[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]



 
                     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




                  U.S. GOVERNMENT PRINTING OFFICE
74-059                    WASHINGTON : 2012
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing 
Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; DC 
area (202) 512-1800 Fax: (202) 512-2104  Mail: Stop IDCC, Washington, DC 
20402-0001




              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

                    HON. RALPH M. HALL, Texas, Chair
F. JAMES SENSENBRENNER, JR.,         EDDIE BERNICE JOHNSON, Texas
    Wisconsin                        JERRY F. COSTELLO, Illinois
LAMAR S. SMITH, Texas                LYNN C. WOOLSEY, California
DANA ROHRABACHER, California         ZOE LOFGREN, California
ROSCOE G. BARTLETT, Maryland         BRAD MILLER, North Carolina
FRANK D. LUCAS, Oklahoma             DANIEL LIPINSKI, Illinois
JUDY BIGGERT, Illinois               DONNA F. EDWARDS, Maryland
W. TODD AKIN, Missouri               BEN R. LUJAN, New Mexico
RANDY NEUGEBAUER, Texas              PAUL D. TONKO, New York
MICHAEL T. McCAUL, Texas             JERRY McNERNEY, California
PAUL C. BROUN, Georgia               TERRI A. SEWELL, Alabama
SANDY ADAMS, Florida                 FREDERICA S. WILSON, Florida
BENJAMIN QUAYLE, Arizona             HANSEN CLARKE, Michigan
CHARLES J. ``CHUCK'' FLEISCHMANN,    SUZANNE BONAMICI, Oregon
    Tennessee                        VACANCY
E. SCOTT RIGELL, Virginia            VACANCY
STEVEN M. PALAZZO, Mississippi       VACANCY
MO BROOKS, Alabama
ANDY HARRIS, Maryland
RANDY HULTGREN, Illinois
CHIP CRAVAACK, Minnesota
LARRY BUCSHON, Indiana
DAN BENISHEK, Michigan
VACANCY
                                 ------                                

              Subcommittee on Investigations and Oversight

                   HON. PAUL C. BROUN, Georgia, Chair
F. JAMES SENSENBRENNER, JR.,         PAUL TONKO, New York
    Wisconsin                        ZOE LOFGREN, California
SANDY ADAMS, Florida                 BRAD MILLER, North Carolina
RANDY HULTGREN, Illinois                 
LARRY BUCSHON, Indiana               EDDIE BERNICE JOHNSON, Texas
DAN BENISHEK, Michigan
VACANCY
RALPH M. HALL, Texas
                      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
                            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

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


                     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.

[GRAPHIC] [TIFF OMITTED] 74059.001

[GRAPHIC] [TIFF OMITTED] 74059.002

[GRAPHIC] [TIFF OMITTED] 74059.003

[GRAPHIC] [TIFF OMITTED] 74059.004

[GRAPHIC] [TIFF OMITTED] 74059.005

[GRAPHIC] [TIFF OMITTED] 74059.006

[GRAPHIC] [TIFF OMITTED] 74059.007

[GRAPHIC] [TIFF OMITTED] 74059.008

[GRAPHIC] [TIFF OMITTED] 74059.009

[GRAPHIC] [TIFF OMITTED] 74059.010

[GRAPHIC] [TIFF OMITTED] 74059.011

[GRAPHIC] [TIFF OMITTED] 74059.012

[GRAPHIC] [TIFF OMITTED] 74059.013

[GRAPHIC] [TIFF OMITTED] 74059.014

[GRAPHIC] [TIFF OMITTED] 74059.015

[GRAPHIC] [TIFF OMITTED] 74059.016

[GRAPHIC] [TIFF OMITTED] 74059.017

[GRAPHIC] [TIFF OMITTED] 74059.018

[GRAPHIC] [TIFF OMITTED] 74059.019

[GRAPHIC] [TIFF OMITTED] 74059.020

[GRAPHIC] [TIFF OMITTED] 74059.021

[GRAPHIC] [TIFF OMITTED] 74059.022

[GRAPHIC] [TIFF OMITTED] 74059.023

[GRAPHIC] [TIFF OMITTED] 74059.024

    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.
    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:]
    [GRAPHIC] [TIFF OMITTED] 74059.025
    
    [GRAPHIC] [TIFF OMITTED] 74059.026
    
    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 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:]
    [GRAPHIC] [TIFF OMITTED] 74059.027
    
    [GRAPHIC] [TIFF OMITTED] 74059.028
    
    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 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:]
    [GRAPHIC] [TIFF OMITTED] 74059.029
    
    [GRAPHIC] [TIFF OMITTED] 74059.030
    
    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.
    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 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 substances, 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.
    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:]
    [GRAPHIC] [TIFF OMITTED] 74059.031
    
    [GRAPHIC] [TIFF OMITTED] 74059.032
    
    [GRAPHIC] [TIFF OMITTED] 74059.033
    
    [GRAPHIC] [TIFF OMITTED] 74059.034
    
    [GRAPHIC] [TIFF OMITTED] 74059.035
    
    [GRAPHIC] [TIFF OMITTED] 74059.036
    
    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.
    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:]
    [GRAPHIC] [TIFF OMITTED] 74059.037
    
    [GRAPHIC] [TIFF OMITTED] 74059.038
    
    [GRAPHIC] [TIFF OMITTED] 74059.039
    
    [GRAPHIC] [TIFF OMITTED] 74059.040
    
    [GRAPHIC] [TIFF OMITTED] 74059.041
    
    [GRAPHIC] [TIFF OMITTED] 74059.042
    
    [GRAPHIC] [TIFF OMITTED] 74059.043
    
    [GRAPHIC] [TIFF OMITTED] 74059.044
    
    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.
    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.
    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 evaluation 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 
comments, 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 reviewers, 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.
    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 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 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 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.
    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.

                 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.
    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:]
    [GRAPHIC] [TIFF OMITTED] 74059.045
    
    [GRAPHIC] [TIFF OMITTED] 74059.046
    
    [GRAPHIC] [TIFF OMITTED] 74059.047
    
    [GRAPHIC] [TIFF OMITTED] 74059.048
    
    [GRAPHIC] [TIFF OMITTED] 74059.049
    
    [GRAPHIC] [TIFF OMITTED] 74059.050
    
    [GRAPHIC] [TIFF OMITTED] 74059.051
    
    [GRAPHIC] [TIFF OMITTED] 74059.052
    
    [GRAPHIC] [TIFF OMITTED] 74059.053
    
    [GRAPHIC] [TIFF OMITTED] 74059.054
    
    [GRAPHIC] [TIFF OMITTED] 74059.055
    
    [GRAPHIC] [TIFF OMITTED] 74059.056
    
    [GRAPHIC] [TIFF OMITTED] 74059.057
    
    [GRAPHIC] [TIFF OMITTED] 74059.058
    
    [GRAPHIC] [TIFF OMITTED] 74059.059
    
    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.
    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:]
    [GRAPHIC] [TIFF OMITTED] 74059.060
    
    [GRAPHIC] [TIFF OMITTED] 74059.061
    
    [GRAPHIC] [TIFF OMITTED] 74059.062
    
    [GRAPHIC] [TIFF OMITTED] 74059.063
    
    [GRAPHIC] [TIFF OMITTED] 74059.064
    
    [GRAPHIC] [TIFF OMITTED] 74059.065
    
    [GRAPHIC] [TIFF OMITTED] 74059.066
    
    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 industry, 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 
high-production 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:]
    [GRAPHIC] [TIFF OMITTED] 74059.067
    
    [GRAPHIC] [TIFF OMITTED] 74059.068
    
    [GRAPHIC] [TIFF OMITTED] 74059.069
    
    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 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:]
    [GRAPHIC] [TIFF OMITTED] 74059.070
    
    [GRAPHIC] [TIFF OMITTED] 74059.071
    
    [GRAPHIC] [TIFF OMITTED] 74059.072
    
    [GRAPHIC] [TIFF OMITTED] 74059.073
    
    [GRAPHIC] [TIFF OMITTED] 74059.074
    
    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, 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 
second-graders 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:]
    [GRAPHIC] [TIFF OMITTED] 74059.075
    
    [GRAPHIC] [TIFF OMITTED] 74059.076
    
    [GRAPHIC] [TIFF OMITTED] 74059.077
    
    [GRAPHIC] [TIFF OMITTED] 74059.078
    
    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.
    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:]
    [GRAPHIC] [TIFF OMITTED] 74059.079
    
    [GRAPHIC] [TIFF OMITTED] 74059.080
    
    [GRAPHIC] [TIFF OMITTED] 74059.081
    
    [GRAPHIC] [TIFF OMITTED] 74059.082
    
    [GRAPHIC] [TIFF OMITTED] 74059.083
    
    [GRAPHIC] [TIFF OMITTED] 74059.084
    
    [GRAPHIC] [TIFF OMITTED] 74059.085
    
    [GRAPHIC] [TIFF OMITTED] 74059.086
    
    [GRAPHIC] [TIFF OMITTED] 74059.087
    
    [GRAPHIC] [TIFF OMITTED] 74059.088
    
    [GRAPHIC] [TIFF OMITTED] 74059.089
    
    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 broad-based 
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 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 petrochemical-
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.
    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 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?
    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 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?
    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.
    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 before--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----
    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.]

                   Answers to Post-Hearing Questions




                   Answers to Post-Hearing Questions
Responses from Dr. Linda S. Birnbaum were not submitted.




















[GRAPHIC] [TIFF OMITTED] 74059.090

[GRAPHIC] [TIFF OMITTED] 74059.091

[GRAPHIC] [TIFF OMITTED] 74059.092

[GRAPHIC] [TIFF OMITTED] 74059.093

[GRAPHIC] [TIFF OMITTED] 74059.094

[GRAPHIC] [TIFF OMITTED] 74059.095

[GRAPHIC] [TIFF OMITTED] 74059.096

[GRAPHIC] [TIFF OMITTED] 74059.097

[GRAPHIC] [TIFF OMITTED] 74059.098

[GRAPHIC] [TIFF OMITTED] 74059.099

[GRAPHIC] [TIFF OMITTED] 74059.100

[GRAPHIC] [TIFF OMITTED] 74059.101

[GRAPHIC] [TIFF OMITTED] 74059.102

[GRAPHIC] [TIFF OMITTED] 74059.103

[GRAPHIC] [TIFF OMITTED] 74059.104

[GRAPHIC] [TIFF OMITTED] 74059.105

[GRAPHIC] [TIFF OMITTED] 74059.106

[GRAPHIC] [TIFF OMITTED] 74059.107

[GRAPHIC] [TIFF OMITTED] 74059.108

[GRAPHIC] [TIFF OMITTED] 74059.109

[GRAPHIC] [TIFF OMITTED] 74059.110

[GRAPHIC] [TIFF OMITTED] 74059.111

[GRAPHIC] [TIFF OMITTED] 74059.112

[GRAPHIC] [TIFF OMITTED] 74059.113

[GRAPHIC] [TIFF OMITTED] 74059.114

[GRAPHIC] [TIFF OMITTED] 74059.115

[GRAPHIC] [TIFF OMITTED] 74059.116

[GRAPHIC] [TIFF OMITTED] 74059.117

[GRAPHIC] [TIFF OMITTED] 74059.118

[GRAPHIC] [TIFF OMITTED] 74059.119

[GRAPHIC] [TIFF OMITTED] 74059.120

[GRAPHIC] [TIFF OMITTED] 74059.121

[GRAPHIC] [TIFF OMITTED] 74059.122

[GRAPHIC] [TIFF OMITTED] 74059.123

[GRAPHIC] [TIFF OMITTED] 74059.124

[GRAPHIC] [TIFF OMITTED] 74059.125

[GRAPHIC] [TIFF OMITTED] 74059.126

[GRAPHIC] [TIFF OMITTED] 74059.127

[GRAPHIC] [TIFF OMITTED] 74059.128

[GRAPHIC] [TIFF OMITTED] 74059.129

[GRAPHIC] [TIFF OMITTED] 74059.130

[GRAPHIC] [TIFF OMITTED] 74059.131

[GRAPHIC] [TIFF OMITTED] 74059.132

[GRAPHIC] [TIFF OMITTED] 74059.133

[GRAPHIC] [TIFF OMITTED] 74059.134

[GRAPHIC] [TIFF OMITTED] 74059.135

[GRAPHIC] [TIFF OMITTED] 74059.136

[GRAPHIC] [TIFF OMITTED] 74059.137

[GRAPHIC] [TIFF OMITTED] 74059.138

[GRAPHIC] [TIFF OMITTED] 74059.139

[GRAPHIC] [TIFF OMITTED] 74059.140

[GRAPHIC] [TIFF OMITTED] 74059.141

[GRAPHIC] [TIFF OMITTED] 74059.142

[GRAPHIC] [TIFF OMITTED] 74059.143

[GRAPHIC] [TIFF OMITTED] 74059.144

[GRAPHIC] [TIFF OMITTED] 74059.145

[GRAPHIC] [TIFF OMITTED] 74059.146

[GRAPHIC] [TIFF OMITTED] 74059.147

[GRAPHIC] [TIFF OMITTED] 74059.148

[GRAPHIC] [TIFF OMITTED] 74059.149

[GRAPHIC] [TIFF OMITTED] 74059.150

[GRAPHIC] [TIFF OMITTED] 74059.151

[GRAPHIC] [TIFF OMITTED] 74059.152

[GRAPHIC] [TIFF OMITTED] 74059.153

[GRAPHIC] [TIFF OMITTED] 74059.154

[GRAPHIC] [TIFF OMITTED] 74059.155

[GRAPHIC] [TIFF OMITTED] 74059.156

[GRAPHIC] [TIFF OMITTED] 74059.157

[GRAPHIC] [TIFF OMITTED] 74059.158

[GRAPHIC] [TIFF OMITTED] 74059.159

[GRAPHIC] [TIFF OMITTED] 74059.160

[GRAPHIC] [TIFF OMITTED] 74059.161

[GRAPHIC] [TIFF OMITTED] 74059.162

[GRAPHIC] [TIFF OMITTED] 74059.163

[GRAPHIC] [TIFF OMITTED] 74059.164

[GRAPHIC] [TIFF OMITTED] 74059.165

[GRAPHIC] [TIFF OMITTED] 74059.166

[GRAPHIC] [TIFF OMITTED] 74059.168

[GRAPHIC] [TIFF OMITTED] 74059.169

































[GRAPHIC] [TIFF OMITTED] 74059.170

[GRAPHIC] [TIFF OMITTED] 74059.171

[GRAPHIC] [TIFF OMITTED] 74059.172

[GRAPHIC] [TIFF OMITTED] 74059.173

[GRAPHIC] [TIFF OMITTED] 74059.174

[GRAPHIC] [TIFF OMITTED] 74059.175

[GRAPHIC] [TIFF OMITTED] 74059.176

[GRAPHIC] [TIFF OMITTED] 74059.177

[GRAPHIC] [TIFF OMITTED] 74059.178

[GRAPHIC] [TIFF OMITTED] 74059.179

[GRAPHIC] [TIFF OMITTED] 74059.180

[GRAPHIC] [TIFF OMITTED] 74059.181

[GRAPHIC] [TIFF OMITTED] 74059.182

[GRAPHIC] [TIFF OMITTED] 74059.183

[GRAPHIC] [TIFF OMITTED] 74059.184

[GRAPHIC] [TIFF OMITTED] 74059.185

[GRAPHIC] [TIFF OMITTED] 74059.186

[GRAPHIC] [TIFF OMITTED] 74059.187

[GRAPHIC] [TIFF OMITTED] 74059.188

[GRAPHIC] [TIFF OMITTED] 74059.189

[GRAPHIC] [TIFF OMITTED] 74059.190

[GRAPHIC] [TIFF OMITTED] 74059.191

                               Appendix 2

                              ----------                              


                   Additional Material for the Record




Letters Submitted by Subcommittee Chairman Paul Broun, House Committee 
                    on Science, Space and Technology


























    Letters Submitted by Subcommittee Chairman Renee Ellmers, House 
                      Committee on Small Business





















                                   
