[Senate Hearing 116-447]
[From the U.S. Government Publishing Office]


                                                      S. Hrg. 116-447

                 AGRICULTURE INNOVATION AND THE FEDERAL 
                  BIOTECHNOLOGY REGULATORY FRAMEWORK

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

                                HEARING

                              BEFORE THE

                       COMMITTEE ON AGRICULTURE,
                        NUTRITION, AND FORESTRY

                          UNITED STATES SENATE

                     ONE HUNDRED SIXTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             MARCH 12, 2020

                               __________

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


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       Available via the World Wide Web: http://www.govinfo.gov/
       
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           COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY


                     PAT ROBERTS, Kansas, Chairman
MITCH McCONNELL, Kentucky            DEBBIE STABENOW, Michigan
JOHN BOOZMAN, Arkansas               PATRICK J. LEAHY, Vermont
JOHN HOEVEN, North Dakota            SHERROD BROWN, Ohio
JONI ERNST, Iowa                     AMY KLOBUCHAR, Minnesota
CINDY HYDE-SMITH, Mississippi        MICHAEL BENNET, Colorado
MIKE BRAUN, Indiana                  KIRSTEN GILLIBRAND, New York
CHARLES GRASSLEY, Iowa               ROBERT P. CASEY, Jr., Pennsylvania
JOHN THUNE, South Dakota             TINA SMITH, Minnesota
DEB FISCHER, Nebraska                RICHARD DURBIN, Illinois
KELLY LOEFFLER, Georgia

             James A. Glueck, Jr., Majority Staff Director
                DaNita M. Murray, Majority Chief Counsel
                    Jessica L. Williams, Chief Clerk
               Joseph A. Shultz, Minority Staff Director
               Mary Beth Schultz, Minority Chief Counsel
                           
                           
                           C O N T E N T S

                              ----------                              

                        Thursday, March 12, 2020

                                                                   Page

Hearing:

Agriculture Innovation and the Federal Biotechnology Regulatory 
  Framework......................................................     1

                              ----------                              

                    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...     3

                               WITNESSES

Johnson, Patrick L. Jr., Producer and Chairman, Environmental 
  Task Force, National Cotton Council, Tunica, MS................     6
Parrott, Wayne, Ph.D., Professor, Department of Crop and Soil 
  Sciences, Institute of Plant Breeding, Genetics and Genomics, 
  University of Georgia, Athens, GA..............................     8
Paustian, Michael, Ph.D., Producer and President, Iowa Pork 
  Producers Association, Walcott, IA.............................     9
Jaffe, Gregory, Director of the Project on Biotechnology, Center 
  for Science in the Public Interest, Washington, DC.............    11
                              ----------                              

                                APPENDIX

Prepared Statements:
    Johnson, Patrick L. Jr.......................................    26
    Parrott, Wayne, Ph.D.........................................    30
    Paustian, Michael, Ph.D......................................    34
    Jaffe, Gregory...............................................    37

Document(s) Submitted for the Record:
Roberts, Hon. Pat:
    Farmers Access to New Biotechnologies, Letter of Support.....    52
    Development of New Breeding Methods and Agriculture 
      Innovation, Letter of Support..............................    54

Question and Answer:
Johnson, Patrick L. Jr.:
    Written response to questions from Hon. Pat Roberts..........    58
    Written response to questions from Hon. Mike Braun...........    58
    Written response to questions from Hon. John Thune...........    59
Parrott, Wayne, Ph.D.:
    Written response to questions from Hon. Pat Roberts..........    60
    Written response to questions from Hon. Mike Braun...........    61
    Written response to questions from Hon. John Thune...........    62
Paustian, Michael, Ph.D.:
    Written response to questions from Hon. Pat Roberts..........    64
    Written response to questions from Hon. Mike Braun...........    65
    Written response to questions from Hon. John Thune...........    66
    Written response to questions from Hon. Tina Smith...........    67
Jaffe, Gregory:
    Written response to questions from Hon. Pat Roberts..........    69
    Written response to questions from Hon. John Thune...........    70

 
    AGRICULTURE INNOVATION AND THE FEDERAL BIOTECHNOLOGY REGULATORY 
                               FRAMEWORK

                              ----------                              


                        THURSDAY, MARCH 12, 2020

                                       U.S. Senate,
         Committee on Agriculture, Nutrition, and Forestry,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:03 a.m., in 
room 328A, Russell Senate Office Building, Hon. Pat Roberts, 
Chairman of the Committee, presiding.
    Present or submitting a statement: Senators Roberts, 
Boozman, Ernst, Braun, Grassley, Thune, Fischer, Loeffler, 
Stabenow, Brown, Bennet, Gillibrand, Casey, and Durbin.

 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 welcome my colleagues, especially our newest member of 
the Senate Agriculture Committee, Senator Loeffler from 
Georgia. Senator Loeffler has first-hand experience in 
production agriculture. She can go into that if she would like, 
but welcome to the Committee, Kelly. We are very happy to have 
you. I will applaud.
    [Applause.]
    Chairman Roberts. When I became the Chairman of this 
Committee five years ago, the first commitment I made to the 
Committee, and to everybody in farm country, was that this 
Committee would put farmers and producers first. I promised to 
be their champion and their voice and to use this committee to 
ensure that the government would listen to their concerns. Much 
work has already been done on behalf of producers in the 
agriculture industry and this morning we continue that effort.
    Agriculture biotechnology is certainly not a new topic for 
this Committee. Over the last few decades, biotechnology has 
become a valuable tool in ensuring the success of the American 
farmer in meeting the challenges of increasing yield in a more 
efficient, safe, and environmentally friendly manner.
    That progress continues today through research that has led 
to new, innovative technologies. These include breeding 
techniques and tools that our producers will increasingly rely 
on to produce safe and affordable food to meet demands at home 
and around the world.
    As science and technology evolve, so must the regulation of 
these products. The coordinated framework for the regulation of 
biotechnology is the multi-agency Federal system that serves to 
assess any risks of new biotechnology products and to ensure 
their safety to the environment and to human and animal health.
    Established back in 1986, the United States Department of 
Agriculture, the Environmental Protection Agency, and the Food 
and Drug Administration each serve roles in the regulation of 
the products of modern agriculture biotechnology through the 
coordinated framework.
    The key word here is ``coordinated.'' There have been 
efforts over the years by these agencies to update or add to 
the framework. There were proposed rules issued in 2008 and 
2017, at the USDA's Animal Plant Health Inspection Service, 
APHIS, and in 2011, at the EPA, none of which were finalized.
    Also in 2017, the FDA issued draft guidance addressing 
animals with altered DNA through new technologies. In June of 
last year, APHIS published a proposed rule to update and reduce 
regulatory burdens for technology developers of advanced 
genetic engineering such as genome editing. This rule is 
currently under review at the Office of Management and Budget.
    Five days later, the White House issued an Executive Order 
directing these respective agencies to modernize the regulatory 
framework, I quote, ``to facilitate innovation, ensure 
coordination across regulatory agencies, and safely enable 
billions of people across America and the world to reap the 
benefits of such products.''
    Additionally, it is our understanding that the EPA has 
confirmed that the OMB is reviewing their proposed rule on 
plant-incorporated protectants in light of advanced breeding 
technologies, though scant detail has been shared regarding 
that proposal.
    As all three of these agencies work to update guidance and 
regulations, let me point out it is absolutely critical that 
they listen to those who would produce with and use this new 
technology every day.
    There are many complexities experienced at the ground level 
by farmers, producers, and ranchers interested in utilizing new 
technologies. These practical concerns must be considered.
    Today, our committee will hear from some of those 
stakeholders. These witnesses will testify about what they view 
as important in an updated regulatory framework, and I fully 
expect that each agency will take these statements into very 
thoughtful consideration. I fully expect that each agency will 
take these statements into very thoughtful consideration. I am 
being repetitive, on purpose.
    The technologies being discussed today can provide 
solutions to deal with some of the world's most pressing 
problems--food insecurity, disease risks, and a changing 
climate. Bottom line: farmers want to utilize technology to 
meet growing needs in spite of increased pressures.
    The regulatory structure must be workable and risk-based. 
It must not stifle adoption of technologies and ultimately make 
the U.S. less competitive.
    In addition to today's statements, I ask unanimous consent 
to submit two letters, one from 24 farmer organizations and one 
from ag State Governors into the hearing record. Without 
objection, it is so ordered.

    [The letters can be found on pages 52 and 54 in the 
appendix.]

    Chairman Roberts. My second commitment as Chairman of this 
Committee was to conduct rigorous and thorough oversight of the 
departments and agencies within this Committee's jurisdiction. 
This hearing is an important part of that oversight process.
    The Department of Agriculture, along with the EPA and FDA, 
do have a responsibility to establish policies that are 
science-based, timely, transparent, and coordinated and 
functional for the industries that rely upon them.
    I thank each witness for providing testimony before the 
Committee on this important issue, and now I recognize the 
distinguished Senator from Michigan, Senator Stabenow, with any 
remarks that she may have.

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

    Senator Stabenow. Thank you, Mr. Chairman, and I join you 
in welcoming the witnesses today for a very important hearing.
    Innovation is the foundation of American agriculture. From 
breakthroughs in plant breeding to advances in crop rotation 
land-grant universities, researchers, and creative farmers have 
all revolutionized what we grow and how we grow it.
    Today, agriculture faces many challenges that will require 
us to push the bounds of what is possible. We know we need to 
increase food production in a sustainable way in order to feed 
a growing global population that is projected to reach nearly 
10 billion people by 2050. At the same time, farmers are seeing 
the impacts of the climate crisis, which has made growing the 
food that we eat even more difficult.
    Biotechnology has the potential to help us increase our 
productivity, while also helping farmers address the climate 
crisis. Drought-tolerant plant varieties can help farmers 
weather historic dry spells. Cover crops are being improved to 
have deeper roots to hold more carbon in the soil, creating new 
opportunities for farmers to sell carbon credits in a voluntary 
market.
    In order to make the most out of the innovative potential 
of biotechnology, consumers and our trading partners both need 
certainty. That is why it is critical to ensure that our 
regulatory system is effective, science-based, and transparent.
    It is also important to balance flexibility that encourages 
new product development with reliable standards that ensure 
products are safe. I am concerned that the USDA's proposed 
biotech rule, published last June, does not provide adequate 
oversight of our biotechnology sector. The hands-off approach 
proposed by USDA lacks the strong scientific justification that 
consumers and our trading partners expect. I urge the USDA to 
include scientific support for the agency's approach when 
publishing a final rule.
    I am also deeply concerned that the proposed rule would 
allow developers of certain products to determine for 
themselves whether the regulations apply. Under the proposed 
rules, a company could make its own determination that its 
product is exempt from the rule. That product could then enter 
the marketplace without any public notification or consumer 
awareness.
    I think that many Americans will find that unacceptable, 
and I am concerned that many of our trading partners will as 
well.
    As recently as 2013, farmers experienced enormous 
disruptions when China began rejecting shipments of corn and 
distillers grains after finding trace amounts of a biotech 
trait that had been approved by the U.S., but was still under 
review in China. Right now, our farmers cannot afford to face 
any more barriers to trade.
    I certainly believe in science and I will say again I 
believe in support science, and science tells us that 
biotechnology is safe. I will say that again--biotechnology is 
safe--and it can improve people's lives. However, we need to be 
fully transparent in order to ensure customers at home and 
abroad are not doubting the safety of these products.
    A broad coalition of biotech industry leaders, 
agribusinesses, and consumer advocates agree on this. Just last 
week, they sent a letter to urge the Office of Management and 
Budget to modify the self-determination provision because they 
understand the importance of transparent and consistent 
regulation.
    It is really important that we get this right. I join in 
encouraging the USDA to listen to this broad coalition of 
stakeholders and modify the rule before publishing it in its 
final version. This is such an important part of our economy 
and of the success of agriculture. Again, I want to make sure 
we get this right.
    Thank you, Mr. Chairman.
    Chairman Roberts. Thank you, Senator.
    We want to welcome to our panel the witnesses before the 
Committee this morning. Our first witness is Mr. Patrick L. 
Johnson of the National Cotton Council. Senator Hyde-Smith was 
planning to introduce you, sir, but she apparently has a 
conflict and so you are stuck with me.
    Our first witness, Mr. Patrick Johnson, hails from Tunica, 
Mississippi. After receiving his bachelor's degree from the 
University of Mississippi, he returned to his family farm where 
he and his wife Emily currently reside. He is the owner and 
operator of Cypress Brake Planting Company, a farming operation 
that includes cotton, rice, corn, and soybeans.
    Mr. Johnson currently serves as the Chairman of the 
National Cotton Council's Environmental Task Force, and brings 
unique knowledge and experience on issues related to 
agriculture production practices and environmental stewardship.
    Welcome, Mr. Johnson, and we look forward to your 
testimony. Senator Loeffler, I turn to you to introduce Dr. 
Wayne Parrott.
    Senator Loeffler. Thank you, Mr. Chairman, Ranking Member 
Stabenow, and my colleagues for your warm welcome to this 
Committee. Having grown up on a family farm, working in the 
fields and the feed lots, I am truly honored to serve on this 
Committee and serve our Nation's farmers. I also thank you for 
the privilege of introducing one of our witnesses for today, 
Dr. Wayne Parrott.
    Dr. Parrott has pursued an esteemed career in a field I 
personally hold dear, as well as leading the industry in my 
home State, which is agriculture. Dr. Wayne Parrott is a 
distinguished research professor in the Department of Crop and 
Soil Sciences at the University of Georgia, alumnus of the 
University of Kentucky the University of Wisconsin-Madison. He 
joined University of Georgia in Athens in 1998.
    Dr. Parrott has been a Georgia Bulldog for more than 25 
years, where he led biotechnology research for the improvement 
of crop plants, particularly genetic engineering and gene 
editing. Dr. Parrott's work aims to solve agronomic problems 
facing farmers in Georgia and across our country, such as 
resistance to insects and increased efficiency of bioenergy 
grasses.
    Thanks to the work done by Dr. Parrott and his colleagues, 
UGA has become a world-renowned center for agricultural 
research. The work done at UGA has changed the game and offered 
a model for safe, effective, and thorough research and the 
application of new seed biotechnology.
    In addition to his work in academia, Dr. Parrott has made a 
difference in the professional agriculture industry. Most 
recently he served on the board of directors for the Society of 
In Vitro Biology and was elected to the Soybean Genetics 
Executive Committee and American Society of Plant Biology.
    Through his accomplishments and associations, though I have 
just mentioned a few, they hardly do his career justice. His 
impact on agriculture science and research, as well as our 
future farmers' education are lasting. I have heard the term 
``rock star'' used to describe Dr. Parrott and his work in 
biotechnology, and it is easy to understand when you take a 
look at his accomplishments.
    I thank this Committee for allowing me to introduce Dr. 
Parrott, and thank him and all of our witnesses for being here 
with us today.
    Chairman Roberts. We thank you, Senator.
    Our third witness is Dr. Michael Paustian. He is a sixth-
generation farmer from Walcott, Iowa--six generations.
    Dr. Paustian. Yes, sir.
    Chairman Roberts. When did
    [Laughter.]
    Chairman Roberts [continuing]. when did you start? When did 
your family start?
    Dr. Paustian. My great-great-great-great grandfather came 
over from the Schleswig-Holstein area of Germany and built the 
house that I grew up in and my parents still live in, back in 
the mid 1800's. We have been there ever since.
    Chairman Roberts. That is outstanding. I can't think of a 
better word.
    His family has a farrow-to-finish hog farm as well as a 
corn and soybean operation. Dr. Paustian has earned a Ph.D. in 
microbiology from the University of Minnesota, after which he 
worked as a research scientist before returning to the family 
farm. He currently serves as the President of the Iowa Pork 
Producers Association.
    Welcome, and thanks for being here today, Doctor.
    Our last witness is Mr. Greg Jaffe. Mr. Jaffe is the 
Director of the Project--oh, I am supposed to yield to you to 
do that.
    Senator Stabenow. That is perfectly all right.
    Chairman Roberts. No, I insist.
    Senator Stabenow. I am still trying to figure out, is it 
six--eight generations? I am still trying to figure that out. 
That is very impressive. I assume you now have electricity and 
running water in the house. You have improved it, yes.
    [Laughter.]
    Senator Stabenow. Okay, good. Indoor plumbing, yes.
    Chairman Roberts. It is the great-great-great-grandfather, 
right?
    Dr. Paustian. Three greats, yes.
    Chairman Roberts. Three, not four. I just did four. Well, 
there you go.
    Senator Stabenow. That is very impressive. Very impressive.
    Chairman Roberts. You have plumbing in that house?
    Dr. Paustian. Not originally, but there is now.
    Chairman Roberts. I got it. Okay. Thank you.
    Senator Stabenow. Well, it is wonderful to have all of you 
here, and I do want to welcome Greg Jaffe, who is testifying 
this morning as the Director of the Biotechnology Project at 
the Center for Science in the Public Interest. Greg came to 
CSPI in 2001 after a long and distinguished career in public 
service. He is a recognized expert on agricultural 
biotechnology and biosafety, and has published numerous 
articles and reports on those topics.
    He has served as a member of the Secretary of Agriculture's 
Advisory Committee on Biotechnology under both Democratic and 
Republican administrations. We welcome you and appreciate your 
input today.
    Chairman Roberts. We will start with you, Mr. Johnson. 
Thank you very much.

 STATEMENT OF PATRICK L. JOHNSON, JR., PRODUCER AND CHAIRMAN, 
  ENVIRONMENTAL TASK FORCE, NATIONAL COTTON COUNCIL, TUNICA, 
                          MISSISSIPPI

    Mr. Johnson. Thank you, Mr. Chairman, Ranking Member, and 
members of the Committee for allowing me to be here this 
morning. As Senator Roberts said, my name is Patrick Johnson 
and I am a cotton, rice, corn, and soybean grower in Tunica, 
Mississippi, and I do serve as the Chairman of the National 
Cotton Council's Environmental Task Force, and recently was 
notified of my acceptance to EPA's Pesticide Policy Dialogue 
Committee for the upcoming term.
    Biotech cotton was first introduced in 1996, and U.S. 
cotton farmers rapidly adopted this new technology. In 2018, 
USDA reported over 90 percent each of cotton, corn, and soybean 
acres were planted in biotech varieties.
    For cotton production in the U.S., the latest estimates of 
the benefits of these insect-resistant varieties are 185 
million pounds per year increase in production, 1.9 million 
pounds per year decrease in insecticide use, and $103 million 
per year increased in net revenue to farmers.
    The benefits of herbicide-tolerant biotech cotton in the 
U.S. include a 6.2 million pound per year decrease in 
herbicide-active ingredients applied, and $133 million per year 
savings in weed control costs.
    As you can see, U.S. cotton farmers have a vested interest 
in the continued availability of new biotechnology products 
under a regulatory system that is efficient and streamlined 
while protecting the health and safety of the public and the 
environment, and regulations have a large impact on the number 
of products being brought to market.
    Under the coordinated framework, agency review is shared 
among USDA, FDA, and EPA, depending on the product use, 
ensuring thorough regulatory oversight. With the President's 
June 2019 Executive order modernizing the regulatory framework 
for agricultural biotechnology products, calling for increased 
transparency and coordination within the agencies, we had hoped 
for a swift update to the coordinated framework to face the 
challenges of the newer technologies coming to the forefront.
    Recently, though, we have again become concerned at the 
apparent lack of policy coordination between the three Federal 
agencies involved in the coordinated framework. This is an 
issue that occurred in past administrations as well, and we 
urge the agencies to move swiftly to produce an efficient 
framework for the future. In fact, APHIS's new regulatory 
approach is intended to prepare the agency for future advances 
in the genetic modification of plants. It is important to our 
industry, and to agriculture as a whole, that the three 
agencies work together as seamlessly as possible to regulate 
both older and newer technologies.
    Recent reports suggest an apparent lack of coordination 
between USDA and EPA on the plant side of new technologies. 
This is concerning to the cotton industry, as it may suggest an 
absence of communication between those two agencies. It is our 
understanding that USDA's revised rule has reached OMB and 
therefore may soon be final. We do not know the status of a 
proposed companion revision from EPA. As a result, the industry 
is worried about the future of new technologies if the 
coordinated framework is not working at its most efficient 
level.
    Our industry needs the framework to operate at peak 
efficiency across all agencies. Currently it takes 20 to 40 
years to bring new traits from diploid cottons into cotton 
varieties through traditional breeding. Newer biotechnology 
techniques can perform the same function in two years if 
allowed to work free of delays created by misunderstandings in 
the public arena and a slow regulatory regime. In the U.S., 
wild cotton relatives have valuable alleles that the industry 
hopes to exchange with commercial alleles using technology such 
as gene editing. They can be edited into cotton in a timely 
fashion if the U.S. regulatory agencies can work together 
within a streamlined coordinated framework.
    Cotton Council would also like to point out that consistent 
policies globally for products of plant breeding innovation are 
essential to avoid trade disruptions. The U.S. cotton industry 
exports more than 85 percent of our annual fiber production, 
and experts of cotton seed to key markets are an important 
component of the economic health for the cotton seed segment of 
our industry.
    We would like to commend the agencies for their intent to 
improve the regulatory system for agriculture biotechnology as 
well as for recognizing the long history of scientific evidence 
that supports the safety of products developed using these 
methods. We believe that making strategic improvements to the 
current regulatory system in terms of speed, efficiency, 
transparency, and coordination will engender broader public 
support, prove easier to implement, and have much more 
immediate impact with fewer unintended consequences.
    Thank you again for the opportunity to testify this 
morning.

    [The prepared statement of Mr. Johnson can be found on page 
26 in the appendix.]

    Chairman Roberts. We thank you very much, Mr. Johnson.
    Dr. Parrott.

  STATEMENT OF WAYNE PARROTT, Ph.D., PROFESSOR, DEPARTMENT OF 
 CROP AND SOIL SCIENCES, INSTITUTE OF PLANT BREEDING, GENETICS 
      AND GENOMICS, UNIVERSITY OF GEORGIA, ATHENS, GEORGIA

    Dr. Parrott. Good morning, Chairman Roberts, Ranking Member 
Stabenow, and members of the Committee. I am Wayne Parrott, a 
professor of plant breeding, genetics, and genomics at the 
University of Georgia. Thank you for the opportunity to be here 
today to talk about innovations in precision plant breeding. 
This is really the most exciting time in my 30-year career to 
be a plant breeder, because of the new tools that are now 
available and that build-upon the crop modifications that 
nature and farmers have been doing for thousands of years to 
improve the food we eat.
    Solving problems by creating new crop varieties is what 
plant breeders have always done. Agriculture has always faced, 
and will always face, new and emerging threats from pests, 
diseases, and adverse growing conditions. Agriculture 
constantly depends on new varieties to help overcome its 
challenges. At the same time, new varieties help meet consumer 
expectations for quality, value, and sustainability.
    Notably, plant breeding also has an amazing safety record, 
with hundreds of thousands of new varieties introduced over the 
past century. With the ability we now have to sequence plant 
genomes, we see that these varieties have highly variable 
genomes between them, and that the genomes are always changing, 
which makes it very clear that modifications at the genomic 
level are not an indicator of risk.
    Now plant breeders have access to gene editing, which is a 
precision breeding method that allows us to make very specific 
changes to a genome, resulting in an end product that is often 
indistinguishable from a plant bred using traditional breeding 
methods. The only difference is that it is done with far fewer 
off-target effects than in the past and with far greater 
efficiency, taking months instead of years, in some cases.
    Today, many gene edited crops are coming through the 
product pipeline. Examples include tomatoes adapted for use in 
vertical farms for urban areas and edited rice that is showing 
improved yields in field trials. With my colleagues at the 
University of Georgia, we are working on a switchgrass that 
yields twice as much and is easier to convert into biofuels.
    We envision future crop varieties that will underpin the 
bioeconomy by becoming a major source of raw materials for the 
manufacturing, bioenergy, and pharmaceutical industries.
    The benefits from tools like gene editing cannot be 
disputed, but for these tools to be used the applicable 
policies must be enabling. The original coordinated framework 
for regulation of biotechnology, written in 1986, as well as 
subsequent reviews and Executive orders reaffirm the need for 
regulatory policy that promotes innovation while protecting 
health and environment.
    The 2019 Executive order also instructed the USDA, the EPA, 
and the FDA to take steps to have consistency in coordination 
among them and to streamline regulations. This work has yet to 
be completed, and it is unclear how much coordination has taken 
place since the Executive order was published.
    At the same time, countries, including Brazil, Argentina, 
Israel, Australia, and Japan, recognizing the lack of unique 
risks from editing, already have policies in place that are 
favorable for the use of gene editing in plants, while the 
United States remains without a coherent policy.
    To conclude, I am excited about these new breeding tools. 
However, the three Federal agencies must have a coordinated 
approach and policies that are risk proportionate and 
scientifically based if the benefits of these innovations are 
to be realized. Given a sound regulatory policy, there is no 
doubt in my mind that American agriculture will meet all the 
challenges that the current century will bring forward.
    Thank you for your time.

    [The prepared statement of Dr. Parrott can be found on page 
30 in the appendix.]

    Chairman Roberts. Right on the money, Dr. Parrott. Dr. 
Paustian.

 STATEMENT OF MICHAEL PAUSTIAN, Ph.D., PRODUCER AND PRESIDENT, 
         IOWA PORK PRODUCERS ASSOCIATION, WALCOTT, IOWA

    Dr. Paustian. Chairman Roberts, Ranking Member Stabenow, 
and members of the Committee, I appreciate the opportunity to 
discuss issues of critical importance to U.S. pork producers. I 
am the President of the Iowa Pork Producers Association and a 
hog farmer from Walcott, Iowa. I am also here today on behalf 
of the National Pork Producers Council, a national association 
representing the interests of 60,000 U.S. pork producers.
    The U.S. pork industry has been built on innovation. Our 
commitment to continuous improvement has made the United States 
the world's leading supplier of high-quality, safe, and 
sustainably produced pork. However, we are currently in danger 
of ceding this advantage to international competitors due to 
the FDA's flawed approach to regulating new animal breeding 
tools.
    These tools, which allow for precise changes within an 
animal's own genome, offer tremendous promise to combat animal 
health and welfare challenges and produce safer food in a more 
sustainable fashion. Livestock producers need access to these 
technologies. While countries like China, Canada, Brazil, and 
Argentina are moving quickly to gain a competitive advantage in 
the market, the U.S. is falling behind.
    I want to be very clear that we are not advocating for 
deregulation of these new technologies. Hog farmers support 
scientifically sound, transparent, risk-based regulations that 
ensure that these new tools are effective and safe for both 
animals and consumers. Regulation should be based on the type 
of genetic changes being introduced, not the method by which 
the changes were made. Our concern is not if this technology 
should be regulated but rather by who and under what authority.
    Under the current regulatory framework, FDA has authority 
over genetic technologies in animals. The agency is proposing 
regulating these new technologies under the Food, Drug, and 
Cosmetics Act by approving the altered genome as a drug. In 
effect, this would regulate the animal, which is 
indistinguishable from the genetic material on every cell of 
its body as a drug under U.S. law.
    There are myriad problems with this approach. I will 
highlight two. First, any edit would have to be individually 
evaluated for every breed, strain, or herd of animals that 
wanted to incorporate a given trait. This would bog down 
approval and make this technology inaccessible to most 
livestock producers like myself.
    The second big problem is the real potential for the United 
States to lose its standing as the top producer of high-
quality, healthy, and affordable pork. Competitor nations are 
already advancing regulatory pathways that are not hampered by 
red tape. We are losing our competitive advantage. We are 
subjecting U.S. exports to damaging trade barriers as our own 
government will have said they are, or at the very least, 
contain drugs. We have had extensive conversations with 
regulators in other countries. They are scratching their heads 
at what we are doing.
    The FDA has insisted that farmers are simply 
misunderstanding its regulatory proposal. Not true. We, along 
with scientific and trade communities, have clearly stated our 
strong objections to FDA's proposal. Alternative strategies the 
FDA could pursue have been put forth by multiple stakeholders 
and quickly rejected. The agency has not addressed this concern 
in any meaningful way.
    The agency remains entrenched in its flawed approach. The 
FDA has been given numerous opportunities to address this 
fundamental issue, only to dismiss it as inconsequential and 
insist that additional clarification is forthcoming. We are 
still waiting.
    It is clear we need a new approach. It is imperative that 
the U.S. place primary authority for regulating all 
agricultural applications of new genetic technologies under 
USDA. The agency has fostered new breeding techniques in plants 
for decades under the Plant Protection Act. They can do the 
same for livestock under the Animal Health Protection Act.
    The USDA can regulate agricultural animals, leaving the FDA 
to focus on other exciting biomedical applications that are 
under development. This shift will remove many of FDA's 
obstacles. It will allow for research and development of these 
technologies to take place at American universities rather than 
overseas; let farmers adopt these new breeding techniques 
without fearing loss of international markets; and demonstrate 
to the world that the U.S. is committed to a pro-innovation, 
risk-based approach to new technology, not a precautionary one.
    In short, this approach will allow U.S. agriculture to 
maintain its global edge. We ask you to support this move from 
the FDA to the USDA.
    Thank you for the opportunity to testify, and I look 
forward to any questions.

    [The prepared statement of Dr. Paustian can be found on 
page 34 in the appendix.]

    Chairman Roberts. We thank you for that testimony, Doctor. 
Mr. Jaffe.

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

    Mr. Jaffe. I want to thank Chairman Roberts, 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. I am here today as the Director of CSPI's 
Biotechnology Project.
    CSPI is a nonprofit consumer organization that was 
established almost 50 years ago. CSPI does not receive any 
funding from the industry, nor do we accept any Federal 
Government grants. Our funding primarily comes from our members 
and individual donors, as well as from independent 
philanthropic foundations.
    For years, CSPI has advocated for improvements in the 
Federal biotechnology regulatory oversight system to ensure 
safety to humans, animals, and the environment. Today, I will 
limit my testimony to several current issues around the 
Executive branch oversight of genetically engineered and 
genome-edited crops and animals.
    USDA regulates genetic-engineered crops under its plant 
pest authority provided by the Plant Protection Act. In the 
last few years, however, a loophole that allows developers of 
genetically engineered crops to avoid USDA's regulatory process 
entirely has emerged. If a GE plant variety is developed 
without using any components of a listed plant pest then USDA 
has no authority to regulate the genetically engineered crop, 
even the experimental field trials.
    USDA's decision to exempt certain genetically engineered 
and genome-edited crops is not based on the scientific analysis 
that those crops are not risky and need no regulation, rather 
the decision is solely the result of those crops not being 
captured by the narrow legal hook USDA uses to regulate. Such 
non-scientific decisions undermine the regulatory system and 
its reputation with the public and the United States with our 
trading partners abroad.
    In 2019, USDA proposed changes to its regulations for 
genetically engineered organisms. Those proposed changes, if 
adopted, would greatly narrow the number of genetically 
engineered and genome-edited crops that USDA would regulate.
    First, the proposed regulations would eliminate oversight 
of most genetically engineered crops that have previously been 
regulated because they utilized agrobacterium in the 
transformation process.
    Second, USDA's proposed rule includes several specific 
exemptions for genome-edited crops without any scientific 
evidence to support those exemptions. CSPI does not object to 
exempting genetically engineered or genome-edited crops if 
there is a scientific evidence that they do not pose risks to 
the environment or agricultural interests.
    Finally, the USDA proposal allows developers to self-
determine if they are regulated or qualify for an exemption. 
While some developers will diligently determine the regulatory 
status of their GE plants, other may not. USDA should be 
required to review and confirm those exemptions. That position 
is supported by both NGO's and also industry stakeholders, as 
Senator Stabenow stated earlier.
    FDA regulates genetically engineered and genome-edited 
animals under the new animal drug provisions of the Federal 
Food, Drug, and Cosmetic Act. CSPI supports FDA oversight of 
animals with intentionally altered DNA. FDA recently made a 
compelling scientific case for such oversight of genome-edited 
animals. Using its statutory authority, the FDA should 
establish a proportionate, risk-based regulatory system with 
different levels of oversight based on the product's potential 
risks. FDA's current guidance, Draft Guidance 187, does not 
establish such a system. Instead, it treats all alterations of 
an animal's DNA the same, when depending on the alteration of 
the potential risk could be extremely different.
    Several stakeholders have suggested that instead of FDA, 
USDA should regulate genome-edited animals under the Animal 
Health Protection Act. Some stakeholders suggest USDA oversight 
because they hope that it will mimic the USDA's review process 
for genome-edited plants. That process requires no oversight 
for most genome-edited plants and will allow developers to 
self-determine whether they are regulated. Clearly such a 
process would not address the legitimate and science-based 
concerns that FDA believes need to be assessed to ensure the 
safety of genome-edited animals.
    Finally, the Federal Insecticide, Fungicide, and 
Rodenticide Act requires EPA to register all pesticides sold in 
the U.S. EPA promulgated a regulation under FIFRA that 
establishes how it will regulate genetically engineered crops 
that have been engineered to produce a pesticide. EPA's 
regulatory system is science-and risk-based, transparent and 
participatory, and CSPI supports it.
    Independent of regulation that CSPI believes is necessary, 
CSPI supports a national registry identifying genome-edited 
products. CSPI has advocated that either USDA or FDA should 
establish a national registry of genome-edited crop products as 
an easy, economical, and accessible way to provide transparency 
about genome-edited products in the food supply.
    In conclusion, agricultural innovation through 
biotechnology has and will continue to provide benefits to 
farmers and the environment, but only if the Federal 
Government, through appropriate regulatory structures, ensures 
safety and gives consumers confidence in those products. Thank 
you.

    [The prepared statement of Mr. Jaffe can be found on page 
37 in the appendix.]

    Chairman Roberts. Thank you, Mr. Jaffe.
    Dr. Parrott, based on your experience interacting with EPA 
and the USDA over the years, what would the consequences be if 
the Department of Agriculture and the Environmental Protection 
Agency take different approaches to regulating products of 
advanced breeding technologies?
    Dr. Parrott. Thank you for the question. We already have--
we can just look back in past history with previous 
technologies to answer that question, and the answer is that a 
lot of crops that would be very useful to farmers and consumers 
simply get left on the shelf. Particularly affected are 
disease-resistant and pest-resistant traits, which as far as 
biotechnology goes are the low-hanging fruit that are easier to 
achieve, and, thus the thing that has been deployed the least, 
because of the barriers that have come from having different 
criteria for evaluation.
    Chairman Roberts. I appreciate that very much. Dr. 
Paustian, as noted in your testimony the FDA is examining 
options on a regulatory structure for the development and 
approval of new livestock technologies. My question is, is the 
FDA working to carry out the commitment made by the 
administration to foster a regulatory environment in which 
businesses and industries can thrive and not be stifled by 
overly burdensome government regulation? How can the FDA best 
uphold this commitment to keep the interests of producers 
paramount?
    Dr. Paustian. Thank you for the question. My short answer 
would be no, they are not, and it is somewhat surprising to me, 
in the past, with other issues that the livestock industry has 
dealt with the FDA, most recently putting all antibiotic usage 
under the supervision of a veterinarian. We have had very good 
back-and-forth conversation and a productive working 
relationship with FDA.
    On the issue of these new genetic technologies, they appear 
to be less responsive to the industry's needs and the 
industry's feedback. That is why, based on the conversations 
that we have had thus far, we feel that the USDA would be a 
more natural place for the regulation of these technologies to 
occur. A lot of that is based on past history with their work 
on regulating on the plant side. We feel that the USDA 
understands the needs of the producers and what is going on on 
the farm and how some of these regulatory decisions will impact 
producers. We feel like that they are a more natural fit for 
some of these issues.
    Chairman Roberts. Thank you, Doctor.
    Dr. Parrott, are there loopholes that allow genetically 
engineered crops to avoid the Department of Agriculture's 
regulatory process?
    Dr. Parrott. When the Coordinated Framework for 
Biotechnology was established, the baseline for regulations was 
supposed to be in comparison to conventional plant breeding. 
Along those lines, the USDA's role was to ensure there were no 
plant pests brought forth into agriculture, and we just to have 
to look back at the history of the past 25 years to see that it 
has done its job very effectively.
    On top of that, because of broad authority under the Plant 
Pest Act, USDA can intervene with any plant pest problems that 
a variety might cause if one were ever to cause one.
    On top of that, there is an obligation that any food that 
is sold is safe and that comes through FDA, so, you know, we 
are never going to escape FDA. Then we still have EPA that will 
come in and look at several traits. The answer is basically 
everything is covered by at least one agency or more.
    Chairman Roberts. I appreciate that. Senator Stabenow.
    Senator Stabenow. Thank you very much, Mr. Chairman.
    First, Mr. Jaffe, I want you to talk a little bit more 
about the APHIS proposed rule that allows biotech developers to 
self-determine whether or not they are regulated or qualified 
for an exemption. I share your concern, and there is a broad 
coalition of agriculture organizations that also share your 
concern, and so I am wondering: If the USDA declines to modify 
this provision in the final rule, what will be the impact, from 
your perspective? What kind of harm could that cause?
    Mr. Jaffe. Thank you for the question. There are two 
things. One, as I stated in my testimony, while many companies 
may properly self-determine whether they qualify for an 
exemption, some may not. We may have some products that should 
be regulated that will not be regulated, and USDA will not even 
know that they are out there to know to regulate them. That has 
an impact both on potential safety here in the United States, 
but it also has impact on international trade and international 
markets because those products, if they are required to be 
regulated in the United States and we do not know about them, 
are probably also required to be regulated in many of our 
foreign markets, and those will cause trade barriers. In fact, 
if they are now regulated there in those markets, they may 
actually be the ones that stop our farmers from growing those 
crops, not our own regulators but regulators in other markets 
since we have to export them.
    The second thing is also that by allowing USDA to determine 
whether they are exempt or not, we have a record of what is 
going out there and there is transparency. Then we have the 
public knows and the food chain knows, and everybody can then 
act accordingly. If we do not have that, we are going to have 
all kinds of organizations, the Non-GMO Project, you know, 
different organizations will come up with their own list of 
what is supposedly out there. It will not be accurate. 
Consumers and the marketplace will be dealing with inaccurate 
information about what is out there, and that only leads to 
problems.
    Senator Stabenow. Well, how would you improve the 
regulation?
    Mr. Jaffe. I think it is a fairly simple fix for this 
particular thing, that companies will submit their 
determination of why they believe they are not exempt. The USDA 
will either say, ``That is correct,'' and they will qualify for 
the exemption. Or USDA will say, ``No, we need more 
information'' or ``We do not think you are exempt.'' There will 
be a record of that. The public will have the record of it; 
USDA will have a public record of it.
    I do not think it adds any additional burden, but I think 
it actually will give a lot more transparency and a lot more 
confidence to the public and to the regulators that at least 
the decisions are being made. We can differ about whether they 
should be exempt, but given that the exemptions may be in the 
final rule, that would be the reason.
    Senator Stabenow. Great. Thank you.
    Dr. Parrott, you talked in your testimony about concern 
that other countries are moving ahead much more quickly on new 
policies that lead to innovation happening abroad, and I think 
that is an important concern. Biotechnology can be enormously 
beneficial, and we want these products developed right here in 
the United States. I am wondering, how are other countries 
approaching the issue of regulating gene editing? How are they 
balancing the need for flexibility and the certainty with 
transparency?
    Dr. Parrott. I have actually been quite fortunate to travel 
to various countries and interact with their gene regulators, 
and some of the legislators have worked on the issue. They are 
primarily--I guess I side with them in saying that, you know, 
with our experience as plant breeders and geneticists, we do 
not see any risk from gene editing, for most types of gene 
editing that is different from what the conventional plant 
breeders have been doing for the past century. On that basis, 
they have a notification requirement that you have to let them 
know so they can verify that you are not covered by their 
statutes, and that is pretty much it.
    Senator Stabenow. Interesting. So from your standpoint, 
that is the approach that we should be taking? When we are 
looking at flexibility and transparency, that, from your 
standpoint, is the balance?
    Dr. Parrott. In general, Dr. Paustian made the remark that 
it is not how you do something, it is what you do. It is the 
product that you are making the trait that you are producing. 
It is really any--if you look at the traits, you can determine 
if they are going to present the risk that needs to be managed 
or not. How you got that trait really is immaterial to the 
risk.
    Senator Stabenow. All right. Thank you. Then if I might 
just very quickly ask Mr. Jaffe one more question. When we are 
looking from the FDA's standpoint and the draft guidance that 
they treat all alterations of an animal's DNA the same when, 
depending on the alteration, the potential risk could be 
different. To me that sounds like you are saying the FDA is too 
one size fits all as they are looking at this. I am wondering, 
what is your view on their authority and ability to develop a 
system that is truly science-based, risk-based, if that is the 
way they are looking at it?
    Mr. Jaffe. When you read their Draft Guidance 187, it does 
seem like it is one size fits all, and that is why I wrote in 
my testimony that I think they need to figure out how to apply 
that to different products in different ways. We have seen that 
they have done that, so for the genetically engineered animals 
that they have regulated, all of the laboratory mice and rats 
that they regulated, they did enforcement discretion and 
decided they did not need to have any oversight of those 
because they are all in contained laboratories.
    For the GloFish, which is the genetically engineered pet 
fish out there, they also decided to use their enforcement 
discretion because they did not go into the food supply and 
because it was, again, because of the way it was going to be 
used. They all fell within Guidance 187, and yet they used 
their discretion to figure out a way, because of the risk 
profile of those products, to regulate them differently. I have 
confidence that if we give FDA time for the genome-edited 
animals and the genetically engineered animals, they will put 
them into categories such that different products, depending on 
their potential risks, get different levels of oversight, 
different levels of data that are required, different kind of 
review, different time for that review. I think, you know, FDA 
wants to use their resources efficiently, and they will if 
given time to sort this out.
    Senator Stabenow. Thank you.
    Chairman Roberts. Senator Fischer.
    Senator Fischer. Thank you, Mr. Chairman.
    Dr. Paustian, livestock and developer groups have expressed 
great frustration with FDA's regulatory approach for animal 
biotechnology. Currently, FDA regulates the animal's DNA as an 
animal drug under the Food, Drug, and Cosmetic Act, which, let 
us be honest, it seems to be like taking a square peg and try 
to put it in a round hole.
    The regulatory approach for drugs is extremely long and it 
is cumbersome. To date, there has been only one biotech food 
animal approved by the FDA, which took 20 years. FDA also wants 
to impose unworkable post-approval requirements like saying the 
animal continues to contain a drug which could jeopardize 
export prospects for these animals to foreign markets.
    Can you share your thoughts on FDA's approach? Should 
Congress be concerned by it?
    Dr. Paustian. Sure, I would be happy to. You know, going 
back to the point I tried to make in my statement, we are 
certainly not saying these things should not be regulated; but 
the problem is if we go too far and the regulation becomes 
overly burdensome, as we have seen in the past, that can stifle 
innovation and it can slow the adoption of new technologies.
    You know, one of the issues with FDA's current approach is 
that anyone bringing a gene-edited animal forward is required 
to show in multiple generations of that line of animals that--
they each have to individually be characterized, and meanwhile 
none of these animals can enter the food supply. That creates 
an enormous financial challenge such that, you know, currently 
there is only one company that I am aware of that is actively 
going through the FDA process. The reason that concerns me is 
that when you have overly burdensome regulation, generally it 
is the smaller companies, the startups, the smaller farmers 
that get kind of stuck on the outside looking in, because they 
will not have access to it because to be perfectly honest, I 
mean, my farm does not have the resources to go through an 
approval process such as FDA currently has laid out.
    I think we run the risk of not only slowing down adoption 
of the technology, but concentrating the benefits of the 
technology amongst the few who are able to navigate the maze of 
red tape and leaving others out.
    Senator Fischer. You know, I think also when we look at FDA 
and their action in regulating animals as drugs, that to me 
throws a lot of questions in the minds of many of our trading 
partners. To continue on that, I understand that some of our 
trading partners--Brazil, Argentina, China, and others--they 
are aggressively developing their own animal biotech 
regulations. You know, we heard about that before, and it is to 
attract researchers and developers and to grant their producers 
that first access to innovations, which leaves our livestock 
producers behind. They start out behind.
    Argentina made a non-GMO determination in less than a year 
for an edited animal. It was a tilapia. That contained no 
foreign DNA. FDA's regulatory approach could take decades to 
grant those regulatory approvals.
    What risks do you see from foreign regulators establishing 
themselves as a primary international expert when it comes to 
this? If you could expand on an earlier answer, I would 
appreciate that.
    Dr. Paustian. Sure. U.S. producers have enjoyed their 
position as leading innovation in agriculture. That is what has 
allowed us to produce more food more safely, more sustainably 
than anywhere else in the world.
    Senator Fischer. Feed the world.
    Dr. Paustian. Yes. U.S. producers--of course, I am most 
familiar with pork producers, but I am pretty confident this 
applies to almost all producers--you know, can compete with 
anyone in the world as far as productivity. A lot of that is 
because of innovation. We are also blessed with tremendous 
natural resources as well and great infrastructure. Those are 
all strengths that we have been able to take advantage of and 
put us in the position we are right now.
    The rest of the world is catching up, and they are doing it 
quickly. They have seen the success that we have had, and they 
are anxious to catch up to us, if not pass us. It is not hard 
to envision it. We really have a case study to look at right 
now on the crop side. If you look at the innovation with 
genetically modified crops and where that has put U.S. 
production in relation to, say, Europe, where they have been 
very slow to adopt new technologies due to their precautionary 
approach, you know, we are far beyond them in production.
    It is really not hard to imagine a situation 10, 15, 20 
years down the road where we are significantly behind other 
nations who have continued to keep pace with advances in 
genetic technology and have left us behind. In my mind, it is 
of critical importance that we have an appropriate regulatory 
structure in place, because as has been mentioned, you know, we 
need to have appropriate regulation to give consumers 
confidence in the products that we are providing. I do not want 
to discount that. Consumer acceptance is kind of a whole other 
hill that we are going to have to climb, and having appropriate 
regulation in place does not guarantee that. That is another 
area where we still have a lot of work to do.
    Senator Fischer. Right. You know, it is good to have good 
spokespeople out there talking about science. Bill Gates, I 
love his comment when he says, GMOs, you know, ``That has been 
settled for over 15 years, and that is why we are able to feed 
the world. There is nothing there.'' Thank you.
    Chairman Roberts. Senator Fischer, thank you, and thank you 
for those most pertinent questions. Dr. Paustian, thank you for 
your response. Senator Durbin.
    Senator Durbin. Thank you very much, Mr. Chairman.
    Mr. Chairman, many years ago, when you and I were on the 
Agriculture Committee, I decided to look at the issue of food 
safety, and I discovered some interesting things. I discovered 
when it came to the safety of meat and poultry, it was the U.S. 
Department of Agriculture, their responsibility, and they 
inspected it on a daily basis. I realized that when it came to 
the food safety of fish, it was the Food and Drug 
Administration's responsibility, and they were not monitoring 
fishermen and the delivery of the catch on a daily basis by any 
stretch.
    Then I came to realize that when it came to whole eggs and 
their safety, it was the responsibility of the Department of 
Agriculture; but broken eggs, Food and Drug Administration. 
Cheese pizza, what do you think? Food and Drug Administration. 
Pepperoni pizza, Department of Agriculture. I thought to 
myself: Why are we doing it this way? Why do we have so many 
different agencies looking at these food products from their 
own perspective? Why don't we put it in a single food agency? I 
set out to do it. Have not achieved it quite yet. Not sure that 
I ever will, because it turns out there is resistance from the 
agencies. They want to keep their responsibility. There is 
resistance from the interest groups because they are afraid if 
somebody else gets in on the act, it may change the rules as 
they know them.
    Now, when it comes to this hearing, it appears that we have 
a similar situation. The Department of Agriculture regulated 
biotechnology as it affects plant and animal health. The Food 
and Drug Administration regulates the products from the human 
health perspective, and the EPA regulates the products from the 
human health and environment perspective.
    Once again we have a general question mark, biotechnology, 
gene editing, for example, that is being addressed by three 
different Federal agencies looking at different aspects of it. 
Now the USDA has changed its basic rule as of June of last year 
in terms of gene editing, but it does not appear that they have 
gone outside their lane when it comes to the statutory 
responsibility.
    Mr. Jaffe, can you tell me why this concerns you if they 
are still in their own lane, they are not dealing with human 
health or environmental aspects of biotechnology?
    Mr. Jaffe. Senator, you get at the major problem here, that 
we have three agencies dealing with these products on a product 
basis without any overarching look to make sure that we are 
ensuring safety to humans, animals, and the environment. 
Sometimes we have overregulation. We have some products that 
are regulated by multiple agencies, so we have certain crops 
that are regulated by both USDA and EPA, and some of that 
regulation is overlapped. We also have products that escape any 
regulation, so if you do not have a food product and it is a 
crop and it is not a pesticide and it is produced using the 
gene gun, it gets regulation by none of these products. 
Unfortunately, so you could have the same product produced two 
different ways, the same gene introduced, the same trait, and 
they might get regulated by one agency and not get regulated by 
another.
    We have instances of overregulation and underregulation, 
arguably. It would be better, but the Coordinated Framework 
back in 1986 made the decision to look at these on product 
statutes, and so we are putting new technologies into product 
statutes that really do not fit very well.
    Senator Durbin. What impact does this have on innovation 
and research that you have three different agencies looking at 
three different aspects of the same basic research?
    Mr. Jaffe. I mean, on one level, as one of the other 
witnesses said, the U.S. has been the leader on genetically 
engineered crops. We are the ones who developed them. We are 
the ones growing them. Even with three levels of oversight of 
those crops, we have still been the leader worldwide. I do not 
think regulation alone prevents innovation, and we could still 
have research and do these things. I do think that long term, 
we need a better system that is more science-based, that has 
science and risk at its core so that we are not overregulating 
and underregulating, which is what we are doing now.
    Senator Durbin. Does the rest of the panel have any 
thoughts on that?
    Dr. Parrott. Yes.
    Senator Durbin. Turn your mic on.
    Dr. Parrott. In many ways, we can say that our biotech 
policy has been a success, and we look at our corn or soybean 
or cotton. We have to recognize that the majority of crops got 
left behind. We do not have biotech peanuts. We do not have 
biotech for most of our vegetables. Specialty crops, barley, 
got left out of the picture. Even traits of regional importance 
have been left out of the picture. We have a problem that is so 
unique to the Southeast, really our current policy cannot cope 
with it.
    Yes, there has been a price to pay. I mean, the three 
agencies do not even use the same definition of ``genetic 
engineering.''
    Senator Durbin. Thanks, Mr. Chairman.
    Chairman Roberts. I thank the Senator.
    Senator Loeffler.
    Senator Loeffler. Thank you, Mr. Chairman, and good morning 
to our esteemed panel. I appreciate your willingness to be here 
today and share your expertise.
    As you all know, farmers face an ever-growing number of 
issues today, both natural and manmade. Whether it is disease, 
international markets, or natural disasters, it is becoming 
harder for the American farmer to thrive let alone survive.
    I applaud the Trump administration and Secretary Perdue for 
their work to address the coordination between relevant 
agencies because we have reached the point where the rollout of 
improved seeds and biotechnology, there is a clear need. 
However, issues remain with the Coordinated Framework that 
affect the speed at which these products are approved.
    While I agree we need to ensure that these products are 
safe, we need to make some changes because ultimately farmers 
and Americans that they feed and clothe are paying the price.
    With that, just a question maybe to build on the last 
question, Dr. Parrott or Mr. Johnson. We have a very diverse 
set of commodities grown in Georgia, and I am thrilled by the 
advances biotech has made for Georgia products like cotton. 
Commodities like peanuts, blueberries, pecans, and other fruits 
and vegetables have not seen the same degree of innovation.
    Could you just expand on why this is the case and what you 
think could be done?
    Dr. Parrott. I have referenced several times that 
particularly with most applications of gene editing, we are 
just doing what has always been done. We are taking the 
randomness out of the process, and we are making our changes 
much more targeted than we have in the past. Yet what all of 
these agencies do is that the trigger for regulation is not 
what trait we do. The trigger is what technique we use. The 
moment we start using a biotech approach, it triggers a series 
of regulations that do not apply to the same crop or the same 
trait if we handled them in a conventional way.
    Actually, in my work we are about to release an insect-
resistant soybean variety for growing in the Southeast, and I 
have been working on that variety for about 25 years. I could 
do it in about a year's time using the tools of biotech, but if 
I did it with biotech, I would have to go through EPA, and it 
would be considered a plant incorporated protectant, and it 
would be in many ways treated like a pesticide; whereas, if I 
did it the slow, less accurate way, then there is pretty much 
no oversight at all. It is this discrimination then that if you 
do things one way, you get all these that barriers you have to 
supersede in order to get something into the market, and the 
cost of compliance and coming up with the necessary information 
is simply far greater than the profit margin that the farmer 
would ever get from using that trait.
    Mr. Johnson. I would just add briefly that I cannot speak 
necessarily to those other crops, but even for crops like 
cotton and some of the larger crops that are grown on larger 
acreages that have made a lot of advancements, we find 
ourselves in a position where we are relying on a small number 
of products heavily, and there is still a real need for a 
streamlined process to bring new technology to the forefront to 
allow us to meet the goals we have for stewardship and 
resistance management and things like that.
    Senator Loeffler. Thank you so much. Thanks for all you do 
for this industry.
    Chairman Roberts. Senator Boozman.
    Senator Boozman. Thank you, Mr. Chairman, and thank you 
Ranking Member so much for having this very important hearing 
that is so timely. I think we all agree that through safety and 
science, we want to protect the consumer. We are blessed we 
have got this cheap, safe food supply that we can be so, so 
very proud of, and then also have the regulatory atmosphere 
that keeps us safe and yet does not impede us going forward, 
not only for our country but for the other countries that are 
in desperate need of different seed varieties, different 
whatever, that would make them so much more beneficial.
    Dr. Parrott and Dr. Paustian, each of you interact with the 
FDA, EPA, and USDA often. How would you rate the communication 
between the stakeholders and the agencies on the topic of the 
biotechnology regulatory framework? For the primary agency you 
have been working with, has communication on the specific 
topics we are hearing about today been consistent with how the 
administration has engaged the stakeholder community on other 
subject matter? You know, we are hearing a lot about the 
problem. Communication is so important. Tell us a little bit 
about what is going on in that regard.
    Dr. Paustian. Sure. As I have alluded to in some of my 
earlier comments, we have been having a lot of conversations 
with the FDA and pointing out some of our concerns in their 
current draft guidance and the implications we feel that would 
have for not only research in this area, but also how we at the 
farm level are able to access the technology and the types of 
regulation that we might fall under. I have to say so far I 
have been very disappointed with the communication that we have 
heard back, which has been, you know, very vague and implying 
that certain things would be at their discretion, they would 
not necessarily do it, but no concrete details, really. That is 
really why, you know, we have taken the stance of moving the 
authority over to USDA, who we have had a very productive 
working relationship with, and we have confidence that the USDA 
understands production agriculture. That is what it comes down 
to, is that we have the confidence that they are fully aware of 
the ramifications of their decisions and what those are going 
to mean to producers. We feel like they would be able to 
adequately address both the concerns of consumers, to make sure 
we have safe products being brought to market, but also balance 
that against the concerns of producers and the innovators who 
are working with this technology to make sure that they do not 
have an overly burdensome hurdle to overcome in order to 
utilize these technologies to improve things on their farms.
    Senator Boozman. Dr. Parrott, can you add anything?
    Dr. Parrott. Yes, sir, I can. Of the various agencies, I am 
just going to begin with APHIS. APHIS made a very concerted 
effort to reach out to stakeholders before it drafted its 
change in its regulatory procedures. They held various 
stakeholder meetings. In fact, we had one at Georgia. They made 
a big point of meeting with scientists to make sure they were 
getting the science right and that they were--that science 
supported the actions that they have.
    As far as the FDA goes, I want to clarify that we deal with 
different parts of FDA. He deals with the Center for Vet 
Medicine, and I am with CFSAN, which is Center for, I think it 
is, Food Safety and Nutrition. CFSAN has actually been also 
very open to stakeholder input. They have held meetings with 
scientists at scientific meetings and have held panels where we 
can go, and, again, they too have been very interested in 
understanding plant genetics and making sure they get the 
science side.
    I really have not heard much from EPA. I heard there was a 
meeting in the Midwest, but certainly there has been nothing as 
far as reaching out to scientific societies or my part of the 
country.
    Senator Boozman. Very good. Thank you, Mr. Chairman, and 
thank you all for being here and sharing with us your concerns.
    Chairman Roberts. Senator Grassley.
    Senator Grassley. Thank you, Mr. Chairman. Very important 
Committee. I am sorry. I had two other committees, Judiciary 
and Budget, before coming here. I did not get your testimony, 
but we have it written and can study it from that point of 
view.
    First of all, Dr. Paustian, thank you for your leadership 
of the Iowa Association, and you are a good spokesman for the 
No. 1 State in pork. You mentioned in your testimony that the 
United States could fall behind other countries in pork 
production if we do not fix all the FDA-regulated animal 
biotechnology. Do you know which countries we could look to as 
a model for biotechnology regulation?
    Dr. Paustian. Thank you, Senator. Well, I think, you know, 
Canada, Argentina, Brazil, they have all moved quickly to put 
frameworks into place to regulate some of these genetic 
technologies, so I think, you know, we have certainly had 
conversations with them to kind of try to understand their 
approach, and we feel that they are for the most part finding a 
nice balance between regulation and accessibility. You know, we 
feel like there are some models out there that we can look to, 
and that gives us confidence that we might be able to reach 
some type of international consensus on how some of these 
technologies are regulated so that we do not encounter some 
trade barriers in the future. You know, we have a lot of 
confidence there.
    Now, there is a lot of activity going on in China as well. 
If you just look at the scientific literature, China is 
producing twice as many research papers as the United States 
that are related to gene editing in agriculture. Their 
regulatory path is somewhat murky, though, and I cannot really 
speak to what they are putting into place. They are moving very 
quickly on this as well.
    Senator Grassley. Could I hear from Dr. Parrott? This will 
be my last question, even though I have still got a lot of time 
left. I would like to hear from you by sharing your thoughts on 
what benefits gene editing will be able to bring to food and 
agriculture where traditional biotechnology has been limited?
    Dr. Parrott. Yes, sir. When we talk about conventional 
plant breeding, I normally like to say--when I simplify it, say 
that, you know, half the time plant breeders are removing 
traits that they do not need or want, think, say, bitter 
flavor, think susceptibility to disease. When they are not 
removing traits you do not want, they are adding traits you do 
want, say a better quality protein or a resistance to a pest.
    Gene editing is an evolving technology, but where it stands 
at the moment, it is far better than anything we have ever had 
before on the removal of unwanted traits side. There are genes 
that limit yields. There are genes that limit nutrition. There 
are genes that limit seed size. There are genes for 
susceptibility to diseases that we can be removing. There are 
also genes that affect how a plant is made--you know, grows so 
we can actually not only increase yields but we can focus on 
root development and sequester carbon. We can focus on things 
like drought tolerance or even flooding tolerance as the case 
may be.
    Overall, it means much more consumer choice in everything 
from flower color to--we actually have a project in the lab for 
lawns that do not need to be mowed as much. Flower color, 
flavor, all the way to resilient higher-yielding crops. As I 
say, it is a really exciting time.
    Senator Grassley. Okay. I am going to yield back my time, 
Mr. Chairman. Thank you very much.
    Senator Boozman. Mr. Chairman, can we ask where we can get 
the seed about the lawn mowing?
    [Laughter.]
    Chairman Roberts. Senator Grassley, since you had time 
left, we would always be interested in any further comment that 
you would like to make given your standing in the Congress.
    Senator Grassley. Well, I think I would limit it to ethanol 
now.
    [Laughter.]
    Chairman Roberts. I think your time has just expired.
    [Laughter.]
    Senator Grassley. Have the President not appeal the Tenth 
Circuit opinion.
    Chairman Roberts. You can never get hurt by what you do not 
say.
    Dr. Parrott, 25 years for a product that you have been 
working on to bring to the marketplace with regard to soybeans? 
Is that correct?
    Dr. Parrott. That is correct.
    Chairman Roberts. That is ridiculous. I do not----
    Dr. Parrott. In part, when we started the project, we did 
not have the tools that we have today. Nevertheless, with the 
tools that we have today, if we were starting from scratch, it 
would still be a decade project if we used conventional 
methods.
    Chairman Roberts. Mr. Johnson, international trade, as we 
all know, we have seen the administration work hard to improve 
the trade situation, and more especially with China, especially 
cotton and soybeans. As long as American farmers have a 
landscape that allows them to be competitive, they will be 
successful in the global marketplace. Can you characterize, 
however, how other countries such as Japan and China might be 
striving--well, they are striving--to improve their scientific 
understanding on the future of these new plant breeding 
technologies and their countries' policies with regard to gene 
editing?
    Mr. Johnson. I do not know that I can speak specifically to 
what those countries are doing, but I know from the cotton 
industry's perspective, it is a high priority that USDA and 
USTR are working with those countries that are trade partners, 
and we certainly would like to come to a place where approval 
in the U.S. met the regulatory requirements in those countries 
we trade with. That is a high priority for us.
    Chairman Roberts. One last question. Dr. Paustian, the 
jurisdiction on the animal side, this Committee has clear 
jurisdiction over livestock and meat. USDA administers 
authority such as the Animal Health Protection Act, guarding 
against pests and diseases, as well as the Federal Meat 
Inspection Act, which provides for safe, wholesome, and 
accurately labeled meat. As the three agencies weigh the risks 
of new technologies and are urged to consider risk consistently 
among them, does the Secretary have adequate authority under 
these acts to regulate these new technologies?
    Dr. Paustian. Well, Mr. Chairman, I am not a lawyer, but I 
have friends who are lawyers, and in my conversations with 
them, we have come to the conclusion that, yes, USDA does have 
the authority if they choose to exercise it. As I have stated 
before, you know, we feel like it is a natural fit to have 
animals and food being regulated, animals and animal products 
as well as plants regulated through USDA. We are confident that 
they have the tools in place to ensure that, you know, only 
safe, healthy products reach the marketplace.
    Chairman Roberts. Maybe we could make it possible for those 
lawyers to be helpful to the Coordinated Framework.
    That will conclude our hearing today. I want to thank each 
of our witnesses for taking time to share your perspectives on 
agriculture innovation and the Federal Biotechnology Framework.
    To my fellow members, we ask that any additional questions 
you may have for the record be submitted to the Committee Clerk 
five business days from today or by 5 p.m. next Thursday, March 
19th.
    The Committee stands adjourned.
    [Whereupon, at 11:25 a.m., the Committee was adjourned.]

      
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