[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]


                  IN DEFENSE OF SCIENTIFIC INTEGRITY: 
                 EXAMINING THE IARC MONOGRAPH PROGRAMME
                         AND GLYPHOSATE REVIEW

=======================================================================

                                HEARING

                               BEFORE THE

              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FIFTEENTH CONGRESS

                             SECOND SESSION

                               __________

                            FEBRUARY 6, 2018

                               __________

                           Serial No. 115-46

                               __________

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

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              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

                   HON. LAMAR S. SMITH, Texas, Chair
FRANK D. LUCAS, Oklahoma             EDDIE BERNICE JOHNSON, Texas
DANA ROHRABACHER, California         ZOE LOFGREN, California
MO BROOKS, Alabama                   DANIEL LIPINSKI, Illinois
RANDY HULTGREN, Illinois             SUZANNE BONAMICI, Oregon
BILL POSEY, Florida                  AMI BERA, California
THOMAS MASSIE, Kentucky              ELIZABETH H. ESTY, Connecticut
JIM BRIDENSTINE, Oklahoma            MARC A. VEASEY, Texas
RANDY K. WEBER, Texas                DONALD S. BEYER, JR., Virginia
STEPHEN KNIGHT, California           JACKY ROSEN, Nevada
BRIAN BABIN, Texas                   JERRY McNERNEY, California
BARBARA COMSTOCK, Virginia           ED PERLMUTTER, Colorado
BARRY LOUDERMILK, Georgia            PAUL TONKO, New York
RALPH LEE ABRAHAM, Louisiana         BILL FOSTER, Illinois
DANIEL WEBSTER, Florida              MARK TAKANO, California
JIM BANKS, Indiana                   COLLEEN HANABUSA, Hawaii
ANDY BIGGS, Arizona                  CHARLIE CRIST, Florida
ROGER W. MARSHALL, Kansas
NEAL P. DUNN, Florida
CLAY HIGGINS, Louisiana
RALPH NORMAN, South Carolina
                            
                            
                            C O N T E N T S

                            February 6, 2018

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

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

                           Opening Statements

Statement by Representative Lamar S. Smith, Chairman, Committee 
  on Science, Space, and Technology, U.S. House of 
  Representatives................................................     4
    Written Statement............................................     6

Statement by Representative Eddie Bernice Johnson, Ranking 
  Member, Committee on Science, Space, and Technology, U.S. House 
  of Representatives.............................................     8
    Written Statement............................................    10
    Minority Staff Report........................................    12

Statement by Representative Frank D. Lucas, Committee on Science, 
  Space, and Technology, U.S. House of Representatives...........    32
    Written Statement............................................    35

Statement by Representative Suzanne Bonamici, Committee on 
  Science, Space, and Technology, U.S. House of Representatives..    37
    Written Statement............................................    39

                               Witnesses:

Dr. Anna Lowit, Senior Science Advisor, Office of Pesticide 
  Programs, Environmental Protection Agency
    Oral Statement...............................................    42
    Written Statement............................................    44

Dr. Timothy Pastoor, CEO, Pastoor Science Communications
    Oral Statement...............................................    55
    Written Statement............................................    57

Dr. Jennifer Sass, Senior Scientist, Natural Resources Defense 
  Council
    Oral Statement...............................................    62
    Written Statement............................................    64

Dr. Robert Tarone, (retired) Mathematical Statistician, U.S. 
  National Cancer Institute and Biostatistics Director, 
  International Epidemiology Institute
    Oral Statement...............................................    77
    Written Statement............................................    79

Discussion.......................................................    89


             Appendix I: Answers to Post-Hearing Questions

Dr. Anna Lowit, Senior Science Advisor, Office of Pesticide 
  Programs, Environmental Protection Agency......................   106

Dr. Timothy Pastoor, CEO, Pastoor Science Communications.........   107

Dr. Jennifer Sass, Senior Scientist, Natural Resources Defense 
  Council........................................................   113

Dr. Robert Tarone, (retired) Mathematical Statistician, U.S. 
  National Cancer Institute and Biostatistics Director, 
  International Epidemiology Institute...........................   116


            Appendix II: Additional Material for the Record

Documents submitted by Representative Suzanne Bonamici, Committee 
  on Science, Space, and Technology, U.S. House of 
  Representatives................................................   122

Documents submitted by Representative Paul Tonko, Committee on 
  Science, Space, and Technology, U.S. House of Representatives..   139

Documents submitted by Representative Jerry McNerney, Committee 
  on Science, Space, and Technology, U.S. House of 
  Representatives................................................   213

Documents submitted by Representative Donald S. Beyer, Jr., 
  Committee on Science, Space, and Technology, U.S. House of 
  Representatives................................................   214

Documents submitted by Representative Lamar S. Smith, Chairman, 
  Committee on Science, Space, and Technology, U.S. House of 
  Representatives................................................   220

 
                  IN DEFENSE OF SCIENTIFIC INTEGRITY:
                 EXAMINING THE IARC MONOGRAPH PROGRAMME
                         AND GLYPHOSATE REVIEW

                              ----------                              


                       TUESDAY, FEBRUARY 6, 2018

                  House of Representatives,
               Committee on Science, Space, and Technology,
                                                   Washington, D.C.

    The Committee met, pursuant to call, at 10:06 a.m., in Room 
2318 of the Rayburn House Office Building, Hon. Lamar Smith 
[Chairman of the Committee] presiding.
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    Chairman Smith. The Committee on Science, Space, and 
Technology will come to order. Without objection, the Chair is 
authorized to declare recesses of the Committee at any time.
    Welcome to today's hearing entitled ``In Defense of 
Scientific Integrity: Examining the IARC Monograph Programme 
and Glyphosate Review.''
    I recognize myself for five minutes for an opening 
statement, and then I'll recognize the opening--I mean the 
Ranking Member as well.
    Today, we will examine the U.S. taxpayer-funded IARC 
Monograph Programme and its assessment of the herbicide 
glyphosate, more commonly known as Roundup. We must ensure that 
the underlying science behind assessments that influence policy 
and the public is based on sound science. The American people 
deserve to know the truth about which substances are safe and 
which ones pose a risk. Glyphosate is the most widely used 
herbicide in the world. Americans and people across the globe 
rely on these crops for high quality, affordable food.
    There are real repercussions to IARC's unsubstantiated 
claims, which are not backed by reliable data. Labeling 
requirements will drive costs up for farmers and consumers and 
create unjustified public fear. IARC's irresponsible handling 
of data does real harm to job creators and the public's view of 
the scientific process.
    Agencies such as IARC have a responsibility to adhere to 
the scientific method and evaluate all relevant scientific 
studies, weigh the evidence, and come to a conclusion that can 
be reproduced. Following the scientific method also means 
forming a conclusion only after all data has been considered.
    According to information gathered by the Committee, there 
appear to be serious problems with the science underlying 
IARC's assessment of glyphosate. The news media recently 
revealed evidence of data deletion and manipulation of draft 
assessments before final publication. IARC's conclusion about 
glyphosate relied only on data that was favorable to its 
conclusion and ignored contradictory data.
    In its assessment, IARC did no direct evaluation of 
glyphosate's effect on humans, no evaluation whatsoever. 
Specifically, IARC appears to have intentionally omitted data 
that showed glyphosate does not cause cancer. It's no surprise 
that the Monograph Programme has refused to publish any of its 
draft assessments. If there is nothing to hide, why the 
secrecy?
    The manipulation of scientific data and lack of 
transparency is not the only defect in IARC's glyphosate 
assessment. Besides altering the data used in the assessment, 
the Monograph Working Group failed to consider the most 
significant study on human exposure to glyphosate. The 
Agricultural Health Study, which was a result of a 
collaboration of several federal agencies such as the National 
Cancer Institute, National Institute of Environmental Health 
Sciences, and the Environmental Protection Agency presented 
information they had collected on over 50,000 humans. Aaron 
Blair, the Chair of the Monograph Programme at the time, 
admitted in a deposition that the study would, quote, ``altered 
IARC's analysis,'' end quote. However, this study was not 
considered by IARC.
    In 2015, IARC published its findings on glyphosate, 
categorizing the herbicide as ``probably'' causing cancer. It 
has become apparent that the Monograph on glyphosate uses 
nothing more than cherry-picked science created by those who 
have a financial stake in the resulting conclusions.
    The Monograph Programme is alone in its determination that 
glyphosate poses a cancer threat. Both the EPA and EFSA, a 
European regulatory agency, have reviewed glyphosate and 
determined that the chemical is unlikely to cause cancer. Last 
December, the EPA released a draft Human Health Risk Assessment 
evaluating the potential of glyphosate to cause cancer. The EPA 
body of research was then evaluated by a Scientific Advisory 
Panel composed of experts appointed during the Obama 
Administration. The EPA's draft assessment reviewed IARC's 
glyphosate Monograph and came to the conclusion that glyphosate 
is unlikely to cause cancer.
    The Committee has written several letters expressing 
concerns about the lack of sound science and biases found in 
IARC's program. When asked to provide a witness for this 
hearing, IARC Director Wild refused to attend. No doubt he 
could not defend IARC's glyphosate findings. The selective use 
of data and the lack of public disclosure raise questions about 
why IARC should receive any government funding in the future.
    [The prepared statement of Chairman Smith follows:]
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    Chairman Smith. That concludes my opening statement, and 
the Ranking Member, the gentlewoman from Texas, is recognized 
for hers.
    Ms. Johnson. Thank you very much, Mr. Chairman.
    Chemicals have the potential to greatly improve our quality 
of life when developed and produced in a responsible manner. 
However, when produced or proliferated irresponsibly or without 
sufficient understanding of their potential impacts, chemicals 
can pose a grave and significant risk to every one of us.
    Unfortunately, by the time we realize the harm being caused 
by unsafe exposure to such toxic chemicals, the damage has 
often already been done, and we're left regretting the fact 
that there might have been preventative actions we could have 
taken to protect ourselves if we had a better understanding of 
the hazards. If we knew then what we know now, would we have 
filled our homes, schools, businesses, hospitals with asbestos? 
Would we have supported the widespread installation of lead 
pipes to provide us with our daily drinking water? Most 
Americans who have had to suffer or who have seen their 
children and other loved ones suffer through the adverse health 
effects of exposures to dangerous chemicals would likely say 
no, of course not.
    The chemicals we are discussing today--glyphosate--is 
already one of the most widely used chemicals in agriculture. 
For example, it is the key ingredient in Monsanto's herbicide 
Roundup that has helped farmers get greater yield of corn and 
other agriculture products. However, the widespread prevalence 
of glyphosate has raised serious concerns about its toxicity 
and potential cancer-causing properties.
    That is why the work done by independent chemical 
assessment organizations like the World Health Organization and 
its International Agency for Research on Cancer is so critical 
to protecting the public health of--those organizations 
evaluate without prejudice or concern about profits, the health 
habits--hazards and risks posed by exposure to toxic chemicals. 
By contrast, there's been extensive documentation of efforts by 
the chemical industry to bias the science and public perception 
of their chemicals to protect their financial interests rather 
than the public health. If we are truly interested in defending 
scientific integrity, we should be doing more than simply 
hearing from the industry-friendly scientists.
    As my colleagues may be aware, the EPA's Office of 
Inspector General has been investigating allegations that 
Monsanto attempted to influence officials at the Environmental 
Protection Agency who were central to EPA's own review of 
glyphosate, as well as potential collusion by those officials 
with Monsanto. If this Committee really wishes to do oversight 
in defense of scientific integrity, those allegations would 
certainly seem to be worthy of our attention. However, I am not 
holding my breath that the majority will undertake such an 
investigation.
    Mr. Chairman, chemical companies will continue to innovate 
and manufacture chemicals that seek to improve human life, and 
I support their initiatives in doing so. But such innovations 
should not come at the cost of human health. That is why the 
work of independent organizations like IARC is so important and 
why we in Congress should be supporting that work rather than 
attempting to undercut it.
    The minority staff has produced a staff report that 
documents some of the tactics Monsanto has used to undermine 
this IARC Monograph and scientific findings and glyphosate in 
general, and I'm attaching this report to my statement.
    I thank you, Mr. Chairman, and I yield back.
    [The prepared statement of Ms. Johnson follows:]
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    Chairman Smith. Okay. Thank you, Ms. Johnson.
    Mr. Weber. Mr. Chairman?
    Chairman Smith. Yes, the gentleman from Texas, Mr. Weber.
    Mr. Weber. If I may, I have reservations about entering 
this report into the record. This Committee received the 
minority's report--staff report late last night and has not had 
sufficient time to completely review this report for factual 
accuracy. I am aware at this time----
    Ms. Johnson. I didn't--oh, sorry.
    Mr. Weber. --of at least one statement of questionable 
accuracy. It's on page 15 and 16. The minority's report appears 
to suggest that the current EPA Administrator Mr. Scott Pruitt 
was somehow involved in the December 2016 decision to remove 
Dr. Peter Infante from EPA's Science Advisory Panel to review 
glyphosate. Mr. Chairman, Dr. Infante was removed during the 
SAP during President--from the SAP during President Obama's 
term while Gina McCarthy was the Administrator. And since Greg 
Pruitt was sworn in February 17, 2017, there really is no 
rational basis to justify this claim. So I hope the minority 
will be able to explain that statement.
    I yield, Mr. Chairman.
    Chairman Smith. Thank you, Mr. Weber.
    Ms. Johnson. Mr. Chairman?
    Chairman Smith. And the gentlewoman from Texas is 
recognized.
    Ms. Johnson. I did not request unanimous consent. I simply 
said I will be attaching the report to my statement.
    Chairman Smith. I think Mr. Weber's point was that it 
contained something that was not accurate and not factual and 
we hope you'll take a look at that.
    Ms. Johnson. I hope everyone will take a look at it.
    Chairman Smith. Okay. Well, Mr. Weber went into some detail 
as to what was inaccurate, and we'll look forward to your 
response later on. Thank you, Ms. Johnson. Thank you, Mr. 
Weber.
    The gentleman from Oklahoma, the Vice Chairman of the 
Committee, Mr. Lucas, is recognized for an opening statement.
    Mr. Lucas. Thank you, Chairman Smith, for holding this 
hearing on the important topic of scientific integrity of the 
International Agency for Research on Cancer's Monograph 
Programme. I look forward to hearing from our panel of expert 
witnesses this morning and want to thank them for their 
voluntary appearance before this Committee.
    First recognized by the World Health Organization in 1965, 
IARC began as a French initiative to find and root out cancer 
both in France and around the world. In pursuit of this goal, 
one of IARC's many endeavors was the identification and 
classification of known carcinogens. This has come to be known 
as the Monograph Programme. While the effort at the time 
represented the best modern understanding of cancer and the 
environmental causes, the methods of IARC's Monograph Programme 
have remained largely unchanged over the years, even as our 
understanding of cancer has evolved.
    This has caused IARC to reach conclusions that not only 
create unnecessary fear in people, but in some cases causes 
IARC to reach conclusions that are contradictions to the best 
available science. This is unfortunate in any scientific 
program but is completely unacceptable in one in which the 
United States, through the NIH and through NIEHS, provides the 
majority of the funding. This is even more true when IARC's 
conclusions are then utilized as the basis of regulations, for 
instance, in places such as California of products like Roundup 
that contain glyphosate.
    In 2015, the IARC Monograph Programme categorized 
glyphosate as ``probably carcinogenic to humans.'' As Chairman 
Smith explained, IARC's glyphosate Monograph contained 
substantial portions of alterations and deletions, it appears, 
to aid the Monograph in drawing a particular conclusion.
    While the appearance of agenda-driven manipulation is 
troubling on its own, it's even more so when considering that 
IARC's final conclusion is not only on the fringe of the 
scientific world but is completely and totally by itself. The 
respected scientific bodies such as the Environmental 
Protection Agency, the European Food Safety Agency, or IARC's 
own parent body, the WHO, has repeatedly found there to be no 
risk posed to humans when glyphosate is used as directed. Yet, 
the IARC Monograph Program persists, reviewing and labeling 
over 900 substances as ``possible'' or ``probable'' carcinogens 
over the past 40-plus years, while the only labeling--only 
labeling one as noncarcinogenic.
    IARC's explanation for all this is that they simply assess 
hazard and not risk; therefore, the actual probability that 
these substances cause cancer cannot be gleaned from their 
Monographs. If left unchallenged, this would excuse IARC's bad 
behavior and give a de facto blessing to their refusal to bring 
their scientific methods into the modern age. This kind of 
shoddy work is unacceptable from any scientific body, let alone 
one funded by the American taxpayer.
    The modern agricultural revolution, of which glyphosate and 
other IARC-labeled ``carcinogenic'' herbicides have played an 
enormous role, has helped feed the world and enabled struggling 
nations to grow and gain a footing on the world stage. All of 
this, however, is threatened by IARC's flawed scientific 
analysis. Far too often, farmers, ranchers, and small 
businesses find themselves on the receiving end of burdensome 
regulations like those that stem from IARC's misleading 
assessments. We should be working to reduce the burdens of 
these hardworking Americans, not funding the growth of them.
    And when a federal or international agency makes decisions 
that have the potential to directly and negatively impact 
American citizens, we in Congress have a duty to ask questions 
to address the concerns of our constituents. Similarly, when a 
federal or international agency utilizes American tax dollars 
to reach conclusions that directly contradict the overwhelming 
majority of scientific knowledge, we have a duty to ask how 
they came to that conclusion.
    This Committee has, on several occasions, attempted to gain 
a greater understanding of IARC's decision-making process. 
Unfortunately, the Committee's simple request for IARC to 
provide a witness to testify on the Monograph Programme has 
been met with resistance. The pursuit of an awesome goal like 
the eradication of cancer should not, cannot, prevent us from 
asking questions regarding the processes and methods utilized 
to reach a certain conclusion. Simply because an organization 
has a commendable goal should never mean the conclusions it 
draws are beyond reproach.
    I look forward to hearing from our witnesses today not only 
about the problems in the methods and procedures of the IARC 
Monograph Programme, of which there are many, but also about 
the fixes they believe that can be made to bring the Monograph 
Programme back into line with modern science.
    And with that, Mr. Chairman, I yield back the balance of my 
time.
    [The prepared statement of Mr. Lucas follows:]
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    Chairman Smith. Thank you, Mr. Lucas.
    And the gentlewoman from Oregon, the Ranking Member of the 
Environmental Subcommittee, is recognized for her statement.
    Ms. Bonamici. Thank you, Mr. Chairman. I'm glad we're 
having this hearing today about the chemical review process.
    Ranking Member Johnson is correct. For too long industries' 
influence on this process has endangered the public's health 
and safety. Today, there is an assault on independent 
scientists and independent scientific organizations by the 
Trump Administration particularly by the Environmental 
Protection Agency. It is important that we review the methods 
and tactics that industry has used to influence this 
Administration and attack independent scientific organizations 
like the World Health Organization's International Agency for 
Research on Cancer or IARC.
    This hearing today will focus on IARC's hazard assessment 
of glyphosate, a key ingredient in Monsanto's Roundup broad-
spectrum herbicide used to kill weeds and grasses. In 2015, 
IARC determined that glyphosate was probably carcinogenic to 
humans. Other reviews, including a draft Human Health Risk 
Assessment released by the EPA in December, concluded that 
glyphosate is not likely to be carcinogenic to humans. Part of 
that discrepancy may be because these reviews have investigated 
different issues.
    IARC conducts hazard assessments while EPA conducts risk 
assessments. According to IARC, a cancer hazard is an agent 
that is capable of causing cancer under some circumstances 
while a cancer risk is an estimate of the carcinogenic effects 
expected from exposure to a cancer hazard. Although there seems 
to be some confusion about these distinct scientific procedures 
of analysis and the science on this issue still appears 
unsettled, the attacks by the chemical industry to discredit 
individual scientists and scientific organizations such as IARC 
is not.
    Internal Monsanto records show that company employees have 
ghostwritten scientific journal articles on glyphosate, 
attempted to orchestrate a public outcry over IARC's glyphosate 
findings, and have targeted specific independent scientists for 
attack. At a time when most of us are sensitive to the cries of 
fake news the Monsanto records show in their own words that 
they have sought to amplify positive messages about glyphosate 
on social media, neutralize the impact of the IARC decision on 
glyphosate, and to use industry front groups as a platform for 
IARC observers and industry spokespersons.
    Attempts by industry to mischaracterize the scientific 
debate appear intended to undercut the scientific evidence 
regarding the possible dangers of glyphosate and its potential 
impact on human health. We must make sure any chemical review 
is not undone by undue corporate influence or misleading 
scientific studies.
    This is all the more important when the chemicals under 
review are so widely used. Glyphosate has been used as an 
herbicide in the United States since 1974, and its use in the 
United States has grown from 11 million pounds in 1987 to 
nearly 300 million pounds in 2016. Since its introduction in 
the United States 1.8 million tons of glyphosate have been 
applied across the country, and 9.4 million tons of glyphosate 
has been used on crops around the world. Recent studies have 
shown that this widescale use of glyphosate has had an impact 
on our food supplies and communities. Glyphosate has been 
detected in crackers, cookies, cereals, as well as in organic 
honey and oatmeal.
    Chemical exposures, just like exposures to asbestos or lead 
or other potentially toxic substances, occur regardless of 
whether we sit on the left or the right of a particular 
political issue. The public health implications of these 
exposures are felt by all Americans and all people. That is 
exactly why an independent scientific review that is not 
unfairly or surreptitiously influenced by industry is 
necessary. We need to come to conclusions regarding the 
scientific evidence concerning glyphosate's potential impact on 
human health in a transparent and complete manner.
    I look forward to hearing the testimony of our witnesses 
today, and I'm glad Dr. Jennifer Sass from the Natural 
Resources Defense Council is here. More than six years ago, Dr. 
Sass wrote a report titled ``The Delay Game: How the Chemical 
Industry Ducks Regulation of the Most Toxic Substances.'' It's 
important that the Committee hear her perspective on these 
issues.
    [The prepared statement of Ms. Bonamici follows:]
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    Ms. Bonamici. And before I yield back, Mr. Chairman, I have 
three responses from Dr. Christopher Wild, the Director of 
IARC, responding to inquiries you made late last year. In 
summary, Dr. Wild provides factually supported rebuttals to 
criticisms you and others have made about the IARC glyphosate 
Monograph, and I ask that these documents be made part of the 
record.
    Chairman Smith. Without objection.
    [The information appears in Appendix II]
    Ms. Bonamici. And I yield back the balance of my time. 
Thank you, Mr. Chairman.
    Chairman Smith. Thank you, Ms. Bonamici. And I'll introduce 
our witnesses now. Our first witness today is Dr. Anna Lowit, 
Senior Science Advisor in the Office of Pesticide Programs at 
the Environmental Protection Agency. Dr. Lowit has been a 
toxicologist in OPP's Health Effects Division since 1998. 
During this time, she has provided expert technical advice and 
guidance on issues related to toxicity, testing human risk 
assessment, and science policy issues. She was elected co-Chair 
of the Interagency Coordinating Committee on the Validation of 
Alternative Methods, a committee of representatives from 16 
federal agencies that require, generate, or disseminate 
toxicological and safety testing information. In January, she 
was named the recipient of the Society of Toxicology's 2018 
Enhancement of Animal Welfare Award. Dr. Lowit received her 
master's of science and Ph.D. in environmental toxicology from 
the University of Tennessee.
    Our next witness is Dr. Timothy Pastoor, CEO of Pastoor 
Science Communications. In addition, he is President of the 
Health and Environmental Science Institute, a D.C.-based 
nonprofit organization. With over 30 years of international 
experience, Dr. Pastoor has been involved with fundamental 
toxicity testing, mode-of-action research, and Human Health 
Risk Assessment. For the majority of his career, he led 
toxicology and risk assessment experts in the conduct of 
safety, health, and environmental studies to assess risk to 
humans and the environment. He retired in 2015 and founded the 
company Pastoor Science Communications, LLC, centered around 
his passion for advancing sound science. Dr. Pastoor received a 
Ph.D. in toxicology from the University of Michigan.
    Our third witness is Dr. Jennifer Sass, Senior Scientist at 
the Natural Resources Defense Council. She is also a 
professorial lecturer in the Environmental and Occupational 
Health Department at George Washington University. In her work 
with the NRDC, Dr. Sass brings a highly specialized expertise 
in U.S. chemicals policy. She has published peer-reviewed 
journals on the regulation of toxic chemicals and emerging 
contaminants such as nanomaterials. Dr. Sass earned a master's 
degree and a Ph.D. in anatomy and cell biology from the 
University of Saskatchewan Canada and has done postdoctoral 
work in toxicology at the University of Maryland.
    Our final witness today is Dr. Robert Tarone, a 
Biostatistics Director at the International Epidemiology 
Institute for 14 years before retiring in 2016. Previously, he 
was a mathematical statistician at the U.S. National Cancer 
Institute and a professor in the Department of Medicine at 
Vanderbilt University. During his career, Dr. Tarone has 
provided statistical assistance to a wide variety of laboratory 
and clinical researchers, including investigators in the field 
of immunology, DNA repair, and cancer-prone inherited diseases. 
He received his bachelor of science, master's of arts, and 
Ph.D. all in mathematics from the University of California 
Davis.
    We recognize and appreciate and welcome you all. And, Dr. 
Lowit, if you will begin.

                  TESTIMONY OF DR. ANNA LOWIT,

                    SENIOR SCIENCE ADVISOR,

                 OFFICE OF PESTICIDE PROGRAMS,

                ENVIRONMENTAL PROTECTION AGENCY



    Dr. Lowit. Good morning, Chairman Smith, Ranking Member 
Johnson, and the rest of the Members of the Committee. My name 
is Anna Lowit. I serve as a Science Advisor for EPA's Office of 
Pesticide Programs. I have a Ph.D. in environmental toxicology 
and have worked in the area of pesticide risk assessment and 
toxicology for nearly 20 years.
    EPA regulates the manufacture and use of all pesticides in 
the United States and establishes maximum levels for pesticide 
residues in food, safeguarding the Nation's food supply, 
workers, and the general public.
    In addition to evaluating new pesticides before they can 
enter the market, EPA reevaluates existing pesticides at least 
every 15 years under a program known as registration review. 
EPA must complete registration review for more than 700 
pesticides by October 1 of 2022. In 2017, EPA evaluated more 
than 120 pesticides using the risk assessment process.
    Glyphosate, commonly known as Roundup, was initially 
registered by EPA in 1974. Glyphosate is one of the most widely 
used herbicides in the United States with about 270 million 
pounds of active ingredient applied annually. Glyphosate is 
used on a large number of crops, primarily corn and soybean, 
and is commonly used by homeowners.
    Registration review for glyphosate was initiated in 2009 
using the statutory registration review process applied to all 
registered pesticides. As part of this process, several types 
of assessments have been initiated, including evaluations of 
human health, ecological risk, carcinogenicity, endocrine 
disruption, and risk to pollinators. The assessments are 
subject to extensive technical review and public comment 
throughout the review process.
    EPA released the draft Human Health and Ecological Risk 
Assessments in December of 2017. Glyphosate is considered to 
have little to no hazard when exposure is to the skin or when 
inhaled. Effects in laboratory animals were only seen through 
ingestion at very high doses. In the case of glyphosate, the 
Human Health Risk Assessment was developed with conservative 
exposure assumptions. Even with these conservative assumptions, 
no risk to humans, including infants and children, were 
identified. This conclusion showing no risk to humans is 
consistent with risk assessment findings in other countries and 
by international organizations such as Canada and the European 
Food Safety Authority.
    Glyphosate was also subject to endocrine screening. Based 
on weight-of-evidence considerations, there's no convincing 
evidence of potential interaction with estrogen, androgen, or 
thyroid pathways, and no additional endocrine related studies 
are considered necessary.
    In 2016, EPA conducted a comprehensive analysis of all the 
available laboratory animal carcinogenicity, mutagenicity, and 
epidemiology data to inform the human risk--the human cancer-
causing potential of glyphosate. EPA presented its evaluation 
to the FIFRA Scientific Advisory Panel and received the panel's 
recommendation in March of 2017. The Agency's cancer issue 
paper was updated to incorporate revisions, and based on the 
comprehensive analysis of all available data and reviews, EPA 
concluded that glyphosate is not likely to be carcinogenic to 
humans.
    While the draft Human Health and Ecological Risk 
Assessments are already publicly available on EPA's website, 
the official public comment period for the draft risk 
assessments and supporting science evaluations will soon be 
announced in the Federal Register. EPA will evaluate the public 
comments and, if needed, will revise the risk assessments and 
then issue a proposed interim decision for public comment. If 
necessary, the proposed interim decision may include labeling 
changes and other risk mitigation measures. After public 
comments on the proposed interim decision are received and 
evaluated, EPA will issue an interim decision. EPA plans to 
complete a final decision after an endangered species 
assessment is complete.
    Thank you for the opportunity to testify today, and I'm 
looking forward to questions from you and the Members.
    [The prepared statement of Dr. Lowit follows:]
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    Chairman Smith. Thank you, Dr. Lowit.
    And Dr. Pastoor?

               TESTIMONY OF DR. TIMOTHY PASTOOR,

              CEO, PASTOOR SCIENCE COMMUNICATIONS

    Dr. Pastoor. Chairman Smith--good morning, Mr. Chairman, 
Ranking Member Johnson, and the distinguished Members of this 
Committee. Thank you for inviting me to this important hearing 
on a very important subject.
    I am representing myself and nine other co-authors of a 
paper that we wrote. These are individuals that are--that come 
from the private sector and the public sector, professors that 
come from both the United States and the European area, as well 
as retired senior scientists from the United States EPA.
    My testimony today is going to focus on the scientific 
process that IARC uses, which the nine authors that I co-
authored the paper with have concluded is badly outmoded and in 
need--in bad need of significant revision or termination. The 
reason is because the program uses an antiquated and irrelevant 
hazard classification scheme to simply declare a substance to 
be carcinogenic or not and provides no context about when, why, 
or how that substance might actually cause that effect.
    Let me illustrate it this way. I would imagine that most of 
the people in this room have consumed water or food or both 
that contained a substance that IARC Monographs Programme has 
declared to be carcinogenic. How does that make you feel? Well, 
the problem with that is that it's a simple declaration about 
something that is in your food that could cause cancer. What 
I'm talking about is caffeic acid. Caffeic acid is found in a 
number of foods that we eat every day that are part of a 
healthy diet, including things like grapes, apples, 
blueberries, lemons, oranges, and it goes on. And oh, by the 
way, caffeic acid is also part of the cup of coffee that I have 
in front of me today. Declaring that caffeic acid is a 
carcinogenic substance is really of no help when you just state 
it that way. It needs to have context.
    As a toxicologist, I'm frequently asked by family and 
friends what it means when they hear something is declared to 
be possibly or potentially carcinogenic. What they want to know 
is how likely is that to happen to me, my family, my friends. 
It's an important subject. My answer is always the same. It 
depends on how potent the chemical is, the substance is, and 
how much exposure is required to cause that effect.
    Let's take potency first. Unfortunately, the IARC Monograph 
Programme fails to provide the crucial context of potency and 
instead lumps highly potent substances like plutonium, sulfur 
mustard, and neutron radiation in the same cancer 
classification as processed meat and salted fish. Clearly, 
there's a difference, but the IARC Monographs Programme fails 
to account for potency.
    My wife is a registered nurse and an integrative healer who 
likes to use plant-based remedies. When I tell her that aloe 
vera and ginkgo biloba are classified by IARC as possibly 
carcinogenic, she rolled her eyes and said--oh, and by the way, 
they're classified in the same category with fuel, oil, and 
gasoline, she simply kind of rolled her eyes back and say, 
``No, that can't be.''
    Such a classification scheme defies common sense, and yet 
IARC has maintained this hazard classification scheme for well 
over--in nearly half-a-century. Along with neglecting the 
important feature of potency, IARC Monographs Programme also 
fails to account for potential exposure. Why is that important? 
Because the central tenet of toxicology is the dose makes the 
poison. And the best way of giving you a good analogy of that 
is aspirin. A little bit of aspirin is not going to do 
anything. A couple tablets of aspirin will relieve your 
headache, and a bottle of aspirin can kill you. But where IARC 
stops is labeling something as being able to kill you. What 
good is that information without the context of benefits and 
dose?
    Nearly all 21st-century regulatory processes such as Dr. 
Lowit described just previously account for potency and 
exposure in their evaluation and therefore the likelihood that 
an adverse effect like cancer could occur. It's known as risk 
assessment. However, the IARC Monograph Programme is not risk-
based and instead is stuck in a hazard classification scheme 
created a half-a-century ago with no consideration of potency 
or exposure.
    In addition to being out of step with 21st-century science, 
the IARC Monograph Programme has also lost credibility because 
of serious flaws in process. I'm here to talk about the 
science, not the process, but that is a concerning issue.
    Outdated science and flawed process are not without 
consequence. Telling you that IARC has pegged caffeic acid as a 
carcinogenic substance in your food and coffee does nothing 
other than sow fear and uncertainty, which is unhelpful and 
irrelevant at best and irresponsible at worst. The IARC 
Monograph Programme needs to be either significantly reformed 
or abolished.
    Thank you very much, Mr. Chairman.
    [The prepared statement of Dr. Pastoor follows:]
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    Chairman Smith. Thank you, Dr. Pastoor.
    And Dr. Sass?

                TESTIMONY OF DR. JENNIFER SASS,

      SENIOR SCIENTIST, NATURAL RESOURCES DEFENSE COUNCIL

    Dr. Sass. Thank you very much for the opportunity to speak 
to--before this Committee today about this very important topic 
of scientific integrity, the IARC Monographs, and the important 
evaluation of glyphosate. I very much appreciate coming before 
you today.
    I've been employed for 17 years at NRDC, the Natural 
Resources Defense Council, and I have advanced degrees in 
anatomy and cell biology with specific expertise in 
environmental health, developmental biology, neurobiology, and 
molecular biology and am also familiar with the Pesticide 
Office operations that Dr. Anna Lowit is Science Advisor before 
because on many, many occasions I've testified either with 
written or oral comments are both to the Pesticide Office 
following their review of pesticides and registration, 
including glyphosate. In addition, I've represented NRDC for 
over a decade on stakeholder advisory panels to the Pesticide 
Office so have participated as a public and stakeholder member 
in those processes.
    I also have knowledge of the IARC practices, having been 
invited to a meeting, a week-long meeting to look at arsenic 
and water disinfection byproducts by the Chair at the time the 
Chief of the Monograph Programme Dr. Jerry Rice, who is a 
colleague of Dr. Tarone's. There have been two Chairs since 
then, and the current Chair, Dr. Kurt Straif, was also working 
at the Monograph Programme during that time, so he brings with 
his leadership continuity to that program and to IARC's 
commitment to environmental public health and scientific 
excellence.
    IARC has undertaken over 1,000 substances for evaluation, 
including important ones like asbestos, tobacco smoke, 
secondhand smoke, diesel exhaust, formaldehyde, vinyl chloride 
and arsenic, methylene chloride benzene, and many others. 
There--many of these--not all of them, but many of them also 
come with people--stakeholders that have deep economic 
interests in these substances, and although there have been 
many, the Director Dr. Christopher Wild of IARC right now 
stated that the pressure that IARC has received in response to 
listing glyphosate as a probable human carcinogen group 2A has 
resulted in unprecedented coordinated efforts to undermine the 
evaluation, the program, and the organization.
    These efforts are largely sponsored and coordinated by the 
agrochemical industry that sought to support its own 
regulation--its registration and approval of glyphosate in the 
United States and around the world, to defend itself in 
litigation against farmers that were once Monsanto customers 
and are now cancer patients, and to prevent the labeling of 
glyphosate-containing products as a carcinogen in the State of 
California, which would inform the public.
    Dr. Jonathan Samet called these strategies that could be 
traced to the playbook of the tobacco industry to discredit 
findings related to active and passive smoking. And I would 
characterize them the same way.
    This hearing is part of a kickoff that happened a few 
months after the IARC Monographs were made public where an 
article in The Hill was published asking for exactly this, for 
the stripping of funding for the IARC Programme by Dr. Bruce 
Chassy, who failed to acknowledge that he was funded by 
Monsanto.
    As far as the science goes, IARC did not ignore relevant 
studies. They included all the relevant studies, including the 
Agriculture Health Study and other review articles that they 
looked at that were sponsored by many--many were sponsored by 
Monsanto or the agrochemical industry, as well as published 
articles. But the key with IARC is that they need to be 
publicly available. It doesn't necessarily have to be published 
but publicly available. How else can they verify the findings?
    In contrast, EPA's 2017 assessment did rely on some of 
these review articles that--where the underlying studies were 
not made public. And I know the Dr. Tarone is going to talk 
about some of those. I would ask Dr. Tarone how long it took 
him to evaluate the underlying data and studies in those 
because the Greim, et al., for example, was only provided 30 
days before the IARC meeting, so there's no way it could have 
been properly evaluated based on a review article.
    The IARC has been following systematic methods that are 
improved worldwide, and in conclusion, I would like to say 
that, fundamentally, this hearing is about the ability of a 
public health agency to call a carcinogen a carcinogen even if 
that carcinogen makes a huge amount of money for powerful 
corporations.
    Thank you.
    [The prepared statement of Dr. Sass follows:]
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    Chairman Smith. Thank you, Dr. Sass.
    And Dr. Tarone.

                TESTIMONY OF DR. ROBERT TARONE,

              (RETIRED) MATHEMATICAL STATISTICIAN,

                 U.S. NATIONAL CANCER INSTITUTE

                  AND BIOSTATISTICS DIRECTOR,

              INTERNATIONAL EPIDEMIOLOGY INSTITUTE

    Dr. Tarone. Good morning. My European Journal of Cancer 
Prevention paper differs from most of the published criticisms 
that you may have seen in the press and elsewhere of the IARC 
glyphosate classification. My paper critiques the deliberations 
of the working group completely on IARC's terms.
    I accept that IARC is evaluating hazard rather than risk, 
that the IARC criteria for determining hazard are reasonable 
and that the body of studies relied upon by IARC is 
sufficiently complete to provide a valid assessment of 
glyphosate. My critique concludes that the IARC classification 
of glyphosate as a probable carcinogen resulted from a flawed 
and incomplete evaluation of the very rodent cancer studies 
that they relied upon.
    Although the working group concluded that there was 
sufficient evidence that glyphosate was an animal carcinogen, I 
conclude that a proper summary of the rodent studies would have 
difficulty supporting even the conclusion that there is limited 
evidence that glyphosate is an animal carcinogen. And I just 
want to discuss briefly one of several examples in which 
exculpatory rodent data were excluded by IARC.
    IARC concluded that glyphosate caused cancer in animals 
primarily on the basis of two studies in CD- mice. In the first 
study, groups of 50 male and female mice were fed diets with--
containing increasing dose levels of glyphosate for two years. 
The original study report noted a positive trend in renal 
adenomas in male mice. The tumor counts were 0,0,1,3 at 
increasing dose levels, and this corresponds to a P value of 
.019 based on an exact test for dose-response.
    Additional pathological examination of renal tumors in this 
study revealed one new adenoma in an unexposed mouse, and three 
of the original renal tumors were upgraded from adenomas to 
carcinomas. So for the final tumor counts after pathology 
review, they were 0,0,1,2 for carcinomas, P value of .063, and 
1,0,1,3 for carcinomas and adenomas combined, P equals .065.
    Now, these marginally significant findings were considered 
to be particularly consequential by the IARC working group 
because of the alleged extreme rarity of such tumors in CD-1 
mice, and it was concluded from this study and the study alone 
that glyphosate caused renal tumors in male mice.
    Now, there was no a priori expectation that glyphosate 
should cause kidney tumors, and ordinarily such a small 
increase in tumors would not be considered especially 
noteworthy since around 20 organs and tissues are typically 
evaluated in each rodent study. Nonetheless, even that small 
observed increase would be of concern if there was also 
evidence of an increase in renal tumors for female mice in that 
same study. Thus, I was surprised to see that the female data 
were not reported with a remarkable sentence stating, quote, 
``No data on tumors of the kidney were provided for female 
mice.''
    IARC has been evaluating rodent studies for over 40 years 
and is aware that the renal tumor rates for female mice 
would've been provided in the same report that provided the 
male tumor rates. IARC's staff should've been highly motivated 
to acquire these tumor rates. I obtained the female tumor rates 
for my review of glyphosate rodent studies in the journal 
Critical Reviews in Toxicology. This is the Greim, et al., 
paper that Dr. Sass referred to.
    For females, no renal tumors were observed, so there was no 
evidence of an increase in kidney tumors for female mice 
exposed to the same high levels of glyphosate as males. But 
even though there was no evidence that glyphosate caused renal 
tumors in female mice in this study, the working group still 
might have argued for a sex-specific effect if there was 
evidence of such an effect in the second CD-1 mouse study they 
relied upon. But inexplicably, in spite of devoting three--and 
I apologize for the--there's an error in the printed comments; 
it's three not two paragraphs to the discussion of renal tumors 
observed in the first mouse study, there is no mention at all 
of kidney pathology in the one paragraph devoted to the second 
mouse study, which is simply astounding. IARC staff should've 
been highly motivated to acquire the renal tumor rates from the 
second study because of the male results in the first study.
    The renal tumor rates for the second study were also 
provided in a review paper. For males, the renal tumor counts 
at increasing glyphosate exposure level were two, two, zero, 
and zero, and this is P equals .042, but for an inverse 
association, decreasing tumor rates with increasing exposure 
level. And it's also noteworthy that two of these supposedly 
extremely rare renal tumors were observed in the unexposed mice 
in this study. Taken together, these two studies provide no 
evidence whatsoever to support the conclusion that glyphosate 
causes renal tumors in male mice, contrary to the working group 
conclusion. And for completeness no tumors were observed for 
female mice in the second study.
    In conclusion, my published paper notes other instances in 
which rodent tumor rates that supported the conclusion that 
glyphosate caused tumors were included in IARC deliberations 
while tumor rates from those same studies that did not support 
that conclusion were excluded. The systematic exclusion of 
exculpatory evidence is inexcusable, particularly when it's 
practiced by an influential source such as the IARC Monograph 
Programme. My paper was published online in August of 2016, and 
not one of the specific claims of data exclusion in that paper 
has been refuted. And reports since my paper was published and 
depositions of key working group members related to lawsuits 
filed against Monsanto have fully substantiated the facts 
presented and questions raised my paper.
    [The prepared statement of Dr. Tarone follows:]
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    Chairman Smith. Thank you, Dr. Tarone.
    Dr. Lowit, in your testimony you mentioned that when mice 
were injected with large doses of glyphosate that some did 
manifest symptoms of cancer-like conditions but that when the 
mice were just exposed to glyphosate, there was no effect. 
There were no symptoms. It seems to me that that's a huge 
difference. No one is suggesting that humans be injected with 
large doses of glyphosate. Why is it that IARC doesn't 
acknowledge the distinction between high doses that are being 
injected and simple exposure or inhalation, which has not 
resulted in any cancer-like symptoms? And it seems to me that 
they are intentionally misleading the American people, and 
maybe they have some kind of a vendetta against chemical 
companies, but why or how do you explain the lack of honesty 
and openness and transparency by IARC?
    Dr. Lowit. So thank you, Chairman Smith, for that question. 
So I'm sorry if my South Carolina accent comes out. So it's 
ingest, so I--through the oral route, not inject through the--
--
    Chairman Smith. Okay. Ingest----
    Dr. Lowit. Ingest through the oral route.
    Chairman Smith. Okay.
    Dr. Lowit. So I apologize for that lack of clarity.
    Chairman Smith. But my----
    Dr. Lowit. So the question is--so I think it's important 
that--I'm not going to comment on the value of the IARC 
process. I can tell you that EPA has been fully transparent in 
our evaluation. Our draft issue paper was reviewed by the 
Scientific Advisory Panel. In fact, the transcript from that 
meeting is publicly accessible. We're now looking forward to 
public comment on our white paper for the cancer.
    Chairman Smith. Any--was that--I didn't understand that. 
It's just a statement as to why you think they have been less 
than transparent?
    Dr. Lowit. I think that's--I'm not going to debate the 
transparency of IARC.
    Chairman Smith. Okay.
    Dr. Lowit. What we have done at EPA whereas in cases where 
IARC has looked at review articles, we've acquired the raw 
study reports, so we've been able to look at information. The 
full study reports for IARC cannot do that.
    Chairman Smith. I'm just curious. When you talked about 
large doses of ingestion by the mice, how much are you talking 
about? A large percentage of their body weight or how much were 
they--did they ingest?
    Dr. Lowit. So in terms of toxicology studies, often 
studies--and with glyphosate are in the ingestion of hundreds 
of milligrams per kilogram per day and what we define as the 
limit dose. Internationally, most regulatory organizations 
recognize 1,000 milligrams per kilogram per day as 
international standard for the limit dose. And in most--in many 
cases, glyphosate studies are actually done at that limit 
dose----
    Chairman Smith. Okay.
    Dr. Lowit. --which is why we conclude there's very little 
hazard.
    Chairman Smith. And it's very unlikely that any human would 
ingest anything near to that equivalent amount?
    Dr. Lowit. Oh, no.
    Chairman Smith. Okay. Dr. Pastoor, you pointed out--and I 
was going to highlight as well--that I think IARC has found 
that something like 999 out of 1,000 substances created cancer. 
Only one was deemed to be probably not cancer-causing. Do you 
think that their process is flawed, their investigations are 
flawed, and do you think they have predetermined conclusions 
they're trying to reach?
    Dr. Pastoor. They may or may not. I can't really comment in 
particular on glyphosate. I'm not here representing a critique 
or a defense of glyphosate. But what I would say is that there 
is a flaw in their scientific process. When you don't take into 
consideration potency--which, Chairman Smith, you just brought 
up--is that if a significant portion of a body weight of an 
animal is being overwhelmed with a particular chemical, whether 
it's glyphosate or anything else, and you're declaring 
something to be carcinogenic, that's erroneous science. That's 
offsetting. That's misinforming the public, and it doesn't 
serve any process and it's actually more harmful than helpful.
    Chairman Smith. Okay. I agree. And I like that phrase 
``erroneous science.'' I'm going to adopt it in this case and 
maybe in other instances as well.
    Dr. Tarone, you wrote a paper in 2016 and you came to the 
conclusion that IARC's designation of glyphosate was a result 
of a, quote, ``flawed and incomplete evaluation of experimental 
evidence.'' What is the general scientific community's response 
been to that paper? And what was IARC's response?
    Dr. Tarone. There's been surprisingly little response 
actually. I've been amazed.
    Chairman Smith. Okay.
    Dr. Tarone. But with regard to IARC, I mean, this paper has 
gone through an incredible--I mean, it's the weirdest 
experience I've ever had in 44 years of publishing in peer-
reviewed journals. And it's--I mean, I just--really, it's 
stunning. But IARC did eventually submit a letter to the 
journal responding to my paper, and I received this in January 
of 2016. And--no, 2017, I'm sorry, and I responded to their 
letter. And I assumed that both letters would be published in 
the journal along with the paper. IARC's letter was not 
responsive to any of the specific criticisms I raised.
    Chairman Smith. Okay.
    Dr. Tarone. They complained about, you know, ``Who wrote--
who paid you to do this and what role did they play in writing 
and editing the paper?'' They raised technical issues about 
what constitutes a research study and that this wasn't a 
research study, but they didn't deal with any of the specifics.
    Chairman Smith. Okay.
    Dr. Tarone. And for some reason neither letter was 
published, and I've never been fully clear about why.
    Chairman Smith. Okay.
    Dr. Tarone. I don't know. I can't figure out why that 
happened.
    Chairman Smith. The point being IARC was not responsive to 
the substance of your----
    Dr. Tarone. Not to the substance, and as I said, nobody has 
specifically refuted any of the claims that I've made about the 
exclusion----
    Chairman Smith. Okay.
    Dr. Tarone. --of rodent studies that should have been 
included.
    Chairman Smith. Okay. Thank you, Dr. Tarone. That concludes 
my time.
    And the gentlewoman from Texas, the Ranking Member, Ms. 
Eddie Bernice Johnson, is recognized for her questions.
    Ms. Johnson. Thank you very much, Mr. Chairman.
    Let me precede my question with this statement. I don't 
believe any company puts anything on the market that they 
knowingly know that it harms people. I think it's like the 
little book Who Moved My Cheese? Sometimes, it's hard to change 
when you find out what the facts are. And so--and every company 
that has any respect for itself is going to defend itself when 
it can.
    But I want to ask Dr. Sass. Can you discuss the importance 
of keeping the development of scientific assessments on 
chemicals such as glyphosate and other toxic chemicals free 
from undue influence by industries or others? An example is 
what are the consequences if chemical risk assessments are 
driven by industry, and more importantly, if industry-sponsored 
chemical assessments are given the same weight and authority as 
truly independent scientific studies?
    Dr. Sass. Thank you. I would like to comment on that, and I 
think that glyphosate is a perfect example of where that's 
happening because we can really see the difference in when you 
have an IARC assessment, which is a public health agency of the 
World Health Organization that links it to some level of 
carcinogenicity probably carcinogenic in humans. And then you 
have--based--including on Monsanto's studies and other studies 
supported by the registrant, and then you have agencies that 
are calling it not likely carcinogenic, EPA, which is a 
regulatory agency.
    And I want to talk about some of those differences because 
the impact on public health is severe potentially. First of 
all, Mr. Smith's comment about the doses that there--that they 
were--that--well, what Anna suggested what--that they were at 
high doses, I want to talk about the limit dose for a quick 
second because it has a toxicological definition, and these 
studies did not exceed it. So an arbitrary 1,000 mgs per kg per 
day was not what IARC used. They used a toxicological 
definition. And these studies didn't exceed it at the high 
dose, so they should have been included.
    Dr. Pastoor's statement referencing 16th century Paracelsus 
medicine, to then criticize IARC being half-a-century behind is 
just ridiculous. Paracelsus did say the dose makes the poison, 
and there's a lot of truth in that, but that's not the whole 
truth. The truth is that what's being missed here is 
considering vulnerable populations potentially. We need to 
protect the EPA, and regulatory agencies need to be able to 
protect the whole population, so--including pregnant women and 
children, elders, people with preexisting diseases and chronic 
diseases, people that are high-end users or highly exposed in--
as well as the Keith Richards of the world. We need to bracket 
all of those people and protect them.
    And, Dr. Tarone, I do have some answers for the exclusion 
of those rodent data, but primarily, they weren't available to 
IARC and IARC relies on public data. The data sets were huge. 
They were hidden in appendices. The IARC only had it 30 days in 
advance. But in addition, had IARC had those data, it would 
have likely come up with an even stronger link to cancer 
because there was even more tumors than Dr. Greim, the author 
of that review article, had revealed. Those have all come to 
light now through EFSA, so the European Food Safety Authority. 
They've been reanalyzed separately by non-industry scientists. 
And we now know that there's data that also show tumors in the 
animals linking to malignant lymphomas and hemangiosarcomas, 
which, Dr. Tarone, I think you didn't analyze. I think you may 
have focused on the kidney tumors only.
    So, in addition, Dr. Greim, the author of that paper, is 
not only of questionable scientific integrity for failing to 
report all those tumors but also ethical potential as well. 
He's the main author in some diesel emissions studies that put 
monkeys into chambers being reported in the New York Times 
right now. So----
    Dr. Tarone. Can I respond?
    Mr. Lucas. [Presiding] Dr. Tarone, would that be 
appropriate for the Ranking Member?
    Ms. Johnson. Yes.
    Mr. Lucas. It's her time. Please respond.
    Dr. Tarone. Well, it's totally incorrect to say that IARC 
should not have acquired those data because if--and I want to 
say something about the Greim paper. I relied on the Greim 
paper only for the data. They included supplemental tables with 
that review paper that included the underlying basic tables of 
tumor rates from every study that they reviewed. So I was not 
relying on Greim, et al., for their conclusion in any sense. I 
was only relying on it for the data.
    Dr. Sass. Well, the summary tables can be used, and EPA had 
those data for years, probably decades and didn't ask for the 
underlying data, so to blame IARC for not having gotten it in 
30 days----
    Mr. Lucas. The gentlelady's time is expired.
    The Chair would note to my colleagues we now have a series 
of three votes underway that, once the votes are over, we will 
return and continue this hearing. And with that, the hearing 
will stand in recess subject to the call of the Chair.
    [Recess.]
    Mr. Lucas. This full Committee hearing of the Science 
Committee is reconvened. I will return to regular order, and I 
believe I was the next one in line to ask questions, so I'll 
recognize myself for five minutes.
    And with that, I turn to Mr. Tarone. Would you care to 
expand and explain a little bit more about your analysis of the 
Monograph 112 program and all those issues?
    Dr. Tarone. Yes. I specifically want to answer a couple of 
issues that Dr. Sass raised. First with regard to 
hemangiosarcomas, I did consider hemangiosarcomas, and it in 
fact is one of the examples in which IARC excluded exculpatory 
data. In the second mouse study where they did not discuss 
renal tumors, they emphasized the finding in hemangiosarcomas 
that Dr. Sass referred to. And there were four hemangiosarcomas 
in the highest dose group, and that was all--none in the other 
three groups.
    But in the first mouse study, the one where they spent 
three paragraphs on renal tumors, they didn't mention 
hemangiosarcomas, so it's the same thing that happened with 
renal tumors. So--and it turns out that in that study there was 
one hemangioma in the low-dose group and one hemangiosarcoma in 
the mid-dose group and none in the highest-dose group. And by 
the way, that highest-dose group, glyphosate was three percent 
of the diet that they ate for every day for two years. It's an 
incredibly high dose. So you would have--if what they saw in 
the second study was a true high dose effect, you would have 
expected to see it in the first study. And--but again that was 
not even mentioned in the IARC Monograph.
    And Dr. Sass also raised the issue of the accuracy of the 
tumor rates that I got from the supplemental tables in the 
Critical Reviews in Toxicology paper. And in fact, as I pointed 
out at the end of my comments, everything in my paper has in 
fact been substantiated by things published since, including 
comments submitted to the EPA glyphosate SAP by Chris Portier, 
who was the scientific expert for the IARC working group. And 
his comments were presenting his statistical analysis of all of 
the rodent studies that EPA was considering. And they 
considered many more than IARC, but they also considered all 
the studies that IARC relied upon.
    If you look at his tables upon which his analysis was 
based, in every case in which I indicated in my paper that IARC 
had excluded tumor rates, those tumor rates are in those tables 
in the comments he submitted to EPA. They were included in his 
EPA analysis, which is an admission that they should have been 
included in the IARC analysis. Moreover, they were exactly the 
rates that I reported that I got from the supplementary tables 
in the Greim, et al., review. So certainly, Christopher Portier 
now thinks that those rates are okay.
    Mr. Lucas. Thank you, Doctor.
    Dr. Pastoor, could you visit with us for a moment about the 
ways in which the current Monograph Programme classification 
system on carcinogenicity might be outdated? Expand on that, 
please.
    Dr. Pastoor. Well, the primary reason that it's outdated 
and outmoded and needs to either be scrapped or considerably 
revised is because they stick with a hazard classification 
system. All they do is declare something as being carcinogenic 
or not. Modern 21st-century risk-assessment-oriented regulatory 
programs such as what Dr. Lowit has described with the United 
States EPA uses that risk-based system to put hazard in context 
of risk: how much would cause that effect; what is the potency 
of that particular chemical? IARC was created over--nearly 50 
years ago, and they really haven't progressed beyond the point 
of only classifying things by its carcinogenicity but not 
putting it in the context of risk.
    Mr. Lucas. Thank you. I think with that now I will yield 
back and turn to--I think in the next order would be the 
gentleman Mr. Tonko for five minutes for questions.
    Mr. Tonko. Thank you, Mr. Chair. And welcome, everyone.
    This hearing has been framed around the need to uphold 
scientific integrity standards in publicly funded research. If 
that is a serious concern for this Committee, then I implore us 
to take up H.R. 1358, which I've authored, the Scientific 
Integrity Act. This Congress has a duty assigned directly to 
this Committee to ensure that public or publicly funded science 
is conducted, reviewed, communicated to the public and 
incorporated into policymaking transparently and free from 
distorting political, ideological, financial, or other undue 
influence.
    Public science informs national policy on everything from 
pesticides to power grids. Our nation's cities and States need 
credible information to prepare for climate change. Our 
families deserve to know if unsafe chemicals are being sprayed 
on their food, dumped in their water, or added into the 
products they buy. As representatives, we need to reach 
conclusions on these high-stakes questions based on rigorous 
independent scientific facts, not predetermined opinions. We 
have a duty to ensure that political interference of the 
scientific process and attacks on the work of federal 
scientists do not get in the way of our responsibility to 
safeguard our public health and our national security.
    The rules and norms of our public science are standards 
that have made America a leading light in the global scientific 
community for decades. We have seen those standards being 
actively and deliberately eroded over the past year. Scientists 
should always be held to the highest ethical and professional 
standards. In return, it is our job to uphold standards that 
ensure scientists are not impugned for reporting their 
impartial findings.
    The Scientific Integrity Act restores our baseline for 
scientific independence by requiring every federal agency that 
funds or conducts scientific research to establish clear 
scientific integrity standards and set basic requirements for 
how the agency will adhere to those principles.
    Science is not about getting the results you want. 
Scientific integrity is about ensuring a process and atmosphere 
in which the science leads us to real, unvarnished results. The 
issue we should be focused on is whether glyphosate is safe, 
and finding the answer to this question is too important for us 
to let this be a partisan issue. These are chemicals that 
people have in their homes. This is on the food our children 
eat. We should be able to trust that the science we rely upon 
to make public health decisions is not being distorted or 
manipulated.
    While the tactics used by industry to influence science may 
have dramatic negative consequences on the independence and 
credibility of scientific review boards or advisory panels, the 
real victims of this kind of designed ignorance are everyday 
people. Without credible science to determine safe levels of 
exposure, millions of people around our country will be at 
risk.
    Dr. Sass, how do science agencies like IARC function in 
order to protect the public health?
    Dr. Sass. Thank you. IARC and other public health 
institutes put out very credible information about the 
potential hazards of chemicals and other substances. After 
reviewing all the data, IARC, for the glyphosate assessment, 
brought experts from all over the world from multiple different 
countries. They have different areas of expertise. They all 
come together as a working group. They--all of the discussion 
of all of the data--publicly available data is done in front of 
everybody. There's a plenary session where people get to also 
discuss what the different subject matter experts have come up 
with in their area.
    And the result of these very credible, transparent, 
publicly generated hazard assessments is to then support 
potentially risk assessments but also to support nonregulatory 
or even non-risk-related decisions that can be made, for 
example, not only by government regulatory agencies but also by 
forward-thinking companies and businesses looking to work with 
safer or less toxic or less hazardous chemicals are starting to 
replace it in their products. There's retailers that care about 
this. There's a whole area of green chemistry that's very 
interested in this, and of course medical professionals, 
occupational health experts, all of these people care about 
understanding the hazard of materials even if they don't--
haven't--there hasn't been a full risk assessment to understand 
potency and dose-response and the other things that come 
afterwards.
    Mr. Tonko. And why is it important that independent bodies 
review chemicals for potential exposure risks?
    Dr. Sass. Well, all the available data should be looked at. 
I believe that, but that's also what the agencies believe and 
it's what IARC did. Many of the studies that relied on were 
supported or sponsored by the regulated industry, and that's 
fine. That's normal. That happens. But there are systematic 
review procedures for reviewing and evaluating confidence in 
those studies on a lot of different parameters. And if all of 
those different parameters aren't available to do a proper 
robust review and assessment of the confidence, then it's more 
difficult.
    And so we should--instead of a priori making decisions 
about what data is in or out of the pot, it should all be 
looked at and reviewed, which is what IARC did.
    Mr. Tonko. Thank you. Mr. Chair, I have several documents 
which I would like included in the record, including the 
Monsanto battle plan, laying out their preliminary attack on 
IARC, the IARC preamble defining the roles of working group 
members and participants, a list of participants from the IARC 
glyphosate Monograph, commentaries by several scientists on the 
strength of the IARC glyphosate evaluation, the FIFRA Science 
Advisory Panel report from December 2016 concluding that EPA 
did not follow its own guidelines for carcinogen risk 
assessment in evaluating glyphosate, and a letter from the 
United Nations special rapporteur stressing how essential the 
work of the National Institute of Environmental Health Science 
is to protecting human rights.
    Mr. Lucas. Without objection.
    [The information appears in Appendix II]
    Mr. Lucas. And the gentleman's time is expired.
    Mr. Tonko. Thank you, Mr. Chair.
    Mr. Lucas. The Chair now turns to the gentleman from Texas, 
Mr. Babin, for five minutes.
    Mr. Babin. Thank you, Mr. Chairman. I appreciate it. And 
thank you to the witnesses for being here.
    Dr. Anna Lowit, if you don't mind, the EPA's risk 
assessment process explicitly includes opportunities for 
experts who did not contribute to the assessment to review and 
comment on a draft of the scientific analysis, is that correct?
    Dr. Lowit. That's correct.
    Mr. Babin. Okay. The EPA's risk assessments like the one on 
glyphosate developed by the Office of Pesticide Programs are 
also subjected to rigorous independent peer review. Is that 
correct?
    Dr. Lowit. So EPA's cancer evaluation has been subject to 
the FIFRA Scientific Advisory Panel. That's true.
    Mr. Babin. Okay. As I understand it, the National 
Academies, which is similar to IARC, develops reports by expert 
panels and has outside peer reviews and evaluate each and every 
report to ensure scientific accuracy. However, unlike EPA and 
NAS, IARC Monographs do not employ any independent outside peer 
reviews. Instead an IARC Monograph working group collaborates 
behind closed doors to select studies, analyze data, and reach 
conclusions. So without any public engagement or independent 
scientific peer review, the working group acts hand-in-hand 
with IARC staff as judges, juries, and executioners. Clearly, 
these IARC procedures fall well short of meeting 21st-century 
standards for transparency and scientific credibility. And I 
would like to know if you agree with that.
    Dr. Lowit. So what I can answer is EPA's transparent 
approach, that our cancer evaluation was reviewed by the 
FIFRA--excuse me--Scientific Advisory Panel. The transcript 
from that meeting is actually publicly available. Our document 
is now available for public--will be open for public comment. 
It's been released on our docket, and so our process is quite 
transparent.
    Mr. Babin. Do any of the other witnesses agree with that 
statement? Now, let me repeat it. Without any public engagement 
or independent scientific peer review, the working group acts 
hand-in-hand with IARC staff as judge, jury, and executioner. 
IARC procedures fall well short of meeting 21st-century 
standards of transparency and scientific credibility. Would you 
other three agree with that? Dr. Pastoor?
    Dr. Pastoor. Yes, I would generally agree with that. I 
think IARC needs to be brought up to the standards of 
transparency that is exhibited by the United States EPA.
    Mr. Babin. Okay. Thank you. Dr. Sass?
    Dr. Sass. I disagree because the meetings are open at IARC. 
Observers are invited. Monsanto was present. Other regulatory 
interests can also be present, so they're public in that sense 
that anybody who wants to be present can.
    And I also want to point out that EPA's Scientific Advisory 
Panel review of the ``not likely'' classification didn't agree 
with that classification.
    Mr. Babin. Dr. Tarone?
    Dr. Tarone. Yes, I wouldn't agree completely with the 
statement, but what I believe is that right now the Monograph 
Programme appears to think they have--they're accountable to no 
one, so I do need--I do think that they need to be brought in 
and show some accountability to somebody. The fact that they 
did what they did with the glyphosate working group, I mean, 
that should not happen. The exclusion of exculpatory rodent 
studies many times, there's just absolutely no way that should 
happen, so I would just like to see more accountability.
    Mr. Babin. Absolutely. Okay. Is it scientifically proper to 
redo a peer-reviewed study's data analysis with a different 
statistical analysis than was originally used for the study and 
then use this reanalysis without first ensuring that it 
undergoes robust independent peer review? Dr. Lowit?
    Dr. Lowit. So the first half of your question is about 
reevaluating scientific data, and I would agree with that 
statement, that that is actually part of an independent 
evaluation of those data is often to reevaluate the statistics. 
And EPA has actually in fact redone some of the statistics for 
the glyphosate cancer evaluation.
    Mr. Babin. Okay.
    Dr. Lowit. The second part of your question is about peer 
review. Peer review is important, and in the case of the cancer 
evaluation, we did have our statistics evaluated as part of the 
Scientific Advisory Panel.
    Mr. Babin. Thank you very much.
    And Dr. Tarone, could I ask you that question?
    Dr. Tarone. I have no problem with people doing independent 
different types of statistical analysis, although, you know, it 
does have to be peer-reviewed because sometimes you can pull 
tricks, you know, get the result you want. I mean, there's a 
lot of data dredging, p-hacking it's sometimes called that goes 
on. So peer review is essential, though, when you're evaluating 
multiple different types of statistical analyses.
    Mr. Babin. Absolutely. And my time is expired, Mr. 
Chairman. Thank you.
    Mr. Lucas. The gentleman's time is indeed expired.
    The Chair now recognizes the gentleman from California, Mr. 
McNerney, for five minutes.
    Mr. McNerney. Well, thank you, Mr. Chairman, and I thank 
the witnesses.
    Dr. Sass, have you ever heard the term chemical trespass?
    Dr. Sass. Yes, I have. It's when you find a chemical in--
usually an industrial chemical not naturally occurring in your 
body that you didn't give permission for it to be there.
    Mr. McNerney. So do you think that term applies to our 
hearing this morning?
    Dr. Sass. I do and not just to glyphosate but certainly 
glyphosate. I mean, my guess is that there's not many people in 
the United States that are unexposed to glyphosate because of 
how widespread its use is. It's almost 300 million pounds 
annually, and every--in agriculture, and every one of those 
pounds are put out onto our fields, our food supplies, get into 
our rivers and streams and drinking water, sources of drinking 
water.
    Mr. McNerney. Well, some studies claim that human exposure 
to glyphosate has increased by 500 percent in 25 years. What 
kind of risks are associated with this kind of proliferation of 
exposure?
    Dr. Sass. So we don't understand the risks, and that's one 
of the things that I think that EPA, you know, should be doing 
is taking on a proper risk assessment after a proper hazard 
assessment where they acknowledge that there's a carcinogenic 
risk and then do a proper slope factor. There's proper 
mechanisms to do that. But the increase is being shown in 
people's urine, and we're--so we know that for sure. And that's 
why I think that there's probably no unexposed population, that 
we're exposed on a daily or routine basis.
    Mr. McNerney. Is it also present in mother's milk?
    Dr. Sass. It is. It's widespread and it's--because it's 
water-soluble, it is present in all those fluids.
    Mr. McNerney. So even the youngest members of our society 
are being highly exposed to this chemical?
    Dr. Sass. It is, and that's what brings up this dose poison 
fallacy, this 16th-century, you know, dose poison thing is that 
although it is true that, you know, we can't be poisoned if we 
don't dose ourselves, that's true if we're not exposed, it's 
also true that there's vulnerable populations. And how each of 
us react to those are differently--are very different so that a 
pregnant woman or a reproductive-age man or woman might be much 
more vulnerable to certain effects, reproductive effects, for 
example. Or if we're exposed to a carcinogen when we're young 
while our tissues are developing and growing and taking in--as 
they take in nutrients taking in those toxic chemicals, that 
could be a much more damaging time. And then the health impacts 
can be hardwired into the system, whereas, for example, if I'm 
exposed to a dose of lead, I have probably no reaction to the 
same dose of lead that could cause irreparable permanent harm 
in a developing child.
    Mr. McNerney. Thank you. Some folks are critical of the 
World Health Organization, and other folks are critical of the 
EPA's risk assessment. Can you explain how those assessments 
differ?
    Dr. Sass. Sure. I mean, primarily, for some reason the--a 
lot of the criticism which I think isn't fair is on whether 
IARC considered some studies that actually weren't available to 
it at the time. And my only answer is they've got to look at 
publicly available data. That's a rule they made in advance. 
Industry knows that in advance. If it wants to get those 
studies to them in advance, they could have done so. The 
chemicals are nominated. They have plenty of time to do that if 
they want to. The--fundamentally, though, some of the ways 
they're looking at it are, for example, EPA is not looking at 
the high-dose tumors. The animals have tumors at high doses, 
but there's no other indication of toxicity to the animals at 
those doses, so there's no real reason not to consider those 
tumor effects to be real or valid. Like I say, instead of using 
an arbitrary number, to actually use toxicological ways of 
assessing whether those doses should be considered. So that's 
one important thing is to consider those doses.
    The other thing is to--when you look at it, does there have 
to be a clear dose-response? EPA is throwing out data if there 
wasn't an--increasing tumors with increasing doses in every 
study, for example, and that's not appropriate because many 
reasons. One is that we don't--we--animals react differently, 
so you have to use your statistics to do that. EPA has used a 
certain statistical test. I argue some different statistical 
tests. The EPA cancer guideline says EPA should use whichever 
one provides the most health-protective outcome.
    Mr. McNerney. Thank you. Mr. Chairman, I have an article 
published this morning by the POLITICO describing the European 
Parliament's decision to create a special committee to 
investigate potential failings in the EU system for reviewing 
pesticides such as glyphosate. The committee will look at 
whether the European Commission followed appropriate 
regulations and avoided conflict of interest when it decided to 
renew the license for another five years. I would like to 
introduce this story for the record.
    Mr. Lucas. Without objection.
    [The information appears in Appendix II]
    Mr. McNerney. Thank you. And I yield back.
    Mr. Lucas. The gentleman yields back.
    The Chair now turns to the gentleman from Arizona, Mr. 
Biggs, for five minutes.
    Mr. Biggs. Thank you, Mr. Chairman. I appreciate all the 
witnesses being here today.
    And I'll start with Dr. Pastoor. You touched on your 
testimony, but I'd like you to expand if you would on 
additional examples besides glyphosate that were perhaps 
classified in a misleading way by IARC.
    Dr. Pastoor. Well, you know, the--what I was trying to get 
at in my testimony is that things like caffeic acid, 
arachidonic, these are chemicals that we find in our diet 
naturally. And by just simply declaring them to be carcinogenic 
is not helpful to the American public. They need some context 
with that. And my criticism of IARC is they don't provide that 
kind of context.
    Mr. Biggs. And so--still with you, Dr. Pastoor. The--you've 
described that as a misleading way to classify these potential 
hazards, and you've advocated for a risk assessment as opposed 
to hazard assessment. And I thought--and I don't want to 
misinterpret, but I thought I heard Dr. Sass refer to this kind 
of dose-level-type thing as being 16th-century--a 16th-century 
approach. Do you want to rebut that?
    Dr. Pastoor. I definitely do. I think it's absolutely as 
true as it was in the 16th century. And the best example I can 
give is the one I gave earlier on aspirin is that the dose 
makes the poison. It's just as good at a low--in fact, the 
actual statement by Paracelsus in the 16th century was that the 
difference between a medicine and a poison is the dose. Aspirin 
is a good example of that. Two tablets will relieve your 
headache. A bottle full of it will kill you. That's the dose 
makes the poison. It's as true today as it was back in the 16th 
century and long before that.
    It's important to realize that because in some of these 
studies that are being cited here, whether it's glyphosate or 
otherwise, these are animals that have been packed full of some 
of these chemicals for a lifetime. And I'm probably one of the 
few people in this room that's actually conducted those very 
studies. And they go on for two years. They're given to animals 
at the maximum dose that they can get, and even though Dr. Sass 
refers to the animals not having any adverse effects, they're 
getting as much as three percent of their diet of that 
particular chemical. That's outrageous. It's something that no 
human would ever see, and the results are meaningless and not 
useful in the context of risk assessment and communication of 
that information to the American public.
    Mr. Biggs. And, Dr. Lowit, I want to just ask you quickly--
I don't want my time to totally expire here, but the EPA sets 
tolerance levels for residue of glyphosate, and you've talked 
about the actual exposure to chemicals, not simply ask if a 
chemical could ever be a carcinogen. And EPA takes a different 
approach than IARC. Why does EPA take the approach it takes?
    Dr. Lowit. So EPA is a risk-based organization, which is 
consistent with federal statute and largely for the reasons 
that Dr. Pastoor just explained, that it is important to assess 
not only the hazard but the exposure of a particular chemical. 
And it is at that intersection of hazard and exposure where we 
understand risk. And our job is to understand risk to the 
American people.
    Mr. Biggs. And I'm going to close out here by just covering 
a couple of statements. We've heard one of--previous 
questioners--when he was giving his statement prior to asking 
question says we don't want the, quote, ``science we rely on is 
not distorted or manipulated,'' close quote. He didn't want 
that--our science to be distorted or manipulated. And 
additionally, the idea of independent bodies look at this--we 
want independent bodies to be looking at these types of 
chemicals and potential hazards to us.
    But what if there is a conflict of interest? And I'm going 
to introduce--Mr. Chairman, without objection, I'd like to 
introduce a letter written in 2002, 15 years ago or so, by one 
of our panelists Dr. Sass where she noted that IARC's working 
groups are made behind closed doors, no transcripts of the 
deliberations are publicly available. Most significant, the 
voting of the working group members is never made public. This 
lack of transparency and lack of public oversight makes peer 
review impossible.
    In the letter that we received back from Dr. Wild, at this 
point there's no indication that any of the processes have 
changed in the last 16 years, and thus, I'm very concerned 
about IARC and their processes in this issuing these monologues 
and--or, excuse me, Monographs. And with that, Mr. Chairman, I 
introduce that letter.
    Mr. Lucas. Without objection.
    [The information appears in Appendix II]
    Mr. Lucas. The gentleman yields back the balance of his 
time?
    Mr. Biggs. I do, thank you.
    Mr. Lucas. And the gentleman--or the Chair now turns to the 
gentleman from Colorado, Mr. Perlmutter, for five minutes.
    Mr. Perlmutter. Thanks, Mr. Chair.
    And, Dr. Sass, I'm just going to ask you a pretty open-
ended question. I've been able to sit through some of this 
testimony. Obviously, there's some very different approaches 
and opinions just listening to the last 15 minutes. So are 
there some issues that you think really need to be brought out 
in more detail? And if so, what are they?
    Dr. Sass. Thank you. With regards to the IARC 2002 letter, 
which I point out is quite a long time ago, at that time that 
was three Chiefs of the Monograph Programme ago, and at that 
point we were concerned that they were allowing people with 
financial conflicted--conflicts of interest to be part of the 
voting working group. And since then, they have established 
conflict guidelines that are world-renowned. They're very well-
respected, they're very well-implemented, and those kinds of 
things are well-tracked and well-reported, and so there's a 
comfort level. And so those issues are not--have not been 
relevant for a long time.
    As far as the differences between the two assessments, it 
really is a difference between whether you're doing the hazard 
only and then going to risk assessment or whether you're 
conflating them together. And IARC is a hazard only. They just 
say whether there's an association with cancer or not, and then 
if you want to do a risk assessment or deregulatory actions, 
those things will come differently.
    I do not understand why the EPA is not going through its 
process to develop a slope factor and a dose response and a 
potency estimate and instead just doing--calling it not likely, 
dismissing quite a lot of evidence of tumors.
    And you're wrong about Dr. Portier. He's actually updated 
his tables, and there's quite a few tumors there, which I would 
be happy to submit or have someone else--have him submit to the 
record that have been disregarded.
    What I don't understand is why the Pesticide Office is 
working with the EPA's Office of Chemical Safety and Pollution 
Prevention, which is the science policy office, which is headed 
by Dr. Nancy Beck, a former chemical industry lobbyist, to 
implement a systematic review procedure for its data that was 
reviewed by the National Academies in 2007 and was called 
fundamentally flawed, something the National Academies have 
never called anything before, instead of, for example, working 
with the EPA IRIS program, the Integrated Risk Information 
System program, which is in the Office of Research and 
Development, the science office of EPA, and which could work 
with them to develop potency estimates and slope factors and 
then a risk assessment at that point.
    Mr. Perlmutter. So--let me see. So the real difference here 
is one is just sort of purely data-driven in determining, you 
know, whether or not there's potential carcinogens, and then 
there's kind of a political and, you know, policy decision 
being made as to, okay, it's risky, it's not, the dose is okay, 
the dose is not okay, but it's problematic to begin with, but 
we've looked at it on behalf of the EPA and the country and 
say, you know, this is okay, but there's a problem. Is that--am 
I off?
    Dr. Sass. No, you are spot on.
    Mr. Perlmutter. Okay. Well, then with that, I'm going to 
yield back.
    Mr. Lucas. Before the gentleman yields back, would he yield 
to the doctor from the EPA for a comment?
    Mr. Perlmutter. Sure. Which--yes.
    Mr. Lucas. Dr. Lowit.
    Dr. Lowit. Thank you for that. So I just think it's 
important that we make sure the record is accurate. The Office 
of Pesticide Program is actually part of the Office of Chemical 
Safety and Pollution Prevention. And in fact Dr. Sass' comments 
about systematic review and the IRIS program are inaccurate. 
The IRIS program, as publicly discussed in many venues in the 
last year, is actually moving to a systematic review which is 
the recommendations of the National Academies of Sciences. So 
EPA's evaluation is consistent with the National Academies.
    Mr. Perlmutter. Dr. Sass, do you have a comment on that?
    Dr. Sass. Yes, there's two different systematic reviews 
happening within EPA and parallel. One is being developed by 
Dr. Nancy Beck, a former ACC American Chemistry Council 
lobbyist until very recently, and one is being developed by the 
scientist within the IRIS program. The IRIS program, it doesn't 
prioritize or preferentially treat industry-supplied data, 
whereas the other systematic review does. For example, 
guideline studies--GLP it's called, good laboratory practices, 
which were developed for industry studies specifically to stop 
them from lying and cheating about their data. If you apply 
systematic review properly, you would look at all the data with 
the same rules.
    Mr. Lucas. The gentleman's time is expired.
    Mr. Perlmutter. My time is expired. I yield back to the 
Chair.
    Mr. Lucas. And on that note, the Chair is going to turn to 
the gentleman from Louisiana, Mr. Higgins, for five minutes.
    Mr. Higgins. Thank you, Mr. Chairman. I thank the panelists 
for appearing before us today.
    We have certainly challenging issues in front of us 
regarding what's real and what's not. We all want to protect 
the American people from unnecessary harm, but we also want to 
move forward with sound science as we do so. So this is a 
bipartisan effort, and I'm quite sure that the scientists 
before us and the experts that have testified before us and 
have met with us in our offices agree that we have a common 
goal here. The American farmer feeds the world.
    And the studies that I've read, including EPA reports and 
various other research documents, use verbiage like ``most 
likely'' and ``probable'' and ``potentially increased risk'' 
regarding the primary chemical within Roundup. It's a herbicide 
used to increase crop yield.
    So I clearly recall a few years ago the rumor that plastic 
bottles cause cancer. It was widespread. Now, we all drink from 
plastic bottles. I've never seen a colleague eat the bottle.
    So the usage of Roundup in reality on farms across America 
and in households is used very carefully because it's very 
expensive. They use computerized dispersion on large farm 
machinery to carefully disperse the stuff. Protective clothing 
is worn.
    So I would say that a hungry child that the American farmer 
feeds across the world by the compassion and generosity of our 
nation, Mr. Chairman, a hungry child is concerned about the--
overcoming that hunger at that moment with food provided by the 
American farmer, as opposed to most likely, probable, or 
potentially increased risk of cancer sometime down the line.
    So I have a question. You said something, Dr. Lowit, very 
interesting earlier. You stated that EPA conducted its 
assessment of glyphosate with conservative risk assumption. Can 
you please clarify for us what that means? What is a 
conservative risk assumption?
    Dr. Lowit. So as a measure to be resource efficient in our 
risk assessment process, we use a tiering process when we 
evaluate exposure. Our tier 1 assessments use high-end 
estimates that are health protective and often even compound 
those assumptions together. And in the case of glyphosate we've 
done a health protective tier 1 level for--in most cases--
assessment that uses health protective conservative assumptions 
and came to the conclusion, despite those conservative 
assumptions, that there's no risk to humans, including infants 
and children.
    Mr. Higgins. Would you recommend changes to the IARC to 
make this program--in this program to ensure transparency and 
reliable reporting to the public that you're attempting to 
inform? Is there some improvement or streamlining of the 
scientific process where data can be shared amongst perhaps 
conflicting conclusions by various scientists, including 
scientists from other--from organizations from other nations? 
Can there be more transparency and inclusion of scientific data 
so that we can come to a conclusion? Because, you know, the 
loss of Roundup would definitely hurt the production of crop 
yield across the world, and there'd be an immediate impact felt 
worldwide. So do you have suggestions on how to improve the 
process so we can arrive at the truth ultimately?
    Dr. Lowit. So EPA is not bound by our IARC conclusions, as 
noted in my testimony. We've come to the conclusion that 
glyphosate is not likely carcinogenic to humans, and that's 
similar to many other nations in the world, including our 
Canadian colleagues and the European Food Safety----
    Mr. Higgins. European colleagues. I concur.
    Dr. Sass, could you add to that?
    Dr. Sass. Well, the European assessment is being 
investigated because it's been shown that they took the first 
draft from Monsanto and they barely redlined it. So I don't 
think that should be held up as the high bar.
    And as far as transparency and the use of glyphosate, I 
just think a proper risk assessment should be done. And what's 
happening here is that the EPA is doing the hazard assessment 
calling it not likely without doing the slope factor and the 
risk assessment I'm guessing because it favor Monsanto's 
interest for selling it abroad.
    Mr. Higgins. Do you recommend that Roundup be pulled from 
the market?
    Dr. Sass. No, that has not been our recommendation.
    Mr. Higgins. Thank you. Mr. Chairman, I yield back.
    Mr. Lucas. The gentleman yields back.
    The Chair now recognizes my neighbor from the great State 
of Kansas, Dr. Marshall, for five minutes.
    Mr. Marshall. Well, thank you, Chairman. And I guess I 
would start by--you had a standing joke with my pastor, and 
every week he would ask me, ``Does coffee cause cancer this 
week, Doc?'' And I would say, ``Well, I hope not'' because I 
usually had a cup of coffee in my hands. So I just continue to 
be amazed. I'm reading this and I see that IARC, once upon a 
time, actually said it was a carcinogen, so that shocks me.
    I'm also a little bit surprised to see that the United 
States has given $48 million to IARC, which is located in Lyon, 
France, a beautiful place by accounts of all the paintings I've 
seen of that area, but I'm not sure why we're spending American 
dollars over there.
    You know, to go to my question, I'll start with Dr. 
Pastoor, the first one. Obviously, there's a big difference 
between hazard and risk, and on its webpage, IARC contends that 
it does not make a judgment about risk. So IARC says it does 
not make a judgment about risk. However, on the front page of 
its Monograph, it states that it evaluates carcinogenic risk to 
humans. This seems really misleading. I'm a biochemist. I'm a 
physician. You can go down the dirt here a little bit if you 
want to, but if it's not saying--talking about making judgment 
regarding to risk, saying something is carcinogenic is exactly 
declaring it's a risk. Can you help me understand this better?
    Dr. Pastoor. Representative Marshall, thank you for that 
question because that's core to the testimony that I'm giving 
today, and that's that the difference between the word hazard 
and risk is absolutely crucially important because if a patient 
comes to you and says, ``Well, what should I do about caffeic 
acid?'' or caffeine or whatever they're asking you about, you 
have to put that in context, minimize your exposure or avoid it 
altogether, whatever it is.
    What IARC does is stops with half a loaf, half of the 
description. They're just saying it's carcinogenic and leaves 
it at that point. It is not a risk assessment. It's simply a 
hazard assessment. That's not useful. It's actually injurious. 
It's also I think irresponsible, and I think it's harmful to 
the American public.
    Mr. Marshall. And one of our jobs here in Congress is to 
prioritize the dollars we do have on research. And in Kansas we 
have big issues with the sugarcane aphid, with the wheat mosaic 
virus. I mean, to me, prioritizing monies for those would seem 
to be--take precedent over this.
    I'll go to Dr. Lowit with my next question. I think just to 
hammer this point home, explain to me the EPA--so I'm new to 
Congress. How does the EPA make its assessment? Is it hazards 
only? When you determine what chemicals are safe or not, do you 
use just the hazard assessment or how do you do it?
    Dr. Lowit. So, consistent with federal statute, EPA does 
risk assessments, so we evaluate both the hazard and the 
exposure and then evaluate them together.
    Mr. Marshall. Does that often lead to a--are there examples 
of some chemicals that are a hazard only and--as opposed to a 
risk as well?
    Dr. Lowit. As a general rule, no. EPA does risk assessment, 
not hazard assessment.
    Mr. Marshall. Okay. Thank you. I yield back.
    Mr. Lucas. The gentleman yields back. I believe everyone's 
had an opportunity for questions.
    Does the Ranking Member have any concluding comments?
    Ms. Johnson. I don't. Thank you.
    Mr. Lucas. The Ranking Member does not.
    The Chair simply wishes to thank our panel for being here 
and to express our appreciation for the insights gained today. 
Obviously, this is a subject matter that we will continue to 
delve into with great depth.
    And in particular to our fellow public official from the 
EPA, I appreciate the challenges you're caught between.
    With that, the record will remain open for two weeks for 
additional written comments and written questions from the 
Members.
    This hearing is adjourned.
    [Whereupon, at 12:32 p.m., the Committee was adjourned.]

                               Appendix I

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                              Appendix II

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                   Additional Material for the Record

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