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74–059PDF 2012

HOW THE REPORT ON CARCINOGENS 

USES SCIENCE TO MEET ITS STATUTORY 

OBLIGATIONS, AND ITS IMPACT 

ON SMALL BUSINESS JOBS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON INVESTIGATIONS 

AND OVERSIGHT 

COMMITTEE ON SCIENCE, SPACE, AND 

TECHNOLOGY 

JOINT WITH THE 

SUBCOMMITTEE ON HEALTH CARE AND 

TECHNOLOGY 

COMMITTEE ON SMALL BUSINESS 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TWELFTH CONGRESS 

SECOND SESSION 

WEDNESDAY, APRIL 25, 2012 

Serial No. 112–79 

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

( 

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

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY 

HON. RALPH M. HALL, Texas, Chair 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

LAMAR S. SMITH, Texas 

DANA ROHRABACHER, California 

ROSCOE G. BARTLETT, Maryland 

FRANK D. LUCAS, Oklahoma 

JUDY BIGGERT, Illinois 

W. TODD AKIN, Missouri 

RANDY NEUGEBAUER, Texas 

MICHAEL T. MCCAUL, Texas 

PAUL C. BROUN, Georgia 

SANDY ADAMS, Florida 

BENJAMIN QUAYLE, Arizona 

CHARLES J. ‘‘CHUCK’’ FLEISCHMANN, 

Tennessee 

E. SCOTT RIGELL, Virginia 

STEVEN M. PALAZZO, Mississippi 

MO BROOKS, Alabama 

ANDY HARRIS, Maryland 

RANDY HULTGREN, Illinois 

CHIP CRAVAACK, Minnesota 

LARRY BUCSHON, Indiana 

DAN BENISHEK, Michigan 

VACANCY 

EDDIE BERNICE JOHNSON, Texas 

JERRY F. COSTELLO, Illinois 

LYNN C. WOOLSEY, California 

ZOE LOFGREN, California 

BRAD MILLER, North Carolina 

DANIEL LIPINSKI, Illinois 

DONNA F. EDWARDS, Maryland 

BEN R. LUJA ́ N, New Mexico 

PAUL D. TONKO, New York 

JERRY MCNERNEY, California 

TERRI A. SEWELL, Alabama 

FREDERICA S. WILSON, Florida 

HANSEN CLARKE, Michigan 

SUZANNE BONAMICI, Oregon 

VACANCY 

VACANCY 

VACANCY 

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT

HON. PAUL C. BROUN, Georgia, Chair 

F. JAMES SENSENBRENNER, JR., 

Wisconsin 

SANDY ADAMS, Florida 

RANDY HULTGREN, Illinois 

LARRY BUCSHON, Indiana 

DAN BENISHEK, Michigan 

VACANCY 

RALPH M. HALL, Texas 

PAUL TONKO, New York 

ZOE LOFGREN, California 

BRAD MILLER, North Carolina 

EDDIE BERNICE JOHNSON, Texas 
(III) 

COMMITTEE ON SMALL BUSINESS 

HON. SAM GRAVES, Missouri, Chair 

ROSCOE BARTLETT, Maryland 

STEVE CHABOT, Ohio 

STEVE KING, Iowa 

MIKE COFFMAN, Colorado 

MICK MULVANEY, South Carolina 

SCOTT TIPTON, Colorado 

JEFF LANDRY Louisiana 

JAIME HERRERA BEUTLER, Washington 

ALLEN WEST, Florida 

RENEE ELLMERS, North Carolina 

JOE WALSH, Illinois 

LOU BARLETTA, Pennsylvania 

RICHARD HANNA, New York 

ROBERT SCHILLING, Illinois 

NYDIA VELAZQUEZ, New York, Ranking Member 

KURT SCHRADER, Oregon 

MARK CRITZ, Pennsylvania 

JASON ALTMIRE, Pennsylvania 

YVETTE CLARK, New York 

JUDY CHU, California 

DAVID CICILLINE, Rhode Island 

CEDRIC RICHMOND, Louisiana 

JANICE HAHN, California 

GARY PETERS, Michigan 

BILL OWENS, New York 

BILL KEATING, Massachusetts 
(IV) 

C O N T E N T S 

Wednesday, April 25, 2012 

Page 

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

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

Opening Statements 

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

Investigations and Oversight, Committee on Science, Space, and Technology, U.S. House of Representatives ............................................................... 26 

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

Statement by Representative Renee Ellmers, Chairman, Subcommittee on 

Health Care and Technology, Committee on Small Business, U.S. House 

of Representatives ................................................................................................ 30 

Written Statement ............................................................................................ 32 

Statement by Representative Paul D. Tonko, Ranking Member, Subcommittee 

on Investigation and Oversight, Committee on Science, Space, and Technology, U.S. House of Representatives ............................................................... 34 

Written Statement ............................................................................................ 36 

Statement by Representative Cedric Richmond, Subcommittee on Investigation and Oversight, Committee on Small Business, U.S. House of Representatives ........................................................................................................... 38 

Witnesses: 

Dr. Linda S. Birnbaum, Director, National Institute of Environmental Health 

Sciences and National Toxicology Program, U.S. Department of Health 

and Human Services 

Oral Statement ................................................................................................. 40 

Written Statement ............................................................................................ 43 

Mr. Charles A. Maresca, Director of Interagency Affairs, Office of Advocacy, 

U.S. Small Business Administration 

Oral Statement ................................................................................................. 49 

Written Statement ............................................................................................ 51 

Discussion 59 

Dr. James S. Bus, Director of External Technology, Toxicology and Environmental Research and Consulting, The Dow Chemical Company 

Oral Statement ................................................................................................. 70 

Written Statement ............................................................................................ 72 

Dr. L. Faye Grimsley, Associate Professor, Tulane School of Public Health 

and Tropical Medicine, Department of Global Environmental Health 

Sciences 

Oral Statement ................................................................................................. 87 

Written Statement ............................................................................................ 89 

Ms. Bonnie Webster, Vice President, Monroe Industries, Inc. 

Oral Statement ................................................................................................. 96 

Written Statement ............................................................................................ 98 

Ms. Ally LaTourelle, Esq., Vice President, Governmental Affairs, Bioamber, 

Inc. 

Oral Statement ................................................................................................. 101 

Written Statement ............................................................................................ 103 
Page

V 

Mr. John E. Barker, Corporate Manager, Environmental Affairs, Safety and 

Loss Prevention, Strongwell Corporation 

Oral Statement ................................................................................................. 108 

Written Statement ............................................................................................ 110 

Dr. Richard B. Belzer, President, Regulatory Checkbook 

Oral Statement ................................................................................................. 114 

Written Statement ............................................................................................ 116 

Discussion 127 

Appendix: Answers to Post-Hearing Questions 

Dr. Linda S. Birnbaum, Director, National Institute of Environmental Health 

Sciences and National Toxicology Program, U.S. Department of Health 

and Human Services (questions submitted by Members; no answers were 

received) ................................................................................................................ 139 

Mr. Charles A. Maresca, Director of Interagency Affairs, Office of Advocacy, 

U.S. Small Business Administration .................................................................. 149 

Dr. James S. Bus, Director of External Technology, Toxicology and Environmental Research and Consulting, The Dow Chemical Company ..................... 163 

Dr. L. Faye Grimsley, Associate Professor, Tulane School of Public Health 

and Tropical Medicine, Department of Global Environmental Health 

Sciences ................................................................................................................. 177 

Ms. Bonnie Webster, Vice President, Monroe Industries, Inc. ............................ 184 

Ms. Ally LaTourelle, Esq., Vice President, Governmental Affairs, Bioamber, 

Inc. ......................................................................................................................... 195 

Mr. John E. Barker, Corporate Manager, Environmental Affairs, Safety and 

Loss Prevention, Strongwell Corporation ........................................................... 222 

Dr. Richard B. Belzer, President, Regulatory Checkbook .................................... 245 

Appendix 2: Additional Material for the Record 

Letters Submitted by Subcommittee Chairman Paul Broun, House 

Committeeon Science, Space and Technology .................................................... 268 

Letters Submitted by Subcommittee Chairman Renee Ellmers, 

HouseCommittee on Small Business .................................................................. 281 

(1) 

HOW THE REPORT ON CARCINOGENS 

USES SCIENCE TO MEET ITS STATUTORY 

OBLIGATIONS, AND ITS IMPACT 

ON SMALL BUSINESS JOBS 

WEDNESDAY, APRIL 25, 2012 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT, 

COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY, 

JOINT WITH THE

SUBCOMMITTEE ON HEALTHCARE AND TECHNOLOGY, 

COMMITTEE ON SMALL BUSINESS, 

Washington, DC. 

The Subcommittees met, pursuant to call, at 10:01 a.m., in Room 

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

[Chairman of the Investigations and Oversight Subcommittee] presiding. 
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Chairman BROUN. Committee on Science, Space, and Technology, 

Subcommittee on Investigations and Oversight, and the Committee 

on Small Business, Subcommittee on Healthcare and Technology 

will come to order. Good morning, everyone. Welcome to today’s 

joint hearing entitled, ‘‘How the Report on Carcinogens Uses 

Science to Meet Its Statutory Obligations and Its Impact on Small 

Business Jobs.’’ 

In front of you are packets containing the written testimony, biographies, and truth in testimony disclosures for both of today’s 

witness panels. Before we get started, since this is a two-panel 

joint hearing involving two House Committees, Subcommittees, I 

want to explain how we will operate procedurally so that all Members understand how the question-and-answer period will be handled. We will take testimony from the first panel and then proceed 

with a question-and-answer period. During the question-and-answer period, we will alternate between the two Committees, starting with the Science Committee majority and then the Science 

Committee minority. We will then call on the Small Business Committee majority, followed by the Small Business minority. If there 

is not a Member of one of these Committees present, we will continue to alternate between the majority and minority Members and 

allow all Members an opportunity for questioning before recognizing a Member for a second round of questions, if we get to a second round. 

We will recognize those Members of either Subcommittee present 

at the gavel in order of seniority on their respective Committee, 

and those coming in after the gavel will be recognized in their 

order of arrival. 

After the first panel has been excused, we will take testimony 

from the second panel and then undertake a question-and-answer 

period in the same fashion as with the first panel. 

I now recognize myself for five minutes for an opening statement. 

I would like to extend a strong, warm welcome to my colleagues 

from the Small Business Committee and thank them for their participation in this joint hearing today. 

The Science, Space, and Technology Committee has a history of 

conducting oversight hearings on agencies and programs that 

produce chemical assessments. While we have delved into the work 

performed by the Agency for Toxic Substances and Disease Registry and the EPA’s IRIS Program on more than one occasion, this 

is the first time I have had the opportunity to hearing from the director of HHS’s National Toxicology Program on the subject of the 

Report on Carcinogens, also known as the RoC. 

I view today’s hearing as a learning opportunity for our Committees so that we may better understand the work performed by NTP 

as it publishes its report on carcinogens. 

As a legislator, I am very concerned with protecting public health 

and safety. I can think of few greater responsibilities that we have 

as public servants. As a physician, I take this responsibility even 

more seriously. When substances are found to be harmful, we 

should make every effort to minimize the public’s exposure. We 

also have a responsibility to ensure that these determinations are 

appropriate and not arbitrary or capricious and are communicated 

correctly. 
27 

While taking the most cautious and precautionary approach to 

making these determinations may seem like the right thing to do, 

this method may actually do more harm than good. When concerns 

and fear are promoted with little actual risk, commerce, small businesses, and everyday citizens are impacted with no appreciable 

benefit to their safety. 

It is often repeated that RoC does not assess risk, just hazards, 

and it is not a regulatory action, and therefore, it is not required 

to meet more rigorous standards. While this may be true, it unfortunately is not the whole story. These assessments are highly influential scientific assessments that influence regulatory actions at 

the earliest stages. When the law that established the RoC was 

passed, its stated intent was, ‘‘to be a first step in regulation.’’ 

Because the RoC has such great import, it is critical that these 

reports reflect the best available science. The recent release of the 

12th RoC demonstrates how confusing this process can be. In a report published last April on the EPA IRIS assessment of formaldehyde, the National Academy of Sciences stated, ‘‘strongly question 

EPA’s claims that exposure to formaldehyde can result in increased 

risk of leukemia and other cancers that had not previously been associated with formaldehyde, asthma, and reproductive toxicity.’’ 

Yet two months after the Academy’s reports, the NTP issued the 

12th RoC with an upgrade in the listing of formaldehydes to a 

known carcinogen, based in part on claims similar to those made 

by EPA and dismissed the Academy’s report in an addendum. Since 

then, concerns have been raised about how the RoC is developed 

and how its findings are communicated. 

Last winter, the Small Business Administration’s Office of Advocacy sent a letter to HHS, as well as to NTP, urging HHS, ‘‘to review and evaluate the RoC’s purpose and objectives and to consider 

whether, if substantial changes cannot be made, the RoC should 

continue to play a role in the Federal Government’s Chemical Risk 

Assessment Program.’’ 

This is a surprisingly forthright comment and one that Congress 

should not take lightly. Separately, in the Omnibus Appropriations 

Bill passed last December, Congress directed the Academies to review the 12th RoC’s listing of two of its substances, and I look forward to reading that report when it is published, hopefully soon. 

Although the RoC is not a regulation, by its own admission, ‘‘the 

RoC can be used by regulatory agencies and others for decision 

making.’’ That makes this a very influential document, because a 

RoC listing has real-world implications, and we will hear about 

some of those implications from the small business witnesses on 

our second panel. 

Ultimately, we have to ensure that the public has the best information possible in order to protect their health. 

[The prepared statement of Mr. Broun follows:] 
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Chairman BROUN. Now, I ask unanimous consent that we add a 

number of letters from various groups to the record. These have 

been shared with the minority in advance of the hearing. 

Without objection, so ordered. 

[The information may be found in Appendix 2.] 

Chairman BROUN. I now recognize the Chair of the Committee 

on Small Business, Subcommittee on Health and Technology, for 

five minutes and her opening statement. Mrs. Ellmers. 

Chairwoman ELLMERS. Good morning, and I thank Chairman 

Broun for working with me and my staff on this very important 

issue. I thank all of our witnesses for being here today, and I am 

looking very much forward to your testimony. 

We are here today to learn about the Report on Carcinogens and 

the impact it has on small businesses across America. According to 

the National Toxicology Program, this report is intended to be a 

science-based, public health communication tool. However, the Report on Carcinogens has been used by federal and State agencies 

as a regulatory document, using its listing of substances as a basis 

for regulatory and legislative action. 

Each year, small businesses with less than 20 employees are burdened with compliance regulations that cost them 36 percent more 

per employee than their larger counterparts. Despite the economic 

downturn, the regulatory burden on small businesses continues to 

grow. Increasing regulations mean small businesses must dedicate 

more money, time, and resources by complying with regulations instead of doing what they do best, creating jobs and innovating new 

products. 

The Federal Government has an important duty in researching 

and identifying substances that could cause harm and hazards in 

the public health. But at the same time, our government must recognize the adverse consequences of requiring businesses to call a 

substance a human carcinogen without definitive evidence. It is irresponsible and could lead to unnecessary strain for small businesses. The regulatory uncertainty this is causing has already resulted in small businesses delaying hiring new employees and is 

causing many small businesses to hold off on making important investment decisions. 

Scientists, small businesses, and their representatives are now 

raising concerns about the quality of this analysis and the process 

used to list these substances in the Report on Carcinogens. Specifically, questions have been raised regarding the peer review process. Reports have shown that this process has failed to meet the 

independent and objective standards that would justify the overbearing burdens being placed on local economies and businesses, 

not to mention the insufficient public comment procedures that remain lacking. 

The Report on Carcinogens was originally mandated by Congress 

in 1978, to help aid the research and prevention of many cancers. 

Although there have been many major breakthroughs in the scientific understanding of cancers and its causes, the process that 

the National Toxicology Program currently uses to identify carcinogens has not kept up with the pace of scientific developments. Despite warnings that the National Toxicology Program review process for the report must be improved, there are new concerns that 
31 

the process for the next report has made only minor substantive 

changes and is merely a rearranging of the deck chairs. 

Small businesses continue to fear the ramifications of this report. 

When the government publishes scientific information that negatively impacts private businesses, the government has the duty and 

responsibility to ensure that the information is the product of an 

objective and scientifically sound process. 

Again, I want to thank each one of our witnesses today for their 

participation, as well as Chairman Broun and the Science Committee for hosting us today. I look forward to working with all of 

you on this very important issue. 

Mr. Chairman, I would like to take a moment to say that I have 

included one letter from a small business in my district as well as 

a letter to the Office of Advocacy, November 22, 2011, to the letter 

of Department of Health and Human Services as part of my opening statement for the record. 

I yield back. 

[The prepared statement of Mrs. Ellmers follows:] 
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Chairman BROUN. Without objection, they will be entered into 

the record at this point. 

[The information may be found in Appendix 2.] 

Chairman BROUN. The Chair now recognizes my good friend from 

New York, Mr. Tonko, for an opening statement. You are recognized for five minutes. 

Mr. TONKO. Thank you, Mr. Chair, and welcome to our witnesses. 

Usually I begin my statement by thanking you for having the 

Subcommittee examine a topic of importance and for inviting witnesses who bring a variety of perspectives and expertise to the subject at hand. 

Unfortunately, I am sorry that I am unable to do that today. We 

did not agree in all particulars of the last Subcommittee hearing, 

but I compliment you for inviting a balanced slate of witnesses to 

inform us on renewable energy tax provisions. When the Subcommittee is in a learning mode, such balance reflects well on the 

Subcommittee and highlights that we are truly interested in coming to a complete understanding of a policy issue. 

Today’s hearing is very disappointing. In theory, we are examining the National Toxicology Program’s 12th Report on Carcinogens. In reality, we are hearing the objections of one industry to 

the listing of one chemical. There is virtually no balance here 

today, in my opinion. Five of the six witnesses invited by the majority are aligned closely with the styrene industry and the American Composite Manufacturers Association. 

Certainly we should hear from the businesses with an interest in 

this report. Their concerns about the implications of the report for 

their businesses are legitimate issues for us to, indeed, consider. 

But in this matter, I would also expect us to bring other concerned 

voices into the room to ensure that we have a complete, complete 

picture of how the report and this program are viewed by all interested parties. 

If we were going to fully examine the deep issues this hearing 

purports to tackle, I would have expected to hear from veterans’ 

groups, environmental justice groups, workers, and distinguished 

public health experts with intimate knowledge of the NTP and the 

Report on Carcinogens. No such individuals were called by the majority. To the degree there is any divergent voice heard today, it is 

because of the minorities’ sense of obligation to try to provide some 

balance. 

I could have recommended witnesses such as retired Marine 

Corps Master Sergeant Jerry Amsfinger and Ms. Erin Brockovich, 

who worked with veterans and communities that have been 

harmed by chemical exposure and fought for years to get toxicity 

information into the public policy arena. I could have recommended 

a fleet of distinguished science policy experts, such as Dr. Phil 

Landrigan of Mount Sinai Medical College, or you could stay with 

the beltway, within the beltway and invite Dr. Lynn Goldman, 

Dean of the George Washington University School of Public Health 

and Dr. Jennifer Sass of the Natural Resources Defense Council. 

In addition, the structure of this hearing suggests that small 

businesses are hurt uniformly and primarily by documents such as 

the RoC. The picture is far more complicated than that. I could 
35 

have recommended a host of small business leaders who would 

have made it clear that their business is expanding and taking 

market share away from petrochemical manufacturers because 

public tastes are, indeed, changing. 

The shift away from substances that cannot be easily recycled or 

composted is a process that gained a full head of steam long before 

the 12th Report on Carcinogens was drafted. I am attaching to my 

statement letters we have received from a wide variety of groups 

asking that this Subcommittee examine the claims of the styrene 

industry with a critical eye and that we understand how important 

the work of the NIEHS is to protecting public health. 

Out of fairness, I want to ask you, Mr. Chair, to commit to a second hearing that would expand the scope of the voices we hear on 

this important matter. The issues are too important to treat in 

such an imbalanced way. The Investigations and Oversights Subcommittee must be viewed as impartial and thorough and should 

build a complete record that includes more than allegations into 

lawsuit the styrene industry has brought against NIEHS. A second 

hearing would allow us to correct the impression that we will dance 

to any single-interest tune. I stand ready to work with you to shape 

such a hearing at your earliest convenience. 

There is one final issue I want to raise. Because the government 

is subject to an ongoing lawsuit in which Dr. Birnbaum as the director of NIEHS has a direct role, she may not be able to answer 

some questions here today. It would be grossly unfair for Members 

to try to use this forum to build the record to assist the industry 

in its lawsuit against the government by asking questions of Dr. 

Birnbaum that she cannot answer and then treating her as if she 

is trying to be evasive. 

So I ask that you be especially sensitive to the legal implications 

of this hearing and protect Dr. Birnbaum in situations where she 

has been counseled not to comment. Last week’s joint hearing was 

marred by abusive conduct towards a witness. I know you found 

the behavior distasteful, and I find it unacceptable. Tough questions are fair game, but we should stand together to ensure that 

things do not move from being tough and probing to being personally abusive. I don’t know whether the NIEHS or the styrene industry is right or wrong on the matters before us. I do not believe 

we have done enough work on this matter, nor invited a diverse 

enough set of witnesses to reach any meaningful conclusions today. 

The letters I am attaching to my statement asks us to believe 

that the styrene industry is wrong, and the Committee is biased in 

its approach. They may or may not be right on the first issue, but 

their second criticism is valid. To restore the perception of our 

independence and objectivity, we desperately need another hearing 

and a different set of witnesses. I hope we can work together on 

that hearing, Mr. Chair, and then we can bring, begin to come to 

a fuller understanding of the complex questions that are, indeed, 

before us. 

I yield back. 

[The prepared statement of Mr. Tonko follows:] 
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Chairman BROUN. Thank you, Mr. Tonko. I want to remind my 

good friend from New York that of the letters that you just asked 

to be admitted into the record, we have already admitted those into 

the record from our side all except for, I think but one of those, and 

we just have so many people, and this is about process and not 

about any given entity or chemical. It is about how the process goes 

on. 

Thank you, sir. I appreciate that. 

The Chair now recognizes my good friend from Louisiana, Mr. 

Richmond, for an opening statement. Sir, you are recognized for 

five minutes. 

Mr. RICHMOND. Thank you, Mr. Chairman. 

It is undisputed that chemicals are a part of our daily lives from 

the food that we eat, the products in our homes, and in our children’s toys. In a great majority of their uses, they improve our 

lives. 

However, in a few instances they can be dangerous. To address 

this, the National Toxicology Program issues a Report on Carcinogens which lists substances that may cause cancer. The report now 

identifies 240 substances that are either known or are likely 

human carcinogens. For consumers, this gives them information 

they can use to make informed decisions. For employers, it can 

help them to protect the workers. For all of us, this report can lead 

to cleaner air and water. By identifying substances that may 

heighten the risk of cancer, the public is made aware of potentially 

life-threatening chemicals in our everyday lives. 

As new chemicals are created and additional uses are found for 

existing ones, companies are able to make their products stronger, 

more durable, and a better value for the consumer. As this process 

evolves, it remains a top priority to understand not only what is 

in them but how they may affect us, our children, and the environment. 

The rapid pace of scientific discovery in the United States makes 

doing so even more important. With this degree of innovation also 

comes a strong sense of corporate responsibility that we are fortunate to have in this country. It is important to remember that no 

business wants to put its employees or the public in danger. Safe 

products and a hazard-free work environment are in a company’s 

own self-interest and simply make good business sense. 

With that in mind, the report’s designation of substances as a 

carcinogen can only significantly impact small businesses. For 

some firms, listing a chemical that they use, even in minimal 

amounts, has the potential to stigmatize their products and their 

business. Unlike their large counterparts, small firms rarely have 

teams of attorneys and research personnel in house to mitigate the 

impact of such a listing. Instead they must hire expensive outside 

consultants or shift resources from production to regulatory compliance, slowing growth and job creation. 

Given these concerns there is a need to examine the report and 

how it is prepared. During today’s hearing, I hope to examine how 

rigorous the listing process is and how open it is to external critique. Sound scientific analysis and methods, as well as public comment and peer review, are key to the legitimacy of the report. 
39 

Transparency is also essential for businesses affected by a listing. They should have an opportunity to give their input throughout the process, especially at those points which try final listing decisions. 

I am also looking forward to hearing testimony on the revised 

process for the 13th report, which HHS recently issued in January. 

These procedures are at the heart of many of the issues that we 

will examine today. It is my hope that we can explore whether or 

not this new process increases transparency in public input. 

The Report on Carcinogens is an important source of information 

on substances that may cause cancer in humans. It remains vital 

for consumers, businesses, and government alike. The listing of 

these substances gives the public and decision makers a necessary 

resource to evaluate the safety of where we live, work, and our children play. Ensuring that this is the most credible scientific approaches and uses, processes that are open and clear, is essential 

not only to our Nation’s public health but also to the economic viability of many small businesses. 

I would just say as a Member whose new footprint represents the 

largest petrochemical footprint in the United States Congress, that 

the concerns go both ways, and I think that the more information 

you have, the more knowledge that you have, the better that we 

can protect our citizens, our families, our children. 

So with that, Mr. Chairman, I would yield back. 

[The prepared statement of Mr. Richmond is not available.] 

Chairman BROUN. Thank you, Mr. Richmond. 

I would like to remind my colleagues on both sides at today’s 

hearing we have invited two Administration witnesses and two witnesses suggested by the minority. Our committee rules only require 

one minority witness. We thought it was important to allow a variety of opinions. Half the witnesses that are here today either represent the Administration or were invited by the minority. We are 

trying to be very candid and fair with, again, this is about process 

and not about any individual entity. 

If there—— 

Mr. TONKO. Mr. Chair, I understand that there is only one Administrative representative here, and that would be Dr. Birnbaum. 

Thank you. 

Chairman BROUN. There is a small business advocacy witness 

from Small Business Administration. 

Mr. TONKO. With their testimony reviewed by the leadership of 

that agency, I believe. Is that correct? It is an independent office. 

Chairman BROUN. Thank you. Let us go ahead. If there are 

Members who wish to submit additional opening statements, your 

statements will be added to the record at this point. 

At this time I would like to introduce our witnesses. First is Dr. 

Linda Birnbaum, the Director of National Institute of Environmental Health Science and National Toxicology Program at the 

U.S. Department of Health and Human Services. 

Madam Chairwoman, would you like to introduce our other witness? 

Chairwoman ELLMERS. Yes. Thank you, Mr. Chairman. I am 

going to introduce Mr. Charles Maresca. He is the Director of 

Interagency Affairs in the Small Business Administration’s Office 
40 

of Advocacy. The Office of Advocacy monitors federal agencies’ compliance with the Regulatory Flexibility Act or RFA, as amended by 

the Small Business Regulatory Enforcement Fairness Act and represents the views and interests of small businesses before federal 

agencies. 

Mr. Maresca, I am looking forward to your testimony. 

Chairman BROUN. Thank you, Mrs. Ellmers. I would like to 

thank the Chairwoman for being here and us doing this together. 

We will now begin hearing from our witnesses. As our witnesses 

should know, spoken testimony is limited to five minutes each, 

after which the Members of the Committee will have five minutes 

each to ask questions. 

It is the practice of the Subcommittee on Investigations and 

Oversight to receive testimony under oath, and we will use that 

practice today here as well. 

Do any of you have—either of you have any objections to taking 

an oath? 

Okay. Let the record reflect that both witnesses are willing to 

take the oath by shaking their head in a normal fashion, side to 

side. You also may be represented by counsel. Do either of you 

have counsel here today? 

Let the record reflect that neither has counsel here today. 

Now, if you will please both stand and raise your right hand. Do 

you solemnly swear to affirm and tell the whole truth and nothing 

but the truth, so help you God? 

Be seated, please. Let the record reflect that both witnesses have 

taken the oath. 

Dr. Birnbaum, you are now recognized for five minutes. 

STATEMENT OF DR. LINDA S. BIRNBAUM, DIRECTOR, 

NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH 

SCIENCES 

AND NATIONAL TOXICOLOGY PROGRAM, 

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Dr. BIRNBAUM. Good morning. I am Linda Birnbaum, Director of 

the National Institute of Environmental Health Sciences, part of 

the National Institutes of Health, and I am also Director of the National Toxicology Program, also known as the NTP. It is my pleasure to appear before you today to discuss the Report on Carcinogens. 

The report is required by biennially under the Public Health 

Service Act and issued by the Secretary of Health and Human 

Services. The Secretary has delegated responsibility for preparing 

the report to the NTP. 

In the United States, approximately one in two men and one in 

three women will develop cancer in their lifetime. We have both a 

legal and a moral obligation to identify substances in our environment that are cancer hazards and to communicate this information 

to ensure that people can choose to live and work in safe environments. 

The Report on Carcinogens is a science-based, public health document that provides information about the relationship between 

the environment and cancer. The report lists a wide range of sub-
41 

stances, including metals, pesticides, drugs, natural and synthetic 

chemicals, and biological agents that are considered cancer hazards 

for people in the United States. 

A listing in the report indicates a potential hazard for cancer. 

Many factors, including the amount and duration of exposure and 

an individual’s susceptibility to a substance affect whether a person 

will develop cancer. The Report on Carcinogens is not a risk assessment document. It is not a regulatory document. 

However, the report does provide decision makers and the public 

with information they can use to make decisions about exposures 

to cancer-causing substances. The Public Health Service Act stipulates that the report lists substances in one of two categories. 

The first is known to be carcinogens. The second category is reasonably anticipated to be carcinogens. These categories are based 

on criteria approved by the HHS secretary in 1996 that was a product of a thorough and public review. 

For a substance to be listed in the known category, there must 

be sufficient evidence from studies in humans that indicates a 

causal relationship between the substance and human cancer. 

Briefly, for a substance to be listed in the reasonably anticipated 

category, any one of three scenarios may apply. One, limited evidence of cancer from human studies, or two, sufficient evidence of 

cancer from animal studies, or three, evidence that the substance 

is in a class of substances already listed in the report or that it 

causes biological effects known to lead to cancer in humans. 

The decision by the NTP to list a substance in the Report on Carcinogens is based on scientific judgment with consideration of all 

relevant research data and input from advisory groups and the 

public. For each listing, the report includes a substance profile with 

information on cancer studies that justifies the listing. The profile 

also provides information about use, production, potential sources 

of exposure, and any current federal regulations to limit exposures. 

Each edition of the report is cumulative and includes substances 

newly reviewed, along with those listed in all previous editions. 

The first report was released in 1980. The most recent 12th report 

in June, 2011. Anyone may nominate a substance for listing in or 

removal from the report. The multistep process to prepare the 12th 

report included expert advisory reviews, independent external peer 

review, and drew upon the science expertise of federal agencies including NIH, CDC, FDA, EPA, OSHA, and the Consumer Product 

Safety Commission. 

The process also increased opportunity for public review and 

input. In fact, public comments were solicited on six separate occasions. 

The NTP is now moving forward with preparation of the 13th report. We have changed some elements to enhance transparency and 

efficiency in the process but still maintain rigorous, independent, 

external peer review, and multiple opportunities for public input. 

Among the changes to enhance transparency, we will now prepare 

a single literature review document that systematically assesses all 

relevant literature and explains how the entity reaches its conclusions for its proposed listing recommendation. This document will 

be disseminated for public comment prior to public external scientific peer review. 
42 

We believe that the Report on Carcinogens is and will remain an 

important public health document that improves the public and decision makers, provides, and empowers the public and decision 

makers with information about cancer hazards. 

I appreciate this opportunity to discuss the report and would be 

happy to answer any questions. Thank you. 

[The prepared statement of Dr. Birnbaum follows:] 
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Chairman BROUN. Thank you, Dr. Birnbaum. 

Mr. Maresca, you are now recognized for five minutes. 

STATEMENT OF MR. CHARLES A. MARESCA, 

DIRECTOR OF INTERAGENCY AFFAIRS, 

OFFICE OF ADVOCACY, 

U.S. SMALL BUSINESS ADMINISTRATION 

Mr. MARESCA. Chairman Broun, Ranking Member—Chairwoman 

Ellmers, Ranking Member Tonko, Ranking Member Richmond, 

Members of the Committees, good morning. Thank you for the opportunity to appear before you today to discuss small business concerns with the Department of Health and Human Services Report 

on Carcinogens. 

As Director of Interagency Affairs at the Office of Advocacy at 

the U.S. Small Business Administration, I manage a team of attorneys that works with small businesses and Federal Government 

agencies during the rulemaking process to reduce regulatory burdens on small business. 

Chief Counsel for Advocacy Winslow Sergeant wrote in a letter 

to HHS on November 22, 2011, that small businesses have two primarily concerns with the report, that substances have been listed 

in the RoC based on potentially inaccurate scientific information 

and that the peer review and public comment processes should be 

improved. 

Accurate and credible scientific assessments are vital for small 

businesses. Listing a substance in the report has the potential to 

curtail the use of the substance. This may lead to substantial adverse economic impacts for small businesses that use that substance, including increased costs of insurance and Workers’ Compensation premiums. 

Further, when the Federal Government incorrectly lists a substance as a carcinogen or as a potential carcinogen, small businesses may experience lasting negative economic impacts. 

Also, technical labels can be misinterpreted and confuse the public about the true lead to questions about the true nature of the 

risk to health and safety. For example, although the report lists 

substances as reasonably anticipated to be a human carcinogen or 

known to be a human carcinogen, the caveat states that the listing 

of substances in the report only indicates a potential hazard and 

does not establish the exposure conditions that would pose cancer 

risks to individuals in their daily lives. The important distinction 

between hazard and risk is not understood by most consumers. 

Consumers and small businesses are likely to be more aware of 

whether the substance is listed than of the caveat. 

Small businesses are concerned with the soundness of the science 

underlying listing decisions. First, because it is a hazard-based listing, not a risk-based listing, the report has little value for estimating actual cancer risk to the general public even though the 

listings appear to indicate that there is a cancer risk. Second, 

NTP’s weight-of-evidence analysis does not appear to account for 

inconsistent or contradictory data. 

A more robust weight-of-evidence analysis would consider all scientific data, including contradictory or inconsistent data. 
50 

Small businesses are also concerned with the report’s preparation process. The 12th RoC process did not provide sufficient opportunity for meaningful peer review or public comment. The peer reviewer process did not include adequate dialogue between NTP and 

the peer reviewers, nor did NTP provide adequate response to peer 

review or public comments. 

Although on paper the 12th RoC preparation process included 

several opportunities for public comment, small businesses found 

that NTP did not respond meaningfully to their comments. Because 

public comment is the primary method by which small businesses 

can contribute to the report’s preparation process, it is important 

that such opportunities be meaningful. 

Finally, Advocacy is concerned with NTP’s recent review of the 

12th RoC preparation process for three reasons. First, the review 

process needs improvement. Second, the review of the 12th RoC 

preparation process was a process-based review only and did not 

address substantive scientific concerns, and, third, the new preparation process for the upcoming 13th RoC should bolster opportunity for peer review or require NTP response to peer review and 

public comment. 

Advocacy commends two positive changes that resulted from the 

12th RoC review process, including an additional opportunity for 

public comment and two additional opportunities for interagency 

comment. 

Small business relies on credible and reliable science. NTP’s review of the 12th RoC demonstrates that it is aware that there are 

concerns with the RoC. However, NTP needs to make further improvements in order to ease concerns. To the extent that NTP can 

improve the scientific reliability as well as the peer review and 

public comment processes for the report, there will be a measurable 

burden reduction on small businesses. 

I would like to thank you once again for inviting me to speak to 

you today. I commend the Committee’s interest in improving and 

fostering legitimacy in the report’s listings, and I would be happy 

to respond to questions. 

[The prepared statement of Mr. Maresca follows:] 
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Chairman BROUN. Thank you, Mr. Maresca. We are going to give 

you that opportunity in just a second. I thank you all for your testimony. 

Reminding Members that Committee rules limit questions to five 

minutes. The Chair will, at this point, open the first round of questions, and I recognize myself for five minutes. 

Dr. Birnbaum, NAS’s review of the 12th RoC listing of styrene 

and formaldehyde regarding that, last year Congress directed HHS 

to contract with the National Academies to review two of the 12th 

RoC’s determinations. What is the status of this review, and when 

will HHS direct NAS to move forward with the review? 

Dr. BIRNBAUM. The Office of the Assistant Secretary of Health 

was charged with that, with contracting with NAS. I understand 

they are in the process of developing that contract with the Academy. They expect it to be in place by the fall. 

Chairman BROUN. Okay. So can we be assured that it will be in 

place by the fall? 

Dr. BIRNBAUM. This is the responsibility for the Assistant Secretary of Health. They are working on it. They are doing everything they can to complete it by the end of this fiscal year, September 30. 

Chairman BROUN. Very good. Thank you so much. I certainly 

look forward to that being completed. 

Mr. Maresca, is the RoC a highly influential scientific assessment? 

Mr. MARESCA. The RoC is the first step in regulations that depend on science. Yes. 

Chairman BROUN. The written testimony submitted by witnesses 

on the second panel have indicated that roughly 250,000 jobs are 

associated with just one substance. OMB considered the scientific 

assessment to be, ‘‘highly influential if it could impact public or private sector by more than $500 million in one year,’’ or is, ‘‘novel, 

controversial, or precedent setting or has significant interagency interests.’’ 

Do you consider the RoC to be a highly influential statement in 

those regards? 

Mr. MARESCA. Mr. Chairman, I do not know how it would be, 

how the impact would be calculated. I do know that it is influential 

among, within the agencies. 

Chairman BROUN. Okay. Very good. Again, Dr. Birnbaum, the 

13th RoC will contain a new category called candidate substances. 

Stakeholders are already concerned that a listing as reasonably anticipated inappropriately stigmatized substances without sufficient 

evidence as evidenced by the attention RoC has received over the 

past year. 

How will HHS prevent substances from being stigmatized simply 

by adding to this lower-level category without any justification or 

review? 

Dr. BIRNBAUM. I am sorry, Mr. Broun, but I am not aware of our 

adding any additional categories. The Congress in its wisdom gave 

us two categories, known and reasonably anticipated. Candidate 

substances are these chemicals or the substances or the biological 

agents that may be considered under the RoC. A candidate substance is not a category of carcinogen. 
60 

Chairman BROUN. Okay, but will this be published with the RoC, 

or is it going to be an interagency or within the agency as a—just 

a process of looking at potential substances? 

Dr. BIRNBAUM. Anyone can nominate candidate substances for 

evaluation in the Report on Carcinogens process. The first step in 

that nomination will be that candidate substances will be, information will be gathered on them and an expert group will review that 

nomination to decide whether there is enough information, and 

that will also include public comments at that point in time to go 

forward with a full-scale evaluation. 

Chairman BROUN. Okay. Very good. Dr. Birnbaum, what action 

should consumers take in response to a substance listing in the 

RoC? 

Dr. BIRNBAUM. Reducing exposure to cancer-causing agents is 

important to public health and the Report on Carcinogens provides 

important information on substances that might pose a potential 

cancer risk, and individual’s knowledge is power, and individuals 

can make decisions about what hazards that they can or are willing to be exposed to. 

Chairman BROUN. One of the substances that are proposed for 

consideration in the 13th RoC is shiftwork involved light, involving 

light at night. Does this mean that people who work the third shift, 

including those in 24-hour places like a police station, the hospital 

should perhaps start thinking about limiting their exposure to the 

substances listed in this report? 

Dr. BIRNBAUM. There is always a balance between risk and benefit, and there is growing new scientific information that indicates 

that shift work may, in fact, have health consequences, including 

cancer. 

Chairman BROUN. So we are going to outlaw working at night, 

I guess, if somebody takes that tact. 

My time has expired. 

Now I will recognize Mr. Tonko for five minutes. 

Mr. TONKO. Thank you, Mr. Chair. 

Now, I care about businesses in America, as I am certain everyone on the panel does, and I am also deeply concerned, however, 

about the impact of carcinogens on the lives of children, workers, 

sailors, soldiers, our veteran’s community, and the public health 

professionals who work with them. Those voices are missing from 

today’s hearing, as I earlier stated. 

Dr. Birnbaum, if you could give us insight into the other stakeholders in the work of the National Toxicology Program that we 

should be hearing from and why they would care about the information and the data you assemble. 

Dr. BIRNBAUM. Thank you, Mr. Tonko. I think it would be very 

important that we heard from some of the expert scientists who actually were involved in the conduct of these studies. I think that 

their expert, unconflicted advice would be very important to understanding the impacts that some of these compounds may have, 

have the potential to have on human health. I think the general 

population, public health experts, workers, but to me, I think it 

would be very important that you heard from the scientists who actually were involved in these studies. 
61 

Mr. TONKO. We highlighted some of those in that stakeholder 

category. Beyond what I made mention, are there others you would 

list that might be included as stakeholders? 

Dr. BIRNBAUM. The National Toxicology Programs reporting carcinogens is intended as a public health document, and so it informs 

all stakeholders. I think it is very important, and many small businesses, in fact, are very interested in making sure that their workers are safe. 

Mr. TONKO. Uh-huh, and today we are hearing allegations that 

the process used for the 12th RoC was not transparent. Can you 

briefly explain how public comments and public input were considered during the listing process? 

Dr. BIRNBAUM. So public comments were taken six times during 

the preparation of the 12th Report on Carcinogens. There were four 

opportunities for written comments. All those written comments 

were not only posted on the Web for information, they were all provided to the different expert panels each time for their consideration. There were also two opportunities for oral public comment, 

both at different public meetings that were held to discuss the RoC. 

All the public comments were looked at. The peer panels and the 

expert panels discussed those public comments, and the NTP took 

them all into consideration in its final determination. 

Mr. TONKO. Now, I also believe there may be some confusion 

about what the Report on Carcinogens is and what the Report on 

Carcinogens is not. Do you consider the RoC to be a regulatory document? And if not, why not? 

Dr. BIRNBAUM. The RoC is not a regulatory document. It is a 

hazard assessment document. It looks at all the information, and 

I think that is important to state. It looks at all the information, 

both positive and negative, that is all evaluated and then the information which supports the determination of whether the compound 

has the potential to cause cancer, either as a known or reasonably 

anticipated carcinogen, is compiled to make the public health document, which is the substance profile part of the Report on Carcinogens. All of the information, however, positive and negative and all 

the discussion about it are available on the Website. 

Mr. TONKO. And do you think the general consensus out there is 

that it, indeed, is not regulatory? Do you hear from groups or individuals? 

Dr. BIRNBAUM. Yes. I think that it is understood by the scientific 

experts and most of the community that it is not a regulatory document. 

Mr. TONKO. Okay. Again, I think that as you have indicated with 

your comments here, the balance that we need to strike as a Subcommittee in order to have an in-depth and fair and balanced review would require that we hear from these other stakeholders and 

then and only then can we come up with a meaningful assessment 

of the NTP and the RoC. 

And so I appreciate your input, and Mr. Chair, I will yield back 

with, again, the request that we put together the efforts to host yet 

another hearing that would provide additional parties so as to 

strike with a full balance. 

Chairman BROUN. Well, thank you, Mr. Tonko. I want to remind 

my good friend that this is about the process, not about the evalua-
62 

tion of any specific substance, and we have included in the record 

six, I think, of the seven letters that you have indicated, and so 

they are part of this record, and we are just trying to look at the 

process in this hearing, not whether a given substance should be 

included or not included. We are just looking at the process and 

what, how that process affects any given entity. 

So I thank you, and we will just, you and I can work together 

as we go forward. 

Mr. TONKO. Mr. Chair, if I might just suggest that developing 

the comments of those who have presented letters, many of us, 

having them more fully develop their thought on the process would 

be, indeed, helpful. 

Chairman BROUN. Well, thank you, Mr. Tonko, and I want to remind you that I am a physician, and I am concerned about these, 

and Mrs. Ellmers is also a registered nurse, and she is concerned. 

She has been in the health care field for a long period of time. 

So both of us as Chairs are really interested not only in this 

process but also in protecting my patients and her patients also. 

Mr. TONKO. Well, for us non-health care professionals on the 

panel, as for us engineers, we want data and be able to assemble 

data and problem solve as engineers do. 

Chairman BROUN. Again, sir, this is about the process of developing the RoC. 

Now recognize Chairman Ellmers for five minutes. 

Chairwoman ELLMERS. Thank you, Mr. Chairman. 

I would like to start, Mr. Maresca, just for clarification purposes, 

to be clear, the Office of Advocacy is part of the U.S. Small Business Administration, a federal agency. Is this correct? 

Mr. MARESCA. That is correct. 

Chairwoman ELLMERS. Okay. The federal agency or the chief 

counsel for the federal agency who heads the Office is an appointee 

of President Obama. Is that correct? 

Mr. MARESCA. That is correct. 

Chairwoman ELLMERS. Thank you. Mr. Maresca, starting with 

the questions that I have for you on this issue, why did the Office 

of Advocacy decide to send a comment letter to the National Toxicology Program regarding the Report on Carcinogens? 

Mr. MARESCA. We did hear from a number of small businesses 

and their representatives that there was a problem with the 12th 

RoC. When we looked into it, we realized that there was going to 

be an impact on small business as a result of the listing of those 

substances, and as a result we sent that letter. 

Chairwoman ELLMERS. All right. What does Advocacy think the 

National Toxicology Program can do to improve the Report on Carcinogens? What would be your input on that? 

Mr. MARESCA. Well, as we said in our letter, we think that they 

can do a weight-of-evidence analysis during the process, looking 

more completely at the contradictory data as well as the data that 

supports the listing. We think that they can also improve the peer 

review and public comment process by including in those stages 

some response to the public comment and to the peer review. 

Chairwoman ELLMERS. Thank you, Mr. Maresca, and Dr. 

Birnbaum, on that last response from Mr. Maresca, what do you 

do with the public comments? Do you respond to all the public com-
63 

ments, and to what point in the process does this occur? Before or 

after the Report on Carcinogens is published? 

Dr. BIRNBAUM. Thank you for the question, Mrs. Ellmers. The 

public comments come at different stages as I said before, and we 

listen to them, we consider them. They often lead to changes in 

what we determine or modifications in how we do things. For the 

12th report, we did respond to all the public comments at the time 

that the document was released. For the 13th report, we intend to 

have the public comments actually discussed at the expert peer review meeting. 

Chairwoman ELLMERS. Now, as the NTP develops the 13th edition of the Report on Carcinogens, do you think that the potential 

regulatory consequences of listing a substance should be considered? Now, I know, you know, as you have pointed out that this 

is a hazard assessment document, but because sometimes it seems 

to be used as this, do you think that this might improve it if we 

did look at the potential regulatory consequences? 

Dr. BIRNBAUM. Our charge from the Congress is to evaluate the 

potential for compounds to be a known carcinogen or reasonably 

anticipated carcinogen. Our charge is not to consider regulatory 

consequences. 

Chairwoman ELLMERS. Okay. When new studies are published 

that provide additional scientific information regarding a substance 

already listed as a known carcinogen or reasonably anticipated to 

be a carcinogen, does the NTP review the new information and reexamine the listing decision? 

Dr. BIRNBAUM. If new information becomes available that might 

question the listing or cause a change in the listing, NTP will, if 

it is nominated to us or we self-nominate, we will begin to the process of evaluating and it can alter the listing about whether something can actually be removed from the list or downgraded or revised. 

Chairwoman ELLMERS. With your response, one of the issues 

that has been raised is the timeframe that we are talking about. 

How quickly does the NTP review and reexamine the listing decisions, and does it take months or years? 

Dr. BIRNBAUM. It would depend upon the topic and the compound 

and the amount of new data that becomes available and how important that new data is. But I can tell you that even at the times 

of the external peer review and response to public comments can 

have an impact on how we might list or not list a compound. 

Chairwoman ELLMERS. Thank you very much to both of you for 

your responses, and I yield back the remainder of my time. 

Chairman BROUN. Thank you, Mrs. Ellmers. 

I now recognize my good friend from Louisiana, Mr. Richmond. 

I sure hope that the crawfish never get on the RoC. Mr. Richmond, 

you are recognized for five minutes. 

Mr. RICHMOND. Well, we certainly have an interest in formaldehyde considering the tens of thousands of trailers that contain 

formaldehyde that our people in Louisiana lived in after the storm. 

Dr. Birnbaum, the specific—and I want to just give you a chance 

to respond to the specific concerns which the 12th RoC process did 

not provide sufficient opportunity for meaningful peer review, and 

there was inadequate dialogue between NTP and the peer review-
64 

ers, lack of peer reviewer access to public comments, inadequate 

time and resources to perform the review and inadequate NTP responses to peer review comments. 

Dr. BIRNBAUM. I am sorry that you have had some misinformation if you heard that there was inadequate time for peer review, 

that the peer reviewers did not receive the public comments. All 

that was—is not true. In fact, the information was provided to all 

of them. There was extensive time for great peer review of all of 

the information. We held a special expert panel dealing with the 

issue of formaldehyde carcinogenesis. 

Mr. RICHMOND. And Mr. Maresca, before I get to you, Dr. 

Birnbaum, and I am trying to apply this to, you know, sometimes 

we speak in theory up here and sometimes I try to get it to reality. 

I remember growing up and my grandfather and all of his brothers 

owned funeral homes, which are, you know, the very basic of small 

businesses, and I noticed after he passed and years when I went 

back, I noticed that the embalming room, the door to the embalming room now has a big sign that says wear protective gear and 

formaldehyde may cause cancer. 

Well, my brother and all of his—I mean, my grandfather and all 

of his brothers who owned funeral homes and who were embalmers 

all developed a sense of cancer. Is this something that would come 

from NTP or at least a warning sign, or is that what we are talking 

about here? Yes. 

Dr. BIRNBAUM. NTP does not provide the warning signs. 

Mr. RICHMOND. Right. 

Dr. BIRNBAUM. It provides some of the information. NTP first 

listed formaldehyde as reasonably anticipated to be a human carcinogen in 1980. It then updated it in the 12th report to known carcinogen based upon a series of epidemiology studies in people, looking at thousands of workers in different occupations. Embalmers 

were one of those occupations. Embalmers, garment workers, and 

chemical workers and in all cases there was a relationship between 

the extent of the exposure, the duration of the exposure, how high 

the exposure was to formaldehyde, and the carcinogenic response, 

which appeared to be myeloid leukemia in those studies. 

Mr. RICHMOND. And just taking those examples and wearing my 

lawyer hat and small business side and all the other hats, it would 

seem to me that that information gives everybody an opportunity 

to act. It gives employers the ability to warn employees, it gives the 

chemical manufacturer the ability to warn suppliers and people 

who are going to use it, and or take necessary action to cover themselves from unnecessary liability and to protect the public at the 

same time. 

Is that the goal of what we are trying to do here? 

Dr. BIRNBAUM. Again, we are providing the information that decision makers and the public can use to protect health, and OSHA 

does take the NTP information and requires, for example, that if 

something is reasonably anticipated to be a human carcinogen, it 

does require labeling information, and it requires that to be on 

their material safety data sheets. 

Mr. RICHMOND. Mr. Maresca, now I will give you the same opportunity to respond to the critiques of the 12th report if you want to 

do that. 
65 

Mr. MARESCA. The—well, our response to the critiques is that we 

do believe the science could be improved and that the peer review 

process and public comment process could be improved. We do 

know that OSHA, that a listing in the RoC would require changes, 

a new listing to the RoC would require changes to manufacturers’ 

safety data sheets. 

Mr. RICHMOND. And I guess the ultimate question, at some point 

a decision is going to have to be made one way or the other no matter how much peer review you have and no matter how much, you 

know, it is almost like being a judge and listening to two dozen experts on each side who are both advocating opposite positions, and 

at some point someone has to make a decision. 

How much do we allow for the back and forth until we are satisfied that the people who are charged with making a decision have 

to make a decision? 

Mr. MARESCA. Well, I think more than what we have now is the 

quick answer to your question. A little bit more response to peer 

reviews, for example, more dialogue between the Agency and the 

public, more dialogue among the peer reviewers. 

Mr. RICHMOND. Thank you, Mr. Chairman. I see that I am out 

of time. I yield back. 

Chairman BROUN. Thank you, Mr. Richmond. 

I now recognize Mr. Miller for five minutes. 

Mr. MILLER. Thank you, Mr. Chairman. I do know Dr. Birnbaum. 

She—I don’t think she lives in my district. She lives in my area, 

and I have seen her on many occasions, and I know her reputation, 

which is excellent, and I know the reputation of the scientific work 

done at NIEHS, and that is excellent, and I have relied upon her 

judgment on some occasions and have always found her judgment 

to be sound. 

Mr. Maresca. 

Mr. MARESCA. Uh-huh. 

Mr. MILLER. In my 20s I spent a year at University, as they 

would say, in London. I am not a gifted natural athlete. I think I 

am on the right slope of the athleticism bell curve, but the curve 

is still really fat where I am. But I like playing pick-up basketball, 

and a buddy I went to school with, the buddy I was at University 

with, played pick-up basketball, but I heard about a pick-up game 

among Americans living in London at an American school on Sunday afternoons. I showed up, and they let me play, but it quickly 

became apparent that I was just way, way out of my depth. And 

between the games I overhead the conversations, and everyone else 

in the game was actually living in Europe because they were playing European pro ball. 

Mr. Maresca, that is probably how you should feel sitting today 

beside Dr. Birnbaum in talking about the subject that is before us. 

Dr. Birnbaum has her Master’s and her Ph.D. in microbiology. She 

has published 700—more than 700 peer reviewed publications, 

book chapters, abstracts, reports. They appear—her own original 

research is entirely in the area of public health effects of chemical 

exposures. She is an adjunct faculty member both in public health, 

toxicology, environmental sciences at the University of North Carolina, Chapel Hill, my alma mater, an excellent institution as well 
66 

as a nearby university of lesser reputation. And you are a lawyer. 

Isn’t that right? 

Mr. MARESCA. That is correct. 

Mr. MILLER. And the agency that you head, the office that you 

head is not a science policy office, and you are not a scientist. Isn’t 

that right? 

Mr. MARESCA. That is correct. 

Mr. MILLER. Okay, and it is not the task of your agency to protect public health or the quality of the environment, environmental 

quality. Isn’t that right? 

Mr. MARESCA. That is correct. 

Mr. MILLER. Okay. Do you have scientists who performed an 

independent assessment of the claims of the styrene industry about 

the evaluation of the scientific literature and any irregularities in 

the scientific process? 

Mr. MARESCA. We do not. 

Mr. MILLER. Okay. Is there anything that you have said in your 

testimony today that—we know the styrene industry has spent 

close to $1 million dollars in lobbying in just the last two years on 

this issue. Is there anything that you said in your testimony today 

that differs in any detail from the criticisms of the styrene industry? 

Mr. MARESCA. I am not as familiar with the, all of the criticisms 

of the styrene industry. They were among the small businesses who 

did come to our office to suggest that there were problems with the 

12th RoC. 

Mr. MILLER. Okay. So your testimony today, your criticisms have 

come to you from the styrene industry. Is that correct? 

Mr. MARESCA. In part. Yes. 

Mr. MILLER. Okay, and you—according to your newsletter and 

actually the styrene industry’s lobbying arms newsletter, claimed 

credit for this hearing today, for having obtained this hearing. 

But your newsletter said that you had a round table discussion 

of NIHES—NIEHS Report on Carcinogens and that representatives 

from the American Chemistry Council and Regulatory Checkbook 

were there. Was anyone from NIEHS there? 

Mr. MARESCA. I do not believe so. 

Mr. MILLER. Okay. Was Dr. Belzer, who will testify on the next 

hearing, was he at that—— 

Mr. MARESCA. I believe he was. 

Mr. MILLER. Okay, and Mr. Tonko’s statement today includes— 

he added to it a small business owner’s statement that they actually manufacture, I wouldn’t have thought of the styrene industry 

as being a small business, but there is someone who is developing 

another form of packing material from mushrooms, and he says 

that actually what you are advocating for today is hurting their interests. Were they included in the round table? 

Mr. MARESCA. I am not familiar with that letter, so I couldn’t tell 

you. 

Mr. MILLER. Okay. Mr. Chairman, I will yield back my last 11 

seconds. 

Chairman BROUN. Glory be. Thank you so much, Mr. Miller. By 

the way, I did not know that Dr. Birnbaum was a professional basketball player in Europe, and I appreciate you bringing that to our 
67 

attention, and I would also like to remind my friend if you had 

looked at the second panel, there is Dr. Bus, who is a toxicologist, 

who will be presenting to us today also. 

So now I recognize my good friend, Mr. McNerney, for five minutes. 

Mr. MCNERNEY. Thank you, Mr. Chairman, and I thank you for 

holding a hearing that is not specifically designed to bash the Administration. 

Dr. Birnbaum, can you tell us what evidence the National Toxicology Program used in listing styrene as a reasonably anticipated 

to be a carcinogen? 

Dr. BIRNBAUM. There were over, between 400 and 500 papers 

that were—— 

Chairman BROUN. Dr. Birnbaum, your microphone. 

Dr. BIRNBAUM. Sorry. There were over 400 to 500 papers or more 

that were looked at in the background document that were involved in assessing the health effects of styrene. There were 

many—there were three groups of expert witnesses who reviewed 

it, plus our Board of Scientific Counselors. There were votes taken 

at all of the expert groups, and of the 32 votes, 30 were for listing 

styrene. Thirty-one of the 32 were for listing styrene, and of those 

31 there were actually several votes for listing it as a known carcinogen. 

Mr. MCNERNEY. So you wouldn’t consider that to be a controversial issue within the review groups? 

Dr. BIRNBAUM. I think not. I think the only discussion among one 

of the review groups was should it be listed as known or reasonably 

anticipated. 

Mr. MCNERNEY. Well, the Report on Carcinogens lists many different substances that are known to be human carcinogens or reasonably anticipated to be human carcinogens. Why do you believe 

that the styrene and the formaldehyde in particular have generated so much controversy? If I may ask. 

Dr. BIRNBAUM. I think these are high-volume use compounds, 

but we have had controversy on some of our listings in the past as 

well. 

Mr. MCNERNEY. Thank you. One of the things that I hear complaining from the industry groups is that there were public comments, and there were no response to those comments. How many 

public comments were there? Would it have overwhelmed the resources of your department to try to respond to each one of those 

comments? 

Dr. BIRNBAUM. Yes. 

Mr. MCNERNEY. Thank you. Mr. Maresca claims, and this is still 

for Dr. Birnbaum, that several studies refute your listing of styrene 

as a reasonably anticipated to be a human carcinogen. Can you explain the discrepancies between the studies, your studies and the 

studies of the other side? 

Dr. BIRNBAUM. We looked at all of the studies, both the studies 

that demonstrated an association in humans for styrene and where 

some of the negative studies. Our conclusions were that the evidence in humans was limited. We also, though, found that styrene 

is a carcinogens in experimental animals by two routes of exposure 

by both oral and inhalation, and we also found that styrene is well 
68 

known to be metabolized to a chemical called styrene oxide, and 

that can be found circulating in the blood of workers who are using 

styrene, and we have also found chromosomal aberrations. Those 

are genetic problems in the blood of workers who are exposed to 

styrene. 

So listing it as reasonably anticipated was based not on one of 

the three potential criteria to put it in that category but upon all 

three. 

Mr. MCNERNEY. Does this listing apply to public use of styrene 

or to workers in styrene production or both? 

Dr. BIRNBAUM. All the human studies involve highly exposed 

workers. 

Mr. MCNERNEY. So using a styrene cup is not really going to expose you to unnecessary cancer risks. 

Dr. BIRNBAUM. We are not concerned about any styrene that 

might leak from a polystyrene cup. 

Mr. MCNERNEY. Thank you for your direct answers, and I yield 

back. 

Chairman BROUN. Thank you, Mr. McNerney. 

I want to thank the witnesses for you all’s valuable testimony 

and the Members for your questions. The Members of this, of either 

Committee may have additional questions for either of you, and we 

will ask you to respond to those questions in writing as expeditiously as you possibly can. 

Mr. TONKO. Mr. Chair. Point of clarification. 

Chairman BROUN. Certainly. 

Mr. TONKO. I am just wanting to clarify, and I am doing this via 

the document from the Office of Advocacy from the SBA, and in 

their coversheet with testimony, they offer a letter to Secretary 

Sebelius at HHS, indicating that as Advocacy, as an independent 

body within the United States Small Business Administration, the 

views expressed by Advocacy do not necessarily reflect either the 

position of the Administration or the SBA. 

So I think that is important to clarify, and also in—— 

Chairman BROUN. I think that letter, I think you already 

have—— 

Mr. TONKO. Right. 

Chairman BROUN. It is submitted, and so you can ask any further questions by writing if you don’t mind because we need to 

forge ahead. 

The record will remain open for two weeks for additional comments from Members, not to cut you off, but it will remain open 

so that you can make other comments. Witnesses are excused. We 

will move to our second panel. Thank you so much for participating 

today. 

And if the second panel will take your seats very quickly, we 

would appreciate it. 

While they are being seated, at this time I would like to introduce our second panel. First is Dr. James S. Bus. He is the Director of External Technology, Toxicology, and Environmental Research and Consulting for the Dow Chemical Company. Ms. Ally 

LaTourelle, Esquire, is the Vice President for Government Affairs 

at Bioamber, Incorporated, and Dr. Richard Belzer is the President 

of Regulatory Checkbook. 
69 

And I recognize Chairwoman Ellmers for introducing the remaining witnesses. 

Chairwoman ELLMERS. Thank you, Mr. Chairman. 

I would like to introduce Dr. Grimsley, who was invited to testify 

by my colleague, Ranking Member Richmond. She is a Certified Industrial Hygienist. She is currently on special leave from Tulane 

University School of Public Health and Tropical Medicine, where 

she is an Associate Professor. 

Chairman BROUN. Thank you, Mrs. Ellmers. 

As our witnesses should know. Oh, I am sorry. 

Chairwoman ELLMERS. I apologize. 

Chairman BROUN. Go right ahead. I thought you had finished. 

Chairwoman ELLMERS. This process is a little different than 

what we have in Small Business, so I—— 

Chairman BROUN. That is quite all right. 

Chairwoman ELLMERS. I would also like to introduce Bonnie 

Webster, who is the Vice President of Monroe Industries in Avon, 

New York. Monroe Industries is a cast polymer company that manufactures high-end custom showers and vanity tops and has seven 

employees. 

I would also like to introduce John Barker. He is Corporate Manager of Environmental Affairs, Safety and Loss Prevention for 

Strongwell Corporation, which is headquartered in Bristol, Virginia. Strongwell Corporation manufactures ballistics panels and 

bridge beams and platforms and employees 465 people in their 

three facilities. 

Dr. Grimsley, Ms. Webster, and Dr. Barker, we very much look 

forward to your testimony today, and I yield back now, Mr. Chairman. 

Chairman BROUN. Thank you, Mrs. Ellmers. 

As our witnesses should know, spoken testimony is limited to 

five minutes each, after which the Members of the Committee will 

have five minutes each to ask questions. 

As I noted before, it is the practice of the Subcommittee on Investigations and Oversight to receive testimony under oath, and we 

will use that practice here today. 

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

Okay. Very good. Let the record reflect that all witnesses are 

willing to take the oath. You also may be represented by legal 

counsel. Do any of you have counsel here today? 

Okay. Let the record reflect that none of the witnesses have 

counsel. 

Now, if you would each would please stand and raise your right 

hand. Do each of you solemnly swear and affirm to tell the whole 

truth and nothing but the truth, so help you God? 

Okay. Please be seated. Let the record reflect that all witnesses 

have taken the oath. 

I now recognize Dr. Bus for five minutes. 
70 

STATEMENT OF DR. JAMES S. BUS, 

DIRECTOR OF EXTERNAL TECHNOLOGY, TOXICOLOGY, 

AND ENVIRONMENTAL RESEARCH AND CONSULTING, 

THE DOW CHEMICAL COMPANY 

Dr. BUS. Good morning. My name is Dr. James Bus. Over my career as a toxicologist, I have served as the President of the Society 

of Toxicology and served on science advisory bodies of the National 

Academy of Sciences, the EPA, the FDA, and the NTP. I am here 

today as a concerned scientist and represent the Styrene Information and Research Center, of which my employer, the Dow Chemical Company, is a founding member. 

I, Dow, and the styrene industry are keenly interested in protecting the health and safety of workers, customers, and the public. 

Objective, evidence-based reviews of the scientific research are essential elements in our decision making about products and facilities. 

The NTP is globally recognized as an authoritative body. Chemical classifications in its RoC carry significant consequences for 

businesses, large and small, including regulatory actions and commercial impacts. 

Thus, it is essential that the RoC classifications represent the 

highest quality scientific evaluations. My comments today focus on 

three shortcomings of the NTP’s RoC process and are based in part 

on issues revealed in recent RoC evaluations, including styrene. 

First, the RoC process is almost entirely ad hoc and lacks explicit 

criteria necessary to assure consistency and transparency. Importantly, NTP’s RoC process is completely silent about criteria needed 

to guide scientific evaluations at several key process stages. 

For example, draft monographs provide the primary rationale for 

RoC classifications. Yet the recently updated RoC process states 

that monograph reviews only include, ‘‘external scientific input as 

needed, for example, consultants, ad hoc presentations, expert panels.’’ 

A 2011 NAS assessment of the EPA review of formaldehyde details a number of scientific best practices for assessments of chemicals in general and points out that ad hoc review processes cannot 

be relied on to produce scientifically valid assessments. 

Indeed, evidence-based approaches are now being used by other 

institutions such as the Institute of Medicine. 

Second, the RoC process lacks adequate checks and balances, including peer review and addressing outside or conflicting data. 

NTP’s new process limits review by its Board of Scientific Counselors to NTP’s initial draft concept document, which is akin to an 

outline of what the NTP’s review intends to examine. Peer review 

of the critical draft monographs by external panels is left entirely 

to the discretion of the NTP, including the key steps of expert 

panel member selection and identification of review charge questions. 

In addition, interagency review of draft monographs is reduced 

to providing inputs that will only be considered at the discretion 

of the NTP and are not further shared with the expert panels or 

the public. 
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Finally, draft monographs are presented to the NTP Board of 

Scientific Counselors for information only, denying this senior advisory panel any meaningful peer review. This is not transparent or 

credible peer review. 

Finally, the RoC fails to employ scientific best practices, relies on 

outdated approaches, and has not adopted recent NAS recommendations. The NAS has specifically outlined several fundamental best practices necessary to assure that the processes for 

toxicology-related assessments of chemicals are evidence based, objective, and scientifically credit. The process used to prepare the 

RoC falls considerably short of those objectives. 

For example, NTP has previously stated that RoC reviews are 

based on strength of evidence as compared to the more comprehensive weight of evidence analyses used by groups such as the Institute of Medicine. The RoC heavily favors finding supporting NTP’s 

proposed listing position while contrary findings are seldom given 

much weight. 

Although external public comment is solicited, NTP has stated as 

a matter of policy it will no longer offer any written response, 

thereby masking the existence of different scientific views. 

In summary, the current RoC process falls well short of producing evidence-based decisions. I urge Congress to oversee a thorough assessment of the RoC, ideally through an NAS review, to ensure that any future RoC listings are evidence based, provide accurate public health information, and reflect the highest scientific 

standards in its processes and to begin to determine the RoC’s fundamental relevancy going forward. This will increase the public’s 

and industry’s confidence in the RoC listings and their applications 

to science-informed decision making. 

Thank you. 

[The prepared statement of Dr. Bus follows:] 
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Chairwoman ELLMERS [presiding]. Thank you, Dr. Bus. 

I would now like to introduce Dr. Grimsley for five minutes. 

Thank you. 

TESTIMONY OF DR. L. FAYE GRIMSLEY, 

ASSOCIATE PROFESSOR, TULANE SCHOOL OF 

PUBLIC HEALTH AND TROPICAL MEDICINE, 

DEPARTMENT OF GLOBAL ENVIRONMENTAL HEALTH 

SCIENCES 

Dr. GRIMSLEY. Good morning. My name is Faye Grimsley. I am 

Associate Professor of Global Environmental Sciences, Tulane University. I am currently on special leave as a Yerby Visiting Associate Professor, Department of Environmental Health, Harvard 

School of Public Health. My testimony today will focus on the process of the NTP Program’s RoC, the impact of the Report on Carcinogens on jobs, and why the National Toxicology Program is important. 

First of all, the process involves a number of peer reviews first 

by Expert Panel; second, by Interagency Scientific Review Group; 

third, the NIEHS/NTP Scientific Review Group; and finally, review 

by the NTP Board of Scientific Counselors. Comments from the 

public are solicited during steps one through three of the process. 

When the Expert Panel meets to review the background documents 

and NTP Board of Scientific Counselors meets to review draft substance profiles, the public is invited to attend. Closed meetings are 

held when listing or removal status recommendations are made for 

selected substances. Although there are a number of closed meetings to discuss and recommend listing status of specific substances, 

the review process is transparent and open to the public for criticisms and opinions during the review process. 

The impact of the NTP RoC process on jobs. We know that according to NIOSH it is well documented that associations between 

occupational exposures and cancer exists. From an environmental 

health scientist point of view and an industrial hygienist, the NTP 

process is a valuable resource of information and is often cited and 

referred when carcinogenic information is needed. Any chemical 

substance listed by the RoC will impact the health of workers and 

the public. The review process should consider what impact this 

will have on businesses of all sizes. Whenever new regulations or 

standards are introduced, use of state-of-the-art technologies and 

practices to protect worker health may be beyond resources of 

small businesses. Small entities often have limited resources. Agencies charged with health and safety of the public and workers 

should anticipate and provide assistance and resources to these entities to relieve any additional strain of compliance. 

Most health and safety personnel, regardless of company size, 

would agree that additional requirements are involved when new 

chemicals are designated as a carcinogen or potential carcinogenic 

agent, but the benefits of knowing that readily available lists of 

carcinogenic chemicals relieve some of the burden of identifying one 

category of toxic substances which workers have a potential for exposures and adverse health effects if needed. 
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Why the NTP is important to public health: with more and more 

chemicals being developed and used by society and in the workplace, databases that contain toxicity and health and safety information developed by the NTP process, and others will continue to 

be used by a number of companies, organizations, and agencies for 

toxicity assessment and decision making to address public health 

issues. Development of exposure limits and carcinogenic classifications is even, is a challenge. 

When workers and community members are unaware of the potential toxic health hazards in their work environment and communities, this makes them more vulnerable to injury and diseases. It 

is important to provide them with information and references to assist in anticipating and recognizing hazards and the health effects 

associated with carcinogens in the workplace and the community. 

If a chemical or agent lacks toxicological and carcinogenic data, it 

is difficult to conduct exposure assessment in public health and 

worker populations, which makes it difficult to respond to affected 

populations concerns and fears of long-term health effects. 

For example, in the aftermath of Hurricane Katrina, the public 

was very concerned about the copious amounts of mold exposure 

and potential health effects. The NTP played an instrumental role 

in gathering knowledge and coordinating potential research questions that could help address the impact of mold and mycotoxin 

and exposures and health effects. 

Potential exposures to chemicals occur in homes and communities. Scientists have the daunting task of combining and assessing data from laboratory studies and information from human population epidemiologic studies to determine a substance’s cancer 

causing ability. Systematic processes are needed to assess toxicity 

and hazards associated with these chemicals. Given the limitations 

of oversight sometimes placed on federal agencies, the NTP is 

uniquely positioned to lead various types of reviews and investigations of chemicals that are of concern across different aspects of 

public health. 

Thank you. 

[The prepared statement of Dr. Grimsley follows:] 
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Chairwoman ELLMERS. Thank you, Dr. Grimsley. 

I will now introduce Ms. Webster for five minutes. Thank you. 

TESTIMONY OF MS. BONNIE WEBSTER, 

VICE PRESIDENT, 

MONROE INDUSTRIES, INCORPORATED 

Ms. WEBSTER. Thank you, Chairman Broun, Chairwoman 

Ellmers, Ranking Member Tonko and Ranking Member Richmond 

for the opportunity to testify before you today. My name is Bonnie 

Webster, and I am the Vice President of Monroe Industries in 

Avon, New York. My husband, John, is here with me today and together we run the company. We have seven employees but often 

hire two to three more seasonally to meet demand. We are a cast 

polymer company and use styrene-based resin to manufacture 

high-end custom showers and vanity tops. 

We are a small operation, but we do go to great lengths to reach 

the highest level of safety. In 1999, we built a new facility away 

from residential areas because styrene, like any chemical, has the 

potential to be harmful when misused. We ensure that every employee uses a respirator and other safety equipment. Unlike larger 

companies we do not have the ability to employ a full-time occupational safety staff, however, we bring in consultants annually to address OSHA matters and ensure that even with small resources we 

are compliant and safe. 

Our company works hard to lessen the environmental impact of 

our production. We have created Robal Glass, a product that uses 

half the amount of resin. Robal Glass uses a bio-based resin and 

recycled glass for which we have won an EPA Environmental Quality Award. Our products have a life cycle of well over 20 years and 

are designed to last the duration of the home. 

Despite our hard work to be on the cutting edge of the composites industry, we are very concerned that the listing of styrene in 

the 12th Report on Carcinogens make it very difficult for us to stay 

in business. 

Currently there is only one company that will insure us. Should 

we be dropped by that company, like other composite companies 

whose coverage has been terminated by long-term carriers, it will 

be impossible for us to continue to make an affordable product. Today’s mentality when it comes to liability lawsuits is who can we 

sue next. We cannot afford to be next and remain in business. If 

the poor science that informed the RoC listing begins to inform the 

EPA or OSHA regulations, our concerns will only worsen. 

Our worries are not unique only to Monroe. Many state air pollution regulatory programs will look at the RoC listing and set styrene ground level exposure limits based on a presumption of carcinogens, and this will make it impossible for composite manufacturers in these states to get or renew operating permits. 

In light of the uncertainty presented by the styrene listing in the 

RoC, we have no plans to expand our production or increase our 

number of employees. We hope with this economy we will be able 

to maintain the business that we have now. Compared to many 

other companies in the cast polymer subset of the composite’s in-
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dustry, we are in a better position than most because our products 

are totally customized and therefore, very difficult to import. 

The current environment has made it nearly impossible for highproduction cast polymer fabricators to compete. Surrounding countries do not have the regulations and additional costs that we have 

here. Unlike larger composite manufacturers who do not have the 

luxury, if you can call it that, of moving production offshore, if this 

trend continues, we will have no choice but to liquidate our companies. 

There is a significant environmental benefit to using our engineered composite products over natural stone products and other 

materials that should be considered. Granite, for example, is mined 

in South America and often shipped to China to be polished before 

shipping, being shipped back to the U.S. to be fabricated. The environmental impact of the transportation aspect alone is considerable. The fact that our engineered surfaces are fully 

manufacturable in the United States, in addition to being partially 

constituted of recycle components, makes them a very green product. 

The RoC has hidden in the shadows pretending only to be harmless input to the public health agencies. It has been largely unsupervised by the Congress, unreachable by the Courts, and not carefully supervised by senior officials in their respective agencies. Yet 

its actions have every bit as much of an impact as regulations 

which in contrast are subject to the Administration Procedure Act. 

Our industry is asking that Congress reform the way the Federal 

Government analyzes the risk of chemicals to make it a more 

transparent, inclusive, and scientific process. Please consider these 

reforms that will ensure that federal programs like the Report on 

Carcinogens leads to valuable assessments that help rather than 

harm American business and the American worker. 

Thank you very much for your time. 

[The prepared statement of Ms. Webster follows:] 
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Chairwoman ELLMERS. Thank you, Ms. Webster. 

I would like to introduce Ms. LaTourelle now for five minutes. 

Thank you. 

TESTIMONY OF MS. ALLY LATOURELLE, ESQUIRE, 

VICE PRESIDENT GOVERNMENT AFFAIRS, 

BIOAMBER, INCORPORATED 

Ms. LATOURELLE. Thank you, Mrs. Chairman. Chairman Broun, 

Chairwoman Ellmers, Members of the Committee, Ranking Member Tonko, and Ranking Member Richmond, thank you for the invitation to speak today. This is the first time I have been before a 

committee, so I would like to, if I may, enter my written testimony 

into the record and summarize those points here for you today. 

Chairwoman ELLMERS. Without objection. 

Ms. LATOURELLE. Thank you. My name is Ally LaTourelle. I am 

the Vice President of Government Affairs for a company called 

Bioamber. We are a renewable chemical company. My work with 

Bioamber includes renewable chemical manufacturing project finance, federal, State, and local financial incentive analysis, renewable chemical and economic policy development, and I currently 

head global sustainability. It is a start-up. 

I am also a former investment advisor, both for private individuals on private companies in the clean tech sector and for public 

companies. So my perspective is a little bit different than the other 

members of the panel. 

Bioamber, just to start, is a next-generation chemicals company. 

We have a proven proprietary process that uses economically viable, sustainable feedstocks rather than oil and coal and natural gas 

to produce platform chemicals. These chemicals are used for a diverse range of applications. 

For example, we produce a non-toxic, bio-based succinic acid. 

This is used in many applications from food additives to fabrics, 

and we do so at lower cost. 

We have also developed bio-based butanediol, a technology that 

will be deployed at our first commercial scale facility in Ontario, 

Canada, along with the succinic acid. Now, in combination these 

two chemicals put together make what is called a modified 

polybutylene succinic, and this is a resin similar to what we just 

heard about. 

This—I did bring some samples here I would just like to show 

so that we can get a practical feel for what we produce. This is the 

modified PBS as it comes out. It goes into extrusion machines. This 

type of plastic is stamped into very familiar objects, coffee cup lids, 

and our technology is special because it gives heat resistance. Not 

only is it biodegradable within 90 days, but you also have heat resistance, which is a very difficult property to engineer. 

Respectfully, I would like to present a few different reactions to 

the issues of concern before the Committee today, from the perspective of a renewable chemistry company. Like Dr. Bus, I, too, question the fundamental relevancy of the RoC to small business, but 

from a different perspective, and my next statement is in no way 

challenging the science or the importance of the RoC itself. We find 
102 

ongoing reporting of carcinogens has a negligible impact on competition in the face of industry-wide 21st century business concerns. 

The ad hoc nature of global chemical regulations is not detrimental to our small business, and it is not a shock. I would like 

to just remind you that the World Health Organization in its International Agency for Research on Cancer moved styrene, for example, from not classifiable to possibly carcinogen to humans in 1987. 

So the impacts of this information should have already come to the 

floor. They reviewed that assessment in 1994 and in 2002, and 

came up with the same conclusions. The U.S. Agency for Toxic Substances and Disease Registry pointed to that report in 2007, and 

the EPA has regulated styrene already in drinking water where it 

has been found. 

To be fair, Canada has found styrene to be non-toxic. However, 

I would like to point out that this in no way, even though we make 

a direct substitution for styrene, has in no way impacted our decision to commercialize, to get to commercial scale in Canada. Last 

year in California, for example, a total ban of styrene was considered. 

These regulations are essentially ongoing discussions, but they 

really take a backseat to the larger concerns of the 21st century. 

We have cost concerns related to energy supply price increases. We 

have shipping and supply chain costs mentioned by Ms. Webster 

associated with radical swings in the price of oil. We have increased demands for transparency, and the chemical industry is 

bringing science and innovation to design products that avoid these 

concerns, as well as toxicity. Our chemical process design takes 51 

percent less energy to run than the incumbent petrochemical players. That means there is a 205 percent energy efficiency that occurs 

pound for pound. In our adipic acid technology, for example, it 

takes 205 percent more energy to create a petrochemical adipic 

acid. 

Chairman BROUN. Ms. LaTourelle, if you would, your time has 

expired, so if you would wrap up quickly, I would appreciate it. 

Ms. LATOURELLE. Oh, yes. I am sorry. 

Chairman BROUN. We would appreciate it. 

Ms. LATOURELLE. My apologies. 

Just to wrap up, I would also like to suggest that regulations 

themselves lead to innovation. If we cannot identify the problems 

and if we do not have access to information, we cannot find the solutions. Large chemical partners also support a shift in this industry to safer alternatives. Familiar names from our strategic and innovation partner list are Dupont, Cargill, Lanxess, Mitsubishi 

Chemical, Mistui. 

I would also like to point out that retail regulation and consumer 

drive is a bigger concern to us than any of the other things mentioned. 

In conclusion, the environmental concerns, the 21st century concerns are quantifiable. Something like the RoC really takes a backseat in terms of small business to competitive answers that are 

readily available. 

Thank you for your time. 

[The prepared statement of Ms. LaTourelle follows:] 
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Chairman BROUN. Thank you, Ms. LaTourelle. 

Mr. Barker, you are recognized for five minutes. 

STATEMENT OF MR. JOHN E. BARKER, 

CORPORATE MANAGER, ENVIRONMENTAL AFFAIRS, 

SAFETY AND LOSS PREVENTION, STRONGWELL 

CORPORATION 

Mr. BARKER. Thank you, Chairman Broun, Chairwoman Ellmers, 

Ranking Member Tonko, and Ranking Member Richmond, for the 

opportunity to testify before you today. My name is John Barker. 

I am Corporate Manager of Environmental Affairs at Strongwell 

Corporation. And I would also like to introduce my colleague, David 

Ring, who is with us from Strongwell. 

Strongwell employs 465 people with facilities in Bristol, Virginia; 

Abingdon, Virginia; and Chatfield, Minnesota. Our primary raw 

materials are styrene, resins, and reinforcements, which we use to 

make many products, including ballistic panels, having shipped 

over 150,000 to protect American troops and soldiers in Iraq and 

Afghanistan. We also manufacture bridge beams, platforms being 

used increasingly to reduce the lifecycle cost and improve sustainability of infrastructure. 

Like any chemical such as styrene, it is critical to follow the safety guidelines. At Strongwell, we pride ourselves in our proactive 

safety programs. Each facility has a Plant Safety Committee and 

an excellent safety record. Our employees are trained periodically 

on each chemical that we use, with all employees being retrained 

at least annually. We ensure that all employees have both the protective equipment and knowledge they need to safely use the 

chemicals that are a part of our production. 

By nearly every count, when following the proper safety guidelines, styrene is a safe chemical. Many studies from both the private and public sectors alike speak to the absence of a threat of 

cancer when using styrene. And regardless, the National Toxicology 

Program listed styrene as a reasonably anticipated carcinogen in 

the 12th Report on Carcinogens. The listing of styrene in the RoC 

is of significant concern to Strongwell and the composites industry 

in general. For one thing, the idea of ‘‘reasonably anticipated’’ has 

caused great confusion among our employees, their families, and 

members of our communities. 

We have taken a very proactive approach of informing employees 

about the ruling and other studies about styrene toxicity. We have 

gone over this matter in depth with city councils of both Bristol, 

Virginia, and Bristol, Tennessee, and have taken community leaders on tours of our facilities to fully explain our safety practices. 

We have spent millions of dollars on emissions reductions and have 

pushed toward direct injection molding, which lessens the exposure 

of workers to styrene. 

And Dr. Bus has explained the scientific problems behind the 

listing of styrene in the Report on Carcinogens. Let me tell you 

about some of the problems it is causing to business. As a company, 

Strongwell has gone to great lengths for many years to have a 

strong and positive relationship with our community. For example, 
109 

we assist the local fire department in their annual training and we 

provide assistance in maintaining their equipment. Lately, we have 

been receiving anonymous phone calls saying things like, ‘‘you do 

know that styrene causes cancer, don’t you?’’ This tells us that people believe the flawed science used in the assessment of styrene 

and it makes it difficult to maintain an open and fair relationship 

with our community. 

A Google search of styrene toxic tort returns a list of many law 

firms that now claim to specialize in styrene injury suits. Styrene 

was not a business opportunity for these law firms a year ago. Because we self-insure, styrene—or Strongwell has had to place a significant amount of money into reserves to protect ourselves against 

potential liability lawsuits. The money that we must reserve for liability purposes could be used for investment and job creation and 

expansion if it weren’t for this listing. 

As I mentioned previously, Strongwell manufactures many important products and these are just a small example of the thousands of applications of composite products. Styrene is an essential 

chemical component of this manufacturing for which there is no 

reasonable replacement. Resins based on other chemicals do exist 

but they are usually far more expensive and not nearly as well understood in terms of health effects on humans. 

Likewise, we are very concerned about the potential regulatory 

burden that could be placed on our operations should the RoC listing form the basis of regulatory changes. Changes to the regulations already in effect by OSHA and EPA could cause the cost of 

compliance to increase substantially. Further, focusing on a matter 

that should be of no concern will make it harder for employees to 

get full attention to the safety issues that are important. 

Because there is no legitimate substitute for styrene and because 

the cost of liability and compliance could increase astronomically, 

there is a concern that the federal treatment of styrene could draft 

composites jobs offshore. And by the way, this is not just a concern 

for Strongwell but for the entire industry that employs over 

250,000 people. 

Chairman BROUN. Mr. Barker, if you could wrap up very quickly. 

You have overstated your five minutes, so please finish quickly. 

Mr. BARKER. Okay. We do have international competition and we 

support reforms with the RoC process. And finally, I would like to 

say that while I am speaking here today, we have got 50 secondgraders from a local elementary school touring our plant in Bristol, 

Virginia, and if we believed that styrene posed any threat of cancer, we would never allow those children from our community to 

our facility. 

Thank you very much for the opportunity to provide these comments. 

[The prepared statement of Mr. Barker follows:] 
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Chairman BROUN. Thank you, Mr. Barker. 

And now, I will recognize Dr. Belzer for five minutes. 

STATEMENT OF DR. RICHARD B. BELZER, 

PRESIDENT, REGULATORY CHECKBOOK 

Dr. BELZER. Thank you, Chairman Broun. I thank you for the opportunity to testify again today. I am Richard Belzer, President of 

Regulatory Checkbook, a nonpartisan, nonprofit organization whose 

mission includes the promotion of quality improvements in science, 

economics, and information quality. 

In August of 2011, I was asked by the Competitive Enterprise Institute to conduct a short study trying to explain why the RoC had 

become so intensely controversial. Regulatory Checkbook received 

an honorarium of $5,000 for a completed published paper. CEI put 

no substantive constraints on my work. Subsequently, Regulatory 

Checkbook supplied an additional $5,000 of unrestricted resources. 

My research shows that the RoC is not a high-quality scientific 

work product and there are two fundamental reasons why. This 

may be a little harder for you to see than I had anticipated. I 

apologize. When Congress wrote the RoC’s authorizing legislation 

in 1978, it asked for a scientific compendium of substances carcinogenic to humans but did not ask for this in a scientific language. 

This you may or may not be able to quite read. The task was to 

list all substances which are either known to be carcinogens or may 

reasonably be anticipated to be carcinogens. And I will get to the 

second item in a moment. 

But science does not know or reasonably anticipate things. 

Science cannot tell you whether a number is significant. These are 

not scientific words; they are the words of lawyers. Given the opportunity, therefore, the NTP has exchanged its white lab coat of 

science for something of a bureaucratic imperative of maximizing 

the number of substances listed. The NTP has achieved this by 

maximizing its flexibility to use or reject scientific information however it sees fit. Thus, while the NTP’s listing determinations have 

scientific content, they are not scientific determinations. 

The NTP defines a known human carcinogen as follows—and 

this is an actual verbatim description of it. A lot of attention has 

been focused on this—the footnote. I want to focus on something 

different. I want to focus on a comma midway through the first 

sentence. And the comma is important, because in English grammar everything that follows this comma is called a parenthetical 

element. It can be removed from the sentence without changing the 

sentence’s meaning. Therefore, the NTP’s definition for a known 

human carcinogen can be shown much more succinctly as follows, 

which is ‘‘there is sufficient evidence of carcinogenicity from studies 

in humans.’’ Everything else is subordinate to that. 

This definition is tautological and utterly opaque. It is tautological because it must be true. It goes without saying that for 

every substance defined as a known human carcinogen by the NTP, 

the evidence was at least sufficient in the judgment of the NTP. It 

is utterly opaque, however, because no one outside the NTP knows 

what makes evidence sufficient. 
115 

Now, a similar story can be told regarding the definition of ‘‘reasonably expected’’ human carcinogen. A comma is located in the 

same place. Everything that follows that comma can be eliminated 

without altering the meaning of the criterion or the sentence. 

So we have ‘‘sufficient evidence,’’ we have ‘‘limited evidence,’’ we 

have in one case ‘‘less than sufficient evidence.’’ All these terms 

used by the NTP are legal terms. They are not scientific terms. So 

while the Congress seems to have asked for a scientific compendium, what the NTP appears to produce is legislative determinations and it does this in a way that makes it look like they are scientific. Biology words are often used, for example. But the determinations themselves cannot be scientific because the definitions 

are themselves not scientific. 

Now, return with me for just a moment to the—an earlier slide. 

There is a second clause, ii, and it is part of the definition of what 

the statute requires for a substance to be listed and that is that 

the substance has to meet the first test of being known or reasonably anticipated. It also has to be a substance to which a significant number of persons residing in the United States are exposed. 

That is in the law. To the best of my knowledge and reading 

through the listing decisions, the NTP does not do this. It doesn’t 

actually fulfill that second prong of the requirement for a listing. 

There are ways of going about that. The NTP could define a significant number of persons residing in the United States. It could 

then define a de minimis cancer risk, and then it would have to 

go about a scientific task of estimating the number of persons exposed. Now, I don’t believe that the NTP has done any of these 

three steps. The first two are strictly policy related. Science again 

can’t speak to whether a number is significant or it can’t speak to 

what constitutes de minimis cancer risk. But science can be used 

to estimate the number of persons exposed. 

Chairman BROUN. Dr. Belzer, if you could go ahead and wrap up, 

please, sir. 

Mr. BELZER. I am sorry. I apologize. 

What can be done—I provided in my written testimony a number 

of different reforms that Congress could consider that would improve the scientific content of RoC and make it more useful for 

public policy purposes, for small businesses, for big business, for 

consumers, for anyone. The problem with the RoC now is that it 

stands as a document that does not actually have the scientific content that Congress had intended 35 years ago when it wrote the 

law. 

Thank you very much. 

[The prepared statement of Dr. Belzer follows:] 
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Chairman BROUN. Thank you, Dr. Belzer. 

I appreciate you all’s testimony. For you all that are not southern, y’all is plural for all y’all. 

I remind Members that Committee rules limit questioning to five 

minutes. The Chair at this point will open the first round of questions and I recognize myself for five minutes. 

Now, my first question is to Dr. Bus and Dr. Belzer. Written testimony submitted for this hearing indicates that roughly 250,000 

jobs are associated with just one substance. OMB considers the scientific assessment ‘‘highly influential’’ if it could impact the public 

or private sector by more than $500 million in one year or is 

‘‘novel, controversial, or precedent setting or has significant interagency interest.’’ Do you consider the RoC to be a highly influential 

scientific assessment, Dr. Bus? 

Dr. BUS. Yes, indeed. In fact, as I pointed out in my testimony, 

the outputs from the report on carcinogens are directly translated 

in some regulatory environment such as California and other locations around the globe in terms of moving forward with regulatory 

action. So although they are not regulatory actions themselves, 

they serve as the foundation for it. 

Chairman BROUN. And bring about regulations? Okay. Dr. 

Belzer. 

Dr. BELZER. It is—I have not looked at the economic consequences of the RoC in any way. I have looked at the amount of 

intense energy devoted to attempting to get good quality science 

out of the RoC. Based on that, I would draw the inference it is 

highly influential. 

Chairman BROUN. Very good. Dr. Bus, you argue that the NTP 

does not apply a weight of the evidence review of substances, yet 

I understand that the Assistant Director of NTP at the December 

15, 2011, meeting of the Board of Scientific Council has made it 

clear that NTP has always considered the full body of evidence for 

every chemical and that all the studies are listed in the background document. Are you really saying that you just disagree with 

how they weighed those studies? 

Dr. BUS. Absolutely not. In fact, the testimony as presented by 

Dr. Bucher indicated that, yes, they do perhaps consider all the evidence but really what is more important is the process by which 

the evidence is evaluated. So, for instance, in the recent NAS review of the formaldehyde document, that is where the National 

Academy of Sciences really outlined a roadmap for how scientific 

data should be evaluated with respect to assessments of the toxicology of chemicals. And they really emphasize that they should 

take a weight-of-evidence approach, which is not just a recitation 

of the numbers of studies that are out there but really a broadbased critical analysis of how you identify the studies, how those 

studies are used, how they are to be interpreted, and where they 

are to be employed. So there is a dramatic difference between a 

weight-of-the-evidence approach versus just simply listing the numbers of studies that are out there. 

Chairman BROUN. Very good. Hopefully, we will have that contract put in place and the Academy can go forward. 

Dr. Belzer, in your testimony you state that the risks’ descriptors 

‘‘known’’ and ‘‘reasonably anticipated’’ are confusing. Can you tell 
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us why this legal language which appears in the statute is confusing and is not appropriate for use in describing the cancer risk 

that a substance may possess or pose? 

Dr. BELZER. Well, as I noted in my oral testimony, the term 

‘‘known’’ or the phrase ‘‘reasonably anticipated,’’ these are just not 

terms that scientists use. Scientists deal with theories and with 

hypotheses and they test them. But to say that something is known 

in science is very difficult. I am not sure what level of confidence 

Congress intended in 1978 for this idea of ‘‘known human carcinogen.’’ One possible interpretation that Congress intended would 

be like ‘‘‘beyond a reasonable doubt,’’ something like that. And it 

would be useful to know if that is the standard the NTP is using. 

The NTP doesn’t—has not, to the best of my knowledge, disclosed 

how it interprets this language. What is the likelihood that a chemical is a human carcinogen? What is enough to be ‘‘reasonably anticipated?’’ Scientists can’t answer that question but the NTP is 

making policy decisions. Presumably, they should be able to answer 

that question. 

Chairman BROUN. Thank you, Dr. Belzer. 

Dr. Bus and Dr. Belzer, do you believe that the RoC truly reflects 

the intent of the law that created it? Dr. Bus. 

Dr. BUS. I believe with the status of ‘‘reasonably anticipated’’ and 

‘‘known,’’ the intent clearly is to identify chemicals that the public 

should in fact take direct attention to. And if—with that degree of 

significance associated with those classifications, I believe the public is best served if, in fact, it has confidence that the scientific 

evaluations that underpin those classifications are based upon the 

highest quality scientific evaluation that can be done. And those 

principles have been outlined, as I have mentioned before, are really centered on evidence-based approaches to evaluation of the data, 

which really promotes a structured, organized way of looking at the 

data that gives you a consistent evaluation of the data from the 

chemical and that builds assurance with the public that, in fact, 

the evaluations that are put forward by the Report on Carcinogens 

in fact can be trustworthy and used for science-informed decision 

making. 

Chairman BROUN. Thank you, Dr. Bus. I am not sure that that 

truly answered whether it follows the intent of the law. And Dr. 

Belzer, my time is expired, so if you would just include that in your 

written answers. 

So now, I recognize Mr. Tonko, my friend, for five minutes. 

Mr. TONKO. Thank you, Mr. Chair. 

Ms. LaTourelle and all of our witnesses, thank you for joining us 

today. But to Ms. LaTourelle, recently I toured a company started 

by a couple of graduates of Rensselaer Polytechnic Institute in my 

district, and they invented a process with the help of the campus 

incubator to use mushrooms and agricultural byproduct to grow 

packing material to replace polystyrene. They are enjoying real 

success and finding interested partners in old line businesses that 

welcome these products to reduce their own carbon footprint and 

meet customer preferences. It seems to me that consumers are 

ahead of some companies about what they want in products. As important as the Report on Carcinogens may be to some, it is irrelevant to the preexisting surge in demand to move away from petro-
129 

chemical-based products. Could you elaborate a little on consumer 

demand as a driver for the change in these given areas? 

Ms. LATOURELLE. Certainly. Consumer demand basically picks 

up where government regulations leave off or where government 

regulation is absent. The move toward greener—however you categorize that, essentially products that have more environmental 

benefit, use less energy, are nontoxic, and use renewable resources—are so in demand that companies like DuPont, for example, in 2010 surveyed 800 of their customers globally and DuPont’s 

customer base is—it spans food and agriculture, transportation, 

chemicals, manufacturing, plastics—they understand that there is 

a long-term demand for these products and alternatives because of 

the larger drivers on the business and they look to their customers 

to be sure that there is going to be a ready market. 

Eight-nine percent of the 800 customers surveyed said that delivering products with environmental benefits is a long-term market 

opportunity, and those are the customers that sell products directly 

to consumers. Ninety-five percent of those surveyed reported customer demand is a key driver for developing products. 

I would also like to point out that there is such an incredible 

shift in the marketplace to these types of alternatives that companies like SC Johnson have created their own metrics through which 

they screen chemicals to use in their products. Theirs is called a 

Green Screen. Staples has been actively dialoguing with their suppliers. They have goals regarding how much renewable products 

they sell and they are working with their suppliers to find ways in 

which products can be less toxic and less harmful to the environment. Wal-Mart is a great example. They have reduced their packaging and found that essentially what it did is it made their shipments almost double in size because the reduction in packaging allowed them to ship more, and this has saved them millions of dollars in transportation costs. 

Mr. TONKO. Thank you. Now, you heard the testimony of the Office of Advocacy from SBA, and it struck me that they are very aggressive intervention into this case based on lobbying from the styrene industry amounts to a government office picking winners and 

losers in the market. Based on what you have learned, does it appear that they are working in the interest of green chemistry 

firms? 

Ms. LATOURELLE. No. Clearly, green chemistry is—let me put it 

this way. The ship has sailed. Green chemistry is here. The alternatives are here. For governments to be determining what is going 

to happen in the green chemistry industry, it is too late. We certainly advocate for more incentives to get to commercial scale so 

that our respected colleagues on this panel can supply customers 

with these products. We are seeing more job creation coming out 

of green chemistry. For government to be inserting itself and disputing the process of a document like the RoC to me is disruptive 

to the larger issues of the availability of toxicology in general. Consumers get their information from many different sources, this 

being just one of them. Yes, it is influential. It influences the customer base, but we are already well beyond concerns of a document 

like this. 

Mr. TONKO. Thank you so much. I yield back, Mr. Chair. 
130 

Chairman BROUN. Thank you, Mr. Tonko. 

Now, I recognize Chairman Ellmers for five minutes. 

Chairwoman ELLMERS. Thank you, Mr. Chairman. 

My first question is for Ms. Webster. If your company had to replace styrene with another substance, would you still be able to sell 

your products at a competitive price and how would that impact 

your bottom line? 

Ms. WEBSTER. No, I would not be able to be competitive. It would 

make it easier—— 

Chairman BROUN. Microphone, please, ma’am. 

Ms. WEBSTER. It would make it definitely easier for imported 

products to come into the United States. I do have a bio-based 

resin that I do use. That has actually gotten us more business. People do like the aspects of us going green, but no, the cost of the 

other resins that do not have styrene are very cost-prohibitive. And 

we have looked at vinyl esters and epoxies and things like that. It 

is just not cost-effective. It will increase imports. 

Chairwoman ELLMERS. It will increase imports and then, obviously, if you were to—and this is just me throwing this out there— 

if you were to use another product, obviously that cost would be 

passed on to the consumer. 

Ms. WEBSTER. Absolutely. 

Chairwoman ELLMERS. My other question for you is you had 

mentioned in your testimony that you, you know, obviously as a 

small business you don’t have the resources for a Regulatory Compliance Officer, is that correct? 

Ms. WEBSTER. Yes. 

Chairwoman ELLMERS. Okay. So who in your company is the person that is responsible to be complying with the federal regulatory 

process? 

Ms. WEBSTER. We hire a company to come in, they do a 

walkthrough, they do training, they do training on the forklifts and 

things like that. Once a year, they come in and go through the 

plant, they let us know if there is any issues, they pat us on the 

back, and knock on wood, we haven’t had any problems. So we hire 

somebody to come in to do that. 

Chairwoman ELLMERS. My next question—thank you, Ms. Webster. I do want to add one last thing and you may not feel comfortable answering this and if you don’t, that is fine. Is that a very 

costly endeavor, having someone have to actually come in and help 

you in that process? 

Ms. WEBSTER. It runs—it is going up every year—— 

Chairwoman ELLMERS. Um-hum. 

Ms. WEBSTER [continuing]. But it runs—it is just under $1,000 

but I think it is based on how many employees you have. 

Chairwoman ELLMERS. I see. Thank you. Thank you for that, Ms. 

Webster. 

For Mr. Barker, I have a couple questions for you. Do you feel 

that the Report on Carcinogens is helping or hindering you in creating a safer workplace? 

Mr. BARKER. At this time I would have to say that it is a hindrance, although I think at this point not as great as it is likely 

to be. And from that hindrance it distracts our employees from the 

real concerns that they should be dealing with on a day-to-day 
131 

basis, wearing the proper protective equipment, being concerned 

about the physical hazards they work with, and they are distracted 

because of the concern about getting cancer from styrene that the 

NTP has said is reasonably anticipated to be a carcinogen. So they 

are concerned about that. And we are concerned that the further 

we go with this as awareness grows, the more distracted they will 

become. 

Chairwoman ELLMERS. And my last question for you is, now, it 

is our understanding that Strongwell participated in a public comment process of the 12th RoC. Is that correct? 

Mr. BARKER. That is correct. 

Chairwoman ELLMERS. Can you tell us whether or not your comments were responded to by the NTP? 

Mr. BARKER. Our comments as far as I know were not responded 

to. 

Chairwoman ELLMERS. Okay. And I would like to just, for the 

record, point out—and there again, in the previous panel, Dr. 

Birnbaum had stated to the best of her knowledge that all comments had been responded to. But I do have an additional question—thank you, Mr. Barker—for Dr. Belzer. In your testimony, 

you noted that the NTP completely ignores exposure or dose in 

making its determinations. And why is it important for exposure 

or dose to be considered when providing information to the public 

about substances that have the potential to cause cancer? I am 

sorry. Dr. Belzer. 

Dr. BELZER. Sorry, it wasn’t clear who you were addressing. 

Chairwoman ELLMERS. I am sorry, no. I apologize. 

Dr. BELZER. The public has an obvious need for information on 

chemicals or substances that could cause cancer but the dose at 

which those substances might cause cancer is very important. If it 

is something that happens at extraordinarily high doses and it happens in animals under laboratory conditions, that is an important 

fact but that is very different than happening at environmental exposure levels. This is the type of thing that people ought to have 

access to. I think that improving the targeting of the information 

so that—well, in 1978 I think there was a general notion that either a substance caused cancer or it didn’t and that seemed to be 

the prevailing state of knowledge at the time. But that is not correct. Things are more far more complicated than that. And the 

NTP is quite capable of being more discriminating and to provide 

information that is more dose-relevant so that people have that information as well as the current worst-case scenario. 

Chairwoman ELLMERS. Great. Thank you so much. Thank you 

for all of your comments and your testimony. Thank you. 

I yield back. 

Chairman BROUN. Thank you, Mrs. Ellmers. 

I now recognize Mr. Richmond for five minutes. 

Mr. RICHMOND. Thank you, Mr. Chairman. It appears to me now 

that this is a styrene hearing. And with that, let me just start 

with—I have heard a lot of testimony about—that there is no legitimate substitute, the benefits of it, and I guess my question—I will 

start with you, Ms. Webster. Let us assume that NTP is right and 

styrene is a carcinogen. Now what? 
132 

Ms. WEBSTER. My company will most likely liquidate, and I will 

have to find another job. 

Mr. RICHMOND. So if it is in fact—if it in fact causes cancer, 

would—with substantial exposure, then it pretty much kills your 

business? 

Ms. WEBSTER. The risk of liability that we would be faced with, 

I wouldn’t be able to sleep at night. I go to work every day feeling 

good about what I do and if this comes out as listed as an anticipated carcinogen, I am not going to feel good about what I do. 

Mr. RICHMOND. And I guess my question is what if they are 

right? What if it does cause cancer? 

Ms. WEBSTER. I guess I would like to see the scientific data. The 

research papers that I have seen and read is not showing that. 

Mr. RICHMOND. And Mr. Barker, I guess I would pose the same 

question to you. What if they are right and a high level exposure 

to it could cause cancer? 

Mr. BARKER. Well, first of all, let me say that we are genuinely 

concerned about our employees and about our community, and we 

do not want our employees to get cancer from exposure to styrene. 

But I think this is part of the problem that Dr. Belzer was talking 

about. So they are right. To what degree? What is the risk? And 

that to me is the whole crux of the problem. Here the NTP has said 

that styrene is reasonably anticipated to be a carcinogen. 

Mr. RICHMOND. Um-hum. 

Mr. BARKER. So how much exposure do you have to have to get 

cancer? Is it 50 parts per million for 10 years, 20 years? Is it 500 

parts per million for eight hours? None of that has been discussed. 

And so that is—our problem right now is our employees, all they 

hear is this stuff causes cancer and there is a great deal of uncertainty. And we feel like there is just not a need for that uncertainty 

at this point. Now, if they were to come back and say, you know, 

something quantitative like, you know, there is pretty high risk 

you are going to get cancer if you work in this environment at 50 

parts per million for 10 years, then, you know, we wouldn’t—that 

would be unacceptable. Then we would start looking at engineering 

alternatives and possibly, you know, other materials. 

Mr. RICHMOND. And I guess my major concern and it is before 

my day and—but it reminds me, at least as I did a little research 

on it of the argument over asbestos or lead in paint and gas—— 

Mr. BARKER. Sure. 

Mr. RICHMOND [continuing]. And all of those things and effects 

on it, and now we are down the road and we still have asbestos 

in a number of things because we just didn’t stop or recognize it 

early enough. But I ask and defer to Dr. Grimsley, I know that 

with BP and the chemicals we use to treat the oil spill, the 

dispersants, they are doing some sort of a study to see—and they 

are using exposure. So how can exposure be included and do you 

think that is a necessary first step in just saying it is likely to or 

could lead to cancer? 

Dr. GRIMSLEY. Yes. I am serving on the Scientific Advisory Board 

for the NIEHS in the Gulf Worker study and they are looking at 

different types of exposures, some of the dispersants and some of 

the hydrocarbons that were related to that. The exposure component is a very important piece that the NIEHS is actually looking 
133 

at. It is always one of the first steps that you want to do in exposure assessments is to actually have good data and to have good 

estimates about the exposures. And so they are going through and 

doing that important step in order to identify if you are going to 

actually have some type of health outcome that is related to any 

particular type of exposure—if it is a low exposure, if it is a medium exposure, if it is a high exposure. 

Mr. RICHMOND. And can that be done with styrene? Or where are 

we in the process of that? 

Dr. GRIMSLEY. Well, I think, Ms. LaTourelle, she has already alluded to the point that some of the other agencies have already 

listed styrene as a carcinogenic agent. I used to work as an industrial hygienist at Texaco. I used to work as an industrial hygienist 

at International Paper and at bigger companies and smaller companies, we try to encourage what we call the ALARA, As Low As Reasonably Achievable. If you have exposure limits, you avoid exceeding the exposure limits, but most definitely try to keep the exposures down as low as possible, then, that is one of the things we 

strive for. 

Chairman BROUN. The gentleman’s time has expired. 

Mr. RICHMOND. Mr. Chairman, I see that my time has expired 

and, Mr. Chairman, if you will allow me, I just wanted to recognize 

that Dow is in my district and they are doing a wonderful job and 

they are expanding. And I went and watched their first responders 

and their safety mechanisms so I am not implying that anybody is 

not concerned about the health of their employees, but the question 

becomes what if NTP is right and other people are wrong? And I 

yield back. 

Chairman BROUN. Thank you, Mr. Richmond. 

As much as my colleagues on the Democrat side would like to 

make this a hearing about styrene, holding a hearing on the RoC 

process, which is what this hearing is all about without discussing 

substances recently listed would be totally irresponsible and we 

need to fully evaluate the process. And that is what this is all 

about and specific substances just serve as case studies. They are 

not—this is not about styrene as much as my colleagues on the 

Democratic side would like to make it be. This is about the process. 

The title of this hearing is ‘‘How the Report on Carcinogens Uses 

Science to Meet its Statutory Obligations, and its Impact on Small 

Business Jobs.’’ So that is the reason that folks are here. 

So now I recognize Mr. Miller for five minutes. 

Mr. MILLER. I thank the Chairman for that clarification, but the 

styrene industry’s lobbyists do take credit for having scheduled this 

hearing. 

Mr. Barker and Ms. Webster, you have both said in your testimony that insurance costs might go up, policies might be canceled 

for firms that use styrene-based products or use styrene in their 

processes. Is that something you are supposing might happen or do 

you actually know of any instances where companies have in fact 

lost coverage or been charged more in premiums because of— 

they—because they used styrene either in their products or in their 

processes so we could check with those companies and the insurance companies directly for more information about that? 
134 

Ms. WEBSTER. I was on a conference call about six weeks ago. 

There was a woman—John Schweitzer might be able to get me her 

name—I think her name was Laurie who was—she was dropped by 

her insurance carrier and the next carrier that picked her up, the 

costs were quadruple. 

Mr. MILLER. Okay. Can you get—I mean, Laurie is not enough 

to go on. 

Ms. WEBSTER. Yeah, I know. The call was about six weeks ago. 

Mr. MILLER. Mr. Barker, do you have—do you know personally 

of any companies that have in fact been dropped or had their premiums raised? 

Mr. BARKER. I am aware of the same company I think that Ms. 

Webster is talking about. 

Mr. MILLER. Okay. Can you get us Laurie’s last name and—— 

Mr. BARKER. Yes. 

Mr. MILLER [continuing]. Contact information—— 

Mr. BARKER. Sure. 

Mr. MILLER [continuing]. As well? And I would hope that we 

could get from her the names of the companies—— 

Mr. BARKER. Sure. 

Mr. MILLER [continuing]. Or rather the names of the insurance 

companies. 

Mr. Barker, in your testimony you said that you had done a 

Google search for styrene toxic tort and there were 12 firms that 

had been—that were advertising to handle styrene toxic torts since 

the 12th RoC came out. Our staff did the same research and found 

that actually only one of those mentioned the RoC in—on their 

Website, and I actually called some of those firms and it appeared 

that all but one—or maybe all of them had actually been doing styrene toxic torts well before the RoC. There were plenty of people 

in the scientific community including toxicologists who—public 

health experts who believe that styrene was a carcinogen before it 

was recognized—before the RoC. Are you aware that actually there 

were lawyers who were handling styrene toxic torts before the RoC, 

and in fact the RoC does not appear to have changed that? 

Mr. BARKER. Yes. 

Mr. MILLER. Okay. You were aware that that has been going on 

right along? 

Mr. BARKER. Yes. 

Mr. MILLER. Okay. Not new, not because of RoC, right along? 

Mr. BARKER. Right. 

Mr. MILLER. Okay. And finally, Mr. Barker, I know that there 

was a miscommunication between our staff—our Democratic staff 

and you yesterday. They sent a request for information in two 

emails to the address that had—to which your invitation to appear 

had been sent and did not get a response. Will you provide the information that they asked for for the record? And could you also 

just kind of tell us what happened now for the record? 

Mr. BARKER. Well, I was on my way here—— 

Mr. MILLER. Okay. 

Mr. BARKER [continuing}. And didn’t have access to email. 

Mr. MILLER. All right. But you will provide us that information? 

Mr. BARKER. Yes. 
135 

Mr. MILLER. All right. Well, Mr. Chairman, I think you said 

glory be before when I yielded back 12 seconds. I will yield back 

a minute and 20 now. 

Chairman BROUN. Hallelujah. As Mr. Miller knows, I have always tried to be very liberal with you, as well as other Members 

of our Committee and have enjoyed serving—— 

Mr. MILLER. A tendency that does not show up in many other 

areas. 

Chairman BROUN. Well, I try to be very lenient with everybody. 

But I also want to remind Mr. Miller that this Committee is not 

responsible for what outside entities state. This is still about process. This is not trying to exonerate or vilify any particular entity 

or industry and this is about the process. That is what I would 

hope to be as a scientist, as a physician, I am very concerned for 

my patients and for all Americans about potential exposure to anything that may cause people harm. And so I share my Democratic 

colleagues’ concern about the health of all Americans and this is 

not to try to hold up any industry in either regard as to exonerate 

them. It is about process and it is not to try to vilify anybody. So 

thank you, Mr. Miller. I appreciate it. 

Now, I recognize my friend, Mr. McNerney, for five minutes. 

Mr. MCNERNEY. Thank you. And I do thank the witnesses for 

coming forth today. It is not easy. 

Ms. LaTourelle, you have significant experience with green chemistry businesses, and jobs are, of course, a big deal to us here in 

Congress. Would you address job creation and the green chemistry 

production as opposed to the traditional petrochemical production 

businesses? 

Ms. LATOURELLE. I would be happy to. And I would like to recommend the source from which the statistics that I am about to 

share are derived, that is the economic benefits of a green chemical 

industry in the United States, renewing manufacturing jobs while 

protecting health and the environment. I think that is something 

we can all get behind. This is a report by the BlueGreen Alliance, 

which is an organization that has environmental concerns and also 

labor concerns. 

It states that using similar input-output analysis, they estimate 

that spending a million dollars on traditional plastics production 

would generate 4.3 jobs while spending a million dollars on bioplastics would generate an estimated 6.9 jobs. It is a pretty significant 

impact. The American Sustainable Business Council represents 

120,000 sustainable businesses. They represent 200,000 sustainable business leaders and they are also a ready source for job creation. They have access to many green businesses, if you would like 

to know more. 

Mr. MCNERNEY. Thank you. Nice answer. 

I understand from your testimony—think I understand from your 

testimony—I am going to ask for your verification that 21st century businesses—for 21st century businesses, the RoC should have 

a little impact. Was that what you intended, and is it because of 

energy efficiency, public perceptions and so on? What are the sort 

of reasons for that, if I am correct? 

Ms. LATOURELLE. Well, first, 21st century businesses have much 

larger concerns than a report like the RoC. I mean as I said be-
136 

fore—sorry to mention styrene again—has been identified since 

1987. These are concerns that businesses should have already vetted. They are not assessing the risk appropriately. I am not saying 

that the RoC has no place for us. It is clearly an important document. However, its impact on small business is questionable because, in any event, these types of documents should be drivers of 

innovation to find solutions—— 

Mr. MCNERNEY. That is great. That leads to my next question. 

I only have a limited amount of time. 

Ms. LATOURELLE. Sorry. 

Mr. MCNERNEY. You say that regulations spur innovation, and I 

have heard that from other witnesses in other hearings, and I just 

want to direct the next question to Mr. Barker. Would you say that 

the 12th RoC, which may lead to regulations, has led to innovation 

at Strongwell? 

Mr. BARKER. Not the RoC at this point, but I would agree to 

some extent that some regulation can lead to innovation, yes. 

Mr. MCNERNEY. Thank you. 

Dr. Grimsley, would you address the controversy between 

strength of evidence and weight of evidence? 

Dr. GRIMSLEY. I am not quite sure what some of the procedures 

that are associated with the evidence, the weight of evidence and 

the strength of evidence, especially how some of the agencies go 

about looking at those, if they have a systematic process. I know 

they have a systematic process. The American Conference of Governmental Industrial Hygienists, the EPA, the NTP, when they go 

through and they actually look at the data that is available, I do 

know they have some type of system but I can’t speak to exactly 

what—is it high, medium, low and to what extent those strengths 

of evidence are. 

Mr. MCNERNEY. All right. Dr. Bus, let me just ask you a simple 

question. Was your objective today to throw down on the validity 

of the 12th RoC and 13th RoC? Is that your basic objective here 

today? 

Dr. BUS. My objective is to make sure that we have the highest 

quality science evaluation supporting these very important decisions such as classifications of carcinogens. And I strongly believe 

as a result of our experiences with styrene and other chemicals 

that what we have witnessed—that there is a significant need for 

refinement of the RoC process. And if those processes are considered and, we believe, as I proposed, a review by the National Academy of Sciences to conduct a review of those processes, in the end 

we will result—we have a process that will deliver classification decisions that we can have far greater confidence in not only as an 

industry but also as the public, which is the ultimate recipient of 

that information. 

So I am a strong believer that, yes, in fact the examples of some 

of the chemicals that have gone through the RoC reveal significant 

flaws in the process that can be solved. And certainly with the advice of the NAS or other advisory bodies, we could end up with a 

process which delivers science that truly is useful for informing decision making. 

Chairman BROUN. The gentleman’s—— 

Mr. MCNERNEY. So in other words this—— 
137 

Chairman BROUN [continuing]. Time is expired and so we will go 

forward. 

And I thank you all for—all you all for you all’s testimony here 

today. Members of either Committee may have additional questions 

for you all, and we ask for you to please respond very expeditiously 

in writing. The record will remain open for two weeks for additional comments from Members. You all are excused. I appreciate 

you all’s participation. 

The hearing is now adjourned. 

[Whereupon, at 12:25 p.m., the Subcommittees were adjourned.] 
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ANSWERS TO POST-HEARING QUESTIONS
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ANSWERS TO POST-HEARING QUESTIONS

Responses from Dr. Linda S. Birnbaum were not submitted. 
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Appendix 2 

ADDITIONAL MATERIAL FOR THE RECORD
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LETTERS SUBMITTED BY SUBCOMMITTEE CHAIRMAN PAUL BROUN, HOUSE COMMITTEE

ON SCIENCE, SPACE AND TECHNOLOGY
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LETTERS SUBMITTED BY SUBCOMMITTEE CHAIRMAN RENEE ELLMERS, HOUSE

COMMITTEE ON SMALL BUSINESS
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Æ