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CHEMICAL RISK ASSESSMENT: WHAT WORKS FOR 

JOBS AND THE ECONOMY? 

HEARING 

BEFORE THE

SUBCOMMITTEE ON ENVIRONMENT AND THE 

ECONOMY 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TWELFTH CONGRESS 

FIRST SESSION 

OCTOBER 6, 2011 

Serial No. 112–93 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

JOE BARTON, Texas 

Chairman Emeritus 

CLIFF STEARNS, Florida 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

Vice Chairman 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

BRIAN P. BILBRAY, California 

CHARLES F. BASS, New Hampshire 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

SUBCOMMITTEE ON ENVIRONMENT AND THE ECONOMY

JOHN SHIMKUS, Illinois 

Chairman 

TIM MURPHY, Pennsylvania 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

JOHN SULLIVAN, Oklahoma 

CHARLES F. BASS, New Hampshire 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

BILL CASSIDY, Louisiana 

CORY GARDNER, Colorado 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

GENE GREEN, Texas 

Ranking Member 

TAMMY BALDWIN, Wisconsin 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

FRANK PALLONE, JR., New Jersey 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JOHN D. DINGELL, Michigan 

HENRY A. WAXMAN, California (ex officio) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. John Shimkus, a Representative in Congress from the State of Illinois, 

opening statement ................................................................................................ 1 

Prepared statement .......................................................................................... 3 

Hon. Gene Green, a Representative in Congress from the State of Texas, 

opening statement ................................................................................................ 5 

Hon. Joe Barton, a Representative in Congress from the State of Texas, 

prepared statement .............................................................................................. 141 

Hon. Mary Bono Mack, a Representative in Congress from the State of 

California, prepared statement ........................................................................... 144 

WITNESSES

Paul Anastas, Assistant Administrator, Office of Research and Development, 

Environmental Protection Agency ...................................................................... 6 

Prepared statement .......................................................................................... 9 

Answers to submitted questions ...................................................................... 151 

David C. Trimble, Director, Natural Resources and Environment, Government 

Accountability Office ............................................................................................ 16 

Prepared statement .......................................................................................... 18 

Answers to submitted questions ...................................................................... 163 

David C. Dorman, Dean for Research and Graduate Studies, North Carolina 

State University, on behalf of the National Academy of Sciences ................... 28 

Prepared statement .......................................................................................... 30 

Michael Honeycutt, Director of Toxicology Division, Texas Commission on 

Environmental Quality ........................................................................................ 57 

Prepared statement .......................................................................................... 60 

Answers to submitted questions ...................................................................... 166 

Harvey Clewell, Director, Center for Human Health Assessment, The Hamner 

Institutes for Health Sciences ............................................................................. 100 

Prepared statement .......................................................................................... 102 

Answers to submitted questions ...................................................................... 175 

Jerry A. Cook, Technical Director, Chemical Products Corporation ................... 105 

Prepared statement .......................................................................................... 107 

Answers to submitted questions ...................................................................... 179 

Thomas A. Burke, Associate Dean for Public Health Practice and Training, 

Department of Health Policy and Management, The Johns Hopkins 

Bloomberg School of Public Health ..................................................................... 120 

Prepared statement .......................................................................................... 122 

Answers to submitted questions ...................................................................... 198 

SUBMITTED MATERIAL

Letter, dated September 1, 2011, from Sunil Widge, Chairman, Specialty 

Steel Industry of North America, to Lisa Jackson, Administrator, Environmental Protection Agency, submitted by Mr. Murphy ...................................... 48 

Letter, dated October 4, 2011, from Cal Dooley, President and CEO, American 

Chemistry Council, to subcommittee leadership, submitted by Mr. Shimkus 55 

Majority memorandum, dated October 4, 2011, submitted by Mr. Shimkus ..... 145 

(1) 

CHEMICAL RISK ASSESSMENT: WHAT WORKS 

FOR JOBS AND THE ECONOMY? 

THURSDAY, OCTOBER 6, 2011 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON ENVIRONMENT AND THE ECONOMY, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 9:07 a.m., in room 

2123 of the Rayburn House Office Building, Hon. John Shimkus 

(chairman of the subcommittee) presiding. 

Members present: Representatives Shimkus, Murphy, Pitts, 

Bass, Harper, Cassidy, Gardner, Barton, Green, Butterfield, Barrow, and DeGette. 

Staff present: Caroline Basile, Staff Assistant; Anita Bradley, 

Senior Policy Advisor to Chairman Emeritus; Jerry Couri, Senior 

Environmental Policy Advisor, Environment; Dave McCarthy, Chief 

Counsel, Environment/Economy; Carly McWilliams, Legislative 

Clerk; Tina Richards, Counsel, Environment/Economy; Chris 

Sarley, Policy Coordinator, Environment/Economy; Brett Scott, 

Staff Assistant; Lyn Walker, Coordinator, Admin/Human Resources; Tom Wilbur, Staff Assistant; Alex Yergin, Legislative 

Clerk; Jacqueline Cohen, Democratic Counsel; and Billie McGrane, 

Democratic Assistant Clerk. 

Mr. SHIMKUS. The hearing will come to order. We want to welcome the first and second panels, and I will start with my first 

opening statement. And I recognize myself for 5 minutes. 

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

It has been no secret to anyone following our Committee that we 

have been taking a very specific look at the regulatory climate in 

this country where it is imbalanced and unworkable. In doing so, 

I and others have been clear that while we advocate the maintenance of commonsense environmental and public health protections, we also need to be careful about the impacts of government 

encroachment and that these efforts not discourage job protection 

and economic growth. Today’s hearing is another step to appreciate 

these issues. 

To understand the final regulatory product and the economic impacts of EPA activities, I think it is important to appreciate the 

process used by the Agency to get those results. Our hearing will 

delve into one of the foundational parts of EPA’s activities: the 

work of the Integrated Risk Information System, also known as 

IRIS. 

2 

I have been a strong advocate for high-quality science that is objective and valid. Moreover, I understand that many are concerned 

about IRIS’s activities on specific chemicals. I am not here to defend any particular chemical. This hearing is not about specific 

chemicals. To truly protect the public from harm and negative economic outcomes, we need an unbiased process informing policymakers about the science, not policymakers informing the science. 

IRIS was created over 25 years ago to provide EPA with information to develop policy surrounding human health effects from exposure to chemicals. There is no doubt providing such high-quality 

science-based assessment is critical to EPA’s mission. The question 

is whether IRIS is in fact fulfilling this goal, or have results begun 

to develop to support specific policy objectives? 

From our subcommittee’s perspective, we need to grasp that IRIS 

is the program making scientific assessments about chemical substances that EPA program offices use to set federal limits for various environmental laws, including the Safe Drinking Water Act 

and the Solid Waste Disposal Act. In addition, many states rely on 

IRIS data for their own environmental program purposes. 

We are honored today to have a collection of very distinguished 

witnesses and I appreciate the time and sacrifices they have made 

to be with us. Among the testimony we will receive is from the administration and their view of IRIS and its role. I look forward to 

getting an update on EPA’s 2009 reforms to IRIS, as well as where 

things stand with the Chapter 7, the long-term recommendations 

of the National Academies of Science for IRIS. 

In addition, we will have insight on whether IRIS assessments 

are doing what they should, if states are finding IRIS work reliable, how much we should care about IRIS assessment impacts on 

jobs and the economy, and is there a better way for EPA to perform 

these assessments? These recommendations could be helpful as we 

think about more global issues affecting the EPA. 

I hope all members will use this opportunity to understand the 

process, discuss the integrity of the basic science assessed at EPA, 

and appreciate how and when policy considerations converge in 

this process and their impact on jobs and the economy. 

And I will now yield back my time and recognize the ranking 

member, Mr. Green, for 5 minutes. 

[The prepared statement of Mr. Shimkus follows:] 

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OPENING STATEMENT OF HON. GENE GREEN, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. GREEN. Thank you, Mr. Chairman. I thank you for holding 

this hearing today entitled ‘‘Chemical Risk Assessment: What 

Works for Jobs in the Economy?’’ 

Risk assessment is a critical component in the protection of public health and the environment. Without adequate risk assessment, 

legislators and regulators cannot make informed and wise decisions 

about risk management. EPA has the responsibility to manage the 

Integrated Risk Information System, or IRIS, to inform the public, 

industry, and policymakers with the strongest and best-available 

science on a variety of potentially hazardous materials in the most 

non-political manner. 

In 1985, they established IRIS to help the Agency develop consensus opinions within the Agency about the health effects from 

the chronic exposure to chemicals. Currently, the EPA has assessments of 550 chemicals. These assessments are utilized by the EPA 

to further their mission and to set standards to protect human 

health and environment. IRIS assessments can be used in regulations that garner a lot of attention. In recent years, this attention 

has not been positive. 

In 2008, the Energy and Commerce Committee held a hearing in 

the Oversight and Investigations Subcommittee on IRIS and a 

GAO report that exposed concerns about the IRIS program. At the 

hearing, the GAO testified that there was a backlog of 70 chemicals 

in the IRIS system that needed to be completed but that only four 

had been completed in 2008. And half the 540 chemicals that were 

currently in IRIS possibly had outdated risk assessments. On tops 

of that, there are hundreds of other chemicals that have been referred to the IRIS system but have not even begun the assessment 

process. I also note that since the hearing in 2008, IRIS has only 

released assessments on 10 additional chemicals. 

In that 2008 hearing, I expressed concern regarding the IRIS assessment of dioxin. If you look at the dioxin section on IRIS 

webpage, you see a timeline. It appears that IRIS has been assessing dioxin since 1985. I asked questions about this assessment in 

2008, and now 3 years later, EPA released a statement that IRIS’s 

assessment on dioxin will be finalized in 2012. 

Dioxin is a compound that we know is very dangerous and far 

too prevalent in and around the district I represent along the 

Houston Ship Channel. Just outside our district, we have the San 

Jacinto Waste Pits Superfund site which consisted of submerged 

waste pits from an old paper mill that were recently discovered to 

be leaching high levels of dioxin in the San Jacinto River and there 

into the Galveston Bay. Fish advisories have been extended to larger and larger areas, creating a threat both to the people who fish 

for food and for the large port fishing industry in the area. 

Dioxin status as a toxic compound should not be controversial, so 

the fact that it has still taken an additional 3 or 4 years for IRIS 

to complete its risk assessment is very discouraging. If the EPA 

wants IRIS’s assessments to be viewed as legitimately scientific 

and reliable, they must take steps to streamline their reviewing 

process to issue assessments in a timely manner so they are not 

6 

outdated or make the assessments clearer and easier to understand. 

The National Academy of Sciences issued guidance on how to improve IRIS assessments, and I hope the EPA witness can update 

the committee on the improvements being made in the IRIS program and what they intend to do in the future to correct the problems within the program. We need to restore the public confidence 

in EPA’s risk assessment and chemical regulatory system and the 

first step must be to ensure the integrity of EPA’s scientific information and practices. 

I look forward to hearing the testimony of all of our witnesses, 

but particularly Dr. Honeycutt from TCEQ who is from my home 

State of Texas and we work with them particularly on that dioxin 

facility in the San Jacinto area. 

And Mr. Chairman, I yield back my time. 

Mr. SHIMKUS. The gentleman yields back his time. 

Does the gentleman from Mississippi seek time for an opening 

statement? Gentleman from Louisiana? Having no other members 

present to seek time, I would like to welcome the first panel. 

First of all, let me introduce the entire panel, and then we will 

go to 5-minute opening statements. 

First we have Dr. Paul Anastas, the Assistant Administrator to 

the Office of Research and Development in the United States Environmental Protection Agency. Sir, welcome. Also, Mr. David 

Trimble, Director of Natural Resources and Environment for the 

U.S. Government Accountability Office; and Mr. David C. Dorman, 

Dean for Research and Graduate Studies at North Carolina State 

University on behalf of the National Academy of Sciences. 

We have two great panels and we again welcome you. And I 

would like to first turn to Dr. Anastas from the EPA for a 5-minute 

opening statement. We have got a lot of members. We have got 

time if you go over. That is not a problem. If it goes too far, then 

it might be a problem. 

So welcome and you are recognized, sir. 

STATEMENTS OF PAUL ANASTAS, ASSISTANT ADMINISTRATOR, OFFICE OF RESEARCH AND DEVELOPMENT, ENVIRONMENTAL PROTECTION AGENCY; DAVID C. TRIMBLE, DIRECTOR, NATURAL RESOURCES AND ENVIRONMENT, GOVERNMENT ACCOUNTABILITY OFFICE; AND DAVID C. 

DORMAN, DEAN FOR RESEARCH AND GRADUATE STUDIES, 

NORTH CAROLINA UNIVERSITY, ON BEHALF OF THE NATIONAL ACADEMY OF SCIENCES 

STATEMENT OF PAUL ANASTAS 

Mr. ANASTAS. Good morning, Chairman Shimkus, Ranking Member Greene and other members of the Committee. My name is Paul 

Anastas and I am the assistant administrator for the Office of Research and Development at the Environmental Protection Agency 

and the Agency’s science advisor. Thank you for the opportunity to 

be with you here this morning to discuss the Integrated Risk Information System, also known as IRIS. 

At the EPA, we firmly believe that the American people deserve 

the best possible scientific information about the chemicals that 

7 

they may encounter in their air, water, and land. When those 

chemicals may potentially affect their health, their children, and 

the health of their communities, we have the duty to vigorously 

study them and share what we know with our citizens. 

Every day, expert scientists in EPA’s IRIS program work to fulfill that duty providing this information by drawing upon the best 

science both from the Agency as well as from universities and research institutes around the world. The assessments that we develop as part of the IRIS program are scientific documents, not regulations. This is an important distinction. While the information 

they contain is useful in our agency decisions, it is also widely used 

by communities, businesses, environmental groups, and public citizens. For those reasons and more, we recognize the importance of 

maintaining the highest level of scientific integrity when generating these IRIS assessments. That is why every draft IRIS assessment is made available to the public, to our sister federal agencies, 

and to the broader scientific community for their review and comment. 

The draft assessments we produce undergo one of the most rigorous, independent peer review processes in any scientific field. 

This peer review process makes our IRIS assessments stronger. 

The comments that we receive are valued and addressed. This is 

precisely why we undergo such rigorous review. This is how the scientific process works. 

We also recognized that continuous improvement is what science 

is all about. That is why in May 2009, Administrator Jackson put 

into place a strengthened and streamlined IRIS process. This new 

process not only strengthened the scientific integrity of the IRIS 

program, it also shortened the average time frame for generation 

of IRIS assessments from 5 years to just 23 months. Since 2009, 

EPA has completed 20 IRIS assessments, twice as many assessments as were finalized in the previous 4 years combined. 

But our efforts to continuously improve didn’t stop there. This 

past July, I announced a plan to further strengthen the IRIS program. Because our assessments are widely used in the decisions of 

state and local governments, businesses, and American citizens, we 

have focused on making them clearer, more concise, and ensuring 

that our methods and scientific assumptions are more transparent 

to the users. These improvements, which we began aggressively implementing in July, directly address the suggestions from the National Academy of Sciences and other independent experts. The 

NAS made six major suggestions to improve the generation of IRIS 

documents, and we are implementing all of those recommendations. Those recommendations and how we are dealing with them 

are detailed in my written testimony, and I will be happy to expand on those. 

We will pursue continuous improvement, but we will proceed in 

a way that does not slow or prevent our ability to provide the best 

scientific information to the public. That is what the American people expect and deserve. We recognize that the only reason to deeply 

understand a problem is to inform and empower its solution. When 

we look at the information that is being transmitted through our 

IRIS assessments, information about what makes a chemical hazardous, that information can be used to design the next generation 

8 

of chemicals so that they are not hazardous in the first place. We 

believe this information empowers innovation in the marketplace. 

Leading companies understand this potential for innovation and 

are pursuing it aggressively through the use of green chemistry. 

Green chemistry is the design of chemical products and processes 

that reduce or eliminate the use and generation of hazardous substances. By understanding the properties that make a chemical 

hazardous, scientists and industry and in academia are meeting 

environmental and economical simultaneously through the principles of green chemistry design. 

New life-saving medicines are being developed in ways that 

produce dramatically less waste through green chemistry. New 

high-performing materials are being invented to serve their purpose and then degrade harmlessly into the environment through 

green chemistry design. New products are being introduced into 

the marketplace that are safe for children and attractive to consumers through green chemistry. All of this progress is being made 

in sectors ranging from agriculture to energy, transportation to 

telecommunications, and cosmetics to computing. Companies across 

the American economy are increasing profits and enhancing competitiveness through green chemistry. That is the power and the 

potential of green chemistry. And that is why the lessons we learn 

from toxicology and the IRIS program are important for feeding innovation. 

In conclusion, whether it is through IRIS or our other cuttingedge scientific research, EPA is providing critical information to 

companies, entrepreneurs, and researchers so they can make new 

discoveries and develop new innovations all while protecting health 

and the environment. That is the real power of understanding 

chemical hazard and that is why EPA’s IRIS program is so critically important. 

We will continue to improve this program using the best science 

not only to understand the problems of today, but to inform and 

empower the solutions of tomorrow. It is what is necessary for the 

environment, for public health, for the economy, and I think we can 

all agree that it is what the American people deserve. 

Thank you for the opportunity to speak here this morning. I will 

be happy to answer any questions as is appropriate. 

[The prepared statement of Mr. Anastas follows:] 

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Mr. SHIMKUS. Thank you, Dr. Anastas. 

And we would now like to recognize Mr. David Trimble. Sir, you 

are recognized for 5 minutes likewise. Take your time and get 

through it, and we welcome you here. 

STATEMENT OF DAVID C. TRIMBLE 

Mr. TRIMBLE. Chairman Shimkus, Ranking Member Green, and 

members of the subcommittee, I am pleased to be here today to discuss our prior work and recommendations on EPA’s Integrated 

Risk Information System. 

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

550 chemicals in the environment. IRIS assessments are a critical 

component of the EPA’s capacity to support scientifically sound risk 

management decisions, policies, and regulations. 

In March 2008, we reported that the IRIS program was at serious risk of becoming obsolete because the Agency has not been able 

to complete timely credible chemical assessments or decrease its 

backlog of 70 ongoing assessments. We found that the time frames 

for completing assessments were unacceptably long, often taking 

over a decade. In many cases, assessments became obsolete before 

they could be finalized and were stuck in an endless loop of assessment and reassessment. 

In April of 2008, EPA revised the IRIS process, but the changes 

made were not responsive to our recommendations. The new process was actually worse than the one it replaced, institutionalizing 

process that resulted in frequent delays by enabling OMB to determine when an IRIS assessment could move forward. Further, this 

process effectively excluded the content of OMB’s comments to EPA 

and those from other interested federal agencies from the public 

record. 

Concerned with these programs and the Agency’s lack of responsiveness, we added EPA’s process for assessing and controlling 

toxic chemicals to our January 2009 report on government-wide 

high-risk areas in need of an increased attention by executive agencies and Congress. In May 2009, EPA had made significant 

changes to the IRIS process. In June of that year, we testified that 

these changes, if implemented and managed effectively, would be 

largely responsive to the recommendations we made in our March 

2008 report. Let me highlight three of these key changes. 

First, the IRIS process would be managed by EPA rather than 

OMB as the former process was, restoring independence to EPA. 

Second, it required that all written comments provided by OMB 

and other federal agencies and draft IRIS assessments be part of 

the public record, adding transparency and credibility to the process. Third, the procedures consolidated and eliminated steps, 

streamlining the process. 

Notably, the new process eliminated the step under which other 

federal agencies could have IRIS assessments suspended indefinitely to conduct additional research. As we have reported, we understand that there may be exceptional circumstances under which 

it may be appropriate to wait for the results of an important ongoing study. However, as a general rule, we believe that the IRIS assessments that are based on the best available science is a standVerDate Aug 31 2005 10:54 Oct 02, 2012 Jkt 037690 PO 00000 Frm 00020 Fmt 6633 Sfmt 6633 F:\112-09~2\112-93~1 WAYNE
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ard that would best support the goal of completing assessments 

within reasonable time periods and minimizing the need to conduct 

wasteful rework. 

While the May 2009 IRIS process changes reflect a significant 

improvement that can help EPA restore the integrity and productivity of the IRIS program, EPA still faces significant management 

challenges as it seeks to completely timely, credible IRIS assessments. 

First, EPA must continue to balance the need for using the best 

available science with completing IRIS assessments in a timely 

manner. As we have reported, even 1 delay can have a domino effect requiring the process to essentially be repeated to incorporate 

changing science. 

Second, EPA faces long-standing difficulties in completing assessments of chemicals of key concern, those that are both widespread 

and likely to cause significant health issues. We believe that EPA 

must continue to focus on the best available science, obtaining 

credible expert review, and finalizing IRIS assessments. 

Third, EPA must be disciplined in keeping the timelines even in 

the absence of fixed statutory deadlines for completing IRIS assessments. 

Lastly, we believe that to produce timely credible IRIS assessments over a sustained period of time, it will be important for EPA 

to maintain a consistent process going forward. 

We are currently reviewing EPA’s implementation of its revised 

2009 IRIS assessment process and its response to our previous recommendations. As part of this review, we will be examining EPA’s 

response to NAS’s recommendations for improvements to the IRIS 

process. We plan to issue this report later this year. 

That concludes the summary of my statement. I will be happy to 

answer any questions any member of this committee may have. 

[The prepared statement of Mr. Trimble follows:] 

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Mr. SHIMKUS. Thank you very much. 

Now, I would like to recognize for 5 minutes Dr. David Dorman, 

who is testifying on behalf of the National Academy of Sciences. 

Sir, welcome. You have 5 minutes, and take your time on the opening statement. 

STATEMENT OF DAVID C. DORMAN 

Mr. DORMAN. Thank you. Good morning, Mr. Chairman and 

members of the subcommittee. My name is David Dorman. I am a 

professor of toxicology at North Carolina State University and I 

served on the National Research Council’s Committee to Review 

EPA’s Draft IRIS Assessment of Formaldehyde. 

The NRC report was developed by 15 scientists drawn by academia, federal laboratories, state government, and other organizations. The scientists that served on the NRC committee were selected by the National Academies and had a wide array of scientific 

expertise related to this effort. As part of the Academy’s process, 

a draft of the committee’s report was subjected to extensive peer 

review prior to release by the NRC. 

It is important to note that the NRC was not asked to conduct 

an independent assessment of formaldehyde but rather we were 

charged with examining EPA’s identification of potential cancer 

and non-cancer health effects, the toxicological basis for those 

health effects, and the way uncertainty factors used to derive the 

reference concentrations and the quantified cancer unit risk estimates for formaldehyde. The major findings of our NRC committee 

were as follows: 

First, we found that the U.S. EPA was faced with the daunting 

task of compiling a complex and large toxicological database for 

formaldehyde. For the most part, the committee agreed that EPA 

achieved this goal. The EPA’s draft assessment for formaldehyde 

was prepared using the Agency’s current format and approach for 

IRIS documents. Our committee found the EPA’s document to be 

quite cumbersome and was too often lacking in clarity and transparency. We were troubled that previous NRC committees reviewing similar assessments for other chemicals had identified similar 

deficiencies. 

Third, our committee therefore offered a set of suggestions for 

changes in the IRIS development process that might help EPA improve its approach. In essence, we provided EPA with a roadmap 

for changes in the development process. The term roadmap was 

used because the topics that needed to be addressed were set out, 

but detailed guidance was not provided by the committee since that 

was seen as beyond our committee’s charge. 

Thus, the committee provided general guidance for the overall 

process and some specific guidance on the specific tests and steps 

of evidence identification, evidence review and evaluation, weightof-evidence evaluation, selection of studies for derivation and calculation of reference concentrations and unit risk. For each of these 

steps, there are underlying processes that would need to be examined and reconsidered. The NRC report provides further details on 

these recommendations. 

Finally, the committee recognized that any revision of the approach would involve an extensive effort by EPA staff and others, 

29 

and consequently, it did not recommend that EPA delay the revision of the formaldehyde assessment while revisions of the IRIS approach were undertaken. In fact, we provided specific guidance as 

to the steps needed to revise the existing draft IRIS assessment. 

Models for conducting IRIS assessments more effectively and efficiently are available, and the committee provided several examples 

in the present report. Thus, EPA might be able to make changes 

in its process relatively quickly by selecting and adapting existing 

approaches as it moves towards a more state-of-art process. 

As a member of the committee, I have been pleased to hear that 

Dr. Anastas and other EPA administrators plan on implementing 

suggestions found in the NRC formaldehyde report. 

In closing, I would like to thank all of you for inviting me here 

to discuss the NRC’s report and I welcome your questions. 

[The prepared statement of Mr. Dorman follows:] 

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Mr. SHIMKUS. Thank you very much. And we will start. 

And I will recognize myself for 5 minutes for the first round of 

questions. 

First to Dr. Anastas, you have been clear in the past that IRIS 

does not perform risk assessments; rather this is done by risk managers in the program office, and I have been trying to handle those 

differences. EPA’s Web site, though, states that IRIS is ‘‘a human 

health assessment program that evaluates quantitative and qualitative risk information on effects that may result from exposure to 

specific chemical substances found in the environment. If this is 

true, how can IRIS not be doing ‘‘risk assessments’’ if it has to distill qualitative risk information and quantitative risk information? 

Mr. ANASTAS. The elements of a full risk assessment have been 

outlined in a landmark 1983 NAS report that looks at risk identification and characterization, dose response as well as exposure. 

What an IRIS assessment is today is looking at the hazard identification and characterization and the dose response. Until that information—which is powerful and actually fundamental to a risk 

assessment—is combined with the exposure models and the exposures that are expected and anticipated under a regulatory program or some other scenario, that is when it becomes a full risk 

assessment and is used in risk management. This is the important 

but only the front-end part of that overall calculus. 

Mr. SHIMKUS. Thank you. You did answer this question in your 

opening statement. I am just going to go through three quick ones. 

You stated in your opening statement that the IRIS office evaluates 

peer review recommendations, correct? Is that what you said in 

your opening statement? 

Mr. ANASTAS. Right. When we get any peer review comments, we 

always review them and address them, yes. 

Mr. SHIMKUS. Do you write draft assessments and evaluate public comments? 

Mr. ANASTAS. We submit our draft assessments for public comment and the public and the scientific community comments on 

those drafts. 

Mr. SHIMKUS. Does your office decide what to include and exclude and what other changes to be made to its own work based 

upon those two responses? 

Mr. ANASTAS. Through an extensive and iterative process, we receive those comments, address those comments, and transparently 

show how we have addressed those comments. 

Mr. SHIMKUS. Thank you. 

Mr. Trimble, what effect does IRIS risk values have on the regulated community or the private marketplace? 

Mr. TRIMBLE. Well, as Dr. Anastas has indicated, it forms the 

basis for many of EPA’s regulatory decisions. For example, in 

drinking water standards, the information in IRIS will be married 

up with occurrence data whether or not the contaminant has been 

found in water across the country to inform decisions about whether or not, for example, to regulate a contaminant. So it is the building block for many of EPA’s regulatory decisions. 

Mr. SHIMKUS. But if the IRIS assessment is not finalized for over 

a period, then what is that effect? 

36 

Mr. TRIMBLE. Then basically everything comes to a screeching 

halt because the mission teams like the water office or air, they 

don’t have sort of the basic science they need to carry out their mission. 

Mr. SHIMKUS. And then the private sector who might be preparing for this are—— 

Mr. TRIMBLE. Everyone is left hanging. 

Mr. SHIMKUS. Thank you. And Dr. Dorman, I have talked about 

this numerous times in my years here on the committee. What is 

the value of a risk assessment value that identifies a level below 

a natural occurring background level? 

Mr. DORMAN. So that is a dilemma for a number of chemicals 

that exist endogenously, and my own opinion—and I think it also 

was echoed in a report—is that for formaldehyde in particular, 

those endogenous levels need to inform the assessment as performed by EPA or other agencies. On a personal note, kind of 

speaking not for the committee, I think that becomes a challenge 

and I think that oftentimes we don’t regulate chemicals, we don’t 

consider the risk assessment in light of that endogenous background. 

Mr. SHIMKUS. And endogenous meaning? 

Mr. DORMAN. That is what is present normally in the body just 

from consumption of food or for metabolism. It is basically what 

your body produces. 

Mr. SHIMKUS. So in the numerous years I have been on this committee and dealing with—you know, we have water issues that 

would have endogenous elements in it, we have ground that has 

endogenous elements, so I guess for the layman, having a standard 

that is lower than naturally occurring, cleaning the soil up and 

then you can’t replace it with the same soil. This same soil is still 

higher than the standard established by this risk assessment, is 

that correct? 

Mr. DORMAN. Correct. That could be the case. 

Mr. SHIMKUS. Thank you very much. 

Now, I would like to recognize my colleague, Mr. Green, for 5 

minutes. 

Mr. GREEN. Thank you, Mr. Chairman. 

And I guess why IRIS is so important—and I happen to represent the largest petrochemical complex in the country—is that all 

the chemicals used properly are something that we really benefit 

from, but that is why IRIS is so important because of those beneficiary uses, but in certain levels. And the best example is formaldehyde and dioxin. We need those but when used properly and 

that is why IRIS is so important to do. 

Mr. Administrator, I mentioned in my opening statement I was 

concerned with the length of time it has taken IRIS to complete assessment of dioxin due to the presence of dioxin super flight in our 

district. It is my understanding that IRIS is expected to release a 

portion of the final dioxin assessment in January of 2012. Is that 

correct? And can you elaborate very briefly on why this is a twopart assessment? Yes, sir. 

Mr. ANASTAS. One of the things that I did try to emphasize is 

that when we receive comments on an assessment, we take them 

extremely seriously and we want to fully address all of these comVerDate Aug 31 2005 10:54 Oct 02, 2012 Jkt 037690 PO 00000 Frm 00040 Fmt 6633 Sfmt 6633 F:\112-09~2\112-93~1 WAYNE
37 

ments. We follow the science. The science is what dictates when we 

can release a final assessment. We submitted the dioxin assessment most recently the received comments on both the cancer portion of the dioxin assessment and the non-cancer portion of the assessment. It is clear that the comments on the non-cancer portion 

of the assessment are things that can be readily dealt with, addressed, and that we can move quickly ahead. 

The complexity of the dioxin cancer portion of the assessment are 

far more complex and will not be completed on the same time 

frame as the non-cancer portion of the assessment. And that is 

based on the science and the complexity of the science and the scientific issues. 

Mr. GREEN. This is not the first hearing that our committee has 

had on IRIS and it is an important program that has been subject 

to review by the GAO and the National Academy of Sciences Committee for years. It has been targeted because of lengthy delays and 

because sometimes the politicalization—surprise, surprise—in 

Washington what should be scientific process. We saw this during 

the Bush Administration when the OMB took over management of 

the IRIS program and the pace of the assessments slowed to a 

crawl. The Government Accountability evaluated the peer review 

process in 2004 and raised certain concerns. 

Mr. Trimble, can you briefly explain the concern GAO had with 

IRIS review system that was in place from 2004 to 2008? And 

again I am trying to remember. Obviously, OMB reviews all regulations from agencies, but this is the first time I had seen that OMB 

would actually control the process between agencies for input. So 

I appreciate, you know, you answering that. 

Mr. TRIMBLE. Briefly, what we found at the time was we had 

concerns regarding productivity with the IRIS program, which we 

have talked about. At that time one of the things that we noted in 

our reports was that OMB had involved itself and taken control of 

2 key steps within the process so that reports and IRIS assessments could now move forward without OMB’s concurrence. And 

that was I believe when reports were being sent out for review and 

when they were being finalized. 

So there was one aspect that dealt with productivity and EPA’s 

independent ability to control the process, but the other aspect that 

we reported on that was troubling was that OMB’s involvement 

and comments were non-transparent so there was a lack of transparency in the public regarding what changes were being made and 

what those comments were. OMB brought in other federal agencies 

and also those comments were not transparent being deemed by 

OMB at the time as deliberative in nature. And so it was those two 

factors that we reported on at the time. 

Mr. GREEN. And again that is a different system than I think we 

are used to, and there are times that as Members if we lose at the 

Agency, whether the EPA or somewhere else, we will go to OMB 

and talk about the economic impacts. And that is what OMB 

should be doing—— 

Mr. TRIMBLE. Um-hum. 

Mr. GREEN [continuing]. And not getting involved in the actual 

scientific assessment. 

38 

Dr. Dorman, I know you briefly described some of the recommendations that National Science made. Can you talk about 

particularly with the issue of formaldehyde? 

Mr. DORMAN. So I think in the case of formaldehyde, we found 

largely that we had a number of areas in which we agreed fully 

with the recommendations or the conclusions that the EPA had in 

the IRIS document. We did have some areas in which we differed 

as far as our interpretation of the EPA document in light of the scientific evidence that is available. We did give the Agency some specific recommendations regarding not relying on certain studies. We 

felt they weren’t the best studies available for certain endpoints 

like sensory irritation and others but hopefully that addresses your 

concern. 

Mr. GREEN. OK, thank you. Thank you, panel. 

Mr. SHIMKUS. The gentleman’s time has expired. 

The chair now recognizes the chairman emeritus, Mr. Barton, for 

5 minutes. 

Mr. BARTON. Thank you, Chairman Shimkus. 

Let me ask Dr. Anastas. Are you career or you a political appointee? 

Mr. ANASTAS. I am a political appointee. 

Mr. BARTON. OK. And you have been in your position since the 

Obama Administration took office? 

Mr. ANASTAS. Shortly thereafter. Actually, it was January—— 

Mr. BARTON. OK. 

Mr. ANASTAS [continuing]. Of 2010. 

Mr. BARTON. Very good. I am going to ask you a little bit different series of question in the hearing because my interest, while 

I share some of the interest on chemical issues, I am very involved 

in the air quality issue. 

Does your office do any of the studies that relate to ozone? 

Mr. ANASTAS. We produce integrated scientific assessments on a 

wide range of national ambient air quality standards, including 

ozone. 

Mr. BARTON. OK. And mercury? 

Mr. ANASTAS. Yes, all of those substances under the program. 

Mr. BARTON. And PM2.5? 

Mr. ANASTAS. Correct. 

Mr. BARTON. OK. Is there any other office within EPA that does 

studies on those similar to your office? 

Mr. ANASTAS. We work closely with our Office of Air and Radiation and while we do the underlying scientific assessments of the 

kind that we are discussing in IRIS and integrated scientific assessments, the Office of Air and Radiation takes those basic scientific documents into their regulatory process. 

Mr. BARTON. When the administrator is looking at tightening the 

standards on the various criteria of pollutants under the Clean Air 

Act, who make the decision whether the study to look at the health 

effects is going to be done internally by your office or externally? 

Mr. ANASTAS. The process of generating a scientific assessment 

on these chemicals would take place internally, relying on a wide 

range of external studies—universities, research institutes—and 

those assessments are conducted internally and then put out for 

peer review. 

39 

Mr. BARTON. Would there ever be an instance where your office 

did not do an internal study, even if the decision was made to do 

an external study? 

Mr. ANASTAS. I am not familiar with a case where it would be 

conducted completely externally. We rely on a wide range of external studies to inform our assessments, but the assessments that 

are fed into the regulatory process are constructed internally. 

Mr. BARTON. Is it your decision whether to do the external study 

or the administrator’s decision or the deputy administrator’s decision or kind of a collective all of the above? 

Mr. ANASTAS. The conduct of the studies are dictated by the 

needs of our regulatory and program offices and they work closely 

with the Office of Research and Development to identify which 

studies are necessary to inform their regulatory actions and then 

we proceed. So that is the process that is used. 

Mr. BARTON. I don’t necessarily understand that answer, but I 

don’t have but a minute and a half. So can you give me a definition 

that is generally accepted of what a premature death is? 

Mr. ANASTAS. One would look at statistically a life expectancy 

using epidemiological models and the absence of a particular effect 

if you are looking at, for instance, a respiratory—— 

Mr. BARTON. Well, give me a layman’s definition. I mean my 

friends on the Democratic side, when we debate these environmental bills where we are attempting to delay some of the EPA 

regulation, they trot out these studies, and they are usually 10 to 

15 years old, they are usually external, and they all seem to predict 

30,000 premature deaths a year, but we have never gotten a definition of what a premature death is. 

Mr. ANASTAS. A premature death would be something that shortens the otherwise—— 

Mr. BARTON. I want to know what the definition is. Is a premature death somebody who has a life expectancy of 80 who dies 

at 40 because of exposure to ozone, dies at 50, dies at 35? I mean 

there should be some standard definition. Apparently, there is not. 

Premature death is in the eyes of the beholder. 

Mr. ANASTAS. Their life expectancy would be shortened from 

what it would otherwise be. So it is not set at a cutoff point of how 

much shorter. That is—— 

Mr. BARTON. Could you provide for the record a written answer 

to what a premature death is? 

Mr. ANASTAS. I would be happy to. 

Mr. BARTON. Whatever the definition is that your agency uses, 

I would like to have it in writing. 

Mr. ANASTAS. Certainly. 

Mr. BARTON. Thank you, sir. 

Thank you, Mr. Chairman. 

Mr. SHIMKUS. The chair now recognizes the gentleman from Mississippi, Mr. Harper, for 5 minutes. 

Mr. HARPER. Thank you, Mr. Chair. 

Dr. Anastas, just a question. Who selects who does the peer review? Who is invited to join in that? Is that open? Tell me how that 

works. 

Mr. ANASTAS. Certainly. The peer reviews can be done, for instance, by the National Academy of Sciences. They can be conVerDate Aug 31 2005 10:54 Oct 02, 2012 Jkt 037690 PO 00000 Frm 00043 Fmt 6633 Sfmt 6633 F:\112-09~2\112-93~1 WAYNE
40 

ducted by our Science Advisory Board. They can be conducted by 

panels of scientific experts. In the case of the National Academies, 

they are selected certainly by the Academy. The Science Advisory 

Board assembled ad hoc panels for those reviews, and each of these 

types of processes is a vetting for balancing different scientific expertise and ensuring that there aren’t ethical or conflicts of interest. 

Mr. HARPER. When a draft is prepared and done, if there is conflicting opinions by the peer review, how is that dealt with? Does 

that appear in your draft assessment that there are conflicting reports? 

Mr. ANASTAS. The results of conflicting opinions are resolved 

within the peer review committee themselves. They can represent 

the different perspectives in their peer review report and we would 

receive that report. 

Mr. HARPER. So is the public ever made aware that there may 

have been a difference of opinion before that came to you? 

Mr. ANASTAS. Thank you. What is a very important point that 

I should have emphasized is that these peer review panels are publicly held. We receive public comment. The peer reviews are publicly available so actually one of the things that was emphasized 

by GAO is the necessary transparency, and that is something that 

is very transparent in this process is the peer review. 

Mr. HARPER. When the peer review is being completed, once a 

final assessment is done, is that final assessment on track to be reevaluated? Is it a perpetual continuous reevaluation? Or something 

new comes in, is that subject to being changed? 

Mr. ANASTAS. There are over 500 assessments on the IRIS database currently, and one of the ongoing processes where we seek 

public input, we receive input from our various program offices and 

regional offices is input on what should be in the pipeline for highest priority either due to knowledge of additional scientific information that requires updating or a need to address actions that need 

to be taken. So that is how we inform how things get updated in 

what order. As was referenced earlier, this is an ongoing challenge 

and why it is so important that we have increased the pace of these 

assessments. 

Mr. HARPER. Can you give me the difference between chemistry 

and green chemistry? 

Mr. ANASTAS. Certainly. Chemistry is the study of all matter and 

material and its transformations and green chemistry is looking at 

how you manipulate the molecules, how you build them from the 

atoms up so that they have a reduced ability to cause toxicity to 

humans or the environment. In the same way that we can design 

a substance to be green or blue, flexible or brittle, we can design 

it so that it is either capable of causing harm or far less capable 

of causing harm. 

Mr. HARPER. Well, when I went to college, you could major in biology or chemistry. Do you anticipate that we will see green chemistry majors in our universities? 

Mr. ANASTAS. As a matter of fact, there are Ph.D. programs in 

major universities both in the United States and elsewhere in 

green chemistry. There are degree programs in everywhere from 

the U.S., India, China, Australia, and the U.K. 

41 

Mr. HARPER. If I have time, I would like to ask Dr. Trimble a 

question if I may. And I am going to reach a quick peer review 

committee. This was the NRC formaldehyde committee review just 

a quote here. 

It says, ‘‘the committee is concerned about the persistence of 

problems encountered with IRIS assessments over the years and 

the draft was not prepared in a consistent fashion. It lacks clear 

links to an underlying conceptual framework and it does not contain sufficient documentation on methods and criteria for identifying evidence from epidemiologic and experimental studies, for 

critically evaluating individual studies, for assessing the weight of 

evidence, and for selecting studies for derivation of the RFCs and 

unit risk assessments.’’ 

Tell me your opinion on that, what that statement was. 

Mr. TRIMBLE. This may be better directed to NAS since GAO has 

not looked or assessed the NAS’s study. 

Mr. HARPER. Well, certainly defer then. 

Mr. DORMAN. Yes, sir. So what we mean by that is that oftentimes when one is trying to put together a database, when you are 

basically doing literature reviews, before you begin that process, 

you start to lay out a framework by which you are going to evaluate the literature. And so as you are starting to go looking at literature, you will find, per se, a chemical like formaldehyde there 

is literally thousands of articles available in the published literature on a chemical where if you search the database using a 

word like formaldehyde you will find. And so one needs to have a 

process by which you start to kind of weed that evidence down to 

a sub-selection of studies and then eventually key studies that you 

start to use in your assessment, and we just felt that EPA was not 

transparent in defining that process by which they would both 

identify what literature you were finding and then either accept or 

not accept certain studies and bring them forward in their assessment. 

Mr. HARPER. I realize I am out of time and if I may, Dr. Trimble, 

what I was wanting to ask was this: the conclusions in that formaldehyde review committee seemed to indicate that the same problems that were noted by GAO in ’06 are still evidence in IRIS and 

I just want to know if you agree or disagree? 

Mr. TRIMBLE. I will probably punt on this. This is going to be 

part of our ongoing review, which we will be reporting on in the 

next couple of months looking at how the process has gone since 

then and part of that review will be looking at the NAS. 

Mr. HARPER. That was a very polite way of not—— 

Mr. TRIMBLE. Yes, I apologize. 

Mr. HARPER. Thank you. 

Mr. SHIMKUS. The gentleman yields back his time. 

The chair now recognizes the gentleman from North Carolina, 

Mr. Butterfield, for 5 minutes. 

Mr. BUTTERFIELD. Let me thank you, Mr. Chairman, for convening this very important hearing today and particularly we 

thank the witnesses for their testimony. 

Mr. Chairman, IRIS, as we all know, is the foundation of our 

public health and environmental policy and it should be reviewed 

periodically to ensure it is being carried out at peak performance. 

42 

And so the witnesses’ testimony today has been very helpful on this 

subject. 

I believe to properly evaluate IRIS’s performance, we must have 

absolute clarity on the function of IRIS. Dr. Anastas, let me start 

with you. Does IRIS make risk assessments? 

Mr. ANASTAS. No, what IRIS does is provide important scientific 

information that gives insight on the hazards of chemicals and potential health consequences of various chemicals, but in order to 

have it be a full risk assessment, it needs to have the exposure 

component. So while this information is fundamental and essential, 

it is not a full and complete risk assessment. 

Mr. BUTTERFIELD. So do you only make hazard assessments or 

do you do both? 

Mr. ANASTAS. The risk assessments are done as part of the regulatory process in our regulatory office. 

Mr. BUTTERFIELD. But don’t you agree that this is a very important distinction between these two? 

Mr. ANASTAS. It is a tremendously important distinction, one 

that is often confused. Many people do view IRIS members as regulations, as risk assessments, and it is an important distinction that 

this is looking at just this element of the scientific information. 

Mr. BUTTERFIELD. That is very helpful. 

Now, does IRIS make EPA regulations? I think we know the answer but I want you to go on the record and say that. 

Mr. ANASTAS. Well, we know how important IRIS values are to 

regulations. They are not regulations and they are not making regulations. 

Mr. BUTTERFIELD. So could we say, then, that the primary work 

of IRIS is to evaluate and integrate existing scientific literature 

into assessments of potential hazard which are then used by EPA 

program offices and others to gauge risk and eventually set thresholds for exposure in programs? Is that correct? 

Mr. ANASTAS. That is correct. 

Mr. BUTTERFIELD. In a little while, Dr. Anastas, we are going to 

hear from Dr. Honeycutt of the Texas Commission on Environmental Quality. He will claim that the EPA’s most recent assessment on formaldehyde calls into question the safety of its hailing. 

Dr. Honeycutt will state that using EPA’s most recent assessment, 

formaldehyde in your breath that results from normal body functions would be five times higher than the highest level of EPA 

would call safe. Was the IRIS assessment asserting that this room 

is now unsafe due to all of the formaldehyde producers currently 

being breathed at this time? How would you respond to this assertion and what are the implications? 

Mr. ANASTAS. Well, the IRIS assessment was not concluding or 

implying that this room is unsafe because of the air that we exhale. 

The formaldehyde assessment benefitted greatly from the comments that were supplied by the National Academies and the comments that the National Academies provided are being addressed 

to strengthen that assessment. But no, the answer is no, the assessment did not imply that we are at risk because of the air that 

we are breathing in this room. 

Mr. BUTTERFIELD. Yes. Thank you very much. 

Thank you, Mr. Chairman. I yield back. 

43 

Mr. SHIMKUS. I thank my colleague. I would just note, Dr. 

Anastas, in your response you said ‘‘not concluding,’’ brings up my 

question about are you doing a risk assessment? So that is the part 

of this whole debate that we are looking into. 

The chair now recognizes the gentleman from Pennsylvania, Mr. 

Pitts, for 5 minutes. 

Mr. PITTS. Thank you, Mr. Chairman. 

Dr. Anastas, is the source of a study’s funding an automatic disqualifier of the contents or quality of the research no matter how 

well characterized or high quality such a study is? 

Mr. ANASTAS. The evaluation of a study is based on the scientific 

integrity of the study. So the short answer to your question is no. 

The importance of the rigor of the study, the way that the study 

is conducted are the important determining factors. With regard to 

such things as the peer review and peer review panelists, ethical 

and conflict of interest are considered at that point, for instance, 

for peer reviewers, but in the conduct of the study, it is the scientific rigor of the study. 

Mr. PITTS. Other than industry funded, please tell the committee 

what other types of funding exist for high-quality scientific work? 

Mr. ANASTAS. I think there is extensive funding for high-quality 

research provided by the Federal Government. There is certainly a 

wide range of our scientific agencies provide funding to researchers 

to conduct on a wide range of topics including toxicology, epidemiology, and these are important sources of funding. Whether it is 

the National Science Foundation, the National Institutes of Health, 

and of course the Environmental Protection Agency. 

Mr. PITTS. Has the EPA ever contracted with the private sector 

or intentionally obtained scientific research that was paid for by a 

private interest? 

Mr. ANASTAS. I want to make sure that I give you an accurate 

answer so I don’t want to be definitive without checking all of the 

facts. What I will pledge to do is get back with you with a clear 

answer on that question. 

Mr. PITTS. All right. To what extent does IRIS rely on the scientific pronouncements made by other federal agencies or coordinate with them on their activities like NTP or ATSDR? 

Mr. ANASTAS. One of the things that we ensure doing is coordinate what assessments will be done so that we certainly wouldn’t 

want to be duplicative or overlapping or redundant. We coordinate 

with sister agencies not only which assessments to do to make sure 

that we are complementary wherever appropriate but also coordinate in our interagency reviews. Interagency reviews are transparent and inclusive and we rely heavily on the scientific expertise 

on our sister scientific agencies and health agencies, as well as others. 

Mr. PITTS. Thank you. 

Dr. Dorman, in your opinion, has EPA’s IRIS process evolved to 

reflect improvements in the field of risk assessment? 

Mr. DORMAN. So speaking for myself and not as a member of the 

panel, I think that approaches have been kind of mixed. In some 

areas, IRIS has been more considerate of modeling efforts and 

things like that which reflect more state-of-the-art. I think there 

are other areas in which the IRIS assessment program probably 

44 

lags a little bit behind. But I think that IRIS does try to keep up 

and I think the EPA should be, you know, recognized for trying to 

keep up with the science as it is evolving. 

Mr. PITTS. Are you familiar with other branches of the Federal 

Government that are engaged in risk assessment, and if so, do 

those offices employ best practices that could be applied here? 

Mr. DORMAN. I serve and do an advisory role on different aspects 

for the Federal Government, and I think there are some examples 

of best practices. Speaking on behalf of the committee, we did identify some of those best practices that we thought could serve a template for the Agency as they move forward on looking at revising 

the IRIS program. 

Mr. PITTS. How important is it for the American public that the 

integrated risk assessment process results in a reasonably correct 

assessment and what are the practical consequences of an overly 

precautionary assessment? What are the practical consequences of 

an assessment that does not identify risk? 

Mr. DORMAN. Again, I think as Dr. Anastas pointed out the IRIS 

program is not doing the risk assessment per se; they are trying 

to compile the data regarding hazard identification, but I think 

that is extremely critical for folks. And I think it is not only an 

issue of an economic issue, but it is also a public health issue 

where the public doesn’t become alarmed over health effects that 

may or may not be present with a certain chemical. And I think 

that is another area that, you know, the EPA IRIS documents do 

try to identify hazard identification and I think it is very critical 

for the public that it is done in the right way. 

Mr. PITTS. Thank you, Mr. Chairman. 

Mr. SHIMKUS. The gentleman’s time has expired. 

The chair recognizes that we have been joined by my colleague 

from Georgia, which I think he will—— 

Mr. BARROW. I thank the chairman. I will waive. 

Mr. SHIMKUS. He waives. The chair now recognizes the vice 

chairman of the subcommittee, Mr. Murphy, for 5 minutes. 

Mr. MURPHY. Thank you, Mr. Chairman. 

Dr. Anastas, the EPA has a draft of the IRIS toxicology report 

for hexavalent chromium, is that correct? 

Mr. ANASTAS. Correct. 

Mr. MURPHY. Are you aware that on May 12, 2011, a panel of 

independent chromium experts had significant concerns with that 

draft? 

Mr. ANASTAS. I am aware of that peer review. 

Mr. MURPHY. And is the EPA prepared to incorporate more upto-date scientific research in that based upon the information that 

came from the peer review and other input? 

Mr. ANASTAS. We are evaluating that peer review. We are evaluating the comments and concerns. While no decisions have been 

made, it is the practice that I have stated and I appreciate the opportunity to emphasize that we consider and we address the concerns raised in peer review. 

Mr. MURPHY. Is there anything you recall in that peer review 

study that sticks out that says there is something that raises concerns of a particularly salient nature for you? 

45 

Mr. ANASTAS. I think that this peer review has raised a number 

of questions about the science that is currently being conducted 

and the potential value of that science informing the assessment 

upon its completion. 

Mr. MURPHY. Are you aware also of the NTP study, the doses 

given to test animals, that something like 5,000 parts per billion 

but the national drinking water standard for total chromium is 100 

parts per million, and drinking water monitoring indicates that 

hexavalent chromium in drinking water is only about 1 to 4 parts 

per billion? I mean these seem to be pretty radical differences in 

terms of information that has come out on hexavalent chromium 

research versus what is really out there. How do you evaluate that 

sort of information when you see studies looking at some extremely 

high levels and then related to what is really out there? 

Mr. ANASTAS. It is certainly I will say a traditional methodology 

when studying the toxicity of a particular chemical that you want 

to be able to get up to the level where you see a particular toxic 

effect, and sometimes these levels that are required are fairly high 

as you mentioned. And then there is the necessary extrapolation. 

So this is not necessarily unusual for studies of this type. 

Mr. MURPHY. But you are also drawing conclusions based upon 

having toxic levels can give us some misinformation. For example, 

a person can reach a toxic level of ingestion of H2O, but that 

doesn’t mean we draw conclusions based upon that. And I just 

want to make sure that we are also looking at these levels. I mean 

what is the real risk? Because none of us want to misdiagnose and 

then mistreat the problem. 

Mr. ANASTAS. This is the basis of dose response—— 

Mr. MURPHY. Um-hum. 

Mr. ANASTAS. —and getting these dose response curves, the ability to determine at which dose an effect may take place or a noeffect level is the basis of dose response, and so this is something 

that I know that Dr. Dorman teaches in his classes all the time in 

North Carolina. 

Mr. MURPHY. I also heard our EPA administrator talk about dose 

response curves and we should look at that. 

Now, the Natural Resources Defense Council I believe suggested 

that chromium alloys pollute our soil and water supplies, but I 

want to make something clear. Isn’t it true that there is no association between the use of chromium alloys in stainless steel in any 

pollution or illness? Am I correct in that? 

Mr. ANASTAS. What we are looking at in the IRIS assessments 

is the toxicity and the one we are discussing is the toxicity of chromium-6 and different matrices you can expect different considerations, and that is part of the risk assessment/risk management 

calculation. 

Mr. MURPHY. OK. Is that chromium-6 something that is used in 

stainless steel? 

Mr. ANASTAS. I believe chromium-6 is used in stainless steel. 

Mr. MURPHY. When it is used in stainless steel, I mean stainless 

steel is also seen as containers for clean drinking water, surgical 

equipment, et cetera. Is that an issue that that chromium is actually leaching out of that stainless steel and contaminating those 

things? 

46 

Mr. ANASTAS. Nothing in the IRIS assessment addresses any of 

those risk scenarios. 

Mr. MURPHY. But you can look at things outside of the IRIS assessment? Here is my concern: If we are saying that that is a toxic 

chemical but it is used in containers which are used to have nontoxic water and sterile equipment, is it correct, then, in saying that 

that chromium is actually leaching out and causing problems? 

Mr. ANASTAS. You are identifying extremely important risk management decisions and exposure factors. Those are exactly the type 

of questions that are—— 

Mr. MURPHY. You are not giving me an answer. You are just saying it is important. I need to know—— 

Mr. ANASTAS. What I am saying is that nothing in this health 

assessment would address those questions. 

Mr. MURPHY. I still don’t have an answer but I realize my time 

is up. Thank you, Mr. Chairman. 

Mr. SHIMKUS. Thank you. And at this time I recognize my friend 

from Colorado, Ms. DeGette, for 5 minutes. 

Ms. DEGETTE. Thank you very much, Mr. Chairman. 

Dr. Anastas, I want to ask you a couple of things I read in your 

written testimony. One is about this rider that was attached to the 

interior EPA appropriations bill this summer that would have delayed all IRIS assessments until the NAS recommendations were 

adopted and would have required NAS review of additional draft 

assessments. Does the administration support that policy? 

Mr. ANASTAS. What I can say is that the effect of those letters 

would be significant. I believe that Mr. Trimble did mention the 

concern I think that we all share of making sure that assessments 

come out in a timely way. The result of these riders would be significant delay of perhaps as much as a year or 2 years, and an important factor to consider is during that delay, would the assessments that are in development be brought out of date? So the impacts of this would be significant and cascading throughout not 

only the development of the assessments themselves but the use of 

these assessments. 

Ms. DEGETTE. What types of significant and cascading developments would there be? 

Mr. ANASTAS. As was mentioned earlier, these assessments are 

important as a foundation for different decisions and actions not 

only in the Agency but by States and municipalities and industry. 

Would these assessments then be able to inform regulatory decisions or other decisions? The answer of course is no because they 

would be delayed by these actions. 

Ms. DEGETTE. Do you think there would be an effect on public 

health or the environment by these delays? 

Mr. ANASTAS. I certainly believe that our regulatory decisions, 

the decisions at the state and local level and decisions made by 

companies and individuals impact human health and the environment, and so yes, if—— 

Ms. DEGETTE. OK. Your answer is yes. 

Mr. ANASTAS. My answer is yes. 

Ms. DEGETTE. Thank you. Now, thinking about it from the other 

side of the issue, the chemical industry and economy in general, if 

we had uncertainty in these standards, would that potentially also 

47 

be harmful to them since they wouldn’t know what was coming 

down the pike? 

Mr. ANASTAS. I think the lack of knowledge is always difficult 

and something to try to avoid, which is why we try to get this information out. 

Ms. DEGETTE. Mr. Trimble, GAO has raised concerns about the 

delays in the IRIS process, and you talked about that earlier and 

what that would mean for the credibility of assessments. Would 

suspending all assessments and all actions on past assessments impact the utility and credibility of the program? 

Mr. TRIMBLE. I think as Dr. Anastas indicated, the impact would 

be felt most immediately by the program offices at EPA, as well as 

the States and others that rely on that to make regulatory decisions. 

Ms. DEGETTE. So there would be a lack of certainty? 

Mr. TRIMBLE. Yes, certainly there would be a lack of certainty 

and predictability. Certainly. 

Ms. DEGETTE. Now, in your testimony you talk about the 

compounding effects of delays on assessments and Dr. Anastas referred to that. Can you please explain what you mean by that? 

Mr. TRIMBLE. Yes, what we have reported on in the past is that 

when studies in the past have been suspended or delayed, what 

happens is that science keeps marching so that when you start to 

restart that study, a lot of the work has to be redone because there 

is new scientific literature. We have talked about evolving scientific 

methods, for example, you know, quantifying risk and things like 

that. All of those, the state-of-the-art practices change over time, 

so when you stop and delay, you have to catch up to what is now 

cutting-edge science to move forward and that causes delays. 

Ms. DEGETTE. In your testimony you mention that IRIS processor forms are not established in regulation or statute. Do you 

have any ideas for this committee about what we can do about that 

that you would like to share with us? 

Mr. TRIMBLE. Well, with that I would politely demur on this. 

Ms. DEGETTE. I thought you might. 

Mr. TRIMBLE. We have a report that is coming out by the end of 

this year looking at the implementation of the IRIS programs since 

the 2009 changes, so we will be reporting on that shortly. 

Ms. DEGETTE. Mr. Chairman, we will all look forward to getting 

a copy of that report. And I yield back. 

Mr. SHIMKUS. The gentlelady yields back her time. 

I ask unanimous consent for Mr. Murphy to do a unanimous consent request. 

Mr. MURPHY. Mr. Chairman, I just ask this letter from the Specialty Steel industry of North America be submitted for the record 

in which it states, ‘‘no hexavalent chromium is present in steel alloys.’’ 

Mr. SHIMKUS. That has been shared with the minority? Is there 

objection? Hearing no objection, so ordered. 

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Mr. SHIMKUS. The chair now recognizes the gentleman from New 

Hampshire for 5 minutes, Mr. Bass. 

Mr. BASS. Thank you very much, Mr. Chairman. 

I want to thank you all for your time and interest in being here 

today. 

Dr. Anastas, OMB guidance defines ‘‘highly influential scientific 

assessment’’ as ‘‘a scientific assessment that could have a potential 

impact of more than $500 million in any year on either the public 

or private sector or is a novel, controversial, or precedent setting 

or has significant interagency interest.’’ Because the estimates support the Agency’s regulatory activities, including costly cleanups, 

are the IRIS assessments routinely recognized as highly influential 

scientific assessments subject to the information quality and peer 

review guidelines? 

Mr. ANASTAS. I think the important discussion that we have been 

having has shown that these assessments are scientific inputs into 

regulatory decisions. They are not regulations; they are not regulatory conclusions. The considerations for economic impact are important and essential and a serious part of the deliberations that 

the Agency has, but these assessments are not regulations and 

should not be viewed as such. 

Mr. BASS. Well, I guess then in making the determination whether an IRIS assessment is ‘‘highly influential,’’ how does the EPA 

determine whether more than $500 million worth of future impacts 

are likely? 

Mr. ANASTAS. The results of regulatory decisions undertake extensive cost-benefit and regulatory impact analyses. Perhaps the 

most important point that I could make on this is that while we 

are, through these assessments, identifying the hazard profile of 

these substances, in the absence of exposure, there is no risk. If 

there is no exposure, there is no risk and so there would be no reason for its management. And so while these are important inputs, 

it would be wrong to assume that because something has a particular hazard profile it is necessarily going to trigger a regulatory 

action. 

Mr. BASS. Is it possible that any IRIS assessment could later be incorporated in a regulation that has impacts of more than $500 

million? 

Mr. ANASTAS. Yes. 

Mr. BASS. OK. All right. I am all set, Mr. Chairman. Thank you. 

Mr. SHIMKUS. The gentleman yields back his time. 

The chair now recognizes the gentleman from Louisiana, Mr. 

Cassidy, for 5 minutes. 

Mr. CASSIDY. Mr. Anastas, you mention, going back to Mr. Barton’s questions, regarding how you define premature. Let us take 

a person with emphysema. We know that person with emphysema 

is more likely to have complications from an inhaled toxin, pick 

ozone, so if the person with emphysema dies at 74 because of a 

bronchospastic asthmatic event triggered by ozone, is he, compared 

to the average age someone dies, say 82 for a man, or is he compared to the average age that somebody with emphysema dies? 

Mr. ANASTAS. So when we are looking at statistical population 

distributions, that distribution is going to have various 

susceptibilities—people who are particularly susceptible—— 

52 

Mr. CASSIDY. Correct. 

Mr. ANASTAS [continuing]. And people who are particularly resilient. So what we are talking about is average lifespan and how different effects would affect a—— 

Mr. CASSIDY. Correct. 

Mr. ANASTAS [continuing]. Population. So I would not draw that 

conclusion based on an individual because I believe that that would 

not be a statistically robust approach. 

Mr. CASSIDY. Wait, you don’t adjust for co-morbidities when determining whether somebody dies prematurely because of exposure 

to a toxin? 

Mr. ANASTAS. No, I am saying that certainly susceptible populations do reside within that overall population—— 

Mr. CASSIDY. But I think—— 

Mr. ANASTAS [continuing]. But I am saying that I wouldn’t apply 

it to an individual. 

Mr. CASSIDY. I can tell you that that would be counter to what 

you would do—I am a doctor. That is what you would do in medicine. You would account for co-morbidities knowing that comorbidities have a huge influence upon the body’s reaction to an 

external event. 

Mr. ANASTAS. And I absolutely agree that in dealing with an individual you absolutely need to factor in the individual’s susceptibility. 

Mr. CASSIDY. But I gather that you are not comparing them—— 

Mr. ANASTAS. That would be the logical calculation. 

Mr. CASSIDY. But I actually think that you actually could find— 

go to the VA database, for example—find the average lifespan for 

somebody with a certain level of pulmonary impairment and you 

would find, yes, for this degree of impairment they die and this degree they die at this age. But I gather that is not necessarily done? 

Mr. ANASTAS. I am saying that in many of the epidemiological 

studies that are relevant to the discussion that we were having 

about decreased lifespan, that that has not been the basis of those 

types—— 

Mr. CASSIDY. OK. I got my answer. And I didn’t mean to be rude. 

I don’t mean to be curt. I apologize. 

Dr. Dorman, did you participate in the critique of this report, the 

IRIS report for formaldehyde? 

Mr. DORMAN. Yes, sir. 

Mr. CASSIDY. Now, I am struck because I just kind of quickly 

eyeball it. I am quickly eyeballing it so it may come in totally 

wrong. Join my wife on most occasions. 

If the lack of knowledge is a bad thing, misinterpretation of 

knowledge is even worse. As I look at the summary of your report, 

you say that ‘‘the committee concludes the weight of evidence suggests formaldehyde unlikely to appear in blood as an attack molecule.’’ You go on to say that, you know, kind of absorbed, quickly 

metabolized, it goes away, unlikely to have a systemic effect. That 

is kind of the, you know, as I scan what I am getting. So even 

though this is 1,000 pages—I looked it up—it is 1,043-page report 

talking about all the things it will do to rat urine and, you know, 

to human nasal mucosa, really all that strongly suggests there is 

53 

pertinent physical effects, and yet your report finds that that may 

be overstated. Is that a fair statement? 

Mr. DORMAN. So I think it is a fair statement that the Academy 

concluded that the current best evidence indicates that formaldehyde does not reach the systemic circulation in an appreciable way. 

And so what we did recognize as well, though, is that formaldehyde 

might have certain health effects that may not require it being delivered systemically. And so, for example, if we have say rhinitis 

or an irritation in the nose, you might also have headache. Even 

though that chemical never got to the brain, that would be an example say of a stress that might be associated with that inflammation in the nose. 

Where we differed from the conclusions probably related most to 

the motive action that EPA was considering for the leukemogenic 

responses that have been associated with formaldehyde exposure 

where we felt that the weight of evidence didn’t strongly support 

their conclusions. 

Mr. CASSIDY. Yes, I am kind of struck that there is 1,043 pages 

of stuff which documents and if you just read it, you think oh my 

gosh, isn’t this terrible? Then I read your report and when you actually analyze it and put it in context, it isn’t quite so frightening. 

Worrisome, but not quite that 1,043 pages of we have got to regulate. I agree with that. 

I also say, as a physician, it seems kind of routine. I am not sure 

why it has taken you so long to implement these suggestions I put 

forth because frankly, as a physician, if there is not rigor of methodology being explained, then the paper would never be published 

in a peer reviewed journal. That seems to be kind of a standard 

sort of scientific method of presentation. 

Mr. ANASTAS. If I could just mention that this is a draft assessment. We put out draft assessments for the purpose of getting this 

kind of critique so that we improve it for the final assessment. This 

is what we do. This is why we seek it out. 

Mr. CASSIDY. Can I have just a minute more? 

Mr. SHIMKUS. Without objection, gentleman is recognized for another minute and a half. 

Mr. CASSIDY. OK. Thank you. 

Going back to green chemistry, it seems to me as if that would 

be the basis for a proposal regarding inherently safer technology. 

Mr. ANASTAS. Correct. 

Mr. CASSIDY. Now, that actually seems you move beyond I think 

Mr. Butterfield suggested your role as analytic—and I will maybe 

paraphrase—analytic not prescriptive, but that is a little disingenuous if you are saying listen, we are going to make a value judgment as to whether or not this has a toxic effect and this does not. 

And frankly, there will be assumptions that credible scientists may 

disagree with your assumptions, and yet your findings are going to 

be the basis, I bet you, for regulation promoting inherently safer 

technology. How would you disagree with that? 

Mr. ANASTAS. What I tried to emphasize in my statement was 

when the information that we generate gives us insights not only 

that an individual substance may or may not be toxic and in what 

ways but how it is toxic, that gives us insights into the design—— 

54 

Mr. CASSIDY. But you are making an assumption of toxicity that 

again scientists in a peer reviewed journal would disagree with 

your assumption, but yet your assumptions are going to guide this 

green chemistry which is going to guide an IST regulation. 

Mr. ANASTAS. With all due respect, what I am saying is not on 

the level of toxicity but the mechanisms by which it has any kind 

of biological effect. This informs the design of the molecular structures of future chemicals so that we can minimize the possibility, 

the probability—— 

Mr. CASSIDY. Give me a specific because right now that sounds 

very nice, but as I try and think of the particular, it seems you 

can’t divorce yourself from assumptions of the toxicity and we already see credible dispute with your assumptions of toxicity. 

Mr. ANASTAS. When I am looking at a molecular structure, I 

know that whether or not a substance has the ability to even cause 

any type of toxic effect—— 

Mr. CASSIDY. But water can drown. Do you see what I am saying? Water has a toxic effect if you put your head underneath it 

for too long. And so you are right, there has to be a dose effect, and 

there has to be a certain substrate in which it interacts. How do 

you account for that? 

Mr. ANASTAS. If a substance cannot be inhaled, if a substance 

cannot be respired, ingested across biological membranes, those are 

all based on its physical/chemical properties. What chemists do is 

develop structures to control their physical/chemical properties. 

You can design a substance to have those physical/chemical properties so as to reduce the probability that it can cause hazardous 

adverse consequences. 

Mr. CASSIDY. I still can’t—so formaldehyde—— 

Mr. SHIMKUS. The gentleman’s time has expired. 

Mr. CASSIDY. Thank you. I yield back. 

Mr. SHIMKUS. There are too many doctors in this room. The IQ 

has gone up and I can’t even understand the English being spoken 

here sometimes. I ask unanimous consent. My colleague Mr. Green 

wanted to make a statement before we adjourn this panel. 

Mr. GREEN. Mr. Chairman, I know we have votes going to be 

scheduled and I think we have exhausted our questions of the 

panel. I want to thank the panel. I know, Doctor, you had to 

change your plans to be here but when I referred to the dioxin facility in our district—actually in Ted Poe’s district—but EPA 

worked in both administrations, both in ’08 and ’09, what I consider bureaucratic light speed to get that site on there, and we actually have it encapsulated now. And the next panel we have our 

Texas Commission on Environmental Quality. They actually are 

the ones that did the research to trace where all this dioxin would 

be coming from in the San Jacinto River, so that is a great example. Most people get mad at EPA. Here in Texas, you all don’t 

think we do anything for the environment, but we do. Thank you. 

Mr. SHIMKUS. And the chair now also wants to ask unanimous 

consent that the letter dated October 4 from the American Chemistry Council be submitted for the record. That has been shared 

with the minority. Without objection, so ordered. 

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Mr. SHIMKUS. I too want to thank the first panel and for the second panel we will convene you after votes and they should be calling them any minute. So it really is not productive for us to start. 

And we will reconvene after votes. So with that, I will recess this 

hearing. 

[Recess.] 

Mr. SHIMKUS. We can get through the next panel and also get 

in between votes on the floor of the House, but I think we have got 

plenty of time, but we do want to get started. 

We want to welcome you. Thank you for your patience. I will do 

as I did with the first panel I am going to introduce you all across 

the board, and then we will recognize you individually for your 5- 

minute opening statements. Because of the time that we have, you 

know, I won’t hold you strictly to the 5 minutes, so take your time. 

Make sure what you want to present is not rushed. 

So on this second panel, we again appreciate you all for being 

here. We have Dr. Michael Honeycutt, Director of Toxicology Division, Texas Council on Environmental Quality. We also have Dr. 

Harvey Clewell, the Hamner Institutes for Health Sciences. We 

have also have Mr. Jerry A. Cook, Technical Director, Chemical 

Products Corporation. It is good to see a mister and not all doctors. 

And then finally Dr. Thomas A. Burke, Associate Dean for Public 

Health Practice and Training, Department of Health Policy and 

Management at Johns Hopkins Bloomberg School of Public Health. 

Gentlemen, thank you for joining us, and I would like to recognize Dr. Honeycutt for 5 minutes for his opening statement. 

STATEMENTS OF MICHAEL HONEYCUTT, DIRECTOR OF TOXICOLOGY DIVISION, TEXAS COMMISSION ON ENVIRONMENTAL QUALITY; HARVEY CLEWELL, DIRECTOR, CENTER 

FOR HUMAN HEALTH ASSESSMENT, THE HAMNER INSTITUTES FOR HEALTH SCIENCES; JERRY A. COOK, TECHNICAL 

DIRECTOR, CHEMICAL PRODUCTS CORPORATION; AND 

THOMAS A. BURKE, ASSOCIATE DEAN FOR PUBLIC HEALTH 

PRACTICE AND TRAINING, DEPARTMENT OF HEALTH POLICY AND MANAGEMENT, THE JOHNS HOPKINS BLOOMBERG 

SCHOOL OF PUBLIC HEALTH 

STATEMENT OF MICHAEL HONEYCUTT 

Mr. HONEYCUTT. Good morning, Mr. Chairman and members of 

the committee. My name is Michael Honeycutt. I am director of the 

Toxicology Division at the Texas Commission on Environmental 

Quality. I would like to touch briefly on Texas’ perspective on the 

science that EPA is using or not using for chemical risk assessments in recent years and the implications for regulatory agencies 

and the public. 

I have been a toxicologist and a risk assessor for Texas for over 

15 years. In past years, we have had disagreements with EPA, but 

they have not really been based on science issues so much as on 

policy issues. An example of this would be that EPA does not want 

to consider TCEQ rules, which in many cases are more stringent 

than their cleanup values when addressing a cleanup site in Texas. 

However, we have always been able to work out our differences 

amicably. 

58 

In recent years, though, EPA chemical risk assessments have become more precautionary in nature instead of relying on scientific 

data. The heart of the matter is that EPA is moving toward the 

philosophy that there is no safe level of exposure to a chemical and 

this is contrary to the cornerstone of the science of toxicology. This 

change in philosophy results in unrealistically low regulatory levels. And as a result, naturally occurring levels of chemicals may be 

higher and often cases it is higher than EPA-safe level. 

As an example, using EPA’s most recent draft assessment of 

formaldehyde, the formaldehyde in your breath that results from 

normal body functions would be over five times higher than the 

highest level that EPA would call safe. Formaldehyde is naturally 

formed in the air from the breakdown of chemicals released from 

vegetation, and according to available air data, the only places that 

would have safe air would be remote locations such as the arctic 

and South Pacific islands. 

In another example, using EPA’s most recent draft assessment of 

arsenic, all fish and shellfish would contain levels of inorganic arsenic that are higher than the highest levels EPA would consider 

safe. And it is not just fish. Normal dietary food and drinking 

water consumption would also have arsenic levels substantially 

higher than EPA-safe level. And we just know that this isn’t true. 

We aren’t seeing the health effects that would be predicted or expected in the general population based on EPA’s new values. 

While we do agree with EPA on being precautious in areas where 

we don’t have good science, we strongly believe that good science 

should not be ignored and should trump EPA’s overuse of precaution. Hexavalent chromium is a good example of this. EPA’s recent conclusion that ingesting hex chrome likely causes cancer in 

humans is based on a study where mice received extremely high 

levels of hex chrome, and EPA dismissed the human epidemiology 

and the wealth of other data that contradict this. And in those 

human studies, there was an occupational study where workers actually had yellow teeth and yellow tongues from ingesting so much 

arsenic. 

And TCEQ isn’t the only organization concerned about the 

science behind EPA’s recent assessments. The National Academy of 

Sciences, many prominent academic researchers, other states and 

other countries have noted the lack of good science in these assessments. 

Because of the lack of scientific defensibility and the implications 

of EPA’s new chemical assessments, Texas has recently decided to 

develop our own chemical assessments. We have written two stateof-the-science guidance documents and had them externally scientifically peer reviewed by panels of imminent scientists, including scientists from EPA, California EPA, and Canada, and we are 

in the process of putting our latest document through a second 

round of public comment. 

We had no desire at all to use our limited resources to develop 

these chemical risk assessments that we have historically been 

able to rely on EPA for. However, the implications of EPA’s new 

assessments have forced our hand. EPA’s new assessments will unnecessarily scare the public and may actually harm public health 

by diverting public, industry, and government attention and reVerDate Aug 31 2005 10:54 Oct 02, 2012 Jkt 037690 PO 00000 Frm 00062 Fmt 6633 Sfmt 6633 F:\112-09~2\112-93~1 WAYNE
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sources away from public health issues that may pose more of a 

risk. 

As an example, EPA currently encourages pregnant women to 

limit their consumption of fish due to concerns of mercury. However, numerous recent studies show that the health benefit from 

pregnant women eating fish outweighs the potential risk for mercury. If EPA finalizes their draft arsenic value as it currently 

stands, then the public, the media, and advocacy groups would perceive fish as being even more unsafe resulting in even more pregnant women avoiding fish and its proven health benefits for them 

and their infants. 

There are also significant implications for remediation programs 

all across the country. Typical soil and water concentrations of 

chemicals, even some naturally occurring, would be considered unsafe. In other words, there is no safe place to live. How can you 

cling to below-background levels if background levels are unsafe? 

All replacement soils that we would use to fill in a backyard would 

also contain these unsafe background levels. So where are we going 

to put this so-called contaminated soil that we would have to dig 

up from somebody’s yard? 

Your constituents will not stand for having soil and water that 

is deemed unsafe by EPA’s new risk assessments even if it is naturally occurring and we can’t do anything about it. So these are just 

some of the issues that we will have to face if EPA stays on their 

course, and I thank you for this opportunity to testify. 

[The prepared statement of Mr. Honeycutt follows:] 

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Mr. SHIMKUS. Thank you for your testimony. 

And now I would like to recognize Dr. Harvey Clewell. Sir, you 

have 5 minutes. And we are getting you fresh water. And you are 

recognized. 

STATEMENT OF HARVEY CLEWELL 

Mr. CLEWELL. Thank you, Mr. Chairman. Good morning, Mr. 

Chairman, members of the subcommittee. My name is Harvey 

Clewell. I am the director for the Center for Human Health Assessment at the Hamner Institutes for Health Sciences in Research 

Triangle Park, North Carolina. 

In my position at the Hamner, as well as in my previous consulting positions, I have performed risk assessment research and 

consulting for a large number of government and industry clients, 

including the EPA. I am here today to present my professional 

opinions. I am not representing the Hamner or any other organization. 

I am very familiar with EPA risk assessment practices. Over the 

last 30 years, I have assisted EPA on risk assessments for a number of compounds including methylene chloride, cadmium, styrene, 

vinyl chloride, trichloroethylene, chloroform, and perchlorate. I 

have served on the EPA’s FIFRA Scientific Advisory Panel and the 

recent EPA Science Advisory Board on IRIS assessments for dioxin. 

I have also served as a peer reviewer for a number of recent EPA 

guidelines, including those for cancer risk assessment and risk 

characterization. 

I consider EPA to be a leader in advancing risk assessment 

methods and have been favorably impressed by a number of recent 

IRIS assessments for which I was a peer reviewer, including those 

for one for dioxane and acrylamide. Nevertheless, I am concerned 

that the lack of objectivity and transparency in some recent IRIS 

assessments will impair the ability of decision-makers to make informed risk management decisions. 

I am particularly concerned that in some recent IRIS assessments, such as those for inorganic arsenic, formaldehyde and 

dioxin, only a single cancer risk assessment approach has been presented: a low-dose-linear default that assumes these chemicals are 

carcinogenic at any concentration. However, there is strong evidence for each of these chemicals that the true dose-response is 

nonlinear, and that the default greatly overestimates the actual 

risk at current human exposure levels. 

This IRIS practice of presenting only a single approach disregards the recommendation in the OMB memorandum entitled, 

‘‘Updated Principles for Risk Analysis,’’ to provide a characterization of the dispersion of risk estimates associated with different 

models, assumptions, and decisions. The OMB principles provide 

valuable guidance for assuring that risk assessments adequately 

inform decision-makers faced with complex risk management options. Following the OMB recommendations should be a key objective of all IRIS assessments. 

The failure to objectively describe the evidence for alternative 

risk assessment approaches and to provide risk estimates other 

than the default has been a major deficiency in the IRIS risk assessment process. Even in the case of IRIS cancer assessments 

101 

where alternative low-dose extrapolation options are discussed, 

there has been a clear bias towards presenting evidence that supports the selection of the default linear approach, even in cases 

where there is strong support for a nonlinear approach in the scientific community. Decision-makers would be better informed by a 

balanced and objective discussion of both alternatives and the presentation of analyses based on both alternative approaches in the 

risk characterization section of the assessment. 

As a justification for presenting only the default low-dose-linear 

risk assessment approach, the IRIS assessments have cited uncertainty in the evidence for alternative approaches. However, EPA 

guidance states that in the face of uncertainty, multiple approaches 

can be presented. The EPA’s 2005 Guidelines for Carcinogen Risk 

Assessment state that ‘‘Nonlinear extrapolation having a significant biological support may be presented in addition to a linear approach when the available data and a weight of evidence evaluation support a nonlinear approach, but the data are not strong 

enough to ascertain the mode of action applying the Agency’s mode 

of action framework. If more than one approach, e.g. both a nonlinear and linear approach are supported by the data, they should 

be used and presented to the decision-maker.’’ 

In a number of cases, NAS and the EPA Science Advisory Board 

peer reviews have requested that the IRIS assessment be modified 

to objectively present multiple risk assessment options but the 

Agency has not complied. I believe that the repeated refusal of the 

EPA to implement recommendations from the NAS and SAB peer 

reviews to objectively present alternative risk assessment options 

has greatly delayed the completion of the IRIS assessments for a 

number of important chemicals, in some cases for more than a decade. 

In addition to being inconsistent with agency guidance, presentation of only a conservative default approach when there is a viable alternative provides the decision-maker with an inaccurate 

characterization of risk that compromises his ability to make informed risk management decisions. 

In my opinion, IRIS assessments currently do not provide an objective and transparent characterization of the potential risks associated with chemical exposure. The inadequacy of the risk characterization in IRIS assessments, coupled with the sole use of conservative default approaches, hampers the ability of decision-makers to make informed risk management decisions and gives the 

public an inaccurate impression of their potential risks from chemical exposure. I believe that this deficiency could to a large extent 

be addressed by assuring that IRIS assessments adhere to the risk 

assessment principles elaborated in the OMB memorandum in the 

information quality principles. 

Thank you. 

[The prepared statement of Mr. Clewell follows:] 

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Mr. SHIMKUS. Thank you. Now, I would like to recognize Mr. 

Cook for 5 minutes, sir. 

STATEMENT OF JERRY A. COOK 

Mr. COOK. My name is Jerry Cook. I am the technical director 

of Chemical Products Corporation, a small 78-year-old Georgia corporation which employs about 200 people in Cartersville, Georgia, 

which is in the metropolitan Atlanta area, on the fringe I guess you 

would say. We are the last U.S. producer of barium chemicals and 

I have been dealing with barium toxicology and regulation for more 

than 28 years. I joined Chemical Products in late October 1982 as 

technical director. 

The IRIS database is supposed to determine sound science concerning the toxicology of chemicals to guide EPA’s regulatory activities as we have heard today. If IRIS functioned properly, that could 

be used as a basis for sane regulation of various chemicals in the 

environment. Unfortunately, in the case of the IRIS barium file, I 

have found that the IRIS chemical managers and their superiors 

were not nearly as interested in sound science as they were in bureaucratic expediency. They simply did not want to hear sound 

science if it caused them to have to reevaluate the positions that 

they had previously taken. 

A brief history of barium regulation is as follows: in 1975 in the 

statement of basis and purpose for the national interim primary 

drinking water regulations, under barium, EPA stated, ‘‘No study 

appears to have been made of the amounts of barium that may be 

tolerated in drinking water or of effects from prolonged feeding of 

barium salts from which an acceptable water guideline may be set.’’ 

They arbitrarily chose a value at that time based on the hypothesis 

that perhaps barium in drinking water could cause a small but significant increase in blood pressure and that that would be a danger 

to those already suffering from high blood pressure. That was a hypothetical effect that they derived from the fact that acute toxicity 

from barium salt ingestion does include heart effects including hypertension for the period of time until the barium is cleared from 

the body. 

The barium chemicals manufactured by Chemical Products Corporation are used in the ceramics industry to manufacture bricks 

and tiles, in the manufacture of luminous paints for highway signage and airport striping, and in heat treating of high-strength steel 

and the manufacture of catalysts. Many of our customers are small 

and medium-sized U.S. companies which are literally fighting for 

survival. Our customers tell us that the costs associated with 

retroregulation of barium are a substantial burden on them. 

In our efforts to change the retroregulation of barium, the IRIS 

determination of what was considered a safe level was cited as the 

reason why the retroregulations were not going to change. So that 

is how IRIS functions. IRIS is the basis upon which regulatory decisions are made. If the science in IRIS is bad, the regulatory decisions are going to be bad. 

The CEO of Summitville Tile, one of our customers, asked me to 

convey the following message to the members of this committee. 

‘‘The overregulation of American industry is making it increasingly 

more difficult for American manufacturers to compete in today’s 

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global economy. Summitville Tiles is a case in point. It is a 100- 

year-old manufacturer of quarry tile and brick products based in 

Eastern Ohio. In recent years, it has had to close 2 tile manufacturing facilities and 16 distribution centers, laying off over 450 employees. Summitville Tile is today one of the last American tile 

companies to remain in business. In fact, it is the only remaining 

charter member of the tile industry’s National Trade Association, 

the Tile Council of North America. With foreign imports now comprising approximately 80 percent of the U.S. domestic tile market, 

the last thing that the tile industry needs is more regulations. 

What is needed more than anything else is regulatory relief.’’ 

I think that sums up the feeling of many of the small and medium-sized manufacturers in this country today. As a small or medium-sized company, they are really not equipped to deal with unnecessary regulatory burdens, and I think that that is exactly how 

I would characterize the regulation of barium because when a 

sound scientific study became available in 1994, when the NTP 

published a lifetime study of the effect of barium on rats and mice, 

IRIS greatly resisted acknowledging that study because it did not 

find the effect that was listed in IRIS. It did not find increased 

blood pressure. It instead found at much higher levels that barium 

would have an effect on the kidneys but the levels to find that effect were orders of magnitude higher than the level that was promulgated in IRIS. 

Let me tell you a little bit about barium if I may. Barium is an 

alkaline earth metal, one of the group which includes magnesium 

and calcium. It is not carcinogenic and barium is rapidly eliminated from the body. In cases of acute barium ingestion, the effects 

are usually gone within a week. Barium is widely dispersed in the 

natural environment in the mineral barite, barium sulfate, which 

is insoluble in water and acids. Because it is insoluble, barium sulfate is not toxic. This is the chemical administered as an x-ray contrast medium for gastrointestinal x-rays. The infamous barium 

meal, I have never had one, but I understand it is not particularly 

tasty. It doesn’t matter which end you put it in, it works for gastrointestinal x-rays. 

If a large amount of soluble barium is ingested or inhaled, it is 

toxic because it temporarily interferes with the body’s cellular potassium transport. EPA’s IRIS database deals with chronic toxicity, 

which is a different situation. It is smaller amounts of a chemical 

consumed daily for many years over a lifetime. There is no known 

instance of any chronic toxic effect in a human due to barium and 

no animal studies were available as I read to you when EPA began 

regulating barium in the mid-1970s. 

Mr. SHIMKUS. Mr. Cook, I did tell folks they could go over 5. You 

are almost at 3 minutes over that so if you can kind of—— 

Mr. COOK. Yes, sir. I appreciate it very much. I think you have 

gotten the gist of my situation. 

Mr. SHIMKUS. We have and we will follow up with questions. 

Mr. COOK. Thank you. 

[The prepared statement of Mr. Cook follows:] 

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Mr. SHIMKUS. Thank you. 

The chair now recognizes Dr. Burke for 5 minutes. 

STATEMENT OF THOMAS A. BURKE 

Mr. BURKE. Thank you, Mr. Chairman. I appreciate this opportunity. I am Tom Burke and I am the associate dean and a professor at the Johns Hopkins School of Public Health, I also direct 

the Johns Hopkins Risk Sciences and Public Policy Institute, I 

served as a member of the Board on Environmental Sciences and 

Toxicology at the National Academy, I am a member of the EPA 

Science Advisory Board, and I chaired the National Academy report 

Science and Decisions, which really took a hard look at risk assessment practices at the EPA. 

Perhaps most relevant to today’s hearing, though, is I have 

served as a state official. I was the director of the Toxics Program, 

the director of Science and Research at the New Jersey DEP, and 

the deputy health commissioner in charge of environmental issues 

in that State. So I worked closely with 4 governors on very challenging issues, responding to public health emergencies, which 

ranged from water contamination to contamination of our beaches 

to food contamination to the cleanup of hazardous waste sites. 

So as a frontline health official, I can tell you that risk assessment is really important. We need information when things bang 

in the night. And it is an essential tool for protecting the public’s 

health. IRIS has been a part of that. So I would like to address 3 

points today. 

One is risk assessment itself as an important tool. Second is the 

IRIS program, and the third I would like to say a little bit about, 

Science and Decisions and the National Academy recommendations 

to change the way we approach risk assessment. 

So first, as I mentioned, risk assessment is really important to 

public health officials and it is used by not just EPA but public 

health agencies around the world. I have helped most of our national agencies from DOD to USDA to use risk assessment. And as 

a state official, I have worked with other state officials in doing 

this. And EPA is recognized as providing most of us with the gold 

standards for evaluating hazards. Part of this is a tremendous use 

of the IRIS documents, but unfortunately, there are inherent uncertainties. 

And as you heard from the panel, there are lots of things about 

toxicology and epidemiology that are uncertain and they provide 

the basis for risk assessment. So for instance, does cancer in laboratory animals necessarily mean that exposure will cause cancer 

in humans? Or more appropriate perhaps in some of the debates 

about IRIS, if you have 2 conflicting studies, one says you see a 

health hazard and the other doesn’t, which one does EPA go with 

and how do you make that decision? Well, there have been lots of 

arguments about this. There is lots of uncertainty that has led to 

a very polarized confrontation, as you might imagine. So I am no 

stranger to this phenomenon called dueling risk assessments. An 

agency will present their risk assessment and their approach to a 

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try’s risk assessments aren’t listened to because they are seen as 

not being protective of public health. 

So the challenge before us is this process itself, how to be more 

transparent, meet the needs of decision-makers, and break the log 

jam we now have. Now, the IRIS program, as you heard today, has 

a very unenviable task of synthesizing a lot of scientific information, and it appears to be the program everyone loves to hate. So 

they provide these very comprehensive overviews of health effects 

and they weigh the scientific evidence, and it is very important in 

determining if we have hazards. Not surprisingly, this is controversial. They are the starting point for many of the Agency’s most difficult decisions. They provide insight into the magnitude of risk but 

they don’t tell us how to manage risks. 

I am very familiar with the challenges of IRIS and I actually 

think the NAS report on formaldehyde provides a sound roadmap 

for them to improve that. 

Now, I would like to finish with a few words about risk assessment. We have blurred the line today I think between risk assessment and the IRIS hazard assessments. Risk assessment is about 

decisions and should start with, as Science and Decision lays out, 

the problem formulation making sure we ask the right questions, 

including the assessment that looks at the various options for control. 

And finally, with risk management decision justification, very 

important to this committee, is this decision justified, particularly 

in light of costs? So I think just to kind of sum up, the framework 

that Science and Decisions offers perhaps can help us improve the 

application of IRIS and risk assessment and risk management and 

consider the very important considerations of economics and jobs. 

So finally, can risk assessments work for jobs and the economy? 

Well, in my experience as a state official in New Jersey, a clean 

environment is definitely good for business, just ask the resort 

owners of the Jersey Shore or the businesses along the redeveloped 

Brownfields and the Hudson River shoreline. Getting better solutions for environmental problems goes well beyond IRIS and should 

focus on advancing risk assessment to better inform our public policies. 

Thank you for the opportunity to speak to you today. 

[The prepared statement of Mr. Burke follows:] 

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Mr. SHIMKUS. Thank you, Dr. Burke. 

And now I would like to recognize myself for 5 minutes for opening questions in this panel. I will start with Mr. Cook because a 

lot of our focus here in this Congress has been on the effects of regulations on jobs and the economy. We do want to make sure that 

that is balanced, but we also, especially in the environment that we 

are in, we know that excessive regulations really are creating a 

burden. 

You have highlighted some of those burdens in your opening 

statement. If the chemicals you produce are not available, what 

substitutes would be made? 

Mr. COOK. In some cases, there would be substitutes available. 

In other cases, I am not sure there would be. In the case of the 

airport striping and signage, our barium carbonate is formulated 

by 2 manufacturers in the United States into very tiny barium 

glass beads. Barium gives that glass a very high refractive index, 

so when light shines on a paint containing these glass beads, it 

glows. I think that is a major safety consideration for airports and 

certainly it helps visibility of highway signs and probably has a 

safety impact there, too. I am not sure what material other than 

lead—lead glass also has a high refractive index. 

Mr. SHIMKUS. Barium would probably be better than lead. 

Mr. COOK. Given as I say there really is no chronic effect to barium until you get to very, very high levels that are just not found 

anywhere in nature. 

Mr. SHIMKUS. And let us just talk through this. Also, you opening statement mentioned if we are not certain that the IRIS analysis is based upon credible sound science, what effect does that 

have on you? 

Mr. COOK. Well, for the past almost 29 years now, I have been 

trying to effect a change in the regulatory limit. And as I said, that 

regulatory limit was established back in the ’70s when there was 

no data. Unfortunately, when IRIS came along in 1987, by that 

point, EPA had funded two studies. One found a slight but—they 

claimed—significant blood pressure increase at low levels of barium 

in drinking water. The study in EPA’s own health effects research 

lab, giving the rats 10 times as much barium for a longer period 

of time found no blood pressure increase. EPA chose to go with this 

study that found the blood pressure increase and said aha, here it 

is, once again, over-precautionary. It was not a particularly good 

study. They recognized that and yet they set their limits on that. 

Mr. SHIMKUS. And there is terminology, abundance of caution, at 

the different levels as the regulation moves forward, and I think 

you are highlighting that. 

Mr. COOK. Yes. 

Mr. SHIMKUS. Dr. Honeycutt, in your written testimony, you are 

pretty blunt. You say, ‘‘because of the lack of scientific defensibility 

and the implications of EPA’s new chemical assessments, we decided to develop our own chemical assessments.’’ Can you describe 

the scientific defensibility that you refer to? Because I hear Mr. 

Cook talk about barium and I am not sure anyone in essence disagrees with that analysis, but can you talk about what you are referring to here? 

130 

Mr. HONEYCUTT. Sure. There is no doubt that EPA comes up 

with safe levels. I mean there is no doubt about that. The question 

is can you have a higher level that is still just as safe? And that 

is where you have to get away from default procedures and actually 

look at how a chemical work in the body. How does it work in the 

rat versus how does it work in the human and then at what levels 

are they exposed to? Because chemicals will exhibit different levels 

of toxicity depending on the dose. A good example is Tylenol. Twenty tablets will kill you, two tablets will cure your headache, a half 

a tablet or a quarter of a tablet won’t do anything to you that is 

an adverse effect. So you have to look at those differences in dose. 

Mr. SHIMKUS. In your opinion, is the IRIS program receptive to 

suggestions for program improvements to address this example you 

just gave? 

Mr. HONEYCUTT. Well, they actually have guidance on some of 

the things that we are talking about. The problem is their inconsistency in using their own guidance. They talk the talk but when 

it comes to doing the assessment, they just revert back to their old 

precautionary selves. 

Mr. SHIMKUS. Thank you. My time has expired. And depending 

upon how many people show up, we may go around a second time. 

I know there is more I want to address. 

So I would like to recognize Mr. Green for 5 minutes. 

Mr. GREEN. Thank you, Mr. Chairman. 

Both Houses of Congress seem to be interested in addressing the 

IRIS recommendations whether it is strengthening IRIS or suspending it. And our colleagues in the Senate sent a letter to one 

of our first panelists calling for suspension of IRIS assessments 

until the NAS recommendations can be incorporated. On the first 

panel, we heard from Dr. Anastas and the NAS on why such a suspension is not necessary and wouldn’t protect public health. Now, 

with this panel, we are fortunate to have an expert on risk assessment who was quoted in that Senate letter. 

Dr. Burke, you are quoted as saying, ‘‘A sleeping giant is the 

EPA sciences on the rocks and if you fail you become irrelevant.’’ 

Would you explain that statement? 

Mr. BURKE. Sure, and thanks for asking that question. So that 

statement was made at a meeting of the EPA Science Advisory 

Board where we presented with the ORD vision for how science 

will be conducted in the future. And knowing the incredible pressures and having been on those frontlines, applying science to society’s problems, I issued that as a warning statement. Obviously, 

there is lots of criticism; then the credibility of science is really important. 

So why is EPA in a crisis? Well, because of the incessant attacks 

on their credibility not because they are not trying to put together 

the best science and not because they don’t have a good Science Advisory Board that provides them, but I think it is important to put 

that into context. EPA is under siege. The very mission of protection of our environment is being questioned, sometimes with good 

cause because of the economic considerations. But I think there is 

a crisis. There is a crisis in credibility and that roadmap of improving IRIS will be a very important step toward addressing that crisis. 

131 

Mr. GREEN. OK. And you are familiar with the rider that I mentioned and do you think that rider would strengthen the IRIS program? 

Mr. BURKE. Unfortunately, I think it would be a disservice to 

public health agencies throughout the country and even perhaps 

the world and it would bring things to a halt in a way that would 

not serve us well. 

Mr. GREEN. OK. It seems there is a difference of opinion among 

our panel members on IRIS assessments and what they should be. 

Dr. Honeycutt suggested in his testimony the IRIS assessment provides EPA’s judgment in how much a chemical can be in fish or 

apple juice for it to be considered safe, but these evaluations require assessing that exposure, something IRIS does not do. Dr. 

Burke, can you clarify the distinction between assessing the hazard 

and assessing the risk? 

Mr. BURKE. Yes, so understanding the hazard it is like knowing. 

So this is anthrax over here and this is bad stuff, can cause a real 

problem and it can cause problem at different levels. So it allows 

us to understand what the risks might be to people who are exposed. That is very different than the problem-oriented process of 

risk assessment that says we have a facility here that has a problem and potentially emitting things into the environment. How do 

we evaluate what is acceptable in terms of a response to manage 

that risk. So the risk assessment is site-specific; it is populationspecific, very different than just identifying the hazard and evaluating the epidemiology and toxicology. 

Mr. GREEN. So there is a difference between the risk assessment 

and what risk is acceptable? 

Mr. BURKE. Yes. And the hazard assessment will never tell you 

what risk is acceptable. That is a societal issue. It can consider social issues. There are lots of things that we don’t regulate to very 

low levels because they are naturally occurring, and it is a policy 

question, not a science question except ability of risk. But understanding a hazard, that is all about good science. 

Mr. GREEN. Well, here we understand asbestos is a toxic substance but you can go out in some places and dig up asbestos since 

it is a rock. And we know we can’t prohibit it because you can be 

exposed by just digging it up. Although asbestos for decades was 

used very substantially to retard fire risks, so an assessment of the 

danger and also what could be acceptable if you encapsulate it and 

do lots of things you can deal with that. 

Dr. Honeycutt, I want to thank you for appearing before the committee, and you have heard, I have worked with TCEQ over the 

years and TCEQ actually alerted our office because for years we 

have had a heightened dioxin level in upper Galveston Bay and the 

Houston Ship Channel and most of my industries are getting 

blamed for it. And there was some concern because we couldn’t 

quantify it until TCEQ did. Can you tell us what efforts TCEQ has 

taken in regard to dioxin just as a substance? Like I joke I want 

dioxin, I want white shirts, but I also know that I don’t want to 

drink it. So if you can tell us what TCEQ in Texas has done with 

it. 

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ber that we have used over the years for dioxin, and as I mentioned in my testimony, we are developing our own procedures for 

coming up with these toxicity values that has been through a peer 

review and that is out for public comment right now. So once that 

is finalized, we are going to run dioxin through a process and see 

what our number looks like. So we are actively looking at that. I 

can’t tell you right now where the number will come, whether ours 

is more or less or higher or lower than EPA’s but we are going to 

be actively involved in that. 

Mr. GREEN. OK. Is there going to be any conflict between when 

EPA is coming out in 2012 or will the TCEQ’s be earlier than, you 

know, a year from now? 

Mr. HONEYCUTT. It won’t be earlier than a year from now definitely. 

Mr. GREEN. OK. It would be good to have two different assessments because, one, that is how you get what we can do with the 

risk and also I know I am over time but I appreciate your testimony that having spent 20 years in the Texas legislature and getting mad at EPA on a regular basis, we also recognize, as you said 

in your testimony, we sit down and can work things out but sometimes we have to lower the decibel level to get there. 

So thank you, Mr. Chairman. 

Mr. SHIMKUS. The gentleman yields back his time. 

The chair recognizes the gentleman from Louisiana, Mr. Cassidy, 

for 5 minutes. 

Mr. CASSIDY. Thank you. I am an erstwhile academic so I will 

speak to Dr. Clewell and Dr. Burke because clearly as I gather 

IRIS is supposed to be here to use science to inform policy. The 

concern, though, is that policy is manipulating process in science 

to achieve an advocacy as opposed to achieving truth, truth being 

the highest calling of science. Fair statement? And that is, if you 

will, the question before us. 

Now, Dr. Clewell, when I read yours that there is clear bias towards presenting evidence that supports the selection of a default 

linear approach even when there is support for a nonlinear approach in the scientific community, if I was co-writing a paper with 

a medical student and she brought something to me that had only 

one explanation even though I knew that there was an alternative 

explanation which she does not address, I would give her a mulligan. I would say you are a medical student; you need to learn to 

do better. Bring it back discussing the alternative explanation and 

use this as a teaching moment. When EPA is using it to drive public policy, my blood pressure goes up. I must have just taken a 

boatload of barium because, you know, why in the world are we 

making decisions that affect an incredible number of jobs on something which doesn’t have a plausible alternative explanation. So 

you have made your point. 

Let me ask Dr. Burke whether or not you disagree with the point 

Dr. Clewell made but by the way is a similar point to what NAS 

made that the neurobiological effects of the formaldehyde could be 

attributed to other things, which the thousand-page document did 

not discuss. So Dr. Burke? 

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ternatives. I think we probably disagree in the fundamental mission of EPA and there in my testimony—— 

Mr. CASSIDY. Can I stop you for a second? 

Mr. BURKE. Yes. 

Mr. CASSIDY. Because I am actually talking about not EPA but 

IRIS. 

Mr. BURKE. OK. 

Mr. CASSIDY. IRIS and a thousand-page document presumably 

presenting a comprehensive discussion—— 

Mr. BURKE. Right. 

Mr. CASSIDY [continuing]. Did not present a plausible alternative 

explanation that NAS came up with. 

Mr. BURKE. Right. 

Mr. CASSIDY. Now, this is not, you know, industry. This is NAS. 

Mr. BURKE. Right. 

Mr. CASSIDY. And so you open a thousand-page document, IRIS 

did not discuss it. It has to beg the question have they moved beyond advocating science for truth to selective presentation of 

science to pursue policy? 

Mr. BURKE. OK. Well, again, not being part of the IRIS program 

and not being part of that review, I know that the standard default 

that not just EPA but public health officials use, again, throughout 

the world particularly for carcinogens is the linear default, that we 

are not quite sure because genetic damage can happen at very low 

levels, just how low that straight line might go. However—— 

Mr. CASSIDY. Now, that I have to say surprises me because we 

know that a 20-pack a year history of cigarette smoking is strongly 

related to a risk of something less is a threshold effect. Indeed, Dr. 

Anastas spoke about how—I have it written down here someplace 

and of course I have lost it—that they look for a dose-related effect. 

Mr. BURKE. Yes. 

Mr. CASSIDY. So that would be a nonlinear effect. I am not sure 

why we are still mired in something conceived of 3 decades ago as 

defining how we should approach a problem in this year. 

Mr. BURKE. Well, I think it is the strength of evidence, and when 

we are looking at hormonal effects and we are looking at neurological effects on the unborn, the fundamental question is, a very 

important one, shouldn’t we present the whole picture about what 

the alternatives may be. But that may not change the public health 

decision that where there is uncertainty we have to make decisions. 

Mr. CASSIDY. But my concern is apparently they are not presenting the whole picture which in effect skews the—— 

Mr. BURKE. That is where I think we agree. 

Mr. CASSIDY. Excuse the assumption. Dr. Clewell, I am kind of 

speaking for you. Could you speak for yourself? 

Mr. CLEWELL. Thank you, sir. I am particularly troubled because 

I worked closely with William Farland when they were developing 

the cancer guidelines trying to change from the old way of doing 

things with just a default. And the cancer guidelines was important 

because it was the first time that priority was given to a chemicalspecific decision that did not rely on the default and a justification 

was required that there was insufficient data to support using a 

default. But in recent years there has been use of 1968 guidelines. 

It is a default. They don’t demonstrate a balanced presentation of 

134 

the different alternatives that are being discussed in the scientific 

community. They paint a picture of evidence supporting the default. 

Mr. CASSIDY. That is either suggesting incompetence or it is suggesting the pursuit of a political agenda. 

Mr. CLEWELL. Absolutely not incompetence. They are very competent people. I believe that they are public health professionals 

who are very concerned about public health and want to make sure 

they are conservative. And in trying to make sure that the protection is provided, they may not provide complete descriptions of alternative approaches that would generate a lower-risk estimate. 

Mr. CASSIDY. That is a patronizing approach to the use of truth 

in science. And I as a person who is sitting on here trying to make 

an informed decision am offended that they assume I don’t have 

the intellectual firepower to figure it out. And that is a disservice 

to the American people. 

Mr. CLEWELL. Actually, the Office of Water has the same problem. They are pretty much hamstrung by the arsenic risk assessment and decisions they would like to make like saying you don’t 

have to clean up the entire western country of arsenic in soil and 

river water are difficult to make when there is only a linear risk 

estimate. 

Mr. CASSIDY. I agree with Dr. Burke that there is indeed a 

threat to IRIS’s reputation and I think we are seeing it in terms 

of an uncovering of how they present facts. I yield back. 

Mr. SHIMKUS. The gentleman yields back his time. 

For the sake of getting my colleagues angry at me, I would like 

to go to a second round. I think the panel is well informed. We are 

learning a lot. The risk will be members may come back which 

might hold you a little bit longer, but I would like to go a second 

round if that is oK with our guests and my colleagues here. If no 

objection, then so ordered. We will go to a second round, 5 minutes 

each. And I may not take my whole 5 minutes, but with that, I will 

recognize myself. 

And this is just a great debate. My concern is an overabundance 

of caution at IRIS and an overabundance of caution at EPA with 

the policymakers could create job loss, economic dislocation, and 

movement of production overseas. So we have got to get the science 

right and I don’t question the public health officials’ intent to protect human health. I do agree that this debate on dosage and what 

is really harmful is very, very important. 

So with that, Dr. Burke, I want to address just one question on 

the delay because the question is what would you deem more 

harmful to human health and the economy? A 1- or 2-year delay 

in an assessment that would ensure the scientific robustness of the 

result or an assessment based on poor processes that is pushed 

through with questionable science? 

Mr. BURKE. I think we owe it to the American public, I think we 

owe it to the scientific community to use the data appropriately 

and to synthesize the scientific information to inform decisions. 

However, having been in emergency situations where the data 

wasn’t perfect, for instance, the trailers in Louisiana where the 

data on formaldehyde weren’t perfect, I worked with the CDC to 

try and make sure we didn’t have acute exposures. So sometimes 

135 

in public health we have imperfect information. However, I agree 

with you, Mr. Chairman, that it would be better to do it right than 

to destroy the credibility of the process. 

Mr. SHIMKUS. And that is this whole debate from the Senate, 

from what we did on the rider to say let the National Academy of 

Sciences’ report be, you know, followed before we continue to move 

forward just so we get it right. But the great thing about a lot of 

things we do on this committee and on our health subcommittee is 

that people in this arena are public servants and want to do things 

right. But again we wanted to raise that issue. 

To Dr. Honeycutt, I raised this in maybe my opening statement 

or the first round. We have talked about it before and we just mentioned it with the water and arsenic in the Southwest. I remember 

it well because one of my colleagues, Heather Wilson, always 

talked about that, arsenic levels in drinking water although it was 

naturally occurring. So with that, this question: In your opinion are 

there broader economic consequences associated with publishing an 

IRIS value that is lower than background levels, and if so, what 

impact do you feel it has on the jobs in the economy? 

Mr. HONEYCUTT. Oh, absolutely there is an impact. Two real 

quick examples, one is mercury. EPA is actually, they are outliers 

from the rest of the world and what is a safe level of mercury in 

fish. All other regulatory agencies have higher safe levels. And they 

came home to Texas just a few weeks ago. 

Mr. SHIMKUS. Let me interrupt. Is that true in the European 

standards? 

Mr. HONEYCUTT. Yes, the World Health Organization has a higher safe level for mercury in fish than EPA does. 

Mr. SHIMKUS. That is funny. I never hear my colleagues mention 

that when we debate that issue. 

Mr. HONEYCUTT. But Lumina Energy laid off 500 people just a 

couple of weeks ago. So it does have direct or indirect—it depends 

on how you look at it—economic consequences. 

And another example is the arsenic that you are talking about. 

In Texas, there are a lot of really small locally owned utilities that 

won’t be able to meet this, so they are going to close down. And 

so people then will have to drill their own water wells and that is 

a real public health concern because that water won’t be tested or 

monitored and they are going to be at their own risk that the public water systems won’t be able to provide that level of safety. 

Mr. SHIMKUS. And let me just finish with this. Mr. Cook talked 

about barium quite a bit in his analysis and his response. His 

statements on barium and the health risk—and I kind of assumed 

everyone sort of agreed with that analysis—can you go on record 

saying you agree with Mr. Cook on his analysis on barium? 

Mr. HONEYCUTT. Yes, sir. Barium in the grand scheme of things 

is not a very toxic chemical at all. 

Mr. SHIMKUS. Dr. Clewell? 

Mr. CLEWELL. Yes, I agree. 

Mr. SHIMKUS. Dr. Burke? 

Mr. BURKE. I really don’t know the issue. I will have to—— 

Mr. SHIMKUS. That is fine. That is fine. And that is why I wanted to clarify because I did make an assumption. I didn’t want to 

do that. 

136 

So I am going to yield back 18 seconds and ask my colleague, Mr. 

Green, to be recognized for 5 minutes. 

Mr. GREEN. Thank you, Mr. Chairman. 

Dr. Burke, in listening to my colleague from Louisiana, Dr. 

Cassidy, and I think your comments sound like it blurs the line between the mission of IRIS, which is to assess the risk and not the 

issue of regulations, which is the management of that risk, which 

is EPA’s job. I guess there may be some concern that by the assessment from IRIS, it may raise the level of concern but, you know, 

like we have heard from Dr. Honeycutt, you know, IRIS is supposed to give the assessment but the risk is an EPA decision and 

not necessarily what may come out of the study. 

For example, the water, you know, obviously water we need for 

our lives, but if you take it from a fire hose, you are going to 

drown. And so there is a reasonable amount that you can have that 

is necessary but it is, you know, too much of anything is bad. 

And Dr. Burke, naturally occurring levels of chemicals, they are 

not always safe. A good example of arsenic in water, I can tell you 

in West Texas and all over the West there are waterholes or water 

that people should not drink and know they shouldn’t drink because of whatever the chemical is in there that are naturally occurring. So just because they are naturally occurring doesn’t mean it 

is safe. You just have to have a certain level of it I guess to keep 

it. And is that something we are continually confused, the difference between assessment and risk? 

Mr. BURKE. Well, it is a very important point. We can’t possible 

clean up the Earth’s crust, nor can we regulate volcanoes for spewing mercury. And we have these naturally occurring materials and 

we have to balance that in the decision-making. On the other hand, 

what we know about arsenic comes from actually naturally occurring contaminated wells in other parts of the world where people 

drank very high amounts and had acute effects as well as cancer 

effects. And so it comes down to being reasonable about how we approach regulation with the right information on the public health 

effects to help us make those decisions. 

Mr. GREEN. OK. You know, I have announced where I come from. 

I have the biggest petrochemical complex in the world in our district—in the country, second largest in the world, and so I guess 

my focus is on the relationship. Dr. Burke, as a former state regulator and you have seen the risk assessment and effective risk 

management, what effect can it have on the jobs? Every product we 

make in the Houston Ship Channel, it wouldn’t be made if somebody didn’t need it. I mean industries don’t do that. They don’t 

make any money on it. So someone needs it but it depends on how 

you make it and how that product is used, whether it be in gasoline or some other additive or something else. 

But is there a direct correlation between effective risk management and the impact on jobs and the economy, which is I think 

what the whole subcommittee was getting at? 

Mr. BURKE. I think that is a very important point in major regulatory decisions. I am not an economist. I can only speak from experience, and clearly there are regulations that have added cost to 

industry and therefore may impact jobs and may impact the general public as well. But as we recommended in Science and DeciVerDate Aug 31 2005 10:54 Oct 02, 2012 Jkt 037690 PO 00000 Frm 00140 Fmt 6633 Sfmt 6633 F:\112-09~2\112-93~1 WAYNE
137 

sions, that should be part of the deal in conducting the assessment 

to make sure you are making the right risk management choice. 

That doesn’t change what happens in the epidemiologic studies 

or in the mice, but we can take that data and if it is properly presented make good decisions. So in my experience again, New Jersey, very industrialized, lots of heavy industry, lots of refineries, 

pollution was much worse for jobs and unsafe workplaces were 

much worse for jobs than environmental regulations. However, I 

completely understand that analyzing the impacts on the economy 

on jobs should be part of the decision process. 

Mr. GREEN. Thank you, Mr. Chairman. And following your lead, 

I will yield back my 46 seconds. 

Mr. SHIMKUS. I thank my friend. 

The chair now recognizes the gentleman from Louisiana, Mr. 

Cassidy, for 5 minutes. 

Mr. CASSIDY. Again, I am learning a heck of a lot in this meeting, so thank you all for all being here. I am struck how sometimes 

processes used to manipulate the response to the findings. Now, 

Dr. Honeycutt, I am impressed that you all—I haven’t read about 

a regression coefficient since I have been here, you know, been 

practicing whatever, and you all did an analysis—now, that is a 

1,043-page document which is stultifying, redundant, and sometimes irrelevant, and yet you had to do all 1,043 pages. Now, it 

makes me think that it would be incredibly time-intensive, resource-intensive to really do an adequate review. If you have a 

statistician doing a regression coefficient on nasopharyngeal cancer 

mortality to criticize or critique the method by which they determined incidents, you got some money tied up in staff working on 

this project. Fair statement? 

Mr. HONEYCUTT. Yes, sir, it is. 

Mr. CASSIDY. Now, if it is 1,000 pages do they give you 120 days 

or—do you see what I am saying? 

Mr. HONEYCUTT. Yes, sir. No, you get the same amount of time. 

And the deal with IRIS is you don’t get to give input on the front 

end; you give input on the back ends after EPA has already—the 

train has left the station and they are recalcitrant to change their 

mind. So that is what you are left with. 

Mr. CASSIDY. I see everybody nodding their head yes. Now, that 

is disturbing because again if we have a premise which I think you 

all agree with is that sometimes they are not given the complete 

picture but at the same time it takes an incredibly intensive process in order to uncover how that is not complete, then you are 

going to have policy decisions made upon something which may, 

some cynics would say, deliberately made onerous upon which to 

review. Again, it goes back to is science deriving policy or is science 

being presented in such a way as to serve as advocacy for a policy 

end? 

Now, we heard in the first panel and NAS and others criticize 

the fact that OMB was allowed to at times review the EPA documents in order to say, oK, wait a second, time out, let us look at 

this. But Dr. Burke, I had a sense from you that in this whole 

analysis needs to be some sort of cost-benefit return on investment, 

what is the true sort of economic cost? Here we have people losing 

their jobs for something which is nominally and maybe even speVerDate Aug 31 2005 10:54 Oct 02, 2012 Jkt 037690 PO 00000 Frm 00141 Fmt 6633 Sfmt 6633 F:\112-09~2\112-93~1 WAYNE
138 

ciously toxic. Now I am thinking maybe OMB needs to be involved. 

I mean maybe there needs to be a delay if once the train has left 

the station you have so little time to review something which is so 

complex to review. 

Dr. Clewell, what would be your comments on that? 

Mr. CLEWELL. I am not what sure what would be the level of 

oversight, but I do believe that OMB plays an important role in 

verifying that the agencies are doing the best job to make the process reviewable, and so I would be in favor of there being a better 

dialogue between OMB and EPA so that that could be accomplished. 

Mr. CASSIDY. And in fairness, I think the critique is that they 

should be more transparent in their questions, but I think there 

was also a criticism as regards sending EPA back to repeat an 

analysis. What I have learned today is that maybe EPA does need 

to be sent back to be more inclusive in their analysis. I am feeling 

more sympathy for OMB right now. So let us see if there is anything else in this. 

Now, who is a chemist? Anybody up there a chemist? The idea 

that Dr. Anastas said that with green chemistry they know the actual effect of every chemical compound is going to have upon skin, 

respiratory system, digestive system, et cetera seems to me like the 

epitome of intellectual kind of hubris. 

Mr. CLEWELL. It might have been somewhat hyperbolic. I think 

he is trying to indicate that there is an ability—and drug companies use it all the time—to try to estimate activity from structural 

properties and that is trying to be harnessed. They are trying to 

harness that in order to develop safer compounds. 

Mr. CASSIDY. There is also the presumption, though, that you can 

make everything inert, and I am not sure you can make life inert. 

Mr. CLEWELL. I am fairly confident you cannot. 

Mr. CASSIDY. Yes, so I agree with that. 

Let me finish up. I will also yield back by saying to Mr. Cook, 

Mr. Cook, you are the only guy in this whole room that creates 

jobs, so on behalf of the American people, thank you for creating 

jobs, and I am very sorry for the impediments put in front of you 

by the Federal Government. We sincerely wish we could be creating a lot more jobs. 

Thank you. I yield back. 

Mr. SHIMKUS. The gentleman yields back. At this time, the chair 

now recognizes Mr. Harper from Mississippi for 5 minutes. 

Mr. HARPER. Thank you, Mr. Chairman. And thank you, witnesses, for being here today and giving your insight into what is 

continuing to be a very important issue for us. 

And I will start if I may with you, Dr. Honeycutt, if I could just 

with some follow up questions on what you had earlier. 

And I have to ask what types of evidence are necessary to establish a causal relationship between exposure to a substance and 

some health effect or health risk. What are you looking for? 

Mr. HONEYCUTT. Yes, that is a very good question and it is well 

known. It is called the Hill criteria for causation. It is well documented. What you need to do is show that a chemical can cause 

the effect that you are looking at and it can cause it at the concentrations you are looking at and that it is reproducible. It hapVerDate Aug 31 2005 10:54 Oct 02, 2012 Jkt 037690 PO 00000 Frm 00142 Fmt 6633 Sfmt 6633 F:\112-09~2\112-93~1 WAYNE
139 

pens over and over again, not just one time in one study, and that 

the effect happens after the exposure. Sometimes we regulate 

chemicals on if the effect happens before the exposure. 

Mr. HARPER. Um-hum. 

Mr. HONEYCUTT. And that it is not just a background occurrence, 

the health effect that you are looking at, that if there is an increased incidence of cancer in this community that it is indeed increased, it is well above background, not just a tiny bit above background. 

Mr. HARPER. Are you always able to figure those problems out? 

It is a search I am sure many times. 

Mr. HONEYCUTT. Sometimes it happens very easily and sometimes it is harder. The health effects of ozone are based on a 1 to 

4 percent increase in premature mortality, whatever that is, and 

how do you quantitate that? It is very, very difficult. And in studies 

the EPA use, you can’t quantitate that. 

Mr. HARPER. And is it true that substances at a high level which 

may create that risk, they may be safe, perhaps even necessary at 

a low level. Would that be certainly true to say? 

Mr. HONEYCUTT. Absolutely. Every vitamin you take, most of the 

minerals in your food that you eat, some of them are essential nutrients that if you get too much of them, they will kill you. 

Mr. HARPER. If I could, Dr. Cook, I wanted to ask you—— 

Mr. COOK. Mr. Cook. 

Mr. HARPER. Mr. Cook, I am sorry. That just shows you the respect that we have for your being here today. 

Earlier today we had on the first panel—I believe you were in 

the room when they were here—Mr. Trimble from GAO testified on 

panel one that the EPA should take the IRIS program back inhouse to avoid meddling from OMB or other departments or agencies. Based upon your experience, do you think that is a wise 

move? 

Mr. COOK. If it had not been for OMB’s implementation of the 

Information Quality Act in 2002, I do not believe we ever would 

have seen IRIS recognize the true chronic effect from barium. Four 

years after the 1994 NTP study, the definitive study was published 

on barium chronic toxicity, the revised IRIS assessment in 1998 

still argued and ignored the sound scientific evidence that there 

was no blood pressure effect from small low levels of barium, if it 

had not been for OMB’s intervention, I don’t think we ever would 

have gotten any response from EPA to make the change that was 

finally put into effect in IRIS in 2005. 

Mr. HARPER. Thank you. Also, Mr. Cook, another question I have 

is, you know, some concerns about IRIS relate to cleanup levels 

that must be attained under our federal environmental laws. Do 

you have any experience where IRIS’s uncertainty or inappropriate 

values caused a hazardous waste cleanup to either stall or be delayed or the costs rise substantially? 

Mr. COOK. We are still in the throes of determining financial responsibility for a superfund cleanup that is still ongoing in North 

Carolina. Ward Transformer Company operated just near the Raleigh, North Carolina, Airport rebuilding transformers from 1963 

until they finally went out of business I think in 2004. They were 

designated as a superfund site, the plant site there I think in about 

140 

1979. Some of the potentially responsible parties negotiated a settlement with EPA to clean up the actual plant site. The contamination is all PCBs from transformer oil. And they were given a choice 

at the time that they came to a settlement with EPA of either 

cleaning up to a 25-parts-per-million standard or a 1-part-per-million standard. The consultant that was working with them reported 

in the document that I obtained from Region 4 EPA that the choice 

to clean up to a very stringent 1–PPM standard was made primarily because of a fear that EPA would come back later and require a further cleanup because the safe level had not been clearly 

defined in IRIS and they were not sure what might come down the 

pike. 

Mr. HARPER. So an abundance of caution made them do that at 

a much greater cost than probably what was necessary. 

Mr. COOK. Yes. I think they even ended up spending about 2– 

1/2 times what they thought they were going to spend to clean up 

to a 1–PPM standard. 

Mr. HARPER. I thank each of you and I yield back. 

Mr. SHIMKUS. I thank my colleagues for joining and for you, 

thank you for putting up with 2 rounds of questions from us. We 

really appreciate it. And you can tell from the questions by my colleagues that they were sincere in trying to work through this process. 

I want to put on the record that the record will be open for 10 

days. You all may see some additional written question as the first 

panel might from us. If you could answer those questions in writing and send them back within that period of time or as soon as 

possible, we would greatly appreciate that. We do appreciate your 

time and I adjourn the hearing. 

[Whereupon, at 12:49 p.m., the subcommittee was adjourned.] 

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