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49–964PDF 2009

FIXING EPA’S BROKEN INTEGRATED

RISK INFORMATION SYSTEM

HEARING

BEFORE THE

SUBCOMMITTEE ON INVESTIGATIONS AND

OVERSIGHT

COMMITTEE ON SCIENCE AND

TECHNOLOGY

HOUSE OF REPRESENTATIVES

ONE HUNDRED ELEVENTH CONGRESS

FIRST SESSION

JUNE 11, 2009

Serial No. 111–33

Printed for the use of the Committee on Science and Technology

(

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

(II)

COMMITTEE ON SCIENCE AND TECHNOLOGY

HON. BART GORDON, Tennessee, Chair

JERRY F. COSTELLO, Illinois

EDDIE BERNICE JOHNSON, Texas

LYNN C. WOOLSEY, California

DAVID WU, Oregon

BRIAN BAIRD, Washington

BRAD MILLER, North Carolina

DANIEL LIPINSKI, Illinois

GABRIELLE GIFFORDS, Arizona

DONNA F. EDWARDS, Maryland

MARCIA L. FUDGE, Ohio

BEN R. LUJA ́ N, New Mexico

PAUL D. TONKO, New York

PARKER GRIFFITH, Alabama

STEVEN R. ROTHMAN, New Jersey

JIM MATHESON, Utah

LINCOLN DAVIS, Tennessee

BEN CHANDLER, Kentucky

RUSS CARNAHAN, Missouri

BARON P. HILL, Indiana

HARRY E. MITCHELL, Arizona

CHARLES A. WILSON, Ohio

KATHLEEN DAHLKEMPER, Pennsylvania

ALAN GRAYSON, Florida

SUZANNE M. KOSMAS, Florida

GARY C. PETERS, Michigan

VACANCY

RALPH M. HALL, Texas

F. JAMES SENSENBRENNER JR.,

Wisconsin

LAMAR S. SMITH, Texas

DANA ROHRABACHER, California

ROSCOE G. BARTLETT, Maryland

VERNON J. EHLERS, Michigan

FRANK D. LUCAS, Oklahoma

JUDY BIGGERT, Illinois

W. TODD AKIN, Missouri

RANDY NEUGEBAUER, Texas

BOB INGLIS, South Carolina

MICHAEL T. MCCAUL, Texas

MARIO DIAZ-BALART, Florida

BRIAN P. BILBRAY, California

ADRIAN SMITH, Nebraska

PAUL C. BROUN, Georgia

PETE OLSON, Texas

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT

HON. BRAD MILLER, North Carolina, Chair

STEVEN R. ROTHMAN, New Jersey

LINCOLN DAVIS, Tennessee

CHARLES A. WILSON, Ohio

KATHY DAHLKEMPER, Pennsylvania

ALAN GRAYSON, Florida

BART GORDON, Tennessee

PAUL C. BROUN, Georgia

BRIAN P. BILBRAY, California

VACANCY

RALPH M. HALL, Texas

DAN PEARSON Subcommittee Staff Director

EDITH HOLLEMAN Subcommittee Counsel

JAMES PAUL Democratic Professional Staff Member

DOUGLAS S. PASTERNAK Democratic Professional Staff Member

KEN JACOBSON Democratic Professional Staff Member

TOM HAMMOND Republican Professional Staff Member

JANE WISE Research Assistant

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C O N T E N T S

June 11, 2009

Page

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

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

Opening Statements

Statement by Representative Brad Miller, Chair, Subcommittee on Investigations and Oversight, Committee on Science and Technology, U.S. House

of Representatives ................................................................................................ 7

Written Statement ............................................................................................ 14

Statement by Representative Paul C. Broun, Ranking Minority Member, Subcommittee on Investigations and Oversight, Committee on Science and

Technology, U.S. House of Representatives ....................................................... 15

Written Statement ............................................................................................ 17

Witnesses:

Dr. Kevin Teichman, Deputy Assistant Administrator for Science, Office of

Research and Development (ORD), U.S. Environmental Protection Agency

(EPA)

Oral Statement ................................................................................................. 26

Written Statement ............................................................................................ 28

Biography .......................................................................................................... 29

Mr. John B. Stephenson, Director, Natural Resources and Environment, U.S.

Government Accountability Office

Oral Statement ................................................................................................. 30

Written Statement ............................................................................................ 31

Biography .......................................................................................................... 36

Discussion

Ensuring EPA’s Program Control ....................................................................... 37

The Effect of an IRIS Listing .............................................................................. 38

How IRIS Assessments Are Used ....................................................................... 38

Transparency Process .......................................................................................... 39

Program Schedule and Productivity ................................................................... 41

Potential Improvements ...................................................................................... 42

Deliberative Process ............................................................................................. 42

The GAO High-Risk List ..................................................................................... 43

Royal Demolition Explosive ................................................................................. 43

Assessment Timeliness ........................................................................................ 44

Peer Reviews ........................................................................................................ 45

Fairness and Time Constraints .......................................................................... 47

More on the Transparency Process ..................................................................... 47

Closing .................................................................................................................. 48

Appendix 1: Answers to Post-Hearing Questions

Dr. Kevin Teichman, Deputy Assistant Administrator for Science, Office of

Research and Development (ORD), U.S. Environmental Protection Agency

(EPA) ..................................................................................................................... 52

Page

IV

Appendix 2: Additional Material for the Record

Nipping IRIS in the Bud: Suppression of Environmental Science by the Bush

Administration’s Office of Management and Budget, Staff Report by the

Majority Staff of the Subcommittee on Investigations and Oversight, June

11, 2009 ................................................................................................................. 56

The IRIS Information Roadblock: How Gaps in EPA’s Main Toxicological

Database Weaken Environmental Protection, Center for Progressive Reform

White Paper #904, June 2009 ............................................................................. 125

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FIXING EPA’S BROKEN INTEGRATED RISK

INFORMATION SYSTEM

THURSDAY, JUNE 11, 2009

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT,

COMMITTEE ON SCIENCE AND TECHNOLOGY,

Washington, DC.

The Subcommittee met, pursuant to call, at 1:11 p.m., in Room

2318 of the Rayburn House Office Building, Hon. Brad Miller

[Chair of the Subcommittee] presiding.

2

3

1The Subcommittee has carried out extensive work on OIRA’s role in relationship to IRIS.

In 2008, the Subcommittee held two hearings on this subject. The first of these hearings was

on May 21, 2008, when the Subcommittee took testimony from Dr. George Gray, the then-Assistant Administrator for Research and Development at EPA, and Ms. Susan Dudley, the then-Administrator of the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget. Additionally, Mr. John Stephenson of GAO testified on findings regarding the

lack of productivity in the IRIS process. In the second hearing, on June 12, 2008, the Subcommittee received testimony from Mr. Jerry Ensminger (U.S.M.C., retired), Mr. Lenny Seigel

(Executive Director, Center for Public Environmental Oversight), and Dr. Linda Greer (Director

of the Health Program at the Natural Resources Defense Council). On June 11, 2008 Chair Miller sent a document request to OMB asking for all materials relating to OIRA’s involvement

in the proposed IRIS entry for trichloroethylene (TCE). In response, the Committee received a

few boxes of materials. The great majority of those materials were either peer reviewed articles,

articles done by EPA staff, or research reports done under contract to industry or polluting

agencies. Subcommittee staff were obliged to visit OMB’s office to review thousands of pages

of documents and take notes because the office refused to provide copies. A clear picture of

OIRA’s almost daily involvement on TCE emerged from that review. However, OIRA refused to

provide access to most documents regarding interagency communications or internal communications surrounding TCE. Because the 110th Congress was drawing to a close, it was not practical to push for a subpoena for these records. We were never shown any document that could

have been construed as having Executive Privilege attached to it. OIRA’s entire approach appeared to amount to little more than obstruction of the work of the Subcommittee; in a sense,

OIRA did to the Subcommittee’s investigation what they have perfected in terms of slow-rolling

IRIS proposals.

HEARING CHARTER

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT

COMMITTEE ON SCIENCE AND TECHNOLOGY

U.S. HOUSE OF REPRESENTATIVES

Fixing EPA’s Broken Integrated

Risk Information System

THURSDAY, JUNE 11, 2009

1:00 P.M.–3:00 P.M. 2318 RAYBURN HOUSE OFFICE BUILDING

Purpose

On Thursday, June 11, 2009, the Subcommittee on Investigations and Oversight of the House Committee on Science and Technology will hold a hearing entitled

‘‘Fixing EPA’s Broken Integrated Risk Information System.’’ We will receive testimony from two witnesses at this hearing: Mr. John Stephenson, Director, Natural

Resources and Environment, U.S. Government Accountability Office, and Dr. Kevin

Teichman, the Deputy Assistant Administrator for Science, Office of Research and

Development, the Environmental Protection Agency. They will testify about the new

Integrated Risk Information System (IRIS) process announced by EPA Administrator Lisa Jackson on May 21, 2009.

Background

By the end of the Bush Administration, the Environmental Protection Agency’s (EPA) IRIS process was broken. What began two decades ago as an initiative at

EPA to establish a reliable database on what science said about the risks of particular chemicals devolved by the end of the Bush Administration into a tortured

round of interagency bickering, mediated by the Office of Information and Regulatory Affairs (OIRA). As a result of the IRIS process breaking down, public health

offices across the country and around the world, as well as concerned citizens, were

left without the reliable, expanding, up-to-date database of chemical risks that they

had come to count on.1

A chemical’s entry in the IRIS database is nothing more than a science-based as- sessment of risks associated with a particular chemical. IRIS entries are produced

in the Office of Research and Development (ORD) of EPA, and those entries are not

an expression of regulatory intent or advice. The entries are not even all that is required of a complete risk assessment as defined in the seminal National Academies

of Science report, Risk Assessment in the Federal Government: Managing the Process

4

2 In that 1983 report, ‘‘Risk Assessment in the Federal Government: Managing the Process,’’

the National Research Council panel identified four components of a complete risk assessment:

hazard identification, dose-response evaluation, exposure assessment, and risk characterization.

IRIS reflects science that addresses the first two conditions. In discussing the difference between

risk assessment and risk management, the Academy panel wrote: ‘‘Risk assessment is the use

of the factual base to define the health effects of exposure of individuals or populations to hazardous materials and situations. Risk management is the process of weighing policy alternatives

and selecting the most appropriate regulatory action, integrating the results of risk assessment

with engineering data and with social, economic and political concerns to reach a decision.’’ See

the discussion on page 3 of the 1983 report. 3This effort by polluters, or those who fear regulation of whatever stripe, of pushing the struggle back to what the science says about a particular risk rather than arguing over how to structure a regulation has been described as ‘‘paralysis by analysis.’’ Science lends itself to endless

study because there is never an absolute, final answer to any question, but always another layer

of research that could add to the body of accumulated knowledge. If those who want to avoid

regulation can shift the terms of discussion from the risk management end of the spectrum to

the science and what uncertainties remain, a regulatory struggle need never begin. For analysis

of how this process has unfolded among regulated industries, see David Michaels, Doubt Is Their

Product: How Industry’s Assault on Science Threatens Your Health, Oxford University Press,

New York, 2008. 4The Subcommittee was also able to review records from 1998 when OIRA first began to push

into the interagency struggles over characterizing risks to former marines and their families

from TCE and other chemicals at Camp LeJeune. At that time, OIRA’s interest was more in

the costs of the studies and making sure the then-proposed survey study met OIRA quality

standards. OIRA reviews all survey instruments as part of its authority under the Paperwork

Reduction Act of 1980. 5 ‘‘Toxic Communities: How EPA’s IRIS Program Fails the Public,’’ Hearing before the Subcommittee on Investigations and Oversight, Committee on Science and Technology, June 12,

2008, p. 132.

(1983).2 And risk assessment is a long step away from a regulatory effort, which is described in the terminology of the panel as ‘‘risk management.’’ However, the

absence of IRIS entries for widely used, toxic chemicals leaves State and local regulators, first responders, and citizens without crucial information that can guide their

response to an emergency or an emerging health or environmental threat. OIRA has been involved in the IRIS process since the closing years of the Clinton Administration. Initially OIRA was pulled into the process to facilitate interagency

discussions about particular chemicals proposed for IRIS listings. Agencies that had

a record of pollution with certain chemicals were concerned that new IRIS standards

would trigger the long march to new regulations and the end result would be that

the polluting agencies would have to change their practices and clean up legacy

wastes. Those who polluted saw that disputing what scientific research had found

about the risks of a particular chemical could become the first line of defense

against the distant possibility of regulation.3 By the late 1990s, OIRA was playing a role as facilitator for contentious interagency discussions for some particular proposed IRIS listings.4

Suppressing IRIS entries essentially shuts down the flow of coherent, reliable in- formation about what chemicals pose what kinds of risks. Testimony received by the

Subcommittee at the second day of hearings on this subject in 2008 emphasized the

important role of IRIS as a public health and safety resource. That hearing, entitled

‘‘Toxic Communities: How EPA’s IRIS Program Fails the Public,’’ took testimony from U.S.M.C. (retired) Master Sergeant Jerry Ensminger, the Executive Director

of the Center for Public Environmental Oversight, Mr. Lenny Siegel, and Dr. Linda

E. Greer, Director for Health Programs at the Natural Resources Defense Council.

Mr. Ensminger was particularly compelling in making a case for why polluting

agencies such as DOD should not be allowed privileged access to discussions about

the science of potential pollutants.

It is a known fact that the United States Department of Defense is our nation’s

largest polluter. It is beyond my comprehension why an entity with that type

of reputation and who has a vested interest in seeing little to no environmental

oversight would be included in the scientific process. Not only are they obstructing science, they are also jeopardizing the public health for millions of people

all around the world . . . and yet this Administration and past Congresses have

allowed DOD’s tentacles to infiltrate the realm of science.5

Mr. Ensminger was stationed at Camp LeJeune. His daughter, Janey, died of acute lymposytic leukemia. Water at the Camp was contaminated with trichloroethylene (TCE) and perchlorate (perc) and these chemicals, as well as other volatile

organic compounds in the water system at the Camp, may have caused Janey’s condition. DOD has been working for many years to block new IRIS standards on TCE

and perc.

5

During the Bush Administration, OIRA’s involvement changed in scope and kind from what it had been in the Clinton Administration. John Graham, the first Director of OIRA in the Bush Administration, brought in technical specialists—including

toxicologists—to tend to science-based discussions of proposed environmental regulations, guidance and IRIS entries. Graham also oversaw a complete overhaul—some

might describe it as an endless evolution—of the review and approval process for

IRIS proposals.

IRIS Process Reforms Past and Present

On April 10, 2008, EPA announced a new IRIS review process for future entries

into the IRIS database. In testimony before the Subcommittee, the then Assistant

Administrator for Research and Development at EPA, Dr. George Gray, described

this new process as ‘‘streamlined.’’ Comparing the process as it existed before 2004

and the process announced on April 10, 2008, it is hard to understand in what sense

the process could be described as ‘‘streamlined’’ (see Attachments 1 and 2). The

fruits of this new process were exactly four new IRIS entries in the years since that

process was announced (actually, they had gone through as a single proposal as they

were four variants on one chemical compound so this could be counted as ‘‘one’’ new

entry and not distort the record). In the two years prior to announcing this new

process, EPA had been allowed to post four new entries (two each year). GAO issued a very strong report concerning mismanagement of the IRIS program in a March, 2008 report (‘‘Chemical Assessments: Low Productivity and New Inter- agency Review Process Limit the Usefulness and Credibility of EPA’s Integrated Risk

Information System,’’ GAO–08–440). In addition, GAO added the IRIS program to

its ‘‘High Risk’’ report in January of 2009—placing additional pressure on EPA and the new Administration to take steps to fix this broken process.

On May 21, EPA Administrator Lisa Jackson announced a new IRIS process that appears to be much improved over the system she inherited (see Attachment 3). It

imposes transparency on interagency comments concerning proposed IRIS entries;

it eliminates the ability of polluting agencies (such as the Department of Energy,

NASA, or the Department of Defense) to further drag out assessments by declaring

particular chemicals as ‘‘mission critical’’; it puts EPA solidly in charge of the entire

process with a timeline for each step in the process.

All of these steps away from an OIRA-dominated system are positive. However, questions still remain about how this process will perform in actual practice.

1. Control: Will EPA really have the muscle to stand up to pressure from more powerful agencies that have historically obstructed IRIS entries as a way of

strangling potential regulation? Will EPA be able to withstand pressure from

offices inside the White House should those offices mobilize to block or significantly redo a proposed IRIS listing? EPA faired badly during the prior

Administration in struggles over science and regulation. Some of those problems reflected the political preferences of the Bush Administration, but some

of those problems reflect the ingrained institutional interests of other agencies who do not want to be regulated and White House offices that want to

have a great measure of control over what EPA (among many agencies) can

and cannot do. Institutional interests do not change with elections, and EPA

will still face some pressure on that front. The Chair’s position has been that

EPA scientists should be in charge of EPA science products.

2. What role will OIRA play? This is really a more specific observation related to control, but the new plan announced by Administrator Jackson is ambiguous about what White House offices will be involved in reviews of EPA IRIS

proposals. Because discussion of proposed listings is supposed to be limited

solely to ‘‘science’’ matters, it is hard to imagine any White House office actually having the time or resources to appropriately weigh in on science matters—even the Office of Science and Technology Policy. There is no office in

the White House that does ‘‘science’’ per se. OIRA is really designed to weigh

in on the ‘‘risk management’’ side of the regulatory equation, not the ‘‘risk

assessment’’ or science side which comes well before any regulatory proposal

is even contemplated. No office in the White House is more influential with

agencies than is the Office of Management and Budget (OMB) precisely because OMB controls every agency’s budget request. OIRA is housed at OMB

and that location gives them a very powerful voice, when they raise it, in

the work of the line agencies. Is it appropriate to let OIRA play any role at

all in science matters?

3. Productivity: While the newly announced process does eliminate some steps

in the IRIS approval process, it remains to be seen whether it will allow for

a substantial increase in IRIS entries being finalized by EPA. With 700 new

6

chemicals entering the marketplace each year, and a backlog of needed updates and new entries, the bare minimum standard for success of IRIS is

probably 20 entries a year—which is what the new process promises to deliver.

The Subcommittee will pursue these matters, and others, during the hearing. If

IRIS is unable to function effectively, public health and safety will ultimately suffer.

Getting this program right is a high priority for the Subcommittee and the country.

The Subcommittee Chair expects to send a request letter to the Government Accountability Office to have them continue to monitor the new IRIS process.

7

Chair MILLER. Good afternoon. The hearing will now come to

order. Welcome to today’s hearing entitled ‘‘Fixing EPA’s Broken

Integrated Risk Information System.’’

A little more than a year ago Susan Dudley, then the head of the

Office of Information Regulatory Affairs at OMB, OIRA, and Dr.

George Gray, then the head of the Office of Research and Development at EPA, testified before this subcommittee. The hearing was

to examine the stunning lack of productivity in a—in new and revised risk assessments for chemicals in the EPA’s Integrated Risk

Information System, IRIS.

Dudley and Gray testified that the productivity was a complicated approval process for assessments which this flowchart produced by EPA, Mr. Whittaker, illustrated. This is the complicated

process that they needed to fix.

So they testified that they had solved the problem by developing

a streamlined approval process which this flowchart, also produced

by EPA, illustrates.

8

Again, Mr. Whittaker, if you could show the complicated system,

chart one, okay, and then the simplified system, chart two.

Gray’s and Dudley’s testimony reminded me of a famous

quotation from Marx—not Karl, Chico. ‘‘Well, who are you going to

believe? Me or your own eyes?’’ Gray’s and Dudley’s testimony

strained credulity in other ways. Dudley explicitly denied in her

testimony that OIRA, the office that she headed, ever challenged

scientific assessments by EPA scientists. Scientific assessment of a

toxic effect of chemical exposure would not even remotely be

OIRA’s job. Our staff today released a report on IRIS that shows

that OIRA did just that on several occasions, enough to conclude

that intruding on scientific assessments was routine for OIRA.

Dudley testified that the streamlined process, that was chart two,

for approving IRIS listings was entirely EPA’s handiwork. Our

staff’s report shows that the process was a result of a multi-year,

interagency process that was driven by OIRA, not by EPA.

OIRA’s conduct in requiring a perpetual paralysis in approval

procedures and intruding on the independence of EPA’s scientists

appears to have been intended to keep IRIS from doing its job and

to keep us all in the dark about the public health consequences of

chemical exposures. It certainly had that effect. While 70 chemicals

were in some stage of review by EPA, EPA averages three new and

revised IRIS entries a year.

The new EPA Administrator, Lisa Jackson, announced a new

process on May 21, 2009. This chart illustrates the new process.

9

10

11

12

13

If we are to believe our own eyes, the new process is substantially streamlined.

Just as important, discussions between Federal Government

agencies about IRIS listings will be transparent. There is no excuse

for keeping interagency discussions secret from Congress and from

the American people. We are entitled—I am speaking as a Member

of Congress and as one of the American people, we are entitled to

know the potential health effects of chemical exposures even if various government agencies find the chemicals very useful.

14

And no agency can trigger an even more tortured approval process by declaring that a chemical is ‘‘mission critical.’’ Under strict

rules of grammar the word ‘‘perpetual’’ is like the word ‘‘naked’’ or

‘‘nude.’’ Neither allows for degrees, but the IRIS approval process

devised by Dudley’s OIRA was perpetual for all chemicals and more

perpetual for ‘‘mission critical’’ chemicals.

We are interested in hearing today about EPA’s new procedures,

and there should be little doubt that the procedures are an improvement, but we need to see how the procedures work in practice

to know whether the procedures are enough of an improvement.

The institutional interests and ambitions of federal agencies survive presidential transitions. There will still be agencies that want

to use chemicals without annoying restrictions and may try to

avoid risk management issues by obstructing the risk assessment

of an IRIS listing. And it is human nature to forsake power reluctantly, even the unwholesome, even sinister power that OIRA exercised over EPA’s scientific assessments.

The American people need and deserve credible, scientificallysound assessments of the health effects of chemical exposures. That

means EPA must be in charge, not OIRA.

The Subcommittee will continue to work to follow the work of

IRIS, and I have written the GAO to ask that they closely monitor

the new IRIS process as well. And I have now included both our

staff report on IRIS as well as a new report from the Center for

Progressive Reform with my statement for the record. [See Appendix: Additional Material for the Record.]

I now recognize my distinguished colleague, Dr. Broun, for his

opening statement.

[The prepared statement of Chair Miller follows:]

PREPARED STATEMENT OF CHAIR BRAD MILLER

A little more than a year ago, Susan Dudley, then the head of the Office of Information and Regulatory Affairs in OMB, and Dr. George Gray, then the head of the

Office of Research and Development at EPA, testified before this subcommittee.

The hearing was to examine the stunning lack of productivity in new and revised

risk assessments for chemicals in the EPA’s Integrated Risk Information System

(IRIS).

Dudley and Gray testified that the productivity problem was a complicated approval process for assessments, which this flow chart produced by EPA illustrated.

But Gray and Dudley said they had solved the problem by developing a streamlined approval process, which this flow chart, also produced by EPA, illustrated.

Gray’s and Dudley’s testimony reminded me of a famous quotation from Marx—

not Karl, but Chico: ‘‘Well, who you gonna believe, me or your own eyes?’’

Gray’s and Dudley’s testimony strained credulity in other ways.

Dudley explicitly denied in her testimony that OIRA, the office that she headed,

ever challenged scientific assessments by EPA’s scientists. Scientific assessment of

the toxic effect of chemical exposure would not even remotely be OIRA’s job. Our

staff today released a report on IRIS that shows that OIRA did just that on several

occasions, enough to conclude that intruding on scientific assessments was routine

for OIRA. Dudley testified that the ‘‘streamlined’’ process for approving IRIS listings

was entirely EPA’s handiwork. Our staff’s report shows that the process was the result of a multi-year, interagency process driven by OIRA, not EPA.

OIRA’s conduct in requiring a perpetual paralysis in approval procedures and intruding on the independence of EPA’s scientists appears to have been intended to

keep IRIS from doing its job, and to keep us all in the dark about the public health

consequences of chemical exposures. It certainly had that effect. While 70 chemicals

were in some stage of review by EPA, EPA averaged three new and revised IRIS

entries a year.

15

The new EPA Administrator, Lisa Jackson, announced a new process on May 21,

2009. This chart illustrates the new process. If we are to believe our own eyes, the

new process is substantially streamlined.

Just as important, discussions between Federal Government agencies about IRIS

listings will be transparent. There is no excuse for keeping interagency discussions

secret from Congress and the American people. We are entitled to know the potential health effects of chemical exposures, even if various government agencies find

the chemicals very useful.

And no agency can trigger an even more tortured approval process by declaring

that a chemical is ‘‘mission critical.’’ Under strict rules of grammar, the word ‘‘perpetual’’ is like the word ‘‘naked’’: neither allows for degrees. But the IRIS approval

process devised by Dudley’s OIRA was perpetual for all chemicals, and more perpetual for mission critical chemicals.

We are interested in hearing today about EPA’s new procedures, and there should

be little doubt that the procedures are an improvement. But we will need to see how

the procedures work in practice to know whether the procedures are enough of an

improvement. The institutional interests and ambitions of federal agencies survive

presidential transitions. There will still be agencies that want to use chemicals

without annoying restrictions, and may try to avoid risk management issues by obstructing the risk assessment of an IRIS listing. And it is human nature to forsake

power reluctantly, even the unwholesome, even sinister power that OIRA exercised

over EPA’s scientific assessments.

The American people need and deserve credible, scientifically sound assessments

of the health effect of chemical exposures. That means the EPA must be in charge,

not OIRA.

This subcommittee will continue to follow the work of IRIS, and I have written

the GAO to ask that they closely monitor the new IRIS process as well.

Mr. BROUN. Thank you, Mr. Chair.

The Integrated Risk Information System (IRIS) process was

originally developed in the mid 1980’s for a specific task. Different

offices throughout the EPA were relying on different assessments

of the health effects of exposure to chemicals.

IRIS was intended to establish a uniform database within EPA

to—that represented a consensus determination. Over time, however, IRIS became an authoritative resource on chemical toxicity.

As a credit to the agency’s diligence, other agencies, states, and the

international community and industries increasingly began to rely

on IRIS, and assessments took on increased importance. These outside groups have sought to impact a process that was not initially

designed to handle external pressures. The result has been an IRIS

process that has effectively broken down.

As we learned from GAO last year, EPA had a backlog of 70 ongoing assessments and managed to complete only two assessments

in each of the last two years. Even when EPA managed to produce

assessments, the National Academy of Sciences has roundly criticized their work. The competing priorities of issuing assessments

in a timely manner and producing assessments that are scientifically credible are central to the problems we face today.

The completely unsatisfactory timeframes for these assessments

are the results of several factors. Reviews are becoming more complex as attention increases for high-profile chemicals. EPA management and program decisions are delaying completion. Outside

stakeholder reviews are becoming more detailed, and Congressional

action is becoming more prevalent.

All of these delays have compounded effects and create a domino

effect on schedules as Mr. Stephenson pointed out in previous testimony. Until recently the IRIS process was an opaque process that

had no schedule deadlines and limited outside review. While the

previous Administration’s proposed process wasn’t perfect, it was

16

the first time that the process was formalized, thoroughly examined, and given strict timelines. If nothing else, the previous Administration recognized the untenable nature of the existing IRIS

process and presented a proposal to fix the problem.

While the previous process wasn’t perfect, neither is this new

process. Previous processes required EPA to develop a consensus

assessment, the original purpose of the IRIS process. The newlyproposed process does not require each EPA office to concur on assessments but rather to simply consult.

Furthermore, these internal agency consultations are not required to be available to the public, which ultimately limits transparency. EPA’s failure to develop consistent assessments raises the

questions of how authoritative and useful IRIS will be in the future.

One of the assessed arguments for the new proposal is its new

streamlined process. As I mentioned earlier, the natural tension between fairness and timeliness begs the question of whether a

streamlined process will ultimately sacrifice scientific credibility,

especially considering recent negative reviews from the National

Academy of Sciences. In order to streamline the process, the new

Administration has cut out quality control measures such as visibility and the adjudication of peer review comments, the requirement for a qualitative assessment review, the public review of that

qualitative assessment, the evaluation of agency interest in closing

data gaps for mission-critical chemicals, design and implementation of new studies for mission-critical chemicals, and the development of short-term research projects that may aid in filling data

gaps.

More importantly, this new streamlined process uses a bit of

slight of hand to take the scientific literature review and data culling periods off the schedule entirely. This work will still be done,

but EPA doesn’t account for this time in its schedule, allowing

them to create the appearance of a speedier process.

One of the largest criticisms of the previous proposal was the role

played by the White House and more importantly OMB and Office

of Regulatory Information and Affairs. Despite these previous criticisms, the new process states that White House offices will continue to be involved in the interagency consultation process.

Apparently this was only a concern when it was politically fashionable. If anyone had a problem with the previous Administration’s meddling, you can probably expect more of the same since

OIRA is staffed almost exclusively by career civil servants.

Somebody tried to dismiss this concern by noting that EPA is not

ultimately responsible for the process but they always had final authority. Even under the previous process it could be claimed that

even with that previous authority, EPA was still subordinate to the

influence of OMB.

Similarly, one could argue that EPA will truly have final authority under the new process, but ultimately the EPA Administrator

still works for the President. The only difference is that now maybe

the Administrator also works for the new environment czar, Carol

Browner. We aren’t really sure about this since she is removed

from any type of Congressional oversight, transparency or accountability.

17

I hope that science’s rightful place doesn’t turn out to be behind the cloak of deliberative process and executive communication.

Despite concerns about White House meddling, OMB has pro- vided useful input into EPA assessments according to GAO’s 2008

report. While OMB should certainly not use this review process to

obstruct or prevent assessments, EPA also shouldn’t be afraid to

address valid scientific inquiries.

Additionally, OMB plays an important role in shepherding the interagency process. Without OMB taking the lead in this process,

it remains to be seen if EPA will have enough clout to force or compel other agencies to comply with its timelines and directions. This also raises another question relating to who will ultimately be the adjudicator of conflicts, an arbiter of scientific disputes. In

an ideal world neither the White House nor EPA would be involved

in this as it is truly a discussion meant for the scientific community. Unfortunately, in the real world there needs to be a bureaucratic referee. Is EPA truly an unbiased partner when they are the agency that drafts the assessments? What incentive does EPA have to

incorporate peer review as comments that may contradict their

opinions? Are we setting up a system when EPA will be responsible

for monitoring its own work? Even if EPA is unbiased or the Office of Research and Development’s staff tasks to conduct these assessment experts on every

chemical are aware of all the science? If the answer is no, then

aren’t we essentially making pure but poorly informed assessments? If none of these questions matter because assessments go

through peer review, why would it matter if other agencies, industry or the White House, were involved since the final product will

be peer reviewed?

As you can tell, I remain very skeptical of the new process, but I do see some commendable aspects. New transparency measures

for the interagency review process are promising, even though they

don’t extend into internal communication between EPA line offices,

which could prove to be just as informative and important. Despite this potential bright spot, several other questions remain.

With that, Mr. Chair, I am attaching a letter from Toxicology Ex- cellence for Risk Assessment to my statement that I will enter in

the record, and I appreciate your indulgence and look forward to

the witnesses’ testimony. [The prepared statement of Mr. Broun follows:]

PREPARED STATEMENT OF REPRESENTATIVE PAUL C. BROUN

The Integrated Risk Information System (IRIS) process was originally developed in the mid-1980’s for a specific task. Different offices throughout the Environmental

Protection Agency (EPA) were relying on different assessments of the health effects

of exposure to chemicals. IRIS was intended to establish a uniform database within

EPA that represented consensus determinations.

Over time, however, IRIS became an authoritative resource on chemical toxicity. As a credit to the agency’s diligence, other agencies, states, the international community, and industries increasingly began to rely on IRIS, and the assessments took

on increased importance. These outside groups have sought to impact a process that

was not initially designed to handle external pressures. The result has been an IRIS

process that has effectively broken down.

As we learned from GAO last year, EPA had a backlog of 70 ongoing assessments

and managed to complete only two assessments in each of the last two years. Even

18

when EPA managed to produce assessments, the National Academy of Sciences has

roundly criticized their work. The competing priorities of issuing assessments in a

timely manner and producing assessments that are scientifically credible are central

to the problems we face today. The completely unsatisfactory timeframes for these assessments are the result of several factors. Reviews are becoming more complex as attention increases for high

profile chemicals, EPA management and program decisions are delaying completion,

outside stakeholder reviews are becoming more detailed, and Congressional action

is becoming more prevalent. All of these delays have compounding effects and create

a ‘‘domino effect’’ on schedules as Mr. Stephenson pointed out in previous testimony. Until recently, the IRIS process was an opaque process that had no schedule deadlines and limited outside review. While the previous Administration’s proposed

process wasn’t perfect, it was the first time that the process was formalized, thoroughly explained, and given strict timelines. If nothing else, the previous Administration recognized the untenable nature of the existing IRIS process and presented

a proposal to fix the problem.

While the previous process wasn’t perfect, neither is this the new process. Previous processes required EPA to develop a consensus assessment - the original purpose of the IRIS process. The newly proposed process does not require each EPA

office to concur on assessments. but rather to simply consult. Furthermore, these

internal agency consultations are not required to be available to the public, which

ultimately limits transparency. EPA’s failure to develop consensus assessments

raises the question of how ?authoritative and useful IRIS will be in the future.

One of the arguments for the new proposal is its new streamlined process. As I mentioned earlier, the natural tension between thoroughness and timeliness begs

the question of whether a streamlined process will ultimately sacrifice scientific

credibility. especially considering recent negative reviews from the National Academy of Sciences. In order to streamline the process, the new Administration has cut

out quality control measures such as visibility into the adjudication of peer review

comments; the requirement for a qualitative assessment review: the public review

of that qualitative assessment: the evaluation of agency interests in closing data

gaps for mission critical chemicals. the design and implementation of new studies

for mission critical chemicals, and the development of short-term research projects

that may aid in filling data gaps. More importantly, this new streamlined process

uses a bit of slight-of-hand to take the scientific literature review and data call-in

periods off the schedule entirely. This work will still be done, but EPA doesn’t account for this time in its schedule, allowing them to create the appearance of a

speedier process.

One of the largest criticisms of the previous proposal was the role played by the White House, and more importantly the Office of Management and Budget (OMB)

and the Office of Regulatory Information and Affairs (OIRA). Despite these previous

criticisms, the new process states that White House offices will continue to be involved in the interagency consultation process. Apparently this was only a concern

when it was politically fashionable. If anyone had a problem with the previous Administration’s ‘‘meddling,’’ you can probably expect more of the same since OIRA is

staffed almost exclusively by career civil servants.

Some may try to dismiss this concern by noting that EPA is now ultimately responsible for the process, but they always had final authority, even under the previous process. It could be claimed that even with that previous authority, EPA was

still subordinate to the influence of OMB. Similarly, one could argue that EPA will

truly have final authority under the new process, but the ultimately the EPA Administrator still worked for the President. The only difference is that now maybe

the Administrator also works for the new Environment Czar Carol Browner. We

aren’t really sure about this since she is removed from any type of Congressional

oversight, transparency, or accountability. I hope that science’s ‘‘rightful place’’

doesn’t turn out to be behind the cloak of deliberative process and executive communication.

Despite concerns about White House meddling, OMB has provided useful input

into EPA assessments according to GAO’s 2008 report. While OMB should certainly

not use this review process to obstruct or prevent assessments, EPA also shouldn’t

be afraid to address valid scientific inquiries. Additionally, OMB plays an important

role in shepherding the interagency process. Without OMB taking the lead in this

process, it remains to be seen if EPA will have enough clout to force or compel other

agencies to comply with its timelines and directions.

This also raises another question relating to who will ultimately be the adjudicator of conflicts and arbiter of scientific disputes. In an ideal world, neither the

White House nor EPA would be involved in this, as it truly is a discussion meant

for the scientific community. Unfortunately in the real world there needs to be a

19

bureaucratic referee. Is EPA truly an unbiased partner when they are the agency

that drafts the assessments? What incentive does EPA have to incorporate peer reviewer’s comments that may contradict their opinions? Are we setting up a system

where EPA will be responsible for monitoring its own work? Even if EPA is unbiased, are the Office of Research and Development (ORD) staff tasked to conduct

these assessments experts on every chemical and aware of all the science? If the

answer is no, then aren’t we essentially making pure, but poorly informed assessments? If none of these questions matter because assessments go through peer review, why would it matter if other agencies, industry, or the White House were involved since the final product will be peer reviewed?

As you can tell, I remain very skeptical of the new process but I do see some commendable aspects. New transparency measures for the interagency review process

are promising even though they don’t extend to internal communications between

EPA line offices which could prove to be just as informative and important. Despite

this potential bright-spot, several other questions remain.

With that, Mr. Chairman, I am attaching a letter from Toxicology Excellence for

Risk Assessment (TERA) to my statement that I will enter into the record. I appreciate your indulgence and look forward to the witnesses’ testimony.

[The information follows:]

20

21

22

23

24

25

Chair MILLER. Thank you, Dr. Broun.

I ask unanimous consent that all additional opening statements

submitted by Members be included in the record. Without objection, so ordered.

It is my pleasure now to introduce our witnesses. Dr. Kevin

Teichman is the Deputy Assistant Administrator for Science in the

Office of Research and Development at EPA, and Mr. John Stephenson is back. He is the Director of Natural Resources and Environment at the Government Accountability Office.

As our witnesses should know, you will each have five minutes

for your spoken testimony. Your written testimony will be included

26

in the record. When you all have completed your spoken testimony,

we will begin with questions. Each Member will have five minutes

to question the panel.

It is the practice of this subcommittee to receive testimony under

oath, although we have not made it our habit to refer cases for perjury prosecution, which I am sure is a great relief to Dr. Gray and

Ms. Dudley. You also have the right to be represented by counsel.

Do any of you have any objection to taking an oath?

Both witnesses indicated that they did not. You also have the

right to be represented by counsel. Do either of you have a counsel

here? Counsel with you?

Also, I understand that you may have—although both of you, I

know, have encyclopedic knowledge of this topic, you may have

other staff with you who may need to—who might need to help

with an answer. Would it be helpful if anybody else from your

staffs who might need to help you with an answer also take the

oath at the same time?

Okay. All right. Please stand and raise your right hand. Do you

swear to tell the truth and nothing but the truth?

The record will show that both witnesses have taken the oath.

We will now begin with Dr. Kevin Teichman. Dr. Teichman,

please begin.

STATEMENT OF DR. KEVIN TEICHMAN, DEPUTY ASSISTANT

ADMINISTRATOR FOR SCIENCE, OFFICE OF RESEARCH AND

DEVELOPMENT (ORD), U.S. ENVIRONMENTAL PROTECTION

AGENCY (EPA)

Dr. TEICHMAN. Good afternoon, Mr. Chair and Members of the

Subcommittee. I am Dr. Kevin Teichman, the Deputy Assistant Administrator for Science in EPA’s Office of Research and Development. I am also the Acting EPA Science Advisor, and in this role

I serve as a member of the Office of Science and Technology Policy’s Task Force on Scientific Integrity. I appreciate this opportunity to discuss with you EPA’s Integrated Risk Information System, IRIS.

Before I begin I would like to thank Congressman Miller and the

Subcommittee for your support of the IRIS Program. The importance of a successful IRIS Program to the health of the American

people was acknowledged by this subcommittee in two past hearings and by Chair Miller’s previous introduction of legislation on

this topic. Your continued interest in the future of the IRIS Program is greatly appreciated.

IRIS is one of EPA’s most important and most public products.

IRIS has been a highly-regarded resource for providing information

on the potential human health risks from long-term exposures to

contaminants. IRIS assessments are used by EPA programs and regions as the scientific foundation for Agency actions to protect

human health.

IRIS assessments are also used by environmental and health

professionals and State and local governments, as well as internationally. Because of the widespread use of IRIS risk information,

it is of utmost importance that the process used to develop this information, and the resulting assessments posted on IRIS, reflect

27

the highest possible standards for scientific quality, scientific integrity, transparency, and timeliness.

Administrator Jackson, coming from careers at both EPA and the

New Jersey Department of Environmental Protection, recognizes

the critical role that EPA plays in disseminating timely, high quality, and accessible human risk information on environmental contaminants. Just four months after coming to EPA she announced

a new IRIS process that is more responsive to the needs of the

Agency and its work to effectively and efficiently protect the health

of all Americans.

The new IRIS process is more timely, transparent, and will ensure the highest level of scientific integrity. It will rely on an opportunity for public review and comment followed by a rigorous,

open, and independent external peer review process to guarantee

the scientific quality of the IRIS assessments.

There are several aspects of the new process that I would like

to highlight. First, the new IRIS process will be entirely managed

by EPA. Second, there is no longer an opportunity for another federal agency to prolong the process by asking that additional research be conducted before an assessment can be produced.

Instead, EPA will announce the chemicals that will be assessed

far enough in advance so that any interested party could conduct

short-term studies that could add to the peer-reviewed scientific literature.

Third, all written comments from other federal agencies and

White House offices will become part of the public record. Opportunities for scientific comment by other federal agencies and White

House offices was maintained in the new process, because EPA

welcomes input from interested experts that may add to the scientific quality of the draft or final assessment.

Also, the assessment process has been streamlined to ensure that

more new and updated assessments are included on IRIS. While

still robust, the assessment development process for most chemicals

will be shortened to 23 months, speeding the availability of IRIS

assessments.

There are two steps introduced in the previous process that were

retained in the new process. First, the opportunity for any interested party to provide information to EPA prior to the external

peer review meeting. These listening sessions allow interested parties to present scientific comments on draft IRIS assessments during the public comment period and before the external peer review

period. EPA has found the listening sessions to be a valuable step

in public outreach and participation.

Second, changes in EPA’s scientific judgments from public comments and peer review will be clearly documented and explained,

maximizing the transparency of the final product.

Finally, to give this new process an added boost, the Administrator has directed that for fiscal year 2010, resources for the IRIS

program should be increased, and the President’s budget request

includes an additional $5 million and ten FTEs full-time equivalents, for the IRIS program.

In conclusion, EPA remains dedicated to listening and being responsive to the public, to independent experts, and to scientists and

other federal science agencies as it develops IRIS human health asVerDate 11-MAY-2000 13:39 Dec 21, 2009 Jkt 049964 PO 00000 Frm 00031 Fmt 6633 Sfmt 6601 C:\DWORK\I&O09\061109\49964 SCIENCE1 PsN: SCIENCE1
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sessments. The ability of EPA’s program to succeed has been significantly improved now that some steps have been removed or revised. EPA is confident that we can continue to provide the critical

human health risk information to EPA’s programs and regions that

ensure the Agency’s actions protect the public health. Thank you very much, and I am happy to answer any questions that you may have. [The prepared statement of Dr. Teichman follows:]

PREPARED STATEMENT OF KEVIN TEICHMAN

Good afternoon, Mr. Chairman and Members of the Subcommittee. I am Dr. Kevin

Teichman, the Deputy Assistant Administrator for Science in EPA’s Office of Research and Development. I am also the Acting EPA Science Adviser, and in this role

I serve as a member of the Office of Science and Technology Policy’s (OSTP’s) Task

Force on Scientific Integrity. I appreciate this opportunity to appear at this hearing

and discuss with you EPA’s Integrated Risk Information System (IRIS). In this written testimony, I will include a brief description of the recent history of the IRIS program as well as discuss some of the highlights of the new IRIS process that was

announced by EPA Administrator Lisa P. Jackson on May 21, 2009.

Before I begin, I would like to thank Congressman Miller and this Subcommittee

on behalf of EPA, and personally, for support of the IRIS program. The importance

of a functioning and successful IRIS program to the health of the American people

was acknowledged by this subcommittee in two past hearings and by Chairman Miller’s introduction of H.R. 7234, the Integrated Risk Information System Authorization Act. Since the purpose of IRIS is to provide timely, high quality, and accessible

human health risk information on environmental contaminants that may endanger

the health of the American public, your continued interest in the future of the IRIS

program is greatly appreciated.

IRIS is one of EPA’s most successful and most public products. IRIS has been a

highly regarded resource for providing information on the potential human health

risks from long-term exposure to various contaminants. The IRIS assessments used

by EPA’s Program Offices and Regions are the science foundation for Agency actions

to protect human health. IRIS assessments are also used by risk assessors and environmental and health professionals in State and local governments, as well as internationally. Because of the widespread recognition and use of IRIS risk information,

it is of utmost importance that the process used to develop this information, and

the resulting assessments posted on IRIS, reflect the highest possible standards for

scientific quality and integrity, transparency, and timeliness.

On April 10, 2008, a new IRIS process was created via a memorandum from

former Deputy Administrator Marcus Peacock that codified the IRIS process. This

process introduced additional, time-consuming steps, some of which were not transparent to the public.

On January 26, 2009, Lisa P. Jackson was sworn in as EPA’s 11th Administrator.

On January 23, 2009, Administrator-Designee Jackson wrote to all EPA staff that,

‘‘As Administrator, I will ensure EPA’s efforts to address the environmental crises of

today are rooted in three fundamental values: science-based policies and programs,

adherence to the rule of law, and overwhelming transparency. By keeping faith with

these values and unleashing innovative, forward-thinking approaches—we can further protect neighborhoods and communities throughout the country.’’ Coming from

careers at both EPA and the New Jersey Department of Environmental Protection,

Administrator Jackson recognized the critical role that EPA plays in disseminating

timely, high quality, and accessible human health risk information on environmental contaminants. Thus, one of her highest priorities was to take the necessary

steps to strengthen and revitalize the process by which EPA develops and disseminates human health risk information.

On May 21, 2009, just four months after coming to EPA, Administrator Jackson

announced a new IRIS process that is more responsive to the needs of the Agency

in its work to effectively and efficiently protect the health of all Americans. The new

IRIS assessment development process, which was implemented immediately, is

more streamlined, transparent, and timely, and will ensure the highest level of scientific integrity. It will rely primarily on an opportunity for public review and comment followed by a rigorous, open, and independent external peer review process to

guarantee the scientific quality of the IRIS assessments.

There are several aspects of the new process that I would like to highlight. The

first is that the new IRIS process will be entirely managed by EPA. Second, there

29

is no longer an opportunity for another federal agency to prolong the assessment

process by asking that additional research be conducted before an assessment can

proceed. Instead, EPA will announce the chemicals that will be assessed far enough

in advance so that any interested party could conduct short-term studies that could

add to the peer-reviewed scientific literature for that chemical. Third, all scientific

comments from other federal agencies and White House offices will become part of

the public record for that chemical assessment. Opportunities for scientific comment

by other federal agencies and White House offices was maintained in the new process, because EPA welcomes input from interested experts that may add to the

science quality of the draft or final assessment.

Finally, the assessment process has been streamlined to ensure that more new

and updated assessments are included on IRIS. While still robust, the assessment

development process for most chemicals will be shortened to 23 months, speeding

the availability of IRIS assessments to the human health risk assessor community

and the public.

There are two aspects that were retained in the new process. First, is the opportunity for any interested party to provide information to EPA prior to the external

peer review meeting. These listening sessions, announced in the Federal Register,

allow all interested parties to present scientific and technical comments on draft

IRIS health assessments to EPA and other interested parties during the public comment period and before the external peer review meeting. EPA has found the listening sessions to be a valuable step in public outreach and participation. The listening

session comments are considered by the Agency as it revises the draft assessment

in response to the independent external peer review and public comments. As with

scientific comments from other federal agencies, listening session comments become

part of the public record. Second, changes in EPA’s scientific judgments from public

comments and peer review will be clearly documented and explained, maximizing

the transparency of the final product.

Finally, to give this new process an added boost, the Administrator has directed

that for fiscal year 2010, resources for the IRIS program should be increased, and

the President’s budget request includes an additional $5 million and 10 FTEs for

the IRIS program.

EPA remains dedicated to listening and being responsive to the public, to independent experts, and to scientists in other federal science agencies as it develops

IRIS human health assessments. The ability of EPA’s IRIS program to succeed has

been significantly improved now that some steps have been removed or revised. EPA

is confident that we can continue to provide the critical human health risk information to EPA’s Programs and Regions that ensure the Agency’s actions protect the

public health.

Thank you for the opportunity to discuss with you EPA’s new and improved IRIS

program. I am happy to answer any questions that you may have.

BIOGRAPHY FOR KEVIN TEICHMAN

Dr. Kevin Teichman is the Deputy Assistant Administrator for Science in the Office of Research and Development (ORD); he is also the Acting Science Advisor for

the Agency. He previously served as the Director of the Office of Science Policy

(OSP) within ORD. In this capacity, he coordinated ORD participation in EPA’s policy-making in all media (air, water, waste, pesticides and toxic substances) to ensure

these policies reflected sound science. In addition, he helped lead the planning of

EPA’s research program, striving to ensure the research program responded to the

needs of EPA’s Program and Regional Offices and maintained its leadership role in

the environmental research community.

During the enactment of the Clean Air Act Amendments of 1990, Dr. Teichman

served as the Associate Director of Science in OSP, and OSP Staff Director of the

Air Staff prior to that, with similar responsibilities to those above but limited to air

pollution. In addition, he managed EPA’s indoor air quality research program, including research devoted to characterizing indoor pollutants sources, assessing indoor exposures, studying associated health effects, assessing potential risks, and developing prevention/mitigation approaches to indoor air pollution.

Dr. Teichman has B.S. and M.S. degrees from the Massachusetts Institute of

Technology and a Ph.D. degree from the University of California at Berkeley, all in

Mechanical Engineering. He lives in Derwood, Maryland where he and his wife

Marsha are proud ‘‘empty nesters.’’

Chair MILLER. Thank you, Dr. Teichman.

Mr. Stephenson is recognized for five minutes.

30

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

ACCOUNTABILITY OFFICE

Mr. STEPHENSON. Thank you, Mr. Chair. I am pleased to be here today to discuss our prior findings and recommendations on EPA’s

IRIS program as well as the results of our preliminary review of

EPA’s most recently announced IRIS reforms announced on May

21, 2009.

As you know, the IRIS database contains EPA’s scientific posi- tion on the potential human health effects of exposure to more than

540 chemicals in the environment. It is the critical component of

EPA’s capacity to support scientifically-sound risk management decisions, policies, and regulations. In March 2008, we reported that the IRIS program was at seri- ous risk of becoming obsolete because the Agency had not been able

to complete timely, credible chemical assessments or decrease its

backlog of 70 ongoing assessments. EPA completed only five assessments last year and has only completed one assessment so far this

year. We also found that the timeframes for completing assessments were unacceptably long, often taking over a decade. In many cases

assessments became obsolete before they could be finalized and

were stuck in an endless loop of assessment and reassessment.

In April 2008, EPA unveiled a revised process, and we were disappointed to find out that it was not responsive to our recommendations and was actually worse than the process that it replaced, institutionalizing a process that would take six to eight

years at best to complete, enabling federal agencies to delay ongoing assessments by requesting additional research and declaring

comments from other agencies deliberative and excluded from the

public record.

As we testified before this subcommittee last year, we were extremely concerned about the consequences of these problems because IRIS assessments are, after all, the cornerstone of scientific

integrity at the Agency. In fact, we added EPA’s toxic chemical assessment and control processes to our January 2009 report on government-wide, high-risk areas in need of increased attention by executive agencies and the Congress, a GAO designation reserved for

only the most serious Federal Government problems.

Today I am pleased to report that while it is too soon to offer a

blanket endorsement, the new IRIS process introduced by EPA on

May 21 of this year appears to be a giant step in the right direction. In particular we believe that the new IRIS process, if managed effectively, will be largely responsive to the recommendations

we made in our March 2008 report.

First the process will be managed by EPA rather than OMB as

the former process was. Second, it addresses key transparency concerns by expressly requiring that all written comments provided by

other federal agencies on draft IRIS assessments be part of the

public record. Third, the new process streamlines the previous one

by consolidating and eliminating some steps and committing to a

two-year completion timeframe. Importantly, it eliminates the step

under which other federal agencies could have IRIS assessments

suspended indefinitely to conduct additional research. We also beVerDate 11-MAY-2000 13:39 Dec 21, 2009 Jkt 049964 PO 00000 Frm 00034 Fmt 6633 Sfmt 6601 C:\DWORK\I&O09\061109\49964 SCIENCE1 PsN: SCIENCE1
31

lieve that the requested increase of $5 million and ten additional

staff positions will help ensure that more resources are allocated to

the IRIS program to meet user needs.

While these changes reflect a significant improvement that can

help EPA restore the integrity and productivity of the program, we

offer the following observations for EPA to consider as it implements the new process.

First, there are no timeframes stated for the literature search

and data call in kind of the pre-Step 1. This tends to understate

the 23-month timeframe for completing assessments.

Second, it is not clear what purpose—what the purpose of the

interagency consultation meetings is, which is Step 3 and Step 6B

on the new process, what the role of OMB and other White House

offices are exactly, and whether decisions will be documented in the

public from decisions coming out of those steps.

Third, it seems to us that comments from the federal agencies,

which is Step 3, could be solicited at the same time draft assessments are sent to independent peer reviewers and the public,

which is Step 4, and saving additional time in the process.

Fourth, it is not clear how EPA plans to respond to our March

2008 report recommendation to provide at least a two-year notice

of planned assessments. The new process does not specifically address such important planning steps as the call for nominations of

chemicals to be assessed and the establishment of an IRIS agenda.

We believe that giving agencies and the public more advanced

notice to plan assessments would enable external parties with an

interest in a given chemical to complete relevant research before

the start of an IRIS assessment, and thus, make the assessment

even more efficient.

Finally, unlike a number of other EPA programs with statutory

deadlines for completing various activities, no enforceable deadlines

apply to the IRIS program. We believe that legislating statutory

deadlines could help EPA better ensure the viability of this critical

program.

Mr. Chair, that concludes the summary of my statement, and I

will be happy to answer questions.

[The prepared statement of Mr. Stephenson follows:]

PREPARED STATEMENT OF JOHN B. STEPHENSON

Mr. Chairman and Members of the Subcommittee:

I am pleased to be here today to discuss our prior findings and recommendations

on the Environmental Protection Agency’s (EPA) Integrated Risk Information System (IRIS) program as well as the results of our preliminary review of EPA’s most

recent IRIS reforms, announced on May 21, 2009. As you know, IRIS is one of the

most significant tools that EPA has developed to effectively support its mission to

protect people and the environment from harmful chemical exposures. The IRIS

database contains EPA’s scientific position on the potential human health effects of

exposure to more than 540 chemicals in the environment and is, therefore, a critical

component of EPA’s capacity to support scientifically sound risk management decisions, policies, and regulations.

In a March 2008 report, we identified significant deficiencies in EPA’s IRIS assessment process that threatened the viability of the program, and we made a numVerDate 11-MAY-2000 13:39 Dec 21, 2009 Jkt 049964 PO 00000 Frm 00035 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\061109\49964 SCIENCE1 PsN: SCIENCE1
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1GAO, Chemical Assessments: Low Productivity and New Interagency Review Process Limit

the Usefulness and Credibility of EPA’s Integrated Risk Information System, GAO–08–440

(Washington, D.C.: Mar. 7, 2008). 2GAO, High-Risk Series: An Update, GAO–09–271 (Washington, D.C.: January 2009). 3See the Related GAO Products section later in this statement.

ber of recommendations to correct them.1 In response, EPA issued a revised assessment process in April 2008 that did not respond to our recommendations but rather

made changes likely to further exacerbate the problems we had identified. Largely

as a result of the agency’s lack of responsiveness, we added transforming EPA’s

processes for assessing and controlling toxic chemicals as a high-risk area in our

January 2009 biennial status report on government-wide high-risk areas requiring

increased attention by executive agencies and Congress.2 In announcing new reforms to the IRIS assessment process on May 21, 2009, EPA echoed our findings—

that the April 2008 assessment changes reduced the transparency, timeliness, and

scientific integrity of the IRIS process—and highlighted both our high-risk designation of this important EPA program and the President’s recent emphasis on the importance of transparency and scientific integrity in government decision-making.

In this context, my testimony today discusses (1) the findings from our 2008 report and testimonies on the prior IRIS assessment processes3 and (2) our preliminary evaluation of EPA’s May 2009 process reforms. For this statement, we have

supplemented our prior work with a preliminary review of the EPA process reforms

and some IRIS productivity data. We conducted our work from May 28 to June 11,

2009, in accordance with generally accepted government auditing standards. Those

standards require that we plan and perform our work to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based

on our audit objectives. We believe that the evidence obtained provides a reasonable

basis for our findings and conclusions based on our audit objectives.

The Viability of the IRIS Program Is at Risk

In March 2008, we reported that the IRIS program is at serious risk of becoming

obsolete because the agency has not been able to complete timely, credible chemical

assessments or decrease its backlog of 70 ongoing assessments. In addition, assessment process changes EPA had recently made, as well as other changes EPA was

considering at the time of our review, would have further reduced the timeliness,

credibility, and transparency of IRIS assessments. Among other things, we concluded the following:

• EPA was unable to routinely complete IRIS assessments in a timely manner.

From 2000 to 2007, EPA completed on average about five IRIS assessments

a year. The more recent trend has been a decline in productivity: In fiscal

years 2006 and 2007, EPA completed two assessments each year; in 2008,

EPA completed five assessments—four of which were related chemicals assessed and peer reviewed together but finalized individually; and thus far in

fiscal year 2009, EPA has finalized one assessment.

• Further, as we reported in 2008, because EPA staff time was dedicated to

completing assessments in the backlog, EPA’s ability to both keep the more

than 540 existing assessments up to date and initiate new assessments was

limited. We found that 48 of the 70 assessments being conducted as of December 2007 had been in process for more than five years—and 12 of those, for

more than nine years. These time frames have lengthened. Currently, of those

70 assessments, 58 have now been ongoing for more than five years—and 31

of those for more than nine years.

• We also found that EPA’s efforts to finalize IRIS assessments have been

thwarted by a combination of factors. These factors include (1) the Office of

Management and Budget’s (OMB) requiring two additional reviews of IRIS

assessments by OMB and other federal agencies with an interest in the assessments, such as the Department of Defense, and (2) EPA management decisions, such as delaying some assessments to await the results of new research.

• The two new OMB/interagency reviews of draft assessments involve other federal agencies in EPA’s IRIS assessment process in a manner that limits the

credibility and transparency of, and hinders EPA’s ability to manage, IRIS assessments. For example, some of these agencies’ review comments could be

influenced by the potential for increased environmental cleanup costs and

other legal liabilities if EPA issued an IRIS assessment for a chemical that

resulted in a decision to regulate the chemical to protect the public. Moreover,

33

the input these agencies provide to EPA is treated as ‘‘deliberative’’ and is

not released to the public. Regarding EPA’s ability to manage its IRIS assessments, in 2007 OMB required EPA to terminate five assessments that for the

first time addressed acute, rather than chronic, exposure—even though EPA

had initiated this type of assessment to help it implement the Clean Air Act.

• The changes to the IRIS assessment process that EPA was considering but

had not yet issued at the time of our 2008 review would have added to the

already unacceptable level of delays in completing IRIS assessments and further limited the credibility of the assessments. For example, the changes

would have allowed potentially affected federal agencies to have assessments

suspended for up to 18 months to conduct additional research. As we reported

in 2008, even one delay can have a domino effect, requiring the assessment

process to essentially be repeated to incorporate changing science.

In April 2008, EPA issued a revised IRIS assessment process. As we testified

before this subcommittee in May 2008, the new process was largely the same

as the draft we had evaluated during our review and did not respond to the

recommendations in our March 2008 report. Moreover, some key changes

were likely to further exacerbate the credibility and productivity concerns we

had identified. For example, EPA’s revised process formally defined comments on IRIS assessments from OMB and other federal agencies as ‘‘deliberative’’ and excluded them from the public record. As we have stated, it is

critical that input from all parties—particularly agencies that may be directly

affected by the outcome of IRIS assessments—be publicly available. In addition, the estimated time frames under the revised process, especially for

chemicals of key concern, would have likely perpetuated the cycle of delays

to which the majority of ongoing assessments have been subject. Instead of

streamlining the process, as we had recommended, EPA institutionalized a

process that from the outset was estimated to take six to eight years for some

chemicals of key concern that are both widespread and likely to cause cancer

or other serious health effects. This was particularly problematic because of

the substantial rework often required to take into account changing science

and methodologies.

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

Overall, EPA’s May 2009 IRIS assessment process reforms represent significant

improvements and, if implemented effectively, would be largely responsive to the

recommendations made in our March 2008 report.

• First, the new process and the memorandum announcing it indicate that the

IRIS assessment process will be entirely managed by EPA, including the

interagency consultations (formerly called OMB/interagency reviews). Under

EPA’s prior process, these two interagency reviews were required and managed by OMB—and EPA was not allowed to proceed with assessments at various stages until OMB notified EPA that it had sufficiently responded to comments from OMB and other agencies. The independence restored to EPA

under the new process is critical in ensuring that EPA has the ability to develop transparent, credible IRIS chemical assessments that the agency and

other IRIS users, such as State and local environmental agencies, need to develop adequate protections for human health and the environment.

• Second, the new process addresses a key transparency concern highlighted in

our 2008 report and testimonies. As we recommended, it expressly requires

that all written comments on draft IRIS assessments provided during the

interagency consultation process by other federal agencies and White House

offices be part of the public record.

• Third, the new process streamlines the previous one by consolidating and

eliminating some steps. Importantly, EPA eliminated the step under which

other federal agencies could have IRIS assessments suspended in order to

conduct additional research, thus returning to EPA’s practice in the 1990s of

developing assessments on the basis of the best available science. As we highlighted in our report, as a general rule, requiring that IRIS assessments be

based on the best science available at the time of the assessment is a standVerDate 11-MAY-2000 13:39 Dec 21, 2009 Jkt 049964 PO 00000 Frm 00037 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\061109\49964 SCIENCE1 PsN: SCIENCE1
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4 As also stated in our report, we understand that under exceptional circumstances, it may

be appropriate to wait for the results of an important ongoing study, such as a major epidemiological study that will provide new, critical data for an assessment.

ard that best supports the goal of completing assessments within reasonable

time periods and minimizing the need to conduct significant levels of rework.4

• Fourth, as outlined in the EPA Administrator’s memorandum announcing the

new IRIS process, the President’s budget request for fiscal year 2010 includes

an additional $5 million and 10 full-time-equivalent staff positions for the

IRIS program, which is responsive to our recommendation to assess the level

of resources that should be dedicated to the IRIS program in order to meet

user needs and maintain a viable IRIS database.

We are encouraged by the efforts EPA has made to adopt most of our rec- ommendations, including those addressing EPA’s ability to manage its IRIS assessment process, transparency practices, and streamlining the lengthy IRIS assessment

process. The changes outlined above reflect a significant redirection of the IRIS

process that, if implemented effectively, can help EPA restore the credibility and increase the productivity of this important program. While these broad reforms provide a sound general framework for conducting IRIS assessments, the manner in

which EPA implements the new process will determine whether the agency will be

able to overcome its long-standing productivity problems and complete credible and

transparent assessments. Specifically, management attention is warranted on certain aspects of the new process that are incomplete or lack clarity.

• EPA’s estimated time frames of about two years for standard IRIS assessments—those that are not particularly complex or controversial—do not include the time required to complete two steps that are nonetheless included

in the assessment process. As a result, EPA has likely understated the time

required to complete an assessment. The steps lacking timeframes—the scientific literature review and the request to the public and other agencies to

submit relevant research (the data call-in)—are integral to developing an assessment. In prior IRIS assessment processes, EPA provided timeframes for

these steps. Importantly, including the time frames for these steps would likely bring the estimated overall time for completing standard assessments closer to three years. We note that this more realistic timeframe may be problematic because when assessments take longer than two years, they can become

subject to substantial delays stemming from the need to redo key analyses

to take into account changing science and assessment methodologies.

• While EPA states that some IRIS assessments may take longer because of

their complexity, large scientific literature base, or high profile, the agency

does not provide any guidance on likely or expected time frames for assessments of these chemicals. This is noteworthy because we found that EPA has

not been able to complete assessments of the most important chemicals of

concern, such as those likely to cause cancer or other significant health effects. For example, EPA’s assessment of dioxin has been ongoing for 18 years.

It is critical that EPA establish timeframes to enable the agency to manage

complex assessments.

• EPA’s new process does not include a discussion of key planning steps. Specifically, it omits important pre-assessment steps included in prior processes—such as a call for nominations of chemicals to be assessed and the establishment of the IRIS agenda, which is list of chemicals that EPA plans to

assess. Accordingly, it is not clear whether or when EPA will implement our

recommendation that it provide at least two years’ notice of planned assessments. Among other things, doing so would give agencies and the public more

advance notice of planned assessments and enable external parties with an

interest in a given chemical to, for example, complete relevant research before

the start of an IRIS assessment.

• Particularly in light of the fact that EPA’s estimates for completing assessments are likely understated, we believe that the agency should continue to

look for additional opportunities to streamline its process. For example, it is

not clear why EPA could not solicit comments from other federal agencies at

the same time it sends the initial draft assessment to independent peer reviewers and publishes it in the Federal Register for public comment. In addition to reducing overall assessment time frames, this change could enhance

transparency. Specifically, by obtaining the first draft of the assessment at

the same time as the other federal agencies, the public and peer reviewers

could have greater assurance that the draft had not been inappropriately biVerDate 11-MAY-2000 13:39 Dec 21, 2009 Jkt 049964 PO 00000 Frm 00038 Fmt 6633 Sfmt 6621 C:\DWORK\I&O09\061109\49964 SCIENCE1 PsN: SCIENCE1
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ased by policy considerations of these agencies, including ones that may be

affected by the assessment’s outcome, such as the Departments of Defense

and Energy. Some of these agencies and their contractors could, for example,

face increased cleanup costs and other legal liabilities if EPA issued an IRIS

assessment for a chemical that resulted in a decision to regulate the chemical

to protect the public.

• The new assessment process states that ‘‘White House offices’’ will be involved in the interagency consultation process but does not indicate which offices. Given that (1) EPA will be performing the coordinating role that OMB

exercised under the prior process and (2) the purpose of these consultations

is to obtain scientific feedback, it is unclear whether OMB will continue to

be involved in the interagency consultation process.

• EPA has specified in its new assessment process that written comments provided by other federal agencies will become part of the public record. However, it is silent as to the purpose of the consultation meetings and, if applicable, whether EPA plans to document for the public record any significant oral

agreements or decisions made at the consultation meetings. In order to ensure transparency and alleviate any concerns of potential bias in the assessments, it will be important for EPA to be clear on these matters.

In addition to addressing these issues, the viability of the IRIS program will de- pend on effective and sustained management and oversight. Collectively, a number

of factors that can impede the progress of IRIS assessments present significant

management challenges. These include the following:

• Unlike a number of other EPA programs with statutory deadlines for completing various activities, no enforceable deadlines apply to the IRIS program.

We have stated in previous testimonies on the IRIS program that if EPA is

not able to effectively maintain this critical program, other approaches, including statutory requirements, may need to be explored. We believe the absence of statutory deadlines may contribute to EPA’s failure to complete timely IRIS assessments. For example, assessment schedules can easily be extended—and consistently are. These chronic delays in completing IRIS assessments have detrimental consequences for EPA’s ability to develop timely and

scientifically sound decisions, policies, and regulations.

• Science and methodologies are constantly changing. Thus, there will always

be a tension between assessing the best available science and waiting for

more information. IRIS will remain viable only if it returns to its model of

using the best science available at the time of its assessments and plans for

periodic updates of assessments to identify the need for revisions.

• An overarching factor that affects EPA’s ability to complete IRIS assessments

in a timely manner is the compounding effect of delays—even one delay can

have a domino effect, requiring the process to essentially be repeated to incorporate changing science. For example, delays often require repeating reviews

of the scientific literature on a chemical to take into account the time that

has passed since the literature review was completed; this, in turn, may require detailed analyses of any new studies found to be relevant.

• Long-standing difficulties in completing assessments of chemicals of key concern—those that are both widespread and likely to cause significant health

issues—stem in part from challenges by external parties, including those that

may be impacted by EPA regulation of chemicals should an assessment lead

to such action. Such challenges are to be expected and can be best addressed

by EPA’s focusing on the best available science, credible expert review, and

completing the assessments.

• The IRIS assessment process has been frequently changed in recent years;

IRIS process reforms, such as those recently issued, are not established in a

regulation or statute and thus can easily be altered. As we have reported,

EPA’s continual changes present a challenge to the chemical managers who

are undertaking the assessments, particularly in the absence of current operating procedures to guide chemical managers on basic procedures and program management responsibilities for the development, review, and finalization of IRIS assessments.

In conclusion, EPA’s most recent changes to the IRIS assessment process appear

to represent a significant improvement over the process put in place in 2008. That

is, if implemented effectively, the changes may appropriately restore to EPA its control of the IRIS process, increase the transparency of the process, and streamline

aspects of the process, among other things. We believe that the agency’s ability to

36

produce timely, credible, and transparent assessments will also depend in large

measure on clear implementation procedures and rigorous management oversight,

given the numerous factors that can impede EPA’s ability to complete timely IRIS

assessments and the lack of clarity on some aspects of the new process. Perhaps

most importantly, EPA needs to hold itself more accountable to the public and Congress for carrying out this important component of its mission, especially since the

IRIS program is discretionary.

Mr. Chairman, this concludes my prepared statement. I would be happy to respond to any questions that you or other Members of the Subcommittee may have

at this time.

GAO Staff Acknowledgments

Contributors to this testimony include Christine Fishkin (Assistant Director),

Laura Gatz, Richard P. Johnson, Summer Lingard, Nancy Crothers, Antoinette

Capaccio, and Carol Kolarik.

Related GAO Products

Scientific Integrity: EPA’s Efforts to Enhance the Credibility and Transparency of Its

Scientific Processes. GAO–09–773T. Washington, D.C.: June 9, 2009.

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

EPA Science: New Assessment Process Further Limits the Credibility and Timeliness

of EPA’s Assessments of Toxic Chemicals. GAO–08–1168T. Washington, D.C.:

September 18, 2008.

Chemical Assessments: EPA’s New Assessment Process Will Further Limit the Productivity and Credibility of Its Integrated Risk Information System. GAO–08–

810T. Washington, D.C.: May 21, 2008.

Toxic Chemicals: EPA’s New Assessment Process Will Increase Challenges EPA Faces

in Evaluating and Regulating Chemicals. GAO–08–743T. Washington, D.C.:

April 29, 2008.

Chemical Assessments: Low Productivity and New Interagency Review Process Limit

the Usefulness and Credibility of EPA’s Integrated Risk Information System.

GAO–08–440. Washington, D.C.: March 7, 2008.

BIOGRAPHY FOR JOHN B. STEPHENSON

Mr. Stephenson is currently the Director of Natural Resource and Environment

issues for the U.S. Government Accountability Office—the independent investigative

arm of the Congress. In that capacity, he has for the past nine years directed numerous studies and research projects, issued hundreds of reports, and testified on

many occasions before several Senate and House Committees. His work has provided invaluable assistance to the Congress in its oversight and legislative role on

diverse environmental protection issues such as clean air, clean water, safe drinking

water, chemical controls, toxic substances, climate change, superfund, and hazardous materials spill prevention and cleanup, as well as critical infrastructure protection.

Prior to his current position, he led numerous GAO studies and investigation in

the information technology and federal acquisition and federal grant areas. He has

extensive experience in dealing with Congressional Committees and Members, federal agencies, trade associations, special interest groups, and State and local governments. From April 1998–February 2000, he was Deputy Staff Director for the Senate Special Committee on the Year 2000 Technology Problem for the Chairman

(Senator Robert Bennett, R–UT), and Vice Chairman (Senator Christopher Dodd, D–

CT). In that capacity, he ran the day-to-day operations of the Committee including

orchestrating over 35 hearings, preparing legislation, organizing briefings and Floor

activities for the Full Senate, working with the White House’s Year 2000 Director

and staff, and organizing numerous press and public events. He returned to GAO

in March 2000 where he was Executive Assistant to the U.S. Comptroller General

(the head of GAO) until entering the Senior Executive Service in October 2000.

Mr. Stephenson holds a BS degree in Industrial Management from Purdue University, an MBA from Xavier University, and is a graduate of the Harvard Kennedy

School of Government’s Senior Executive Fellows program. He lives in Fairfax Station, Virginia with his wife, 11-year-old daughter, and 9-year-old son. He also has

two grown sons who reside in Cincinnati, Ohio.

37

DISCUSSION

Chair MILLER. Thank you, Mr. Stephenson.

We will now begin our first round of questions, and I now recognize myself for five minutes.

ENSURING EPA’S PROGRAM CONTROL

Mr. Stephenson, I want to talk about control of IRIS by EPA.

IRIS, as Dr. Broun pointed out in his opening statement, has always provided for control, at least according to the statute, stated

control by EPA. But in the last eight years certainly EPA’s control

was very much eroded by pressures from other agencies, that although the IRIS listing has no regulatory affect, it is a precursor

to regulation. And there were agencies that liked using chemicals

without restrictions and didn’t want to have to mess with the risk

management issues. So it was easy to stymie a risk assessment

through IRIS and not have to worry about it.

And there were officials at OMB who seemed to be more than

happy to help them in that effort at OIRA. Whether it was the

other agencies or the manufacturers of the chemicals or simply an

anti-regulatory zeal, OIRA was more than happy to block it.

Mr. Stephenson, in light of all that history, how can we be sure?

Should we continue to worry that EPA will not, in effect, be in control, even though it may, according to the stated procedures, be in

control?

Mr. STEPHENSON. A multi-faceted question. OMB does serve a

purpose in facilitating interagency comments. There is no question.

The problem with the old process was that all of those comments

were declared delivered evidence, so there was no honest broker, if

you will, as to what comments were being provided and when. So

we think the fact that this process allows for complete transparency and all of those comments, which are supposed to be comments on the scientific integrity of the assessment, be made public.

So that is huge.

Having said that, you know, EPA like every other agency works

for the White House, and OMB is an office of the White House, and

so the proof is going to be in the pudding as to how much influence

OMB may or may not have in this current process. And now with

you asking us to do so, we are going to be watching that closely.

Chair MILLER. Are there things for us to watch for? Are there

going to be early indicators that will tell us that EPA is truly in

charge or only nominally in charge, and it is still being run out of

OIRA or by the White House?

Mr. STEPHENSON. Well, the only thing you can really do is track

individual assessments through the process, and see what kind of

comments are made and by whom and what the reaction is to those

comments. Interestingly, in the old OMB, while it is true they said

that EPA was in charge, if you talked to OIRA, if you talked to the

other part of OMB, they would—who did the part reviews if you

are familiar with those, they clearly said that OMB was in charge.

So even within OMB it was unclear who was in charge of that IRIS

process.

38

THE EFFECT OF AN IRIS LISTING

Chair MILLER. Mr. Stephenson, the opening statements kind of

raised the question of whether there should be more process, more

procedures, more of a chance to challenge EPA, that EPA should

not be the final decider, should not make the final decision on IRIS

listings. But do IRIS listings have any regulatory effect? Is there

anything that anybody cannot do or has to do because of the way

a chemical is listed in IRIS?

Mr. STEPHENSON. No. You correctly mentioned that it is a precursor to deciding how to control dangerous chemicals, if you need

to at all, and so we view it as a purely scientific process that

shouldn’t be meddled—you shouldn’t be mixed with science policy,

which also has a legitimate role.

Chair MILLER. Well, if there is a regulatory effort after the—

after an IRIS listing to manage the—a risk that IRIS, an IRIS listing identifies, does—how is the science treated there? Are all the

same issues revisited in the regulatory process?

Mr. STEPHENSON. Well, sure. I mean, you have an opportunity to

question the relevance of the science for a given regulation, but

each one is a case-by-case issue. The beauty of IRIS is that it is

the official agency position on a given chemical, and therefore, the

starting point to decide where you want to go from there. It doesn’t

mean anything about regulation purely.

Chair MILLER. But if the formaldehyde industry, for instance,

wanted to argue that formaldehyde is actually good for you, they

could do that in the regulatory process for risk management regulations. Is that correct?

Mr. STEPHENSON. Well, I would think they would do it in both

places; in the IRIS process as well as the regulatory process.

Chair MILLER. My time has expired.

I now recognize Dr. Broun for five minutes.

Mr. BROUN. Thank you, Mr. Chair.

HOW IRIS ASSESSMENTS ARE USED

Just to go along with what Chair Miller was just talking about,

Mr. Stephenson, it is my understanding that a lot of private sector

stakeholders are basically using IRIS assessments as a de facto

regulatory statement. Is this true?

Mr. STEPHENSON. I have no way of knowing that.

Mr. BROUN. Okay. What part in IRIS’s process should outside

stakeholders play?

Mr. STEPHENSON. If they have—remember, IRIS is supposed to

be a collection and a synthesis of existing research that is available

at the time the assessment is—begins, essentially, and so there are

good researchers and scientists throughout industry, throughout

the other federal agencies, throughout academia. All of those people are allowed to contribute to an individual assessment once they

see the draft assessment and it goes out for public comment. And

all of those comments can be seen by the public and vetted by other

scientists, and everyone in this process seemingly can see how EPA

dispenses with each of those comments.

39

TRANSPARENCY PROCESS

Mr. BROUN. Chair Miller referred to me as Dr. Broun. I am a

physician. There are some on this whole committee that would

argue that I am not a scientist, but I am. There are some research

scientists that would argue that, but I am an applied scientist, and

I believe in the scientific process and believe in peer review and

lots of it. The more peer review that enters into the process, the

greater I think we have in scientific integrity.

When I graduated from medical school, the things I was being

taught at that time, to be absolutely factual, have subsequently

been shown to not be factual, and I think we have a lot of things

going on in public policy today such as climate change caused by

human effects on the climate are part of that, but it is kind of—

I don’t want to go off on that tangent, but to get back to IRIS, so

is—I am just real concerned that there is not enough transparency,

Mr. Stephenson.

You talked about the transparency, but is all the discussion within the agency or within anybody who has comments on the assessments being done, is all of that available for public peer review?

Mr. STEPHENSON. It is supposed to be.

Mr. BROUN. Everything?

Mr. STEPHENSON. We hope so. Like you say, it is a scientific process, and we would hope all of that is very public and vetted in the

public.

Mr. BROUN. How about the oral arguments, interagency oral arguments, any consultation meetings, things like that? Will all of

those things be available for public peer review?

Mr. STEPHENSON. We don’t know, but that is why we say more

clarification is needed in those consultation steps within the process, and if there are any decisions made, our recommendation

would be that they be made public. But EPA may have a better

clarification on that.

Mr. BROUN. Doctor?

Dr. TEICHMAN. It is certainly our intention to make sure that all

the written comments are put in the public docket, but we also

know that there is sometimes discussions that go on orally. We

would hope in those discussions, and what we have tried to do

since we will be controlling the process, is to encourage people to

provide the important points even in those oral discussions in writing so they are made open and transparent to the public. And that

is just within the interagency discussion steps at 3, Step 3 and

Step 6A in your chart number three, Mr. Chair, if I remember correctly.

I think it is also important to note that when there are disagreements potentially between agencies, which can occur, that that is

when it is a good time, in fact, to turn to peer review, Mr. Broun,

just as you have identified. And so it is the consultations both inside of the Agency where we may have some scientific disagreements on a draft assessment, as well as when we had the interagency discussions, that those become, in fact, very good charge

questions to the peer review panel for them to opine on to inform

us in the federal system.

40

Mr. BROUN. Well, I hope that you can assure this committee that

all opinions, particularly dissentive views, within any oral discussion, consultation is available for public preview, because I think

it is absolutely critical for scientific integrity, first thing. Secondly

is to guarantee that there is a correct peer review process and that

there is not a quashing of opposing views by any entity, whether

it is an agency or an individual scientist, what have you. I think

it is absolutely critical for the health of this country and its science

that those things—so please assure this committee that that is

going to be the policy at EPA.

Dr. TEICHMAN. It is certainly something as I think Mr. Stephenson has mentioned that is a bit vague in the process as identified

and something that requires further discussion and clarification to

be more precise. So I would prefer to have that discussion before

I assure this committee at this particular time. But it is something

we will certainly have discussion about.

If I may for just a brief moment, however, I want to make sure

we are distinguishing sometimes between those comments that are

scientific in nature and those that may be policy in nature, because

it is, indeed, we hope with our IRIS process to really focus on the

scientific comments, because, indeed, our IRIS assessments are not

regulatory.

And if I may draw attention actually to a report by the bipartisan policy center that you may be familiar with since it is cochaired by Sherwood Boehlert, a friend, I believe, of this committee

in the past, okay, and has esteemed Members on it such as Lynn

Goldman and John Graham from, therefore, across the political

spectrum.

Chair MILLER. I think the screen is actually obscuring the portrait of Mr. Boehlert.

Dr. TEICHMAN. That I can’t see. I apologize. But, anyway, I did

want to make it clear that, indeed, your—the comments about scientific disagreements we certainly want to make sure are aired,

but we want to distinguish those from policy ramifications. These

are the recommendations, in fact, from Sherwood Boehlert’s bipartisan committee:

‘‘Distinguishing between science and policy is not always easy

or straightforward, and scientists must make choices based on

values in the course of their work. Nonetheless, policy debate

would be clarified and enhanced if a systematic effort were

made to distinguish between questions that can be resolved

through scientific judgments and those involved judgments

about values and other matters of policy.’’

So what we are trying to do here is to keep the focus on the scientific arguments that are the basis for the conclusions drawn in

our IRIS assessments, and it is later in subsequent steps when regulations occur that the policy ramifications can be debated as well.

Mr. BROUN. Well, thank you, Doctor. My time is long up, and the

Chair——

Dr. TEICHMAN. I apologize.

Mr. BROUN.—has been very long suffering, but I just want to

make one statement from a—Mr. Chair. Policy makes a difference,

too, and it needs to be transparent, and we need to make absoVerDate 11-MAY-2000 13:39 Dec 21, 2009 Jkt 049964 PO 00000 Frm 00044 Fmt 6633 Sfmt 6601 C:\DWORK\I&O09\061109\49964 SCIENCE1 PsN: SCIENCE1
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lutely certain that any discussion, policy or scientific, I think is

available for the public.

Thank you, Mr. Chair.

Chair MILLER. Thank you, Mr.—Dr. Broun.

I now recognize Ms. Dahlkemper for five minutes.

Ms. DAHLKEMPER. Thank you, Mr. Chair, and I want to thank

you and the Ranking Member for bringing forward this important

hearing and thank the witnesses for joining us today.

PROGRAM SCHEDULE AND PRODUCTIVITY

I want to talk a little bit about the productivity side of things,

and as we are looking at your new process here, you have certain

durations, Dr. Teichman, on there, and I want to ask you about

how EPA will guarantee that these dates are met. Obviously, it is

a good, aggressive schedule, I believe, but how are you going to

make sure that these dates are met with the different processes?

Dr. TEICHMAN. We are going to do our absolute best. In terms of

a guarantee, I cannot promise that every assessment will last only

23 months. There will, indeed, be situations, and we hope they are

few and far between, and indeed, this is stated in the Administrator’s testimony as well that she gave two days ago on the other side

of the Hill, if you will, that most assessments we expect to try and

stick to the 23 months.

I have worked for the Administrator now for five months. I can

tell you she is a very intelligent, very aggressive individual who

keeps us on our toes and does everything she can to support our

efforts.

In that regard you also should hopefully take some solace in the

fact that the policy was discussed. I was certainly not in the room,

as it was, but among the Administrator and her staff and officials

within OMB, and I don’t know, other agencies, perhaps, too, and

it was agreement across the board on this particular process. So I

believe there will be other agencies who will be held to task as we

try and hold to the schedule to commitments that they made to the

Administrator in those initial negotiations.

Ms. DAHLKEMPER. Mr. Stephenson, do you have any comments

on this in terms of how you think this could be achieved?

Mr. STEPHENSON. We have already mentioned that some of the

early steps are missing, so you are already behind the eight ball

on the 23 months. Most importantly it is mentioned on the chart

here that you are going to do a comprehensive literature search

and data call, which will be in the notice, so there is a process that

has to be followed to do that, which will take some time.

In addition, our recommendation from 2008, about the importance of a two-year planning window is critical here so that the

whole research community, well in advance, will know which

chemicals are going to be assessed two years down the road and

can put together any research they deem appropriate before the

process actually starts. That will completely avoid, you know, the

development of research as the particular chemical is being assessed and make the whole process more efficient.

We think this is really ambitious, but we are going to be watching.

42

POTENTIAL IMPROVEMENTS

Ms. DAHLKEMPER. Also, as you were speaking, Mr. Stephenson,

you were mentioning different—about five or six different improvements that you would like to see, and I guess I want to ask you,

Dr. Teichman, about that, you know, about his, Mr. Stephenson’s

testimony on that.

Mr. STEPHENSON. Well, some of them were just clarifications but

yes.

Dr. TEICHMAN. Well, some were clarifications and some I have

written down. I am not sure I have got them all correctly written,

but I will state that as, hopefully, and I think I can—if I parrot

back correctly, the statement of my co-witness here, that if managed effectively, the new EPA process for IRIS would be considered

very responsive to the GAO recommendations of the past.

Therefore, we are trying to demonstrate a commitment to seriously consider what GAO tells, and we will consider the recommendations that the co-witness has asked. We would like to

have a chance to try the process as it has been agreed to, and I

think Mr. Stephenson has said it is worth a try, but we need to

take a look and see how we progress. I know the Chair has asked

GAO in a year to report back, and I think we are anxious to follow

that particular path. But we will still, nonetheless, consider certainly for clarification, the recommendations from GAO and even

some of the potential changes if, indeed, they enhance the process

in our estimation as well.

Ms. DAHLKEMPER. I thank you, and I yield back.

Chair MILLER. Thank you, and I now recognize myself for a second round of questions.

My—we will be called for votes in maybe 20 minutes, half an

hour, and my intention will be just to have questions probably until

that time and then that will be the end of our hearing when we

get called for votes.

DELIBERATIVE PROCESS

Dr. Teichman, there were questions about written, everything

written is going to be available. There is no assertion that it is deliberative. We all get to see it. Congress sees it, the American people sees it. It is public.

Dr. Broun asked questions about oral discussions, telephone conversations, conversations at a water cooler, whatever, meetings.

And to the extent that they produce in writing, that will then—the

writing will be available. There is—it is probably not reasonable to

expect that everything will be transcribed, but in the past when we

have asked, specifically Ms. Dudley, about who was involved in

what conversations and what conversations there were and what

was said, she asserted a deliberative process privilege, which I read

the cases that discuss deliberative process privilege, it is a very

light privilege. It is basically—it protects anything—discussions—

if the only reason that Congress or a court is asking for it is out

of idle curiosity, but if there is any real need for it at all, that it

should be available.

It—my understanding is the Administration does not—EPA now

does not assert a deliberative process privilege for any oral conVerDate 11-MAY-2000 13:39 Dec 21, 2009 Jkt 049964 PO 00000 Frm 00046 Fmt 6633 Sfmt 6601 C:\DWORK\I&O09\061109\49964 SCIENCE1 PsN: SCIENCE1
43

versations. So if Congress calls upon people involved in the decision

to tell us who was in the discussion, what they had to say, that

that would be—those would be questions that you would answer as

well as you could remember them. Is that correct?

Dr. TEICHMAN. I am not a lawyer, but that is certainly my interpretation as well.

THE GAO HIGH-RISK LIST

Chair MILLER. Okay. All right. I think Ms. Dahlkemper asked

around the high-risk list or came close to it. Mr. Stephenson, I assume that being on the GAO’s high-risk list is something that a

Federal Government agency would regard about the same way a

bank would regard being on the FDIC’s watch list. It is not a favorite place to be.

How long do you expect it would take IRIS to kind of earn their

way off that list?

Mr. STEPHENSON. The high-risk designation is not only designated to IRIS, it has to do with TOSCA reform as well.

Chair MILLER. Uh-huh.

Mr. STEPHENSON. So we need to wait and see proof that the problems that we have observed have been addressed, and there is no,

you know, it is not—it is fairly subjective. It is up to GAO when

we decide to add or remove things from that risk. It doesn’t carry

any designation other than the fact that we hope that the Agency

and the Administration will devote greater attention to it, and the

Congress for that matter. That is why we do it.

So to get on that list we are very, very, very concerned. We are

a conservative agency, and it doesn’t get put on that list lightly.

There were only three new additions to the list this year, and this

was one of them.

Chair MILLER. Dr. Teichman, I assume it is a high priority to get

off that list?

Dr. TEICHMAN. Most certainly, sir.

ROYAL DEMOLITION EXPLOSIVE

Chair MILLER. Okay. Thank you. Mr. Stephenson, you examined

in the GAO report last year the IRIS process specifically for a

chemical called Royal Demolition Explosive or RDX. What is the

status of that?

Mr. STEPHENSON. We haven’t done any specific work on that. It

was one of the chemicals we highlighted to illustrate how broken

the process was and how long it was taking. I believe it had been

in assessment over a decade. In updating for this hearing we noticed that it had been removed from EPA’s list of chemicals undergoing assessment, and we haven’t been able to follow up onto exactly why that happened. It was on there a month ago and removed as of a day ago.

Chair MILLER. Dr. Teichman, do you know why RDX has gone

missing?

Dr. TEICHMAN. I can tell you what response I got when I posed

that same question to the staff. Nonetheless, I would prefer to give

a full response to a question for the record on where the chemical

managers involved would be able to comment on the decision procVerDate 11-MAY-2000 13:39 Dec 21, 2009 Jkt 049964 PO 00000 Frm 00047 Fmt 6633 Sfmt 6601 C:\DWORK\I&O09\061109\49964 SCIENCE1 PsN: SCIENCE1
44

ess that is involved with that particular chemical. But it was, indeed, listed for possible assessment under the IRIS Program, but

we have identified 48 assessments that we think are priority

chemicals, and in the second batch an additional 48. RDX is in the

second batch, so I would prefer, again, for a question for the record

to give the decision process as to why it is in the second batch. Chair MILLER. If you would submit it on the record. Mr. Whittaker, in a show of bipartisanship would you like to— would you raise the screen so we can all see the portrait of Mr.

Boehlert?

I now yield back the remaining 10 seconds of my time and recog- nize Dr. Broun for another round of questions.

ASSESSMENT TIMELINESS

Mr. BROUN. Thank you, Mr. Chair. I understand there is a nat- ural tension between fairness and timeliness with assessments.

The question is, will this streamlined process ultimately sacrifice

scientific credibility, especially considering the recent negative reviews of the assessments by the National Academy of Science? And

the question I have really for both of you is, if EPA can’t get the

assessment right in 10 years, what makes you think, each one of

you, that you can produce better results in 23 months?

Mr. STEPHENSON. I mean, we are going to—we think 23 months is optimistic. We are going to be looking, but the problem is it is

like a domino effect. If the assessment takes too long, there is new

research that becomes available. You have to reconsider, and it

goes back to square one again. That is what I meant about the endless assessment and reassessment. This is supposed to be a process

that synthesizes existing research that is available at the time and

should be able to be done fairly quickly and vetted. These assessments are supposed to be updated routinely, you know, every 10

years. So with 540 chemicals on the list, if you are not doing at

least 54 a year, you are not even keeping up. So we think this is very ambitious. We are not sure there is enough resources devoted to this yet, but that is a very good question.

Dr. TEICHMAN. It is a very ambitious goal.

Mr. STEPHENSON. It is an ambitious goal. I don’t disagree, and we have certainly asked for additional resources to help us meet

that goal in the President’s budget request. There are a couple of

things I think, though, that are different than perhaps the past as

we look at the new process.

The first is this new process as I mentioned earlier was developed in consultation with other federal agencies, and therefore, I

believe there is a mutual commitment to try and meet the schedule

that has been identified. This does not mean that it isn’t aggressive

and that we shouldn’t take a look and see in a year’s time if we

have been able to stick to it. We welcome that type of a review and

hope to be able to successfully demonstrate we were able to meet

that goal of 23 months.

Second is the listening sessions that I referred to earlier are still

maintained in this process. This is a chance where the external

peer review meeting that—where there used to be an opportunity

for somebody to speak for two or three minutes or perhaps as many

45

as five or seven minutes, no longer than I was able to testify today,

I would add, most likely, that that was perhaps insufficient time

for real discussion and exchange. The listening sessions actually

now are for much longer periods of time, more interchanged with

those who have any opinions they wish about our draft assessments, and that listening session is, indeed, also shared with the

external peer review panel and their assessment.

So I believe that is a very positive step that will hopefully enable us to air for greater, longer periods of time potential disagreements

in the scientific facts and let the external peer review panel tell us

their position on those arguments.

Mr. BROUN. Has the timeframe for peer review changed at all?

Dr. TEICHMAN. I believe the time period is 60 days at this point. I think it might have been a little longer. I have to check. I apologize.

Mr. STEPHENSON. I got it at 105 days.

Mr. BROUN. Mr. Chair, I am not real interested in a lot of conversations that go around the water fountain, but those conversations that do have to do with scientific integrity as well as the scientific process I think are very important, and I hope that we can,

as a committee be reassured that those conversations will be reported and will be open and for public view. And it is just something that I think is absolutely critical for scientific integrity, and

I just want—I just throw that out as a comment to both of you all. And with that I will yield back to the Chair for the next round, if we have one.

Chair MILLER. Thank you. Just one more brief round. I do want to point out that when we raised the screen to reveal

the portrait of Mr. Boehlert, we also revealed the portrait of a substantially slimmer Chair Sensenbrenner, which is perhaps more bipartisan than I really intended to be.

PEER REVIEWS

Dr. Teichman, Step 4 of the new process is an independent expert peer review, which Dr. Broun has been asking about already,

and our staff understands that that will usually be done on a faceto-face basis, meetings, and perhaps that could be transcribed or—

but in some cases it will also be done by the National Academy of

Sciences. We understand that peer review can be done by mail, it

can be done through the Internet, it can be done face to face, it can

be done through an Academy of Sciences study. Can you give us a sense of what each of those different methods

for peer review will cost and how you will decide which method?

Dr. TEICHMAN. First of all, let me since I was under oath correct

the statement I said before about 60 days indeed as my co-witness

has said it. Now that I have it in front of me, it is 105. I was confusing with a different step.

In terms of the cost for each of the individual types of peer reviews, I would like to provide that as information for the record.

However, it is important to state that we very carefully consider

the complexity of a given assessment as to which form of peer review that we would use. To use a letter if you want an IRIS assessment would be very rare. At the other end of the spectrum to go

the National Academy of Sciences, which we have done, one of the

46

most controversial chemicals, is hopefully equally rare. More times

than not we will convene a peer review panel, which would have

a face-to-face meeting that might be the contractor choosing the

panelists, or it might be our own science advisory board.

And the cost for those four different options we will be glad to

provide, but certainly they vary as from the letter review to the

NAS, based on the complexity of the assessment.

Chair MILLER. Can you, Dr. Teichman, can you tell us who some

of the contractors are who have been contracted with—that EPA

contracted with to conduct the peer review?

Dr. TEICHMAN. I am only familiar with one and any mention is

not considered an endorsement, but nonetheless, I think the Eastern Research Group has been one of the organizations that our National Center for Environmental Assessment has used to locate

peer reviewers and pull together such panels.

Chair MILLER. What procedures do you have in place to make

sure that there are no conflicts of interest with forums conducting

the peer review process?

Dr. TEICHMAN. The firms themselves, again, I would prefer to

have a better chance to put this in the record than I will be able

to convey right now, but if you are talking about the choice of the

firms, those are competed, and I don’t know what confidentiality or

impartiality statements they may have to be to be a successful bidder on the contract.

However, the people who they hire as subcontractors, as panelists there, there are, indeed, statements that have to be provided

where people state what their potential associations are, and they

demonstrate that they are impartial.

Chair MILLER. Mr. Stephenson, are you familiar with any work

that the GAO has done on outside contractors for peer reviews?

Mr. STEPHENSON. Not specifically contractors but there are two

different brands of scientific advisory committees the EPA uses.

There is 24 of them in total, and we noted in the testimony in the

Senate that seven of those have specific conflict of interest procedures for their membership, but the others do not. And they are—

that may not be inappropriate because you are trying to seek

points of view on a given chemical or giving a scientific assessment

or a given regulation. So we just observe that EPA should not confuse the purpose of both of those two different kinds of scientific

advisory committees.

Chair MILLER. Dr. Teichman, it seems that some of the most

widely-used chemicals with perhaps the most troubling health consequences are the ones that are tied up for the longest time in—

or have been in the past in IRIS: formaldehyde, TCE, Perk, Dioxin.

How are you going to set priorities for completing assessments?

Dr. TEICHMAN. Well, indeed, we wish to tackle those chemicals

that we think pose the greatest risk to the American public, and

those become our priorities. It is not an issue of any particular

stakeholder group interest one way or the other, anybody influencing our decision other than we believe it poses a high risk, and

those become the chemicals that we go after.

And we believe we do it in a rigorous fashion that everybody has

an opportunity to comment and to tell us if we have gotten it right

47

in our draft and hopefully we have done it correctly by the time

we have the final assessment.

Chair MILLER. Okay. Are you going to include others, both interagency suggestions or outside——

Dr. TEICHMAN. We take suggestions from everybody as we publish our list of potential chemicals we could be working on and others that people wish to recommend, and that includes other federal

agencies, it includes State and health organizations. It is a FR—

a Federal Register notice asking for people’s thoughts on what our

agenda should be.

Chair MILLER. I yield back the remaining three seconds of my

time.

Dr. Broun, do you have any more questions?

FAIRNESS AND TIME CONSTRAINTS

Mr. BROUN. Going back to peer review process, Doctor, I am looking at the document actually here, and you were correct the first

time, that you are supposed to announce a public comment period

of 60 days for peer review, and again, as a physician I am concerned that 60 days, 105 days may or may not be enough, and 23

months may not be enough time to adequately evaluate each of

these chemicals.

How can you guarantee—but in the review process how can you

guarantee fairness in that IRIS process if you give the public only

60 days to review?

Dr. TEICHMAN. We believe 60 days will be adequate to give the

public fair opportunity to comment. We believe the combination of

the listening sessions gives them even a chance to interact with us

on the draft assessment prior to the external peer review panel

coming together. If indeed somebody in a rare instance asks for an

extension and indeed the material in front of you discusses that potentiality, we do, indeed, offer such an extension, but we can’t

promise, in fact, that their comments will be before the peer review

committee. And we believe it is best for as many public comments

to be shared with the peer review committee as they make their

deliberations.

Mr. BROUN. Was the 60-day number just picked somewhat arbitrarily? Did you all just think that that is a good period of time,

or was there a particular thought in giving enough time but not too

much?

Dr. TEICHMAN. I think that is a fair way of putting it. It was not

arbitrary in terms of we plucked it randomly, we plucked it out of

midair. We think this is an appropriate amount of time. If it turns

out as we have explored this that people feel they must have 90

days, for example, it is something to consider down the road.

MORE ON THE TRANSPARENCY PROCESS

Mr. BROUN. All right. Thank you, sir. Back to the transparency,

will you commit to truly making the IRIS process transparent by

creating a public docket for all materials received at EPA related

to each IRIS assessment, including materials that EPA has received but which it decides will not, it will not allow them to make

its assessment decisions?

48

Dr. TEICHMAN. Yes, indeed. All comments that we receive in the

written form as we have discussed will be in the public docket. We

always include all the information that has been given to us,

whether or not it is what we use in our final assessment, so that

people see the total record, and they can choose from among it as

to what they think should be influencing our final word.

Mr. BROUN. So that it is a promise to us that that will be done,

and I hope you can promise us at some point that all those oral

discussions and those conversations and consultations that do occur

orally will be provided for the public also.

With that, Mr. Chair, I yield back.

Dr. TEICHMAN. May I just comment for a moment, Mr. Chair, if

I can?

Chair MILLER. Dr. Teichman.

Dr. TEICHMAN. Again, we will be—the oral comments I wish to

come back to the Agency and have further discussion on. On the

written, I am not aware that we have never or that we have ever

not put every written comment that we got from the public or as

part of the peer review in the docket. What is interesting and new

in this process is, in fact, now the written comments we get from

other agencies will also be in the public docket.

CLOSING

Chair MILLER. I think we are now done with our questions.

There is a phrase I have heard all my life, which I suspect is a

southern phrase. I am sure Dr. Broun has heard it as well then.

When we want to disassociate ourselves from someone else, not

take full responsibility for the conduct and other, we say, ‘‘I didn’t

take him to raise.’’

But it appears that I have taken IRIS to raise, this subcommittee

has taken IRIS to raise, GAO has taken IRIS to raise. So we will

continue to close—to watch IRIS closely. We think it is important

that IRIS perform its mission and produce the right number of very

sound, credible, scientifically-sound, credible assessments.

Mr. BROUN. Mr. Chair, would you yield?

Chair MILLER. Mr.—Dr. Broun.

Mr. BROUN. Thank you for yielding, sir. I am very happy you

have taken IRIS to raise and that we are having this hearing and

that you are continuing this process because I think it is absolutely

critical for the public to have total confidence in what assessments

are made by IRIS and by the government across the board.

I think there are many things that are being put out by the government that are declared scientific that aren’t, and it does not—

things in the way of determinations that aren’t accepted by the

public, and I think rightfully so. And so I am glad you have taken

IRIS to raise, sir, and I am eager to continue in this process with

you, so I thank you very much, and I congratulate you on taking

IRIS to raise.

Chair MILLER. Thank you, Dr. Broun. We may not think alike,

but we do talk alike.

Before we bring the hearing to a close I want to thank our witnesses today for testifying before the Committee. We may see you

again.

49

Under the rules of the Committee the record will remain open for

two weeks for additional statements from the Members and for any

answers to any follow-up questions the Committee may have for

the witnesses. Dr. Teichman, you had said you wanted to provide

additional information.

And with that the witnesses are excused, and the hearing is now

adjourned.

[Whereupon, at 2:15 p.m., the Subcommittee was adjourned.]

(51)

Appendix 1:

ANSWERS TO POST-HEARING QUESTIONS

52

ANSWERS TO POST-HEARING QUESTIONS

Responses by Kevin Teichman, Deputy Assistant Administrator for Science, Office of

Research and Development (ORD), U.S. Environmental Protection Agency (EPA)

Questions submitted by Chairman Brad Miller

Q1. During the hearing, we discussed the status of the chemical called Royal Demolition Explosive (RDX), in the IRIS process. Please explain the decision process

and process for removal of RDX from EPA’s list of chemicals undergoing IRIS

assessment.

A1. There are over 80 assessments in progress in the IRIS program, all at various

stages of development.

EPA made a decision to focus its resources on those assessments that were farthest along in the process and work as quickly as possible to finish up that first

set and then turn its attention to the second set of chemicals/substances. The first

set consisted of 48 assessments. Each of those 48 was at the internal Agency review

step or further in the process. As assessments are completed and staff are available

to work on the next set of assessments, focus will shift to the approximately 40

other assessments on the IRIS agenda, which will become the priority list for 2010–

2011. RDX was one of the assessments where development of the IRIS toxicological

review report had not progressed to the point where a draft assessment was in, or

ready, for internal Agency review. Thus, RDX will be on the second set of IRIS

chemical assessments.

Q2. We also discussed the independent expert peer review step of the new IRIS process. Please clarify the timeframes provided for peer review and the anticipated

costs for each method of peer review. Moreover, please explain EPA’s plan for

mitigating conflicts of interest during the peer review process.

A2. Part 1—Types of Reviews:

Timeframes for IRIS Peer Reviews

The timeframe provided in the new IRIS process provides for a 105-day peer review process. We are working on processes to be put into place for peer reviews conducted through a contractor convened peer review panel and the EPA’s Science Advisory Board (SAB) peer review panel to meet that timeframe. We will also work

with the National Academy of Sciences (NAS) to determine if they would be able

to meet the 105-day timeframe. We recognize that, on occasion, there will be particularly complex assessments that may take longer than 105 days.

Costs for IRIS Peer Reviews

Letter Review: All independent external peer reviews for IRIS draft assessments

are conducted at public meetings. Thus, letter reviews are not used for external peer

review of draft IRIS human health assessments.

Contractor-Convened Panel: Extramural cost for these types of peer reviews

range from $35,000 to $70,000. Cost depends on the complexity of the assessment,

which determines the number of different types of expertise needed, the number reviewers required, the number of days scheduled for the public review meeting, and

the cost of the meeting venue. The staff time required is around 80 hours on average. This includes four staff attending the day(s)-long panel meeting and preparing

materials for presentation at the meeting. The rest of the staff time is spent by the

work assignment manager, project officer, and contracting officer writing and approving Statements of Work, working out the details of the date and location of the

meeting, making sure the panel members have the needed range of expertise, etc.

Estimates:

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

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

Science Advisory Board (SAB) (chartered under Federal Advisory Committee Act [FACA]): The estimated cost of a standard peer review by the Agency’s

SAB is $200,000 to $250,000. The cost includes: contractor support, travel, Special

Government Employee (SGE) salary, plus EPA FTE cost in the office of the SAB,

Designated Federal Official (DFO), management, and personnel staff. This does not,

however, include EPA scientist(s) or management staff time in the office requesting

SAB’s review of the draft assessment. The staff time required is around 80 hours

53

on average. This includes four staff attending the day(s)-long panel meeting and

preparing materials for presentation at the meeting.

Estimates:

SAB’s costs: $200,000 to $250,000

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

National Academy of Sciences/National Research Council (NAS/NRC): External peer review by the NAS/NRC is estimated to cost $800,000–1,000,000. This does

not, however, include EPA scientist(s) or management staff time in the EPA office

requesting NAS’s review of the draft assessment. The staff time required is difficult

to estimate because often times the NAS has multiple meetings; however, an estimate may be 120 hours on average.

Estimates:

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

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

A2. Part 2: EPA’s Plan for Mitigating Conflict of Interest (applies to all types of re- views)

Since the Agency’s Peer Review Policy was first affirmed in 1994, EPA has made tremendous strides in building a strong and well recognized peer review program.

EPA’s Science Policy Council has updated and improved the EPA Peer Review

Handbook including clarifying conflict of interest and impartiality issues. This Handbook is used to guide and implement peer review across the Agency, including IRIS peer reviews. A recent report by the EPA Inspector General provided several

suggestions for how we can improve our peer review practices. We welcome the opportunity for continuous improvement. EPA’s Science Policy Council is updating the

EPA Peer Review Handbook to clarify the definition of the ‘‘appearance of a lack of impartiality.’’ In addition, our Office of Research and Development is updating some

of its procedures to enhance its use of peer review.

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

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

Step 1—document development,

Step 2—internal EPA review,

Step 3—interagency science consultation,

Step 4—external peer review and public comment,

Step 5—document revision,

Step 6A—final internal EPA review,

Step 6B—interagency science discussion, and

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

The new process affords federal agencies and White House offices three opportuni- ties to comment on science issues in draft IRIS assessments (Steps 3, 4 and 6B).

In Step 3, the Interagency Science Consultation, federal agencies and White House

offices will be invited to provide written scientific comments on the draft Toxicological Review and draft charge to external peer reviewers before the assessment

is released for public review and comment. Also, in Step 4, the External Peer Review and Public Comment, the federal agencies and White House offices may provide written comments on the draft Toxicological Review during the public comment

period. All comments received during the announced public comment period automatically become part of the public docket for the assessment. Finally, in Step 6B,

the Interagency Science Discussion, federal agencies and White House offices will

be invited to provide written scientific comments specifically on EPA’s response to

external peer review and public comments before the final assessment is posted on

IRIS.

As specified in the new IRIS process, all written comments received during the Interagency Science Consultation (Step 3) and the Interagency Science Discussion

(Step 6B) will be documented in the public record. This applies to all comments received on or after May 21, 2009. When the draft assessment is released for external

peer review and public comment, the following documents will be posted on the

docket at www.regulations.gov and on the National Center for Environmental Assessment (NCEA) and IRIS web sites:

• Interagency Science Consultation draft Toxicological Review

54

• Interagency Science Consultation draft external peer review charge

• All written comments as received from agencies as part of the Interagency

Science Consultation

• External Peer Review draft Toxicological Review

• Final Charge to External Peer Reviewers

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

• Interagency Science Discussion draft Toxicological Review with summary and

disposition of external peer review and public comments

• Interagency Science Discussion draft IRIS Summary

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

• Final Toxicological Review and IRIS Summary.

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Appendix 2:

ADDITIONAL MATERIAL FOR THE RECORD

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Æ