Urology 2004 (in press).

McGreevy KM, Hoel B, Lipsitz SR and Hoel DG. Impact of Nutrients on 
        Insulin-like Growth Factor-I, Insulin-like Growth Factor 
        Binding Protein-3 and their Ratio in Black and White Males. 
        Public Health Nutrition, 2004 (accepted).

Hoel, DG, Carnes B. Cancer Dose-Response Analysis of the Radium Dial 
        Workers. Proceedings from the HEIR 2004 9th International 
        Conference on Health Effects of Incorporated Radionuclides--
        Emphasis on Radium, Thorium, Uranium and their Daughter 
        Products. GSF-National Research Center, Neuherberg, Germany, 
        November 29-December 1, 2004. 2005 (in press)

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