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STATUS OF REFORMS TO EPA’S 

INTEGRATED RISK INFORMATION SYSTEM 

JOINT HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT & 

SUBCOMMITTEE ON ENVIRONMENT 

COMMITTEE ON SCIENCE, SPACE, AND 

TECHNOLOGY 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

SECOND SESSION 

JULY 16, 2014 

Serial No. 113–86 

Printed for the use of the Committee on Science, Space, and Technology 

( 

Available via the World Wide Web: http://science.house.gov 
(II) 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

HON. LAMAR S. SMITH, Texas, Chair 

DANA ROHRABACHER, California 

RALPH M. HALL, Texas 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

FRANK D. LUCAS, Oklahoma 

RANDY NEUGEBAUER, Texas 

MICHAEL T. MCCAUL, Texas 

PAUL C. BROUN, Georgia 

STEVEN M. PALAZZO, Mississippi 

MO BROOKS, Alabama 

RANDY HULTGREN, Illinois 

LARRY BUCSHON, Indiana 

STEVE STOCKMAN, Texas 

BILL POSEY, Florida 

CYNTHIA LUMMIS, Wyoming 

DAVID SCHWEIKERT, Arizona 

THOMAS MASSIE, Kentucky 

KEVIN CRAMER, North Dakota 

JIM BRIDENSTINE, Oklahoma 

RANDY WEBER, Texas 

CHRIS COLLINS, New York 

BILL JOHNSON, Ohio 

EDDIE BERNICE JOHNSON, Texas 

ZOE LOFGREN, California 

DANIEL LIPINSKI, Illinois 

DONNA F. EDWARDS, Maryland 

FREDERICA S. WILSON, Florida 

SUZANNE BONAMICI, Oregon 

ERIC SWALWELL, California 

DAN MAFFEI, New York 

ALAN GRAYSON, Florida 

JOSEPH KENNEDY III, Massachusetts 

SCOTT PETERS, California 

DEREK KILMER, Washington 

AMI BERA, California 

ELIZABETH ESTY, Connecticut 

MARC VEASEY, Texas 

JULIA BROWNLEY, California 

ROBIN KELLY, Illinois 

KATHERINE CLARK, Massachusetts 

SUBCOMMITTEE ON OVERSIGHT

HON. PAUL C. BROUN, Georgia, Chair 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

BILL POSEY, Florida 

KEVIN CRAMER, North Dakota 

BILL JOHNSON, Ohio 

LAMAR S. SMITH, Texas 

DAN MAFFEI, New York 

ERIC SWALWELL, California 

SCOTT PETERS, California 

EDDIE BERNICE JOHNSON, Texas 

SUBCOMMITTEE ON ENVIRONMENT

HON. DAVID SCHWEIKERT, Arizona, Chair 

JIM BRIDENSTINE, Oklahoma 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

DANA ROHRABACHER, California 

RANDY NEUGEBAUER, Texas 

PAUL C. BROUN, Georgia 

RANDY WEBER, Texas 

LAMAR S. SMITH, Texas 

SUZANNE BONAMICI, Oregon 

JULIA BROWNLEY, California 

DONNA F. EDWARDS, Maryland 

ALAN GRAYSON, Florida 

KATHERINE CLARK, Massachusetts 

EDDIE BERNICE JOHNSON, Texas 
(III) 

C O N T E N T S 

July 16, 2014 

Page 

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

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

Opening Statements 

Statement by Representative Paul C. Broun, Chairman, Subcommittee on 

Oversight, Committee on Science, Space, and Technology, U.S. House of 

Representatives .................................................................................................... 9 

Written Statement ............................................................................................ 10 

Statement by Representative Suzanne Bonamici, Ranking Minority Member, 

Subcommittee on Environment, Committee on Science, Space, and Technology, U.S. House of Representatives ............................................................... 11 

Written Statement ............................................................................................ 13 

Statement by Representative David Schweikert, Chairman, Subcommittee on 

Environment, Committee on Science, Space, and Technology, U.S. House 

of Representatives ................................................................................................ 14 

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

Witnesses: 

Dr. David Dorman, Member, Committee to Review EPA’s IRIS Process, National Research Council 

Oral Statement ................................................................................................. 16 

Submitted Biography ....................................................................................... 18 

Dr. Kenneth Olden, Director, National Center for Environmental Assessment, 

U.S. Environmental Protection Agency 

Oral Statement ................................................................................................. 28 

Written Statement ............................................................................................ 30 

Ms. Rena Steinzor, Professor of Law, University of Maryland; President, 

Center for Progressive Reform 

Oral Statement ................................................................................................. 39 

Written Statement ............................................................................................ 41 

Mr. Michael P. Walls, Vice President of Regulatory and Technical Affairs, 

American Chemistry Council 

Oral Statement ................................................................................................. 75 

Written Statement ............................................................................................ 77 

Discussion ................................................................................................................. 87 

Appendix I: Answers to Post-Hearing Questions 

Dr. David Dorman, Member, Committee to Review EPA’s IRIS Process, National Research Council ....................................................................................... 96 

Dr. Kenneth Olden, Director, National Center for Environmental Assessment, 

U.S. Environmental Protection Agency .............................................................. 100 

Ms. Rena Steinzor, Professor of Law, University of Maryland; President, 

Center for Progressive Reform ............................................................................ 114 

Mr. Michael P. Walls, Vice President of Regulatory and Technical Affairs, 

American Chemistry Council .............................................................................. 123 
Page

IV 

Appendix II: Additional Material for the Record 

Prepared statement by Representative Eddie Bernice Johnson, Ranking Member, Committee on Science, Space, and Technology, U.S. House of Representatives ........................................................................................................... 128 
(1) 

STATUS OF REFORMS TO EPA’S 

INTEGRATED RISK INFORMATION SYSTEM 

WEDNESDAY, JULY 16, 2014 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON OVERSIGHT AND SUBCOMMITTEE ON

ENVIRONMENT, 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY, 

Washington, D.C. 

The Subcommittees met, pursuant to call, at 1:32 p.m., in Room 

2318 of the Rayburn House Office Building, Hon. Paul Broun 

[Chairman of the Subcommittee on Oversight] presiding. 
2 
3 
4 
5 
6 
7 
8 
9 

Chairman BROUN. Good afternoon. This joint hearing of the Subcommittee of Oversight and the Subcommittee on Environment will 

come to order. Good afternoon, everyone. We welcome you to today’s joint hearing. In front of you are packets containing the written testimony, biographies, and truth in testimony disclosures for 

today’s witnesses. 

Before we get started, since this is a joint hearing involving two 

Subcommittees, I want to explain how we will operate procedurally, 

so all Members understand how the question and answer period 

will be handled. We will recognize those Members present at the 

gavel in order of seniority on the Full Committee, and those coming 

in after the gavel will be recognized in the order of arrival. 

And before I give my opening statement, I want to thank—publicly thank the witnesses, as well as Members, and staff on both 

sides for your flexibility. We have a long series of votes that are 

going to occur about 2:30, 2:45 this afternoon. We wanted to have 

plenty of time for Members, as well as the witnesses, to give their 

statements and ask and answer questions, and so I deeply appreciate everyone’s flexibility in this. Now the Chairman recognizes 

himself for five minutes for an opening statement. 

Again, I would like to welcome and thank all of our witnesses for 

being here today, and for your flexibility in coming in early to accommodate our vote schedule. We don’t have control over such matters, so I especially appreciate you all and the Members’ cooperation. 

Over the past decade, this Committee has held many oversight 

hearings to examine the EPA’s Integrated Risk Information System, or IRIS program. As you all know, IRIS was established three 

decades ago to provide a single source of information on the risk 

associated with exposure to environmental chemicals for use by 

EPA regulatory offices, states, the international community, as well 

as industry. 

Unfortunately, the program has come under increased scrutiny 

as a result of issues related to the pace of assessments, the lack 

of transparency, and failure to develop and use consistent approaches to weighing evidence, and characterizing risk in a manner 

divorced from actual human exposures. 

This scrutiny has come in many forms. Internally, from the EPA 

program offices, which have established their own chemical assessments separate from ours, as well as other federal agencies, including the White House, and externally from stakeholder groups that 

have increasingly weighed in to express their concern about IRIS 

assessments. Even the U.S. Government Accountability Office 

placed the program on its high risk series, a list it provides to Congress every two years, for being at high risk for waste, fraud, 

abuse, and mismanagement, or in need of broad based transformation. 

Congress, and especially this Committee, has shined a spotlight 

on the IRIS program for several years, particularly as the National 

Research Council has been directed to review some of the more 

complex and challenging IRIS assessments. One such example is 

the 2011 formaldehyde assessment. When the NRC published their 

review, it went beyond its charge to add a very pointed and critical 

chapter seven in their report that offered recommendations and 
10 

suggestions on how EPA could improve the IRIS process. That 

eventually led to the NRC report published this May, which identified ‘‘substantial improvements’’ in the initial stages of EPA’s proposed changes to the IRIS program. 

That is quite a turnaround from the 2011 report, and I was 

pleased to read that, just as I was pleased to read when EPA announced two years ago that it had tapped Dr. Ken Olden to lead 

the agency’s National Center for Environmental Assessment. Dr. 

Olden has been a refreshing ambassador for the IRIS program, and 

I applaud his commitment to an open and transparent IRIS process 

that includes early communication, and increased opportunities for 

meaningful stakeholder input. 

But it is clear that the objective of transparency is not a sentiment shared by all. Unfortunately, we have seen opposition to 

openness, transparency, and greater public comment from some 

corners. Sunshine is the only way to ensure that this reform effort 

succeeds, and anti-industry conspiracy theories, and the boycotting 

of public meetings do not help the program improve. Dr. Olden and 

his staff should be commended for opening up the process to all 

stakeholders, and I greatly appreciate your efforts, Dr. Olden, in 

that regard. 

With that, I am interested in learning more about EPA’s timeline 

on when it expects to complete its reform process, and, more importantly, when it will publish IRIS assessments that reflect the recommendations and suggestions offered by the NRC to substantially 

improve the program. 

IRIS will be considered a success when the science behind the assessments is viewed by all stakeholders as rigorous and accurate. 

The real metric for progress for IRIS should be the actual content 

of the assessments. Are they credible? Do they correctly characterize risk and uncertainty? Can users trust them? Are they overly 

conservative in a way that limits the options available to risk managers? If EPA develops such guidelines, handbooks, or policies, 

then fails to consistently follow them, we will have spent years, 

and millions of taxpayers’ dollars to reform IRIS on paper. 

As a physician, I understand how important it is to ensure the 

best possible scientific methods are being utilized to protect our 

most sensitive populations, including children, pregnant women, 

and the elderly, all from undue harm. Because of this widespread 

use, we must be certain that the IRIS program is using the best 

possible science, and scientific process, in a timely fashion to publish assessments that engender confidence by all stakeholders. 

Anything less than that is a mission not accomplished. Thank you. 

[The prepared statement of Mr. Broun follows:] 

PREPARED STATEMENT OF SUBCOMMITTEE ON OVERSIGHT

CHAIRMAN PAUL BROUN

Good afternoon. I want to welcome and thank all of our witnesses for being here 

today. 

Over the past decade, this Committee has held many oversight hearings to examine the EPA’s Integrated Risk Information System, or IRIS program. As you all 

know, IRIS was established three decades ago to provide a single source of information on the risks associated with exposure to environmental chemicals for use by 

EPA regulatory offices, states, the international community, and industry. Unfortunately, the program has come under increased scrutiny as a result of issues related 
11 

to the pace of assessments, lack of transparency, failure to develop and use consistent approaches to weighing evidence, and characterizing risks in a manner divorced from actual human exposures. 

This scrutiny has come in many forms: internally, from EPA program offices—who 

have established their own chemical assessments separate from IRIS - as well as 

other federal agencies, including the White House, and externally, from stakeholder 

groups who have increasingly weighed in to express their concerns about IRIS assessments. Even the U.S. Government Accountability Office placed the program on 

its High-Risk series, a list it provides to Congress every two years, for being at high 

risk for waste, fraud, abuse, and mismanagement or in need of broad-based transformation. 

Congress, and especially this Committee, has shined the spotlight on the IRIS 

program for several years, particularly as the National Research Council has been 

directed to review some of the more complex and challenging IRIS assessments. One 

such example is the 2011 formaldehyde assessment. When the NRC published that 

review, it went beyond its charge to add a very pointed and critical Chapter Seven 

in the report that offered recommendations and suggestions on how EPA could improve the IRIS process. That eventually led to the NRC report published this May, 

which identified ‘‘substantial improvements’’ in the initial stages of EPA’s proposed 

changes to the IRIS program. 

That is quite a turn-around from the 2011 report, and I was pleased to read that, 

just as I was pleased when EPA announced two years ago that it had tapped Dr. 

Ken Olden to lead the agency’s National Center for Environmental Assessment. Dr. 

Olden has been a refreshing ambassador for the IRIS program and I applaud his 

commitment to an open and transparent IRIS process that includes early communication and increased opportunities for meaningful stakeholder input. 

But it is clear that the objective of transparency is not a sentiment shared by all. 

Unfortunately, we have seen opposition to openness, transparency, and greater public comment from some corners. Sunshine is the only way to ensure that this reform 

effort succeeds, and anti-industry conspiracy theories and the boycotting of public 

meetings do not help the program improve. Dr. Olden and his staff should be commended for opening up the process to all stakeholders. 

With that, I am interested in learning more about EPA’s timeline on when it expects to complete its reform process, and more importantly, when it will publish 

IRIS assessments that reflect the recommendations and suggestions offered by the 

NRC to substantially improve the program. IRIS will be considered a success when 

the science behind the assessments is viewed by all stakeholders as rigorous and 

accurate. The real metric for progress for IRIS should be the actual content of the 

assessments. Are they credible? Do they correctly characterize risk and uncertainty? 

Can users trust them? Are they overly conservative in a way that limits the options 

available to risk managers? If EPA develops useful guidelines, handbooks, or policies, then fails to consistently follow them, we will have spent years and millions 

of dollars to reform IRIS on paper. 

As a physician, I understand how important it is to ensure the best possible scientific methods are being utilized to protect our most sensitive populations, including, children, pregnant women, and the elderly, from undue harm. Because of its 

widespread use, we must be certain that the IRIS program is using the best possible 

science and scientific process in a timely fashion to publish assessments that engender confidence by all stakeholders. Anything less than that is a mission not accomplished. 

Thank you. I now recognize the Ranking Member, the gentleman from New York, 

Mr. Maffei, for anopening statement. 

Chairman BROUN. And now I recognize the Ranking Member of 

the Environment Subcommittee, Ms. Bonamici, for an opening 

statement. 

Ms. BONAMICI. Thank you very much, Mr. Chairman. And thank 

you to our witnesses for testifying before the Subcommittees today. 

I want to note that the absence of more Members on this side is 

not indicative of our concern about the issue. The change in time 

and conflicting hearings are to blame. 

So I also want to start by emphasizing, on behalf of my colleagues on my side of the aisle, that we are not anti-industry, nor 

are we opposed to the development of new chemicals. We simply 

want to ensure that scientific information is available to determine 
12 

the health effects that might result from exposure. This is about 

protecting human health. I am glad you recognize that, Mr. Chairman. 

The Integrated Risk Information System, IRIS, was intended to 

be a database that would provide a comprehensive source of best 

information on the health risks of chemicals. Approximately 700 

new chemicals enter the market every year, joining about 85,000 

industrial chemicals already in use. Companies that manufacture, 

distribute, or use these chemicals are not required to demonstrate 

that the chemicals are safe. 

When a company wants to introduce a new chemical, the company notifies the EPA, but the company is not required to share 

any data regarding the safety of that chemical. EPA cannot even 

request safety data unless it can show that there is a potential risk 

by pointing to available academic or industry data. It often takes 

many years before harms associated with the chemical can begin 

to be identified. Thus, there is no good public safety check in place. 

There is what seems to be an obvious need for transparency. Despite that, since the 1990s, the industry appears to have used some 

strategies to try to slow IRIS entries, tie EPA up in lengthy reviews and inter-agency dialogues, or generally cast doubt on claims 

that a particular chemical might have an adverse health effect. 

For example, during the Bush Administration, the Office of Management and Budget hired a toxicologist and epidemiologist to run 

so-called peer reviews of draft IRIS entries, a policy that resulted 

in endless requests from OMB that EPA go back and look at different literature, or make minor changes to their findings. The 

Bush Administration also created an inter-agency review process 

that allowed agencies with significant pollution problems to challenge the EPA IRIS drafts. Production of new IRIS assessments 

was so slow that the GAO put IRIS on their watch list—you mentioned that, Mr. Chair—and there was a bipartisan push to let 

EPA take control of their program and expand their productivity. 

The Obama Administration sought to strengthen IRIS, and 

moved OMB into the background while lessening unnecessary 

inter-agency review mechanisms. The response from those who are 

opposed to IRIS has been to call on the National Research Council 

to continually review IRIS assessments. The NRC was drawn into 

IRIS several times prior to the 2011 formaldehyde review. In each 

case, they largely supported EPA’s findings, but offered advice 

about how to complete more systematic reviews, and how to improve the science assessments. Invariably, the overall assessments 

of EPA’s findings were lost in the noise about what the EPA did 

not do, or could have done better. 

The 2011 report was a little different. The National Research 

Council used that report to praise the substantial improvements— 

thank you, Dr. Olden—made by the EPA thus far, and offer a road 

map how to make IRIS more efficient to accelerate and streamline 

the assessments. EPA embraced the advice of the NRC, and, as the 

most recent report acknowledges, has made significant progress in 

putting into place the process reforms recommended in 2011. 

Now we are faced with a question. What is the National Academy’s off-ramp strategy for getting out of the business of doing endless IRIS reviews? Questions have been raised about whether the 
13 

American Chemistry Council may have an interest in keeping IRIS 

unproductive. Does every NRC report offer an opportunity for criticisms about the quality of the science at the EPA? These are issues 

we hope you will address today. 

At this point I am very interested to hear whether the Academy 

has reached the end of its productive contributions. If not, where 

is that point? Frankly, the combination of the 2011 report, the new 

leadership at the Center for Environmental Assessment, which has 

focused on building a better relationship with industry, has had the 

effect of crippling IRIS, rather than putting the EPA on a path to 

streamline production of IRIS entries. In fact, unless changes are 

implemented, it very well may cripple the program as much as 

when OMB was involved, with repeated peer reviews. So I am very 

interested to hear from Dr. Olden what you intend to do to get production of IRIS assessments moving. 

I look forward to the testimony from each of the witnesses. There 

have been a lot of questions raised, but, importantly, this Committee needs to hear how we are going to get out of the way, let 

EPA do its job of producing assessments of chemicals that may be 

suspected of, and may be causing harm to our constituents and our 

communities. Thank you very much, Mr. Chairman, and I yield 

back. 

[The prepared statement of Ms. Bonamici follows:] 

PREPARED STATEMENT OF SUBCOMMITTEE ON ENVIRONMENT

RANKING MINORITY MEMBER SUZANNE BONAMICI

Thank you, Mr. Chairman, and thank you to our witnesses for testifying before 

our Subcommittees today. I want to start by emphasizing on behalf of my side of 

the aisle that we are not anti-chemical or opposed to the development of new chemicals—we simply want to assure that scientific information is available to determine 

the health effects that might result from exposure. This is about protecting human 

health. 

The Integrated Risk Information System, IRIS, was intended to be a database 

that would provide a comprehensive source of best information on the health risks 

of chemicals. Approximately seven hundred new chemicals enter the market every 

year, joining about 85,000 industrial chemicals already in use. Companies that manufacture, distribute, or use these chemicals are not required to demonstrate that the 

chemicals are safe. 

When a company wants to introduce a new chemical, the company notifies the 

EPA, but the company is not required to share any data regarding the safety of that 

chemical. EPA cannot even request safety data unless it can show there is a potential risk by pointing to available academic or industry data. It often takes many 

years before harms associated with a chemical can begin to be identified, thus there 

is no good public safety check in place. 

There is what seems to be an obvious need for transparency. Despite that, since 

the 1990s the chemical industry appears to have used strategies to try to slow IRIS 

entries, tie EPA up in lengthy reviews and interagency dialogues, and generally cast 

doubt on claims that a particular chemical might have an adverse health effect. For 

example, during the Bush Administration, the Office of Management and Budget 

hired a toxicologist and an epidemiologist to run so-called ‘‘peer reviews’’ of draft 

IRIS entries, a policy that resulted in endless requests from OMB that EPA go back 

and look at different literature or make minor changes to their findings. The Bush 

Administration also created an interagency review process that allowed agencies 

with significant pollution problems to challenge the EPA IRIS drafts. Production of 

new IRIS assessments was so slow that GAO put IRIS on their ‘‘watch list,’’ and 

there was a bipartisan push to let EPA take control of their program and expand 

their productivity. 

The Obama Administration sought to strengthen IRIS, and moved OMB into the 

background while lessening unnecessary interagency review mechanisms. The response from those who are opposed to IRIS’s work has been to call on the National 
14 

Research Council to continually review IRIS assessments. The NRC was drawn into 

IRIS several times prior to the 2011 Formaldehyde review. In each case they largely 

supported EPA’s findings, but offered advice about how to complete more systematic 

reviews and how to improve the science assessments. Invariably, the overall endorsements of EPA’s findings were lost in the noise about what EPA did not do or 

could have done better. 

The 2011 report was a little different. The National Research Council (NRC) used 

that report to praise the substantial improvements made by EPA thus far, and offer 

a road map for how to make IRIS more efficient, and to accelerate and streamline 

the assessments. EPA embraced the advice of the NRC and, as the most recent report acknowledges, has made significant progress in putting into place the process 

reforms recommended in 2011. Now we are faced with a necessary question: what 

is the National Academy’s off-ramp strategy for getting out of the business of doing 

endless IRIS reviews? Organizations such as the American Chemistry Council may 

have an interest in keeping IRIS unproductive, and discrediting its work could keep 

the Academy busy as every NRC report offers an opportunity for criticisms about 

the quality of the science at EPA. At this point, I am very interested to hear whether the Academy has reached the end of its productive contributions. If they have 

not reached that point, where might that point be? 

Frankly the combination of the 2011 report and the new leadership at the National Center for Environmental Assessment, which has focused on building a better 

relationship with industry, has had the effect of crippling IRIS rather than putting 

the EPA on a path to streamlined production of IRIS entries. In fact, unless changes 

are implemented, it may very well cripple the program as much as when OMB was 

involved with repeated ‘‘peer reviews.’’ So I am very interested to hear from Dr. 

Olden about what he intends to do to get production of IRIS assessments moving. 

I look forward to the testimony from each of the witnesses. But importantly, this 

Committee needs to hear how we are going to get out of the way and let EPA do 

its job of producing assessments of chemicals that are suspected of and may be causing harm to our constituents and our communities. 

Chairman BROUN. Thank you, Ms. Bonamici. Now the Chair recognizes the Chairman of the Subcommittee on Environment, the 

gentleman from Arizona, Mr. Schweikert, for his opening statement. You are recognized for five minutes. 

Mr. SCHWEIKERT. Thank you, Mr. Chairman. We will do this 

quickly, to be economical with time, because of the votes coming 

up. Welcome to the chaos of this time of year. 

I have three quick things. One, I need to say goodbye to Mr. 

Woods here, though his unwillingness to shave demonstrates he 

knows he is leaving us this coming week. Number two, something 

that almost has never happened in my couple years around here, 

I talked to some folks who care very much about what is done here, 

and they actually said nice things about you, Dr. Olden. You have 

no idea how rare it is to hear nice things about anyone around 

here. 

And, number three, one of the comments that came up, both from 

some folks I met who you consider on the left and the right, is the 

encouragement and the hope that the continued movement to be 

more transparent with data, so folks can review and understand, 

continues. There was a great warmth from both sides that was 

heading in the right direction. With that, Mr. Chairman, I yield 

back. 

[The prepared statement of Mr. Schweikert follows:] 

PREPARED STATEMENT OF ENVIRONMENT SUBCOMMITTEE

CHAIRMAN DAVID SCHWEIKERT

EPA’s Integrated Risk Information System, or ‘‘IRIS,’’ is designed to provide quantitative and non-quantitative toxicity information for a suite of chemicals. The purpose of this program is to provide basic scientific determinations about what is a 

safe level and to be used by both EPA program offices and States. 
15 

This program has never been authorized by Congress and, over the last decade, 

has been strongly criticized by the National Academy of Sciences, the Government 

Accountability Office (it was listed as a ‘‘High risk’’ program in 2009 and remains 

on the list), the environmental community, industry, and both parties. 

The National Research Council rightly found that critical reforms that promote 

greater openness, transparency, and stakeholder engagement are currently underway by EPA, led by Dr. Ken Olden. 

It is important to note that these limited reforms are simply a work in progress— 

not a single complete assessment has benefited from this new framework. The NRC 

report was a snapshot in time, and even these limited reforms have been criticized 

in some corners. 

Specifically, the NRC called on EPA to: 

• Increase the transparency of how IRIS assessments are conducted and of the 

criteria EPA uses; 

• Adopt better methodologies for systematic review of the literature, for evaluating evidence, and for integrating evidence across different types of scientific 

information; 

• Rely on more high quality studies; 

• Conduct better peer review; 

• Increase the role of outside experts; and 

• Better manage the program to improve its efficiency and to stay current with 

scientific advances. 

Most of these reforms have focused on process, but there are key areas in the content of these assessments that limit their credibility. States, industry, and the public do not trust the IRIS assessments. 

The former Science Advisor for EPA recently wrote in Nature that: ‘‘Fundamentally, the EPA should replace risk values that are built on science-policy assumptions with risk estimates that acknowledge underlying uncertainties. The EPA’s definitive values are illusions; they conceal uncertainty that cannot be resolved scientifically.’’ 

Chairman BROUN. Well, that was quick. Thank you, Mr. 

Schweikert. If there are Members who wish to submit additional 

opening comments or statements, your statements will be added to 

the record at this point. 

Chairman BROUN. At this time I would like to introduce our 

panel of witnesses. Our first witness is Dr. David Dorman, member 

of the National Research Council’s Committee to Review the EPA’s 

IRIS Process. 

Our second witness, and star, is Dr. Ken Olden, Director of the 

National Center for Environmental Assessment at the U.S. Environmental Protection Agency. And, I just want to reiterate what 

Mr. Schweikert said. It is just so nice to have good comments, and 

it is rare around here, Dr. Olden. 

Our third witness is Ms. Rena Steinzor, Professor of Law at the 

University of Maryland, and President of the Center for Progressive Reform. Glad to have you, as well as our final witness, Mr. Michael Walls, Vice President of Regulatory and Technical Affairs at 

the American Chemistry Council. 

Now, as the witnesses should know, spoken testimony is limited 

to five minutes each, and if you would please try to limit your comments to five minutes. I am not going to gavel you down, but we 

do have votes forthcoming fairly quickly. So if you would, please try 

to limit your comments to five minutes, after which Members of the 

committee will have five minutes each to ask questions. 

It is the practice of the Subcommittee on Oversight to receive 

testimony under oath. If you would all please stand. Raise your 

right hand. Do you solemnly swear to affirm to tell the whole truth, 

and nothing but the truth, so help you God? Dr. Dorman? Okay, 
16 

very good. You may be seated. Let the record reflect that the witnesses participating have all taken the oath. 

I now recognize Dr. Dorman for five minutes. 

TESTIMONY OF DR. DAVID DORMAN, 

MEMBER, COMMITTEE TO REVIEW EPA’S IRIS PROCESS, 

NATIONAL RESEARCH COUNCIL 

Dr. DORMAN. Okay. Good afternoon, Dr. Broun, Chairman 

Schweikert, Ranking Member Bonamici, and other Members of the 

Subcommittees. My name is David Dorman. I am a professor of 

toxicology at North Carolina State University, and I served as a 

member of the National Research Council Committees to review 

the IRIS process, and the NRC Committee to review EPA’s draft 

IRIS assessment of Formaldehyde. I am pleased to appear before 

you today to discuss aspects of the report, ‘‘Review of EPA’s Integrated Risk Information System Process’’, which was released earlier this year, in May of 2014. 

This report, which I have a copy of, and—was written by a 15 

member committee of the National Research Council of the National Academies. The committee was asked to assess the scientific, 

technical, and process changes being implemented or planned by 

EPA, and to recommend modifications, or additional changes, as 

appropriate, to try to improve the scientific and technical performance of the IRIS process. Recommendations in the earlier NRC 

formaldehyde report, as mentioned earlier, provided the impetus 

for the changes to EPA’s IRIS program. 

Overall, the IRIS committee found that the changes that EPA 

has proposed and implemented to various degrees constitute substantial improvements in the IRIS process. If current trajectories 

are maintained, some of the inconsistencies identified in our report 

are addressed, and planned revisions still to be implemented are 

successfully completed, the IRIS process will become much more effective and efficient in achieving the program’s basic goal of developing assessments that provide an evidence-based foundation for 

ensuring that chemical hazards are optimally addressed, and assessed through a transparent and replicable approach. 

The IRIS committee reviewed and evaluated the overall process, 

and each individual step of the process, and the changes that EPA 

has made, or is planning to make, and offered recommendations. 

Additionally, the IRIS committee identified three broad areas on 

which the EPA should focus attention. 

First, EPA’s assessment methods will need to be updated in a 

continuing strategic process, and EPA should develop a plan for 

doing so. Second, the sources of inefficiencies in the IRIS process 

need to be identified and addressed systematically. Third, EPA 

management needs to evaluate human and technologic resources 

that are needed to conduct IRIS assessments, and support 

methodologic research, and the implementation of new approaches. 

The IRIS committee emphasized that if sufficient financial and 

staff resources are not available to EPA, then it will not be able 

to continue to improve the IRIS program, and keep pace with scientific advancement. 

As noted, the IRIS committee found that substantial improvements in the IRIS process have been made, and it is clear that 
17 

EPA has embraced, and is acting on the recommendations in the 

NRC formaldehyde report. The NRC formaldehyde committee recognized that these suggested changes would take several years, 

and an extensive effort on the part of EPA staff to implement. Substantial progress, however, has been made in a short time, and the 

IRIS committee’s recommendation should be seen as building on 

the progress that EPA has already made. 

Thank you for the opportunity to testify, and I would be happy 

to answer any questions that the Committee would like me to address. Thank you. 

[The prepared statement of Dr. Dorman follows:] 
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Chairman BROUN. Thank you, Dr. Dorman. The Chair now recognizes Dr. Olden for five minutes. 

TESTIMONY OF DR. KENNETH OLDEN, DIRECTOR, 

NATIONAL CENTER FOR ENVIRONMENTAL ASSESSMENT, 

U.S. ENVIRONMENTAL PROTECTION AGENCY 

Dr. OLDEN. Good afternoon, Chairman Broun, Ranking Member 

Maffei, Chairman Schweikert, and Ranking Member Bonamici, and 

distinguished Members of the Committee. My name is Kenneth 

Olden, and I am the director of the National Center for Environmental Assessment, in the Office of Research and Development in 

the U.S. Environmental Protection Agency. We appreciate your interest in the Integrated Risk Information System, commonly called 

IRIS. Today I am pleased to report that the changes that we have 

made in the program over the past two years have been welcomed, 

and well received. 

A May 2014 report by the National Academies National Research 

Council commended our progress, and recognized that we have 

made a tremendous amount of progress in a short time. Yes, we 

are pleased that the NRC committee recognized the progress that 

we have made. However, it is not time to celebrate, or to declare 

victory. In fact, we are humbled by the work that remains to be 

done. 

Our vision is to complete the transformation of IRIS into a highly 

effective world class scientific enterprise. To achieve this objective, 

the IRIS program has embraced the use of the best science and informational technologies available to estimate the risk from chemical exposures. Furthermore, we have instituted several structural 

and programmatic changes to ensure transparency, objectivity, and 

scientific rigor in the assessment process. 

In the interest of time, I will highlight three in my oral testimony today. First, we incorporated principles of systematic structured review methodologies to identify, to evaluate, and to integrate data from the three different evidence streams that we use 

in toxicity—in estimation of toxicity values. These approaches 

make use of explicit pre-specified rules to select, to evaluate, and 

to synthesize data relevant to the specific chemical assessment. 

Such approaches give results that are highly reproducible, and 

eliminate bias associated with expert judgment. 

However, I might add that methodologies used in systematic review and evidence integration were developed for the use of evidence medicine. In such cases, one is comparing effectiveness of 

Drug A versus Drug B in a chemical trial. In the case of IRIS assessments, we are integrating evidence from three streams, epidemiology, animal studies, and mode of action, or mechanistic studies. 

Except for the Bradford-Hill guidelines used in cancer hazard assessment, the effectiveness and potential for risk of bias for integration of evidence from such diverse sources using these methodologies have not been evaluated. While useful in evidence-based 

medicine, these methodologies may need to be customized for IRIS 

purposes. However, I caution that we do not want to make the 

structured process so rigid as to exclude expert judgment. In the 
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end, we may end up with a process that combines expert judgment 

with some sort of structured approach. 

Second, we instituted activities to proactively engage the public 

during critical stages of the assessment process. For example, we 

hold bimonthly IRIS public meetings to discuss scientific issues related to preliminary assessment materials and draft IRIS assessments. These meetings provide opportunity for public input on the 

literature identified, and evidence tables that we have prepared for 

use in the assessment. For example, have we failed to identify all 

the studies pertinent to the assessment? Have we identified the 

right disease endpoints likely to be caused by the specific chemical 

exposure? 

And finally, to improve quality and consistency of peer review, 

we have created a standing chemical assessment advisory committee under the auspices of EPA’s Scientific Advisory Board to 

conduct peer review of IRIS assessments. Since we will have regular and frequent interactions with this committee, systemic and 

recurring problems can be defined and eliminated, and consensus 

opinions of the committee will provide quality assurance, and will 

lend credibility to the assessments. Moreover, impetus to be responsive to the peer review recommendations will be much higher. 

However, it is my job to ensure the quality and integrity of IRIS 

assessments. 

And, in summary, the transformation of IRIS is well underway. 

As the individual with primary responsibility for the IRIS program, 

I can assure you that the EPA fully intends to successfully complete the transformation. The recommendations made by the NRC 

committees are absolutely consistent with our commitment to 

transparency and scientific excellence. While we are fully cognizant 

of the urgency to completely implement the NRC recommendations, 

our number one priority is to get the science and the process right. 

Thank you, and I would be pleased to respond to any questions 

that you might have. 

[The prepared statement of Dr. Olden follows:] 
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Chairman BROUN. Thank you, Dr. Olden. Ms. Steinzor, you are 

recognized for five minutes. 

TESTIMONY OF MS. RENA STEINZOR, 

PROFESSOR OF LAW, UNIVERSITY OF MARYLAND; 

RESIDENT, CENTER FOR PROGRESSIVE REFORM 

Ms. STEINZOR. Thank you for the opportunity to testify this afternoon about how to get EPA’s IRIS program back on track. IRIS assessments are invaluable because they are robust and well documented, are summarized clearly and concisely, and are available to 

anyone who has access to the Internet. Individuals, community 

groups, public interest organizations, government officials, in short, 

everyone, not just in this country, but around the world, can get 

information they need to make well informed decisions about toxic 

hazards. Conversely, delaying the production of IRIS profiles 

causes real and devastating harm to public health. It also saves the 

chemical industry lots of money. 

My testimony today makes three points. First, IRIS assessments 

have once again slowed to a crawl, sinking to the depths of the 

poor performance achieved under the Bush Administration. The 

Obama Administration needs to stop jawboning with industry 

stakeholders, and concentrate on revitalizing this vital initiative. 

The highest best use of the National Academy’s expertise would 

be to help the IRIS program identify ways to develop a significantly 

larger number of robust assessments quickly, on a limited budget. 

Congress, the EPA administrator, and the National Academies 

must confront the very serious problem of regulated industry’s commandeering the IRIS assessment process by barraging the agency 

with endless minor repetitive and irrelevant objections to risk assessments. 

Unfortunately, although its potential is great, IRIS’s promise is 

compromised by disturbing data gaps. As GAO has reported, IRIS 

is rapidly becoming one of EPA’s walking dead programs. The 

agency’s efforts to fill IRIS’s data gaps were largely stymied during 

the Bush Administration, and not by accident. That administration 

imposed reforms designed to subject EPA’s scientists to a host of 

political pressures from government agencies with neither scientific 

expertise, nor an interest in protecting public health and the environment. 

The Obama Administration recognized the problem, but its revisions to the IRIS process left key issues unaddressed. Of late, the 

administration has displayed a disturbing tendency to retreat in 

the face of a blistering and self-serving industry campaign to stifle 

this vital program once and for all. 

The two National Academies committees responsible for reviewing IRIS have missed golden opportunities to provide constructive 

advice on how to develop new assessments quickly. Rather than 

flyspecking the faults of specific IRIS assessments, and subjecting 

the program as a whole to a round robin of highly critical examination, three issues must be addressed to solve this problem, revamping the IRIS program’s agenda, adopting so-called stopping rules, 

and ending duplicative rounds of stakeholder consultations dominated by regulated industries. 
40 

Once EPA starts an IRIS assessment, there must be an end in 

sight, an assessment must be declared finished, and its results 

posted on the web. When significant new science is produced suggesting that the numbers must be lowered or raised, EPA can reexamine the profile. But as exemplified by the chromium compound 

assessment, regulated industries often manage to push EPA onto 

a treadmill, where it never escapes the wait for another study. The 

trouble, of course, is that science is always evolving. EPA cannot 

wait on all the science to resolve itself, and the truth to be announced. That simply is not the nature of the scientific enterprise. 

The final problem is the decision by EPA political appointees to 

deal with the attacks on IRIS by hosting numerous stakeholder engagement events, some tied to specific assessments, others related 

to broader science issues, or even general concerns about the program as a whole. EPA’s political appointees seem to harbor the 

naı ̈ve idea that this process will placate its critics. Instead, endless 

jawboning has left the agency vulnerable to cynical exploitation. 

In sum, let us not lose sight of what is really at stake, the priceless notion that the water we drink and the air we breathe ought 

to be clean and healthy. Thank you. 

[The prepared statement of Ms. Steinzor follows:] 
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Chairman BROUN. Thank you, Ms. Steinzor. Mr. Walls, you are 

recognized for five minutes. 

TESTIMONY OF MR. MICHAEL P. WALLS, 

VICE PRESIDENT OF REGULATORY AND TECHNICAL AFFAIRS, 

AMERICAN CHEMISTRY COUNCIL 

Mr. WALLS. Good afternoon, Dr. Broun, Ranking Member 

Bonamici, Chairman Schweikert, and the Members of the Committee. We very much appreciate the opportunity to appear here 

today to comment on progress in the IRIS program. 

You can count me among the fans of Ken Olden. We would like 

to compliment Ken for his leadership in the IRIS program. The 

changes he has instituted since the NAS report in 2011 is—are 

bringing IRIS closer to a high standard of public engagement, 

transparency, and openness. We share his interest, and the program’s interest, in assuring that IRIS assessments can help EPA 

and others do a better job of protecting health and the environment. 

We are concerned, however, that some of the policies and practices in the program continue to perpetuate the development of unrealistic overestimates of risk. These shortcomings can have real, 

if unintended, consequences. And that is because the risk management decisions that are made by federal and state governments, for 

example, routinely draw upon the numbers generated in assessment programs like the IRIS program. 

Now, ACC recently released a set of principles that set out attainable high level benchmarks for federal assessment programs. 

Our principles focus on four areas, improvement in assessment design, improvement in data and method integration and review, how 

those assessments are communicated, and review and accountability in those programs. Our principles are consistent not only 

with the NAS reports, but are consistent as well with the administration’s own science integrity goals. 

At this point in time, however, and I think as Dr. Olden has 

noted, much work remains to be done to ensure those benchmarks 

are achieved in the program. The 2011 report identified significant 

scientific shortcomings in the program. EPA, to its credit, is committed to fully implementing those recommendations. 

But now, three years after the 2011 report was released, many 

of the most critical changes remain to be fully implemented. In 

fact, materials released by the agency just last week—in those materials released just last week, EPA indicated that only two of the 

chemicals now in the IRIS pipeline even have any chance of being 

fully consistent with the 2011 recommendations, as well as the enhancements that Dr. Olden himself has implemented. The NAS’s 

2014 report acknowledged that progress has been made. It also reiterated several of the same concerns noted in 2011, and made further recommendations for improvement. 

Now, in our view, the most critical area for IRIS reform is evaluating and integrating scientific evidence in a transparent and robust manner. For example, IRIS has identified study quality considerations for certain scientific evidence, but the assessments have 

not systematically and transparently evaluated the studies against 
76 

those considerations. NAS recommended that in 2011, and did so 

again in 2014. 

IRIS assessments needs to consistently address mode of action. 

That is how the human body works, and the way the chemicals 

interact with the body at different levels of exposure. But EPA’s 

approach, however, has left stakeholders guessing about how mode 

of action and mechanistic information will be used. If IRIS assessments are designed well from the very beginning, the agency can 

organize the available information to evaluate the plausible alternative hypotheses, and they can do so in a much more timely way. 

They will be much more productive at getting assessments completed. We think EPA should also articulate a better standard for 

using data, instead of default assumptions, as well as more effectively addressing peer review. 

Finally, how the agency characterizes and communicates this information to the public is critically important. When assumptions 

are used in lieu of data, the assumptions should be disclosed, along 

with the justification for their use. The NAS this year called on the 

EPA to develop guidelines for uncertainty analysis and communication. The IRIS assessments themselves should provide a complete 

picture of what is known and what is inferred. 

But just this past Monday, at a meeting of the chemical assessment advisory committee, in their review of the ammonia assessment, it demonstrated that the panel itself couldn’t figure out why 

EPA—how EPA chose some numbers, and why they did that. So we 

are looking forward to continuing our work with your Committee, 

with Dr. Olden, and other stakeholders to make sure that the NAS 

recommendations, as well as the principles we have articulated are 

implemented in the program. 

We hope, in fact, that other EPA program offices, and other federal agencies, will carefully consider the recommendations by the 

NAS to make appropriate improvements in their own programs. 

We share a mutual interest in ensuring that high quality information is applied to make better, more timely public health decisions. 

Thank you. 

[The prepared statement of Mr. Walls follows:] 
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Chairman BROUN. Thank you, Mr. Walls. We have been informed 

that we are going to start having votes at about 2:10, about a 

minute or a minute and a half from now, and it is going to be long 

series. So, to try to expedite things, and get to as many Members 

as we possibly can, the minority and I have agreed that we are 

going to limit each Member to three minutes so that we can try to 

get through as many Members as possible. We will offer you all the 

opportunity to answer questions, and their questions for the record, 

QFRs, as we normally call them, so please be expeditious in giving 

those back to us. Thank you all for your testimony. I will open the 

first round of questions now, and I recognize myself for three minutes. 

Dr. Olden, as I mentioned in my statement, I appreciate all of 

your efforts to reform the IRIS program, including your attempts 

to increase transparency and stakeholder input. I do wonder, however, when will this process be completed, and when will the EPA 

publish its first IRIS assessment that will reflect all of the recommendations and suggestions offered by NRC to substantially improve the program? 

And then, furthermore, do you anticipate the first couple of IRIS 

assessments that will incorporate all of the NRC recommendations 

to be on new chemicals, and if so, which ones will be first, or will 

there be updates of old assessments, and if so, which ones? 

Dr. OLDEN. Chairman Broun, any chemical that was started 

after the 2011 formaldehyde report will have all the recommendations that were included in the formaldehyde NRC committee report. So how many chemicals that is, I am not absolutely certain. 

But I would say by—in three to five years we will have completely 

implemented all the recommendations of the NRC reports. 

Chairman BROUN. Are you talking about three to five years from 

now, or when you began the process? 

Dr. OLDEN. —three to five years from now. 

Chairman BROUN. Okay. 

Dr. OLDEN. Right. 

Chairman BROUN. Are new chemicals involved in the assessment, or are you just going to do old ones? And which ones are you 

going to test? 

Dr. OLDEN. There are new chemicals in the pipeline that will be 

involved in the assessment. And there are probably some old ones. 

I can get back to you with the specifics. But there will be both new, 

and possibly some old chemicals. 

Chairman BROUN. Okay. 

Chairman BROUN. Can you give us a number? 

Dr. OLDEN. What we are doing now is doing a strategic—long 

term strategic planning to identify the needs of the agency. And 

once we get—so we send a survey out to all the program directors 

and regional directors, and we are getting that information back. 

When we assemble that information, we will make—know which 

chemicals the agency needs, and we will make assessment of those 

chemicals our highest priority. 

Chairman BROUN. Thank you, Dr. Olden. Ms. Bonamici, you are 

recognized for three minutes. 

Ms. BONAMICI. Thank you very much, Mr. Chairman. 
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Ms. Steinzor, you mentioned in your testimony some of the 

health effects of chemicals for which IRIS has provided scientific 

documentation, for example—or scientific determinations, excuse 

me, brain damage, cardiovascular illness, reproductive dysfunction, 

cancer. That is a list that should cause us to pay attention, and I 

want to bring up something that you mentioned in your written 

testimony, the January 2014 chemical spill in West Virginia. As 

you indicated in your testimony at the time of the spill, the chemical being used, called Crude MCHM, was not in the IRIS database. 

So, briefly, and then I will ask you to expand in writing, under 

the current IRIS and EPA process, what would have to happen before a chemical like MCHM would be subject to an IRIS assessment? 

Ms. STEINZOR. Well, the problem with that chemical is it is not 

listed in any of the statutes, such as the Clean Air Act or the Safe 

Drinking Water Act, as being a contaminant of concern, and yet we 

saw that it caused very grave problems in West Virginia. For it to 

make its way onto the IRIS list, and actually have an assessment 

completed, our calculations are it would take decades at the rate 

they are going, and that is very unfortunate. 

As you know, the people there have been told that they need to 

make a personal decision about whether to shower, or bathe their 

babies in the water. 

Ms. BONAMICI. And I am going to try to get a couple more questions in. Now, recently this Committee took up a bill alleging secret 

science at the EPA. We hear a lot about the need for transparency. 

Now, it is my understanding that the companies do not have to 

demonstrate the safety of their products. And, in fact, safety data 

is often treated as proprietary. So we all know that we need chemicals for modern society, but how can we be confident that the 

chemicals in the marketplace are not harming us? 

Ms. STEINZOR. I don’t think we can be confident, as the West Virginia example shows, and I would urge you to take a very careful 

look at that bill. That bill would make it even more difficult for 

EPA to assess chemicals by raising the burden of what kind of evidence they have to have, in lieu of a testing requirement, very 

high. 

Mr. WALLS. Ms. Bonamici, may I make a comment quickly on 

that? 

Ms. BONAMICI. Well, I only have 41 seconds. For the record, 

please do submit. 

Dr. Dorman, thank you for the Academy—for all your work that 

you have done. Can you tell me when the Academy’s work will be 

completed, and at what point will you be finished with changing 

the process, or contributing to the process? 

Dr. DORMAN. So with respect to the report that was issued in 

May, I mean, that is a project that has been completed. One of the 

things to keep in mind is that the Academy’s activities, having 

been a member of several committees now, have largely been directed by either Congress, mandated by Congress, or else requested 

by EPA. And so, really, a lot of the work that the Academies is 

doing with respect to the IRIS program is being driven by those 

factors. 
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Ms. BONAMICI. And do you still have productive contributions to 

make? 

Dr. DORMAN. So right now to my knowledge, the Academies—the 

only IRIS process—one that we are looking at right now, or the 

Academies is looking at, is related to arsenic. 

Ms. BONAMICI. Thank you. I am out of time, and, Dr. Olden, I 

will be submitting more questions for the record. I yield back—— 

Chairman BROUN. Thank you, Ms. Bonamici. 

Chairman Schweikert, you are recognized for three minutes. 

Mr. SCHWEIKERT. Thank you, Mr. Chairman. It feels sort of like 

the lightning round. As Ms. Bonamici touched on, one of the benefits, obviously, of the Secret Science Bill is if EPA uses industry 

data, it has to become public. The baseline data sets become public. 

So I am hoping that actually sort of provides a benefit for everyone. 

Mr. Dorman, I have one concern, and let us see if I can articulate 

this quickly. A standard parts per million is created in this process. 

Don’t we have OSHA, CDC, even other parts of EPA, and then on 

occasion I will see European standards, as well as others. Are we 

in a world right now where we have lots and lots of different 

benchmarks being offered? Is there a need to start trying to do a 

consolidation of what is the standard of health attributes? And 

then—first that one, then there is an auxiliary to that. 

Dr. DORMAN. So you raise a great point. There are a number of 

different agencies charged by individual companies, or countries, to 

try to come up with different types of exposure standards, for example, Health Canada versus EPA, and sometimes there are divergent numbers that are developed both within the United States 

and elsewhere. A lot of that depends upon what the populations at 

risk sometimes represent. So, for example, if OSHA is creating a 

standard for workers, that standard may be very different than 

what EPA is required to do for the general population. 

But the methodologies—I think one of the things that our committee was stressing is that in any case, what EPA—when they are 

developing those numbers, try to be as transparent as possible so 

people can look at how those numbers were actually developed. 

Mr. SCHWEIKERT. Okay. Mr. Dorman, so, if we knew all these different regulators that are publishing data on different chemicals 

are following a standardized methodology for analysis—— 

Dr. DORMAN. Right. 

Mr. SCHWEIKERT.——, then there is the next part of that. Instead 

of saying, here is my benchmark, it is blank parts per million, 

shouldn’t it be blank parts per million when handled in this fashion? In this fashion, you might have other types of mitigation. Are 

we also doing a good enough job providing those other levels a definition of it also has to do with environment, being used in industry, 

mechanics, the other attributes around it? 

Dr. DORMAN. Right. So, very quickly, again, it comes back to— 

for example, on the OSHA numbers, those oftentimes will look at 

personal protection, which was—not be available to the general 

population, which EPA is now viewing for, say, the RFC or RFD 

values. So these numbers that EPA is developing are for unprotected populations at risk. 

Mr. SCHWEIKERT. Okay. And, Mr. Chairman, I promise all of you 

I will have some questions in writing. I have a sort of a fixation 
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on data, whether you think it helps you or hurts you, becoming 

public, because I think we need to also trust the kids at a university, a left wing group, a right wing group, from being able to have 

opportunities to analyze data, and compare with other data sets. 

With that, I yield back, Mr. Chairman. 

Chairman BROUN. Thank you, Mr. Schweikert. Ms. Clark, you 

are recognized for three minutes. 

Ms. CLARK. Thank you, Mr. Chairman. 

Dr. Dorman, when Dr. Samet testified before this Committee on 

the 2011 formaldehyde report, he made it very clear that the NAS 

panel was not calling for the EPA to suspend IRIS assessments, 

and was not saying that they could not do quality, solid assessments. Instead, was recommending reforms in the process that 

could be implemented in parallel with continuing IRIS assessments. Can you tell me, is that still the position of the NAS panel? 

Dr. DORMAN. So I think that Dr. Samet’s comments were echoed 

in our recent IRIS report, and—— 

Ms. CLARK. Um-hum. 

Dr. DORMAN. —the bottom line is that for EPA, when the Committee was trying to look at the changes that EPA was making, 

those were in progress. And so what we felt as a committee, and 

felt strongly, was that implementation of different attributes within the process may take different periods of time in order to fully 

implement. And so we recognize that, both in the formaldehyde report that I served on, as well as the IRIS committee. 

And so I think the bottom line was neither committee had the 

anticipation that we would see full cloth changes, but rather we 

were seeing a progress that was occurring, that we could then 

judge to see where they were going. 

Ms. CLARK. And in both the new report, and in your testimony, 

it was found there were substantial improvement in EPA’s process, 

in line with those recommendations from 2011. Do you see any evidence that EPA is producing what some have called flawed assessments? 

Dr. DORMAN. So I think it is important that we were charged 

with looking at the process, rather than any individual assessments, per se. So we weren’t asked to do any independent assessments, or reviews of assessments, but what we did see was a pattern on the part of EPA in which they were very proactively implementing the changes in the formaldehyde. And what we see is, 

once these are all fully implemented, we believe that the quality 

of the assessments will actually improve dramatically. 

Ms. CLARK. Thank you. 

Mr. Walls, in your testimony you talked—referred a few times to 

timely manner of these assessments. Do you believe the IRIS program is completing assessments in a timely manner? 

Mr. WALLS. Congresswoman Clark, I think our view would be 

that IRIS can do a better job, and, if it systemically implements the 

recommendations made by the NAS, for example, can get to a 

steady state stage, where they can regularly and confidently 

produce these assessments. 

Ms. CLARK. Would the industry support additional resources to 

make this happen for IRIS? 
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Mr. WALLS. We have made clear our support for the agency having appropriate resources to do this work. 

Ms. CLARK. Thank you. 

Chairman BROUN. Thank you, Ms. Clark. 

Mr. Swalwell, you are recognized for three minutes. And please 

be quick, because I would like to get to Ms. Edwards, if we can, 

before—and give her a chance too. So you are recognized for—— 

Mr. SWALWELL. I will, and I have just one question for Professor 

Steinzor, and I am a former University of Maryland School of Law 

student, so I am thrilled—— 

Ms. STEINZOR. Fantastic. 

Mr. SWALWELL. —you are there. Professor Steinzor, you acknowledged in your testimony that the science of risk is always evolving, 

yet the Academies have suggested, in their recent report, that EPA 

adopt firm stopping rules for key points in the IRIS process. Although it may appear obvious to most, could you elaborate on the 

need for EPA to incorporate stopping rules into the IRIS process, 

and how would a lack of stopping rules impact the IRIS process? 

Ms. STEINZOR. So a stopping rule would be, we are going to look 

at this information that is available as of this point. We are going 

to apply a weight of the evidence analysis to it. We are going to 

write an IRIS profile, and then we are going to put the profile out. 

And if there are subsequent studies, we will take a look at those, 

and revise the profile as appropriate, on a cycle of five years, as 

an example, which is what applies to national ambient air quality 

standards, and it has worked fairly well. 

Mr. SWALWELL. Thank you. Go Terps, and I yield back the balance of my time. 

Ms. STEINZOR. Fear the Turtle. 

Dr. OLDEN. May I add to that? We have, in fact, developed firm 

stopping rules in our enhancements that we rolled out about last 

summer, in July. There are firm stopping rules today. 

Thank you. 

Chairman BROUN. Very good. Thank you, Dr. Olden. Ms. Edwards, you are recognized for a very quick three minutes, please, 

ma’am. 

Ms. EDWARDS. Thank you very much, Mr. Chairman, and I will 

be quick. My question is for Mr. Walls. You represent the American 

Chemical Council. Is it true that the council spent about $2.9 million in lobbying expenses over this last year, in 2014? 

Mr. WALLS. I would assume that is correct. 

Ms. EDWARDS. And then in 2013 you spent about $13 million in 

lobbying expenses? 

Mr. WALLS. I don’t have those figures in front of me, but we do 

make lobbying expenditures, yes, ma’am. 

Ms. EDWARDS. And I just want to be clear. So my understanding 

is that the council has opposed the assessment for formaldehyde, 

opposed the assessment coming forward for arsenic, opposed the assessment coming forward for trichloroethylene, TCE, that is 

present in our drinking water. Is there an assessment that you all 

support the EPA moving forward on? 

Mr. WALLS. Congresswoman, our interest is ensure that the best, 

highest quality, most reliable science is brought forward to make 

those decisions. 
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Ms. EDWARDS. Right. What is the—— 

Mr. WALLS. The regulatory—— 

Ms. EDWARDS. —last assessment that you—what is the last assessment that you supported the EPA moving forward on? 

Mr. WALLS. We—— 

Ms. EDWARDS. Give me one. 

Mr. WALLS. We give—we support a number of assessments. 

There is—EPA, for example, has a work plan chemical assessment 

program in the Office of Pollution Prevention and Toxics, and we 

have been clear that we support the agency’s moving forward. 

Ms. EDWARDS. Have you supported the agency moving forward 

on the arsenic assessment? 

Mr. WALLS. Congresswoman, we have made clear that our interest is in—— 

Ms. EDWARDS. Have you supported the EPA moving forward—— 

Mr. WALLS. To date—— 

Ms. EDWARDS. —on the arsenic assessment? 

Mr. WALLS. We support moving forward on assessments in a way 

that is—— 

Ms. EDWARDS. Have you supported the EPA moving forward on 

the arsenic assessment? 

Mr. WALLS. I—— 

Ms. EDWARDS. Have you supported the EPA moving forward on 

the formaldehyde assessment? 

Mr. WALLS. We have supported the agency moving forward on 

IRIS assessments, but to do so in a manner that—— 

Ms. EDWARDS. Have you—I just want a yes or no, if you could. 

Have you supported the—— 

Mr. WALLS. I can’t—— 

Ms. EDWARDS. —EPA moving—— 

Mr. WALLS. I can’t—— 

Ms. EDWARDS. —forward on the—— 

Mr. WALLS. —a yes or no—— 

Ms. EDWARDS. —formaldehyde assessment? 

Mr. WALLS. —Congresswoman. 

Ms. EDWARDS. No? 

Mr. WALLS. We have supported moving forward on the assessment in a way—— 

Ms. EDWARDS. On the formaldehyde assessment? 

Mr. WALLS. In a way that—— 

Ms. EDWARDS. Support—— 

Mr. WALLS. —reflects the—— 

Ms. EDWARDS. —the EPA—— 

Mr. WALLS. —recommendations made—— 

Ms. EDWARDS. —moving forward on the—— 

Mr. WALLS. —by the—— 

Ms. EDWARDS. —formaldehyde assessment? Did you—did the 

American Chemistry Council have anything at all to do, or spend 

any lobbying expenses, on ensuring that the EPA could not move 

forward, and this Congress could not move forward, on the arsenic 

assessment? Did you all lobby on that issue at all—— 

Mr. WALLS. I—— 

Ms. EDWARDS. —in the Congress? 
93 

Mr. WALLS. I don’t have direct knowledge of that, but I assume 

we did, yes. 

Ms. EDWARDS. I will be following up with additional questions. 

Mr. WALLS. I will look forward—— 

Ms. EDWARDS. Thank you very—— 

Mr. WALLS. —to your questions. 

Ms. EDWARDS. —much to the witnesses. 

Chairman BROUN. Thank you, Ms. Edwards. Apologize for the 

fast round of questions. We have two more minutes in this vote, 

so we are going to submit questions for the record, and you can answer them. You can put a lot more flesh on these. Thank you for 

your flexibility. And, again, I apologize for the hasty period of time. 

I thank Members for you all’s flexibility. The record will remain 

open for two weeks for additional comments and written questions 

from Members. The witnesses are now excused. This hearing is adjourned, and thank you all. 

[Whereupon, at 2:27 p.m., the Subcommittees were adjourned.] 

(95) 

Appendix I 

ANSWERS TO POST-HEARING QUESTIONS
96 

ANSWERS TO POST-HEARING QUESTIONS

Responses by Dr. David Dorman 
97 
98 
99 
100 

Responses by Dr. Dr. Kenneth Olden 
101 
102 
103 
104 
105 
106 
107 
108 
109 
110 
111 
112 
113 
114 

Responses by Dr. Ms. Rena Steinzor 
115 
116 
117 
118 
119 
120 
121 
122 
123 

Responses by Dr. Mr. Michael P. Walls 
124 
125 
126 
(127) 

Appendix II 

ADDITIONAL MATERIAL FOR THE RECORD
128 

PREPARED STATEMENT OF FULL COMMITTEEE RANKING MEMBER

EDDIE BERNICE JOHNSON

Thank you Mr. Chairman. Virtually every aspect of our daily lives is impacted by 

the use and presence of chemicals. The goal of the Integrated Risk Information System (IRIS) at EPA is to provide information to the American people about the risks 

associated with exposure to certain chemicals. It should be obvious to anyone that 

information about the health effects of chemical exposures can only benefit the public. Unfortunately, the value of IRIS is too often obscured by the criticisms of those 

who stand to gain by interfering with EPA’s mission to protect human health and 

the environment. 

The National Academies report released this May praises the substantial improvement made by EPA in addressing issues that had been raised about the IRIS process. Specifically, the report states that if EPA continues on this path of improvement, ‘‘the IRIS process will become much more effective and efficient in achieving 

its basic goal of developing human-health assessments that can provide the scientific foundation for ensuring that risks posed to public health by chemicals are 

assessed and managed properly.’’ The report also points out two important future 

steps which EPA can take to further improve the quality of their IRIS assessments. 

First, EPA must continue to expand opportunities for stakeholder input and discussion. The chemical industry is not the only stakeholder in public health assessments. Community groups and public health organizations do not always have the 

same resources to support meaningful participation in the public processes of IRIS. 

The EPA must not permit a privileged few to monopolize a process meant to foster 

open discussion. 

Second, EPA should be diligent in developing firm ‘‘stopping rules,’’ that guard 

against undue delay in releasing its assessments. Hundreds of new chemicals are 

released onto the market every year with no requirement that their safety be demonstrated. IRIS was created to address this lack of information on the potential toxicity of these chemicals and their influence on human health. 

Unfortunately, the pace at which IRIS finalizes its assessments has slowed to an 

unacceptable rate. It is time EPA moves ahead with urgency to bridge this gap and 

fulfill its mission. I am looking forward to hearing from Dr. Olden on this matter. 

It is clear that IRIS provides a valuable service to the American people. We must 

encourage EPA to be diligent in its efforts for continued improvement, and support 

them as they implement the recommendations of the National Academies. 

Thank you, and I yield back. 

Æ