[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
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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.
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Chairman Broun. Committee on Science, Space, and
Technology, Subcommittee on Investigations and Oversight, and
the Committee on Small Business, Subcommittee on Healthcare and
Technology will come to order. Good morning, everyone. Welcome
to today's joint hearing entitled, ``How the Report on
Carcinogens Uses Science to Meet Its Statutory Obligations and
Its Impact on Small Business Jobs.''
In front of you are packets containing the written
testimony, biographies, and truth in testimony disclosures for
both of today's witness panels. Before we get started, since
this is a two-panel joint hearing involving two House
Committees, Subcommittees, I want to explain how we will
operate procedurally so that all Members understand how the
question-and-answer period will be handled. We will take
testimony from the first panel and then proceed with a
question-and-answer period. During the question-and-answer
period, we will alternate between the two Committees, starting
with the Science Committee majority and then the Science
Committee minority. We will then call on the Small Business
Committee majority, followed by the Small Business minority. If
there is not a Member of one of these Committees present, we
will continue to alternate between the majority and minority
Members and allow all Members an opportunity for questioning
before recognizing a Member for a second round of questions, if
we get to a second round.
We will recognize those Members of either Subcommittee
present at the gavel in order of seniority on their respective
Committee, and those coming in after the gavel will be
recognized in their order of arrival.
After the first panel has been excused, we will take
testimony from the second panel and then undertake a question-
and-answer period in the same fashion as with the first panel.
I now recognize myself for five minutes for an opening
statement.
I would like to extend a strong, warm welcome to my
colleagues from the Small Business Committee and thank them for
their participation in this joint hearing today.
The Science, Space, and Technology Committee has a history
of conducting oversight hearings on agencies and programs that
produce chemical assessments. While we have delved into the
work performed by the Agency for Toxic Substances and Disease
Registry and the EPA's IRIS Program on more than one occasion,
this is the first time I have had the opportunity to hearing
from the director of HHS's National Toxicology Program on the
subject of the Report on Carcinogens, also known as the RoC.
I view today's hearing as a learning opportunity for our
Committees so that we may better understand the work performed
by NTP as it publishes its report on carcinogens.
As a legislator, I am very concerned with protecting public
health and safety. I can think of few greater responsibilities
that we have as public servants. As a physician, I take this
responsibility even more seriously. When substances are found
to be harmful, we should make every effort to minimize the
public's exposure. We also have a responsibility to ensure that
these determinations are appropriate and not arbitrary or
capricious and are communicated correctly.
While taking the most cautious and precautionary approach
to making these determinations may seem like the right thing to
do, this method may actually do more harm than good. When
concerns and fear are promoted with little actual risk,
commerce, small businesses, and everyday citizens are impacted
with no appreciable benefit to their safety.
It is often repeated that RoC does not assess risk, just
hazards, and it is not a regulatory action, and therefore, it
is not required to meet more rigorous standards. While this may
be true, it unfortunately is not the whole story. These
assessments are highly influential scientific assessments that
influence regulatory actions at the earliest stages. When the
law that established the RoC was passed, its stated intent was,
``to be a first step in regulation.''
Because the RoC has such great import, it is critical that
these reports reflect the best available science. The recent
release of the 12th RoC demonstrates how confusing this process
can be. In a report published last April on the EPA IRIS
assessment of formaldehyde, the National Academy of Sciences
stated, ``strongly question EPA's claims that exposure to
formaldehyde can result in increased risk of leukemia and other
cancers that had not previously been associated with
formaldehyde, asthma, and reproductive toxicity.''
Yet two months after the Academy's reports, the NTP issued
the 12th RoC with an upgrade in the listing of formaldehydes to
a known carcinogen, based in part on claims similar to those
made by EPA and dismissed the Academy's report in an addendum.
Since then, concerns have been raised about how the RoC is
developed and how its findings are communicated.
Last winter, the Small Business Administration's Office of
Advocacy sent a letter to HHS, as well as to NTP, urging HHS,
``to review and evaluate the RoC's purpose and objectives and
to consider whether, if substantial changes cannot be made, the
RoC should continue to play a role in the Federal Government's
Chemical Risk Assessment Program.''
This is a surprisingly forthright comment and one that
Congress should not take lightly. Separately, in the Omnibus
Appropriations Bill passed last December, Congress directed the
Academies to review the 12th RoC's listing of two of its
substances, and I look forward to reading that report when it
is published, hopefully soon.
Although the RoC is not a regulation, by its own admission,
``the RoC can be used by regulatory agencies and others for
decision making.'' That makes this a very influential document,
because a RoC listing has real-world implications, and we will
hear about some of those implications from the small business
witnesses on our second panel.
Ultimately, we have to ensure that the public has the best
information possible in order to protect their health.
[The prepared statement of Mr. Broun follows:]
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Chairman Broun. Now, I ask unanimous consent that we add a
number of letters from various groups to the record. These have
been shared with the minority in advance of the hearing.
Without objection, so ordered.
[The information may be found in Appendix 2.]
Chairman Broun. I now recognize the Chair of the Committee
on Small Business, Subcommittee on Health and Technology, for
five minutes and her opening statement. Mrs. Ellmers.
Chairwoman Ellmers. Good morning, and I thank Chairman
Broun for working with me and my staff on this very important
issue. I thank all of our witnesses for being here today, and I
am looking very much forward to your testimony.
We are here today to learn about the Report on Carcinogens
and the impact it has on small businesses across America.
According to the National Toxicology Program, this report is
intended to be a science-based, public health communication
tool. However, the Report on Carcinogens has been used by
federal and State agencies as a regulatory document, using its
listing of substances as a basis for regulatory and legislative
action.
Each year, small businesses with less than 20 employees are
burdened with compliance regulations that cost them 36 percent
more per employee than their larger counterparts. Despite the
economic downturn, the regulatory burden on small businesses
continues to grow. Increasing regulations mean small businesses
must dedicate more money, time, and resources by complying with
regulations instead of doing what they do best, creating jobs
and innovating new products.
The Federal Government has an important duty in researching
and identifying substances that could cause harm and hazards in
the public health. But at the same time, our government must
recognize the adverse consequences of requiring businesses to
call a substance a human carcinogen without definitive
evidence. It is irresponsible and could lead to unnecessary
strain for small businesses. The regulatory uncertainty this is
causing has already resulted in small businesses delaying
hiring new employees and is causing many small businesses to
hold off on making important investment decisions.
Scientists, small businesses, and their representatives are
now raising concerns about the quality of this analysis and the
process used to list these substances in the Report on
Carcinogens. Specifically, questions have been raised regarding
the peer review process. Reports have shown that this process
has failed to meet the independent and objective standards that
would justify the overbearing burdens being placed on local
economies and businesses, not to mention the insufficient
public comment procedures that remain lacking.
The Report on Carcinogens was originally mandated by
Congress in 1978, to help aid the research and prevention of
many cancers. Although there have been many major breakthroughs
in the scientific understanding of cancers and its causes, the
process that the National Toxicology Program currently uses to
identify carcinogens has not kept up with the pace of
scientific developments. Despite warnings that the National
Toxicology Program review process for the report must be
improved, there are new concerns that the process for the next
report has made only minor substantive changes and is merely a
rearranging of the deck chairs.
Small businesses continue to fear the ramifications of this
report. When the government publishes scientific information
that negatively impacts private businesses, the government has
the duty and responsibility to ensure that the information is
the product of an objective and scientifically sound process.
Again, I want to thank each one of our witnesses today for
their participation, as well as Chairman Broun and the Science
Committee for hosting us today. I look forward to working with
all of you on this very important issue.
Mr. Chairman, I would like to take a moment to say that I
have included one letter from a small business in my district
as well as a letter to the Office of Advocacy, November 22,
2011, to the letter of Department of Health and Human Services
as part of my opening statement for the record.
I yield back.
[The prepared statement of Mrs. Ellmers follows:]
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Chairman Broun. Without objection, they will be entered
into the record at this point.
[The information may be found in Appendix 2.]
Chairman Broun. The Chair now recognizes my good friend
from New York, Mr. Tonko, for an opening statement. You are
recognized for five minutes.
Mr. Tonko. Thank you, Mr. Chair, and welcome to our
witnesses.
Usually I begin my statement by thanking you for having the
Subcommittee examine a topic of importance and for inviting
witnesses who bring a variety of perspectives and expertise to
the subject at hand.
Unfortunately, I am sorry that I am unable to do that
today. We did not agree in all particulars of the last
Subcommittee hearing, but I compliment you for inviting a
balanced slate of witnesses to inform us on renewable energy
tax provisions. When the Subcommittee is in a learning mode,
such balance reflects well on the Subcommittee and highlights
that we are truly interested in coming to a complete
understanding of a policy issue.
Today's hearing is very disappointing. In theory, we are
examining the National Toxicology Program's 12th Report on
Carcinogens. In reality, we are hearing the objections of one
industry to the listing of one chemical. There is virtually no
balance here today, in my opinion. Five of the six witnesses
invited by the majority are aligned closely with the styrene
industry and the American Composite Manufacturers Association.
Certainly we should hear from the businesses with an
interest in this report. Their concerns about the implications
of the report for their businesses are legitimate issues for us
to, indeed, consider. But in this matter, I would also expect
us to bring other concerned voices into the room to ensure that
we have a complete, complete picture of how the report and this
program are viewed by all interested parties.
If we were going to fully examine the deep issues this
hearing purports to tackle, I would have expected to hear from
veterans' groups, environmental justice groups, workers, and
distinguished public health experts with intimate knowledge of
the NTP and the Report on Carcinogens. No such individuals were
called by the majority. To the degree there is any divergent
voice heard today, it is because of the minorities' sense of
obligation to try to provide some balance.
I could have recommended witnesses such as retired Marine
Corps Master Sergeant Jerry Amsfinger and Ms. Erin Brockovich,
who worked with veterans and communities that have been harmed
by chemical exposure and fought for years to get toxicity
information into the public policy arena. I could have
recommended a fleet of distinguished science policy experts,
such as Dr. Phil Landrigan of Mount Sinai Medical College, or
you could stay with the beltway, within the beltway and invite
Dr. Lynn Goldman, Dean of the George Washington University
School of Public Health and Dr. Jennifer Sass of the Natural
Resources Defense Council.
In addition, the structure of this hearing suggests that
small businesses are hurt uniformly and primarily by documents
such as the RoC. The picture is far more complicated than that.
I could have recommended a host of small business leaders who
would have made it clear that their business is expanding and
taking market share away from petrochemical manufacturers
because public tastes are, indeed, changing.
The shift away from substances that cannot be easily
recycled or composted is a process that gained a full head of
steam long before the 12th Report on Carcinogens was drafted. I
am attaching to my statement letters we have received from a
wide variety of groups asking that this Subcommittee examine
the claims of the styrene industry with a critical eye and that
we understand how important the work of the NIEHS is to
protecting public health.
Out of fairness, I want to ask you, Mr. Chair, to commit to
a second hearing that would expand the scope of the voices we
hear on this important matter. The issues are too important to
treat in such an imbalanced way. The Investigations and
Oversights Subcommittee must be viewed as impartial and
thorough and should build a complete record that includes more
than allegations into lawsuit the styrene industry has brought
against NIEHS. A second hearing would allow us to correct the
impression that we will dance to any single-interest tune. I
stand ready to work with you to shape such a hearing at your
earliest convenience.
There is one final issue I want to raise. Because the
government is subject to an ongoing lawsuit in which Dr.
Birnbaum as the director of NIEHS has a direct role, she may
not be able to answer some questions here today. It would be
grossly unfair for Members to try to use this forum to build
the record to assist the industry in its lawsuit against the
government by asking questions of Dr. Birnbaum that she cannot
answer and then treating her as if she is trying to be evasive.
So I ask that you be especially sensitive to the legal
implications of this hearing and protect Dr. Birnbaum in
situations where she has been counseled not to comment. Last
week's joint hearing was marred by abusive conduct towards a
witness. I know you found the behavior distasteful, and I find
it unacceptable. Tough questions are fair game, but we should
stand together to ensure that things do not move from being
tough and probing to being personally abusive. I don't know
whether the NIEHS or the styrene industry is right or wrong on
the matters before us. I do not believe we have done enough
work on this matter, nor invited a diverse enough set of
witnesses to reach any meaningful conclusions today.
The letters I am attaching to my statement asks us to
believe that the styrene industry is wrong, and the Committee
is biased in its approach. They may or may not be right on the
first issue, but their second criticism is valid. To restore
the perception of our independence and objectivity, we
desperately need another hearing and a different set of
witnesses. I hope we can work together on that hearing, Mr.
Chair, and then we can bring, begin to come to a fuller
understanding of the complex questions that are, indeed, before
us.
I yield back.
[The prepared statement of Mr. Tonko follows:]
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Chairman Broun. Thank you, Mr. Tonko. I want to remind my
good friend from New York that of the letters that you just
asked to be admitted into the record, we have already admitted
those into the record from our side all except for, I think but
one of those, and we just have so many people, and this is
about process and not about any given entity or chemical. It is
about how the process goes on.
Thank you, sir. I appreciate that.
The Chair now recognizes my good friend from Louisiana, Mr.
Richmond, for an opening statement. Sir, you are recognized for
five minutes.
Mr. Richmond. Thank you, Mr. Chairman.
It is undisputed that chemicals are a part of our daily
lives from the food that we eat, the products in our homes, and
in our children's toys. In a great majority of their uses, they
improve our lives.
However, in a few instances they can be dangerous. To
address this, the National Toxicology Program issues a Report
on Carcinogens which lists substances that may cause cancer.
The report now identifies 240 substances that are either known
or are likely human carcinogens. For consumers, this gives them
information they can use to make informed decisions. For
employers, it can help them to protect the workers. For all of
us, this report can lead to cleaner air and water. By
identifying substances that may heighten the risk of cancer,
the public is made aware of potentially life-threatening
chemicals in our everyday lives.
As new chemicals are created and additional uses are found
for existing ones, companies are able to make their products
stronger, more durable, and a better value for the consumer. As
this process evolves, it remains a top priority to understand
not only what is in them but how they may affect us, our
children, and the environment.
The rapid pace of scientific discovery in the United States
makes doing so even more important. With this degree of
innovation also comes a strong sense of corporate
responsibility that we are fortunate to have in this country.
It is important to remember that no business wants to put its
employees or the public in danger. Safe products and a hazard-
free work environment are in a company's own self-interest and
simply make good business sense.
With that in mind, the report's designation of substances
as a carcinogen can only significantly impact small businesses.
For some firms, listing a chemical that they use, even in
minimal amounts, has the potential to stigmatize their products
and their business. Unlike their large counterparts, small
firms rarely have teams of attorneys and research personnel in
house to mitigate the impact of such a listing. Instead they
must hire expensive outside consultants or shift resources from
production to regulatory compliance, slowing growth and job
creation.
Given these concerns there is a need to examine the report
and how it is prepared. During today's hearing, I hope to
examine how rigorous the listing process is and how open it is
to external critique. Sound scientific analysis and methods, as
well as public comment and peer review, are key to the
legitimacy of the report.
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:]
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Chairman Broun. Thank you, Dr. Birnbaum.
Mr. Maresca, you are now recognized for five minutes.
STATEMENT OF MR. CHARLES A. MARESCA,
DIRECTOR OF INTERAGENCY AFFAIRS,
OFFICE OF ADVOCACY,
U.S. SMALL BUSINESS ADMINISTRATION
Mr. Maresca. Chairman Broun, Ranking Member--Chairwoman
Ellmers, Ranking Member Tonko, Ranking Member Richmond, Members
of the Committees, good morning. Thank you for the opportunity
to appear before you today to discuss small business concerns
with the Department of Health and Human Services Report on
Carcinogens.
As Director of Interagency Affairs at the Office of
Advocacy at the U.S. Small Business Administration, I manage a
team of attorneys that works with small businesses and Federal
Government agencies during the rulemaking process to reduce
regulatory burdens on small business.
Chief Counsel for Advocacy Winslow Sergeant wrote in a
letter to HHS on November 22, 2011, that small businesses have
two primarily concerns with the report, that substances have
been listed in the RoC based on potentially inaccurate
scientific information and that the peer review and public
comment processes should be improved.
Accurate and credible scientific assessments are vital for
small businesses. Listing a substance in the report has the
potential to curtail the use of the substance. This may lead to
substantial adverse economic impacts for small businesses that
use that substance, including increased costs of insurance and
Workers' Compensation premiums.
Further, when the Federal Government incorrectly lists a
substance as a carcinogen or as a potential carcinogen, small
businesses may experience lasting negative economic impacts.
Also, technical labels can be misinterpreted and confuse
the public about the true lead to questions about the true
nature of the risk to health and safety. For example, although
the report lists substances as reasonably anticipated to be a
human carcinogen or known to be a human carcinogen, the caveat
states that the listing of substances in the report only
indicates a potential hazard and does not establish the
exposure conditions that would pose cancer risks to individuals
in their daily lives. The important distinction between hazard
and risk is not understood by most consumers. Consumers and
small businesses are likely to be more aware of whether the
substance is listed than of the caveat.
Small businesses are concerned with the soundness of the
science underlying listing decisions. First, because it is a
hazard-based listing, not a risk-based listing, the report has
little value for estimating actual cancer risk to the general
public even though the listings appear to indicate that there
is a cancer risk. Second, NTP's weight-of-evidence analysis
does not appear to account for inconsistent or contradictory
data.
A more robust weight-of-evidence analysis would consider
all scientific data, including contradictory or inconsistent
data.
Small businesses are also concerned with the report's
preparation process. The 12th RoC process did not provide
sufficient opportunity for meaningful peer review or public
comment. The peer reviewer process did not include adequate
dialogue between NTP and the peer reviewers, nor did NTP
provide adequate response to peer review or public comments.
Although on paper the 12th RoC preparation process included
several opportunities for public comment, small businesses
found that NTP did not respond meaningfully to their comments.
Because public comment is the primary method by which small
businesses can contribute to the report's preparation process,
it is important that such opportunities be meaningful.
Finally, Advocacy is concerned with NTP's recent review of
the 12th RoC preparation process for three reasons. First, the
review process needs improvement. Second, the review of the
12th RoC preparation process was a process-based review only
and did not address substantive scientific concerns, and,
third, the new preparation process for the upcoming 13th RoC
should bolster opportunity for peer review or require NTP
response to peer review and public comment.
Advocacy commends two positive changes that resulted from
the 12th RoC review process, including an additional
opportunity for public comment and two additional opportunities
for interagency comment.
Small business relies on credible and reliable science.
NTP's review of the 12th RoC demonstrates that it is aware that
there are concerns with the RoC. However, NTP needs to make
further improvements in order to ease concerns. To the extent
that NTP can improve the scientific reliability as well as the
peer review and public comment processes for the report, there
will be a measurable burden reduction on small businesses.
I would like to thank you once again for inviting me to
speak to you today. I commend the Committee's interest in
improving and fostering legitimacy in the report's listings,
and I would be happy to respond to questions.
[The prepared statement of Mr. Maresca follows:]
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Chairman Broun. Thank you, Mr. Maresca. We are going to
give you that opportunity in just a second. I thank you all for
your testimony.
Reminding Members that Committee rules limit questions to
five minutes. The Chair will, at this point, open the first
round of questions, and I recognize myself for five minutes.
Dr. Birnbaum, NAS's review of the 12th RoC listing of
styrene and formaldehyde regarding that, last year Congress
directed HHS to contract with the National Academies to review
two of the 12th RoC's determinations. What is the status of
this review, and when will HHS direct NAS to move forward with
the review?
Dr. Birnbaum. The Office of the Assistant Secretary of
Health was charged with that, with contracting with NAS. I
understand they are in the process of developing that contract
with the Academy. They expect it to be in place by the fall.
Chairman Broun. Okay. So can we be assured that it will be
in place by the fall?
Dr. Birnbaum. This is the responsibility for the Assistant
Secretary of Health. They are working on it. They are doing
everything they can to complete it by the end of this fiscal
year, September 30.
Chairman Broun. Very good. Thank you so much. I certainly
look forward to that being completed.
Mr. Maresca, is the RoC a highly influential scientific
assessment?
Mr. Maresca. The RoC is the first step in regulations that
depend on science. Yes.
Chairman Broun. The written testimony submitted by
witnesses on the second panel have indicated that roughly
250,000 jobs are associated with just one substance. OMB
considered the scientific assessment to be, ``highly
influential if it could impact public or private sector by more
than $500 million in one year,'' or is, ``novel, controversial,
or precedent setting or has significant interagency
interests.''
Do you consider the RoC to be a highly influential
statement in those regards?
Mr. Maresca. Mr. Chairman, I do not know how it would be,
how the impact would be calculated. I do know that it is
influential among, within the agencies.
Chairman Broun. Okay. Very good. Again, Dr. Birnbaum, the
13th RoC will contain a new category called candidate
substances. Stakeholders are already concerned that a listing
as reasonably anticipated inappropriately stigmatized
substances without sufficient evidence as evidenced by the
attention RoC has received over the past year.
How will HHS prevent substances from being stigmatized
simply by adding to this lower-level category without any
justification or review?
Dr. Birnbaum. I am sorry, Mr. Broun, but I am not aware of
our adding any additional categories. The Congress in its
wisdom gave us two categories, known and reasonably
anticipated. Candidate substances are these chemicals or the
substances or the biological agents that may be considered
under the RoC. A candidate substance is not a category of
carcinogen.
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:]
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Chairwoman Ellmers [presiding]. Thank you, Dr. Bus.
I would now like to introduce Dr. Grimsley for five
minutes. Thank you.
TESTIMONY OF DR. L. FAYE GRIMSLEY,
ASSOCIATE PROFESSOR, TULANE SCHOOL OF
PUBLIC HEALTH AND TROPICAL MEDICINE,
DEPARTMENT OF GLOBAL ENVIRONMENTAL HEALTH SCIENCES
Dr. Grimsley. Good morning. My name is Faye Grimsley. I am
Associate Professor of Global Environmental Sciences, Tulane
University. I am currently on special leave as a Yerby Visiting
Associate Professor, Department of Environmental Health,
Harvard School of Public Health. My testimony today will focus
on the process of the NTP Program's RoC, the impact of the
Report on Carcinogens on jobs, and why the National Toxicology
Program is important.
First of all, the process involves a number of peer reviews
first by Expert Panel; second, by Interagency Scientific Review
Group; third, the NIEHS/NTP Scientific Review Group; and
finally, review by the NTP Board of Scientific Counselors.
Comments from the public are solicited during steps one through
three of the process. When the Expert Panel meets to review the
background documents and NTP Board of Scientific Counselors
meets to review draft substance profiles, the public is invited
to attend. Closed meetings are held when listing or removal
status recommendations are made for selected substances.
Although there are a number of closed meetings to discuss and
recommend listing status of specific substances, the review
process is transparent and open to the public for criticisms
and opinions during the review process.
The impact of the NTP RoC process on jobs. We know that
according to NIOSH it is well documented that associations
between occupational exposures and cancer exists. From an
environmental health scientist point of view and an industrial
hygienist, the NTP process is a valuable resource of
information and is often cited and referred when carcinogenic
information is needed. Any chemical substance listed by the RoC
will impact the health of workers and the public. The review
process should consider what impact this will have on
businesses of all sizes. Whenever new regulations or standards
are introduced, use of state-of-the-art technologies and
practices to protect worker health may be beyond resources of
small businesses. Small entities often have limited resources.
Agencies charged with health and safety of the public and
workers should anticipate and provide assistance and resources
to these entities to relieve any additional strain of
compliance.
Most health and safety personnel, regardless of company
size, would agree that additional requirements are involved
when new chemicals are designated as a carcinogen or potential
carcinogenic agent, but the benefits of knowing that readily
available lists of carcinogenic chemicals relieve some of the
burden of identifying one category of toxic substances which
workers have a potential for exposures and adverse health
effects if needed.
Why the NTP is important to public health: with more and
more chemicals being developed and used by society and in the
workplace, databases that contain toxicity and health and
safety information developed by the NTP process, and others
will continue to be used by a number of companies,
organizations, and agencies for toxicity assessment and
decision making to address public health issues. Development of
exposure limits and carcinogenic classifications is even, is a
challenge.
When workers and community members are unaware of the
potential toxic health hazards in their work environment and
communities, this makes them more vulnerable to injury and
diseases. It is important to provide them with information and
references to assist in anticipating and recognizing hazards
and the health effects associated with carcinogens in the
workplace and the community. If a chemical or agent lacks
toxicological and carcinogenic data, it is difficult to conduct
exposure assessment in public health and worker populations,
which makes it difficult to respond to affected populations
concerns and fears of long-term health effects.
For example, in the aftermath of Hurricane Katrina, the
public was very concerned about the copious amounts of mold
exposure and potential health effects. The NTP played an
instrumental role in gathering knowledge and coordinating
potential research questions that could help address the impact
of mold and mycotoxin and exposures and health effects.
Potential exposures to chemicals occur in homes and
communities. Scientists have the daunting task of combining and
assessing data from laboratory studies and information from
human population epidemiologic studies to determine a
substance's cancer causing ability. Systematic processes are
needed to assess toxicity and hazards associated with these
chemicals. Given the limitations of oversight sometimes placed
on federal agencies, the NTP is uniquely positioned to lead
various types of reviews and investigations of chemicals that
are of concern across different aspects of public health.
Thank you.
[The prepared statement of Dr. Grimsley follows:]
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Chairwoman Ellmers. Thank you, Dr. Grimsley.
I will now introduce Ms. Webster for five minutes. Thank
you.
TESTIMONY OF MS. BONNIE WEBSTER,
VICE PRESIDENT,
MONROE INDUSTRIES, INCORPORATED
Ms. Webster. Thank you, Chairman Broun, Chairwoman Ellmers,
Ranking Member Tonko and Ranking Member Richmond for the
opportunity to testify before you today. My name is Bonnie
Webster, and I am the Vice President of Monroe Industries in
Avon, New York. My husband, John, is here with me today and
together we run the company. We have seven employees but often
hire two to three more seasonally to meet demand. We are a cast
polymer company and use styrene-based resin to manufacture
high-end custom showers and vanity tops.
We are a small operation, but we do go to great lengths to
reach the highest level of safety. In 1999, we built a new
facility away from residential areas because styrene, like any
chemical, has the potential to be harmful when misused. We
ensure that every employee uses a respirator and other safety
equipment. Unlike larger companies we do not have the ability
to employ a full-time occupational safety staff, however, we
bring in consultants annually to address OSHA matters and
ensure that even with small resources we are compliant and
safe.
Our company works hard to lessen the environmental impact
of our production. We have created Robal Glass, a product that
uses half the amount of resin. Robal Glass uses a bio-based
resin and recycled glass for which we have won an EPA
Environmental Quality Award. Our products have a life cycle of
well over 20 years and are designed to last the duration of the
home.
Despite our hard work to be on the cutting edge of the
composites industry, we are very concerned that the listing of
styrene in the 12th Report on Carcinogens make it very
difficult for us to stay in business.
Currently there is only one company that will insure us.
Should we be dropped by that company, like other composite
companies whose coverage has been terminated by long-term
carriers, it will be impossible for us to continue to make an
affordable product. Today's mentality when it comes to
liability lawsuits is who can we sue next. We cannot afford to
be next and remain in business. If the poor science that
informed the RoC listing begins to inform the EPA or OSHA
regulations, our concerns will only worsen.
Our worries are not unique only to Monroe. Many state air
pollution regulatory programs will look at the RoC listing and
set styrene ground level exposure limits based on a presumption
of carcinogens, and this will make it impossible for composite
manufacturers in these states to get or renew operating
permits.
In light of the uncertainty presented by the styrene
listing in the RoC, we have no plans to expand our production
or increase our number of employees. We hope with this economy
we will be able to maintain the business that we have now.
Compared to many other companies in the cast polymer subset of
the composite's 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:]
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Chairwoman Ellmers. Thank you, Ms. Webster.
I would like to introduce Ms. LaTourelle now for five
minutes. Thank you.
TESTIMONY OF MS. ALLY LATOURELLE, ESQUIRE,
VICE PRESIDENT GOVERNMENT AFFAIRS,
BIOAMBER, INCORPORATED
Ms. LaTourelle. Thank you, Mrs. Chairman. Chairman Broun,
Chairwoman Ellmers, Members of the Committee, Ranking Member
Tonko, and Ranking Member Richmond, thank you for the
invitation to speak today. This is the first time I have been
before a committee, so I would like to, if I may, enter my
written testimony into the record and summarize those points
here for you today.
Chairwoman Ellmers. Without objection.
Ms. LaTourelle. Thank you. My name is Ally LaTourelle. I am
the Vice President of Government Affairs for a company called
Bioamber. We are a renewable chemical company. My work with
Bioamber includes renewable chemical manufacturing project
finance, federal, State, and local financial incentive
analysis, renewable chemical and economic policy development,
and I currently head global sustainability. It is a start-up.
I am also a former investment advisor, both for private
individuals on private companies in the clean tech sector and
for public companies. So my perspective is a little bit
different than the other members of the panel.
Bioamber, just to start, is a next-generation chemicals
company. We have a proven proprietary process that uses
economically viable, sustainable feedstocks rather than oil and
coal and natural gas to produce platform chemicals. These
chemicals are used for a diverse range of applications.
For example, we produce a non-toxic, bio-based succinic
acid. This is used in many applications from food additives to
fabrics, and we do so at lower cost.
We have also developed bio-based butanediol, a technology
that will be deployed at our first commercial scale facility in
Ontario, Canada, along with the succinic acid. Now, in
combination these two chemicals put together make what is
called a modified polybutylene succinic, and this is a resin
similar to what we just heard about.
This--I did bring some samples here I would just like to
show so that we can get a practical feel for what we produce.
This is the modified PBS as it comes out. It goes into
extrusion machines. This type of plastic is stamped into very
familiar objects, coffee cup lids, and our technology is
special because it gives heat resistance. Not only is it
biodegradable within 90 days, but you also have heat
resistance, which is a very difficult property to engineer.
Respectfully, I would like to present a few different
reactions to the issues of concern before the Committee today,
from the perspective of a renewable chemistry company. Like Dr.
Bus, I, too, question the fundamental relevancy of the RoC to
small business, but from a different perspective, and my next
statement is in no way challenging the science or the
importance of the RoC itself. We find ongoing reporting of
carcinogens has a negligible impact on competition in the face
of industry-wide 21st century business concerns.
The ad hoc nature of global chemical regulations is not
detrimental to our small business, and it is not a shock. I
would like to just remind you that the World Health
Organization in its International Agency for Research on Cancer
moved styrene, for example, from not classifiable to possibly
carcinogen to humans in 1987. So the impacts of this
information should have already come to the floor. They
reviewed that assessment in 1994 and in 2002, and came up with
the same conclusions. The U.S. Agency for Toxic Substances and
Disease Registry pointed to that report in 2007, and the EPA
has regulated styrene already in drinking water where it has
been found.
To be fair, Canada has found styrene to be non-toxic.
However, I would like to point out that this in no way, even
though we make a direct substitution for styrene, has in no way
impacted our decision to commercialize, to get to commercial
scale in Canada. Last year in California, for example, a total
ban of styrene was considered.
These regulations are essentially ongoing discussions, but
they really take a backseat to the larger concerns of the 21st
century. We have cost concerns related to energy supply price
increases. We have shipping and supply chain costs mentioned by
Ms. Webster associated with radical swings in the price of oil.
We have increased demands for transparency, and the chemical
industry is bringing science and innovation to design products
that avoid these concerns, as well as toxicity. Our chemical
process design takes 51 percent less energy to run than the
incumbent petrochemical players. That means there is a 205
percent energy efficiency that occurs pound for pound. In our
adipic acid technology, for example, it takes 205 percent more
energy to create a petrochemical adipic acid.
Chairman Broun. Ms. LaTourelle, if you would, your time has
expired, so if you would wrap up quickly, I would appreciate
it.
Ms. LaTourelle. Oh, yes. I am sorry.
Chairman Broun. We would appreciate it.
Ms. LaTourelle. My apologies.
Just to wrap up, I would also like to suggest that
regulations themselves lead to innovation. If we cannot
identify the problems and if we do not have access to
information, we cannot find the solutions. Large chemical
partners also support a shift in this industry to safer
alternatives. Familiar names from our strategic and innovation
partner list are Dupont, Cargill, Lanxess, Mitsubishi Chemical,
Mistui.
I would also like to point out that retail regulation and
consumer drive is a bigger concern to us than any of the other
things mentioned.
In conclusion, the environmental concerns, the 21st century
concerns are quantifiable. Something like the RoC really takes
a backseat in terms of small business to competitive answers
that are readily available.
Thank you for your time.
[The prepared statement of Ms. LaTourelle follows:]
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Chairman Broun. Thank you, Ms. LaTourelle.
Mr. Barker, you are recognized for five minutes.
STATEMENT OF MR. JOHN E. BARKER,
CORPORATE MANAGER, ENVIRONMENTAL AFFAIRS,
SAFETY AND LOSS PREVENTION, STRONGWELL CORPORATION
Mr. Barker. Thank you, Chairman Broun, Chairwoman Ellmers,
Ranking Member Tonko, and Ranking Member Richmond, for the
opportunity to testify before you today. My name is John
Barker. I am Corporate Manager of Environmental Affairs at
Strongwell Corporation. And I would also like to introduce my
colleague, David Ring, who is with us from Strongwell.
Strongwell employs 465 people with facilities in Bristol,
Virginia; Abingdon, Virginia; and Chatfield, Minnesota. Our
primary raw materials are styrene, resins, and reinforcements,
which we use to make many products, including ballistic panels,
having shipped over 150,000 to protect American troops and
soldiers in Iraq and Afghanistan. We also manufacture bridge
beams, platforms being used increasingly to reduce the
lifecycle cost and improve sustainability of infrastructure.
Like any chemical such as styrene, it is critical to follow
the safety guidelines. At Strongwell, we pride ourselves in our
proactive safety programs. Each facility has a Plant Safety
Committee and an excellent safety record. Our employees are
trained periodically on each chemical that we use, with all
employees being retrained at least annually. We ensure that all
employees have both the protective equipment and knowledge they
need to safely use the chemicals that are a part of our
production.
By nearly every count, when following the proper safety
guidelines, styrene is a safe chemical. Many studies from both
the private and public sectors alike speak to the absence of a
threat of cancer when using styrene. And regardless, the
National Toxicology Program listed styrene as a reasonably
anticipated carcinogen in the 12th Report on Carcinogens. The
listing of styrene in the RoC is of significant concern to
Strongwell and the composites industry in general. For one
thing, the idea of ``reasonably anticipated'' has caused great
confusion among our employees, their families, and members of
our communities.
We have taken a very proactive approach of informing
employees about the ruling and other studies about styrene
toxicity. We have gone over this matter in depth with city
councils of both Bristol, Virginia, and Bristol, Tennessee, and
have taken community leaders on tours of our facilities to
fully explain our safety practices. We have spent millions of
dollars on emissions reductions and have pushed toward direct
injection molding, which lessens the exposure of workers to
styrene.
And Dr. Bus has explained the scientific problems behind
the listing of styrene in the Report on Carcinogens. Let me
tell you about some of the problems it is causing to business.
As a company, Strongwell has gone to great lengths for many
years to have a strong and positive relationship with our
community. For example, 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:]
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Chairman Broun. Thank you, Mr. Barker.
And now, I will recognize Dr. Belzer for five minutes.
STATEMENT OF DR. RICHARD B. BELZER,
PRESIDENT, REGULATORY CHECKBOOK
Dr. Belzer. Thank you, Chairman Broun. I thank you for the
opportunity to testify again today. I am Richard Belzer,
President of Regulatory Checkbook, a nonpartisan, nonprofit
organization whose mission includes the promotion of quality
improvements in science, economics, and information quality.
In August of 2011, I was asked by the Competitive
Enterprise Institute to conduct a short study trying to explain
why the RoC had become so intensely controversial. Regulatory
Checkbook received an honorarium of $5,000 for a completed
published paper. CEI put no substantive constraints on my work.
Subsequently, Regulatory Checkbook supplied an additional
$5,000 of unrestricted resources.
My research shows that the RoC is not a high-quality
scientific work product and there are two fundamental reasons
why. This may be a little harder for you to see than I had
anticipated. I apologize. When Congress wrote the RoC's
authorizing legislation in 1978, it asked for a scientific
compendium of substances carcinogenic to humans but did not ask
for this in a scientific language. This you may or may not be
able to quite read. The task was to list all substances which
are either known to be carcinogens or may reasonably be
anticipated to be carcinogens. And I will get to the second
item in a moment.
But science does not know or reasonably anticipate things.
Science cannot tell you whether a number is significant. These
are not scientific words; they are the words of lawyers. Given
the opportunity, therefore, the NTP has exchanged its white lab
coat of science for something of a bureaucratic imperative of
maximizing the number of substances listed. The NTP has
achieved this by maximizing its flexibility to use or reject
scientific information however it sees fit. Thus, while the
NTP's listing determinations have scientific content, they are
not scientific determinations.
The NTP defines a known human carcinogen as follows--and
this is an actual verbatim description of it. A lot of
attention has been focused on this--the footnote. I want to
focus on something different. I want to focus on a comma midway
through the first sentence. And the comma is important, because
in English grammar everything that follows this comma is called
a parenthetical element. It can be removed from the sentence
without changing the sentence's meaning. Therefore, the NTP's
definition for a known human carcinogen can be shown much more
succinctly as follows, which is ``there is sufficient evidence
of carcinogenicity from studies in humans.'' Everything else is
subordinate to that.
This definition is tautological and utterly opaque. It is
tautological because it must be true. It goes without saying
that for every substance defined as a known human carcinogen by
the NTP, the evidence was at least sufficient in the judgment
of the NTP. It is utterly opaque, however, because no one
outside the NTP knows what makes evidence sufficient.
Now, a similar story can be told regarding the definition
of ``reasonably expected'' human carcinogen. A comma is located
in the same place. Everything that follows that comma can be
eliminated without altering the meaning of the criterion or the
sentence.
So we have ``sufficient evidence,'' we have ``limited
evidence,'' we have in one case ``less than sufficient
evidence.'' All these terms used by the NTP are legal terms.
They are not scientific terms. So while the Congress seems to
have asked for a scientific compendium, what the NTP appears to
produce is legislative determinations and it does this in a way
that makes it look like they are scientific. Biology words are
often used, for example. But the determinations themselves
cannot be scientific because the definitions are themselves not
scientific.
Now, return with me for just a moment to the--an earlier
slide. There is a second clause, ii, and it is part of the
definition of what the statute requires for a substance to be
listed and that is that the substance has to meet the first
test of being known or reasonably anticipated. It also has to
be a substance to which a significant number of persons
residing in the United States are exposed. That is in the law.
To the best of my knowledge and reading through the listing
decisions, the NTP does not do this. It doesn't actually
fulfill that second prong of the requirement for a listing.
There are ways of going about that. The NTP could define a
significant number of persons residing in the United States. It
could then define a de minimis cancer risk, and then it would
have to go about a scientific task of estimating the number of
persons exposed. Now, I don't believe that the NTP has done any
of these three steps. The first two are strictly policy
related. Science again can't speak to whether a number is
significant or it can't speak to what constitutes de minimis
cancer risk. But science can be used to estimate the number of
persons exposed.
Chairman Broun. Dr. Belzer, if you could go ahead and wrap
up, please, sir.
Mr. Belzer. I am sorry. I apologize.
What can be done--I provided in my written testimony a
number of different reforms that Congress could consider that
would improve the scientific content of RoC and make it more
useful for public policy purposes, for small businesses, for
big business, for consumers, for anyone. The problem with the
RoC now is that it stands as a document that does not actually
have the scientific content that Congress had intended 35 years
ago when it wrote the law.
Thank you very much.
[The prepared statement of Dr. Belzer follows:]
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Chairman Broun. Thank you, Dr. Belzer.
I appreciate you all's testimony. For you all that are not
southern, y'all is plural for all y'all.
I remind Members that Committee rules limit questioning to
five minutes. The Chair at this point will open the first round
of questions and I recognize myself for five minutes.
Now, my first question is to Dr. Bus and Dr. Belzer.
Written testimony submitted for this hearing indicates that
roughly 250,000 jobs are associated with just one substance.
OMB considers the scientific assessment ``highly influential''
if it could impact the public or private sector by more than
$500 million in one year or is ``novel, controversial, or
precedent setting or has significant interagency interest.'' Do
you consider the RoC to be a highly influential scientific
assessment, Dr. Bus?
Dr. Bus. Yes, indeed. In fact, as I pointed out in my
testimony, the outputs from the report on carcinogens are
directly translated in some regulatory environment such as
California and other locations around the globe in terms of
moving forward with regulatory action. So although they are not
regulatory actions themselves, they serve as the foundation for
it.
Chairman Broun. And bring about regulations? Okay. Dr.
Belzer.
Dr. Belzer. It is--I have not looked at the economic
consequences of the RoC in any way. I have looked at the amount
of intense energy devoted to attempting to get good quality
science out of the RoC. Based on that, I would draw the
inference it is highly influential.
Chairman Broun. Very good. Dr. Bus, you argue that the NTP
does not apply a weight of the evidence review of substances,
yet I understand that the Assistant Director of NTP at the
December 15, 2011, meeting of the Board of Scientific Council
has made it clear that NTP has always considered the full body
of evidence for every chemical and that all the studies are
listed in the background document. Are you really saying that
you just disagree with how they weighed those studies?
Dr. Bus. Absolutely not. In fact, the testimony as
presented by Dr. Bucher indicated that, yes, they do perhaps
consider all the evidence but really what is more important is
the process by which the evidence is evaluated. So, for
instance, in the recent NAS review of the formaldehyde
document, that is where the National Academy of Sciences really
outlined a roadmap for how scientific data should be evaluated
with respect to assessments of the toxicology of chemicals. And
they really emphasize that they should take a weight-of-
evidence approach, which is not just a recitation of the
numbers of studies that are out there but really a 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.
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Appendix 2
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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