[Senate Hearing 114-261]
[From the U.S. Government Publishing Office]






                                                        S. Hrg. 114-261

                       AGRICULTURE BIOTECHNOLOGY:
                      A LOOK AT FEDERAL REGULATION
                      AND STAKEHOLDER PERSPECTIVES

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

                                HEARING

                               before the

                       COMMITTEE ON AGRICULTURE,
                        NUTRITION, AND FORESTRY

                          UNITED STATES SENATE


                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION


                               __________

                            OCTOBER 21, 2015

                               __________

                       Printed for the use of the
           Committee on Agriculture, Nutrition, and Forestry

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]




        Available via the World Wide Web: http://www.fdsys.gov/
                                  ______

                         U.S. GOVERNMENT PUBLISHING OFFICE 

98-991 PDF                     WASHINGTON : 2016 
-----------------------------------------------------------------------
  For sale by the Superintendent of Documents, U.S. Government Publishing 
  Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; 
         DC area (202) 512-1800 Fax: (202) 512-2104 Mail: Stop IDCC, 
                          Washington, DC 20402-0001
                          

















           COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY



                     PAT ROBERTS, Kansas, Chairman

THAD COCHRAN, Mississippi            DEBBIE STABENOW, Michigan
MITCH McCONNELL, Kentucky            PATRICK J. LEAHY, Vermont
JOHN BOOZMAN, Arkansas               SHERROD BROWN, Ohio
JOHN HOEVEN, North Dakota            AMY KLOBUCHAR, Minnesota
DAVID PERDUE, Georgia                MICHAEL BENNET, Colorado
JONI ERNST, Iowa                     KIRSTEN GILLIBRAND, New York
THOM TILLIS, North Carolina          JOE DONNELLY, Indiana
BEN SASSE, Nebraska                  HEIDI HEITKAMP, North Dakota
CHARLES GRASSLEY, Iowa               ROBERT P. CASEY, Jr., Pennsylvania
JOHN THUNE, South Dakota

               Joel T. Leftwich, Majority Staff Director
                Anne C. Hazlett, Majority Chief Counsel
                    Jessica L. Williams, Chief Clerk
               Joseph A. Shultz, Minority Staff Director

                                  (ii)

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                            C O N T E N T S

                              ----------                              
                                                                   Page

Hearing(s):

Agriculture Biotechnology: A Look at Federal Regulation and 
  Stakeholder Perspectives.......................................     1

                              ----------                              

                      Wednesday, October 21, 2015
                    STATEMENTS PRESENTED BY SENATORS

Roberts, Hon. Pat, U.S. Senator from the State of Kansas, 
  Chairman, Committee on Agriculture, Nutrition, and Forestry....     1
Stabenow, Hon. Debbie, U.S. Senator from the State of Michigan...     2

                                Panel I

Gregoire, Michael, Associate Administrator, Animal and Plant 
  Health Inspection Service, U.S. Department of Agriculture, 
  Washington, DC.................................................     4
Jordan, William, Deputy Director, Office of Pesticide Programs, 
  U.S. Environmental Protection Agency, Washington, DC...........     6
Mayne, Susan, Ph.D., Director, Center for Food Safety and Applied 
  Nutrition, Food and Drug Administration, College Park, MD......     7

                                Panel II

Lidback, Joanna, Producer, The Farm at Wheeler Mountain, Barton, 
  VT.............................................................    35
Thomas, Daryl E., Senior Vice President, Herr Foods, Inc., 
  Nottingham, PA.................................................    36
Hirshberg, Gary, Chairman and Co-Founder, Stonyfield Farm Inc., 
  Concord, NH....................................................    38
Jaffe, Gregory, Project Director, Biotechnology, Center for 
  Science in the Public Interest, Washington, DC.................    40
Kleinman, Ronald E., M.D., Physician in Chief, MassGeneral 
  Hospital for Children, Boston, MA..............................    42
                              ----------                              

                                APPENDIX

Prepared Statements:
    Gregoire, Michael............................................    56
    Hirshberg, Gary..............................................    61
    Jaffe, Gregory...............................................    65
    Jordan, William..............................................    76
    Kleinman, Ronald E...........................................    84
    Lidback, Joanna..............................................    87
    Mayne, Susan.................................................    94
    Thomas, Daryl E..............................................   111
Document(s) Submitted for the Record:
Hirshberg, Gary:
    ``It's time for Congress to require GMO labeling'' The 
      Register's Editorial.......................................   118
Question and Answer:
Gregoire, Michael:
    Written response to questions from Hon. Pat Roberts..........   120
    Written response to questions from Hon. Debbie Stabenow......   121
    Written response to questions from Hon. Joni Ernst...........   122
    Written response to questions from Hon. Patrick J. Leahy.....   122
    Written response to questions from Hon. David Perdue.........   123
    Written response to questions from Hon. John Thune...........   124
Hirshberg, Gary:
    Written response to questions from Hon. Sherrod Brown........   126
    Written response to questions from Hon. Heidi Heitkamp.......   127
    Written response to questions from Hon. Patrick J. Leahy.....   128
    Written response to questions from Hon. Joni Ernst...........   130
Jaffe, Gregory:
    Written response to questions from Hon. Sherrod Brown........   144
    Written response to questions from Hon. John Thune...........   145
Jordan, William:
    Written response to questions from Hon. Pat Roberts..........   147
    Written response to questions from Hon. Joni Ernst...........   148
    Written response to questions from Hon. Heidi Heitkamp.......   149
    Written response to questions from Hon. Patrick J. Leahy.....   150
    Written response to questions from Hon. David Perdue.........   150
    Written response to questions from Hon. Ben Sasse............   151
    Written response to questions from Hon. John Thune...........   152
Kleinman, Ronald E.:
    Written response to questions from Hon. Joni Ernst...........   234
    Written response to questions from Hon. John Thune...........   234
Lidback, Joanna:
    Written response to questions from Hon. Joni Ernst...........   235
    Written response to questions from Hon. Heidi Heitkamp.......   235
    Written response to questions from Hon. Patrick J. Leahy.....   236
    Written response to questions from Hon. John Thune...........   237
Mayne, Susan:
    Written response to questions from Hon. Pat Roberts..........   239
    Written response to questions from Hon. Debbie Stabenow......   241
    Written response to questions from Hon. Joni Ernst...........   241
    Written response to questions from Hon. Patrick J. Leahy.....   241
    Written response to questions from Hon. John Thune...........   243
Thomas, Daryl E.:
    Written response to questions from Hon. Joni Ernst...........   244
    Written response to questions from Hon. Heidi Heitkamp.......   244
    Written response to questions from Hon. Patrick J. Leahy.....   245
    Written response to questions from Hon. John Thune...........   249
 
                       AGRICULTURE BIOTECHNOLOGY:
                      A LOOK AT FEDERAL REGULATION
                      AND STAKEHOLDER PERSPECTIVES

                              ----------                              


                      Wednesday, October 21, 2015

                              United States Senate,
         Committee on Agriculture, Nutrition, and Forestry,
                                                     Washington, DC
    The committee met, pursuant to notice, at 10:04 a.m., in 
room 106, Dirksen Senate Office Building, Hon. Pat Roberts, 
Chairman of the committee, presiding.
    Present or submitting a statement: Senators Roberts, 
Boozman, Hoeven, Perdue, Ernst, Tillis, Sasse, Grassley, Thune, 
Stabenow, Leahy, Brown, Klobuchar, Bennet, Gillibrand, 
Donnelly, Heitkamp, and Casey.

 STATEMENT OF HON. PAT ROBERTS, U.S. SENATOR FROM THE STATE OF 
KANSAS, CHAIRMAN, U.S. COMMITTEE ON AGRICULTURE, NUTRITION, AND 
                            FORESTRY

    Chairman Roberts. Good morning. I call this meeting of the 
Senate Committee on Agriculture, Nutrition, and Forestry to 
order.
    I have said many times that one of our committee's main 
goals is to conduct thorough oversight of issues within our 
jurisdiction. We have a responsibility to ensure that 
government agencies carry out laws passed by Congress in an 
efficient and effective manner.
    Today's hearing is an important step in the committee's 
work as we hear from the three agencies tasked with regulating 
agriculture biotechnology: USDA's Animal and Plant Health 
Inspection Service, the Environmental Protection Agency, and 
the Food and Drug Administration. We will also hear from 
witnesses that represent different perspectives in the value 
chain of agriculture and food production: A farmer, a food 
manufacturer, as well as representatives of other consumer 
opinions and a medical professional.
    We have all heard about our growing global population, 
currently at seven billion and estimated to reach over 9.6 
billion in the next several decades. We have seen too many 
examples in recent years where shortfalls in grain and other 
food items or increases in prices at the consumer level have 
helped to trigger outbreaks of civil unrest and protest in 
places like the Middle East and Africa.
    In light of these global security threats, today's farmers 
are being asked to produce more safe and affordable food to 
meet the demands at home and around the globe. At the same 
time, they are facing increased challenges to production, 
including limited land and water resources, uncertain weather, 
and pest and disease issues. Over the past 20 years, 
agriculture biotechnology has become a valuable tool in 
ensuring the success of the American farmer in meeting the 
challenge of increasing yield in a more effective, safe, and 
responsible manner.
    So, as we review these issues, we must continue to be 
guided by the best available science, research, and innovation. 
Today, I look forward to our government witnesses highlighting 
the steps their agencies have taken to ensure that agriculture 
biotechnology is safe--safe to other plants, safe to the 
environment, and safe to the food supply. We do have a 
regulatory system that makes biotechnology crops among the most 
tested in the history of agriculture.
    The multi-agency approach referred to as the Coordinated 
Framework for the Regulation of Biotechnology was established 
with a science and risk-based approach back in the 1990s, and 
the White House Office of Science and Technology Policy has 
recently initiated a process to review the regulatory system. 
Now, their objective is a long-term strategy to ensure that the 
federal regulatory system can assess any risks associated with 
products of biotechnology while supporting innovation and 
protecting health and the environment, maintaining public 
confidence in the regulatory process, increasing transparency 
and predictability, and reducing unnecessary costs and burdens. 
That is a mouthful. That is quite a mission statement.
    Today, we will also hear from representatives of the value 
chain of agriculture and food production. This includes 
witnesses with firsthand experience farming and in food 
production and it includes perspectives of those that deal with 
hunger and health issues on a daily basis.
    Increasingly, many Americans have taken an interest in 
where their food comes from and how it is made. Throughout this 
discussion, I hope we remember the importance of focusing on 
science and consider our role to help ensure a safe, affordable 
food supply for consumers at home and all around the globe.
    I thank each witness for providing testimony before the 
committee on such an important issue, and I ask consent to 
include other statements and information submitted to the 
committee along with the hearing record.
    With that, I recognize our distinguished Ranking Member, 
former Chairperson Senator Stabenow, for any remarks that she 
would like to make.

STATEMENT OF HON. DEBBIE STABENOW, U.S. SENATOR FROM THE STATE 
                          OF MICHIGAN

    Senator Stabenow. Well, thank you very much, Mr. Chairman, 
and I also want to thank the administration officials that are 
here and all of the food industry leaders for testifying today. 
Your comments, your perspectives are very important to us and I 
look forward to hearing your testimony.
    I agree that throughout the history of our country, 
American agriculture has been at the forefront, developing 
cutting-edge technology, from John Deere's invention of the 
steel plow, to Norman Borlaug's use of novel plant breeding 
techniques to create high-yielding wheat that has helped 
prevent hunger and famine around the world.
    Today, that same spirit of innovation is helping drive 
agriculture production and efficiency to amazing new heights. A 
growing global population, coupled with the effects of climate 
change and the stress placed on much of our natural resources, 
has created a sense of urgency for new innovations if we are to 
maintain our nation's agricultural leadership.
    That is one reason why I support the use of biotechnology 
in agriculture. Biotechnology has proven to be safe, 
beneficial, and I believe will play a major role in helping to 
solve these dual global challenges of climate change and global 
food security.
    I also recognize the desire by a growing number of American 
consumers to know more about the food they eat. This growing 
demand for information is one reason why in the 2014 farm bill 
we had unprecedented investments in areas like organic 
production and local food systems, which help ensure consumers 
have increased choices.
    As we know, several states have passed laws to disclose 
more about the production of food, and I believe this issue 
will only continue to build steam in the months and years 
ahead. I share the concern about the difficulty in doing 
business across our country if 50 different states have 50 
different standards and requirements, and, frankly, it will not 
work. However, we also need to recognize and respect the 
interests of many American consumers who care deeply about 
where and how their food is produced.
    In order to address legitimate concerns from our farmers, 
our food companies, our consumers, I believe we need to work 
together, and I am committing myself, Mr. Chairman, to do that 
in a bipartisan way, to develop and pass a bill that can pass 
the Senate by the end of the year. This needs to move quickly 
in order to address these issues, and I believe they need to 
meet the following tests.
    First, a solution that addresses the problem of a 50-state 
patchwork of regulations.
    Second, a national system of disclosure and transparency 
for consumers who wish to know more about their food.
    Third, an approach that does not stigmatize biotechnology.
    Nearly 30 years ago, the White House Office of Science and 
Technology Policy established the Coordinated Framework for the 
Regulation of Biotechnology. Since its inception, this 
framework has helped establish what sound oversight of 
agricultural biotechnology must be. With the continued 
development and increased use of biotechnology and other 
science-based breeding techniques, it makes sense that these 
standards are revisited, and I applaud the administration for 
taking that step earlier this summer. Ensuring that the 
Coordinated Framework is updated to reflect the latest research 
and science on biotechnology will help instill additional 
confidence about the safety and soundness of the use of these 
technologies.
    As we look at updating the rules to reflect advancements in 
biotechnology, it makes sense that we examine the way in which 
consumers have access to the information they need to make 
informed decisions about the food they eat and purchase for 
their families.
    As members of this committee, we recognize that American 
farmers and ranchers are the best in the world and they use the 
most sophisticated farming practices to produce the most 
abundant and safest food supply in the world. We should strive 
to build confidence in these technologies so that all consumers 
can better understand their benefits and recognize and 
appreciate the role of innovation in American agriculture 
today.
    Mr. Chairman, I look forward to working with you on this 
issue. I know this is a very important hearing today.
    Chairman Roberts. I want to thank the distinguished Ranking 
Member, and we will be moving with legislation as quickly as 
possible.
    Welcome to our first panel of witnesses before the 
committee this morning. Our first panelist is Mr. Gregoire, who 
serves as the Associate Administrator of APHIS. In addition to 
a focus on the agency's policy, budget, and administrative 
responsibilities, he manages the biotechnology and regulatory 
services as well as the plant protection and quarantine issue 
areas. Welcome, and I look forward to your statement.

STATEMENT OF MICHAEL GREGOIRE, ASSOCIATE ADMINISTRATOR, ANIMAL 
    AND PLANT HEALTH INSPECTION SERVICE, U.S. DEPARTMENT OF 
                  AGRICULTURE, WASHINGTON, DC

    Mr. Gregoire. Thank you very much, Chairman Roberts and 
Senator Stabenow and members of the committee. Thank you for 
the opportunity today to appear before you and discuss an 
important topic to American agriculture, that is the complex 
issues surrounding biotechnology and the federal government's 
role in regulating it.
    I am Michael Gregoire, Associate Administrator of USDA's 
Animal and Plant Health Inspection Service. APHIS is 
responsible for ensuring that new biotechnology products do not 
inadvertently harm plant health in the U.S.
    APHIS regulates the importation, the interstate movement, 
and field testing of genetically engineered organisms. Our 
specific role is to ensure that new GE crops do not pose a risk 
to plant health, such as causing disease or damage to other 
crops or plant products in the United States.
    If a GE product requires USDA's oversight, developers must 
apply for an APHIS permit and adhere to APHIS regulations to 
maintain adequate confinement of a regulated organism during 
field trials. After developers have the scientific information 
which they believe is sufficient for us to conclude that a GE 
organism is unlikely to pose a plant pest risk, they can 
petition APHIS for non-regulated status.
    We then prepare an appropriate plant pest risk assessment 
and environmental analysis that informs our decisions. If our 
officials conclude then that a GE organism does not pose a 
plant pest risk, APHIS deregulates the product and that 
organism may be freely moved or planted without further APHIS 
oversight and permits or other regulatory requirements.
    Over the years, APHIS has--over the recent years, APHIS has 
undertaken a process to significantly improve the timeliness of 
our biotechnology regulatory decisions. We have been able to 
provide a more timely review process that does not sacrifice 
the thoroughness or the quality of our scientific reviews while 
also giving the public an additional opportunity to provide us 
with input.
    APHIS has completed 30 of the 37 pending and new petitions 
since implementing our new process in March of 2012, and we 
plan to complete three more by the end of this year. Since 
March of 2012, we have also cut the time down for review of new 
petitions from between three to five years to just over 18 
months, and we are on a course to get that down to more like 15 
months, on average.
    Again, APHIS's authority to regulate GE products is based 
on their potential plant pest risk. We regulate based on the 
specific product and the environment into which it is being 
introduced, not the production process that created the 
organism. Developers may seek a written determination from us 
if they are unsure whether or not their product requires 
regulatory oversight.
    We work regularly with the Food and Drug Administration and 
EPA to ensure that the development, testing, and use of 
biotechnology products happens in a way that is safe for plant 
and animal health, human health, and the environment. We 
regularly communicate with our colleagues in FDA and EPA to 
ensure that any safety or regulatory issues that may arise are 
appropriately resolved. We have great confidence in the safety 
of the GE crops that have been approved under the U.S. 
regulatory system.
    Recently, the Executive Office of the President released a 
memo that directed our three agencies to work with them to 
update the Coordinated Framework of 1986, and we are working 
very closely with our colleagues on this review and update.
    Complementing the interagency effort to update the 
Coordinated Framework is our renewed effort in USDA to revise 
and update APHIS's regulations. We plan to align our 
regulations with current authorities and regulate GE organisms 
that pose a plant pest or weed risk in a manner that balances 
oversight and risk and that is based on the best available 
science. We plan to continue to engage the public throughout 
the rulemaking process and will provide ample opportunities for 
public input in that process.
    To summarize, USDA is committed to a sound, science-based 
and modern approach to the regulation of products derived from 
biotechnology. We will continue to work with our federal 
partners and stakeholders as we build upon the many years of 
our work in this area.
    Mr. Chairman, that concludes my opening remarks.
    [The prepared statement of Mr. Gregoire can be found on 
page 56 in the appendix.]
    Chairman Roberts. Thank you very much for your statement.
    Our next witness is Mr. Bill Jordan. He joins us today as 
the Deputy Director for EPA's Office of Pesticide Programs, and 
I understand that he has plans to retire at the end of the 
year, after a distinguished career in public service. Maybe we 
can talk you out of that here this morning.
    [Laughter.]
    Chairman Roberts. He has worked in several capacities in 
the Office of Pesticide Programs since 1988 and previously 
served in the EPA's Office of General Counsel.
    I look forward to your testimony and your experience, sir.

    STATEMENT OF WILLIAM JORDAN, DEPUTY DIRECTOR, OFFICE OF 
   PESTICIDE PROGRAMS, U.S. ENVIRONMENTAL PROTECTION AGENCY, 
                         WASHINGTON, DC

    Mr. Jordan. Good morning, and thank you, Chairman Roberts 
and Ranking Member Stabenow and members of the committee. I 
appreciate the chance to testify about EPA's role in regulating 
products of biotechnology.
    EPA administers two strong laws, FIFRA and the Food, Drug, 
and Cosmetic Act, to regulate pesticides, a term that includes 
genetically engineered plants that express pesticidal 
properties. We call a pesticide like that a plant incorporated 
protectant, or PIP, for short. I will be talking a lot about 
PIPs.
    Under FIFRA, we register pesticides to ensure that they are 
used in a way that is safe for humans and the environment, and 
in order to obtain a registration, an applicant must 
demonstrate that the pesticide will not cause unreasonable 
adverse effects on humans or the environment.
    EPA also regulates the safety of pesticide residues in food 
under the FFDCA by establishing maximum residue limits, called 
tolerances. Here, we may establish a tolerance only if there is 
a reasonable certainty that no harm will result from exposure 
to pesticide residues.
    As described more fully in my written testimony, EPA's 
regulation of PIPs and other pesticides is guided by several 
principles. First, our decisions are based on the best 
available science.
    Second, we operate with consistency and fairness in a 
transparent manner.
    Third, we collaborate with our partners at USDA and FDA.
    I want to emphasize the important role that science-based 
risk assessment plays in our regulatory process. When making 
decisions about PIPs, the Agency knows we must be fully 
informed by the best available information and expert advice. 
So, EPA requires applicants for registrations and tolerances to 
provide extensive data on their PIPs. EPA's staff experts 
carefully review all of this information to see if a product 
meets the safety standards in our statutes. EPA also has sought 
advice from external independent experts on biotechnology 
through nearly two dozen meetings of the FIFRA Scientific 
Advisory Panel. At the end of the day, we are very confident 
that we can stand behind our conclusions that the PIP products 
we approve meet the demanding protective standards of FIFRA and 
FFDCA.
    We have approved 86 PIP registrations. Most of these are 
for products that produce a protein that is toxic to particular 
kinds of insects, but has practically no effect on humans or 
other species. Growers have widely adopted PIP products. Today, 
tens of millions of acres are being planted with EPA-approved 
varieties of PIPs.
    A number of groups, including the National Academy of 
Sciences, have studied how the introduction of PIPs has 
affected the use of synthetic chemical pesticides. These 
experts concluded that by planting PIPs, growers have reduced 
by many millions of pounds their reliance on broad spectrum 
synthetic insecticides. The result is less exposure to such 
pesticides for workers and non-target wildlife, less ground and 
surface water contamination, and less pesticide residue in 
food. In addition, PIPs solve pest problems that conventional 
chemical pesticides have not, as shown with the plum pox 
example described in my written testimony.
    The use of PIPs in agriculture has already produced real 
benefits, but we cannot say that future products will always be 
risk free. Therefore, before a new PIP is introduced into the 
environment, it is important that EPA have sufficient data and 
opportunity to evaluate the potential for risks. In addition, 
because PIPs have proven to be effective and safer alternatives 
to conventional pesticides, EPA believes they should be managed 
in a way that preserves the technology long into the future. 
That will likely require controls on the use of PIPs to prevent 
the development of pest resistance.
    In sum, EPA recognizes the potential benefits that products 
of modern biotechnology can bring to agriculture and the 
environment, and we also believe the country needs a strong, 
effective, and efficient regulatory system that embodies the 
principles of sound science, transparency, and collaboration. 
We believe we have such a system at EPA, and working with our 
colleagues at FDA and USDA, we look forward to continuing to 
fulfill our responsibility for ensuring the safety of products 
of modern biotechnology.
    I would be happy to answer questions later.
    [The prepared statement of Mr. Jordan can be found on page 
76 in the appendix.]
    Chairman Roberts. We thank you, Mr. Jordan.
    We have both of our witnesses finishing exactly on time. We 
may set a record here this morning.
    [Laughter.]
    Chairman Roberts. Our third witness, Dr. Susan Mayne--I did 
not mean to put that on your shoulders----
    [Laughter.]
    Chairman Roberts. --comes to us from the FDA Center for 
Food Safety and Applied Nutrition. Dr. Mayne has served as the 
Director of FDA's Center for Food Safety and Applied Nutrition 
since January 2015. In this role, she leads the Center's 
efforts related to the composition, the quality, the safety and 
labeling of foods, food and color additives, and cosmetics. 
Previously, Dr. Mayne was the C.-E.A. Winslow Professor of 
Epidemiology and Chair of the Department of Chronic Disease of 
Epidemiology at the Yale School of Public Health, as well as 
Associate Director of the Yale Cancer Center.
    Welcome. I look forward to your testimony and your insight.

  STATEMENT OF SUSAN MAYNE, PH.D., DIRECTOR, CENTER FOR FOOD 
  SAFETY AND APPLIED NUTRITION, FOOD AND DRUG ADMINISTRATION, 
  U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, COLLEGE PARK, 
                            MARYLAND

    Ms. Mayne. Thank you, Chairman Roberts and Ranking Member 
Stabenow and members of the committee. Thank you for the 
opportunity to be here today to discuss FDA's regulatory 
program for genetically engineered, or GE, foods.
    Over the last 20 years, FDA has reviewed information on 
more than 150 plant-derived GE foods, ranging from herbicide-
tolerant soybeans to canola oil with a modified fatty acid 
profile. Based on our evaluations, we are confident that the GE 
foods in the U.S. marketplace today are as safe as their 
conventional counterparts.
    The selection and genetic improvement of plants for 
agricultural use has been going on for thousands of years, 
typically through cross-breeding and hybridization. Many of the 
foods that are common in our diet, such as hybrid corn or 
nectarines, are obtained from plant varieties that were 
developed using such conventional genetic cross-breeding 
techniques.
    Since the late 1980s, by inserting one or more specific 
genes into a plant, scientists are able to produce a plant with 
new, advantageous characteristics. These techniques give 
scientists the ability to isolate specific genes of interest 
and introduce them and their corresponding traits into plants 
without introducing undesirable genes and traits.
    Any of these genetic modification techniques has the 
potential to change the composition of a food in a manner that 
is relevant to food safety. FDA, however, has well established 
scientific procedures for evaluating the safety of new foods, 
including any new substances in a food, and our guidelines help 
developers address any safety concerns prior to marketing.
    FDA regulates the safety of all foods within our authority, 
including those derived from GE plants, under the Federal Food, 
Drug, and Cosmetic Act. Foods developed from genetically 
engineered plant varieties such as fruits, vegetables, grains, 
and their byproducts, are subject to the same safety 
requirements as foods derived from non-GE plants. Food growers, 
manufacturers, and distributors are responsible for taking the 
steps necessary to ensure that their products are safe.
    To help developers of food derived from GE plants comply 
with their safety obligations, the agency encourages 
participation in our voluntary consultation process prior to 
commercial distribution. Since the consultation process was 
created, developers of GE plants have completed the process 
more than 100 times. Typically, the consultation begins early 
in the development, when the agency advises the developer on 
what tests would be appropriate to test safety. After the 
studies are completed, a summary of the data reflecting safety 
and nutritional composition are provided to FDA for review.
    FDA expects developers of GE foods to analyze the 
composition of the foods from their new crop varieties to 
ensure that any changes compared to the food's conventionally 
derived counterpart are appropriately considered and addressed 
before marketing.
    As part of our review and analysis, we consider whether any 
newly introduced protein is likely to be allergenic or toxic 
and whether levels of any important nutrients have been changed 
in a way that is important to food safety or nutrition. We also 
consider whether any newly introduced protein requires pre-
market approval as a food additive.
    Examples of the information evaluated by FDA include the 
name of the food and the crop from which it is derived; the 
sources, identities, functions, and stability of introduced 
genetic material; the purpose of the modification and its 
expected effect on the composition and characteristics of the 
food; the identity and function of any new substances 
introduced by the genetic material; a comparison of the 
composition and characteristics of the GE food to that of the 
parental variety; and information on whether the genetic 
modification altered the allergic or toxic potential of the 
food.
    FDA also regulates the labeling of food, including GE 
foods, under the Act and our regulations. The Act establishes 
that a food is misbranded if its labeling is false or 
misleading. Labeling is misleading if it fails to reveal facts 
that are material with respect to representations made or 
suggested in the labeling or if it fails to reveal consequences 
that may result from the use of the food.
    FDA has taken the position that the use of genetic 
engineering in the development of a food is normally not by 
itself material information within the meaning of the Act. 
Federal courts have held that FDA's position that the use of 
genetic engineering by itself does not constitute a material 
fact or require labeling to indicate that the food has been 
developed through genetic engineering is entitled to deference.
    Finally, I want to note that FDA is engaged with our 
colleagues at USDA and EPA to implement the activities laid out 
in the 2015 memorandum on modernizing the regulatory system for 
biotechnology products. On October 30, at our campus in Silver 
Spring, Maryland, FDA will host the first of three public 
meetings to involve the public in this modernization effort.
    In closing, I want to assure you that FDA's consultation 
process for foods derived from GE plants works well and 
provides for a rigorous food safety evaluation of GE foods. The 
agency will continue to be vigilant in ensuring the safety and 
integrity of the nation's food supply. Thank you.
    [The prepared statement of Ms. Mayne can be found on page 
94 in the appendix.]
    Chairman Roberts. We thank you.
    This is for all witnesses with regards to my question. 
Based on the best available science at your agency, do you 
believe that biotechnology is safe? Additionally, how does the 
regulatory scrutiny for agriculture biotechnology compare to 
the regulatory review process for other food ingredients at 
your respective agencies? Mr. Gregoire.
    Mr. Gregoire. Yes. Thank you, Mr. Chairman. We are very 
confident in the safety of the products that we have reviewed 
through our regulatory process. The genetically engineered 
crops that we review in terms of the plant risks that we 
review, they get more scrutiny than would, say, conventional 
bred crops.
    Chairman Roberts. Mr. Jordan.
    Mr. Jordan. We, too, at EPA are very confident in the 
judgments that we have made about the safety of the PIP 
products that we have reviewed. The PIP products, pesticides 
and conventional pesticides, must meet the same rigorous safety 
standard, and we require companies to give us as much data as 
we need in order to make that decision. So, both conventional 
pesticides and PIPs are rigorously examined.
    Chairman Roberts. Dr. Mayne.
    Ms. Mayne. As I indicated before, we have had a long 
established pre-market consultation process. To our knowledge, 
all of the firms that are intending to commercialize GE plants 
in the U.S. have consulted with FDA prior to marketing. As I 
indicated, we review newly inserted DNA protein product, 
allergenicity, potential toxicity. We look for key nutrient 
changes, toxicants, et cetera. So, our process is rigorous. Our 
process is thorough. It is consistent with how we regulate food 
in general under the Federal Food, Drug, and Cosmetic Act.
    Chairman Roberts. A second question for all witnesses. When 
the White House Office of Science and Technology Policy 
announced the review of the Coordinated Framework for the 
Regulation of Biotechnology in July, key objectives included 
ensuring public confidence in the regulatory system and 
preventing unnecessary barriers to future innovation and 
competitiveness. How can the three agencies and the 
administration, as well as this committee, do a better job, 
especially conveying to the public their belief in science and 
risk-based work of the agency experts? Will this process help 
convey more confidence to the public? Mr. Gregoire.
    Mr. Gregoire. Yes, Senator, I believe it will. The process 
that we have undertaken will look at clarifying roles and 
responsibilities of the three agencies in the regulatory 
oversight. It will position us for the future products of 
biotechnology and we will also be getting outside expert review 
of the future landscape of biotechnology. So, the purpose is 
really to make the overall system more clear and transparent 
and predictable, both for developers and for the public.
    Chairman Roberts. Mr. Jordan.
    Mr. Jordan. I agree with Mr. Gregoire and I would only add 
that the process going forward by which we intend to update the 
Coordinated Framework and develop a long-term strategy will 
include, as Dr. Mayne has noted, opportunities for public 
input. We are hoping to learn from that feedback how to do our 
job as well as we possibly can.
    Chairman Roberts. Dr. Mayne.
    Ms. Mayne. So, I concur with that. We are--FDA is committed 
to work with the other agencies to update the Coordinated 
Framework after we have had public input into the process. We 
will be looking towards long-term strategies to thinking about 
how we can assure that this is working as effectively as 
possible into the future. We look forward to the input from 
independent analyses, from National Academies and others, as to 
how we can do this most effectively.
    Our goal through this process is to provide clarity to the 
regulatory process to encourage innovation while we are 
managing risks, and we look forward to that process.
    Chairman Roberts. Speaking for all members on this 
committee, we will continue our oversight responsibilities in a 
partnership effort with you. This is the first time, I think, 
for Senator Stabenow, for ten years that we have had a hearing 
on biotechnology. So, I guess we are a little late, but we are 
here.
    Senator Stabenow, please.
    Senator Stabenow. Well, thank you very much, Mr. Chairman, 
and again, thanks to each of you for your testimony.
    I would like to just expand a little bit more on what the 
Chairman was talking about in terms of the 1986 Coordinated 
Framework that you are now involved in updating, and I think 
the objective is a really important one, quote, ``ensure public 
confidence in the regulatory system and to prevent unnecessary 
barriers to future innovation and competitiveness by improving 
transparency, coordination, predictability, and efficiency of 
regulations.'' So, that is a lot and it is also very, very 
important to do.
    I wonder if you could expand a little bit as you look at 
how you have seen technologies evolve in recent years and how 
that will inform you as you are looking to update the plan. I 
wonder if each of you might. Mr. Gregoire, you might go first.
    Mr. Gregoire. Yes. Thank you for that question. Certainly, 
the science has advanced greatly since the Coordinated 
Framework was put into place and the technology is changing 
rapidly. There are a lot of new plant breeding techniques that 
have been developed that allow developers to confer traits with 
more precision more quickly than conventional breeding and at 
less cost. So, there are many different advances in this 
technology.
    Senator Stabenow. Thank you.
    Mr. Jordan.
    Mr. Jordan. Thank you, Senator. One of the changes that we 
at EPA think is very encouraging is that technology developers 
have been able to combine different genetically engineered 
traits into a single plant, making the plant's ability to 
resist different kinds of insects and to deal with pest 
resistance more effective. I think, is a notable advance in the 
technology in recent years.
    As Mr. Gregoire has indicated, companies, technology 
developers, are extraordinarily innovative in terms of the 
ability that they--the variety of products that they are 
bringing to us, and because those products are different, then 
we need to be able to be clear, first, about which agency has 
responsibility for regulating them, and then to look carefully 
at how the different types of products may present different 
issues in terms of risk and environmental effects.
    Senator Stabenow. Dr. Mayne.
    Ms. Mayne. So, the science has evolved and continues to 
evolve, the techniques for doing this type of genetic 
engineering, and our scientists attend the same conferences, 
read the same scientific journals, and do all they can to stay 
abreast of advances in science and technology.
    In some cases, we have to stay abreast of all the science, 
but that also presents opportunities, and one example is that 
through the genomic revolution, we now have the ability to have 
sequences on all kinds of different things. We now have the 
ability to, for example, screen proteins against known 
sequences for proteins that have allergenic potential. So, we 
have better tools now to identify things like potential 
allergenicity through advances in science and technology.
    Senator Stabenow. Thank you.
    Just a comment, Mr. Chairman. One of the things that I find 
frustrating on this issue, and I have said it to so many people 
who are involved in doing the technology and so on, is really 
breaking this down in a way that the public can understand that 
does not sound scary, because the reality is, and I will never 
forget reading a great book called Our Daily Bread about Norman 
Borlaug, and we now have a statue of him in Statuary Hall, and 
to look at what he did both in the field and laboratory and 
starting in 1944 with the Rockefeller Foundation. Then he spent 
decades doing basically what can be done in a lab now. It is 
speeding up what he did. That is how I view this.
    So, he spent decades trying to create a situation where 
there was broader and more stable disease resistance and higher 
yields. He was called the Father of the Green Revolution. He 
got a Nobel Peace Prize for literally saving millions of people 
by feeding people around the globe because of the work he did. 
Now, because we can do this in a laboratory faster rather than 
taking decades, it has now become a whole other thing that we 
talk about.
    So, one of my frustrations is the fact that this is not 
explained well at all, or understood. Is there anything that 
all of you are doing that will help sort of break this down? I 
mean, this is about how we--just as we do better medical 
research in a lab than we used to do, with technology, we are 
now doing better plant science and seed science than we used to 
do because of technology. We, I think in general, as a country, 
and industries have not explained this very well, and it is 
very unfortunate.
    So, I do not know if there is anything that you are 
involved in that will help make that more clear about what that 
means in terms of how science is positive in this sense or not, 
but it certainly would be helpful. I do not know if anybody 
wants to respond to that or not. That is more of an editorial 
comment, Mr. Chairman, but if anyone would want to respond. I 
do not know if the Framework does anything to translate this 
into real world for people and why this is positive in terms of 
health and safety, but is that anywhere in the Framework or 
not? I do not know.
    Ms. Mayne. Well, I would just----
    Chairman Roberts. Feel free.
    Ms. Mayne. I would just say, at the end of this process, I 
would hope that the public would have greater confidence and 
that we will continue to try to communicate the strength of the 
science, as you hear today, that we have confidence in the 
safety of these products, in the case from FDA, for the food 
supply.
    Senator Stabenow. Thank you. Thank you, Mr. Chairman.
    Chairman Roberts. Thank you, Senator. Your sense of 
frustration folds very neatly into our challenge here on the 
committee. This is the first time in ten years that we have had 
a hearing on biotechnology, and we have experts that have 
testified basically to the American public that biotechnology 
is safe. Each of us have our megaphones that we can talk to our 
farmers and ranchers and all of agriculture, and, for that 
matter, the food industry. But, it is a challenge and I thank 
you for bringing that up.
    Senator Thune.
    Senator Thune. Thank you, Mr. Chairman, and thank you for 
being a pioneer on this subject. It is important. It is the 
first one--I did not realize, the first one in ten years, but 
it is an important subject, so thank you to you and Ranking 
Member Stabenow for bringing this issue in front of us.
    It goes without saying that biotechnology has provided my 
home State of South Dakota and its number one industry, 
agriculture, with dramatic yield increases, drought tolerant 
crops, sustainability, and economic benefits that far exceed 
expectations from ten or 20 years ago. Farmers in South Dakota 
and across the United States take great pride not only in the 
amount of the crops that they produce, the number of people 
they feed, but most importantly in the safety of the food 
supply they provide, not only for the United States and global 
populations, but also for their own families.
    Now, based on testimony that is provided and going to be 
provided at today's hearing, I am greatly concerned that just 
like many other areas of regulatory overreach, future 
regulation of our biotechnology crops, especially regarding the 
approval process, could become much more cumbersome and 
complicated and send the wrong message to our trading partners 
overseas, which could be very detrimental to my home state, as 
it depends heavily on export markets.
    Additionally, the uncertainty that is created by states 
individually passing mandatory GMO labeling laws would be 
devastating to producers, as our supply chains are much too 
complex to meet the needs of 50 different states.
    So, I start with that. I have a couple of questions I would 
like to ask, and I want to direct this one first to Mr. Jordan, 
because opponents of biotechnology have been raising questions 
about the safety of glyphosate herbicide with certain GM crops, 
notwithstanding its 40-year history of safe use, and the fact, 
by the way, that no regulatory agency in the world considers 
glyphosate to be a carcinogen.
    In April of this year, EPA issued a desk statement 
regarding glyphosate and the IARC conclusion. In this 
statement, EPA stated, in part, and I quote, ``In 2014, EPA 
reviewed over 55 epidemiological studies conducted on the 
possible cancer and non-cancer effects of glyphosate. Our 
review concluded that this body of research does not provide 
evidence to show that glyphosate causes cancer and it does not 
warrant any change in EPA's cancer classification for 
glyphosate. This is the same conclusion reached in 2004 by the 
United Nations Food and Agriculture Organization and affirmed 
this year by Germany's pesticide regulatory officials.'' That 
is the end of the quote.
    So, I just want to ask you the question, can you confirm 
that this is the most recent public statement EPA has issued 
addressing the safety of glyphosate?
    Mr. Jordan. Yes, sir, that is the most recent statement 
that we have issued on that, and I helped write it with the 
input of the experts at EPA. We are currently reviewing the 
IARC report and we expect by the end of this year, possibly 
sooner, to have another statement addressing that document.
    Senator Thune. You in your testimony, when discussing 
regulation of plant incorporated protectants, or what you 
referred to as PIPs, that, quote, ``Our decisions are based on 
the best available science. We operate with consistency and 
fairness in a transparent manner and we collaborate fully with 
our regulated partners in the Coordinated Framework,'' end 
quote. Then you went on to say that the EPA believes we have a 
responsibility to convey to the public that our decisions are 
consistent, scientifically solid, and fully protective of human 
health and the environment.
    Based on the collaborative efforts of EPA, FDA, and USDA 
APHIS using sound science to ensure food safety, especially for 
foods derived from genetically engineered plants, do you 
believe consumers need mandatory labeling of foods produced 
from GMO plants?
    Mr. Jordan. Sir, I believe that the genetically engineered 
plants that we have reviewed do not pose any risk in the food 
supply. It is not EPA's purview to address labeling questions, 
but that lies with FDA.
    Senator Thune. Okay, and thank you for that nice segue 
there. Dr. Mayne, you provide in your testimony the FDA is 
supportive of voluntary labeling that indicates whether foods 
have or have not been developed through genetic engineering, 
provided that such labeling is truthful, not misleading. You 
also provide in your testimony that, and I quote, ``FDA's 
voluntary pre-market consultation process provides for a 
rigorous food safety evaluation of foods derived from 
genetically engineered plants. As a result of these pre-market 
consultations, we are confident that foods derived from GE 
plants in the U.S. marketplace today are as safe as their 
conventional counterparts,'' end quote.
    So, if you are confident that foods derived from GE plants 
are just as safe as foods derived from conventional 
counterparts, does not the whole idea that you put forward of 
labeling send a mixed message?
    Ms. Mayne. So, if we were to require mandatory labeling, 
that would be a different interpretation. As I indicated 
previously, there is no basis for us to require labeling based 
upon a material difference in the products, and federal courts 
have upheld that position. We recognize consumers want to know 
this information, and that is why FDA has issued guidance on 
voluntary labeling procedures for industry. So, mandatory 
labeling also has some enforcement challenges, and so it is not 
grounded in science or in the basis of our authority to require 
mandatory labeling.
    Senator Thune. I would like to continue that line of 
questioning, Mr. Chairman. My time has expired, so I will 
perhaps get it on another round or submit some questions for 
the record.
    Chairman Roberts. The Chair would inform the distinguished 
Senator that he will be granted any time after the members 
present have their questions. You have flown at 2,000 feet. We 
have been flying at 30,000 feet, so, obviously, those are some 
very pertinent questions.
    Let us recognize the former distinguished Chairman of the 
committee, Senator Leahy, who I am sure has very interesting 
questions. Senator Leahy.
    Senator Leahy. I have just been fascinated by all the 
questions already asked. Mr. Chairman, and Ranking Member 
Stabenow, I appreciate you holding this hearing, bringing 
together a diverse panel of witnesses. As I have mentioned to 
you both, I have to go off to another scheduled event and so I 
will not be able to stay much longer.
    I just wanted to, before I left, welcome a fellow 
Vermonter, Joanna Lidback of Barton, to the committee. She and 
her husband have worked very hard on this subject. We also had 
a chance to talk about the foliage in Vermont. That is a view 
off my front lawn.
    Senator Stabenow. Rub it in.
    [Laughter.]
    Senator Leahy. It probably is different in Kansas, but----
    Chairman Roberts. Did you want to hold that up and----
    Senator Leahy. No, no, no. It would sound too much like 
bragging and we never do that in Vermont even though we have 
the best----
    Chairman Roberts. I cannot see anything for the trees.
    Senator Leahy. We do not brag about it, because even though 
we do have the best foliage in the world, but----
    [Laughter.]
    Senator Leahy. --but we will not brag. I know that--Joanna, 
I do appreciate the amount of time you spent talking to my 
staff and others. I know you are going to bring a unique 
perspective on biotechnology to the hearing. I also note that 
she, like other farmers in Vermont and throughout our country, 
take great pride in providing safe, nutritious food for all of 
us, and this is a complicated issue. I hope we are going to 
hear from even more witnesses, to reflect the broad scope of 
issues at play.
    Mr. Gregoire, you mentioned in your testimony that the USDA 
regulates GE crops under its plant pest authority provided by 
the Plant Protection Act, but the Plant Protection Act, when it 
was considered by Congress back in 2000, did not include any 
language relevant to GE crops. In the legislative record, I 
have gone back, I do not see anything in it that says Congress 
intended to address GE crops. So, it is a kind of narrow hook, 
suggesting the remote possibility that GE crops could become a 
plant pest. We have many new GE crops that are not made using 
plant pests in their development, so they fall outside USDA's 
regulatory authority. Will the proposed rule on risk-based 
regulation address this, or are we trying to put a square peg 
in a round hole?
    Mr. Gregoire. Thank you, Senator, for that question. You 
are correct that the Plant Protection Act does not specifically 
address biotechnology or genetically engineered crops, nor does 
it define any plant breeding methodology per se. What that Act 
provides the Secretary is very broad authority to prevent the 
introduction and dissemination of plant pests and noxious weeds 
in the U.S. to protect the health of our agriculture industry. 
That is really the focus of the mission of our agency, and it 
is through this lens that we look at the products of 
biotechnology as we would look at any other organism that might 
present a plant pest----
    Senator Leahy. The reason I get this, we seem to have 
conflicting agencies. Those who oppose the labeling and 
regulations often point to the FDA's policy statement from 1992 
that GE foods can be marketed without labeling because they are 
not materially different from other foods. But that is in sharp 
contrast to the U.S. Patent and Trademark Office, which holds 
that GE foods are novel for patent purposes.
    So, I ask both Dr. Mayne and Mr. Gregoire, is it defensible 
to maintain that GE foods are not materially different from 
other foods when the U.S. PTO recognizes them as a novel 
invention? Help a layman out here. I am new to all this kind of 
thing----
    Mr. Gregoire. Well----
    Senator Leahy. --after 40 years.
    Mr. Gregoire. So, some of the things that we look at in our 
reviews for a new GE crop are: does the trait that has been put 
into this plant cause disease or damage to other plants or 
plant products? Does the trait make the plant more weedy? 
Things of that nature. Again, what we are trying to get at is 
not so much how it was transformed, but if the product of the 
technology has potential to cause physical damage or harm to 
other agriculture, and what we have found in every one of the 
117 deregulations that we have done, is that those plants are 
essentially no different in those regards than their 
conventional counterparts.
    Senator Leahy. Dr. Mayne, what do you have to say about the 
U.S. PTO?
    Ms. Mayne. Again, from the materiality difference, we look 
to see whether these foods are any different from their 
conventional counterparts with regard to issues of food safety 
and nutrition. So, we do not look at the production method. 
That is not what we consider in the materiality. What we look 
at is the food itself and are the characteristics of the food 
itself materially different from the conventional counterparts. 
As a class, we have concluded that they are not materially 
different.
    If they were, if there were a material difference, then we 
would want that labeled. So, for example, if there was a 
different nutritional content, we would indicate that, for 
example, high oleic acid soybean.
    Senator Leahy. Thank you.
    Thank you, Mr. Chairman, and I would ask consent to submit 
some questions for the record.
    Chairman Roberts. Without objection. I would offer only the 
comment that every member is certainly free to put a picture of 
their state on the front of their briefing book, but comments 
therein will be limited to raising them on high and mentioning 
them for ten seconds.
    [Laughter.]
    Chairman Roberts. I would also offer the opinion that 
neither one of us should be talking about foliage.
    [Laughter.]
    Senator Leahy. I think we are referring to a different 
type.
    Chairman Roberts. Yes.
    [Laughter.]
    Chairman Roberts. Senator Boozman.
    Senator Boozman. Thank you, Mr. Chairman, and I thank the 
panel for being here. We appreciate all that you all do to 
ensure that our food is safe.
    Chairman Roberts. Yes.
    Senator Boozman. Again, thank you to the Chairman and 
Ranking Member for having this very, very important hearing.
    Mr. Jordan, all of you have--well, first of all, all of you 
have stated that the biotech crops are safe, and Mr. Jordan, in 
your testimony, you mention that PIPs have had positive impacts 
in the environment and that they are safer than conventional 
pesticide. Can you elaborate on the benefits you have seen from 
PIPs?
    Mr. Jordan. Certainly. First and foremost, farmers are 
adopting the PIP technology because it works. It is effective 
at controlling the pests. So it meets their needs.
    Secondly, PIPs, the ones that we have reviewed and that 
have been so widely adopted, use a genetic material from a 
bacterium called Bacillus thuringiensis. It is a common soil 
microbe that actually has been adapted to use in the organic 
program, and it produces a protein that is harmful to the 
insects that eat corn or soybeans or other crops, and it kills 
those insects but it has virtually no effect on any other 
species. So, it is safer than conventional broad spectrum 
pesticides, chemical pesticides that not only affect the target 
insect, but also other insects and sometimes other species in 
humans, as well. By using PIP plants, there has been less use 
of those conventional pesticides and that means less pesticide 
residues in our food and our water, less exposure for workers 
and wildlife.
    Senator Boozman. Thank you, Mr. Jordan.
    Dr. Mayne, I have heard from folks asking about the FDA's 
pre-market consultation process. To me, it would seem to be in 
the developer's interest to consult with the FDA both for 
safety and trade reasons. Can you walk us through the FDA pre-
market consultation process.
    Ms. Mayne. Certainly. So, the way the process works is we 
encourage the plant developers to come in to us early in the 
process, in part because we can help to identify the types of 
data that might be needed to review the safety of that process. 
So, it is a voluntary consultation process. They can come to us 
multiple times to get the package of data information together 
that they would submit to the agency and then we would review 
that evidence for safety.
    Senator Boozman. So, you have got confidence in the 
process.
    Ms. Mayne. We do have confidence in the process.
    Senator Boozman. How long does it take?
    Ms. Mayne. So, the time is variable, depending upon, like, 
when do we start the clock when they first come to us. But once 
the package is together and once they have submitted that 
information to us, generally, it takes between one and two 
years to complete the final consultation.
    Senator Boozman. Yes. Has any developer of a biotech plant 
ever not followed your pre-market consultation process?
    Ms. Mayne. In terms of our consultation process, we are not 
aware of anyone that has not gone through the consultation 
process that has then commercialized a product into the U.S. 
market.
    Senator Boozman. How does the regulatory scrutiny that 
biotech crops undergo compare to the regulatory process for 
other food ingredients?
    Ms. Mayne. Again, we use the same safety standards, the 
same legal standards for conventional as well as for food 
produced through genetic engineering.
    Senator Boozman. Mr. Gregoire, does the USDA have full 
authority to regulate any plant in the U.S. if it is shown to 
be a pest, even if it is a biotech crop?
    Mr. Gregoire. Yes, Senator. The Plant Protection Act gives 
the Secretary very broad authority to take measures to control, 
prevent, mitigate the introduction or dissemination of plant 
pests in the U.S. So, regardless of how that may have been 
created, we do have that authority and that ability.
    Senator Boozman. Very good. Thank you, Mr. Chairman. Thanks 
to the panel. So far, your information has been very, very 
helpful. We appreciate you coming.
    Chairman Roberts. I thank the Senator, very pertinent 
questions.
    Senator Heitkamp.
    Senator Heitkamp. Thank you, Mr. Chairman.
    I am going to take this in a little different direction 
because I do not think there is anyone on this committee who 
has not reviewed the science and who does not believe 
everything that you are saying. This is not a new issue. During 
the 1990s, I served on something called Trade and the 
Environment Policy Advisory Committee for the USTR where 
European labeling of genetically engineered foods was starting 
to surface as an issue in terms of a trade barrier. We know 
that there has been a growing and brewing controversy around 
this kind of technology, for good or bad.
    You take a look at the fight that we are fighting right now 
on vaccines, the fight that we are fighting on pasteurized 
milk. You can go down the list. All these technologies that 
have really helped create more food, helped keep our food safe 
and are being challenged all the time.
    I have a question that goes to maybe not the regulatory 
scheme, but goes to why it is that we have this controversy 
given the unanimous consent of all of the regulatory agencies 
that these products are safe. What is it that we are not doing 
in terms of making the information that you provide more 
accessible to the average consumer so that they understand? We 
are up against a huge social media network where things get 
said that should be challenged, but yet we do not seem to find 
the way to challenge them.
    My question for all of you is how can you make the 
information that you utilize to make these determinations more 
accessible to the American public in a way that they understand 
and that they have confidence in the work that you have done. 
We would start with the FDA.
    Ms. Mayne. So, that is a challenging question. It is a 
communications issue, and we do work with a very talented 
communications team every time we have new information that we 
put out onto the market. I have only been at the agency for 
nine months, but I can tell you, for example, we recently 
finished a consultation process on two new genetically 
engineered products. One was an Arctic apple. The other was a 
potato. We put the information out in the media, and to my 
surprise, we did not have much media attention.
    So, I am thinking that the times are changing and perhaps 
we are getting more embracing of the genetic engineering and 
the technology and how it can be used. But, it is really a 
communications challenge and we need to go to our most trusted 
communicators to communicate that to our public.
    Senator Heitkamp. Dr. Mayne, if it were getting more 
acceptable we would not be in this room with a room full of 
people.
    Ms. Mayne. Yes.
    Senator Heitkamp. I think that is pretty clear. There is 
something about what we are not communicating in terms of the 
science that is not getting through.
    Mr. Jordan, can you offer any comments?
    Mr. Jordan. I will try. It is a very challenging issue, and 
I think the general decline in confidence in all parts of 
government plays a role in this. For what it is worth, we at 
EPA believe that doing our work transparently, making available 
all of the information, all of our analysis that underlies our 
decisions, seeking outside experts who do not have government 
affiliations to weigh in on difficult issues is the way that we 
as government can demonstrate that we are doing a responsible, 
effective job of making decisions.
    Senator Heitkamp. Except what people hear is ``blah, blah, 
blah, blah, blah.''
    Mr. Jordan. I know that.
    Senator Heitkamp. I think that is a serious problem as it 
relates to what we are trying to do, because we are talking 
about how do we provide consumer information, information 
consumers want, versus what consumers need. That really is what 
we are talking about here, and I believe the science is so 
strong in this area that these are products that will not have 
an adverse effect in any way on health, in fact, can improve 
health by making it more accessible worldwide, food products 
worldwide. But, yet, we seem to be losing, I think, the fight, 
not just on labeling, but losing the fight on how we are going 
to make these products more acceptable.
    I think, Mr. Gregoire, maybe you can offer some comments, 
as well.
    Mr. Gregoire. Yes. Thank you. It is certainly very, very 
challenging to explain to the public very complex scientific 
issues. Some of the things that we do, all of the analyses that 
we do are made available to the public. Any regulatory 
decisions we make, we call attention to those decisions either 
with a press release or an e-mail to our stakeholders to let 
them know the decisions that we have made and how we have made 
those. We do have an annual stakeholder meeting where members 
of the public can----
    Senator Heitkamp. I am out of time. I just want to make one 
final point, if I can. The data that you are presenting and the 
information you are presenting is not presented in a way that 
is accessible to the public. It is easier to say this is bad 
than explain why this is good, especially when the technology 
is so elevated. I would really challenge all of you to think 
about how you discuss your findings with the public so that we 
can advance this beyond regulation and all the discussion but 
actually have a conversation with consumers.
    Senator Boozman. [Presiding.] Senator Hoeven.
    Senator Hoeven. Thank you, Mr. Chairman.
    The availability, the affordability, and the quality of our 
food, though often taken for granted, is a linchpin of every 
American's personal security. There is a tremendous amount of 
interest in what is in our food and how it is produced and, 
specifically, genetically engineered plants and the food that 
is produced them.
    I want to thank Chairman Roberts for holding this hearing 
because I do think it is important for the American public to 
understand what is being done to ensure the safety of the food 
that Americans eat. I also think it is important to hear about 
how fundamental biotech ag products are to our ability as a 
nation to provide for our food security.
    I have been working with our Chairman, Chairman Roberts, 
and with the Ranking Member, Senator Stabenow, on putting 
together bipartisan consensus legislation to address the issue 
of labeling of food made with genetically engineered, or GMO, 
products. I have had a lot of good conversation with my 
colleagues on both sides of the aisle and I am hoping that 
today's hearing can further those discussions.
    So, with that in mind, my first question for each of you 
is, from a scientific perspective, is there anything that makes 
genetically engineered crops less safe for humans or the 
environment than traditional plant breeding techniques, such as 
cross-breeding? Mr. Gregoire, if you would start.
    Mr. Gregoire. Yes. We have not found that to be the case 
with any of the products that have gone through our regulatory 
system, and we have confidence in the safety of the GE plants 
that we have approved.
    Senator Hoeven. Mr. Jordan.
    Mr. Jordan. For EPA, the products that we have looked at 
are safe. They pose no greater risks than the conventional 
crops that are not genetically engineered.
    Senator Hoeven. Dr. Mayne.
    Ms. Mayne. Similarly, the products that have been through 
our consultation process, we have determined are as safe as the 
conventional counterparts.
    Senator Hoeven. A second question would be how can your 
agencies better communicate the safety of products that you 
have vetted? How can you better communicate? Mr. Gregoire.
    Mr. Gregoire. I mentioned some of the things we do, and 
that is to be transparent in our decision making and share the 
analyses that inform the regulatory decisions that we make. I 
think the undertaking that is the review of the Coordinated 
Framework will help with this, as well, because one of the 
objectives there is to make the system more clear, transparent, 
and understandable for both the public and for developers.
    Senator Hoeven. Mr. Jordan.
    Mr. Jordan. We at EPA are doing many of the same things 
that Mr. Gregoire mentioned, making our decisions and the basis 
for them public, giving the public lots of opportunities to 
engage us if they either do not understand or disagree, and we 
always respond to the comments. We will use the Coordinated 
Framework to revisit our activities and see if we can do a 
better job.
    Senator Hoeven. Dr. Mayne.
    Ms. Mayne. I would say the same, that as part of the 
Coordinated Framework, we should make it a deliverable to try 
to figure out how we can better enhance communication around 
this complicated topic. Having the involvement of external 
review from the National Academies may be helpful to us in that 
regard.
    Senator Hoeven. What recommendations would you have, if 
any, for food labeling in regard to GMOs? Mr. Gregoire.
    Mr. Gregoire. So, the labeling belongs with our colleagues 
in the Food and Drug Administration. We do recognize that 
having a multitude of disparate laws and statutes among the 
different states and local governments can be confusing to 
consumers, and developers and food companies and the USDA wants 
to be helpful in this process.
    Senator Hoeven. Mr. Jordan.
    Mr. Jordan. EPA has no authority or responsibility for food 
labeling and our agency has not taken a position on that issue.
    Senator Hoeven. Dr. Mayne.
    Ms. Mayne. From an FDA perspective, our goal is to make 
sure that the labeling is truthful and not misleading, and that 
is our goal. As we indicated previously, we have issued 
voluntary guidance as to how manufacturers can label their 
foods with regard to either the presence or absence of 
ingredients from genetically engineered products.
    Senator Hoeven. Do you have any other recommendations?
    Ms. Mayne. Truthful and not misleading.
    Senator Hoeven. Okay. Thank you.
    Thank you, Mr. Chairman.
    Chairman Roberts. [Presiding.] Senator Bennet.
    Senator Bennet. Thank you, Mr. Chairman. Thank you for 
holding this important hearing, and it is good to try to 
establish a shared understanding of the facts, and I think that 
is a very important place to start. For all the reasons Senator 
Thune said, this has been very important to the West and to 
Colorado, to increase the yields of some of our most important 
crops like corn and sugar beets.
    This is for you, Mr. Gregoire. However, I have heard 
concerns that biotech crops can sometimes accidentally mix with 
non-GMO crops in neighboring fields. This includes organics, 
which consumers expect to meet very specific standards. How is 
APHIS working to avoid contamination--working with our farmers 
to avoid contamination of non-GMO crops and develop best 
practices for growing all types of crops?
    Mr. Gregoire. Thank you for that question, Senator. So, 
there are two aspects of this. While GE crops are under 
regulation, and in field trials our regulations are designed to 
keep them confined and so that this problem does not occur, I 
think the greater issue is once we have deregulated and the 
products have become commercialized that we see these issues of 
gene drift and so on.
    The Secretary has recognized this is an important issue for 
our stakeholders. Our policy in USDA is that we support all 
forms of agricultural production, be it conventional, biotech, 
or GE. That should be the farmers' choice with what they grow.
    Given that, the Secretary and the Department have 
undertaken a number of measures, working with stakeholders to 
identify ways that we can strengthen coexistence among the 
different agricultural production systems. APHIS and other USDA 
agencies have been part of that effort, and so we have 
announced things in USDA, like additional research to prevent 
gene flow, for example, looking at crop insurance programs, 
looking at best management practices that we can share with 
producers to mitigate these kinds of issues. So, it is not just 
APHIS, but the Secretary is using the resources throughout USDA 
to address this issue.
    Senator Bennet. How big a risk do you think it currently 
is? Is it a risk that is growing, and are the recommendations 
that you are making actually getting out to the country, or is 
this still internal in the bureaucracy of the agency?
    Mr. Gregoire. No, much of this has already been shared. We 
are still in discussions with stakeholders about additional 
measures that the Department can take to strengthen 
coexistence. There are a lot of measures that the industry has 
undertaken themselves to deal with these issues, as well.
    Senator Bennet. Dr. Mayne, every year, as you have 
testified here, more GMOs successfully move through the FDA's 
food safety review process. While the studies that have been 
cited today have concluded that GMOs are safe, some of my 
constituents have concerns about the changing landscape of 
biotechnology, evolution of biotechnology, especially when the 
FDA does not conduct its own tests of the GMO foods. In your 
view, are the current practices for evaluating GMO foods at the 
FDA keeping pace with innovation in biotechnology, and how are 
you thinking about that coming challenge?
    Ms. Mayne. So, I would say, at this point, yes, we are 
keeping pace with changes in biotechnology, and one of the 
things we will be looking at as part of the Coordinated 
Framework is more horizon scanning. What do we need to do in 
the future, and what types of challenges might we anticipate 
coming at us in the future and how do we best prepare to deal 
with those challenges. So, that will be one of the things we 
will be looking at.
    Senator Bennet. I am just--as you--what was that term you 
used, horizon scanning?
    Ms. Mayne. Horizon scanning, yes.
    Senator Bennet. So, as you think about the coordination the 
White House has asked you to do, maybe I will close just by 
asking each of you what you think that interagency work--what 
kind of horizon scanning that is going to make possible beyond 
the question that I just asked Dr. Mayne. What are some things 
that are going to be at the forefront of the discussion you 
have?
    Mr. Jordan. Senator, I think that there are a couple of 
things that have already begun. First and most important is 
conversations between the regulatory agencies--FDA, USDA, and 
EPA--and parts of the executive branch engaged in research that 
includes work with new breeding technologies. As the 
researchers discover what they can get done, knowing about that 
as a regulator is helpful to us because it helps us both 
prepare for eventual commercial products and also give feedback 
to the researchers if there is an issue that they might 
encounter once those products become subject to the regulatory 
process.
    Senator Bennet. Thank you, Mr. Chairman.
    Chairman Roberts. Senator Ernst, and Senator, I understand 
that Iowa Public Television is covering this event, and I know 
that you will be at your best.
    Senator Ernst. It is wonderful. Thank you very much, Mr. 
Chair. I appreciate that.
    Well, thank you, folks, for joining us here today in this 
committee hearing. I just came from the Armed Services 
Committee, and, of course, we focus very much on national 
security, and Senator, I believe you mentioned national 
security and food security in your opening statement, so, thank 
you for doing that.
    The Director of National Intelligence, DNI, released a 
report last week pointing out the national security threats 
posed by global food insecurity. If we fail to embrace 
biotechnology as a safe, affordable, and timely way to bring 
better food production methods to developing and unstable 
nations, we are ultimately putting our military and our country 
at greater risk. How can this administration and your agency 
specifically work to help the public better understand the 
science supporting biotechnology so we can better address the 
national security challenges laid out by DNI? I would open that 
up to our entire first panel.
    Mr. Gregoire. Well, I have mentioned some things that we 
are already doing in terms of being transparent in our decision 
making, and the Coordinated Framework review that we have 
undertaken is, at least in part, designed to get at this issue. 
Beyond that, I think we just need to really redouble our 
efforts to communicate better about our processes and the 
science behind them.
    Senator Ernst. Thank you.
    Mr. Jordan. Government needs to speak clearly, to answer 
questions responsibly, to lay out fully all of the information 
that we have, and I hope and expect that anyone who gives that 
fair consideration will conclude, as we have, that our 
decisions are protecting public health, the environment, and 
the food is safe.
    Senator Ernst. Okay. Thank you, Mr. Jordan.
    Dr. Mayne.
    Ms. Mayne. I would say just to continue to educate as best 
we can, using plain language techniques as best we can to 
communicate what the science really indicates with regard to 
the processes and how we review these commodities for safety.
    Senator Ernst. Well, I appreciate that. I do think that--
and many of us use this phrase in our own home communities, 
but--since many of us are from agricultural areas, but we do 
feed and fuel the world, and I do believe that that is very 
important to maintain stability around the globe and making 
sure that populations are fed. So, I appreciate your answers 
today. But, it is something that we need to continue working 
on. I believe that GMOs are safe. I believe we should have them 
available to the globe, so thank you very much. We appreciate 
it.
    Chairman Roberts. Senator Klobuchar.
    Senator Klobuchar. I think I am going to defer to Senator 
Casey. He has another commitment. Then I will go after that.
    Chairman Roberts. Senator Klobuchar has yielded to Senator 
Casey. Senator Casey is recognized.
    Senator Casey. I want to thank Senator Klobuchar, and I 
will be brief, so whatever time I have used, I will double that 
and give it back to her on another day.
    [Laughter.]
    Senator Casey. So, thanks very much, and I will be brief, 
Mr. Chairman. I have to run, and we are all going in different 
directions for hearings and meetings. So, I will only pose one 
question. It will be for the whole panel.
    But, let's start by talking about a number which I think 
stares a lot of us in the face. Some of us had mentioned, as 
Senator Ernst did, national security. Here is a number which I 
think--I will call it the 34 percent/70 percent number. 
According to the Food and Agriculture Organization of the 
United Nations in an October 2009 paper entitled, ``How to Feed 
the World in 2050,'' they conclude that by 2050, the world's 
population will reach 9.1 billion, which is 34 percent higher 
than today. That is the 34 percent number. In order to feed 
this larger population, food production must increase by 70 
percent. So, if those numbers are correct, we have a major 
challenge we confront.
    So, I guess, one of the basic questions I would ask is in 
light of the fact that all three of you represent part of the 
executive branch, and of July of this year, the Executive 
Office of the President issued a memorandum, as others have 
referred to, directing three organizations which have the 
primary regulatory responsibility for this area, meaning 
biotechnology. The Executive Order asked that an update of the 
Coordinated Framework for the Regulation of Biotechnology be 
undertaken.
    I would ask you, in succession, and maybe we can start left 
to right, what is the current status of this work, and are 
there areas where both--or, I should say, all three, APHIS, 
EPA, and FDA, can increase collaboration? Maybe we will start 
on my left. I am sorry. We will start with APHIS.
    Mr. Gregoire. Yes. Well, the review has just gotten 
underway and there are three focus areas. One is to clarify the 
roles and the responsibilities of the respective agencies. The 
second is to take a strategic look at how we can prepare for 
the future products of biotechnology. The third is to get an 
outside expert study of the future landscape of the products of 
biotechnology.
    So, there is work that has gotten underway in each of those 
three areas. APHIS is cooperating fully. We have put some of 
our best scientific staff on this work. FDA is hosting a public 
meeting later this month. APHIS anticipates hosting one of the 
future meetings after this first one.
    Senator Casey. Okay. Mr. Jordan.
    Mr. Jordan. There will be three public meetings, and EPA 
gets the third one, so that each of us will actively reach out 
to stakeholder communities and draw them into this conversation 
about how to improve coordination, improve clarity and 
transparency.
    One thing that the July memorandum accomplished that no one 
has spoken to yet is the creation of a formal coordination 
mechanism, a committee, and it is a mouthful. It is the 
Emerging Technology Interagency Policy Coordination Committee. 
But, it gives us a formal opportunity, a regularly scheduled 
place to bring our issues together and talk about them. We 
already do have such conversations among our staffs at FDA and 
USDA and EPA, but making this more formal, I think, will be a 
good thing.
    Senator Casey. Thank you.
    Doctor, if you could limit it to 30 seconds. Sorry about 
that.
    Ms. Mayne. Well, I echo what they said. We are putting 
together formal mechanisms to get together on a regular basis, 
which had already been happening, but now we have a clear 
mandate on tasks that we should be thinking about. As you 
heard, FDA is preparing for a public meeting which will be held 
October 30. So, we are engaged in a process to get public 
comment on things that we should be considering as the three 
key agencies responsible here.
    Senator Casey. That is great. Thanks for being so brief.
    Mr. Chairman, before I relinquish the microphone, on the 
second panel that I may or may not be back for, I want to make 
sure that I highlight one of our witnesses, do a quick bio here 
for Mr. Daryl Thomas. He is a Pennsylvanian, of course, He 
started his career at Herr Foods as a salesperson. He served in 
both the Navy and the Army National Guard. His first job, I 
believe, at Herr's was to manage their quality assurance 
program. After getting a Bachelor's degree, he got a Master's 
of Science degree in food marketing from St. Joe's, a great 
university where my daughter attended some years after Daryl 
did.
    Daryl serves now as Herr's Senior Vice President of Sales 
and Marketing. He is married to his wife, Martha. They have 
three sons, Daryl, Jeremiah, and Hans, and Hans, I am told, is 
married to Daryl's daughter-in-law Emily. They reside in 
Southern Lancaster County.
    Thank you for letting me introduce him quickly. Not bad.
    Chairman Roberts. Well, thank you, Senator Casey. That 
means that I will not have to read that again.
    [Laughter.]
    Chairman Roberts. But I will if you want me to.
    Senator Casey. I will come back and read it if I can.
    Chairman Roberts. All right, that is fine. Thank you so 
much.
    Senator Tillis.
    Senator Tillis. Thank you, Mr. Chair. I want to thank all 
of the panelists for being here.
    I know that this question may have been asked in a 
different way, but I tell you, back in North Carolina, there 
are a lot of misconceptions about biotechnology and the safety 
of the food supply. So, if you are sitting at a diner or a 
barbecue joint in North Carolina and somebody asks you a 
question about biotechnology-driven breeding techniques versus 
other ones, what would you tell them? Are they any more or less 
safe? I will start down the line with Ms. Mayne.
    Ms. Mayne. As I have said, they are as safe. It is----
    Senator Tillis. As safe.
    Ms. Mayne. It is a different way to accomplish 
incorporating desirable genes into plants.
    Senator Tillis. But, in your opinion, there is no science 
to suggest that they are any less safe?
    Ms. Mayne. That is our opinion, any less safe than their 
conventional counterparts.
    Senator Tillis. Mr. Jordan, what would you tell the person 
at that diner table?
    Ms. Mayne. Senator, I would say we have looked at these 
products six weeks to Wednesday and we are convinced, and so, 
too, are outside experts, that these things are safe.
    Senator Tillis. Mr. Gregoire.
    Mr. Gregoire. I would just emphasize the very thorough 
review that they get by the U.S. Government agencies before 
they are commercialized.
    Senator Tillis. So, we have senior people from three very 
important agencies, FDA, EPA, and USDA, all saying that the 
science suggests this is safe and that while we always want to 
scan the horizon, as Ms. Mayne said, till it for any other 
potential threats, there is no evidence to suggest that the 
crops that we have in the field today, the techniques that we 
are using for breeding, are in any way unsafe and a threat to 
our food supply.
    I have another question. This may be an unfair question for 
you, Mr. Gregoire, but I do want to get it out there so that we 
can research it. Let us say we roll back the clocks. Some 
believe that all of these techniques are bad and that we should 
basically eliminate them. Has there been any research done to 
determine what that would look like in terms of the impact on 
our production or our food supply today? So, roll back the 
clock. Get rid of all the gains that we have made in terms of 
agriculture output. Let's go back to a pre-biotech era to get 
some idea of what that would really mean to our food supply.
    I know, for example, in Iowa, about 95 percent of the corn 
grown there is a product of biotechnology. If we really look 
back--I think that there are really some who would think that 
would be a good idea--I am just trying to get an idea of how 
that would affect us.
    Mr. Gregoire. I do not know if that question has been put 
to us in that particular way. I can tell you, though, that 
biotech crops have been widely adopted by producers in the U.S. 
Upwards of 90 percent now of corn, cotton, soybeans, and sugar 
beets are now genetically engineered. So, had that not been the 
case--I think we probably have some reports and statistics that 
we might be able to share with the committee from the Economic 
Research Service in USDA that might be helpful to provide for 
the record.
    Senator Tillis. I guess there are some that say the 
baseline regulations our agencies are using to oversee biotech 
and breeding techniques have not really been updated since the 
1980s. Are they broken and do we need to fix them, or are they 
sufficient for you all to do your respective jobs? Dr. Mayne, 
we will start with you.
    Ms. Mayne. I feel they are sufficient for us to do our 
current jobs.
    Senator Tillis. Mr. Jordan.
    Mr. Jordan. EPA administers two laws. We think they work 
very well.
    Senator Tillis. Mr. Gregoire.
    Mr. Gregoire. I believe that our regulatory system in APHIS 
has served the country very well in terms of protecting plant 
health. We are pursuing updating our regulations so that we are 
in a good position in the future, going forward. We have got 
many years of experience now. We would like to apply the 
lessons learned over these many years of regulation and also, 
account for the new science and the technology.
    Senator Tillis. Well, the flip side of that question would 
be, if it does not look like we need any more or new 
regulations or processes put into place, what, in your opinion, 
could we do based on our knowledge of the science to stream for 
regulators? There was a lot less certainty in the 1980s than 
there is today based on the science that has been developed 
over that period of time. Are there things that we could do to 
actually ease the regulatory burden and potentially make the 
processes that people have to go through for approval more 
efficient, less burdensome, and more likely that we are 
increasing productivity and producing better outcomes for 
agriculture?
    Mr. Gregoire. Two points on that, Senator. One is that we 
have made a real effort in APHIS over the last three years to 
improve the timeliness of our regulatory decisions. We 
appreciate that Congress has provided additional resources for 
our program to do that. We have pretty much eliminated the 
backlog in petitions that we are dealing with and we have 
reduced the time frame that had gotten up to more than three 
years, on average, down to about 18 months, and I think we can 
get it down to about 15 months.
    As we start talking about a new regulatory system, or an 
updated regulatory system, those are the kind of questions that 
we will be looking at and talking to stakeholders about, as 
well.
    Senator Tillis. Thank you, and thank you, Mr. Chair.
    Chairman Roberts. Senator Tillis, are you not going to ask 
Mr. Jordan the same question? I mean, he does come from the 
EPA.
    Senator Tillis. Well, I just wanted to make sure that the 
Marine Chairman would be okay for me going into overtime, but I 
would like to ask that question of Mr. Jordan and Dr. Mayne, if 
I may.
    Chairman Roberts. I am very interested in their response.
    Senator Tillis. Thank you.
    Mr. Jordan. Thank you, Senator. Congress has passed an 
amendment to the Federal Insecticide, Fungicide, and 
Rodenticide Act referred to as the Pesticide Registration 
Improvement Act, PRIA. Everything has an acronym. It sets 
deadlines for EPA to review and make decisions on applications 
for all sorts of pesticides, including PIPs. Our deadline for 
PIPs varies, depending on the type of product, from 12 to 18 
months, and it provides us resources to do that. That is on the 
same timeline as USDA's reviews are now taking place and the 
FDA reviews. So, we are able to align our review schedules with 
those of other agencies, share information, and that is an 
efficiency for the companies as well as for the agencies.
    Ms. Mayne. Just quickly, I would say that from an FDA 
perspective, the fact that our process is voluntary but has 
worked very well is an efficient way for us to enforce the Act.
    Senator Tillis. Thank you, Mr. Chair.
    Chairman Roberts. Senator Klobuchar will be recognized 
next, but Mr. Jordan, the Department of Labor is in the 
business now of issuing regulations on the pesticide 
application process to many farmers and ranchers and that has 
caused quite a fuss. Are you working with the Department of 
Labor folks? I am very hopeful the answer is, yes, in a 
positive way, with the question raised by Senator Tillis on 
regulations that we feel are not necessary and are very 
burdensome.
    Mr. Jordan. Senator, the Department of Labor and EPA do 
work together on safety when it comes to pesticide issues. Yes, 
we are looking for streamlined and streamlining regulatory 
processes and avoiding undue burdens.
    Chairman Roberts. Well, in that arm wrestling contest, I 
hope that you speak up loud and clear.
    Dr. Mayne, do you have any comment about that?
    Ms. Mayne. No specific comment on that.
    Chairman Roberts. Senator Klobuchar.
    Senator Klobuchar. Thank you very much, Mr. Chairman.
    Dr. Mayne, you just mentioned the FDA pre-market approval 
process and the voluntary process. Do you think there is 
anything--as we look at--and I know a lot of the White House 
effort on coordinating and making sure things are not falling 
through the cracks is about safety, but it is about consumer 
confidence, as well. Do you think there should be any statutory 
changes to that process or do you think it works?
    Ms. Mayne. I mean, as I indicated, it is a voluntary 
process. We do believe it has worked well. We are unaware of 
any product that has come into the U.S. market, been 
commercialized, that has not gone through the voluntary 
process. There are many incentives for a developer to go 
through the process. So, our experience is that it has been 
working well.
    Senator Klobuchar. Okay. Senator Casey asked all of you 
about the Coordinated Framework among the agencies that are 
represented here today, and you answered the process questions 
about what was happening. Are there any preliminary results 
that have come out of that which you could share with us? Mr. 
Gregoire.
    Mr. Gregoire. You are referring to the coordinated review?
    Senator Klobuchar. Yes.
    Mr. Gregoire. No, it has really just gotten underway----
    Senator Klobuchar. Yes.
    Mr. Gregoire. --so it is a little too early to say.
    Senator Klobuchar. Okay. Do you know when we will have some 
preliminary results?
    Mr. Jordan. The different agencies are pressing ahead 
quickly. As we mentioned, there is a public meeting on October 
30. There is also a Federal Register notice inviting the public 
to comment both on how to update the Coordinated Framework and 
ideas for consideration as part of the long-range strategies 
that our three agencies are working on. We are aiming to pull 
that information together and have something fairly early next 
year, but it will probably be an updated version of the 
public--of the Coordinated Framework for public comment.
    Senator Klobuchar. Okay. Mr. Gregoire, I know you were 
asked--all of you have been asked about the advances in biotech 
research in the last ten years and how your own processes have 
evolved with new products coming in. Since biotech crop 
varieties first became commercially available in the mid-1990s, 
APHIS has approved more than 14,000 field trials of plants, it 
is my understanding. How has your division evolved in order to 
handle the workload, and can you comment on some of the 
challenges you faced with the development of the new crops.
    Mr. Gregoire. Well, the program has certainly grown and 
Congress has increased the funding for our biotechnology 
regulatory services program rather substantially a few years 
ago. We feel like we have the resources we need to do the job, 
to provide the regulatory oversight and to make our decisions 
in a timely sort of a way. So, the workload and staffing has 
been a challenge, but I think we have met that challenge, and 
keeping up with the science, and our scientists, like the 
scientists from the other agencies, do a lot to keep abreast of 
the changes in plant breeding technology and so on. So, that is 
a very important sort of thing, too.
    Senator Klobuchar. Okay. My state, as you know, is the 
nation's fifth largest agriculture producing state, about 
79,000 farms. I think you also know agriculture is cyclical in 
nature and producers face natural and market challenges. Your 
agency helps producers deploy farm management practices, which 
have been increasingly sophisticated over the years. Can you 
comment on if and how you have seen biotech develop in that 
context of farm management.
    Mr. Gregoire. Well, it is certainly a technology that has 
been widely adopted. Our role is not so much an extension kind 
of a role, working with individual producers on this. We review 
the products for the safety for plant health and that is 
generally the procedure that all the developers go through 
before it is widely commercialized. We have, as the Department 
and USDA, shared information on best practices for things like 
weed management and coexistence and so on.
    Senator Klobuchar. All right. Thank you.
    Chairman Roberts. The Chair recognizes no stranger to the 
Iowa Public Television audience, the distinguished Senator, 
Senator Grassley.
    Senator Grassley. Well, after a comment like that, I am 
going to have to thank you for holding this very, very, very 
important hearing. I think it is important that we do review 
regulation from time to time to ensure that our policies and 
regulations are functioning.
    Biotechnology holds great promise for agriculture, and as 
the population grows around the world, and it is going to 
continue to grow very dramatically, food security will become a 
more important issue for--and a very critical issue for people 
around the world. Biotechnology will help us continue to meet 
future requirements, and I was glad to read what Director Mayne 
said in her testimony. The science says that there is no 
difference between foods derived from plants that utilize 
biotechnology in foods.
    I also often run into this issue of safety or what 
consumers want to eat when European parliamentarians come 
around to our job, and you know how farmers around the country 
are. It is a very imprecise test of when a grain is ready to 
harvest, but sometimes you take a bean or a kernel of corn and 
put it between your teeth and see if it is ready to harvest. I 
always tell them I have been doing this for 20 years and I am 
alive. I am a living laboratory for the safety of 
biotechnology.
    [Laughter.]
    Senator Grassley. I have one question of the panel, but I 
would like the three of you to do it. You may think I am asking 
this question that I expect you to know about the regulatory 
process in other countries. That is not what my question is 
about. It is about what other countries do, and it comes from 
the fact that China rejected several shipments of dried 
distiller grain because of an unapproved biotech trait that 
they said was present. This caused disruption in the grain 
trade that is still being sorted through by lawyers.
    From a scientific standpoint, I would like to have each of 
you tell me how sensitive is testing for GMO traits by other 
countries that they can find traces of GMO traits on a large 
ocean-going vessel.
    Mr. Gregoire. I do not know if I could put a number to it, 
Senator, other than to say there are very sensitive tests that 
are available to detect even trace amounts of a product in a 
large shipment.
    Senator Grassley. Okay.
    Mr. Gregoire. We certainly recognize and are focused on the 
issues of trade with China. The Secretary has personally done a 
lot in this realm. There was a recent bilateral between the 
U.S. and China. That was during President Xi's visit. Both 
sides committed to further improving the biotech approval 
process and reaffirmed the importance of a timely, transparent, 
predictable, and science-based approval for biotech products. 
The Foreign Agricultural Service in USDA is very focused on 
these kinds of issues and APHIS plays a supporting role to them 
to try to address these issues and trade disruptions.
    Senator Grassley. Mr. Jordan, will you respond, please, and 
then Dr. Mayne.
    Mr. Jordan. Certainly. With regard to the sensitivity of 
analytical methods, my understanding is, like Mr. Gregoire's, 
that the methods are very sensitive and capable of detecting 
very low level presence of genetically engineered traits in 
large shipments. I am sure many others are aware, we recognize 
that when we have approved something here in the United States 
and it then goes to a country where it is not approved, that 
which could be the source of trade problems. That is why we at 
EPA work with our colleagues at the Foreign Agricultural 
Service and USDA to provide information about our regulatory 
decisions to other governments. That is why we participate in 
international organizations to develop worldwide standards that 
would ensure consistent outcomes when different countries are 
looking at the same kinds of products.
    Senator Grassley. Dr. Mayne.
    Ms. Mayne. From a food safety point of view, I would say we 
do engage in a dialogue with other countries, including China. 
We similarly had a meeting with some of the high-level Chinese 
food safety experts just recently.
    The other thing I will reiterate is the food safety 
approaches we use are consistent with the CODEX international 
guidelines. So, we are adhering to international standards when 
we consider how we review the safety of these commodities.
    Senator Grassley. Okay. Thank you, Mr. Chairman.
    Chairman Roberts. Thank you, Senator Grassley.
    Dr. Mayne, when you are working with China, are you getting 
the static that they are putting up about that one shipment? I 
hope it is just one, but it could be more. I understand the 
shipment was turned away in China, but it did sell the product 
to another country. So, that is an interesting thing. But, is 
this coming from your experience from the scientists involved 
that you work with, obviously, on a collaborative basis, or 
does this come from higher up? Where is the problem, as you see 
it?
    Ms. Mayne. I do not--I cannot comment on the specific 
problem. What I can say is we are engaged in a dialogue with 
Chinese officials about how to assure food safety, and that is 
a commitment we have broadly, not just with genetically 
engineered foods. But, we work with Chinese officials to try to 
assure a safe food supply.
    Chairman Roberts. Tell them we have your back.
    Senator Brown.
    Senator Brown. Thank you, Mr. Chairman.
    I would like to ask a question of the whole panel, and I 
guess I will start with USDA, if I could. If Congress were to 
task each of your agencies, USDA and EPA and FDA, to task each 
of your agencies with developing a label, whether voluntary or 
mandatory, what are some of the factors you would look at to 
ensure a label that is truthful and not misleading? If you 
would, just give us your thoughts on that.
    Mr. Gregoire. Well, APHIS has really not had any 
involvement or experience with food labeling. That is in FDA's 
realm. I will say, though, that we hear from stakeholders about 
concerns they have with the potential proliferation of 
different laws and statutes that might be coming out from the 
different states and local governments. We would be happy, if 
the committee is going to be looking at the House bill, to 
provide technical assistance on looking at that bill with our 
scientific people and attorneys in USDA.
    Senator Brown. Mr. Jordan. Even though nor does EPA write 
the labels, but if you would give thoughts on the kind of input 
you would want to see result in a voluntary or mandatory label 
that is useful, not misleading, to consumers.
    Mr. Jordan. That is an area that I have not personally 
worked on, nor has my agency. My sense is that public 
perception and understanding of different types of labeling 
would be an important consideration as to how they would take 
particular words and whether they would form an impression that 
was inconsistent with the reality, so whether it was misleading 
in FDA's terms.
    There would be issues about definition of what is a 
genetically engineered ingredient. Would a product from 
livestock that fed on grain sources that were genetically 
engineered, would the livestock products be covered? Some 
definitions of what constitutes genetically engineered 
materials would also be an important consideration.
    Senator Brown. Dr. Mayne.
    Ms. Mayne. So, FDA issued draft guidance in 2001 on how 
companies could voluntarily label products. We have examples in 
that draft guidance. We received over 155,000 comments on that 
draft guidance. So, we have received public input on how to get 
voluntary labels out through this process and we are hoping to 
finalize the final guidance before the end of the year.
    Senator Brown. Mr. Jordan, let me ask you a question, a bit 
unrelated. Farmers obviously face challenges in the field every 
year, expected, unexpected challenges. One challenge that has 
become concerning is weed and pest resistance. Does EPA 
consider weed and pest resistance during its risk analysis of 
FIFRA registered products, and how has consideration of 
resistance changed in the past three or four or several years?
    Mr. Jordan. Thank you, Senator. EPA does consider pest 
resistance, both weed resistance and insect resistance, as we 
make our regulatory decisions about pesticides. Over the last 
several years, I would say that we have changed our position. 
In the past, we relied on the marketplace and farmers and 
education programs directed at farmers to encourage them to 
follow the kinds of behaviors that would prevent resistance 
from arising or would slow its spread. In certain cases, we 
recognize that it has not worked as well as we had hoped and 
wanted, and so we have begun to work with the companies that 
register pesticides to get them to play a greater role and to 
look at more effective ways of getting growers to adopt 
practices that address pest resistance.
    Senator Brown. Thank you. Thank you, Mr. Chairman.
    Chairman Roberts. Senator Gillibrand.
    Senator Gillibrand. Thank you, Mr. Chairman. I appreciate 
this hearing.
    Dr. Mayne, you said that you hope to issue the final 
guidance at the end of this year, is that correct?
    Ms. Mayne. That is correct.
    Senator Gillibrand. Apart from the 150,000 comments you 
received, how is the FDA engaging with producers for this 
option?
    Ms. Mayne. With the industry?
    Senator Gillibrand. Correct.
    Ms. Mayne. We have consulted with industry. Industry also 
has the ability to submit comments into the docket on any 
proposed thing that we put out there. So, industry is part of 
the dialogue.
    Senator Gillibrand. Great. While all domestic producers who 
have brought GE crops to market have been through the voluntary 
FDA consultation process, I am not confident that this is 
always the case, particularly as foreign biotech companies 
expand. Has FDA worked with foreign companies that are 
interested in marketing their GE products in the U.S.?
    Ms. Mayne. We have. In fact, some of the more recent 
approvals have come in for other countries. For example, the 
Arctic apple was a Canadian company that we have worked with, 
and we have worked with companies from other countries, as 
well.
    Senator Gillibrand. Do you think that the current FDA 
review process has sufficient time where we could continue to 
import a growing number of parts--a growing share of our food? 
What safeguards do you have in place so that you have an 
appropriate review process for GE products coming in? Do you 
have a way to scan the horizon and really do the oversight that 
you want to do?
    Ms. Mayne. So, with imports, obviously, if we are aware of 
a developer that is making a--or working on a new application 
in another country, we would encourage them to come into our 
process. So, we work with Foreign Agricultural Service and 
others to be aware of crops that would be being developed 
overseas.
    But, the ultimate answer is that the importers have the 
same responsibility to assure that their foods are safe that 
are brought into the U.S. market as any other crop. So, we have 
our import authorities to ensure the safety of all foods, 
including any genetically engineered foods, coming from other 
countries.
    Senator Gillibrand. Mr. Gregoire, the USDA draws its 
authority to regulate GE products from the Plant Protection 
Act, which obviously is concerned with potential plant pests. 
While some older genetic engineering tools relied on plant pest 
bacteria and viruses to modify the DNA, many newer tools do 
not. Does APHIS have sufficient authority to regulate GE crops 
that are developed with the new engineering editing tools?
    Mr. Gregoire. Thank you, Senator. We do. We do have 
sufficient authority. I do not think there are any gaps in our 
ability to deal with risks to animal and plant health. The 
Plant Protection Act gives us a very, very broad authority in 
this area. Again, just as a core principle, the coordinated 
framework is the underpinning of our regulations; the focus is 
not so much on the method by which a plant is transformed but 
the product of the transformation and what risks that product 
might pose.
    Senator Gillibrand. Can you explain whether a gene that is 
inserted into a plant with a gene gun is any more or less 
concern than one that is inserted by bacteria?
    Mr. Gregoire. No, it is not. It really, again, goes to what 
trait is being put in what organism and how that would be put 
into the environment. Those are the things that we would really 
be focused on looking at.
    Senator Gillibrand. Do you think you need any more refined 
authority to do that?
    Mr. Gregoire. I do not think we need any more statutory 
authority to do that.
    Senator Gillibrand. This question, I do not think because 
it is not your area of expertise, but I saw that the USDA 
announced a way for companies to receive a voluntary label from 
USDA certifying that their product is GE-free. For the record, 
if you do not know the answer, can you have someone describe 
the process to receive this label and how it differs from the 
organic label that is also provided by USDA. Also, what is the 
USDA doing to promote the new label and what effect do you 
think it will have on consumer choice? Are producers showing an 
interest in this new label?
    Mr. Gregoire. Those programs are run by the Agricultural 
Marketing Service. That is one of our sister agencies, and I 
think it would be best if we just responded to----
    Senator Gillibrand. That would be great.
    Mr. Gregoire. --to that question for the record.
    Senator Gillibrand. That would be wonderful.
    Mr. Gregoire. Thank you.
    Senator Gillibrand. I just want to go back to Dr. Mayne for 
one second. At the end of your consultation process from 
producers, you issue a letter that says, no further questions, 
on your determination. How come you do not end that process 
with a letter that says your product is safe?
    Ms. Mayne. So, the consultation process is a service that 
we provide to industry to help assure that they are meeting 
their compliance obligations to have a safe food. It is 
voluntary, and to date, it has worked well.
    Senator Gillibrand. But, you do not make an assessment or 
whether it is safe?
    Ms. Mayne. Well, what we do is we consult on the safety. 
So, we consult as to whether or not we believe that anything 
has any antigenic or allergenic potential, any toxic potential. 
But it is ultimately industry's responsibility to assure the 
safety of that product. So, we consult with them on this.
    Senator Gillibrand. Okay. So, you do not determine if it is 
safe. You just create a dialogue to make sure they are doing 
their job.
    Ms. Mayne. Well, correct. We review the science. We review 
the data to make sure that we have no further questions about 
the safety. If we were to have to attest to that safety 
specifically, then that would shift some of that burden to 
FDA----
    Senator Gillibrand. To you.
    Ms. Mayne. --with obvious resource implications.
    Senator Gillibrand. Got it. Thank you.
    Thank you, Mr. Chairman.
    Chairman Roberts. I think we now are going to move to the 
second panel. We thank the witnesses from the first panel. You 
have provided excellent testimony. You have shown a great deal 
of patience and we thank you very much.
    We would ask the second panel to come forth and be seated, 
please.
    [Pause.]
    Chairman Roberts. Welcome to our second panel of witnesses 
before the committee this morning.
    Joanna Lidback, a dairy producer from Vermont. Our foliage 
expert, Senator Leahy, introduced this witness. It is important 
for us to hear directly from farmers on the issue before the 
committee, and Joanna Lidback operates the Farm at Wheeler 
Mountain in Northeastern Vermont along with her husband, Adam. 
They milk Jerseys and Holsteins and manage a grass-based 
cropping and grazing program and run a Jersey beef direct sales 
business. Mrs. Lidback also works as a business consultant with 
a Farm Credit Association. Welcome. I look forward to your 
testimony.
    In the interest of time, I am going to introduce all the 
witnesses.
    Our second witness is Daryl Thomas. Senator Casey has 
already introduced this witness. Mr. Thomas is the Senior Vice 
President for Sales and Marketing from Herr Foods, Inc., from 
Pennsylvania.
    I regret not introducing you twice, but in the interest of 
time, I would like to move to Gary Hirshberg, co-founder and 
Chairman of Stonyfield Farm from New Hampshire. Senator 
Stabenow is scheduled to introduce this witness, and I would 
refer to her at this point.
    Senator Stabenow. We actually do not--I think you have the 
introduction, Mr. Chairman, if you would like to proceed.
    Chairman Roberts. I would be delighted. Mr. Hirshberg is 
the co-founder and Chairman of Stonyfield Farm, an organic 
yogurt producer. He is here on behalf of Just Label It, a 
national campaign to label genetically engineered foods. 
Welcome and thank you for joining us.
    Our fourth witness is Greg Jaffe, the Director of the 
Project on Biotechnology, Center for Science in the Public 
Interest, from Washington, DC Mr. Jaffe is the Director of the 
Project on Biotechnology at the Center for Science in the 
Public Interest, a nonprofit consumer organization. Previously, 
he served in the Department of Justice's Environmental and 
Natural Resources Division and with the EPA. I appreciate you 
sharing your testimony with us.
    Mrs. Lidback.
    Mrs. Lidback. Thank you. Chairman Roberts, Ranking Member 
Stabenow, and other members----
    Chairman Roberts. Mrs. Lidback, I am sorry. I did not 
introduce Dr. Ronald Kleinman. We would not want to do that to 
the good Doctor.
    I apologize. You are the Physician in Chief at the 
Massachusetts General Hospital for Children from Massachusetts. 
Dr. Kleinman is the Physician in Chief at the Massachusetts 
General Hospital for Children, the Chair of the Department of 
Pediatrics at the Massachusetts General Hospital, and the 
Charles Wilder Professor of Pediatrics at Harvard Medical 
School.
    His major areas of interest include gastrointestinal 
immunology, nutrition support of infants and children, and 
nutrition and public health. We also look forward, sir, to your 
statement and experience.
    Now, Mrs. Lidback, the Chair has corrected my egregious 
error and we look forward to your testimony.

  STATEMENT OF JOANNA LIDBACK, PRODUCER, THE FARM AT WHEELER 
   MOUNTAIN, WESTMORE, VERMONT, ON BEHALF OF AGRI-MARK DAIRY 
    COOPERATIVE AND NATIONAL COUNCIL OF FARMER COOPERATIVES

    Mrs. Lidback. Well, thank you again. Chairman Roberts, 
Ranking Member Stabenow, and other members of the committee, 
thank you for inviting me here to talk about agricultural 
biotechnology. I am testifying on behalf of Agri-Mark Dairy 
Cooperative and the National Council of Farmer Co-Ops.
    I live with my husband and our two young boys on a 50-cow 
dairy in the beautiful Northeast Kingdom of Vermont. In 
addition to selling our milk to the co-op, we grow hay, raise 
Jersey steers to sell beef locally, and we market a small 
amount of composted manure. We farm about 200 acres of land, 
including 50 acres of pasture where we graze our herd.
    My husband and I are both proud to be first-generation 
farmers. Starting out on our own to build a dairy operation has 
been trying at times, but all of the hard work we have endured 
could never outweigh the chance to raise our boys in a farming 
lifestyle, all the while producing food for our little corner 
of the world.
    When we started building our operation, we knew that 
environmental and economic sustainability would be important in 
order to pass the farm along to our sons someday. We needed to 
diversify our operation and use modern technology at the same 
time to have a positive impact on our farm and our community. 
My husband always says, as a farmer and a small farmer at that, 
we have so much working against us, we need to make use of all 
the things that will work for us.
    Biotech crops are essential to sustaining our dairy and 
keeping our feed prices affordable. To compare, a non-GMO basic 
feed would cost us $555 per ton and the same conventional feed 
that we currently purchase is $305 per ton. We purchase 16 tons 
of grain each month, and if you do the math, we would be paying 
an additional $4,000 a month, or $48,000 per year, for non-GMO 
feed. I do not see how we could profitably farm in the long 
term with those increased feed costs. I am certain our small 
farm would be pushed out of business.
    Biotechnology is also a key to our stewardship of the land. 
One myth I have heard is that biotech crops increase pesticide 
use. My neighbors growing these crops would tell you that the 
truth is exactly the opposite. In fact, according to the USDA, 
overall pesticide usage in the U.S. peaked in 1982 and has been 
trending downward ever since.
    I am disappointed that my home State of Vermont passed a 
mandatory GMO labeling law set to take effect next year. The 
main argument for passing this bill was this idea that 
consumers have a right to know what is in their food. In my 
opinion, the new label would not better inform consumers, but 
instead, it would serve as a warning sign.
    I find the law to be frustrating and full of 
contradictions. For example, it applies to packaged and 
processed foods, but not if they contain meat. So, a can of 
vegetable soup would carry a label, but that same soup with 
added meat would not. Restaurant food is exempt. So, a frozen 
pizza from the grocery store might carry a label, but not a 
restaurant delivery pizza. At this time, dairy is also exempt, 
but my worry is that, over time, these odd exclusions would 
fall away.
    I believe there are better uses of the state's time and 
taxpayer resources than imposing regulations on a technology 
that has been proven safe time and time again. I am also 
concerned about the impact this law will have on the cost and 
availability of food in Vermont's grocery stores and whether or 
not food companies will decide to simply not ship to the state 
because of the law's nonsensical labeling requirements.
    With mandatory GMO labels, the cost of food at the grocery 
store will go up. A study out of Cornell University estimates 
an increase of about $500 per family of four per year. That may 
not seem like a lot to us in the room today, but the burden of 
this increase would be felt by those who could least afford it, 
including people in my own community. Eighty percent of the 
children in our local elementary school qualify for free or 
reduced price lunch already. These are the families who would 
be hardest hit for no good reason.
    If a small percent of consumers are to drive a GMO labeling 
requirement, I believe it should be done in a voluntary and 
cohesive way at the federal level. Again, I do not believe 
those consumers, who can least afford it, should have to bear 
the burden for such a small percent of consumers that are 
pushing for mandatory labeling.
    We know more now about growing food and caring for animals 
than we ever have and this helps us achieve a level of 
productivity that previous generations of farmers would envy. I 
am proud of how far the American farmer has come, just as I am 
proud of how far we have come on our own farm. I look forward 
to the day when our boys are grown and tell us they are ready 
to take over the farm. I know they will carry the values my 
husband and I have instilled in them, to be good stewards of 
the land, animals, and community, and I hope they still have 
the ability to use the latest tools and technology to help them 
do so.
    Thank you.
    [The prepared statement of Mrs. Lidback can be found on 
page 87 in the appendix.]
    Chairman Roberts. We thank you for your testimony, Mrs. 
Lidback.
    Mr. Thomas.

 STATEMENT OF DARYL E. THOMAS, SENIOR VICE PRESIDENT OF SALES 
   AND MARKETING, HERR FOODS, INC., NOTTINGHAM, PENNSYLVANIA

    Mr. Thomas. I, too, would like to thank this committee, 
Chairman Roberts, and Ranking Member Stabenow for holding this 
hearing. I greatly appreciate the opportunity to be here.
    My name is Daryl Thomas and I am with Herr Foods. Herr's is 
a family-owned snack food company that was started in 1946 by 
my father-in-law. Our corporate headquarters are located in 
Pennsylvania and we operate two manufacturing facilities and 22 
warehouses throughout the Northeast.
    The regulation of foods derived from biotechnology is an 
important issue facing our industry today, especially since the 
State of Vermont recently approved the nation's first mandatory 
GMO labeling law. Absent a federal solution, by July 2016, when 
Vermont's law takes effect, manufacturers will have three 
options to comply. The first is to redesign packaging. Second 
is to reformulate products so that no label is required. Or, 
three, halt sales to that state.
    While we have not made a final decision, we are considering 
several factors that will make it difficult to continue sales 
in Vermont. One factor is the ability of our distribution chain 
to segregate products for Vermont, since it is the food 
manufacturer who is liable if mislabeled products make it onto 
store shelves. We recently received a note from one of the 
largest grocery wholesalers in the nation. The letter informed 
us that they will not take additional steps to segregate or 
otherwise specifically direct a shipment of Vermont-only 
products into Vermont.
    Discussions about mandatory GMO labeling laws reducing 
consumers' choices are becoming much less theoretical and much 
more real. If the number of products on store shelves 
decreases, not only will consumers lose choices, but the lack 
of choice and competition could drive up cost. For some 
households, that might be easy to absorb. For others, it could 
be significantly more difficult.
    You might wonder, so, why does not Herr's just change all 
of our ingredients to be non-GMO or at least change the 
ingredients in Vermont? It sounds simple, but it would actually 
be very difficult. The first problem would be sourcing the 
ingredients. Soybeans, cotton, and corn are three top 
ingredients used by manufacturing companies such as Herr's, and 
more than 80 percent of these crops grown in the U.S. are 
genetically modified. As a mid-sized company, it would be 
difficult to compete for the limited supplies of these 
ingredients.
    There is also the issue of food product verification. In 
today's environment of increased litigation, we would want a 
third-party verification when we label a product as non-GMO. At 
Herr's, we use third-party certification for our non-GMO 
popcorn product, and in addition to the cost, the process took 
approximately six months. To do this for all 411 of our 
products would be both time and cost prohibitive.
    The fact that states seem to be considering different 
standards for what is deemed genetically modified for labeling 
purposes only compounds this problem. For individual states to 
define the term GMO, set labeling protocol, and legislate fines 
for noncompliance, our food distribution system could be 
crippled. Segregation of non-GMO products from some states and 
GMO-containing products for the rest of the country would be 
even more difficult.
    Just the additional cost of different packaging for one 
state versus another would be virtually insurmountable. To 
change the label on a bag can cost up to $5,500 per product. To 
do this for our entire product line would cost Herr's more than 
$2.2 million for every state with a different law. That is a 
cost our family-owned business simply cannot afford. Mandatory 
labels are unnecessary to provide consumer choice. For those 
consumers who do not want GMO products, there are already 
voluntary labeled products available to them in the form of 
organic foods and non-GMO certified foods. We support giving 
consumers transparency and choice, but transparency should not 
be defined by different states.
    The second question I considered in preparation for today 
is why does Herr's not just label all products as GMO if we 
cannot change--if non-GMO if we cannot--or as GMO if we cannot 
change our ingredients? My answer is simple. Mandatory labels 
on food products are reserved for critical information about 
nutrition and safety. GMO ingredients do not change the 
nutritional profile or safety of our products.
    While it might not be the intent of mandatory GMO labels to 
imply inferior food or safety or nutrition, some groups have 
made unfound negative claims about genetically modified crops. 
The fact is that we have the safest, most abundant, and most 
affordable food supply in the world. I fear that a mandatory 
GMO label could be used by some to unfairly question the safety 
of our products.
    Let me be clear. I am not here to testify about the safety 
of GMOs. That has already been confirmed by the FDA. I am here 
to advocate for a federal solution to a critical issue that 
could force hundreds of family-owned companies like ourselves 
to make distribution decisions that would negatively impact the 
sales, jobs, and food choices.
    In conclusion, Herr's is extremely concerned about 
mandatory labeling for products containing GMO. We urge the 
Senate to pass a national set voluntary standard before the law 
in Vermont can take effect.
    Again, thank you for the time to be here and I look forward 
to answering your questions.
    [The prepared statement of Mr. Thomas can be found on page 
111 in the appendix.]
    Chairman Roberts. Thank you, Mr. Thomas.
    Mr. Hirshberg.

     STATEMENT OF GARY HIRSHBERG, CHAIRMAN AND CO-FOUNDER, 
STONYFIELD FARM INC., CONCORD, NEW HAMPSHIRE, ON BEHALF OF JUST 
                            LABEL IT

    Mr. Hirshberg. Thank you, Chairman Roberts and Ranking 
Member Stabenow, for the opportunity to testify today. My name 
is Gary Hirshberg. I am the co-founder, Chairman, and former 
30-year CEO of Stonyfield Farm. I also serve or have served as 
a director and advisor for numerous conventional and organic 
food companies now owned by firms such as Coca-Cola, Hormel, 
and General Mills, among others.
    Today, however, I am appearing as Chairman of Just Label 
It, a coalition of more than 700 businesses and organizations 
dedicated to a mandatory disclosure system for products 
containing genetically modified organisms, or GMOs.
    I have seen firsthand a remarkable and encouraging shift in 
consumer interest in food in the last 20 years. Consumers, 
especially millennials, are demanding transparency as never 
before. Consumer interest in food and farming is a trend that 
should be welcomed, because our food choices have enormous 
impact on our health and on the health of our environment.
    Grown in demand for sustainably-grown food is also good for 
agriculture, because two decades of double-digit annual growth 
in these categories is creating billions of dollars of new 
revenue, creating millions of jobs, and creating new 
opportunities for farmers, especially younger farmers.
    When I started Stonyfield, most consumers had no idea what 
organic meant. Now, annual organic sales are nearing $40 
billion, and most of the nation's largest food manufacturers 
are actively engaged in this category.
    Our position is simple. Consumers have the right to know 
what is in their food and how it is grown, the same right held 
by citizens in 64 other nations. Recent polling and consumer 
data tell us that nine out of ten Americans, regardless of age, 
income, race, or party affiliation, want the right to know 
whether the food they eat and purchase for their families 
contains GMOs. Consumers give many reasons for wanting these 
disclosures, but chief among them is the extent to which GMO 
crops have increased the use of herbicides linked to serious 
health problems.
    Let me be very, very clear. We strongly support a national 
GMO disclosure system that provides factual information. We do 
not support a warning or a disclosure system that renders a 
judgment on GMOs, and we are certainly not seeking a ban on GMO 
crops. Rather, we support a value-neutral disclosure that 
respects the rights of consumers to make their own choices.
    Actual experience shows that food prices have not increased 
in the 64 nations that have adopted GMO labels, nor do 
consumers in these countries view GMO disclosures as warnings. 
At the same time that GMO disclosures have been adopted around 
the globe, GMO crop acreage has steadily increased, from 27 
million acres in 1997, when the first GMO label was introduced, 
to 448 million acres in 2014.
    The world's second-largest producer of GMO crops, Brazil, 
implemented mandatory labeling in 2003, yet less than one 
percent of food sales in Brazil are organic, and Brazilians 
have accepted GMO foods in the marketplace. Claims that a 
mandatory disclosure would disrupt GMO expansion were disproved 
by actual marketplace experience.
    I know from my own experience that food companies change 
our labels all the time to highlight new innovations and that 
food companies and farmers already segregate GMO and 
conventional ingredients to serve our markets at home and 
abroad.
    I also know from experience that a value-neutral disclosure 
will not cause sudden shifts in consumer behavior. In fact, a 
recent five-year study of consumer data confirmed that American 
consumers will not view a GMO disclosure as a warning.
    The Just Label It coalition and I welcome the opportunity 
to work with the committee and with farmers, food 
manufacturers, and other stakeholders to craft a disclosure 
that is national, that is factual, that is mandatory, that 
works for consumers, and that works for farmers and the food 
industry. You should not have to live in Vermont to know what 
is in your food and how it is grown.
    The Des Moines Register in a 2014 editorial entitled, 
``It's Time for Congress to Require GMO Labeling'' put it very 
simply. Quote, ``Congress should set a nationwide standard of 
disclosure and then let the individual consumers decide whether 
the presence of GMOs in a product is something that concerns 
them. But keeping consumers in the dark is never the right 
thing to do,'' unquote.
    In the absence of such a system, we urge the Senate to 
reject efforts to block state GMO disclosures or limit the 
administration's authority to develop a national solution. Such 
efforts contradict Congress's longstanding view that states 
should be able to require simple factual disclosures on food 
labels and that the FDA and USDA should have the authority to 
require disclosures that help consumers make informed 
decisions.
    Farmers should, of course, have choices, and so, too, 
should consumers. The fastest creators of new on-farm and 
factory jobs are the companies and brands that are most 
transparently responsive to consumer desires. The 21st century 
consumer demands food that is, above all, transparent, and 
Congress as well as the food industry should honor and support 
and most certainly not block this fundamental right.
    Thank you for the opportunity to testify and I look forward 
to your questions.
    [The prepared statement of Mr. Hirshberg can be found on 
page 61 in the appendix.]
    Chairman Roberts. We thank you, Mr. Hirshberg.
    Mr. Jaffe.

  STATEMENT OF GREGORY JAFFE, BIOTECHNOLOGY PROJECT DIRECTOR, 
   CENTER FOR SCIENCE IN THE PUBLIC INTEREST, WASHINGTON, DC

    Mr. Jaffe. Thank you, Chairman Roberts and Ranking Minority 
Member Stabenow and other committee members for inviting me as 
a witness on behalf of the Center for Science in the Public 
Interest.
    It is appropriate to review and possibly modify the roles 
of the Food and Drug Administration, the USDA, and the EPA in 
ensuring those crops' safe use. While current GE crops grown in 
the U.S. are safe and beneficial, the federal regulatory 
oversight system needs improvements to ensure safety for future 
products and to provide consumers with confidence about their 
safety.
    I am here today as the Director of CSPI's Biotechnology 
Project. CSPI is a nonprofit consumer organization that was 
established 44 years ago. CSPI works primarily on food safety 
and nutrition issues and publishes Nutrition Action Health 
letter to educate consumers on issues surrounding diet and 
health. CSPI does not receive any funding from industry or from 
the federal government. Our funding primarily comes from our 
members and donors, as well as from independent philanthropic 
foundations.
    CSPI has long advised consumers, journalists, and 
policymakers that foods and ingredients made from currently 
grown GE crops are safe to eat. The current crops have also 
provided tremendous benefits to farmers and the environment in 
both the U.S. and around the world. However, actions by 
developers selling GE seeds and by farmers growing GE crops 
have led to the highly troublesome development of insects and 
weeds that are resistant to widely used pesticides.
    Today, I will limit my oral testimony primarily to 
legislative changes at FDA and USDA. CSPI believes that FDA 
should determine the safety of all GE food crops before foods 
from those crops enter our food supply. FDA should review the 
safety data submitted by the developer, conduct its own 
analysis of those data, and provide the developer and the 
public with its opinion of whether foods from that GE crop are 
safe to eat by humans and animals. This new regulatory process 
would further ensure safety of future crops and allay consumer 
concerns about biotechnology.
    While GE crop developers in the United States have always 
completed the consultation process, there is no guarantee that 
they will continue complying with the consultation process in 
the future. Similarly, it is unclear whether GE crop developers 
in India or China would consult with FDA, especially since they 
may be exporting finished food products.
    CSPI believes that a mandatory pre-market approval process 
by FDA should have the following four components. First, all 
genetically engineered crops, irrespective of their intended 
use, should go through that approval process.
    Second, the mandatory approval process should be legally 
included in the Food, Drug, and Cosmetic Act as opposed to 
being established in an agency policy that could change at any 
time.
    Third, after FDA has received public comments and completes 
its safety review, FDA must provide the developer and the 
public with its opinion about the GE crop's safety.
    Finally, until FDA determines if the GE crop meets that 
safety standard, it would be illegal to market foods or 
ingredients made from that crop.
    USDA regulates GE crops under its plant pest authority 
provided by the Plant Protection Act. To date, USDA has granted 
117 petitions for non-regulated status and never once found a 
commercial GE crop that is a plant pest that requires continued 
oversight. Developers and USDA spend significant resources 
determining that a GE crop is not a plant pest when they could 
use those resources to analyze and address real impacts from GE 
crops, such as development of resistant weeds and pests or gene 
flow to wild relatives and non-GE farms.
    In the last few years, a large loophole has emerged that 
allows developers of GE crops to avoid USDA's lengthy and 
expensive regulatory process. If a GE plant variety is 
developed without using any component of a listed pest, then 
USDA has no authority to regulate that crop, even its 
experimental trials. USDA's decision to exempt certain crops is 
not based on a scientific analysis that the particular crops 
are not risky and need no regulation, but instead the decision 
is solely because the crop is not captured by the narrow legal 
hook USDA uses to regulate GE crops.
    Such arbitrary and non-scientific decisions undermine the 
regulatory system and its reputation with the public in the 
United States and our trading partners abroad. Congress should 
pass new legislation that would require USDA to regulate all 
gene crops, whether developed here or abroad, and ensure that 
the review addresses the real and potential risks and impacts 
of those crops instead of expending resources addressing 
nonexistent plant pest risks.
    I appreciate the time the committee has given me to testify 
today and I look forward to your questions.
    [The prepared statement of Mr. Jaffe can be found on page 
65 in the appendix.]
    Chairman Roberts. We thank you, Mr. Jaffe.
    Dr. Kleinman.

  STATEMENT OF RONALD E. KLEINMAN, M.D., PHYSICIAN IN CHIEF, 
    MASSGENERAL HOSPITAL FOR CHILDREN, BOSTON, MASSACHUSETTS

    Dr. Kleinman. Chairman Roberts, Ranking Member Stabenow, 
thank you very much for asking me to appear today. As a 
pediatrician, I know that food safety is critically important 
to moms and to children and I am called upon to help parents 
understand facts and the fictions around food and nutrition, 
including GMOs.
    Plant biotechnology has been with us safely for 20 years or 
more. Not a single human illness or adverse effect has been 
documented.
    GM technology allows us to move a handful of carefully 
selected genes and traits among species and to achieve 
characteristics that conventional breeding will not permit. 
Commercial GM crops undergo testing and safety assessment that 
far exceeds the little, if any, testing of conventional 
varieties, despite the fact that GM technology is far more 
precise. Genes, DNA, RNA, and resulting proteins are a part of 
every living thing and, thus, every whole food we consume. 
Undue concern regarding a few carefully selected genes makes no 
biological sense when considered against the hundreds of 
thousands of untested genes and gene products in the natural 
diet.
    In my professional opinion, existing GM crops are safe, 
based on the fundamental science of DNA, RNA, and protein in 
foods, upon extensive safety and compositional testing, and 
upon an extensive body of scientific studies, both short-and 
long-term.
    Our current system for the review and safety assessment of 
GM crops by the FDA and EPA is robust and comprehensive. They 
are the most studied foods in history. The science and risk-
based regulatory system we have in place is robust and provides 
a solid food safety and environmental affirmation to the 
American people.
    The nutritional value of GM crops is assured via extensive 
compositional testing. Food labeling on GM content conveys no 
useful nutrition or safety information to consumers. It is 
often misleading and will simply present confusing and 
confounding information to consumers, including the parents 
that I personally advise.
    Nutritional enhancement through GM technology is a reality. 
Globally, vitamin A deficiency afflicts millions of children 
annually with blindness, stunting, or death. The GM Golden Rice 
which provides this essential nutrient remains on the shelf is 
an incalculable tragedy.
    In the developed world, we know that adult heart disease 
has its origins in the diet of children. Existing, approved, 
but currently unavailable GM offerings for heart health include 
vegetable oils very low in saturated fats and plant-derived 
oils providing benefits of long chain fatty acids found mainly 
in fish, the latter being under-consumed, expensive, and in 
short supply.
    Globally, we must sustainably feed a growing population 
while conserving limited land, water, and other resources. GM 
crops have resulted in dramatic reductions in chemical 
insecticide use, support conservation tillage to retain soils 
and conserve water, and reduce fuel use and carbon footprint. 
Traits in development include improved water and nitrogen 
utilization and, therefore, enhanced yield, which, in 
combination with breeding and hybrid technology, will be 
essential to providing ongoing food security.
    Much of the recent controversy surrounding GM crops 
revolves around the concomitant use of glyphosate. Improved 
techniques allow detection of minute quantities of chemicals in 
body fluids, but presence does not equal risk. Measurement of 
glyphosate demonstrates that intakes in the general population 
are far below allowable daily intakes determined to be safe by 
the EPA and by similar agencies globally. Reports of glyphosate 
in breast milk have not been replicated using validated 
techniques.
    The recent opinion from the IARC that glyphosate is a 
probable human carcinogen is not supported by the data and 
flies in the face of comprehensive assessments from multiple 
agencies globally. Older allegations suggesting that glyphosate 
and GMOs are somehow associated with food allergy, autism, and 
other medical conditions are wholly unfounded speculation. 
Thus, concerns regarding glyphosate residues are unsupported 
and the fear-mongering surrounding them unjustifiable.
    Despite the obesity problem, hunger remains a challenge in 
the U.S. today. Roughly one in five children live in households 
that are food insecure. This is often driven by economic 
limitations and often afflicting the most vulnerable children 
and the elderly. Sub-optimal nutrition remains common in 
adults, with excessive intakes of saturated fats and inadequate 
intakes of long chain omega fatty acids. In the developing 
world, malnutrition and food security remain daunting 
challenges.
    Enhanced sustainable food production is essential in both 
the developed and developing world. Advancing agricultural 
technology, including GM technology, is and will remain 
essential to meeting global production demands, and to not just 
meeting, but optimizing global nutrition.
    So, in summary, this is essential not just for personal 
health, but for community health, global economic development, 
social order, and transnational security. Thank you very much.
    [The prepared statement of Dr. Kleinman can be found on 
page 84 in the appendix.]
    Chairman Roberts. I thank you, Doctor.
    I am going to start with you. As a pediatrician, you 
obviously highlighted concerns related to both sound science 
and nutrition, and you talked about visiting with parents. Can 
you talk about your conversations with mothers about biotech, 
and can you speak about the importance of accurately trying to 
communicate to the public about science, especially as it 
relates to what you highlighted--food production, malnutrition, 
and hunger around the world?
    Dr. Kleinman. Those are fairly broad questions, but I will 
do my best. As far as conversations with parents, I enjoy an 
open dialogue with all the parents that I talk to. I am often 
talking to them about nutrition and I usually start by asking 
what they have read on the Internet and what kinds of questions 
they have that they would like me to address.
    At the end of those conversations, I always assure them 
that the food supply in the United States is safe as it is 
currently regulated and assessed and that issues raised about 
GMOs have not stood the test of scientific investigation over a 
very long period of time.
    I think this whole issue of explaining GMOs to parents is 
complicated and not easily addressed in a couple of sentences. 
If I were to ask everyone in this room to raise their hand if 
they took a course in DNA chemistry or molecular biology, there 
would not be a lot of arms up in the air, and I think that is 
highlighted by two questions that I have seen on surveys about 
labeling GMOs.
    The first is the question of whether people feel GMOs 
should be on the food label, and a substantial number of people 
will say yes to that question.
    The second question, however, I think, highlights the 
issue, because when you ask those same people if we should 
label all foods that contain DNA, the same number of people 
raise their hands. All fruits and vegetables, meat, fish and 
fowl contain DNA. We consume DNA on a daily basis in 
significant quantities, and we also have a significant amount 
of foreign DNA in our own bodies. The germs that inhabit our 
intestine all have DNA, and there are thousands of trillions of 
those germs.
    So, that is the challenge. It is simplifying this in a way 
that reassures people that we have a safe food supply, 
explaining that the efforts to ensure that the food is safe are 
adequate and appropriate, and that these new technologies do 
not change that risk at all and that they have been carefully 
assessed over a period of 20 years to give us that guarantee.
    The last thing I will say is that it is not easy standing 
up and defending GMO today. This has become really an era in 
which ad hominem attacks on those who disagree with others are 
very difficult to tolerate. We see now the use of the Freedom 
of Information Act, for example, directed against a whole range 
of academic investigators, scientists who have spent careers 
looking at GMOs and how they behave, both with the environment 
and with human health, and many of these people are now being 
subjected to severe personal attacks and Freedom of Information 
Act requests.
    So, I think we have a big challenge before us, but I hope 
that many who counsel parents directly, who have a forum and 
can speak to this in a public way, will be able to work with 
government agencies like we heard this morning the members of 
the first panel discuss so that we can assure the population of 
the United States that they have nothing to fear from GMOs as 
they are currently used.
    Mrs. Lidback. Chairman Roberts, may I add a quick comment?
    Chairman Roberts. Certainly.
    Mrs. Lidback. I talk about biotech crops with my 
pediatrician all the time, and he is very much in support of me 
being here and sharing my perspective and my message about 
biotech crops. Thank you.
    Chairman Roberts. I appreciate that very much.
    I have exhausted my time limit, but it was for good 
purpose. Doctor, thank you so much for a very eloquent and 
persuasive response, and I thank you for what you are doing.
    Dr. Kleinman. Thank you.
    Chairman Roberts. As a matter of fact, I know of three 
individuals that you could visit with. They happen to be my 
kids and grandchildren. So, maybe we can work that out. Thank 
you.
    I had other questions, but I think I will yield to the 
distinguished Ranking Member.
    Senator Stabenow. Thank you very much, Mr. Chairman, and 
thank you to all of you for your important testimony.
    Mr. Hirshberg, I wanted to start with you today because you 
have long been a leader in the call for mandatory labeling of 
genetically modified food. You talked about in your testimony 
that this was a direct result of your experience running a 
large food company, so I wondered if you could talk about what 
motivated you to be where you are today as an advocate in 
bringing together businesses and leaders on this issue.
    Mr. Hirshberg. Thank you, Senator. When we started 32 years 
ago, my company, there was, of course, no organic industry, and 
the world has changed dramatically since that time. We now 
have, as I mentioned, a $40 billion sector. This growth in this 
sector has been strictly and completely a result of responding 
to consumer demand for transparency about what is in our foods 
and how they are grown. The company and the industry, indeed, 
have evolved to be engaged in highly robust contact with 
consumers, because, frankly, that has been our strength, our 
competitive strength.
    But, by 2011, questions about GMOs really dominated 
Stonyfield's social media. This is before the creation of 
``Just Label It'' and certainly before any of these state 
efforts. What we have deduced, and only deduced since then, and 
I think you have heard ample evidence of it today, is complete 
and utter confusion out there.
    We have had a voluntary labeling guidance from the FDA 
since 2001, and yet confusion runs amok, questions of does not 
natural prohibit GMOs, et cetera, and I could go into many more 
examples. But, in the interest of time, I would simply say that 
despite the voluntary labeling system, it has not addressed the 
confusion. In fact, I might even go further and say that I 
believe that the trust issue that has been talked about with 
many of the Senators' questions today could be addressed by 
simply going ahead and having a value-neutral label. I think it 
would put the trust issue to rest, because we would be stating 
a fact to consumers.
    In any case, to your point, these questions and this 
confusion is really, in our view in industry, a logical 
consequence of the rapid success of GMOs, which has certainly 
been talked about today. Two-thirds of acreage planted in the 
U.S. is now GMO, as has been mentioned.
    But it also came to a head for me when HTA--herbicide 
tolerant alfalfa--was approved in 2011 and we came to 
understand the quarter-billion pounds of glyphosate that has 
been referenced today, now being used per year, super weeds as 
a result in over 60 million acres and the need to use 2,4-D, et 
cetera. Indeed, herbicide use has gone up. That is a fact. It 
is USDA survey data. So, we recognize that this extraordinary 
change in U.S. agriculture has happened in less than a 
generation with no citizen or consumer input and that 64 other 
nations had solved this problem with mandatory disclosure.
    So, from our vantage point, we recognize that the FDA has 
the authority under the Federal Food, Drug, and Cosmetic Act to 
implement mandatory labeling, just as they have with many other 
foods and many other attributes. We organized ``Just Label It'' 
to seek mandatory disclosure to address this confusion and 
choice and to engage the marketplace.
    I would say quickly that I share the same opinion as you 
have heard from many of my co-panelists today. America needs 
help now resolving this. This is crafting a disclosure system 
that is value-neutral. I certainly do not support, nor have we 
supported, the 50-state patchwork solution. That would be a 
nightmare for all of us. Thank you.
    Senator Stabenow. Thank you. Just as a follow-up, because I 
was going to ask you----
    Chairman Roberts. Dr. Kleinman wanted to----
    Senator Stabenow. Oh, yes. Dr. Kleinman, did you want to 
respond?
    Dr. Kleinman. If I might just add to that briefly, we all 
applaud an effort towards transparency, and transparency in the 
production process seems to be a laudable goal. But these 
efforts that we are talking about today are purely restricted 
to transparency about GMOs. There are some 3,000 fruits and 
vegetables today that are produced from seeds that are 
developed using chemical and radiation mutagenesis. We do not 
talk at all about labeling those. There are fruits and 
vegetables that are produced using exploited labor. We do not 
talk at all about labeling that.
    I am not going to go on and on about this, I promise, but 
how much do we put on that label? What is the difference 
between need to know and right to know? I think Senator 
Heitkamp was getting at that in her question that she addressed 
to the first panel. So, I will stop there.
    Senator Stabenow. Yes, thank you very much.
    I did want to do just a quick follow-up with Mr. Hirshberg, 
though, because I wanted to get your perspective on how we 
provide consumers the right to know. People want to know about 
their food and are more engaged, and that is a good thing, that 
people are more engaged in this whole process. I mentioned in 
the farm bill part of our reason, part of my push to make sure 
we were doing more around choices for people was to really 
address that important desire.
    But, how do we do that without stigmatizing biotechnology 
or having this interpreted as a food safety warning? That is 
the concern from industry's standpoint, when you have heard all 
of the issues as it relates to safety. Yet, at the same time, 
consumers have a right to know.
    Mr. Hirshberg. Yes. Well, I will be brief, but we fully 
support and agree with you. You cannot stigmatize. Farmers need 
choice. Consumers need choice. From the beginning, as I said 
before, before any state initiative had been launched, we were 
advocating for factual value-neutral presence disclosure, 
mandatory so that the playing field is level. As we have seen 
with the NLEA and other valuable legislation, when you have a 
level playing field, it really stimulates innovation and is 
fair to emerging smaller operators. National, again, not the 
50-state solution. Acceptable to farmers, acceptable to 
consumers, and acceptable for industry.
    In other words, all stakeholders need to agree, this works, 
and we are open, from Just Label It's perspective, to any 
system. The focus has been on labels, but certainly there is a 
lot of discussion about technology. Any discussion. Our plea is 
to bring the stakeholders together for a constructive 
discussion about a value-neutral solution. We have not been 
prescriptive intentionally because we know many stakeholders 
need to weigh in.
    I will quickly say in closing, in response to you, that to 
us, the European standard makes the most sense. It is two 
words. They are innocuous. They are value-neutral in the 
ingredient panel. It seems to be similar. But we are open to 
technology. We have a lot of questions about how scanners would 
work and so on and so forth, but again, we need to be open.
    This is a problem that need to be solved, as the Senators 
know, and you have heard ample evidence of it today. This 
discussion is raging in 35 states. Vermont is not the only 
state that has taken this up. Three other states have passed. 
Several more will be passing. So, it really needs to be solved 
at the national level, and it really does need to be non-
disparaging. Thank you.
    Senator Stabenow. Thank you.
    Thank you, Mr. Chairman.
    Chairman Roberts. Senator Hoeven is next. Senator Donnelly, 
welcome to this discussion, and I will recognize you next. But 
I am going to take the Chairman's prerogative here to ask Mr. 
Thomas, hearing Mr. Hirshberg, how could your company manage 
any additional cost to implement what he is talking about?
    Mr. Thomas. Well, obviously, there would be costs. I am 
impressed with how much agreement that there is across these 
different persons testifying.
    You know, I think we would support a government determined 
standard for non-GMO or GMO particularly declared foods. I 
think I would disagree with the point of doing it as a 
mandatory label. I believe that the vast testimony that we have 
heard this morning supports that our foods are safe. I 
understand that there is great consumer interest and curiosity 
around this issue. To respond with a determination of it is GMO 
or it is not GMO, I think, does not really aid the consumers' 
curiosity and maybe even lack of information that they have had 
thus far. I think it would tend to make it more misunderstood 
because you would have it interpreted as a pass/fail indicator 
on packaging.
    So, I support the voluntary use of it. I think the market 
is working pretty well right now and that there are many 
products that are----
    Chairman Roberts. But who would pay the cost? I mean, how 
would you handle the cost?
    Mr. Thomas. Well, ultimately, the cost gets passed on to 
the consumer or else you go out of business, so to analyze 
products, to change all of our packaging, I mean, over time, it 
can be absorbed as a cost of doing business, but----
    Chairman Roberts. What I am worried about is--well, I am 
worried about that, but I am worried about any mandate that 
comes from Washington, with all due respect----
    Mr. Thomas. Right.
    Chairman Roberts. --how ably described or what flag you are 
waving.
    Mr. Thomas. Ultimately, those costs do get passed through 
to the end user.
    Chairman Roberts. I am worried about them going back down 
to the farmer and the rancher.
    Mr. Hirshberg. Mr. Chairman, may I respond? We, as was 
mentioned earlier today, I believe, we change our labels almost 
annually. If you look across the food industry, every time a 
Disney movie comes out or a Super Bowl hero comes through, 
companies change their labels. It is a routine part of 
business. So, the act of changing the label itself has never 
been passed along to either our end user or our supply. It is 
just a normal----
    Chairman Roberts. Well, with all due respect, Mr. 
Hirshberg, a Disney label is a little bit different than what 
we are talking about on a pass/fail kind of test mentioned by 
Mr. Thomas on the safety of our food supply.
    I am going to move on and mention, Mr. Hoeven--I do not 
mean to cut you off--Mr. Hoeven, Senator Hoeven, dear friend 
and colleague, please proceed.
    Senator Hoeven. Thank you, Mr. Chairman.
    I would like to ask each of the witnesses, do you believe 
that genetically engineered plants are safe, starting with Mrs. 
Lidback.
    Mrs. Lidback. Yes, I do.
    Senator Hoeven. Mr. Thomas.
    Mr. Thomas. Yes, I do.
    Senator Hoeven. Mr. Hirshberg.
    Mr. Hirshberg. The evidence is clear from the earlier panel 
that this is our federal policy and I am not qualified to 
disagree with it. I would only say that there is significant 
debate and discussion that has not been included in today's 
discussion.
    Senator Hoeven. Mr. Jaffe.
    Mr. Jaffe. For the current crops that are grown in the 
United States, yes.
    Senator Hoeven. Dr. Kleinman.
    Dr. Kleinman. Yes, they are safe, and I think that this has 
been demonstrated and agreed to by over 240 international 
oversight agencies and scientific groups.
    Senator Hoeven. For both Mr. Thomas and Mr. Jaffe, if there 
is not labeling, and it is not a food safety issue but 
consumers still want to know more about GMO as it pertains to 
any food they are purchasing, what are the ways they would do 
that? Maybe, Mr. Thomas, you could start on that.
    Mr. Thomas. Well, there is--I think the market is 
responding to the interest in some of these organic or natural 
products and there are products that have been flooding the 
market. They are pretty clearly labeled. Those products are 
made with great intention. They are sourced, the ingredients 
are sourced. They are formulated with great intention to 
deliver those products to market. So, companies are taking 
advantage of commercializing that interest and are putting big 
call-outs on the packaging. So, I think the determinant or 
whether a product is or is not is already well underway. I 
think it could be polished a little bit through the voluntary 
program we have talked about here.
    You know, social media today, there is certainly a lot of 
information that is out there, and one of the things that I 
would say that as we get communication from our customers, the 
questions are more broad than--we are not being flooded by 
inquiries as to specific products and what have you. I think 
they are getting their information from the media and broader 
sources than individual companies.
    Senator Hoeven. Mr. Jaffe.
    Mr. Jaffe. So, I think transparency is very important to 
consumers and I think consumers are looking for information 
about lots of things regarding their foods. I think that, 
little by little, the industry needs to move to have increased 
transparency so that if consumers want to find out more details 
about the foods that they are buying, they can find that out.
    In terms of specifically knowing about genetically 
engineered ingredients in foods, I would alert the committee to 
Wegman's supermarket chain. They have done a really excellent 
job in a Q&A about GMOs and why they support the farmers who 
are growing them, where they are in their supermarket, which 
products people can find contain GMOs and which products they 
can buy to avoid them. Wegman's did what I thought was an 
extremely good job of being both neutral, explaining the 
regulatory system, the safety, as well as where they are and 
why they support farmers growing those crops.
    Senator Hoeven. Mr. Jaffe, how do they do that? How is that 
provided?
    Mr. Jaffe. It is on their website.
    Senator Hoeven. On their website.
    Mr. Jaffe. They have a series of frequently asked 
questions. But, also, if you are a customer of Wegman's, you 
know they have a quarterly magazine and in that quarterly 
magazine, Danny Wegman, the chairman or CEO--I am not sure of 
his position--wrote a letter about Wegman's position on GMOs. 
They also put it on their blog. So, they----
    Senator Hoeven. So, it is on their website----
    Mr. Jaffe. --they expressed it in a number of ways.
    Senator Hoeven. It is on their website, but not 
specifically on all their food products, or is there a 
reference on the food product to the website?
    Mr. Jaffe. I do not think they are on their food products.
    Senator Hoeven. Okay. Mr. Hirshberg, when you talk about a 
value-neutral label, please, what is that? Describe it.
    Mr. Hirshberg. Thank you, sir. Again, as I mentioned, in 
Europe and throughout most of the world, the standard is 
including two words in the ingredient label. If it is a 
genetically engineered soy or genetically engineered corn, it 
would be identified as such. As was mentioned in the earlier 
panel, we have tremendous scientific ability now to test and 
sense even minute amounts. You might recall the discussion 
earlier about the large shipping containers. So, these programs 
just simply identify the presence, the factual presence in the 
supply chain.
    Senator Hoeven. Dr. Kleinman, do you have any 
recommendations about how the federal government could better 
communicate and convey the safety of GMO products?
    Dr. Kleinman. I do not think the way to do that is to put a 
mandatory requirement for GMOs on labels. I think, certainly, 
that a well designed effort within the agencies that we heard 
from this morning towards this effort would be very welcome. I 
do not think that currently exists, and I think it is extremely 
important. It is analogous to what Mr. Jaffe was just 
describing at Wegman's. It is very possible to create 
information for the Internet, in brochures, in various other 
forms of media, and the government can play a role in that just 
as producers and distributors can do that.
    So, I think this is a concerted effort by all of us who 
have an opportunity to educate the consumers to take that 
opportunity and to run with it. In particular, I think, as I 
said, creating a specific effort in government towards 
communication is very important.
    Senator Hoeven. Thank you.
    Chairman Roberts. Senator Donnelly.
    Senator Donnelly. Thank you, Mr. Chairman.
    Mrs. Lidback, you come from a very beautiful area. I think 
I represent a beautiful state, too. I know you have young kids 
on the farm, and protecting the environment is important to 
you, as it is to the farmers in my state. You testified biotech 
goes hand-in-hand with various conservation practices, things 
like cover crops and no till as well as significantly reduced 
pesticide use. Can you speak in more detail to the ways you 
have seen the genetically engineered crops change the way you 
farm and how it helps the environment in regards to similar 
things like cover crops and no till?
    Mrs. Lidback. Okay. Thanks for the question, Senator. I can 
speak to how my neighbors farm. We actually only grow grass. We 
do not grow biotech crops. But, I can tell you that they spray 
less pesticides, which in turn means that they are going over 
the ground less. There is less soil impaction and less soil 
erosion.
    The no till cropping, a neighbor--actually, she just posted 
on Facebook about using glyphosate in order to convert one of 
her hilly fields into--from grass into corn for next year, and 
the first step is to spray glyphosate to get rid of the grass, 
and then they will use no till planting because of the hilly 
nature of their field so it helps to prevent soil erosion.
    Cover crops were once thought to not be an option for our 
area because of the cold weather, but more and more folks, 
specifically farmers that I work with directly, are utilizing 
cover crops along with growing biotech crops. Actually, Vermont 
has one of the highest rates of GE crops grown--corn grown for 
silage in the country, and so they are utilizing that seed with 
cover cropping and no till, given the need of their farm, 
trying to make the best of their resources.
    Senator Donnelly. Thank you.
    Mr. Thomas, one of my great passions is small business and 
family businesses. I must say, I have consumed your products 
and they are of extraordinarily high quality--on numerous 
occasions. But, when I look at a company like yours, we have 
talked to a number of Indiana firms who have come into our 
office and said, here are the challenges we face. Here are the 
challenges that this will cause.
    We have some ice cream companies. I have heard there is an 
ice cream company in Vermont, Mr. Hirshberg. I do not know if 
that is true or not, but we have some ice cream companies in 
Indiana, too, and they said, we have 68 varieties times 50 
different labels. If it gets to a certain point, it becomes 
unworkable for us.
    What are the kind of challenges you anticipate? I know you 
have talked about it a little bit before, as to how difficult 
this will be on a firm like yours. Is it a series of 
accumulating challenges that you are looking at, then?
    Mr. Thomas. I think it depends on if it would be state by 
state or a mandatory enforcement that was done in a short 
period of time. Obviously, that would accelerate our changing 
of packaging, and the costs that I alluded to are real. To 
change 411 SKUs of our product would cost close to $2 million. 
So, those are real costs.
    I think, obviously, there would be great incentive, I 
think, if it was a mandatory practice because people would, 
probably look more at how they land on the non-GMO. I am not 
making a judgment whether that is the right thing to do or not.
    So, there are costs in segmenting the product. Now you have 
to segment. Your manufacturing processes become a lot more 
complicated as you have to protect one product from the others 
to prevent cross-contamination. So, through complexity, higher 
raw material costs, changing of packaging, all those things 
contribute increased costs of manufacturing.
    Senator Donnelly. Thank you.
    Mr. Thomas. Also marketing.
    Senator Donnelly. Thanks.
    Mr. Jaffe, one of the things I have looked at has been 
barriers to international agricultural trade caused by varying 
approval processes for GE foods. Indiana grain producers are 
suffering because of drawn-out approvals for their products 
within the United States and also overseas in, like, the 
Chinese regulatory systems. You discussed the need for a U.S. 
regulatory system consistent with those in other countries. So, 
the question is, do you believe it is possible for an updated 
U.S. regulatory policy to reduce trade barriers in countries 
like China, and how would current regulations need to shift in 
order to do that and to promote our trade?
    Mr. Jaffe. So, the short answer is, I think that having FDA 
more involved in the oversight of GE crops with an approval 
process where they give their opinion about safety will 
actually help both our exporting of crops and ensuring the 
safety of our importing of foods.
    I can give the example, so, right now, as was said in the 
earlier testimony on the first panel, FDA does not give its 
opinion about the foods and it does not explain why those GE 
crops are safe. So, therefore, China, for example, has nothing 
to rely upon from our country. They have to start from scratch 
in doing their own food safety assessment.
    I have worked, for example, in Vietnam, and Vietnam has now 
passed a regulation to implement their regulatory system that 
says if there are five countries that follow the OECD 
guidelines and approved a GE food, for grain, for an import, 
then they do not have to go through and approve it. It is 
automatically approved in that country. We are seeing that kind 
of regulation occurring in other countries around the world.
    The problem is, the U.S. does not have an approval for GE 
food, so we may not count as one of those five. I think if we 
want to get streamlined processes, we have to put our own 
opinion on the table first for those crops so that others can 
rely upon it. Our FDA is independent. It is one of the most 
well respected regulatory agencies around the world. Yet here, 
as you heard in the first panel, it avoids coming forward and 
saying that it thinks that these crops are safe. So, I think 
that would help consumer confidence in the U.S. but would also 
help the export of our grain products.
        [I have since found out that Vietnam does count the FDA 
        voluntary consultation submission as an approval for 
        purposes of allowing an engineered crop into its 
        country for food of feed purposes.]
    It would also help the imports in the sense that China 
will, sooner or later, have BT rice, genetically engineered 
rice, and when they do that, we are not going to grow it in our 
country, but we will import the rice noodles, and will they go 
through that consultation process? I am not convinced of it. 
So, I think there are big advantages here.
    Senator Donnelly. Thank you to the panel, and Mrs. Lidback, 
come back with your family some day and enjoy this process 
without being behind a table.
    Chairman Roberts. Senator Stabenow.
    Senator Stabenow. Well, Mr. Chairman, I just want to thank 
you for the hearing and everyone on the panel and members. 
Obviously, there is a great deal of interest in this.
    I want to just indicate as we close that we have been 
talking a lot about science today, and I believe in science, 
and because I believe in science, I know that climate change is 
real. Because I believe in science, I believe that genetically 
modified foods are safe. I hope we will continue to focus on 
science and I am also hopeful that we can come together in a 
bipartisan way that addresses the legitimate and growing 
concerns of consumers about having information about their 
food. Thank you.
    Chairman Roberts. Thank you, Senator.
    Today, we have heard clearly from the regulators that 
agriculture biotechnology is safe, and foods consisting of such 
ingredients are safe. As this committee and the Senate moves 
forward to address issues on labeling or other regulations, it 
seems to me we must keep in mind the role of government and the 
mandates imposed by the government, mandates at any level of 
government, should be based on science and address the concerns 
of health and safety. Mandating regulations based on any metric 
with any yardstick other than science, health, and safety 
exceeds the role of government.
    If producers and manufacturers want to meet consumer demand 
for food product information not based on science, health, and 
safety, then they have every right and opportunity today to 
meet those demands, and it is important to meet those consumer 
demands, because I can assure you the most effective tool 
consumers have to change our food system is in their 
pocketbooks.
    To my fellow members, we would ask any additional questions 
you may have for the record be submitted to the committee clerk 
five business days from today, or by 5:00 next Wednesday, 
October 28.
    Thank you to the panel and all the patience that you have 
demonstrated.
    The committee is adjourned.
    [Whereupon, at 1:03 p.m., the committee was adjourned.]

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


                            A P P E N D I X

                            OCTOBER 21, 2015



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

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

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


                   DOCUMENTS SUBMITTED FOR THE RECORD

                            OCTOBER 21, 2015



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


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

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


                         QUESTIONS AND ANSWERS

                            OCTOBER 21, 2015



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

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]