[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]


                   AGRICULTURAL BIOTECHNOLOGY: 21ST 
                        CENTURY ADVANCEMENTS AND
                              APPLICATIONS

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

                             JOINT HEARING

                               BEFORE THE

                            SUBCOMMITTEE ON
                   LIVESTOCK AND FOREIGN AGRICULTURE,

                                AND THE

                            SUBCOMMITTEE ON
               BIOTECHNOLOGY, HORTICULTURE, AND RESEARCH

                                 OF THE

                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             FIRST SESSION

                               __________

                            OCTOBER 26, 2021

                               __________

                           Serial No. 117-19


          Printed for the use of the Committee on Agriculture
                         agriculture.house.gov
                         

[GRAPHIC NOT AVAILABLE IN TIFF FORMAT] 

                                _________

                    U.S. GOVERNMENT PUBLISHING OFFICE                    
47-125                     WASHINGTON : 2022                     
          
-----------------------------------------------------------------------------------   
                        

                        COMMITTEE ON AGRICULTURE

                     DAVID SCOTT, Georgia, Chairman

JIM COSTA, California                GLENN THOMPSON, Pennsylvania, 
JAMES P. McGOVERN, Massachusetts     Ranking Minority Member
FILEMON VELA, Texas                  AUSTIN SCOTT, Georgia
ALMA S. ADAMS, North Carolina, Vice  ERIC A. ``RICK'' CRAWFORD, 
Chair                                Arkansas
ABIGAIL DAVIS SPANBERGER, Virginia   SCOTT DesJARLAIS, Tennessee
JAHANA HAYES, Connecticut            VICKY HARTZLER, Missouri
ANTONIO DELGADO, New York            DOUG LaMALFA, California
BOBBY L. RUSH, Illinois              RODNEY DAVIS, Illinois
CHELLIE PINGREE, Maine               RICK W. ALLEN, Georgia
GREGORIO KILILI CAMACHO SABLAN,      DAVID ROUZER, North Carolina
Northern Mariana Islands             TRENT KELLY, Mississippi
ANN M. KUSTER, New Hampshire         DON BACON, Nebraska
CHERI BUSTOS, Illinois               DUSTY JOHNSON, South Dakota
SEAN PATRICK MALONEY, New York       JAMES R. BAIRD, Indiana
STACEY E. PLASKETT, Virgin Islands   JIM HAGEDORN, Minnesota
TOM O'HALLERAN, Arizona              CHRIS JACOBS, New York
SALUD O. CARBAJAL, California        TROY BALDERSON, Ohio
RO KHANNA, California                MICHAEL CLOUD, Texas
AL LAWSON, Jr., Florida              TRACEY MANN, Kansas
J. LUIS CORREA, California           RANDY FEENSTRA, Iowa
ANGIE CRAIG, Minnesota               MARY E. MILLER, Illinois
JOSH HARDER, California              BARRY MOORE, Alabama
CYNTHIA AXNE, Iowa                   KAT CAMMACK, Florida
KIM SCHRIER, Washington              MICHELLE FISCHBACH, Minnesota
JIMMY PANETTA, California            JULIA LETLOW, Louisiana
ANN KIRKPATRICK, Arizona
SANFORD D. BISHOP, Jr., Georgia

                                 ______

                      Anne Simmons, Staff Director

                 Parish Braden, Minority Staff Director

                                 ______

           Subcommittee on Livestock and Foreign Agriculture

                    JIM COSTA, California, Chairman

ABIGAIL DAVIS SPANBERGER, Virginia   DUSTY JOHNSON, South Dakota, 
JAHANA HAYES, Connecticut            Ranking Minority Member
J. LUIS CORREA, California           SCOTT DesJARLAIS, Tennessee
JOSH HARDER, California              VICKY HARTZLER, Missouri
RO KHANNA, California                DAVID ROUZER, North Carolina
CYNTHIA AXNE, Iowa                   TRENT KELLY, Mississippi
BOBBY L. RUSH, Illinois              DON BACON, Nebraska
STACEY E. PLASKETT, Virgin Islands   JAMES R. BAIRD, Indiana
ANGIE CRAIG, Minnesota               JIM HAGEDORN, Minnesota
SANFORD D. BISHOP, Jr., Georgia      TRACEY MANN, Kansas
------                               RANDY FEENSTRA, Iowa
                                     BARRY MOORE, Alabama

              Daniel Feingold, Subcommittee Staff Director

                                  (ii)


       Subcommittee on Biotechnology, Horticulture, and Research

               STACEY E. PLASKETT, Virgin Islands, Chair

ANTONIO DELGADO, New York            JAMES R. BAIRD, Indiana, Ranking 
KIM SCHRIER, Washington              Minority Member
JIMMY PANETTA, California            AUSTIN SCOTT, Georgia
CHELLIE PINGREE, Maine               ERIC A. ``RICK'' CRAWFORD, 
SEAN PATRICK MALONEY, New York       Arkansas
SALUD O. CARBAJAL, California        RODNEY DAVIS, Illinois
AL LAWSON, Jr., Florida              DON BACON, Nebraska
JOSH HARDER, California              JIM HAGEDORN, Minnesota
J. LUIS CORREA, California           CHRIS JACOBS, New York
ANN KIRKPATRICK, Arizona             TROY BALDERSON, Ohio
                                     MICHELLE FISCHBACH, Minnesota
                                     JULIA LETLOW, Louisiana

              Malikha Daniels, Subcommittee Staff Director

                                 (iii)
                                 
                                 
                             C O N T E N T S

                              ----------                              
                                                                   Page
Baird, Hon. James R., a Representative in Congress from Indiana, 
  opening statement..............................................     6
Costa, Hon. Jim, a Representative in Congress from California, 
  opening statement..............................................     1
    Prepared statement...........................................     3
    Submitted letter on behalf of Sarah Gallo, Vice President, 
      Agriculture and Environment, Biotechnology Innovation 
      Organization...............................................    63
Johnson, Hon. Dusty, a Representative in Congress from South 
  Dakota, opening statement......................................     4
Plaskett, Hon. Stacey E., a Delegate in Congress from Virgin 
  Islands, opening statement.....................................     5
    Prepared statement...........................................     6
    Submitted letter on behalf of Agricultural Retailers 
      Association, et al.........................................    64
Thompson, Hon. Glenn, a Representative in Congress from 
  Pennsylvania, opening statement................................     8

                               Witnesses

Chou, Ph.D., Fan-Li, Vice President for Scientific Affairs and 
  Policy, American Seed Trade Association, Washington, D.C.......     9
    Prepared statement...........................................    11
Rice, Ph.D., Elena, Chief Scientific Officer, Genus plc, 
  DeForest, WI...................................................    14
    Prepared statement...........................................    15
Bobo, Jack A., Chief Executive Officer, Futurity, Potomac, MD....    20
    Prepared statement...........................................    21
    Supplementary material.......................................    65
Oatley, Ph.D., Jon M., Associate Dean of Research, Professor, 
  Director, Functional Genomics Initiative, School of Molecular 
  Biosciences, College of Veterinary Medicine, Washington State 
  University.....................................................    24
    Prepared statement...........................................    26

 
                   AGRICULTURAL BIOTECHNOLOGY: 21ST 
                        CENTURY ADVANCEMENTS AND
                              APPLICATIONS

                              ----------                              


                       TUESDAY, OCTOBER 26, 2021

                  House of Representatives,
         Subcommittee on Livestock and Foreign Agriculture,
                                             joint with the
 Subcommittee on Biotechnology, Horticulture, and Research,
                                  Committee on Agriculture,
                                                   Washington, D.C.
    The Subcommittees met, pursuant to call, at 10:02 a.m., via 
Zoom, Hon. Jim Costa [Chairman of the Subcommittee on Livestock 
and Foreign Agriculture] presiding.
    Representatives present: Representatives Costa, Plaskett, 
Delgado, Hayes, Schrier, Panetta, Harder, Axne, Carbajal, Rush, 
Lawson, Craig, Johnson, Baird, DesJarlais, Hartzler, Crawford, 
Davis, Kelly, Bacon, Hagedorn, Jacobs, Mann, Feenstra, 
Fischbach, Moore, Letlow, and Thompson.
    Staff present: Lyron Blum-Evitts, Malikha Daniels, Prescott 
Martin III, Caleb Crosswhite, Ricki Schroeder, Patricia 
Straughn, Erin Wilson, and Dana Sandman.

   OPENING STATEMENT OF HON. JIM COSTA, A REPRESENTATIVE IN 
                    CONGRESS FROM CALIFORNIA

    Mr. Costa. I call to order the joint hearing of the 
Subcommittee on Livestock and Foreign Agriculture and the 
Subcommittee on Biotechnology, Horticulture, and Research. And 
we will come to order, and I want to thank all the Members, and 
those who are participating via Zoom, on this joint 
Subcommittee hearing. After opening brief remarks, Members will 
receive testimony from today's witnesses, and then, as we do 
pro forma, we will allow Members to ask questions. You will 
have your allocated 5 minutes, alternating between Majority and 
Minority Members, as we always do, and you will be recognized, 
and in this day of Zoom, we all have to remember not only to 
unmute our microphones so that we can make our comments heard, 
or ask our questions, but just as importantly, as we have all 
had to painfully learn, to mute your microphones when you are 
not presenting, and maybe having a sidebar conversation of 
sorts, because we don't need that necessarily to become a part 
of the formal hearing. So I just want to remind all of us, 
maintain muted to minimize background noise, and I hope to get 
to as many questions as possible.
    Let me make my opening statement by saying good morning to 
everyone again. I want to thank both Chair Plaskett and Ranking 
Members Johnson and Baird, and other Subcommittee Members from 
both Subcommittees. We know that biotechnology is a critical 
subject, with lots of potential in solving some of our most 
pressing issues as we try to ensure that we maintain our 
competitiveness in terms of trade, but investing in research 
and streamlining our regulatory system to help facilitate what 
America has traditionally done, which has led the world in 
terms of the transformation of our ability to produce food and 
fiber in the most nutritious fashion, in the most cost-
effective way, that has allowed us not only to feed our nation 
for all American consumers every day, but also to allow us to 
export to feed parts of the world.
    And we know that with climate change, these challenges 
become greater, and I would like to hearken back to, we are 
talking a lot about infrastructure here the last several 
months, and how we invest in America's infrastructure. And, 
when you talk about agriculture, and we remember our history, 
two meaningful pieces of legislation were signed a long time 
ago, when President Lincoln was trying to keep the country 
together during the Civil War, perhaps our most divided moment 
in America's history. And on July 1, he signed the Act that 
created the transcontinental railroad to bind the nation from 
coast to coast, but the very next day, July 2, he signed the 
Morrill Act that created land-grant universities, and I think 
that is not traditionally seen as infrastructure, but land-
grant universities have been part of America's ability to 
maintain its cutting edge in technology, and how much that has 
transformed our ability to be so successful.
    Throughout our history farmers have researched ways to 
optimize their ability to produce livestock and crop 
production, and over the past few decades, but even further 
back, going back to the development of our land-grant 
university system, working with the private-sector, we have 
been able to figure out ways to grow more sustainable food at a 
faster rate, and therefore it is incumbent upon us, as 
policymakers, to ensure that we take advantage of the latest 
cutting-edge technology, because with climate change we know--
just last week the Department of Defense highlighted 13 
countries in the world in which water allocation is going to be 
so critical that their ability to maintain stability in those 
countries is going to be a question mark.
    And so, whether it is biotechnology, more drought-resistant 
plants, or whether it is technologies to use water more 
efficiently, are all part of what we have to do. The staggering 
drought that we have having in the West is a reflection of 
these changes in climate. And in California we are seeing 
drought conditions that we have not seen since 1976 and 1977, 
and so I am very familiar, as a third-generation farmer in 
California, the consequences, so I am very interested in 
innovative solutions that the panel will provide today. The 
testimony of our witnesses provides us opportunities to learn 
of new technological advancements in light of climate change, 
and how we optimize the use of our water. As we like to say in 
California, where water flows, food grows.
    So while I believe we must address the underlying problems 
that are involved in climate change, and we are hoping to do 
that as a part of this infrastructure package, we also need to 
begin to adapt to other changing conditions, and we need to 
look at the experts on how we can do a better job down the 
road. And, whether we are talking about at home or abroad, 
changing populations and straining our food systems, we see how 
supply chain shocks impact our ability to put food on America's 
dinner table. When you close restaurants and schools, as we did 
last spring, you take a complex, complicated food supply chain 
and you turn it upside down. And we are dealing with the 
consequences of that.
    And then we see--well, obviously we must strengthen supply 
chains when we see the circumstances in our ports and harbors, 
and the bottlenecks that have taken place in recent months, how 
more difficult it is, in fact, to make that supply chain 
operate in a way that reflects our needs of our country, and 
who we trade with around the world. So there are a lot of 
impacts here, there is a lot of complexity, and I think this 
hearing will help us focus on a number of these issues. I look 
forward, again, to hearing with the four experts that bring a 
wealth of knowledge in biotechnology and agriculture. Their 
testimony will provide important information.
    [The prepared statement of Mr. Costa follows:]

Prepared Statement of Hon. Jim Costa, a Representative in Congress from 
                               California
    Good morning. To start I'd like to thank our witnesses, Chair 
Plaskett, Ranking Members Johnson and Baird and the other Members of 
the Subcommittees. Agricultural biotechnology is a critical subject 
with lots of potential for solving some of our most pressing issues. 
Through opening trade, investing in research, and streamlining our 
regulatory system we can help facilitate the use of biotechnology to 
address threats like food scarcity and climate change. Throughout 
history farmers have searched for ways to optimize their livestock and 
crop production through selecting for the most favorable traits. Over 
the past few decades scientific advancement has given us an opportunity 
to safely grow more sustainable food at a faster rate. It is incumbent 
upon us as policy makers to understand how technological advancement 
can benefit our food system and create new avenues for promoting the 
use of biotechnology in novel settings.
    Just this year we have seen staggering drought as a result of 
climate change. Being from California, I am very familiar with the 
consequences of extreme drought and I am always interested in 
innovative solutions. In their testimony some of our witnesses will 
discuss the potential for biotechnological advancements to help address 
the effects of climate change, specifically through optimizing water 
use. While I believe we must address the underlying problems that are 
causing climate change, it is also necessary for us to begin to adapt 
to changing climate conditions. I look forward to hearing more from our 
experts on how biotechnology can be used to address climate change and 
what sorts of innovations are on the horizon that may help us create a 
more sustainable, less water intensive agricultural system.
    Another challenge where I believe biotechnology has a significant 
role to play is food security. Both at home and abroad changing climate 
conditions, the economic impacts of the pandemic, and growing 
populations are straining our food system. While not a silver bullet, 
biotechnology is an important tool that can help our food system 
increase its resilience to a changing world. For many years I have 
worked closely with our international food assistance programs and I 
believe that if farmers have access to innovation and sound 
information, they'll be able to reduce hunger around the world.
    An important aspect of progress in agricultural biotechnology is 
acceptance by consumers both domestically and abroad. We have a 
stringent regulatory process that does an exceptional job of 
guaranteeing the safety of any product created using biotechnology. 
Trust in those systems is vital to ensuring that we can realize the 
benefits that biotechnology has to offer. I look forward to hearing 
from our witnesses on how they believe we can increase the acceptance 
of these products in foreign markets.
    We have before us four experts in their fields that bring a wealth 
of knowledge on biotechnology in agriculture. Their testimony will 
provide us with important information about the various applications 
for biotechnology and what needs to be done to catalyze innovation. 
Before the introduction of our witnesses, I'd like to recognize the 
Ranking Member, Mr. Johnson of South Dakota, for any remarks he'd like 
to make.

    Mr. Costa. So now I would like to defer to the Ranking 
Member from South Dakota, Mr. Johnson, for any opening remarks 
that he would like to give, and then our Subcommittee Chair 
from the wonderful U.S. Virgin Islands, Stacey Plaskett, will 
have her opening statement, with her Ranking Member as well. 
So, Representative Johnson from South Dakota, please--you have 
the floor.

 OPENING STATEMENT OF HON. DUSTY JOHNSON, A REPRESENTATIVE IN 
                   CONGRESS FROM SOUTH DAKOTA

    Mr. Johnson. Thank you very much, Mr. Chairman, and I agree 
with Ms. Plaskett, it is good to see G.T., and good to see you 
looking well, Mr. Ranking Member. I think it is good we are 
doing this hearing together, because clearly technological 
advances, innovation, they have had a tremendous impact on 
livestock and on horticulture, and we are going to get a lot 
more done together than we would separately, so thank you to 
both Chairmen for making this happen.
    There is a moral and a technological issue that is facing 
this Committee and society, how are we going to feed a growing 
world at the same time that we work to be good stewards of our 
environment? I suspect you all know the numbers. The United 
Nations Population Division expects there will be nearly ten 
billion people on this planet by the year 2050, and we are 
called to feed the world. But, we are not going to succeed 
without innovation, without technology, embracing innovation 
and technology. We will increase yields, we will reduce our 
carbon footprint, we will improve animal welfare, and, again, 
we are only going to do these things by embracing ingenuity, 
progress, and innovation.
    And agriculture has a positive story to tell. It is 
innovation that has allowed our producers to produce more food 
with fewer resources. And certainly livestock producers in 
South Dakota and elsewhere have been doing that by adopting 
things like genetically advanced EPDs, IVF and embryo transfer, 
as well as extensive artificial insemination to increase 
profitability and the efficiency of the genetics, which are so 
critically important. But the technology is advancing even 
further, though. We have a tendency so often, when we are 
talking about technological improvements in ag, to focus on 
crops, and there has been a lot there, but I would tell you 
that the pace of change is accelerating on the livestock side 
as well, from disease-resistant pigs to polled Holstein cattle, 
these innovations have the potential to vastly improve the 
production landscape.
    So I look forward to hearing from our panel on what is and 
what is not working with our current laws and regulations. For 
example, where we stand on efforts like the implementation of 
the National Bioengineered Food Disclosure Standard, and views 
on how the coordinated framework can, and should be, applied to 
GE livestock, and any other evolving regulatory hurdles. Making 
progress on these issues will also require an international 
approach, and, Madam Chair and Mr. Chairman, as I close, let us 
just be frank. There are too many in this world who cast doubts 
on science as a tool, and they actively lobby international 
institutions to adopt their anti-innovation agenda. And I look 
forward to working with this Committee in a bipartisan way to 
ensure that the United States maintains a science-driven 
regulatory system, and that we actively advocate that position 
abroad. That is going to mean a lot of consumer education. It 
is also going to mean working through trade agreements and 
relationships so that we can maintain internationally a 
predictability on standards that our producers need to feed the 
world, and be good stewards of the environment.
    So with that, Mr. Chairman, I look forward to working with 
you and all others on the Committee on these issues. Thank you, 
and I yield back.
    Mr. Costa. Well, I thank the gentleman, and I couldn't 
agree with you more. I think that a strong science-based 
regulatory framework is what we need to do to have an 
international standard that we can all comply with. I think 
phytosanitary standards, not only in this country, but around 
the world, need to be shared and respected, but I feel that way 
on all bases. I think public health needs to be science-based 
as well, and I just get very frustrated when I see some people 
ignoring the importance and the success that science has 
allowed us to make such important progress on.
    Having said that, I am so excited to have our Subcommittee 
Chair, Ms. Plaskett from the U.S. Virgin Islands, who I have 
had the pleasure to work with over the years, and she chairs 
the Biotechnology, Horticulture, and Research Subcommittee, for 
opening remarks that I know that she has. And, Ms. Plaskett, 
the floor is yours.

  OPENING STATEMENT OF HON. STACEY E. PLASKETT, A DELEGATE IN 
                  CONGRESS FROM VIRGIN ISLANDS

    Ms. Plaskett. Thank you, Mr. Chairman. Well, this looks to 
be a very informative hearing today, as we discuss the 
advancements and application, excuse me, of agricultural 
biotechnology. Thank you, Mr. Costa, Chairman of the 
Subcommittee on Livestock and Foreign Agriculture Subcommittee, 
in convening this hearing, and sharing your expertise. This 
sort of collaboration will help us all--excuse me, all view our 
work on the Agriculture Committee through a broader lens, and 
facilitate more holistic conversations as we look ahead to the 
next farm bill. Today's hearing will be an opportunity for 
Members to learn and evaluate the regulatory framework of 
agriculture biotechnology, and engage with experts in plant and 
animal agricultural innovation.
    I look forward to hearing updates on innovation coming down 
the pipeline, as well as what we on the Agriculture Committee 
can be doing to ensure these innovations are getting into the 
right hands to produce a more resilient food supply, and 
generate opportunities in our agricultural communities. I would 
like to highlight the exciting research that is going on in my 
district, in the University of the Virgin Islands Agricultural 
Experiment Station, in working on vital biotechnology research 
in traditional Caribbean crops such as papaya, passion fruit, 
pineapple, casaba, sweet potato varieties, and more.
    This important research is working to develop varieties of 
crops that are disease resistant, better adapted to local soil 
types, and provide a multiple of other benefits. I would also 
like to, at this time, submit for unanimous consent the 
following letter by the agricultural stakeholders' community 
for the record.
    Mr. Costa. Hearing no opposition, the information will deem 
accepted.
    [The letter referred to is located on p. 64.]
    Ms. Plaskett. Thank you. Again, I look forward to having an 
informative and productive dialogue today, and to working with 
the Chairman and both Ranking Members here as we continue this 
discussion. And with that, Mr. Chairman, I yield back.
    [The prepared statement of Ms. Plaskett follows:]

 Prepared Statement of Hon. Stacey E. Plaskett, a Delegate in Congress 
                          from Virgin Islands
    Hello, and welcome to what is sure to be an informative hearing 
today as we discuss the advancements and applications of agricultural 
biotechnology.
    Thank you, Mr. Costa, Chairman of the Subcommittee on Livestock and 
Foreign Agriculture Subcommittee, for your partnership in convening 
this hearing and sharing your expertise. This sort of collaboration 
will help us all view our work on the Agriculture Committee through a 
broader lens and facilitate more holistic conversations as we look 
ahead to the next farm bill.
    Today's hearing will be an opportunity for Members to learn and 
evaluate the regulatory framework of agricultural biotechnology and 
engage with experts in plant and animal agricultural innovation.
    I look forward to hearing updates on innovations coming down the 
pipeline, as well as what we on the Agriculture Committee can be doing 
to ensure these innovations are getting into the right hands to produce 
a more resilient food supply and generate opportunities in our 
agricultural communities.
    I would also like to highlight the exciting research that is going 
on in my District--the University of the Virgin Islands Agriculture 
Experiment Station is working on vital biotechnology research into 
traditional Caribbean crops such as papaya, passion fruit, pineapple, 
cassava, sweet potato varieties, and more. This important research is 
working to develop varieties of crops that are disease resistant, 
better adapted to local soil types, and provide a multitude of other 
benefits.
    Again, I look forward to having an informative and productive 
dialogue today, and to working with the Chairman and both Ranking 
Members here today as we continue this discussion. And with that Mr. 
Chairman, I yield back.

    Mr. Costa. Thank you very much, Subcommittee Chair, for 
those insightful comments, and I share your enthusiasm for this 
morning's two Subcommittee joint hearings, I should say. Mr. 
Baird, you are recognized for any opening remarks you would 
like to give.

  STATEMENT OF HON. JAMES BAIRD, A REPRESENTATIVE IN CONGRESS 
                   FROM THE STATE OF INDIANA

    Mr. Baird. Good morning, and I want to thank you, Mr. 
Chairman, and Chair Plaskett, for calling this hearing today. I 
appreciate our friends from the Livestock and Foreign 
Agriculture Subcommittee for also joining us for this 
discussion, and I am very excited to see our Subcommittees have 
the opportunity to discuss this incredibly important topic. I 
am also happy to see our Ranking Member G.T. Thompson with us 
as well. And, I really want to thank our witnesses for joining 
us today for this dialogue. I look forward to hearing from each 
one of them about the extensive work and research that they 
have done in this field, and I want to hear from them their 
vision of the future for biotechnology, and how we can better 
serve and improve this technology, moving forward.
    From my perspective, biotechnology is the future of 
agriculture, and the future of food security for our changing 
planet. It has the ability to reshape the direction of our 
industry, and our world, as we strive to advance the 
sustainability of agriculture, improve animal health and well-
being, and it plays a role in all the efforts to feed, clothe, 
and fuel our ever-changing planet.
    However, this can only be the case if we are able to take 
advantage of this technology, and allow innovation to happen. 
At the present time, I don't think our regulatory system is 
keeping up with the technology of the products that are being 
developed from this industry, and so our system needs to 
improve, and become more rapid about approving biotechnology 
products. So I look forward to our conversation this morning 
between our guests and colleagues, and truly hope that this 
hearing will be a fruitful exercise, guiding future debate, 
legislation, and regulatory changes.
    I value this as an opportunity to hear directly from the 
industry and academia about our current regulatory framework, 
how the system does or doesn't work, and how we can balance 
what industry needs to make this technology successful against 
an important need for consumer trust and confidence. I hope to 
hear about upcoming changes to these regulatory frameworks, and 
what benefits and challenges they may bring to the industry 
rulemaking like the SECURE (Sustainable, Ecological, 
Consistent, Uniform, Responsible, Efficient) Rule, the National 
Bioengineered Food Disposure Standard, and rulemakings on the 
horizon like FDA's guidance on gene editing plants, EPA's PIP 
(Phenol, Isopropylated Phosphate) Rule, and USDA's ANPR on 
animal biotechnology.
    Ms. Plaskett and I recently sent a letter to USDA, 
encouraging all involved to take advantage of this tremendous 
opportunity to shape the industry, and I look forward to 
hearing directly from our stakeholders to what extent we can 
take advantage of this technology. So far, in the commercial 
life of these products, interagency cooperation has had a 
tremendous impact on the success, or lack thereof, for biotech 
products. I hope that our witnesses today will share with us 
their experiences and thoughts regarding this cooperation, and 
how this process can be improved.
    As we continue to work domestically on how best to bring 
current and future biotech advancements to market, it is 
tremendously important that we keep an eye on, and actively 
participate, in how our trade partners, particularly those with 
large impacts on the demand for U.S. ag products, advance their 
own regulations for these products. We must continue to ensure 
that these partners continue to regulate on the basis of 
science and risk, not speculation and fear, and ultimately 
ensure that we don't inadvertently innovate ourselves out of 
the global marketplace.
    As I have mentioned many times before, I have a real 
passion for agriculture, and for better understanding the 
opportunity that surrounds innovation and technology in our 
industry. At a time when technology continues to quickly 
advance, our policy must be able to keep up an effort to ensure 
safety, transparency, and fairness in the marketplace. I truly 
hope that today's conversations will shed additional light on 
what this policy should look like in the ideal world, and I 
look forward to today's conversation, and really appreciate the 
opportunity to engage, and to hear from such talented 
stakeholders. Thank you all again, and with that, Mr. Chairman, 
I yield back.
    Mr. Costa. I thank the gentleman from Indiana for his 
comments, and, as is customary when Subcommittees hold hearings 
or meetings, we always afford the opportunity for the Chairman 
of the full Committee, or the Ranking Member of the full 
Committee, to make any comments that they might like to make, 
and it is my understanding Chairman Scott is unable to be here 
at this point in time, although if he joins us later on, we 
will certainly love to hear his comments or thoughts. I do see 
the Ranking Member of the full Committee, Representative G.T. 
Thompson from Pennsylvania. And if the Ranking Member would 
like to make some comments at this time, we certainly would 
afford him that opportunity.

 OPENING STATEMENT OF HON. GLENN THOMPSON, A REPRESENTATIVE IN 
                   CONGRESS FROM PENNSYLVANIA

    Mr. Thompson. Well, Mr. Chairman, thank you so much. Thank 
you for this hearing. First of all, just thank you for all the 
well wishes, thoughts, prayers, the texts. It is great to work 
with such a great farm team that works hard for the best 
interests of rural America, and those folks who work so hard 
each and every day to provide us our food, our fiber, our 
building resources, and our energy. Thank you to you, Chairman 
Costa, Chair Plaskett, Ranking Member Johnson, and Ranking 
Member Baird, for holding a hearing on this exciting topic. I 
will say, Chair Plaskett, you made me hungry when you were 
going down that list of great agricultural products that you 
all produce. And I want to say thank you to our distinguished 
panel of witnesses for agreeing to participate, and share your 
expertise.
    If appropriately embraced, agriculture biotechnology holds 
tremendous promise for addressing many of the challenges facing 
our nation, and namely the challenge of sustainably feeding a 
rapidly growing population. We all know this, and this hearing 
is important because it puts it on record, American agriculture 
is about science, technology, and innovation. That is what it 
always has been about, since those very first early days. It 
was crude, it was rudimentary; but, and the reason settlers 
worked through it was just so their family could live through 
another season.
    But today it is so much more sophisticated, and, if 
embraced, there is so much more that we can do with it. I look 
forward to hearing from each of you about the promising 
advancements on the horizon. I also look forward to your 
perspectives on any hurdles that may be getting in our way, 
whether that be cumbersome regulation, conflicting 
international standards, a lack of consumer knowledge and 
acceptance of technologies, or, quite frankly, government 
bureaucracy that is resistant to adopting this science, 
technology, and innovation.
    The United States has long been a leader in agriculture 
innovation, and to maintain that competitive edge, it is 
important that our nation's policies don't inadvertently hamper 
innovation domestically, and ultimately drive that important 
work overseas. Now, thankfully, the modernization of the 
regulatory framework for biotechnology has been a bipartisan 
effort spanning multiple Administrations, multiple generations, 
and I am very pleased at the progress made under the Trump 
Administration, from the Executive Order regarding agriculture 
biotechnology products, the USDA SECURE Rule, updating plant 
technology regulations for the first time in 30 years, to the 
advance notice of proposed rulemaking on much-needed reforms to 
the regulation of genetically engineered animals. I remain 
hopeful the current Administration will continue listening to 
the needs of the agriculture community as it works to build off 
that important work.
    Now, again, thank you all for being here. I look forward to 
today's conversation. With that, I yield back.
    Mr. Costa. Well, we thank the gentleman from Pennsylvania, 
and wish you a quick recovery, and hope to see you next week. 
With those opening statements concluded, we now move into the 
real purpose of the hearing, and that is to listen to some of 
the distinguished guests that we have who are experts in their 
field. We have four witnesses on the panel this morning, and we 
want to thank them for their time and their efforts to provide 
their presentation to the two Subcommittees.
    Let us begin with our first witness, Dr. Fan-Li Chou, who 
is the Vice President of Scientific Affairs and Policy for the 
American Seed Trade Association. Remember to keep your 
microphones muted, my fellow colleagues, because it works a lot 
better that way, unless you are recognized. So, without further 
ado, Dr. Fan-Li Chou, we look forward to hearing your comments 
this morning, and you have 5 minutes, and the clock will begin 
on your opening statement.

STATEMENT OF FAN-LI CHOU, Ph.D., VICE PRESIDENT FOR SCIENTIFIC 
     AFFAIRS AND POLICY, AMERICAN SEED TRADE ASSOCIATION, 
                        WASHINGTON, D.C.

    Dr. Chou. Thank you. Good morning, Chair Plaskett, Chairman 
Costa, Ranking Member Thompson, Ranking Member Baird, Ranking 
Member Johnson, and the Members of the Subcommittees. I am so 
pleased to be here representing ASTA's nearly 700 member 
companies at today's hearing. Our members produce everything 
from grass and turf seed, to row crop seed, to vegetable and 
ornamental seed, to true potato seed for conventional, genetic 
engineered, and organic seed markets. ASTA has been around 
since 1883, so as we consider the current advances in 
agricultural biotechnology, and look forward to the 
applications in the 21st century, I think it is worthwhile to 
reflect on the common thread that runs from 1883 to now, and 
that common thread is plant breeding.
    So plant breeding has been around since our ancestors 
domesticated crops, but in the last several decades plant 
scientists and plant breeders have accumulated an impressive 
collection of tools to unlock the genetic potential of plant 
crops, and using these tools, we have safely and reliably 
introduced into the food system hundreds of thousands of new 
plant varieties over the last century. In the 21st century we 
are all facing critical challenges to our agricultural food 
system. Climate change, a rapidly growing global population, 
environmental degradation. The need for new, improved plant 
varieties is more pressing than ever. But thankfully, plant 
breeders have an unprecedented number of tools to drive 
solutions. The most exciting of late is gene editing.
    So in agriculture, gene editing is an enabling tool. It 
supports, rather than supplants, the fundamentals of plant 
breeding. It enables our plant breeders to leverage the decades 
of accumulated scientific discoveries and understanding of 
plant genetics to increase the accuracy, the precision, and the 
efficiency of plant breeding. Gene editing has been used across 
all crops, including specialty crops, and by breeding programs 
of all sizes, including public universities and small 
companies. We are using gene editing to work within the plant's 
genetic family, similar to what is done in conventional 
breeding, or can occur in nature.
    So let me share a few examples. Some non-browning varieties 
are being developed for fruits and vegetables, like potatoes, 
avocados, and lettuce. For potatoes alone, non-browning 
varieties could eliminate 1.5 billion pounds of wasted 
potatoes. We are working on water efficient crops, from 
lettuce, to wheat, to rice. We are using gene editing to 
discover cover crops that can be cash crops, bringing both 
environmental and economic benefits. It is used to encourage 
healthy eating, modifying soybeans so it is heart healthy, to 
make berries more consistent and more available to consumers. 
And many of these examples are based on public and private 
partnerships. But whether these examples, and others like them, 
and the tremendous benefit they can provide, becomes widely 
available would depend in part on research investment, and more 
notably, on the policy and regulatory environment in the U.S., 
and around the world.
    At ASTA, we commend the regulatory improvement that USDA 
has made in its final rule for biotech regulation that was 
published in May 2020. That final rule recognizes the 
longstanding safety record associated with plant breeding, and 
extends to certain types of plants that could have been done 
through conventional breeding, or occur through nature, and we 
look forward to working with USDA to implementing the various 
elements of that final rule. We also appreciate the proposed 
rules by EPA, and we look forward to the leadership by EPA's 
Administrator in getting that rule to the finish line. Finally, 
we are awaiting clarifying guidance from FDA. It is critical 
that these three agencies are consistent and coordinated in 
their policy approach.
    In closing, the 21st century is looking right at us. We are 
in the middle of it. We have the tools to develop solutions to 
the challenges facing our food system. But to ensure those 
tools are widely accessible across all crops, across operations 
of all sizes, production methods, and geography, it is 
important to maintain strong investment in plant breeding 
research, and for domestic and international policies to be 
clear, risk-based, risk-proportionate, science-based, and 
harmonized. Otherwise, innovation would be limited to a very 
few crop varieties, and the benefits would never be fully 
realized across the broad agricultural sector. I really 
appreciate the opportunity to share my thoughts with you today, 
and I will be happy to take any questions, and I look forward 
to the discussion. Thank you.
    [The prepared statement of Dr. Chou follows:]

Prepared Statement of Fan-Li Chou, Ph.D., Vice President for Scientific 
 Affairs and Policy, American Seed Trade Association, Washington, D.C.
    Good morning, Chair Plaskett, Chairman Costa, Ranking Member Baird, 
Ranking Member Johnson, and Members of the Subcommittees. I am Fan-Li 
Chou, Vice President of Scientific Affairs and Policy at the American 
Seed Trade Association (ASTA). Prior to joining ASTA, I served for over 
a decade at USDA, including as the Agricultural Biotechnology Advisor 
to the Office of the Secretary and in positions with the Foreign 
Agricultural Service and the Animal and Plant Health Inspection 
Service. I am pleased to be here today to discuss Agricultural 
Biotechnology: 21st Century Advancements and Applications.
    Founded in 1883, the ASTA represents nearly 700 member companies 
involved in seed production and distribution, plant breeding, seed 
treatment and related industries in North America. The U.S. seed 
industry is highly specialized and diversified with hundreds of 
varieties per crop species. ASTA's member companies produce everything 
from grass and turf seed to row crop seed, to vegetable, ornamental and 
flower seed, to true potato seed--for conventional, genetically 
engineered, and organic seed markets.
    My remarks today will focus on plant breeding's impact to each of 
us, to our economy and to our environment. The importance of plant 
breeding innovations, including agricultural biotechnology such as 
genome editing; and actions needed to fully realize the real-world 
benefits of plant breeding innovation.
    Plant breeding is not new, it dates back thousands of years to when 
people first domesticated wild plant varieties. Over time, plant 
breeders have accumulated an impressive collection of tools, such as 
cross breeding, selection, hybridization, induced mutagenesis, 
biotechnology and molecular markers to unlock the genetic potential of 
plant crops. Using these breeding tools, the plant breeding community, 
both the public and private sides, have safely and reliably introduced 
to the food system hundreds of thousands of new plant varieties over 
the past century. To be commercially released, new plant varieties, 
regardless of the breeding tools used, are subjected to strict, 
multiyear, multi-location evaluation and assessment for quality and 
performance.
    We have all benefited from, and continue to benefit from, the 
innovations of plant breeding. The food we eat, the clothes we wear, 
the fuel that powers our cars--all these things and more start with a 
seed in the ground. New plant varieties have enriched our lives, by 
increasing our food choices, for example seedless grapes, easy-peel 
citrus, tastier tomatoes of all sizes and shapes, and snackable 
peppers; by beautifying our landscapes with ornamental varieties 
adapted to all seasons and geographies.
    New varieties developed from plant breeding allow our farmers to 
produce more using fewer inputs. According to USDA Economic Research 
Service's report on Agricultural Productivity in the U.S., since 1948, 
domestic agriculture productivity nearly tripled. While some of the 
gains can be attributed to better management practices, some experts 
estimate that improved varieties account for more than a 50 percent 
productivity gain. This is because new varieties are bred to be more 
productive, more disease and pest resistant, and better adapted to 
environmental stresses such as drought and excess water.
    Our economy has benefited and continues to benefit from plant 
breeding. The U.S. seed market was valued at $14.51 billion in 2020, 
which is about 25% of the global seed market. In 2020, U.S. planting 
seed exports exceeded $1.6 billion to 144 countries. Our industry 
enjoys the global reputation of providing seed with the highest quality 
assurance standards and the most innovative technologies and genetic 
resources.
    In the 21st century, we are facing the convergence of critical 
challenges to the agricultural food system: climate change, rapidly 
growing global population, expansion of the global middle class, 
environmental degradation, and biodiversity loss. The need for improved 
plant varieties is more pressing than ever. Thankfully, plant breeders 
have an unprecedented number of tools to work with. The most exciting 
of late is gene editing.
    In agriculture, gene editing is an enabling tool, supporting, 
rather than supplanting, the fundamentals of plant breeding. Gene 
editing enables plant breeders to leverage the decades of accumulated 
scientific discovery and understanding of plant genetics, its natural 
variability, and its interaction with the environment, to increase the 
accuracy, precision, and efficiency of plant breeding. One of the most 
exciting developments around gene editing and agriculture is that we 
see it being used across all crops, including specialty crops, and by 
breeding programs of all sizes, including the public- and private-
sectors. Plant breeders are using gene editing to create genetic 
variability within the plant's own genetic family, similar to what 
could be achieved with conventional breeding or could occur in nature.
    Let me share a few examples of how gene editing could be used in 
plant breeding to help drive solutions to the growing pressures of 
climate change, food and nutritional security, and sustainability.
    Bruised and browning produce are a top contributor to food waste in 
restaurants and grocery stores. Research shows shoppers avoid 
purchasing bruised produce, even if the vegetables are perfectly 
healthy and taste fine. And in restaurants, produce prepped before the 
dinner rush often need to be thrown out at the end of the night because 
of their brown color. Using innovations like gene editing, plant 
breeders are unlocking the code to make potatoes more resistant to 
bruising and browning. The new non-browning characteristic could 
eliminate 1.5 billion pounds of wasted potatoes, translating to 
resources saved. The same application is being applied to other 
produce, from mushrooms to apples and avocadoes.
    With 70% of the world's freshwater used for agriculture, reducing 
the amount of water needed to grow food could have a significant 
environmental impact. Plant breeders are using gene editing to develop 
new, water-efficient varieties of crops. For example, lettuce struggles 
in the heat. But promising research is showing that gene editing can be 
used to develop lettuce varieties that have the same heat tolerance as 
certain wild relatives, with the same taste and nutritional value as 
the lettuce we enjoy today. Drought tolerant varieties are also under 
development for wheat and rice.
    Gene edited is being employed to develop plant varieties that can 
better support carbon capture. Gene edited crops with stronger, deeper 
roots can capture carbon and sequester it in the soil for longer 
periods of time. Gene editing and plant breeding will also expand 
farmer choices in cover crops, as well as developing cover crops as a 
source of income for farmers. With funding from the USDA National 
Institute for Food and Agriculture, a consortium of university 
researchers from Illinois, Minnesota, Ohio, and Wisconsin, as well as 
start-up company CoverCress, have used gene editing to develop a cover 
crop, pennycress, with edible oil and meal, bringing environmental, as 
well as economic, benefits to the farmers.
    Gene edited plants can support healthy eating. Calyxt, company that 
was founded by a University of Minnesota professor, commercialized a 
variety of soybean that has been gene edited so that its oil is heart 
healthy, with a similar composition to olive oil. The same company is 
working on wheat varieties with higher protein and fiber, and less 
gluten. Pairwise, a startup food and tech company that uses gene 
editing to develop new varieties of fruits and vegetables, is part of a 
collaboration with USDA ARS and others to identify and characterized 
genetic diversity in berries. The outputs from this collaboration will 
be used to bring new and better berries to producers, and to make 
berries more consistent and more available to consumers.
    The 21st century is an exciting time for plant breeding and for 
plant breeders and plant scientists. We are faced with unprecedented 
challenges, yet we are equipped with extraordinary tools and scientific 
understanding to find solutions. A continued and robust investment in 
public sector agriculture research is needed. The work of the public- 
and private-sectors complements each other. The public sector's role is 
critical in fundamental research, germplasm collection and maintenance, 
addressing emerging plant diseases and pests, and training of our 
future breeders and scientists. The strength of the seed industry is 
taking a promising concept to market, to shoulder the expensive and 
time-consuming process of delivering high performing plant products to 
farmers around the world.
    In addition to these groundbreaking examples of public-private 
partnerships in gene editing, a long-standing example of public-
private-sector collaboration is the Germplasm Enhancement of Maize 
project, or GEM. GEM is a cooperative effort of the USDA ARS, land-
grant universities, and the seed industry. Similarly, on the specialty 
crop side, the close collaboration between seed companies and 
University of California Davis (UC Davis), has resulted in identifying 
key pre-commercial research priorities. Seed Central at UC Davis 
provides a networking forum that facilitates the public-private 
collaborations often needed to shift these pre-commercial research 
priorities to commercial applications.
    As I previously mentioned, plant breeding innovation, like gene 
editing, is currently being researched and used across a vast array of 
plants, including fruits, vegetable, and ornamentals, what we consider 
specialty or small acreage crops. Whether these crops--and the 
tremendous benefits they can provide--will become widely available will 
depend in part on research investment and more notably on the policy 
and regulatory approach.
    Numerous Administrations, across more than 3 decades, have 
consistently agreed on the foundational principles and policies for 
effective and efficient regulatory oversight. These principles were 
articulated in the 1993 Executive Order (EO) Regulatory Planning and 
Review and reiterated in the 2011 EO Improving Regulation and 
Regulatory Review.[1]-[2] Specifically, for emerging 
technologies such as agricultural biotechnology, the foundational 
principles of effective and efficient regulatory oversight were 
reaffirmed in the 2011 Memorandum Principles for Regulation and 
Oversight of Emerging Technologies, the 2015 Memorandum Modernizing the 
Regulatory System for Biotechnology Products, and the 2019 EO 
Modernizing the Regulatory Framework for Agricultural Biotechnology 
Products.[3]-[5]
    In advancing innovation in agriculture, the stated policy goals are 
that regulatory oversight must ``ensure the fulfillment of legitimate 
objectives of protection of safety, health, and the environment'' and 
``avoid unjustifiably inhibiting innovation, stigmatizing new 
technologies, or creating trade barriers''.[3] Regulatory 
agencies are to, among other things:

   Identify and consider all regulatory alternatives, including 
        the alternative of not regulating.

   Regulate only when there is a significant problem that is 
        best solved by regulation, and where the benefits of regulation 
        justify the costs.

   If regulation is warranted, it should be commensurate with 
        the risk, and ``avoid arbitrary or unjustifiable distinction 
        across like products developed through different technology''.

   Base regulatory decisions on the best available scientific 
        and technical information.

   Provide sufficient flexibility to accommodate new evidence 
        and learning, and review regulations on a regular basis to 
        ensure they continue to meet the regulatory objectives in the 
        least burdensome way.

   Use clear language and provide opportunity for stakeholder 
        and public involvement.

   Promote interagency coordination and harmonization; avoid 
        interagency duplication and inconsistency.

   Promote international coordination to minimize trade 
        impacts.

    With regards to products of plant breeding innovation such as gene 
editing, I also note the commitments for agencies to provide regulatory 
clarity in the 2016 National Strategy for Modernizing the Regulatory 
System for Biotechnology Products and the 2019 EO Modernizing the 
Regulatory Framework for Agricultural Biotechnology 
Products.1-2  
---------------------------------------------------------------------------
    \1\ https://obamawhitehouse.archives.gov/sites/default/files/
microsites/ostp/biotech_national_
strategy_final.pdf.
    \2\ https://www.federalregister.gov/documents/2019/06/14/2019-
12802/modernizing-the-regulatory-framework-for-agricultural-
biotechnology-products.
---------------------------------------------------------------------------
    ASTA commends the regulatory improvements USDA made in the Final 
Rule for biotechnology regulation, published in May 2020. The Final 
Rule reflects the over 30 years of regulatory experience accumulated by 
USDA, recognizes the longstanding safety record associated with plant 
breeding, and exempts types of plants that could be developed through 
conventional breeding or occur in nature. As USDA proceeds in 
implementing the various elements in the Final Rule, we believe it is 
imperative for the plant breeding community to be consulted to assure a 
smooth transition to the new processes and to mitigate against 
unintended barriers to smaller organizations and public sector 
institutions involved with the development of new crop varieties, 
especially specialty crops.
    ASTA appreciates the proposed rule published by the Environmental 
Protection Agency in December 2020, proposing exemptions of certain 
plant-incorporated protectants derived from newer technologies that are 
like those developed through conventional breeding. We look forward to 
Administrator Regan's leadership in shepherding the proposed rule 
revision to finalization and implementation.
    We eagerly await clarifying guidance on food derived from plant 
breeding innovation such as gene editing by the Food and Drug 
Administration. It is critical that these three agencies are consistent 
and coordinated in their policy approaches.
    One of the exciting things about gene-editing tools is the 
potential for widespread access across breeding programs of all sizes, 
including the public- and private-sectors, across all crops, and across 
farming operations of all sizes, production methods, and geographies. 
Federal and global policies will play a huge role in access to these 
products. It is important that policies be clear, and risk- and 
science-based; it's also important that there is harmonization across 
global policies--otherwise, innovation will be limited to very few crop 
varieties, and the benefits will never be fully realized across the 
agriculture sector. Appropriate policies can incentivize investments in 
plant breeding innovation, such as gene editing, creating new jobs and 
market opportunities, and boosting sustainability throughout the 
agriculture and food value chain.
    In conclusion, the 21st century food and agriculture system faces 
unprecedented challenges, from climate change to a growing population, 
and rapidly evolving pests and diseases. In order to maintain the U.S.' 
position as an economic world-leader in innovation, and to enable long-
term economic, social and environmental sustainability, we must make 
strong investments in plant-breeding research and ensure the alignment 
of science-based policies, at the domestic and global levels. Thank you 
for the opportunity to testify before you today. I'll be happy to take 
your questions.
 
 
                               [Endnotes]
 
    [1] https://www.archives.gov/files/federal-register/executive-orders/
 pdf/12866.pdf.
    [2] https://obamawhitehouse.archives.gov/the-press-office/2011/01/18/
 executive-order-13563-improving-regulation-and-regulatory-review.
    [3] https://obamawhitehouse.archives.gov/sites/default/files/omb/
 inforeg/for-agencies/Principles-for-Regulation-and-Oversight-of-
 Emerging-Technologies-new.pdf.
    [4] https://obamawhitehouse.archives.gov/sites/default/files/
 microsites/ostp/modernizing_the_reg_sys
 tem_for_biotech_products_memo_final.pdf.
    [5] https://www.whitehouse.gov/presidential-actions/executive-order-
 modernizing-regulatory-framework-agricultural-biotechnology-products/.
 


    Mr. Costa. Thank you very much, Dr. Fan-Li Chou, and I like 
your screensaver, it is a nice background. But we now move on 
to our next witness today, Dr. Elena Rice, Chief Scientific 
Officer for Genus plc. And Dr. Rice, please begin with your 
opening statement--the time clock there. We look forward to 
hearing from you.

STATEMENT OF ELENA RICE, Ph.D., CHIEF SCIENTIFIC OFFICER, GENUS 
                       plc, DeForest, WI

    Dr. Rice. Chairman Costa, Chair Plaskett, and Ranking 
Members Thompson, Johnson, and Baird, and Members of the 
Committee, my name is Dr. Elena Rice, and I am the Chief 
Scientific Officer of Genus plc. I also serve on the Board of 
the Biotechnology Innovation Organization's Agriculture and 
Environment Government Board. I am honored to testify before 
you today to discuss how innovation in animal breeding will 
help to protect our food supply, feed our growing population, 
and feed more healthy and sustainable food system.
    Genus plc is a world-leading animal genetics company. We 
are breeding better pigs and cattle so farmers can produce high 
quality meat and milk more efficiently and sustainably. Genus 
has a long history of leadership in research, development, and 
delivering porcine and bovine genetics, and we apply new ideas 
using gene editing, reproductive biology, and other breeding 
technologies to improve genetics for sustainable production in 
healthy and disease-resistant animals. Genus's R&D and ABS, our 
global bovine business, have headquarters in DeForest, 
Wisconsin, and PIC, our global porcine business, has 
headquarters in Nashville, Tennessee. Our firm belief is we 
need more science to improve animal health and welfare, and 
continue America's leadership in meeting global protein demand. 
Additionally, as climate change and zoonotic diseases present 
even greater risk today to animal and human health, and to our 
economy, more science is urgently needed to find mitigating 
solutions. I appreciate the opportunity to appear today because 
the innovative work being done by Genus, and others in the 
biotechnology and livestock industry, is so critical.
    Due to science and technology, we see livestock genetics, 
along with industry practices, reducing animals' carbon 
footprint. For example, the amount of feed needed for a pig to 
build body weight has fallen by nearly 60 percent over the last 
50 years. In dairy, 30 percent fewer cows today are producing 
76 percent more milk. Put simply, the animal footprint in the 
United States is going down, and in large part this is due to 
improved knowledge and application of innovative animal 
practices science and technology.
    Beyond these benefits, we see even great opportunity in the 
prevention of disease. Through Genus's gene editing program we 
have an opportunity today to eradicate Porcine Reproductive and 
Respiratory Syndrome, or PRRS virus. PRRS is a global endemic 
disease which causes animal death and suffering, which impacts 
the livelihood of all farmers. We are excited to share that, 
through small deletion in one gene, and not a single addition 
to the pig genome, in our research trials PRRS-resistant pigs 
showed complete resistance, and I mean 100 percent resistance, 
to the PRRS virus. The product is currently going through 
regulatory review by the FDA. As this Committee notes, in your 
letter to--an efficient risk and science-based regulatory 
system is imperative to capitalizing on this solution, and we 
agree.
    For Genus, our ethical commitments guide our efforts, 
including our commitment to partner and comply with all global 
government regulations, including testing and safety 
requirements. However, to bring these solutions to commercial 
reality, we need practical, less expensive, risk- and science-
based regulatory system that provides a safe and predictable 
path to market. We believe a regulatory framework for animals 
should create certainty for innovators, investors, producers, 
and consumers. And it should be practical in allowing the 
benefits of the technology to be efficiently and safely 
realized, while at the same time cementing the U.S. as a 
pioneer in innovation in this sector. We also need a 
coordinated global regulatory framework to avoid trade 
disruption, allowing producers and farmers to embrace these 
solutions.
    In closing, as we look to the future, we truly believe new 
technologies can lead to eradication of animal diseases, 
provide the opportunity for less use of antibiotics, produce 
more protein from fewer animals, resulting to less 
environmental impact. If these innovations are stifled, society 
will miss out on huge solutions for improving the 
sustainability of our food system. Thank you, I look forward to 
your questions.
    [The prepared statement of Dr. Rice follows:]

  Prepared Statement of Elena Rice, Ph.D., Chief Scientific Officer, 
                        Genus plc, DeForest, WI
    Chairman Scott, Chairman Costa, Chair Plaskett, Ranking Member 
Thomp[s]on, Ranking Member Johnson, Ranking Member Baird, and Members 
of the Committee, my name is Dr. Elena Rice, Chief Scient[i]fic Officer 
for Genus plc. I also serve on the Biotechnology Innovation 
Organization's (BIO) Agriculture and [Environment] Section Governing 
Board.
    I am honored to testify before you for today's hearing on 
``Agricultural Biotechnology: 21st Century Advancements and 
Applications'' and discuss how innovation in animal breeding will help 
to protect our food supply, feed our growing population, and create a 
more healthy and sustainable food system to help nourish the world.
    First, and most importantly, let me acknowledge and thank the 
strong support from the House Agriculture Committee in the recent 
letter \1\ Subcommittee Chair Plaskett and Ranking Member Baird led 
calling on the U.S. Food and Drug Administration (FDA) and the U.S. 
Department of Agriculture (USDA) to modernize these efforts and improve 
the regul[a]tory approach to meet the challenges our food supply and 
society are facing.
---------------------------------------------------------------------------
    \1\ https://baird.house.gov/news/
documentsingle.aspx?DocumentID=201.
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Introduction
    Let me tell you a bit more about my company. Genus plc is a world-
leading animal genetics company by breeding better pigs and cattle so 
farmers can produce high quality meat and milk more efficiently and 
sustainably. We do this by accurately analyzing animals' DNA and look 
for markers we know are linked to desirable [characteristics], and 
select animals with desirable characteristics to breed subsequent 
generations which help farmers raise healthier and more sustainable 
animals.
    With 1,300 employees in the United States, Genus' long history of 
leadership in animal breeding and innovation is focused upon developing 
improved genetics, healthier and disease resistant animals and 
improving the sustainability of agriculture.
    Research and development is at the forefront of Genus' focus of 
applying new ideas in the industry using gene editing, reproductive 
biology and other traditional breeding technologies and approaches.
    Genus's global porcine and bovine genetics businesses, PIC and ABS, 
then deliver leading genetics to tens of thousands of small and large 
farmers globally by focusing on addressing farmers's biggest needs, 
which are production efficiency, healthy and robust animals, and data 
and information to manage the farms.
    PIC is hea[d]quartered in Hendersonville, Tennessee and ABS is 
headquartered in DeForest, Wisconsin.
    We work on all these needs and demands by improving feed 
efficiency, meat and milk quality, and health traits through genomic 
science and breeding, achieving more production with less 
[environmental] impact. We also provide data such as genotypes to 
farmers helping them to manage their own breeding programs and improve 
[quality] and productivity of their animals..
Global Challenges
    We believe more science and technology, not less, is required to 
meet the nourishment needs of a projected global population of 9.5 
billion and the ability to meet a doubling of demand for animal-derived 
protein by 2050.\2\
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    \2\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5532560/.
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    We believe in our efforts to continue America's unsurpassed 
leadership in an innovative and sustainable food and fuel system, more 
science and technology is necessary, not less.
    And we believe more science and technology, not less, is necessary 
as zoonotic diseases become more prevalent and present greater risks to 
animal and human health and to our economy.
    Beyond addressing the challenge of global food and health security, 
we also recognize many consumers are not familiar with animal 
agriculture, what breeding methods are in use today, and what science 
and technology can offer in ensuring a healthy and sustainable food 
system in the future.
    For example, proposed state ballot initiatives in Colorado and 
Oregon which restricts traditional animal husbandry practices such as 
the use of artificial insemination, will impact practices used by 
[veterinarians] to care for livestock, impact ranchers ability to 
improve herd genetics which can make agriculture less sustainable by 
driving up carbon emissions, and impacting the cost of food production 
by disrupting supply chains.
    We also hear more and more concern about greenhouse gas emissions, 
the use of land, water management and opportunities for regenerative 
farming practices, where often these discussions lack any scientific 
basis or misrepresent the facts, where in fact, improved livestock 
genetics is reducing the carbon footprint per animal.
    Even though we're an animal genetics and breeding company, as 
consumer's are increasingly making food choices based on personal 
values in addition to nutrition, taste and cost, we have spent the last 
several years [engaging] with, and listening to consumers and other 
food and industry leaders to understand their interests and views, and 
to have a dialogue on the role of animal breeding as part of a healthy 
and sustainable food system.
    The good news is through this effort we have learned we share 
aligned values around the role of science, technology and animal 
genetics towards public and animal health and welfare, disease 
prevention and environmental concerns, and animal genetics is a missing 
piece of the puzzle for a more healthy and sustainable food system.
Solutions with Innovation
    As shared earlier, research and development is at the forefront of 
Genus' vision of pioneering animal genetic improvement to help nourish 
the world, through better understanding and innovative strategies 
through genomics of farm animals, and ground-breaking efforts like 
advanced reproductive technologies, the use of big data to drive new 
genetic insights, gender skewed semen, and gene editing which help 
customers produce animal protein more effectively and efficiently, 
enhancing nutrition, and making animals healthier and reducing animal 
suffering.
    Examples of our efforts include:

   Genetic improvement using genomic science and breeding 
        enables us to produce more protein more efficiently than ever 
        before. For example, in pigs, the feed conversion ratio--the 
        amount of food needed to build bodyweight (lbs of feed/lbs of 
        edible protein at slaughter)--has fallen 58% since 1970, 
        resulting in over 1.5 times a pig's body weight in feed being 
        saved.

   In the dairy industry, over a 40 year period, 13% fewer cows 
        are producing 76% more milk--another massive improvement in the 
        sustainability of protein production. While improved genetics 
        is not responsible for all of this staggering improvement, 
        genetics has been the major driver. Based on industry studies 
        and our own analysis, we estimate 50-60% of the improvement has 
        been driven by better genetics.

   Developing pigs through gene editing which are fully 
        resistant to PRRS (Porcine Reproductive and Respiratory 
        Syndrome) virus, a global, endemic disease impacting the pig 
        industry, that causes animal death and suffering as well as the 
        loss of billions of dollars in farm production worldwide. 
        Addressing this disease not only protects the livelihood of 
        farmers small and large, it offers an opportunity for a 
        reduction in the use of veterinary drugs to alleviate the 
        symptoms of the disease. This product is currently going 
        through regulatory approval process led by the FDA.

   Over the last 7 years Genus has invested in our proprietary 
        beef genetic program, NuEra Genetics, that allows us the 
        flexibility to create the genetic improvement needed for a more 
        sustainable beef animal, which is increasingly demanded by the 
        beef supply chain. The NuEra genetics program is making faster 
        genetic improvement than competing programs and has 
        demonstrated a reduction in carbon footprint per animal by 
        selecting for a balanced portfolio of traits related to 
        production efficiencies and outcomes.

   Another approach we are developing is utilization of NuEra 
        terminal line for Beef on Dairy progeny production which 
        substitutes higher efficiency beef genetics for unwanted dairy 
        genetics and provides increased production of beef while 
        maintaining lactation in dairy cows.

   We use genotyping to understand the links between DNA and 
        animal characteristics and how to positively influence them. 
        This enables us to make the right breeding decisions much 
        earlier and much more precisely thus enabling faster genetic 
        i[mpr]ovement.

   We have created a semen sorting technology platform, 
        IntelliGen Technologies, which helps with screening and 
        processing to select semen that carries only female or male 
        gender. The female gender is essential for dairy farmers in 
        replacing their heifers and eliminating production of not 
        needed male animals. The male gender is desirable by beef 
        farmers as it allows to reduce amount of feed needed to reach 
        required [carcass] weight.

   Creating embryos using in vitro fertilization, which allows 
        us to combine the best male and female genetics and rapidly 
        accelerate genetic improvement of the farmer's heard.

    And finally, as important to our innovation, are our Ethical 
Commitments \3\ to the use of innovative research. Both in today's 
research and tomorrow's potential commercialization, Genus R&D prides 
itself on an extensive testing system to make sure all animals 
resulting from Genus' genetics are safe and healthy and produce safe 
and nutritious meat and dairy products.
---------------------------------------------------------------------------
    \3\ https://www.genusplc.com/rd/innovation-technologies/gene-
editing-ethical-commitments/.
---------------------------------------------------------------------------
USA Regulatory Framework
    We know it is important to U.S. consumers that new technologies 
comply with all government regulations related to testing and safety. 
We also know it is important to provide information to our customers, 
partners and consumers about our use of innovative breeding 
technologies, such as gene-editing, and to collaborate with food system 
partners to create a process that makes information transparent to the 
public.
    Further, in our work with key export markets, the USA stamp-of-
approval sends a very strong signal to the safety of U.S. food and 
animal-products, critical for expanding global exports of U.S. 
products, and the livelihood of U.S. farmers, ranchers and the food 
industry.
    Yet, we also believe the current U.S. regulatory approach for 
animals is not fit for purpose. We believe the U.S.'s oversight of 
animal biotechnology needs to be consistent with efforts to streamline 
biotechnology regulations, and empower American research, job growth 
and innovation.
    We are encouraged by recent comments from USDA Secretary Tom 
Vilsack these new technologies should be used to address critical 
issues, such as climate and animal health issues, saying ``it won't 
happen'' if we don't take advantage of science, and about the 
importance of speeding up the FDA process for animals, which should 
look forward and not backwards.
    Broadly, in order to foster innovation, we believe the U.S. safety 
assessment of animal biotechnology needs to be grounded in the spirit 
of the Coordinated Framework for Regulation of Biotechnology by 
focusing on the characteristics of the product and not the process, and 
be done as part of an open, transparent and integrated effort across 
U.S. agencies.
    Ultimately, a fit-for-purpose regulatory framework for animals 
should consider what is most practical for the advancement of animal 
technologies, allowing the benefits of the technology to be realized to 
ensure animal health, safety, and welfare.
    This includes:

   Product-based, with risk and science-based criteria, and 
        clarity and predictability is necessary to drive innovation and 
        have access to these solutions. Specifically, Genus believes 
        product specific safety reviews should be performed on a case 
        by case basis considering the principles of the complexity and 
        familiarity of the intended change, and whether the change made 
        is replicating what could have occurred naturally or could 
        possibly be created using the conventional breeding and 
        mutagenesis approaches. These principles were highlighted as 
        part of the 2017 U.S. Government report Modernizing the 
        Regulatory System for Biotechnology Products: Final Version of 
        the 2017 Update to the Coordinated Framework for the Regulation 
        of Biotechnology;

   Familiarity and degree of complexity of the edit should 
        inform the regulatory pathway, so that when an animal with a 
        precise change has been shown to be safe, further regulatory 
        oversight is not necessary and it should not be treated any 
        differently in the food value-chain. Today, irrespective of the 
        nature of the genome edit, it is being treated as drugs in the 
        U.S. This may result in unnecessary complexity of production 
        and prevent it from entering the market. At a minimum, FDA 
        should conduct a thorough review of its premarket review 
        process and post-market-oversight system and implement specific 
        changes to improve its decision-making, transparency, and 
        timelines to ensure that its oversight does not unintentionally 
        disincentivize innovation and market adoption;

   Providing clarity to developers and producers on regulatory 
        pathways, data requirements and timelines for approval is 
        critical for informing key business and development decisions, 
        such as [financial] investments, approval timing, product 
        commercializations and pathways towards global regulatory 
        adoption, and finally;

   A simpler, transparent regulatory approach, which assures 
        safety and efficacy of edits and the safety of food, allows 
        entrepreneurs and technology developers--academic institutions, 
        small companies, and large corporations--to continue to bring 
        innovation to U.S. agriculture.
Global Regulatory Frameworks
    Given the importance of global trade to U.S. producers, farmers and 
ranchers, we also work closely with key customers and livestock 
organizations to monitor and engage in the development of global 
regulatory frameworks in critical export markets.
    For key global export markets, the regulations and agencies 
generally cover both plants and animals, and in some countries, such as 
Japan, Brazil and Argentina, and draft legislation in South Korea, the 
produ[c]ts are first asses[s]ed whether they fall outside of scope of 
standards for traditional GMO products. In China, existing GMO 
frameworks are being used for product safety assessments.
    In Japan, both the Ministry of Health Labor and Welfare (MHLW) and 
the Ministry of Agriculture, Forestry and Fisheries (MAFF) request 
product developers consult with them to determine if the product needs 
a safety review as a genetically engineered (GE) product. If MHLW or 
MAFF determine the product does not need to undergo the GE safety 
review, then developers need to complete a notification process defined 
by each agency and when completed, MHLW and MAFF publishes information 
provided by the developer about the product.\4\
---------------------------------------------------------------------------
    \4\ USDA, Foreign Ag Service, Report Number: JA2021-0106, ``MHLW 
and MAFF Update Policies and Procedures for Genome Edited Food and 
Agricultural Products'', July 09, 2021.
---------------------------------------------------------------------------
    Canada defines and regulates the commercial use, registration and 
licensing of any biotechnology derived animal products as novel foods, 
which is viewed as an alteration to the food that would result in food 
having characteristics outside of the accepted limits of natural 
variation in regard to its composition, structure, and nutritional 
quality.\5\
---------------------------------------------------------------------------
    \5\ USDA, Foreign Ag Service, Report Number: CA2020-009, 
``Agricultural Biotechnology Annual'', January 5, 2021.
---------------------------------------------------------------------------
    One critical export market of concern, however, is Mexico, where 
they have yet to develop a regulatory approach to gene edited 
agricultural products and so consequently, we are moving forward 
without the benefit of regulatory clarity in this critical market.
    We are encouraged by the commitments made by the USDA Secretary 
Vilsack and U.S. Trade Representative Katherine Tai to use bilateral 
and multilateral efforts to work with Mexico, though time is 
increasingly of the essence and the need for regulatory clarity is 
absolutely critical.
    And, finally, thank you for your efforts so far in supporting U.S. 
Government engageme[n]t with Mexico Government officials, as well as 
encouraging the Administration to consider the use of enforcement tools 
available within the USMCA if necessary to ensure fair trade of 
biotechnology products for U.S. farmers and ranchers.
Consumer Acceptance and Use
    After decades of providing superior bovine and porcine breeding 
genetics to livestock producers, we find ourselves in a place where the 
opportunities of the rapid advances in science and technology are 
inte[r]secting with the consumer desire to know how their food is 
produced.
    We know we need to tell our story about the how genetic improvement 
of animal protein contributes to a more sustainable food system, and 
with BIO we are working with and engaging a wide variety of food value-
chain stakeholders and key opinion leaders about the use of new 
breeding innovation technology in food and agriculture, and building 
trust and acceptance of genetic technologies.
    As noted earlier, we have committed to be transparent and clearly 
show the rigorous safety testing and commitments we live by when using 
technology, and our Ethical Commitments guide our use of new breeding 
approaches, such as gene editing, in today's research and tomorrow's 
potential innovations and products. These commitments range from 
transparency, regulatory compliance, focus on disease, environmental 
stewardship, and monitoring for unintended consequences.
Conclusion
    As we continue to look to the future, new innovations in animal 
breeding, particularly harnessing our growing knowledge of genetics and 
data, can lead to things like:

   Eradication of animal diseases and suffering;

   Less use of antibiotics;

   Less production of methane;

   More protein from fewer animals resulting in less 
        environmental impact (less food, water, waste);

   Ensuring our animals are resilient to climate change while 
        meeting the needs of local geographical needs like climates and 
        cultures.

    However this will require an efficient, risk and science-based 
regulatory system that can create a safe, predictable path to market. 
It will also require working with all the stakeholders we discussed 
earlier, from producers to investors, employees to consumers, and 
legislators to regulators.
    Sustainability is the heart of what Genus is all about. There is an 
opportunity to drive a more sustainable food system with better 
breeding and if these technologies are dismissed, they remove huge 
solutions for improving the sustainability of our food system and 
meeting broader food industry sustainability goals.
    The act of genetic improvement fundamentally enables more animal 
protein to be produced with fewer resources, and technology and 
innovations can be part of the solution if we will allow it.

    Mr. Costa. I want to thank you, Dr. Rice, for your concise 
testimony, informative testimony, and both witnesses for 
staying within the timeline. That is always appreciated. I now 
defer to our Subcommittee Chair, Chair Plaskett, to introduce 
our third panel member. Subcommittee Chair Plaskett, the floor 
is yours.
    Ms. Plaskett. Thank you very much, Mr. Chairman. Our third 
witness today is Mr. Jack Bobo, who is the Chief Executive 
Officer of Futurity. Thank you so much, Mr. Bobo, for being a 
part of the hearing today, and for sharing your expertise and 
knowledge, and supporting the work of our Subcommittees. Thank 
you, and you have 5 minutes now.

 STATEMENT OF JACK A. BOBO, CHIEF EXECUTIVE OFFICER, FUTURITY, 
                          POTOMAC, MD

    Mr. Bobo. Good morning. Thank you, Chair Plaskett, Chairman 
Costa, Ranking Member Baird, Ranking Member Johnson, and 
Members of the Subcommittee for having me here today. As was 
mentioned, I am Jack Bobo, the CEO of Futurity, a food 
foresight company, however, I previously served for 4 years as 
the Chief Communications Officer for Intrexon Corporation, a 
synthetic biology company. While you may not be familiar with 
the Intrexon name, you are likely familiar with some of the 
company's products, which included the non-browning Arctic 
apple, genetically engineered mosquitoes, animal clones. I also 
served on the Board of AquaBounty Technologies. Before that, I 
served for 12 years with the U.S. Department of State as the 
Senior Advisor for Global Biotechnology under four Secretaries, 
and during two Administrations.
    I am pleased to be here today to talk about agricultural 
biotechnology, 21st century advancements and applications. 
There can be no more important topic than the future of 
agriculture, because the future of the planet depends on the 
food we eat, and the choices we make about that food over the 
next 3 decades. The impact of agriculture on the planet is 
enormous in terms of land, water, and climate change, and, 
unfortunately, as was already mentioned, things are going to 
get worse before they get better because we need to produce 50 
to 60 percent more food by the year 2050. Transforming the food 
system to be more sustainable and resilient provides one of the 
best opportunities to make change for the better. My remarks 
here today focus on agricultural biotechnology in contributing 
to a more sustainable, just, and nutritious future not because 
it is a silver bullet, but because it is an important tool.
    Let me share a couple of examples. The most popular fruit 
in the world today is the banana, however, the most common 
variety, the cavendish, is at risk of extinction from plant 
disease. Biotech research currently underway in the United 
States and overseas, has the potential to save this variety, 
and it is critical that these products be able to make it to 
market. They also have impacts on small holder farmers around 
the world. Similar benefits will accrue from the deployment of 
animal biotech products such as the AquAdvantage salmon, which 
would add jobs domestically, and reduce U.S. dependence on $3 
billion of salmon imports.
    Globally, the picture is quite diverse. We see some 
countries forging ahead with deployment of genetically 
engineered and gene edited products, while others continue to 
put in place regulatory barriers to adoption. In Asia, Japan 
has traditionally taken a cautious approach to ag biotech, 
however, the country took a great leap forward this year with 
the placing on the market of the first plant and animal gene 
edited product, a tomato with a healthier nutrient profile, and 
a meatier fish. Japanese regulations allow such products to be 
marketed without the regulatory hoops required of a genetically 
engineered food product, though they must be registered with 
the Ministry of Health. Unfortunately, consumer acceptance of 
ag biotech continues to lag behind the global consensus among 
regulators in the safety of products currently on the market, 
as well as confidence in the technology from the scientific 
community.
    The United States has long held a comfortable lead in the 
development and application of new biotech products, but that 
leadership is now in doubt. This can be seen in the recent 
advances in Japan, in the case of gene editing. It is also on 
display in other areas of food technology, such as cell culture 
and cell cultivated meat, with governments in Singapore and 
Israel giving the green light to products ahead of U.S. 
regulatory agencies, despite the long history and the long lead 
time in terms of technology development here in the United 
States.
    In conclusion, innovation is the only way to produce 50 
percent more food using less land and water, and while 
dramatically reducing emissions. Agriculture has a long history 
of reducing impact while increasing output. In order to see 
even greater gains over the next 30 years, we must prioritize 
investments in agriculture and development of policies that 
promote more sustainable outcomes. This will ensure that the 
United States remains the global leader in technology 
development, and, most importantly, provides leadership to the 
rest of the world to follow suit. Thank you for providing me 
the opportunity to discuss this critical topic. I look forward 
to the questions.
    [The prepared statement of Mr. Bobo follows:]

Prepared Statement of Jack A. Bobo, Chief Executive Officer, Futurity, 
                              Potomac, MD
    Good morning, Chair Plaskett, Chairman Costa, Ranking Member Baird, 
Ranking Member Johnson, and Members of the Subcommittees. I am Jack 
Bobo, CEO of Futurity, a food foresight company. Prior to joining 
Futurity, I served for 4 years as the Chief Communications Officer and 
Senior Vice President for Global Policy for Intrexon Corporation, a 
synthetic biology company, which has since rebranded as Precigen. While 
you may not be familiar with the Intrexon name, you are likely familiar 
with some of the company's subsidiaries which included Okanagan 
Specialty Fruits, developer of the non-browning Arctic Apple, Oxitec 
developer of the genetically engineered mosquitoes that targeted the 
vector for zika and yellow fever, Viagen, the market leader in animal 
cloning, and Trans Ova Genetics, a market leader in animal genetics. I 
also previously served on the board of AquaBounty Technologies, which 
developed the AquAdvantage salmon.
    Prior to joining Intrexon I served for 12 years as the senior 
advisor for global biotechnology at the U.S. Department of State under 
four Secretaries and during two Administrations. I also ran the 
Department's Biotechnology Division in the Economic Bureau. During that 
time, I traveled to approximately 50 countries meeting with ministers, 
parliaments, executives, scientists and students to discuss 
biotechnology policy and regulations. I also participated in and/or led 
numerous biotech trade negotiations. In 2015 I was recognized by 
Scientific American as one of the one hundred most influential people 
in biotechnology.
    In my current role as CEO of Futurity I work with food technology 
startups and big food brands to help them understand what the future of 
food looks like and where consumer attitudes are going so they can 
navigate an ever more complex world. Earlier this year I published the 
report: `The role of innovation in transforming the global food 
system.' \1\ Most recently I published the book, `Why smart people make 
bad food choices.'
---------------------------------------------------------------------------
    \1\ https://www.agshowcase.com/the-role-of-innovation-in-
transforming-the-global-food-system.
---------------------------------------------------------------------------
    I am pleased to be here today to discuss Agricultural 
Biotechnology: 21st Century Advancements and Applications.
     There can be no more important topic than the future of 
agriculture because the future of the planet depends on the actions we 
take about the food we eat over the next 3 decades. Agriculture will 
either save the planet or destroy it.
    Despite producing more food than ever, there are still nearly 800 
million people undernourished and over two billion people facing 
moderate to severe food insecurity. The situation has grown more severe 
as COVID-19 has led to increasing unemployment, which 
disproportionately impacts lower income communities. Meanwhile, about 
two billion people are overweight or obese, contributing to a growing 
incidence of food related diseases. At the same time, an estimated \1/
3\ of all food produced globally is lost or goes to waste.
    Climate change is creating more challenges to food production due 
extreme weather conditions, such as droughts, floods, and fires around 
the world. However, our global food system is also a part of the 
problem. The footprint of agriculture is enormous in terms of land, 
water, and climate change.
    In fact, [f]orty percent of all the land on earth that could be 
used for agriculture is being used for agriculture today. The amount of 
cropland is the size of South America and the amount of pasture land is 
the size of Africa. In terms of water, there is nothing more important 
than agriculture as well. Seventy percent of all freshwater is used for 
agriculture. The Colorado River, the fifth largest river in America no 
longer flows to the sea, largely because of agricultural withdrawals. 
Ten to fifteen percent of greenhouse gas emissions come from 
agriculture and another ten to fifteen percent from deforestation, 
eighty percent of which is caused by agriculture. As if that weren't 
bad enough, eighty percent of biodiversity loss is also caused by 
agriculture.
    Unfortunately, the situation is likely to get worse before it gets 
better. The global population is expected to increase by an additional 
two billion people by 2050. Demand for food is expected to rise even 
faster as a result of increasing incomes. As a result, we will need 
fifty to sixty percent more food by 2050.
    Despite this incredible challenge, there is also reason for hope. 
Over the last 50 years the global food system has managed to increase 
production faster than the growth in global population, leading to 
significant reductions in hunger as a percent of population. If we were 
farming today using 1960s technology, we would need an additional 1 
billion hectares of land to produce the food we do today, which is more 
than a quarter of the 3.6 billion hectares of forest remaining on the 
planet.
    Transforming the food system to be more sustainable and resilient 
provides one of the best opportunities to make change for the better. 
Counterintuitively, agriculture is both the biggest driver of 
deforestation and the biggest protector of forests through productivity 
gains. An improved food system will not only promote rich biodiversity 
and ecosystems, but people who are resilient and empowered as well.
    Many organizations are waking to these challenges and calling for 
changes to how food is produced, processed, and consumed, from the 
United Nations to the World Economic Forum. By considering the food 
system as a whole, we are better positioned to understand problems and 
to address them, in a more connected and integrated way.
    Decisions about how and what to grow inevitably result in 
tradeoffs. Over the last fifty years, advances in farming practices and 
technologies, such as the Green Revolution, dramatically reduced global 
hunger as well as deforestation, but they also had negative 
consequences, including eutrophication of waterways, reduced soil 
fertility, soil erosion and toxicity, diminishing water resources, and 
pollution of ground water. The alternative, of course, was greater 
hunger and starvation, which would have also had negative impacts on 
the environment.
    To address the very real challenges faced by people and the planet 
we need all tools at our disposal. Initiatives aimed at transforming 
the food system cannot succeed in delivering the benefits desired 
without acknowledging the role innovation played in the past and 
ensuring that it plays an equally robust role in the future. This 
includes advances in food production that regenerate soil and sequester 
carbon, but also innovations that allow more food to be produced on the 
same land using fewer inputs.
    My remarks today focus on the role of agricultural biotechnology in 
contributing to a more sustainable, just, and nutritious future, not 
because it is a silver bullet, but because it is an important tool. We 
could as easily spend our time discussing the critical importance of 
cover crops, field margins and intercropping, but those are topics for 
another day and other subcommittees.
    My fellow panelists will provide more detailed examples of the 
contributions of plant and animal biotechnology to sustainability and 
health, but I would like to illustrate the importance with a few 
examples.
    Thirty to forty percent of all food produced in America is wasted. 
Food waste exacts a terrible toll in terms of the environment. Potatoes 
and apples are the second and third most wasted food items (bread is 
number one). Non-browning versions of these products are already 
available. Wider adoption of these varieties would benefit the 
environment and consumers, as well as the bottom line of producers. 
Similar benefits will accrue from the deployment of animal biotech 
products such as the AquAdvantage salmon, which could add jobs 
domestically and reduce U.S. dependence on $3 billion in Atlantic 
salmon imports.
    Globally, the picture is quite diverse. We see some countries 
forging ahead with deployment of genetically engineered and gene-edited 
products, while others continue to put in place regulatory barriers to 
adoption.
    In Asia, Japan has traditionally taken a cautious approach 
agricultural biotechnology. However, the country has taken a great leap 
forward this year with the placing on the market of the first plant and 
animal gene-edited products--a tomato with a healthier nutrient profile 
and a meatier fish. Japanese regulations allow such products to be 
marketed without the regulatory hoops required of a genetically 
engineered food product, though they must be registered with the 
Ministry of Health.
    On the other hand, the European Union took a step in the other 
direction last week with the Parliament's adoption of the Commission's 
Farm to Fork Strategy (FtF), which would move gene editing regulations 
in the direction of genetically engineered food products rather than 
regulating them like their conventional counterparts. This outcome 
occurred despite a concerted effort on the part of academic and 
research communities in Europe to limit the regulatory hurdles for 
these products to promote innovation and accelerate adoption.
    Studies conducted on the impact of the FtF Strategy by the USDA,\2\ 
HFFA Research,\3\ the Joint Research Centre of the EU (JRC),\4\ Kiel 
University as well as Wageningen University and Research (WUR) \5\ all 
conclude that this strategy would have several significant negative 
impacts in terms of emissions, imports and hunger.
---------------------------------------------------------------------------
    \2\ https://www.fas.usda.gov/newsroom/economic-and-food-security-
impacts-eu-farm-fork-strategy.
    \3\ https://hffa-research.com/wp-content/uploads/2021/05/HFFA-
Research-The-socio-economic-and-environmental-values-of-plant-breeding-
in-the-EU.pdf.
    \4\ https://publications.jrc.ec.europa.eu/repository/handle/
JRC121368.
    \5\ https://grain-club.de/fileadmin/user_upload/Dokumente/
Farm_to_fork_Studie_Executive_
Summary_EN.pdf.
---------------------------------------------------------------------------
    For example, the JRC study anticipates that the decrease of between 
40 and 60 percent of GHG emissions from European agriculture from the 
implementation of Farm to Fork targets will lead to outsourcing 
European agricultural production, including its agricultural footprint 
(and emissions) to third countries. The Kiel University study projects 
that Europe could become a net food importer, in direct contradiction 
to the European Commission's expressed strategic goals. Finally, the 
USDA study concludes that the targets set out in the Farm to Fork 
strategy could lead to food insecurity for 22 million people.
    Consumer acceptance of agricultural biotechnology continues to lag 
behind the global consensus among regulators in the safety of products 
currently on the market as well as confidence in the technology from 
the scientific community. Over the last decade public discourse about 
the technology has become muted as consumer groups have focused on 
other issues such as highly processed foods.
    Despite the lack of understanding among the general population 
about the science behind agriculture biotechnology, vague concerns 
about the technology remain and are reflected in consumer purchases of 
products labeled non-GMO. This is similar to consumer behavior around 
many other food ingredients, nutrients and chemicals found in food, 
from the stigma of gluten to synthetic pesticides, which are based in 
fear rather than an assessment or understanding of actual risk.
    What will it take for the U.S. to remain a leader in the field?
    The United States has long held a comfortable lead in the 
development and application of new agricultural biotechnologies, but 
that leadership is now in doubt. This can be seen in the recent 
advances in product development and regulatory approval of products in 
Japan in the case of gene editing. It is also on display in other areas 
of food technology such as cell-cultured or cell-cultivated meat with 
governments in Singapore and Israel giving the greenlight to products 
ahead of U.S. regulatory agencies despite the long head start by U.S. 
technology developers.
    Agricultural biotechnology, including genetic engineering and gene-
editing tools, offers tremendous opportunities to develop new products 
from a wide range of public- and private-sector actors around the world 
to address some of the global challenges mentioned previously. The 
policies adopted and implemented in the United States will set an 
example for the rest of the world, which will ultimately determine the 
extent to which these technologies contribute meaningfully to a more 
sustainable food system.
    Appropriate policies can incentivize investments from public- and 
private-sector stakeholders as well as promote consumer trust in the 
food system. It is critical both that the U.S. pursues a transparent, 
predictable and science-based regulatory approach that is risk-based 
and that the Federal Government works closely with the global 
scientific community and other nations to promote harmonized policies 
around the world. The United States must also invest heavily in 
agricultural research, which currently lags far behind investments in 
medical research despite the fact that food-related illnesses are one 
of the major drivers of healthcare costs.
    In conclusion, innovation is the only way to produce fifty percent 
more food using less land and water and while dramatically reducing 
emissions. Agriculture has a long history of reducing emissions while 
increasing output. For example. a bushel of corn today results in 35 
percent fewer greenhouse gas emissions and requires 40 percent less 
land, 50 percent less water, and results in 60 percent less erosion 
than a bushel produced in 1980.
    In order to see even greater gains over the next 30 years we must 
prioritize investments in agriculture and development of policies that 
promote more sustainable outcomes. This will ensure that the United 
States remains the global leader in technology development and, more 
importantly, provides leadership to the rest of the world to follow 
suit. If we are successful then agriculture will indeed save the 
planet.
    Thank you for providing me this opportunity to discuss this 
critical topic. I'll be happy to take your questions.

    Mr. Costa. Thank you very much, Mr. Bobo. Our fourth 
witness, that will complete our panel, and we will begin the 5 
minutes for each Member for questions and comments, is Dr. Jon 
Oatley, who is the Associate Dean of Research, and the 
Professor of the School of Molecular Biosciences, and Director 
of Functional Genomics Initiative, College of Veterinary 
Medicine, at Washington State University. Dr. Oatley, that is a 
mouthful, but clearly Washington State is one of our premiere 
universities in the country, and your leadership as the 
Associate Dean is well respected, and we look forward to 
hearing your comments.

STATEMENT OF JON M. OATLEY, Ph.D., ASSOCIATE DEAN OF RESEARCH, 
PROFESSOR, DIRECTOR, FUNCTIONAL GENOMICS INITIATIVE, SCHOOL OF 
                           MOLECULAR 
         BIOSCIENCES, COLLEGE OF VETERINARY MEDICINE, 
            WASHINGTON STATE UNIVERSITY, PULLMAN, WA

    Dr. Oatley. Good morning, Chairman Costa, Chair Plaskett, 
Ranking Members Johnson, Baird, and Thompson, Congresswoman 
Schrier from Washington State, and other Members of the 
Subcommittees. My name is Jon Oatley. I am the Associate Dean 
of Research, and a Professor in the College of Veterinary 
Medicine at Washington State University. My testimony will 
reflect how I see the current state of biotechnology in animal 
agriculture, in particular the potential for gene editing 
technologies to improve how the human population is fed now, 
and in the coming decades.
    The lens I see this area through has been shaped by an 
array of experiences. Beyond serving as a research 
administrator for a Tier I land-grant university, I am also a 
scientist working at the ground level to develop gene editing 
applications in farm animals. I have also gained an 
academician's perspective on early stage navigation of the 
current regulatory approval process for biotechnology in 
animals, and I served as a member of the recent task force on 
gene editing and livestock that was established by the American 
Association of Veterinary Medical Colleges and Association of 
Public and Land-grant Universities.
    As has been mentioned several times already, food security 
is a global issue. At present, nearly one billion people are 
malnourished and in starvation conditions, and, based on 
historic trend, the human population is estimated to reach ten 
billion by the year 2050. That is a 28 percent increase from 
where we are today. Although opinions vary, most scientists 
agree that a significant increase, somewhere in the 
neighborhood of 60 percent, will be needed in agricultural 
production, both plant and animal, and that is just to maintain 
today's nutritional standards for feeding the future in 2050.
    The farm animal of the future will need to be more 
efficient in converting inputs, such as feed and water, into 
outputs for human consumption, and it will need to do this in 
increasingly harsher environments, while having less impact on 
the climate. We will need to tailor food animals for feeding 
more with less, and now is the time to start the process, not 
years from now. Humans have been engineering the genome of 
domesticated animals for thousands of years by way of selective 
breeding, but it is really the last 10 years of scientific 
discovery where they have been a game changer, through advent 
of gene editing as a molecular tool for precision genome 
engineering in creating dramatic positive impact on production 
traits.
    We are already starting to see applications be advanced 
from the research lab into commercial channels, including 
strategies to make PRRS-resistant pigs that were developed by 
scientists at the University of Missouri and the Roslin 
Institute, and surrogate sires breeding technology that was 
developed at Washington State University that is designed to 
amplify the impact of desirable or elite genetics across the 
spectrum of livestock production. Global adoption of innovation 
for producing agricultural animals can significantly strengthen 
the food supply and positively impact economic prosperity. 
Applications of gene editing to enhance traits is the present 
and the future of innovation in livestock production.
    For the promises to be realized in feeding the future, 
processes for Federal regulatory approval and monitoring must 
be rooted in science, and aligned to the pace of development. 
The current U.S. Federal regulatory framework that governs 
processing of intentional genetic alteration of animals was 
designed for molecular technologies of more than 3 decades ago, 
and is not well-aligned with state of the art gene editing. A 
modernization is needed that likely includes re-envisioning of 
agencies that approve and monitor applications in food animals. 
To this end, I believe the advance notice of proposed 
rulemaking on the regulation of animals developed by genetic 
engineering that was released by the USDA in 2020, and the MOU 
created in 2021 by officials of the USDA and HHS that calls for 
collaboration between the FDA and USDA in establishing a 
coordinated framework to assess genetic alteration of food 
animals, and streamline the approval and monitoring processes, 
are both steps in the right direction.
    I urge Congress to consider modernizing the Federal 
regulatory framework of gene editing in food animals, and to be 
judicious with enacting it. We have the tools at our disposal 
for designing the farm animal of the future that will feed more 
with less. We now need a Federal regulatory landscape that is 
conducive for making material gains in advancing discoveries 
from laboratory to the public domain.
    I would like to close by paraphrasing a quote from George 
Washington that was written in a letter in 1794: I know of no 
pursuit in which more real and important services can be 
rendered to any country than by improving its agriculture and 
its breeding of useful animals. That statement was relevant 227 
years ago, and I believe it still rings true today in guiding 
the next frontier of animal agriculture, and that will 
undoubtedly involve applications of gene editing. Thank you for 
the opportunity to testify before this panel, and I would be 
glad to try to address any questions.
    [The prepared statement of Dr. Oatley follows:]

Prepared Statement of Jon M. Oatley, Ph.D., Associate Dean of Research, 
    Professor, Director, Functional Genomics Initiative, School of 
Molecular Biosciences, College of Veterinary Medicine, Washington State 

                        University, Pullman, WA
Introduction
    Good morning, Chair Plaskett, Chairman Costa, Ranking Member Baird, 
Ranking Member Johnson, Congresswoman Kim Schrier from Washington State 
and Members of the Subcommittees. My name is Jon Oatley and I am the 
Associate Dean of Research and a Professor in the College of Veterinary 
Medicine at Washington State University.
    WSU is Washington State's land-grant university and a public 
research university committed to its mission and tradition of service 
to society. With six campuses across the State of Washington and a 
presence in every county through its Extension system, WSU has an 
enrollment of 31,159 students statewide. In FY 2020, WSU's total 
research and development expenditures exceeded $350 million. The 
College of Veterinary Medicine at WSU is a flagship program for the 
university that houses five departments with a cadre of stellar faculty 
and staff studying an array basic and applied life and health sciences 
topics.
    My testimony today will reflect how I see the current state of 
biotechnology applications in animal agriculture, in particular the 
potential impact of gene editing technologies for improving how the 
human population is fed now and in the coming decades. The lens I see 
the animal biotechnology arena through has been shaped by an array of 
experiences. Beyond serving as a research administrator for a tier 1 
land-grant university, I am a scientist and developer of gene editing 
applications in farm animals. In addition, I have gained an 
academician's perspective on early-stage navigation of the Federal 
regulatory approval process for biotechnology in animal agriculture 
through interaction with the Food and Drug Administration (FDA). I also 
worked with the American Association of Veterinary Medical Colleges 
(AAVMC) and Association of Public and Land-grant Universities (APLU) to 
establish the recent task force on gene editing in livestock and 
subsequently served as a core member.
    A genome is the complete set of genetic information contained 
within DNA that is present in a cell or organism. Genetic engineering 
can be defined simply as the manipulation of an organism's genome by 
way of human intervention. With food animals (e.g., livestock such as 
cattle, pigs, chickens, sheep, etc.), humans have been engineering the 
genome for thousands of years via selective breeding as an effort to 
improve how protein products are generated. This ancient practice is 
still used today and impacts, both positive and negative, can be 
observed in all livestock sectors. While opportunity still exists for 
making gains in traits of livestock to feed the growing global human 
population that is projected to reach nearly ten billion by the year 
2050, the pace and precision needed to ensure the future of food 
security is not achievable with this strategy alone. Application of 
cutting-edge technologies such as CRISPR gene editing offers a new 
frontier for tailoring the traits of livestock for optimized growth, 
resiliency, and climate smart performance in a variety of environments 
and within a timeframe of months to years rather than decades and 
generations that selective breeding requires.
    Global adoption of innovation in production of agricultural animals 
can significantly strengthen the food supply and positively impact 
economic prosperity of the U.S. Applications of gene editing to enhance 
the traits of animals is the present and future of innovation in 
livestock production. For the promises of this groundbreaking 
technology to be realized in feeding the future, processes for Federal 
regulatory approval and monitoring must be rooted in science and 
aligned to the pace of development. A modernization of the U.S. Federal 
regulatory framework governing applications of genetic modification in 
animals, including gene editing, is needed for streamlined and cost-
effective approval and monitoring. In doing so, the science of gene 
editing can be advanced from research laboratory to the public domain 
in a safe and effective manner never before seen in the U.S., thereby 
addressing the real-world challenges with food security now and over 
the next 100 years.
Background on Feeding the Human Population through Animal Products
    The origins of animal genome engineering by humans are ancient, 
being traced to over 10,000 years ago following domestication of 
various species which led to the practice of selective breeding that is 
still in use today. The central purpose of this intervention has been 
to shape the traits of animals that generate products (e.g., meat, 
milk, and fiber) for human consumption. The demand for animal sourced 
protein in the human diet has always existed and continues to rise as 
more people are added to the planet every day. According to statistics 
from the United Nations Food and Agricultural Organization (FAO), the 
global demand for animal protein increased by 80% between the years of 
1970 and 2000; this trend is expected continue in lockstep with human 
population growth.\1\
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    \1\ https://www.fao.org/documents/card/en/c/cb4474en.
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    Food security is a critical global issue. The United Nations 
Population Division projects that there will be 9.8 billion people on 
[E]arth by the year 2050. Providing food at sufficient quantity and 
nutritional quality for this number of people will require major 
improvements in production efficiency for both plant and animal 
agriculture so that outputs for human consumption are generated from 
minimal inputs and accomplished in a climate smart way.
    The intrinsic element of both plants and food animals that 
significantly influences traits for resiliency and production of 
products for human consumption is the genetic makeup or genome. 
Although the conventional practice of selective breeding has had major 
impact on physical traits of food animals since the dawn of 
domestication, advances are often incremental and take decades to 
manifest. In addition, the lack of precision and need for multiple 
generations to achieve material gains through use of selective breeding 
carries an inherent risk of creating unintended negative genetic 
combinations that reduce the welfare, resilience, and production 
efficiency of a food animal. For these reasons, the common livestock 
production practice of selective breeding is not sufficient to meet the 
demands of food security that arise from an exponentially expanding 
human population.
    The future of food animal production must align to a goal of 
feeding more with less. As arable land and water resources continue to 
decline globally, production of animal sourced protein through 
livestock production will need to increase with use of fewer inputs. In 
addition, although agriculture accounts for only 10% of greenhouse gas 
emissions in the U.S.,\2\ livestock production is still considered a 
major contributor to global warming and climate change. The farm animal 
of the future will need to be resilient in ever changing and often 
harsher climates while contributing a reduced carbon footprint; farming 
practices and livestock will need to evolve to be climate-smart.
---------------------------------------------------------------------------
    \2\ https://www.epa.gov/ghgemissions/sources-greenhouse-gas-
emissions.
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    The science of gene editing holds major potential to address global 
food security now and for the future. As a biotechnology, gene editing 
applications in animals are subject to approval and monitoring at the 
Federal level. As gene editing strategies such as CRISPR technology are 
evolving to dramatically expand the toolbox for precision agriculture, 
so must the Federal regulatory framework.
Overview of Biotechnology Approaches to Shape the Genome of Animals
    The science of animal biotechnology has held great promise for 
decades as a modern-day complement to selective breeding for the 
shaping production traits of livestock. Indeed, the diverse field of 
biotechnology is regarded as a major component of the ongoing fourth 
industrial revolution. Although much of the animal side of the 
biotechnology sector is still in a research and development phase, the 
advent of gene editing technologies and their rapid deployment as tools 
in the animal research arena has led to several applications in 
livestock that are poised for entry into the marketplace.
    A first generation of approach for genetic engineering of livestock 
is the science of transgenesis. This conventional biotechnology 
involves the use of recombinant DNA for integration of genetic 
information found in other organisms into a target animal's genome. As 
such, genetic changes made by way of transgenic technologies could not 
arise in nature and have resulted in livestock possessing them being 
labeled ``genetically modified organisms'' or GMOs.
    Unlike conventional approaches to genetic engineering of animals 
such as transgenesis, gene editing technologies can precisely target 
specific sites in the genome to bring about favorable changes using 
natural processes within a cell or organism. Importantly, many gene 
editing applications do not involve integration of recombinant or 
foreign DNA into the genome of an animal. Rather, the gene edit is 
simply created by breaking DNA at a precise spot in the genome and 
relying on the repair of that break to bring about a change. This 
process of DNA breaking and being repaired in a different way is 
inherent to mammalian cells and occurs constantly in animals. Gene 
editing simply directs where a DNA break and natural repair change will 
happen.
    Public attitudes to genetically modified organisms have tended to 
be negative. In the U.S., the 2019-2020 Pew Research Center's 
International Science survey reported that 27% of Americans thought 
GMOs were generally safe to eat, 38% responded they were unsafe to eat, 
and 33% said they did not know enough about the topic to say.\3\ This 
negative perception of food derived from GMOs has presented a major 
impediment for advancing biotechnology applications to improve 
livestock production in the public domain.
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    \3\ https://www.pewresearch.org/science/2020/12/10/biotechnology-
research-viewed-with-caution-globally-but-most-support-gene-editing-
for-babies-to-treat-disease/.
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    Currently, the leading edge of biotechnology application for 
genetic engineering of livestock has moved from the conventional and 
often time imprecise nature of transgenesis to precision approaches of 
gene editing. Importantly, the technical science and intended outcomes 
of gene editing in livestock are substantially different compared to 
transgenesis. Thus, a ``one box fits all'' model for regulatory 
statutes in the U.S. should not be applied to genetic engineering of 
livestock. A model that allows for fluidity to adapt with contextual 
categorizing of the genetically altered animals and applying logic-
based decision making, while still ensuring safety, is needed.
    In contrast to inherent randomness and dependence on the 
possibility of admixture of favorable versions of genes that 
conventional breeding is based on, gene editing offers a precise and 
efficient means for introducing favorable genetic elements into the 
genome of animals that will drive beneficial traits for improving the 
production of meat, milk, or fiber for human consumption. Applying gene 
editing to create lines of livestock with unique and enhanced genotypes 
is an efficient way to help ensure food security. To realize this 
potential, global regulations and policies must be framed to allow for 
facilitated deployment of the technology into production systems and 
the widespread dissemination of gene edited animals into the food 
chain, while still ensuring the safety of the food from these animals, 
as well as the welfare of the animals and the environment.
Leading Edge Applications of Gene Editing in Farm Animals
    With the advent of gene editing technologies for mammalian cells 
nearly a decade ago, a new frontier was opened for the application of 
biotechnology to improve food animal production. Over the last 5 years, 
several applications of gene editing in livestock have been devised and 
advanced to the brink of being useful for U.S. farmers and ranchers. 
The leading edge of gene editing applications in production animal 
agriculture can be defined as improving growth efficiency, disease 
resistance, welfare, and reproductive capacity. Recent reports of gene 
edits in pigs that confer resistance to Porcine Reproduction and 
Respiratory Syndrome Virus,4-5   and produce surrogate 
breeding strategies for a range of livestock \6\ and poultry \7\ to 
advance genetic gain are poised to make significant impacts on food 
animal production in the U.S. and globally. At present, none of these 
gene editing applications have fully navigated the U.S. Federal 
regulatory approval process and are therefore unable to be capitalized 
on by America's farmers and ranchers to enhance the food supply and 
economic prosperity of the agriculture sector.
---------------------------------------------------------------------------
    \4\ https://pubmed.ncbi.nlm.nih.gov/29925651/.
    \5\ https://pubmed.ncbi.nlm.nih.gov/26641533/.
    \6\ https://pubmed.ncbi.nlm.nih.gov/32929012/.
    \7\ https://pubmed.ncbi.nlm.nih.gov/31575742/.
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    Reproductive capacity is a staple of livestock production. The flow 
of genetic information between generations occurs through sperm and 
eggs. Thus, the basis of selective breeding that has been used for 
thousands of years to shape the traits of animals is directing the 
combination of sperm from choice males and eggs from choice females. 
Most genetic change in livestock production is made through selective 
use of males because millions of sperm are made every day for directed 
breeding purposes. This principle of selected use of breeding males has 
had enormous impacts on shaping what the world's livestock populations 
look like today, but the impact was kept primarily on a regional scale 
until the 1950s when artificial insemination technology was developed. 
This breeding strategy allows for collecting of sperm from what are 
deemed elite or genetically desirable males and shipping around the 
world for artificial introduction into females that would result in 
pregnancies. Effective application of artificial insemination in 
livestock production requires freezing of sperm and then artificially 
introducing it into the reproductive tract of a female during a 
specific window of time in her reproductive cycle. Therefore, sperm 
freezing and accurate detection of the window of female receptivity are 
crucial. These nuances are conducive for intensive livestock production 
systems such as the dairy industry in which >80% of dairy cattle are 
bred by artificial insemination. Indeed, the impact of this breeding 
approach on genetic makeup of dairy cattle in the U.S. has been a major 
contributor to the quadrupling of milk production per cow between 1950 
and today.
    In beef cattle production, use of artificial insemination has been 
limited, with only 7% of animals being bred with the technology 
because of logistical disconnects. Most beef cattle are managed in 
range or pasture-based systems which do not allow for tracking the 
window of receptivity in females nor are they conducive with workforce 
needed to artificially inseminate large numbers of females. Natural 
breeding is the primary approach of most beef cattle production.
    In swine production, although 70% of pigs are bred using 
artificial insemination to influence genetic gain, survival of pig 
sperm during freezing is poor, thus the influence of elite genetics is 
regionally limited to regions and global dissemination is a challenge.
    For all other livestock populations, such as goats and sheep, 
artificial insemination is not utilized widely due to need of 
specialized techniques; thus, introducing new genetics to improve 
production traits of populations worldwide has been marginal.
    There has been lost opportunity to improve production traits for 
many livestock production sectors due to limited innovation in breeding 
technologies over the past several decades. Surrogate Sires technology 
was developed at Washington State University to address the unmet need 
of a novel tool that can be effectively applied in a natural breeding 
context to disseminate elite genetics in all livestock populations on a 
worldwide scale. The premise of the technology is transfer of stem 
cells that are responsible for continual sperm production from an elite 
male into the testicles of a battery of recipient males that lack their 
own sperm producing cells. The recipient males are then able to produce 
sperm containing the donor male's genetics and are used throughout the 
world in natural breeding schemes. This capability would provide the 
benefits of selective utilization of elite genetics without the need 
for intensive management practices or sperm cryopreservation. Moreover, 
the tool would be conducive with modern beef cattle, swine, and sheep/
goat production practices.
    Surrogate Sires technology relies on creating male livestock that 
lack their own sperm producing cells is to use CRISPR based gene 
editing to knockout a gene called NANOS2. The only known function of 
NANOS2 in all mammals that have been studied to date is for production 
of sperm producing cells. Therefore, gene edited NANOS2 knockout males 
are ideal Surrogate Sires. Importantly, recent peer-reviewed science 
has shown that following transplantation of donor sperm stem cells into 
testicles of a NANOS2 knockout male, sperm production commences, and 
all possess the non-edited genome of the donor. Thus, the offspring 
produced via natural breeding of the Surrogate Sire would not possess 
the gene edits created by CRISPRs. Moreover, the edits in the NANOS2 
gene of the Surrogate Sire are mutations that could arise in nature.
    Washington State University has established Investigational New 
Animal Drug (INAD) files with the Food and Drug Administration (FDA) 
for NANOS2 gene editing in multiple farm animal species to begin 
navigating the current U.S. Federal regulatory approval process.
History of Regulatory Framework on Genetic Engineering of Food Animals 
        in the U.S.
    Established by the White House Office of Science and Technology 
Policy (OSTP) in 1986, the Coordinated Framework for Biotechnology lays 
out the U.S. Federal regulatory policy for how products derived from 
biotechnology are developed and introduced into the public domain. 
Composition and intended use are the basis of the Framework and a 1992 
update reaffirmed that regulation should be based on the product and 
not the process by which the product was derived. The Framework does 
not assign biotechnology products to individual regulatory agencies or 
a single governing statute and as such, has evolved over time to assign 
primary jurisdiction of biotechnology oversight to the Food and Drug 
Administration (FDA), United States Department of Agriculture (USDA), 
or Environmental Protection Agency (EPA). Acts governing how 
agricultural biotechnology products are assigned to these Federal 
agencies were established well before the advent of gene editing 
technologies. Thus, there is need to modernize the Coordinated 
Framework for Biotechnology in a manner that aligns with the state-of-
the-art for how this area of science is being applied to livestock 
production today and into the future.
    Within the U.S., multiple Federal agencies have directives for 
regulatory jurisdiction over different aspects of livestock and the 
products they produce that could be impacted by the application of gene 
editing. As a means to mitigate the spread of diseases that affect 
livestock, the Animal Health Protection Act (AHPA) of 2002 established 
regulatory authority with the USDA Animal and Plant Health Inspection 
Service (APHIS) to oversee the importation and interstate movement of 
live animals in the U.S. Likewise, authority for monitoring safety of 
livestock products that are intended for human consumption has rested 
with the USDA Food Safety and Inspection Service (FSIS). Additionally, 
under the authority of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), the FDA has authority for the safety of non-meat food and feed 
products derived from animals.
    At present, as assigned by the FFDCA, regulatory oversight of 
genetically modified animals in the U.S. rests with the FDA. Through 
interpretation of this authority, substances other than food that 
affect the structure/function of an animal are considered to be a drug. 
As such, the molecular elements such as DNA that alter the genome of an 
animal are considered a drug. In this manner, gene editing approaches 
are channeled into a regulatory approval process that is not well 
matched for how the technology alters the genome, is transmitted to 
subsequent generations, or the intended purposes. At present, 
developers of a gene editing application in livestock must undergo an 
Investigation New Animal Drug (INAD) process during early-stage proof-
of-concept and the full New Animal Drug Application (NADA) process in 
order to achieve commercialization and use in the public domain. Both 
these processes were designed for development of actual drugs and not 
for hereditary changes in the genome.
A Need for Modernization of Regulatory Framework
    In 2017, draft Guidance for Industry (GFI) #187: Regulation of 
Intentionally Altered Genomic DNA in Animals was issued by the FDA for 
framework that regulates approval and oversight function of genetically 
altered livestock.\8\ GFI #187 considers gene editing technologies as 
animal drugs and does not discriminate from genomic changes that could 
arise in nature (e.g., insertions, deletions, rearrangements, and 
single nucleotide polymorphisms) versus those that are novel and 
generated only through a genetic engineering process (e.g., use 
recombinant DNA and transgenesis). Of note, the long-standing practice 
of selective breeding results in the creation of genomes by way of 
human intervention and therefore can be considered as intentional 
genomic alterations in animals. Yet, this common practice in animal 
breeding is not regulated by the FDA or any other Federal agency.
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    \8\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/cvm-gfi-187-regulation-intentionally-altered-genomic-dna-
animals.
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    In 2021, the USDA and officials of the Department of Health and 
Human Services (HHS) signed a Memorandum of Understanding (MOU) for the 
FDA and USDA to collaborate on shaping a modernized Federal regulatory 
framework that would streamline a cost-effective approach to approving 
and monitoring gene editing in domestic animals.\9\ Under authority of 
the AHPA and Federal Meat Inspection Act, the MOU proposes that the 
USDA would establish a rulemaking process for pre-market evaluation and 
post-market monitoring of safety concerns related to both human and 
animal health for genetic engineering applications, including gene 
editing, in agricultural species. The MOU also lays out how the FDA 
would retain jurisdiction of intentional genomic alterations in animals 
intended for purposes other than agricultural use. Moreover, the MOU 
calls for collaboration between the USDA and FDA in fully vetting 
safety and health concerns that are not clearly addressable by the 
streamlined USDA evaluation process. I fully support this MOU and the 
accompanied Advanced Notice of Proposed Rulemaking (ANPR) on regulating 
the movement of animals modified or developed by genetic engineering 
posted by the USDA in 2020.
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    \9\ https://www.aphis.usda.gov/biotechnology/downloads/mou-usda-
fda.pdf.
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    Because the science and technology of genetic engineering and 
potential applications in domestic animals is complex, ranging from 
generation of novel biomedical models to gene therapy to enhancing 
traits for the improvement of animal agriculture, assigning Federal 
regulatory jurisdiction to a single agency is challenging and could 
[stymie] innovation. The current state for Federal evaluation, 
approval, and monitoring of intentionally genetically altered animals 
in the U.S. are based on processes established for transgenic 
technologies which do not align well with the state-of-the-art gene 
editing technologies. In addition, these processes are viewed by many 
developers of genetic engineering applications in livestock as 
ambiguous, glacial in pace, and cost prohibitive.
    The House Committee on Agriculture has recognized the importance of 
navigating this regulatory process with the recent letter signed by 
many Members of the Subcommittees asking Secretary Vilsack and 
Commissioner Woodcock to address this issue with a timely improved 
regulatory process. Thank you for your leadership.
A Call to Action by the AAVMC/APLU Task Force on Gene Editing of 
        Livestock
    In 2020, a task force on gene editing of livestock was assembled by 
joint efforts of the AAVMC and APLU as an effort to generate a blended, 
yet cohesive, perspective on how applications of gene editing in 
livestock could be regulated within the U.S. WSU leadership worked with 
colleagues in the AAVMC and APLU to establish the task force and charge 
it with addressing mutual interests of the developer, Federal 
regulatory entities, animal, and consumer. To this end, a group of 
academicians with international reputation as experts in the science of 
animal genetic engineering, commercial sector representatives, 
engagement specialists, and animal bioethicists were assembled as a 
thinktank. The task force was effective in melding of perspectives 
voiced by these groups into a series of recommendations that were 
provided to Federal regulators for consideration when envisioning what 
a modernized and progressive framework for the regulation of gene 
edited livestock in the U.S. should be.\10\
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    \10\ https://www.aavmc.org/wp-content/uploads/2021/07/AAVMC-Gene-
Editing-Report-12.pdf.
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Conclusion
    George Washington once wrote that, ``I know of no pursuit in which 
more real and important services can be rendered to any country than by 
improving its agriculture, its breed of useful animals, and other 
branches of a husbandman's cares''. This statement was relevant 200 
years ago and still rings true today. The U.S. has been providing 
leading edge innovation in animal agriculture for nearly 100 years and 
the next frontier in devising strategies to effectively feed a growing 
global human population will be defined by gene editing technologies. 
Harmonization of the regulatory processes beyond the U.S. is key and 
the regulatory community across the globe look towards the U.S. for 
stewardship and leadership. For the U.S. to remain as a world-wide 
leader in shaping how livestock products are produced in sufficient 
quantity to be cost-effective sources of high-quality protein in the 
human diet, the Federal regulatory landscape for approving and 
monitoring of genetic engineering applications must evolve and align 
with the interests of the developer and consumer. To this end, a 
coordinated assessment and approval process between the USDA and FDA 
will be essential in establishing a framework that is streamlined, 
cost-effective, and ensures safe food, with the decision-making process 
anchored on logic and science-based fact. Humans have been consuming 
animal products with mutations in DNA that arose naturally and were 
propagated by way of selective breeding for thousands of years. Thus, 
developing a regulatory channel for approval of animals possessing gene 
edits that could have arisen in nature as safe for human consumption 
should be considered.
    Thank you for the opportunity to testify before this panel today 
and I would be glad to address your questions.

    Mr. Costa. Thank you, Dr. Oatley, for that informative 
testimony, and I think President George Washington was correct 
in his observation then, and I think that is instructive for us 
today. Now we are at that opportunity, having completed the 
testimony, where Members will be recognized for any questions 
or comments they wish to make in order of seniority, 
alternating between the Majority and Minority Members, both 
between the Subcommittee on Livestock and Foreign Agriculture 
and the Subcommittee on Biotechnology, Horticulture, and 
Research. And I want to once again thank our Subcommittee Chair 
Stacey Plaskett for her graciousness, and her efforts with her 
staff, to, in a very challenging sort of way, pull together 
these two Subcommittees for this joint hearing in a completely 
Zoom environment. This is not a hybrid. It is all, obviously, 
virtual.
    But, realizing that, I will, as best as I know--and please, 
for all the Members that are participating, please let your 
staff know, to the--our Subcommittee staff, I will recognize 
you in the order that the staff passes me the cards, in terms 
of the times that you have been there, trying to recognize 
Majority and Minority Members on an alternating basis. And, 
again, the suggestion that we be careful about having our 
microphones muted when we are not having our 5 minutes to ask 
our questions. With that said, I will recognize myself for 5 
minutes, and let me begin.
    Mr. Bobo, you talked about how biotechnology can help solve 
environmental problems. In my home State of California, with a 
strong environmental ethic, we have seen the challenges both in 
droughts and fires. As a matter of fact, we say we no longer 
have a fire season, we have a fire year. What can be done to 
help improve crops, given the extreme drought conditions we are 
facing in the West, and other parts of the world? Would you 
please comment?
    Mr. Bobo. Yes, I will, and I am sure that Dr. Fan-Li Chou 
has a lot to say on this as well. But I think, certainly, 
drought tolerance is something that we need to begin breeding, 
well, we have been breeding in, but needs to be more of a 
focus. We need to not--ensure that it doesn't have any kind of 
a yield drag, because it is not enough that we are able to 
create crops that are good when years are bad, but they also 
have to----
    Mr. Costa. We are trying to produce more with less, right?
    Mr. Bobo. Yes, and they have to be able to perform when 
conditions are good, as well under the drought conditions. And 
so I think that there needs to be an effort on that, but also, 
in terms of--it is not just the biotechnology, but it is also 
in the agricultural practices, to ensure low, minimal drip, and 
irrigation, and other things. So it is going to be a 
combination.
    Mr. Costa. Well, we have done a lot of that in many parts 
of American agriculture. Dr. Fan-Li Chou, do you have anything 
to add to that?
    Dr. Chou. Sure. I was just in California a few weeks ago, 
and just talked to some of the farmers on the ground. I think, 
from our perspective at ASTA, seed is one thing you cannot 
replace, right? No matter whether you are going to have better 
fertilizers or better water use, you have to start with the 
seed. So for the genetics--the best seed to be able to 
germinate under drought conditions, or under less water 
conditions, is super important. And once that seed germinates a 
plant, how it uses water efficiently is very, very important.
    There is lots of research that is happening at UC Davis on 
lettuce, which is grown very widely in California, and which I 
think every single one of us probably eats every day, or if we 
don't, we should. So I think there is a lot of research been 
working, and rice. So there is lots of excitement around this, 
because water is one of the most--both limited and expensive 
inputs, if we are talking about California, into agriculture, 
and how we can limit that, if this would be useful not just for 
agriculture, but across the board.
    And I think too, as you are thinking about increased 
precision of water usage, increased precision of herbicide or 
fertilizer, plant breeding and plant genetics can help with 
that, right?
    Mr. Costa. And on that point, the partnership--you talked 
about UC Davis, which is one of the premiere land-grant 
universities in the country on ag science, how do we best 
utilize the public-private partnerships today, from a 
standpoint of innovation?
    Dr. Chou. So for public and private, it is the foundation 
of U.S. agriculture. It is been around for a long time. The 
public universities take on fundamental research. It trains our 
scientists, it trains the next generation workforce. The 
private-sector takes on the burden of the long regulatory 
process, the long process of investment, of financial burden, 
to take a very promising product to the commercial space, and 
they have the resources, both financial and long-term horizon, 
to do that. Universities do not have the time to do that, or 
money.
    Mr. Costa. Correct, and I would like talk to you more about 
that, in terms of the time. My time is expiring, so I want to 
make sure I get my questions in here. Mr. Bobo, we talked about 
phytosanitary standards, and both Mr. Johnson and I commented 
upon a level playing field. The farm to fork strategy that we 
see in Europe, which has important goals, but is it well 
thought out, and its application around the world, and possibly 
here in the United States? I would like to get your thoughts.
    Mr. Bobo. So the farm to fork strategy is focused on 
reducing the impacts of agriculture, which means that they are 
going to be producing less food in Europe. As a result, they 
are going to be exporting their agricultural footprint to the 
rest of the world. The country that sends the most food to 
Europe right now is Brazil, the largest deforester on the 
planet, so that is going to create challenges for the rest of 
the world. In some respects it is an opportunity for the United 
States, because if they can't produce the food themselves, 
somebody else has to produce it, but it is actually challenging 
for the rest of the world if Europe, one of the largest 
producers, chooses low productivity in a world in which we 
actually need to be producing more food.
    Mr. Costa. Well, thank you. And I would like to--Dr. 
Oatley, you talked about gene editing, and provide more food 
with less inputs. You want to be--tell us where the--I mean, we 
have same-sex semen, we have genetics in dairy that are 
allowing us to produce more lactates and nutrition portions of 
milk products that we have never seen before. My time has 
expired, but I would like you to comment on that at a later 
date, if you could think about that, and I want to defer now to 
my Ranking Member, Representative Johnson from South Dakota.
    Mr. Johnson. Thank you, Mr. Chairman. I suspect all of our 
panelists know that Mexico recently published a decree 
announcing their intention to phase out a number of different 
important agricultural technologies, and included in that 
announcement was that they wanted imports of biotech corn for 
human consumption to be eliminated in Mexico by 2024. This is 
in contravention of the bulk of scientific evidence, and it is 
in violation of USMCA, and we are seeing more and more of this 
kind of maybe protectionist, or maybe overly cautious approach 
toward innovation and technology, so we have a mixed panel 
here.
    So for folks who know a lot about crops, I want 
specifically for them to share with us what Congress should do, 
given this threat from Mexico, and then for the folks who know 
more about livestock, tell us to what extent we are seeing 
similar behavior in the international marketplace on the 
livestock and animal side, and what Congress should do about 
that. Let us go in the order of the presenters who spoke, so, 
Dr. Fan-Li Chou, you are first.
    Dr. Chou. Thank you, Congressman Johnson. I think the USMCA 
actually has a chapter on agricultural biotechnology, and it is 
not just plant-focused, even though most of our trade right now 
is in plants, but it is--it can be used across the board, so I 
think it is really important for us to enforce that chapter. It 
creates a mechanism to settle trade disruption, it creates a 
mechanism to minimize trade disruption, and it also creates a 
mechanism for us to talk about the future technologies that we 
are going to use in agriculture, so it is full of current-
looking and forward-looking. So I think it is important for 
this Administration to really use that biotechnology text, 
because it is actually the first time that we had a biotech 
text in a trade agreement, and I think that is great precedent 
for us to use that in other forums as well.
    I think it is very short-sighted of Mexico. We are all 
not--it--global climate change--it is a global climate change, 
not a U.S. climate change. They need to produce food, we need 
to produce food, and you don't want to cut off your arm just to 
do things with one hand tied behind your back. But I think, as 
we look forward to gene editing, there is an opportunity that 
we are all, across the world, looking at. Many governments are 
taking their GMO position, and rethinking it in light of gene 
editing, because it is working within the plant's own genetic 
resources and own genetic gene pool. So I am hopeful that 
Mexico will take a look at that, and really rethink how they 
look at the future of the 21st century, and not look backwards.
    Thank you.
    Mr. Johnson. Thank you very much. Dr. Rice?
    Dr. Rice. Thank you. Mexico is a key market for our pork 
producers, and as we invest a lot into PRRS-resistant pigs 
today, we are facing a very uncertain future for this very 
important product to come to the market, because if our 
producers cannot export pork to Mexico, that will close door 
for this important product. And, saying that, we also know, 
because we had a lot of conversations with pork producers in 
Mexico, that they are very interested in this very critical 
trade for them. They are facing a lot of diseases, just like 
every producer everywhere else, and this inability for us, or 
uncertainty with Mexico, really creates a significant barrier 
for all trades that we can bring to our producers. So having 
our government to work on the trade agreements with Mexico is 
absolutely critical. Thank you.
    Mr. Johnson. Mr. Bobo, about 45 seconds, and then Dr. 
Oatley after that.
    Mr. Bobo. Sure. Dr. Chou already spoke to the regulatory 
aspects. I think I would just add that there is also the human 
impact in terms of food security. This is going to dramatically 
increase the cost of food in Mexico, but there aren't a lot of 
other markets for that corn that are not biotech, and so, if 
they are going to produce dramatically more corn in Mexico, it 
is going to be with more modern varieties, which is going to 
eliminate a lot of the land races that are in Mexico which are 
traditional, and so it is actually going to have an impact on 
sort of the global center of biodiversity for maize to move in 
this direction, so there is both an environmental impact, a 
long-term consequence of food security, and current hunger that 
I think we will see rise out of this decision.
    Mr. Johnson. Thank you. Dr. Oatley?
    Dr. Oatley. I agree with everything that has been said so 
far. I just want to reiterate one point, and that is, on the 
animal side at least, a lot of the gene editing changes that 
are being made to the genome of animals can, and likely do, 
arise in nature at some level, and I think that needs to be 
taken into account when we are talking about regulation of 
trade of animal biotechnology products amongst countries.
    Mr. Johnson. Yes. I think that is all very well said. Thank 
you to the panelists, and this is a serious threat, and we want 
to work with the global community to make sure we get this 
right. Too much is at stake environmentally, too much is at 
stake from a hunger perspective. We need American leadership 
now more than ever. Thank you, Mr. Chairman, and I yield back.
    Mr. Costa. I thank the gentleman from South Dakota. Now it 
is the Chair's pleasure to recognize the Subcommittee Chair 
from the U.S. Virgins, Chair Stacey Plaskett.
    Ms. Plaskett. Thank you very much, Mr. Chairman, and thank 
you again to the witnesses who are here with us. This is a 
question that is directed to Mr. Bobo. I just want to know, are 
there reasons to be cautious, or to be optimistic, in using 
agricultural biotechnology as a tool to advance climate change 
adaption and mitigation in plant and animal agriculture? I just 
want to know your thoughts on this topic.
    Mr. Bobo. Well, in terms of the science, I am actually 
dramatically hopeful. If we were farming today with 1960s 
technology, we would need one billion additional hectares of 
land in order to produce the food we do, which is more than \1/
4\ of all the forests on the planet. So innovation has saved 
more forest than agriculture has led to the destruction of. I 
think that it is not a question of can we do it, it is a 
question of will we choose to do it. Science tells us what we 
can do, but the public tells us what we should do, and 
therefore it is critical that there is transparency and 
engagement with the public so that they have trust in the 
companies that are developing these technologies so they will 
allow us to bring them to market.
    Ms. Plaskett. Thank you. You talk about what science is 
doing, and the research and the work that is really advancing 
at a rapid rate. Does the U.S. regulatory system guide or 
inhibit innovation in agricultural biotechnology, and what 
improvements, if any, should there be made to support 
innovation, while at the same time reacting positively and 
responsibly to the concerns of people as well? And that is for 
any of the witnesses.
    Mr. Bobo. Yes, I can begin. Certainly I think the U.S. 
regulatory system is recognized around the world as being a 
leader, however, I do think that we need to ensure that the 
level of regulation is consistent with the threat that is 
actually there, or the risk that is there. And with many of 
these technologies, the risk is not actually much higher than 
with traditional breeding, and in many cases it is exactly the 
same, or even less, and so we need to ensure that there is that 
balance between actual risk, and then there are tradeoffs 
between the choices that we make. If we choose not to apply 
these technologies, then we will be living with the 
consequences of increased climate change, increased hunger, and 
other things. And so we really need to keep those in check.
    And, finally, the United States could be doing a lot more. 
Much of this has come down to political will, that the 
regulations, if there is political will, you can move more 
quickly. Europe's regulations are not all that different than 
the United States. There is just a lack of political will that 
allows products to come out the other end of the regulatory 
system.
    Ms. Plaskett. Thank you. Is there anything, Dr. Oatley, Dr. 
Chou, that you would like to add?
    Dr. Oatley. Yes, I would like to add that the Federal 
regulatory framework that exists now is not necessarily a 
hindrance, it is just it was created for technologies that were 
developed several decades ago, and gene editing is quite 
different than conventional transgenesis that uses recombinant 
DNA. And so I think modernization is needed in order to speed 
up the process for assessment, as well as monitoring. I think 
many in the academic world view it as glacial and somewhat 
ambiguous at the moment, and I think that needs to be improved 
on as we are developing some of these gene editing applications 
that, again, can and do arise in nature, and are somewhat more 
precise than kind of a messy system that is selective breeding. 
And so I think those things need to be taken into account as we 
are looking to modernize what the Federal regulatory landscape 
looks like.
    Ms. Plaskett. Thank you. You talked about gene editing. Dr. 
Chou, can you talk--at the University of the Virgin Islands, we 
are doing research in biotechnology application and traditional 
Caribbean crops. Dr. Oatley just talked about gene editing 
solutions. Are any emerging technology or gene editing 
solutions related to staple or specialty crops like these? Is 
any of that work being done that you are aware of?
    Dr. Chou. Yes. So this is the exciting thing about gene 
editing in plants, is that it is applicable across all crop 
varieties. So we are doing--there is lots of work being--
happening in fruits in vegetables, in casaba, in African 
countries that it is a subsistence--sorry, can't say that 
word--crop, and I think that is the excitement. I was a 
research scientist, and the seed science seems really fast, but 
it is quite slow. I am sure Dr. Oatley has been working on his 
project for years and years, and gene editing and plant 
breeding has been occurring for years and years. So the speed 
of regulation seems to be even slower, and we need to kind of 
speed that up a little bit so that, as the science advancements 
are getting ready to commercialization, that the regulatory 
processes are there to meet it.
    Ms. Plaskett. Thank you. Thank you so much. My time has 
expired. I want to thank you, my fellow Chair, for this 
opportunity. And, as I am hearing these questions and these 
answers, yes, there is regulatory work that we need to do on 
our end, but we really do rely on all of you, as witnesses, and 
the industry to make the information that you are doing with 
gene editing palatable, and such that the layman can understand 
so that our constituency and others are not afraid of what is 
happening, that they have comfort in the work that you are 
doing that will then give us some leeway to be able to support 
your work as well. Thank you.
    Mr. Costa. Well, I thank the Chair, and I think your point 
is well taken, and, in my own conversations with our 
counterparts within the European Union, and Members of the 
European Parliament, I think creating the trust factor, as we 
try to meet the demands of a growing world population, and 
understanding that--about biotechnology, and food, and plant 
science--animal science that we are not going to be able to do 
this. And we already know that we have almost a billion people 
that are malnutritioned, and in need of good food, so it is a 
challenge, and you are correct to point this out. It is more 
work that we need to do with both Subcommittees, I believe.
    Our next witness--excuse me, our next Committee Member to 
be recognized is the Ranking Member, Mr. Baird, from Indiana, 
and you will be recognized for 5 minutes.
    Mr. Baird. Thank you, Mr. Chairman. I really appreciate you 
having such knowledgeable witnesses testifying today, and I 
really enjoy these kinds of committee hearings. But I am going 
to start with Dr. Rice, because I am excited about the work you 
are doing with PRRS-resistant pigs through gene editing, and I 
am going to select this question because I think it has an 
impact not only on producers, but it has an impact on 
consumers, so it is just one example of what we can do to help 
promote disease resistance.
    PRRS is a threat to hog farmers of all sizes. The disease 
attacks the pig's reproductive and respiratory systems, and it 
makes it difficult for them to breathe, as well as to give 
birth. And it can devastate an entire herd of 1,000 pigs in 
just 2 short months. I think African Swine Fever may be even 
faster than that. But, unfortunately, it cannot be effectively 
prevented or treated by traditional veterinary medicines or 
vaccines. So could you talk about Genus's technology on 
developing disease resistant pigs using gene editing?
    Dr. Rice. Yes. Thank you for this question. The research on 
PRRS resistance was done originally by Missouri State and 
Roslin University of Edinburgh. So, as a company, we took that 
challenge to bring this very important product to the market. 
So it took us quite a few years to develop the right 
technological approach to make resistance in the pigs, and 
what--I think most importantly, we started our interaction with 
the FDA, and entered the regulatory process with the FDA, last 
year. The gene editing is really--it gives us a really simple 
tool. We are deleting one very small portion of the gene, and, 
as a result of that, the virus cannot enter the body of the 
pigs. So basically pigs become--they don't see the virus 
anymore. There is no foreign material being inserted in the 
genome of the pigs. It is really just one small deletion. So 
pigs continue to grow the same way, they develop the same way. 
There is absolutely no other differences, except that those 
pigs cannot get sick from PRRS virus.
    So as we entered into the regulatory process last year, we 
have very good relationship with FDA. We have a lot of 
discussions. At the same time, the process is very long. Why? 
Because we need to show and demonstrate different trait--well, 
confirm our testing across multiple generations of pigs. 
Because of the life cycle of the animals, it takes quite a few 
years, so we assume it would be at least 5 years before we can 
bring this to the market.
    Mr. Baird. So has this been in the process for 5 years? Is 
that what I am understanding?
    Dr. Rice. Well, we will be finishing all required--by the 
end of 2023, and we hope that we will get approvals in 2024.
    Mr. Baird. Okay. Super. Dr. Oatley, given your veterinary 
medicine background and so on, do you have any thoughts to add 
to this on disease resistance, and how we might use gene 
editing and so on?
    Dr. Oatley. Thank you for the question. I think gene 
editing strategies provide an opportunity to create pigs that 
are resistant to pathogens like PRRS, even addressing African 
Swine Fever. One of the interesting things about African Swine 
Fever is that both domestic pigs as well as wild warthogs are 
hosts for the virus. However, only domestic pigs are 
susceptible to the disease, and warthogs are asymptomatic. And 
so there is potential to identify what is unique about the 
warthog genome that allows them to be resistant to the virus, 
and then use gene editing to engineer that into a domestic pig. 
So I think those are some of the concepts that can come out for 
getting disease resistance across the spectrum of pathogens 
that infect and harm our livestock.
    Mr. Baird. Thank you. And I see I have 12 seconds left, so, 
Dr. Fan-Li Chou, I appreciate you being here, but I can't ask a 
question, and same for you, Mr. Bobo, but I appreciate all of 
your answers. All right, I yield back.
    Mr. Costa. I thank the gentleman from Indiana for his 
questions, and our next Member to be recognized is 
Representative Jahana Hayes from Connecticut. You are 
recognized for 5 minutes.
    Mrs. Hayes. Well, thank you, Mr. Chairman, for having this 
very important hearing today. Genetic engineering is woven 
throughout Connecticut agriculture and agricultural research. 
UConn Extension, which is in my district, was among the first 
in the world to clone animals and have an active hemp and 
cannabis genetic program. Connecticut dairy farmers use 
genetically modified corn, beet pulp, and soybeans for 
livestock feed and feed rations.
    Another area of genetic engineering research happens in my 
district as well, and it relates to environmental protection. 
UConn Extension is researching how they can breed plants to be 
responsive to climate change. So, Dr. Chou, can you give me a 
few examples of how gene editing can lead to climate change 
mitigation, and what applications of biotechnology have proven 
most effective for addressing climate change in agriculture?
    Dr. Chou. Thank you for the question. Let me just say that 
climate change is the most pressing issue facing our farmers 
right now, and it is because of the unpredictability of the 
climate they have. In California they have been historically 
dealing with a drought, but then just recently they had a huge 
bunch of rain, and it is difficult for farmers to adjust to 
that. I think plant breeding has a lot to contribute to climate 
change, both from an adaptive perspective, and also from a 
mitigation perspective.
    On the adaptive perspective, we can breed plants that can 
adapt to drought conditions or to high water conditions, right? 
From the mitigation perspective, there are scientists that are 
working on making plants with stronger roots that can sequester 
carbon for longer. They are creating plants--new cover crops 
that farmers can plant when the fields are fallow to keep the 
soil healthy, but instead of just having a non-economic crop, 
these oil seeds are now gene edited so it can be fed to 
animals, and that creates a cash crop for the farmers.
    So we, as the plant research community, are really excited 
about these kind of things that could occur, but I think for us 
it is not just about climate adaptation and climate mitigation, 
it is all about creating food, and making food, and making that 
food nutritious and tasty for consumers across the board, 
right? So we are also looking on nutrition security. So berries 
is something that everybody likes--I have two small children--
but they don't last very long in my fridge. So just thinking 
about making berries more available, and more shelf friendly, 
shelf--stay fresh longer for consumers, that will have 
tremendous benefit, from a nutritional perspective, for us, and 
for the value chain, so you can stay on market shelves longer.
    So these are the things that are really important. And I 
think the last thing I want to mention is food waste, right? So 
I have little kids. Every time I cut an apple, if it is brown, 
they won't eat it. There is nothing wrong with that apple, 
right? It tastes fine. So there is lots of work working on non-
browning apples, non-browning potatoes, non-browning lettuce. 
So it is not about just producing enough food, but also, like, 
using the food that we are not producing and not wasting it. 
Because every time we waste food, we are wasting resources. We 
are wasting water, we are wasting labor, we are wasting gas. So 
I think those, across the board, are all the things that we 
need to do from a climate-friendly perspective in agriculture.
    Mr. Costa. Would the gentlewoman yield?
    Mrs. Hayes. Yes. Yes, Mr. Chairman.
    Mr. Costa. Just a quick question, how much food is 
estimated that we waste in the United States each year?
    Dr. Chou. I don't have that figure off the top of my head, 
but I would think it is--so for potatoes, it was the--there is 
a study that demonstrate--if we can just have non-browning 
potatoes, we will save 1.5 billion pounds of potatoes a year. 
That is a lot of French fries. So I think if you take that 
across apples and lettuce--like, just think about all the 
lettuce we throw away when it gets brown, and we don't finish 
it by the end of the week. It is a lot. And that is just in our 
kitchen.
    Mrs. Hayes. Thank you, Dr. Chou. I can tell you that you 
have made my colleague, Representative Schrier--Ms. Schrier 
very happy, because this is something that she talks about 
often. I just have one follow-up question. Even with these 
exciting developments, I have also heard concerns that gene 
editing may drive reliance on environmentally detrimental 
herbicides. How do you believe we should balance our efforts 
with climate change mitigation with those concerns?
    Dr. Chou. I think if you look at the research that is 
happening right now on how gene editing is used in crop 
species, and even in animals, it is broader than just herbicide 
use. We are talking about nutrition, we are talking about water 
usage, we are talking about things that would allow us to use 
less inputs. So I think we have to think broadly, and not think 
about how we use agricultural biotechnology, the 20th century 
agricultural biotechnology, but thinking more ahead in the 21st 
century. As we are learning more about plants, we are getting 
more precise about how we are doing things, and I think that 
creates a lot of opportunities.
    So at ASTA we actually have a website called Innovature 
that talks about food. It doesn't talk about agriculture, it 
talks about food, and how plant breeding impacts our lives both 
from an environmental perspective, but a health perspective. So 
I really encourage you all to take a look at that, because it 
is very appealing for foods. I did not start in ag, so I think 
it is targeted at folks that are not in ag, which really need 
to understand and appreciate all the efforts we all put into 
agriculture.
    Mrs. Hayes. Thank you so much for being here today, and for 
working with us on sustainable agriculture. As we look for ways 
to address food insecurity, that is something that is big for 
me, so thank you very much for your work in this area. Mr. 
Chairman, with that, I yield back.
    Mr. Costa. Well, thank you very much, Representative Hayes, 
for your good questions, and for yielding. I appreciate that. I 
had Committee staff just send me some numbers that--the amount 
of food that is wasted in the United States is in excess of--
depending upon the different products we are talking about, in 
excess of 30 percent. It is a very significant number, and we 
have to figure out a better way to deal with that waste issue.
    The next representative that staff has put before me, and 
that is the order I am going on, is Representative Crawford 
from Arkansas. Representative Crawford, you are recognized for 
5 minutes.
    Mr. Crawford. Thank you, Mr. Chairman, I appreciate it, 
appreciate the hearing and the presenters, and I will throw 
this out there just to anybody what might want to address this 
topic. Mr. Baird alluded to this earlier in his questioning, 
African Swine Fever is a significant threat to our food supply, 
our economy, our environment, and it was recently detected in 
the Caribbean, and has also caused the loss of more than seven 
million pigs in Asia, Africa, and Europe. I am just wondering 
if anyone wants to comment on biotech research specific to this 
disease. What are the prospects of using biotech to protect the 
nation's swine industry as it applies to African Swine Fever?
    Dr. Oatley. As I mentioned to Mr. Baird about the warthog 
being a host for the virus, but resistant to the virus, whereas 
the domestic pig is susceptible to the virus, there has been 
some research in trying to understand what is unique about the 
warthog that allows it to be resistant, and hopefully find the 
genetics to drive that trait, and engineer that, using gene 
editing, into domestic pigs. I think it is at the very 
beginning stages of concept, from a research and development 
standpoint, but I think applications like that hold great 
promise for us to be able to address big problems like African 
Swine Fever.
    Mr. Crawford. What about biotech that can be developed and 
used to reduce the need for antibiotics? As you know, 
antibiotics are, and continue to be, a controversial topic as 
it applies to animal agriculture. Any comments on that?
    Dr. Oatley. Yes, I can comment on that as well. We heard 
about gene edited pigs that are resistant to Porcine 
Reproductive and Respiratory Syndrome virus, and I think those 
are likely closest to the public domain. If those were in a 
production setting, there would be less use of antibiotics. 
Another example is gene editing strategies to make cattle 
resistant to bovine respiratory disease, one of the major 
disease problems in feedlot cattle. Considering that one of the 
causative agents of the disease is bovine coronavirus, I think 
that studying a disease like bovine respiratory disease, and 
the viruses that cause it, and devising ways to make cattle 
resistant to it, we would surely learn more about coronaviruses 
in general, and that may be a public win for solving COVID-19, 
or future pandemics as well. So somewhat related to antibiotic 
use, but studying disease resistance in livestock I think can 
be a win-win for the public.
    Mr. Crawford. And research going on addressing BSE, and 
FMD, and others?
    Dr. Oatley. Yes, I am not as familiar with where the state 
of the art is for those diseases, but perhaps others on the 
panel know more.
    Dr. Rice. Yes, I can add few words here. So there is 
research that we proactively engage on, for example, such 
diseases as influenza, and in cattle, BRD. And all these 
diseases, the biggest problem, that producers have to treat 
sick animals, and very often antibiotics are used as a 
preventative measure from secondary effects caused by the 
virus. So it is not directed at the virus, but more of the 
secondary effect. If we--and we show with research on PRRS--if 
we can prevent the key reason for the animal getting sick, 
being affected by the virus, then the use of antibiotics in 
general will significantly go down.
    Mr. Crawford. Let me switch gears a little bit. I am 
concerned about China and Mexico not fulfilling their biotech 
trade obligations under the China Phase One agreement and USMCA 
respectively, and, quite frankly, I have some questions on 
whether the Administration is doing anything to address the 
problem. But I am just wondering what impacts this might have, 
this flagrant disregard for established trade obligations, what 
impacts that might have on future research and development in 
the biotechnology space?
    Dr. Chou. Congressman Crawford, if you will allow me?
    Mr. Crawford. Sure.
    Dr. Chou. I think for the research space, we are going to 
go on doing research. Science is going to move on in the U.S. 
But from a trade perspective, it had a huge chilling effect. 
The seed industry is global in nature. We talk about seed 
movement, so as seed as getting freed, and increase from 
foundational seed to commercial seed, it is moved across the 
world many times because of seasonality, and also because of 
the kind of labor we need for making and developing seed. And 
then, when our customers grow these seeds, the products that 
they produce moves across the world. So as other countries are 
taking on an anti-science approach in their regulation, it is 
not a good situation for U.S. seed producers or U.S. food 
producers everywhere.
    I think from my perspective, from our perspective, the 
USMCA and the China Phase 1 agreement has very strong language 
about biotechnology and science-based, risk-based, regulation 
across the board that is consistent with international 
standards, so I think we need to enforce those. But from 
China's perspective, they just put out their 5 Year Strategic 
Plan, and in that plan they made a specific point that they are 
going to modernize their seed system in China. I think it would 
be really--they cannot achieve that goal without using 
technology, so my expectation is that in the future the world, 
regardless of where you are, cannot move forward without really 
taking on agricultural biotechnology like gene editing on 
board. And if you look at China's research strategy, they are 
spending a lot of money on gene editing, so we need to be 
prepared to be as competitive as we can from a research 
perspective, but also from an economic perspective.
    Mr. Costa. We thank you for your comments, time has 
expired, the Chair will now recognize the gentlewoman from 
Washington State, and she has one of her own university 
associate professors who is on our panel, and we are pleased to 
recognize Representative Kim Schrier for your 5 minutes.
    Ms. Schrier. Thank you, Chairman Costa, thank you, Chair 
Plaskett, for holding this important hearing. And first I want 
to take a moment to acknowledge Dr. Jon Oatley from Washington 
State University, in my home state. Thank you for being here, 
and thank you so much for your invaluable work, and taking the 
time to appear before my colleagues and me this morning.
    Speaking of Washington State University, I want to 
highlight a terrific example of the results of innovative 
agriculture research and biotech happening in my district, 
otherwise known as the apple capital of the world. More than 20 
years ago Washington State University's apple breeding program 
first started developing the cosmic crisp apple to be a perfect 
balance of taste, texture, and usability. And in 2019, these 
apples first became available for purchase in grocery stores 
around the country. It was a much-awaited event. Today, WSU has 
planted 17 million cosmic crisp trees all in modern high 
density trellising, with a focus on the future of possible 
machine harvesting.
    Now, this apple was bred to have high acidity levels and 
sugar content that preserves the taste throughout harvest, 
storage, packing, shipping, and sale, and cosmic crisps can 
stay fresh for a whole year in storage, leading to minimal 
waste in packing houses. They also don't brown when cut. We 
have been talking about not browning. This revolutionizes 
school lunches, after school snacks, fruit salads, and it 
further reduces food waste, which we have already heard has a 
very detrimental effect on the environment, in terms of 
methane. Cosmic crisps are also relatively easy to grow, 
compared to other apples, because they don't have a lot of 
physiological vulnerabilities, and these unique characteristics 
minimize environmental impacts and ensure orchard 
sustainability, exactly what biotech innovation should seek to 
achieve.
    Dr. Chou, in your testimony you mentioned research being 
done to develop heat tolerance in lettuce, and, as I am sure 
you know, the Pacific Northwest was hit with a record-breaking 
heat wave this summer that dramatically impacted agricultural 
yield and quality. Can you tell us a little bit more about this 
research, and other innovative work done to help farmers and 
ranchers, and maybe even whether that same type of engineering 
could extend to other crops, like blueberries, and even maybe 
touch on heat, drought, and wildfire smoke?
    Dr. Chou. Sure, thank you. And I just want to put a plug in 
for our conservation side of the ASTA members. So for anytime 
there is--after a wildfire, you need to replant that, our 
members provide the seedlings and the seed to do that. So every 
time we make a new highway, and there is this--up on the--
highway you can see wildflowers or grass, that is our members, 
so we don't just do fruits and veg, and soy, and cotton, we do 
all sorts of things. So I just want to give them a shout-out on 
that.
    Ms. Schrier. Thank you.
    Dr. Chou. I think the drought-resistant--it is a very 
interesting topic, because there are two things that need to 
happen. When a seed goes into the ground, the water conditions 
have to be right for the seed to sprout. And then, once the 
seed sprouted, the drought--the conditions have to be right for 
the plant to grow. And the plant sweats, I want to say, just 
like we do, so it opens its pores and closes the pores, 
depending on weather condition. And scientists are looking at 
that to see whether they can control that opening and closing 
of their sweat pores, if you will, to decrease water loss.
    And Innovature, the website I keep talking about, actually 
has a really interesting story about lettuce, because a plant 
scientist--she was driving around, and there was an abandoned 
gas station, and there was a wild lettuce that was growing in 
the cracks, and she was like, this is not getting water. How is 
it growing? So she took it back to the lab, and there she 
discovered how it was able to germinate and produce, so now 
they are trying to move that gene, or that modification, into 
lettuce that we eat so it is nutritionally--and it tastes 
better. I am sure wild lettuce does not taste very good.
    So this is science, right? Ninety-five percent 
perspiration, five percent inspiration. But science doesn't 
happen so quickly. Like, these scientists have been working on 
drought-resistant lettuce at UC Davis for 25 years. So gene 
editing just allow us to make it more efficient, and more 
accurate, and more effective. It doesn't change the 
fundamentals of science. It does not change the fundamentals of 
plant breeding, or making sure that that variety is performing 
as they need it throughout the years. Before anything heads to 
market, there are so much quality control that goes into it 
before it comes--like the cosmic apple, it did not happen 
overnight, right? And trees take a long time, but the farmers 
have to make sure that everything is performing adequately 
before it reaches the consumer, so there are lots of layers of 
that. So I would really encourage you to check out the 
Innovature website to learn more about drought-tolerant 
lettuce.
    Ms. Schrier. Thank you very much. And I just have to add, 
in a little joking way, inspiration, perspiration, and then 
transpiration. Thank you very much.
    Mr. Costa. Thank you very much, Representative Schrier, and 
thank you for your response to our Member's questions. The next 
Member that I have before me is Ranking Member Thompson from 
Pennsylvania, and then that is followed by Representative Rush 
from Illinois. So, Representative Thompson, you are recognized 
for 5 minutes.
    Mr. Thompson. Thank you. Mr. Chairman, thank you so much 
for a great hearing. I have seen reports in recent years that 
FDA's cumbersome approach to regulating animal biotechnology is 
forcing U.S. academics and developers to consider moving 
research or commercialization of their product to international 
markets. I have a significant concern with that. Dr. Oatley, 
have you heard these sorts of concerns, or seen these sorts of 
moves, among your peers, and if so, what are the implications 
for domestic research, development, and ultimately access to 
innovation for our U.S. livestock producers?
    Dr. Oatley. Thank you for the question. To be short, yes, I 
have heard amongst peers, in various conferences on gene 
editing and food animals that I participate in, discussions 
with my colleagues in the space both within the U.S. and 
outside the U.S. There are always discussions about moving R&D, 
as well as commercialization efforts, to outside the borders of 
the U.S., where a regulatory approval and monitoring process 
may be more streamlined and less costly.
    My opinion, this is not a good thing for access to 
innovation by U.S. livestock producers, nor is it a good thing 
for scientific discovery and innovation. And I think that 
scientists are going to follow paths of least resistance on 
developing their ideas through rigorous experimentation. And 
so, if they can do rigorous and trustworthy science where the 
Federal regulation process is more aligned with the pace of 
development than it is in the U.S., it is always going to be 
considered as a potential option.
    Mr. Thompson. Dr. Oatley, thank you. I certainly concur 
with your opinion. I will say that, whether it is FDA or USDA, 
United States bureaucrats should be the last to deny, and to be 
a barrier, to the continued leadership of U.S. agriculture when 
it comes to science, technology, and innovation. Over the past 
two Administrations we have seen bipartisan recognition of the 
importance of modernizing the nation's biotechnology regulatory 
framework, however, as many of you made clear in your 
testimony, work remains to ensure these regulations are based 
in science, and are competitive globally. Now, whether USDA, 
FDA, or EPA, can any of the panelists given their opinion on 
particular areas that are in need of regulatory clarity, 
improvement, or modernization? And I will leave that to any of 
the panelists that would like to respond.
    Mr. Bobo. I will----
    Dr. Rice. I can start--go ahead.
    Mr. Bobo. I was just going to say, absolutely there is a 
lot of room for improvement, in the animal biotech area, in 
particular, also with gene editing. There are absolutely 
animals that have--products that have been introduced in 
Argentina for approval before they were introduced in the U.S., 
even though the technology was developed here, because they 
didn't know what the regulatory path was in the United States, 
and that is still unclear a decade after we have been looking 
at it. And so we definitely need to clarify those paths to 
market.
    And the reason we are talking about gene editing is because 
genetic engineering has been so slow to be able to bring more 
products to market. The technology is capable of doing much 
more than we are doing, but the regulatory burden and the cost 
is so high that we have moved on to new technologies.
    Mr. Thompson. Very good.
    Dr. Rice. I think I would like to add that we definitely 
need to simplify regulations for gene editing where there is no 
foreign DNA inserted into the genome, and changes can occur 
naturally. We also need to reconsider multiple generational 
testing. Considering animal life cycle, it takes many years 
before the studies can be completed. And, finally, I think 
today we still consider modified DNA in the animal as a drug, 
and it is continued to be regulated. I think that is--provides 
undue burden on producers, and can really limit our ability to 
bring those products to the market.
    Mr. Thompson. All right. Very good. Well, thank you for 
that. And finally, as some of you may know, just last week, 
very appreciative, this Committee passed legislation to support 
research efforts on Chronic Wasting Disease, or CWD, that 
impacts all cervids, a highly contagious prion disease 
affecting cervids across North America, and in my home State of 
Pennsylvania in particular. I have been heartened by the 
development of diagnostic tools to detect increased 
susceptibility and transmissibility of CWD, and with these 
types of advancement already in the works, do any of the 
panelists have thoughts about potential of modern genetic tools 
to improve CWD resilience? And, actually, I would ask to please 
consider a written response, because my time has expired. Mr. 
Chairman, thanks so much. Great job.
    Mr. Costa. Thank you very much, Mr. Chairman--Ranking 
Member, excuse me, but the gentleman from Pennsylvania is 
always welcome. And our next Member is the gentleman with a 
great deal of experience and expertise from Illinois, 
Representative Bobby Rush.
    Mr. Rush. I want to thank you, Mr. Chairman, and I am so 
well pleased, Mr. Chairman, that we are having this critical 
hearing this morning. As a proud Member of the Agriculture 
Committee, as well as the Energy and Commerce Committee, I was 
pleased to join my esteemed colleagues, Chair Plaskett and 
Ranking Member Barrett, earlier this month in sending a letter 
on this very issue to USDA Secretary Vilsack, and FDA Acting 
Commissioner Janet Woodcock.
    Mr. Chairman, we must ensure that our regulatory framework 
is able to work seamlessly across agencies and departments to 
incentivize innovation through--biotechnology. This is the only 
way that we will be able to successfully address the 
challenges, like food insecurity and climate change. That leads 
to my question this morning.
    Mr. Bobo and Dr. Chou, in your testimonies, you both 
discussed the problem of having limited land and resources for 
farming. As we increase the use of biotechnology and related 
innovations in our nation, can you explain what role urban 
farming can play, and how it can be best utilized for the good 
of our nation?
    Dr. Chou. Sure. I think urban farming has a huge role to 
play, not just in producing food, but educating our urban 
population about agriculture. As we have mentioned here before, 
we need science, we need regulation, and we need consumer 
acceptance, and consumer acceptance comes from understanding. 
So I keep mentioning I have two little kids. When they started 
learning, they were still reading Old MacDonald. Old MacDonald 
has not changed since I was a child, and farming has changed. 
They don't have a new Old MacDonald that has AI, drones, 
electronic tractors. They are still talking about Old MacDonald 
with the red tractor. So I really think we need to change the 
way we talk about agriculture, and talk about food, with our 
urban population as early as we can. So urban farming has a 
role to play in that, in producing food for the urban 
population, but also as an educational tool.
    From a plant breeding perspective, urban farming, if we are 
talking about indoor ag, has very different criteria than if I 
was farming in the field in California, or in Illinois, or 
elsewhere. So in that perspective, the genetics of the seed 
that is put in there has to be specific for urban farms, for 
indoor ag, and that is where the plant breeding comes in, how 
we can provide genetics. So I can ask Dr. Rice to talk about 
urban farming from the animal perspective, and Dr. Oatley too.
    Mr. Rush. Mr. Bobo, can you address this also?
    Mr. Bobo. Sure. So I would add, in addition to indoor ag, I 
think community gardens have been growing in many communities, 
and, as Dr. Chou said, I think this gives communities access to 
fresh fruits and vegetables, it gives them access to 
understanding how our food is produced, which gives them a 
better understanding of what goes into that, and the challenges 
that go into that. So while it may not be feeding our 
communities, it is feeding their minds, in many ways even more 
than their bodies, and I think that is critical for regaining 
that great relationship and connection to our food source. But 
it also diversifies our source of food, and I think that is 
critical, going forward, that we need to be thinking about new 
ways of producing food, not just doing it the same way we have 
been doing for 200 years.
    Mr. Rush. Dr. Chou, in addition to making farming more 
efficient, and reducing food waste, does biotechnology have the 
potential to lower the costs of fresh fruits and vegetables to 
make them more affordable, and how specifically would it impact 
food insecurity in lower income communities around the country?
    Dr. Chou. Thank you, Congressman Rush, for that question. I 
think lowering food insecurity in the low-income population of 
the country is really, really important, and some of that has 
to do with shelf life. All right, so, we have lots of--I grew 
up in an immigrant community, so I am aware of the lack of 
supermarkets in some areas, as we buy our food from the local 
bodega, if you will. So to stock fresh fruits and vegetables is 
difficult, because every couple weeks you had to restock 
because the food doesn't stay fresh, like berries or lettuce. 
So if we can use gene editing and other technology to increase 
how food can stay fresher for longer, that will allow some of 
these stores in these neighborhoods to stock shelves, right? So 
I think that is super important, from a food security 
perspective.
    But also making food more nutritious, and more tastier, so 
that we actually eat it. I can put a vegetable in front of my 
child. Whether she eats it or not is a completely different 
story. So I think that is also important, is how we address 
both from the production perspective, but also from the 
consumption perspective. We can make strawberries all year 
round, but if it doesn't taste good, then we are not going to 
eat it. If it cannot stay fresh, we are not going to have it. 
So those are important things from a food security perspective 
as well.
    Mr. Rush. Thank you, Mr. Chairman. I yield back. I yield 
back, Mr. Chairman.
    Mr. Costa. Yes, I am sorry. I was trying to find my mute 
button. Thank you very much, Representative Rush, the next 
Member that I have before me to be recognized is another 
gentleman from Illinois, Representative Rodney Davis, for 5 
minutes. Representative Davis?
    Mr. Davis. Well thank you, Mr. Chairman. Thank you to Chair 
Plaskett, and also Ranking Member Baird, and even Ranking 
Member Johnson. I would like to throw him in there too. This 
has been a great opportunity to actually hear from some of the 
experts in the field. I do want to make sure that we talk about 
these biotechnology advancements and applications well into the 
21st century that have been mentioned throughout this entire 
hearing. And as you know, and has been said, research shows 
that gene editing tools like CRISPR, result in outcomes that 
could technically be achieved through conventional breeding, 
which has proved to be a valuable and promising technology in 
agriculture to enhance the quality, and the yields, and 
sustainability of crops.
    But my question to any of the witnesses right now is 
whether the Federal Government, or any government around the 
world, for that matter, should regulate these edited products 
any differently than their conventionally bred counterparts?
    Dr. Chou. Congressman Davis, I really like the way you put 
that, regulate them any differently, because all food is 
regulated, regardless of how it is produced. All different 
plant varieties are regulated. We have general food safety. So 
I think the question that everyone--all governments around the 
world are answering is whether these products, that could have 
been done through conventional breeding, or occur in nature, 
but we used advanced technologies to do it, whether they should 
be differentially regulated, and that differential regulation 
is what commonly is termed GMO regulation. And internationally 
there is consensus now, growing consensus, that these products 
that could have been done through conventional breeding, but 
the method to get there was different, does not need to be 
differentially regulated, so it does not need to go through the 
GMO regulation.
    So in the U.S. we don't have such a clear-cut GMO in, GMO 
out. We have three agencies that have their own regulatory 
triggers, and their own regulatory policies, and then we have 
all mentioned how important it is for those three agencies, 
USDA, EPA, and FDA, to be coordinated and consistent in their 
policy, both from a scoping perspective, but also from an 
implementation perspective, meaning they need to make timely 
decisions together, not separately. We cannot wait on one. It 
is a three-legged stool that we are sitting on here. So as we 
are looking into the 21st century, USDA has made some progress, 
EPA has made some progress, and we are waiting for FDA to join 
the ranks, so I think there can be better coordination and 
cooperation between the three agencies.
    Mr. Davis. Well, thank you. Anybody else want to take that 
on?
    Mr. Bobo. Yes.
    Dr. Rice. Yes. I want to add here one thing, today we 
regulate in technology. I think the right way would be to 
regulate products. And if products are no different, and not 
outside of what occur naturally, then they should go through 
minimal safety testing regulatory process. So I think that 
small change can make a big difference, not to regulate 
technology, but to look at the product.
    Mr. Davis. Okay.
    Mr. Bobo. Let me just add onto that, they shouldn't be 
differentially regulated, however, if different countries do 
regulate them differently, it is important that governments are 
aware of the changes, and, therefore, the registry that Japan 
has is useful for governments because we want to ensure that 
trade continues to flow as well.
    Mr. Davis. Great. Thank you all for your responses. One of 
the priorities of this Subcommittee is agricultural research, 
and how can we better utilize and leverage any existing Federal 
research programs under NIFA or AFRI, and hopefully AGARDA 
also, once funded, to actually enhance technology, and more 
importantly too, based on my previous question, enhance the 
public's understanding of it. Do you have any suggestions you 
want to make about how we can let the USDA and other regulating 
agencies, know what we expect into the future?
    Dr. Oatley. I think, as a university professor, maybe I can 
begin to address that. I think it probably comes as no surprise 
to hear me say that I think research funding in the public-
sector really is the heart and soul of innovation for 
biotechnology within the U.S. Many of the basic and most 
groundbreaking discoveries happen at our land-grant 
universities. I think our research programs live and die based 
on being or not being awarded extramural funding every year. 
And so every year conducting research at a university becomes 
more expensive and competitive, and Federal funding for 
biotechnology in the animal space has remained largely 
stagnant, or even reduced.
    So being an academic researcher can be quite stressful, in 
not knowing whether you can keep a lab going from year to year, 
and it is becoming more and more of a challenge for faculty to 
convince the next generation of graduate students who are 
trying to train to follow in our footsteps and become academic 
researchers. So, in my opinion, I think if the U.S. is going to 
keep pace with other countries in science and innovation, we 
need to bolster Federal funding for university research through 
USDA, NIFA, and AFRE foundational programs. I also think land-
grant universities have an aging infrastructure for livestock 
research, and this needs to be addressed at some point.
    Mr. Costa. Well, Dr. Oatley, thank you for your response 
and your answers, and I couldn't agree more with your final 
comments--I think it is important that we make those 
investments. The next gentleman is a colleague, and good friend 
of mine, from the Sunshine State we call California, 
Representative Salud Carbajal.
    Mr. Carbajal. Thank you, Mr. Chairman, and thank you to all 
the witnesses joining us today. Dr. Oatley, biotechnology has 
great potential to help address many of the challenges facing 
agriculture in our society today. Academic research is 
essential as we advance these technologies. I have seen 
incredible progress made through universities in my district, 
such as Cal Poly San Luis Obispo. With your experience as the 
Associate Dean of Research at Washington State University, what 
recommendations would you offer Congress to help improve the 
ability to deploy or better utilize important innovations 
happening within our education system?
    Dr. Oatley. Thank you for the question. I think at land-
grant universities our funding for doing research is primarily 
extramurally awarded by agencies, such as the USDA, NIFA, AFRI 
foundational programs. I think that the funding for the 
foundational granting mechanisms through the USDA, NIFA, and 
the AFRI Program, has not kept pace with the cost of doing 
research. It is more expensive now to do animal research than 
it was even 5 years ago. It is more expensive for the personnel 
to do the research. It is more expensive to keep animals on a 
university campus to do research. It is more expensive to run 
the research labs, and yet the funding that is available 
through extramarital grant awards has not kept pace.
    Our infrastructure is also aging. The infrastructure that 
was put in place for conducting livestock research, large 
animal research, at our land-grant universities, and supported 
federally, is aging, and now we are looking to how do we 
improve that infrastructure? Does it come from the private-
sector, or is this something that should be supported at the 
Federal level. I would think it should be supported at the 
Federal level, being a land-grant university. So I think that a 
bolstering of the funding available for basic and applied 
research in the universities, and an improvement to our aging 
infrastructure is desperately needed.
    Mr. Carbajal. Thank you very much. Mr. Bobo, finding 
innovative ways to make our food system more sustainable and 
resilient is becoming increasingly important, however, global 
acceptance of biotechnology products continues to be 
inconsistent, and I know we touched on this with several of my 
colleagues' questions earlier. Mr. Bobo, how have uncertainties 
regarding other countries' approvals of new genetically 
engineered products affected U.S. seed and biotechnology 
companies? What can be done to increase acceptance of 
biotechnology products abroad?
    Mr. Bobo. Yes, so there have been dramatic impacts of the 
decisions that other countries have made. It could be China 
blocking imports of food, which cause disruptions around the 
world. It could be slow regulatory approvals in Europe, that 
cause delays of years in the adoption of products in the United 
States. So slowing down the adoption, increasing the cost, all 
of those things have a dramatic impact, and a chilling effect, 
in other parts of the world, and so there needs to be more 
investment in other places, not just here in the United States. 
But, to be clear, we invest 50 to 100 times more in medical 
health than we do in agriculture, and yet one of the biggest 
drivers of health impacts is food, and the food choices we 
make.
    And so I think that there is a big opportunity to help 
other countries to develop technology so that they understand 
the benefits of these technologies for themselves. Dialogue 
with Europe, the changes that have happened in Japan, I think 
are very encouraging, and we need to leverage those 
conversations with other places like China and Europe. There 
have been recent developments in the UK. They are opening up to 
gene editing. Very critical conversations should be happening 
around that to leverage that movement in order to shape global 
opinion.
    Mr. Carbajal. Thank you very much. Mr. Chairman, I yield 
back.
    Mr. Costa. I thank the gentleman from the great Central 
Coast for his questions and observations. The next Member that 
is in the order given to me is representative from Minnesota, 
Mr. Jim Hagedorn, and that will be followed by the next Member, 
Mr. Lawson, I believe. I am trying to let Members know in terms 
of the order, when you are up next. Mr. Hagedorn from 
Minnesota.
    Mr. Hagedorn. Thank you, Chairman Costa. I appreciate you, 
and the other Chair and Ranking Members for holding this 
hearing, and the witnesses for testifying. I really appreciate 
it. It is a very important subject, and it is one that we 
should keep addressing. I happen to represent southern 
Minnesota's 1st District, which has some of the great grain and 
livestock farmers in our country. We happen to rank number two 
for hogs, as far as the value, I think number three for the 
number of hogs produced, and so, pork production is really 
important to us.
    Long before anybody had ever heard of COVID-19, I was on 
the House floor, and working in bipartisan fashion with many 
Members of this Committee to make sure that we could address 
something called African Swine Fever. And, African Swine Fever 
is one of those things that we really need to make sure we 
protect our producers in America against, at the ports with 
more folks to do inspections, the Beagle Brigade and everything 
else. And, Mr. Chairman, I would encourage you to--maybe we 
could bring the USDA and DHS people down to talk a little bit 
about their plan for how we would address an outbreak of 
African Swine Fever in our country, particularly since USDA 
just found it in the Caribbean. It is getting a little close, 
and we need to do everything we can. So if we can move on that, 
that would be terrific, in the near future.
    The problem with this disease is that it killed seven 
million or more hogs in places like China and Vietnam. It would 
just be devastating if it came into the United States. And it 
wouldn't just be pork producers. We would be talking about 
everybody up and down the chain. Seed corn dealers, you are 
looking at feed mills, implement dealers, packers, truckers, 
grocers, and, of course, consumers would be harmed the most in 
the end, probably, with much higher prices and less choice. And 
all that spills into our rural communities. If pork product in 
areas like ours is down, that means less people shopping on 
main street, going to our schools, and everything else.
    So I say that this is an issue that we should keep 
investigating, and I would ask all the witnesses to please 
chime in. What do you think we can do? If you can, please speak 
about the biotechnology research for African Swine Fever. What 
is going on, where do you think it needs to go, how far along 
are we, that type of thing.
    Dr. Oatley. I can chime in on that question, again, with 
the need to understand why some wild populations of animals are 
resistant to things like African Swine Fever, like the warthog. 
So I think there is biotechnology applications in the form of 
gene editing to try to address that. But I think there is 
another angle to work there, and that is also targeting the 
vector, and that is the tick that is transmitting the virus 
amongst animals. And so I think there is--it is a two-pronged 
approach. Probably gene editing of an animal, but also 
targeting the vector through vaccines, or other strategies to 
eliminate the ticks that are carrying the virus.
    Mr. Hagedorn. Something like that would be quite a bit down 
the road, though, right? We are not talking about even next 
year, it could be a lot longer. So you would recommend that the 
government do everything possible in order to protect the 
country, not allow those hogs and hog products to come in our 
country and disease our population, correct?
    Dr. Oatley. In the short-term, yes.
    Mr. Hagedorn. Any of the other witnesses like to discuss 
this issue a little bit?
    Dr. Rice. I think just recent progress that USDA 
demonstrated the new vaccine against the--by that vaccine. It 
seems to be working better than any previous vaccine we have 
seen, so that is really promising. In terms of biotechnology 
application, we are at the beginning, and it is going to be a 
long time before we will find solution. But I want to say that 
where we are, this other biotechnology trait, might have 
chilling effect on how much investment would be put toward 
this. If we cannot even bring product that already showed 
efficacy to the market, or it takes very long time, and a lot 
of very expensive process, it does have really chilling on how 
much investment will be in the future toward ASF and other 
diseases.
    Mr. Hagedorn. So you recommend common sense regulations, 
streamlined regulations, working internationally, and 
everything else, right?
    Dr. Rice. Absolutely. And make it faster. That would really 
help.
    Mr. Hagedorn. I only have about 20 seconds left. I 
appreciate your answers. This is really a subject we are going 
to continue to press upon. It would be just devastating to our 
consumers, and everybody in the hog industry, if we had an 
outbreak in the United States, so I appreciate everybody 
supporting this effort. Mr. Chairman, I yield back.
    Mr. Costa. The gentleman yields back his time, and the 
Chair will now recognize the gentleperson from Florida, Mr. 
Lawson, for 5 minutes, and that will be followed by 
Representative Feenstra from Iowa. Representative Lawson, you 
are recognized.
    Mr. Lawson. Thank you, Mr. Chairman, for this meeting, and 
Ranking Member, and welcome to all the members of the panel. 
Dr. Oatley, you spoke a little about how American's negative 
perception of food derived from the GMOs has presented a major 
barrier to advancing biotechnology application to improve 
livestock productions. Now, the critical question is, what are 
some of the things that can be done, especially by Congress, if 
we can do anything, to increase public approval?
    Dr. Oatley. Thank you for the question. Yes, I think that 
the public acceptance of biotechnology applications in food is 
absolutely critical. We can do the most important and the 
coolest science in the lab, but if we can't advance it into the 
public because it is not accepted, then what is it for? I do 
believe that there is lack a of understanding about science 
behind biotechnology in the general public domain, and that is 
because it was a narrative shaped 20 years ago, and has been 
handed down from generation to generation. I think the science, 
the application, the importance of the use of biotechnologies 
to improve food production is very different now.
    At Washington State University, we are working towards 
trying to develop a new public narrative on gene editing of 
livestock by interlacing science with bioethics. Prior to the 
pandemic, we were gearing up for a major public engagement 
campaign that would start locally, hopefully grow statewide, 
and hopefully find traction nationally. I do think land-grant 
universities have an opportunity, in serving as a think tank 
and opinion-makers, to play a role in changing the public 
narrative on biotechnology and animals. I guess I would 
encourage Congress to find ways to support that through Federal 
grants, or other ways to fund the efforts that are going on at 
land-grant universities to engage at the public level better, 
even down to having educational programs at our grade school 
and high school levels about what gene editing is, and how it 
can help feed the future.
    Mr. Lawson. Okay. Thank you very much. Within the U.S., 
multiple Federal agencies have regulatory jurisdiction over 
approval of agricultural biotechnology, as you just mentioned 
earlier, and traditionally the process for approval is time 
consuming and burdensome. And this is for the whole panel, in 
your opinion, what are some changes that need to be made to 
streamline the process for approval, and to ensure that small- 
and mid-sized companies can still compete in research, and 
innovation in agricultural biotechnology? For the whole panel.
    Mr. Bobo. Well, I would just jump in and say that the lower 
the regulatory burden, the more companies will be in the field. 
It is guaranteed that if we can minimize the red tape, that 
more companies will be able to do it, and bring products to 
market. Second, I would say that we still need more investment, 
and that would benefit small- and medium-sized companies more 
than others. And, finally, to the consumer acceptance piece, we 
need to bring products to market that people want and love. In 
Japan they are bringing a tomato that lowers blood pressure, 
and they are selling seeds directly to consumers so you can 
grow these heart-healthy tomatoes right at home. And so, we 
need to think about products that are going to be relevant to 
consumers.
    Dr. Chou. Thank you, Congressman Lawson. I think that that 
is one of the things, is to have a product that excites the 
consumers' imagination, right? So we cannot ask consumers to 
accept technology. I think that is difficult. And we have to 
ask consumers to think about what is important for them, from a 
food perspective. So we use Impossible Burgers all the time. It 
has a huge consumer pull, and it does use GMO soybeans. So I 
think the future is here, and we have to make a distinction 
between gene editing, where we are modifying within the animal 
and the plant's genome that could occur in nature, or through 
conventional breeding, and I think that is changing the 
narrative of consumer acceptance not just in this country, but 
around the world. Dr. Oatley, I am sorry, I cut you off.
    Dr. Oatley. No worries. I was just going to add that I 
think the current regulatory framework is somewhat 
unnecessarily cumbersome and expensive for many gene editing 
applications, and I think the process is potentially too 
ambiguous for gene editing, and the pace of review is somewhat 
glacial. So I think if we are going to foster innovation to 
design that farm animal of the future, that gene edits that can 
arise in nature, and be propagated by selective breeding, 
should have limited regulatory oversight.
    Mr. Lawson. Okay. Thank you. Mr. Chairman, I am going to 
yield back, but, for the record, Mr. Chairman, I want to know 
what kind of tomato that is going to lower blood pressure? And 
so if you can get some information back, that will be 
interesting.
    [The information referred to is located on p. 65.]
    Mr. Costa. Well, if I find that tomato, my friend, I will 
make it mandatory that a case be supplied to every Member of 
the Agriculture Committee, because we could certainly use that 
to lower our collective blood pressure.
    Mr. Lawson. Okay.
    Mr. Costa. Which is good health. We will work on that.
    Mr. Lawson. All right.
    Mr. Costa. One of the takeaways of this joint Subcommittee 
hearing. The next person that we have to recognize, Mr. 
Feenstra from Iowa, and then that follows by my friend and 
colleague from California, Mr. Panetta. Mr. Feenstra, you are 
recognized for 5 minutes.
    Mr. Feenstra. Thank you, Chairman Costa, Chair Plaskett, 
and all the Ranking Members, Baird and Johnson. Thank you for 
having this hearing today, very informative. As many of you 
know, Iowa's Norman Borlaug, and all his work, contributed 
extensively to increases in agricultural production using 
genetics, and gene editing, and things like that. So obviously 
I am very supportive of the use of genetic innovation to help 
improve resiliency in our crops, or flocks, or herds, animal 
diseases, and everything. As the U.S. continues to develop 
products through biotechnology, it is important that we 
streamline the regulatory approval process that we just talked 
about. We cannot let our own regulatory hurdles get in the way 
of more productive agriculture and global competitiveness.
    With gene editing and biotechnology, a lack of information 
could also lead to a lack of trust. We are seeing it around the 
world. Dr. Chou, I just want to ask you, back in your time, 
during your time at USDA, what was the position at that time, 
or what do you think the position is today on gene editing of 
our agricultural food products?
    Dr. Chou. I think the position of USDA when I was there 
just a few years ago and now has not changed. We need to use 
all the technology that we have in our toolbox to make our 
agriculture more sustainable, both productive and also 
sustainable, and I think the latest Secretary's initiative on 
that is--it demonstrates that it has not--I think that attitude 
hasn't changed. But I think it is--what we have been talking 
about here is potential. It is a dream.
    We need a plan, right, to achieve what we need to achieve, 
and it is both from a regulatory perspective, how we modify and 
modernize our regulatory system so we recognize this experience 
we have gained in all these years regulating products, and also 
the new science and new evidence that is out there. So we are 
not asking to decrease the regulatory burden unnecessarily, we 
are asking that regulatory burden to be justified by the risk. 
So I think that is all we are--that is what we are asking for. 
So for these new products that could have been done through 
conventional breeding, both on the animal side and the plant 
side, there are multiple layers of oversight both from a public 
perspective and a private perspective that ensure that these 
products are safe for consumption and for production, so that 
additional regulatory hurdles on the government side need to be 
proportionate to the risk we are talking about here.
    Mr. Feenstra. Yes. Yes.
    Dr. Chou. We also need to recenter investment. I think that 
is super important as well.
    Mr. Feenstra. Yes. Yes. Yes, I would agree. I think there 
is a PR issue, a public relations issue, with the public, and 
what the public sometimes perceives as concerns. Do you think 
there is anything that we, or the Department, can do to create 
better perception in this arena?
    Dr. Chou. I think we all have a role in that. I think, from 
a regulatory perspective--the job of the regulatory agency to 
ensure that we have a safe food supply. It is not the job of 
the regulatory agency to ensure that there is market 
acceptance. They need to regulate this on real risk, not on 
perceived risk. It is incumbent on the rest of us in the 
agricultural community to actually talk about why we do the 
things we do. I think Jack mentioned this. We can do lots of 
these things, but why do we do it? We do it from animal welfare 
purposes, we do it from climate change purposes, we do it from 
food security and nutritional security purposes, and those are 
things that matters to consumers, so I think that is where we 
need to focus our attention.
    Mr. Feenstra. Yes. Thank you so much for your comments. So, 
just like my good friend, Representative Hagedorn, I have the 
largest swine production in my district, and obviously I am 
very concerned about African Swine Fever and what is happening. 
Dr. Oatley, does the approach proposed by the USDA in its ANPR 
make sense for animal innovations, and do you see USDA having a 
role in the regulation of animal agriculture innovations moving 
forward?
    Dr. Oatley. Yes, thanks for the question. I absolutely do 
see a role for the USDA, and I am very much supportive of that 
advanced notice for proposed rulemaking that was released by 
the USDA. When it comes to African Swine Fever, as we have 
talked about several times during this hearing already, I think 
if we are going to use biotechnologies, it is probably years 
out before we address that, so we need a quicker solution for 
addressing the potential threat now. But the long-term solution 
rests with biotechnology, with gene editing.
    Again, I think the pace at which the discoveries can be 
advanced from concept in a research lab, to developing through 
a research and development pipeline, and then getting into 
commercial channels, is influenced greatly by the Federal 
regulatory landscape. And so some sort of coordinated landscape 
process that is coordinated between the USDA and the FDA I 
think is critical, going forward. I think many small 
businesses, even academic labs, that are trying to develop 
applications in this space start to just fall off into the 
margins as the process for monitoring and approval becomes more 
burdensome and more costly, and that is stifling to innovation.
    Mr. Feenstra. Yes. Yes. Thank you, Dr. Oatley. I fully 
agree with you. And we have a lot of private organizations and 
nonprofits doing that. Thank you, and I yield back.
    Mr. Costa. I thank the gentleman for your questions, and my 
colleague from California, representing a wonderful part of 
California's Central Coast, Congressmember Jimmy Panetta. You 
are recognized for 5 minutes.
    Mr. Panetta. Thank you, Chairman Costa, and thank you, 
Chair Plaskett, and, of course, the Ranking Members for this 
joint hearing. I really appreciate this opportunity, and of 
course, thanks to all the witnesses who showed up today via 
Zoom. Thank you very much. I want to address just a couple of 
areas. I know a lot have been already mentioned, so let me just 
focus on public-private partnerships, one, and I am going to 
hit Dr. Chou with that question, and then the increasing 
acceptance of biotech abroad, and I am going to ask Mr. Bobo 
and Dr. Rice on that.
    So, Dr. Chou, obviously, thank you for being here. As you 
might have heard mentioned by Rodney Davis, my co-Chair of the 
Ag Research Caucus, we have been able to work pretty well, or 
at least see the success of public-private partnerships, 
especially when they leverage the USDA and its resources. And 
so I was wondering, Dr. Chou, when it comes to biotechnology 
innovation, can you provide some real world examples of public-
private partnerships in action? And if anybody else would like 
to weigh in, feel free to do it, but I will start with Dr. 
Chou.
    Dr. Chou. As you look at public-private partnership that is 
funded by USDA and NIFA, we have to focus on gene editing. 
Because of the regulatory burden for traditional GM products, 
they have never invested in that because it just--they cannot 
meet that regulatory hurdle. So a couple examples on gene 
editing that--is cover crops. There is a consortium that is 
funded by NIFA of public universities all across the Midwest 
states, including a private company, a small company, a startup 
company that is gene editing penny crust, that is a cover crop, 
so that the oils are now edible, and can be used in animal 
feed. So farmers can plant it, from an environmental 
perspective, but they also can sell them seasonal for a cash 
crop perspective. So that is in early commercial stages, and it 
is very exciting.
    And another thing that AFRI has been funding is this 
consortium with another startup company called Pairwise that is 
looking at the genetic diversity within berries, and trying to 
use gene editing to make discovery, but also to implement that 
so the berries can be thornless, can have better nutrition, so 
that there is more availability to consumers and to producers.
    So those are two things that--where there is specific 
investment and utility of gene editing. But I think there are 
some great examples of public-private partnership that goes 
beyond gene editing and plant breeding, right? UC Davis's 
strawberry program putting out 60 varieties, a patented variety 
of strawberries, which is 93 percent of what is being grown in 
California. A great public-private partnership. The GEM 
Program, the program for maize, land-grant universities, 
private companies, bringing--into the U.S. So those are two 
great examples on the plant side for continued public-private 
partnerships.
    Mr. Panetta. Great, great. And I have just got some time 
here, so I want to move on to my next area of questions, and 
that is the exceptions to the biotech abroad. Obviously we have 
heard about the challenges that producers and the biotech 
industry face when it comes to increasing acceptance of 
biotechnology products, not just here, as I think 
Representative Lawson talked about, but also abroad. And we 
know that there are consumers that are very skeptical abroad. 
Obviously here too, but also abroad. How can our government 
help those consumers understand the safety and efficacy of 
those--of these technologies that we have been talking about? 
And, obviously, it is more pronounced, I think in other nations 
than in the United States, so what can we do to help those 
nations come to more of an acceptance? Mr. Bobo or Dr. Rice, do 
you want to take that question?
    Mr. Bobo. Yes, I can begin. This was my job when I was at 
the State Department for 12 years. I traveled to 50 countries, 
met with scientists, policymakers, and others. Within the State 
Department there are outreach funds, so there are PR efforts 
that are done to hold meetings to do workshops and other 
things. Similarly, the Foreign Agricultural Service every day 
is out there having these conversations with other governments 
about their regulations, about the potential of the technology, 
advocating for partnerships with U.S. institutions.
    But the funding for those outreach programs is about $1 
million a year, and when you think about $100 billion industry, 
one might think that we could be investing a little bit more. 
Whenever there is a regulatory or disruption it costs hundreds 
of millions, if not billions, of dollars, and so we could 
provide more resources to those agencies that are on the front 
lines.
    Dr. Rice. Yes, I can just add that we have conducted 
several rounds of consumer research, and what we see out of 
this research that, for consumers, regulatory approval is 
extremely important, as well as safety and testing of the 
product. But also what is important is better communication 
about the benefits of those products. This is on the top of the 
mind for consumer acceptance, and simple answer to your 
question, Congressman, is we need to ensure U.S. regulatory 
framework is functional, fit for purpose, and information about 
benefits is broadly available.
    Mr. Panetta. Great. Thank you, Dr. Rice. Thanks to all the 
witnesses. I yield back. Thank you, Mr. Chairman.
    Mr. Costa. I thank the gentleman for his comments and 
questions, and staff and I have coordinated with my co-Chair, 
Representative Plaskett on this, and what we will do, I 
believe, is--the last Member to ask questions that I have 
before me is Representative Fischbach, and I am told Barry 
Moore from Alabama. So it is the Chair's intention to close the 
joint hearing between the two Subcommittees after the gentleman 
from Alabama has a chance to ask questions, and then we will 
allow a brief opportunity for my co-Chair and the Ranking 
Members, if they have any thoughts that they would like to 
follow up with so that we can--with the busy schedule that we 
all have this afternoon and this week, conclude the hearing. 
So, with that said, Representative Fischbach from Minnesota, 
you are recognized for 5 minutes.
    Mrs. Fischbach. Thank you very much, Mr. Chairman. And, I 
would just like to explore a little bit. I know that 
Congressman Feenstra was talking to Dr. Oatley a little bit 
about the FDA process, and I understand you have firsthand 
experience with that. You used the phrase coordinated 
landscape, which, like I said, you mentioned a little bit 
earlier. I am wondering if you could potentially expand on 
that? What kind of things could we do to improve that process? 
Because I am very, very excited about the use of biotechnology, 
particularly in the ag field, and I think there are great 
strides that we can make, but don't want those kinds of burdens 
in the way of innovation, and we move forward. Can you walk us 
through the process, and maybe offer improvements, or how you 
would like to approach that, since you do have the firsthand 
experience? What can we do to help that process, and 
potentially even lower those costs to get these products, or to 
get this innovation moving?
    Dr. Oatley. Thank you for the question. Now, let me first 
say that my experience with the FDA approval process is at the 
investigational stage. That is the kind of first line of 
communication with the FDA, by opening an investigational new 
animal drug filing, and I do have several of those now. 
Essentially, this allows for communication with the FDA to 
share information about what the gene editing application is in 
a food animal. The FDA has created a few other channels that 
are less bureaucratic, but really they all converge into this 
first step of having an investigational new animal drug filing. 
When you are going from concept, to gene editing application, 
to trying to get final approval, it would be in the form of an 
investigational new animal drug filing.
    With these filings in hand, a developer like myself can 
share information about the concept, provide experimental data 
supporting the concept. At some point, when enough data has 
been collected, and the concept has been matured 
experimentally, then the investigation finally gets converted 
to the next stage, and that is where a more rigorous process 
kicks in, and eventually leading to a decision-making point.
    I think the challenges for developers like myself is the 
ambiguity in what defines the next steps, the ambiguity in what 
information is needed to progress along the process, and, in my 
experience, it seems like it is a show me what you have, and we 
will tell you whether it is good enough approach, and that is 
discouraging for early stage investigators. It is also somewhat 
expensive, if you are not a nonprofit organization. So every 
year that that investigational new animal drug filing exists, 
there is a maintenance fee that is rather hefty, unless we get 
exemptions, by being a land-grant university, from having to 
pay that fee. But if we were a small business, or a large 
company, we wouldn't have those same exceptions, and so it 
becomes quite expensive to maintain those filings, which I 
think suppresses the small business early stage developers.
    I think that having a process where we can streamline the 
assessment and the approval in such the changes in the DNA that 
are being made to animals that can, and probably do, arise in 
nature, are addressed with enforcement discretion, and have 
limited oversight, because we are probably already eating 
products from animals that have these changes. We just don't 
screen millions and millions of animals looking for that rare 
variant. And so I think there needs to be different sets of 
criteria, different paces of oversight, different paces of 
approval, and different costs of those approvals based on the 
type of gene editing that is being pursued.
    Mrs. Fischbach. Thank you very much. And I just have less 
than a minute left, if any of the other panelists wanted to add 
to that? Well, then, thank you very much, Mr. Chairman, and I 
yield back.
    Mr. Costa. I thank the gentlewoman for her comments and 
questions. The next Member of the Subcommittee is Mr. Moore 
from Alabama, who is recognized for 5 minutes.
    Mr. Moore. Thank you, Mr. Chairman, and I appreciate all 
the witnesses appearing before the Committee today. I would 
like to follow up on a few of the questions so far relating to 
the Federal regulation of biotechnologies. Many countries 
around the globe have a single regulatory entity that oversees 
agricultural biotechnologies, but in the United States we have 
three, the USDA, the EPA, and the FDA. Dr. Chou, for our 
education, can you provide sort of a brief overview of what 
role each of these agencies play?
    Dr. Chou. Sure. I will just talk about it from the plant 
perspective, where three agencies play, and it is based on what 
the intended product will do. So FDA will regulate food and 
feed to make sure it is safe for animals and humans to consume. 
USDA will regulate a product for agricultural purposes so it is 
safe for planting, and EPA, it regulates products if there is 
an intended pesticidal effect. It is a little bit in the weeds. 
So only a specific plant that perhaps is bred to protect itself 
against pests, EPA will regulate that.
    So in this way, to Dr. Oatley's point, if you are a 
researcher in a university, trying to figure that out is pretty 
difficult, and so USDA, and FDA, and EPA actually have a joint 
website now that you can ask a question, says, this is my 
product, who should I talk to, and they jointly have to respond 
to and answer. So there are efforts to streamline the process 
and make it more approachable.
    Mr. Moore. Okay. Thank you, Dr. Chou. I have no further 
questions, Mr. Chairman. Thank you.
    Mr. Costa. All right. Thank you very much, Mr. Moore, and I 
believe our last Member to ask questions, or make some 
comments, is Representative Letlow from Louisiana. You are 
recognized for 5 minutes.
    Ms. Letlow. Thank you, Chairman Costa, and thank you to the 
witnesses for your time and testimony here today. Agriculture 
research and innovation is at the forefront of agriculture 
resiliency and sustainability across this nation and abroad. 
Whether it is adopting new practices, implementing new 
technologies, or mitigating for potential risks, research plays 
an essential role in the implementation of new biotechnologies.
    In my home State of Louisiana the LSU Agricultural Center 
is one of nine campuses of the LSU system. Its main focus is on 
research, extension, and teaching, to make advancements that 
will benefit future generations. Research conducted by the LSU 
Ag Center examines ways to expand the food and fiber supply, 
while improving agriculture's valuable contributions to the 
state's economy. Through Dr. Mike Deliberto's research on 
production agriculture at the LSU Ag Center, advances in 
biotechnology have allowed commodity producers to increase 
output in an efficient manner. One example of this great work 
is the Rice Breeding Project at the H. Rouse Caffey Rice 
Research Station in Crowley. Their primary objective is the 
development of superior varieties, with emphasis on herbicide 
resistance, in addition to studies examining the direct or 
indirect contributions of variety development, like milling 
quality, and mutation breeding.
    In 2019 the Food and Drug Administration indicated that it 
would develop guidance for foods derived from new plant 
varieties produced using genome editing. However, it is now 
late 2021, almost 2\1/2\ years later, and FDA has not yet 
published this guidance. To any of the witnesses, how important 
is it to the research and developer community that FDA clarify 
its approach to gene editing, and second, does the current lack 
of guidance have any impact on the consistency of the 
regulatory approach to gene editing internationally?
    Dr. Chou. Congresswoman Letlow, if you can allow me to 
start? I am sure everyone has an opinion on this. I think it is 
really important--as the previous Congressman mentioned, we 
have three agencies, so the three agencies need to be 
coordinated not just in a regulatory approach, but in timeline. 
So right now FDA is not putting out their clarifying policy, it 
is a bit concerning, all right? So we do need all three 
agencies to be coordinated.
    From an international perspective, it makes it difficult 
for us to advocate, and from a public-sector perspective, from 
a government perspective, because our house is quite not in 
order. So in that way, we need all three agencies to get 
together to get our house in order so we can remain leaders not 
just in research and development, and in commercial production, 
but also in regulatory science and regulation.
    So, in my view, we are really looking towards the three 
agencies to work better together so that they are putting out 
policies together, that they are coordinating and 
collaborating. Not just sharing information, but actually 
working together to make sure that there is not too much 
duplicity in the way they regulate, and to be as streamlined as 
possible, especially for these products of gene editing, where 
we are working within a plant and animal genome that could have 
been done through conventional breeding or naturally occurring. 
I know we keep coming back to that point, but this is really 
the 21st century advances that we are trying to talk about 
here.
    Ms. Letlow. Thank you. Would anybody else like to comment?
    Dr. Oatley. May I speak on the animal side, I would say 
that genetic engineering of animals right now goes through a 
drug review process at the FDA. That drug review process was 
set forth by the Federal Food, Drug, and Cosmetic Act, and this 
assigned regulatory oversight of genetically modified animals 
to the FDA. Through interpretation of that authority, 
substances other than food that affect the structure and 
function of an animal are considered to be a drug, and so those 
molecular elements, like DNA, that alter the genome of an 
animal are now considered a drug. And this Act was established 
during a time of genetic engineering called transgenesis that 
used recombinant DNA to alter the genome, put something foreign 
into the genome. That is not the state of the art for gene 
editing, and so I think continuing to regulate it as a drug in 
changes to the DNA that can and do arise in nature is not 
aligned with the state of the art of the science, as well as 
the pace of development.
    Ms. Letlow. Thank you for that comment.
    Dr. Rice. Another point here to bring up that the absence 
of clarity today between three agencies, the fact that animal 
gene editing is being regulated as drug, but not plant gene 
editing, all confuses our consumers. And what we see that--when 
consumers are confused, they refuse to accept the technology, 
and products that originate from the technology, and that is 
what we see as a major issue today, because, at the end, the 
products only will be available to the market if consumers will 
accept them.
    Ms. Letlow. Thank you so much. I appreciate those 
responses. Mr. Chairman, I yield back.
    Mr. Costa. I thank the representative for yielding back. 
Her time has expired. And now, with the support of both 
Subcommittees, I would like to bring this hearing to a close. 
Mr. Johnson has indicated that he has had to leave for other 
appointments. Mr. Johnson, do you have any closing comment you 
would like to make? I guess not. Mr. Baird, do you have any 
closing comment you would like to make?
    Mr. Baird. Yes, Mr. Chairman. I really appreciate that 
opportunity, because I want to express how much I appreciated 
the witnesses today, and the expert work that they are doing, 
and that it really is encouraging to me that we recognize that 
biotechnology in agriculture really does represent a true 
bright spot in the future for our global economy. And so with 
that, I just want to say that we also, in the discussion today, 
recognize that we need to ensure that regulation does not 
stifle the innovation, and the appropriate agencies regulate 
the technology of agriculture, and that where interagency 
cooperation and regulation is unavoidable, that it happens 
efficiently.
    So I can't tell you how much I enjoyed hearing the 
witnesses today. I could just spend the rest of the afternoon 
discussing some of these issues, so I want to make sure that we 
thank them for being here, and I yield back. Thank you.
    Mr. Costa. Okay. Well, we thank you for your enthusiasm and 
your focus, and I will now yield to our colleague and co-Chair, 
who, without her participation, and enthusiasm, and focus, and 
her staff's efforts, this joint Subcommittee hearing would not 
have been possible. So, Chair Plaskett, for any closing 
comments you might like to make?
    Ms. Plaskett. Yes, thank you, Mr. Chairman, and thank you 
so much to my colleagues on both sides of the aisle for what I 
believe was an extremely informative discussion. And, of 
course, to the witnesses, whose expertise has been invaluable 
to us not only understanding what is happening in this field, 
but supporting us in trying to make decisions about how 
Congress plays a role in this. As we bring the hearing to the 
close, I of course want to thank the staff, both mine, yours, 
Mr. Costa as well, in particular the Committee staff who have 
made this possible, and our colleagues who took time to be here 
and ask really pertinent questions.
    As the last year has made abundantly clear, it is crucial 
that we continue to find ways to increase the resiliency of our 
food and agricultural systems. We need to work with researchers 
and farmers to accelerate efforts to develop crops and animals 
that are better suited to adapt to the increasingly severe 
impacts of climate change, and, paired with improved practices, 
better help us mitigate climate change. As well, we have 
learned that there is, in fact, a role both for us as 
regulators, and to the industry to make consumers feel more 
comfortable with the strides that science has made, and I can't 
wait to get to work with my colleague and Ranking Member, Mr. 
Baird, to see how our Subcommittee, working with you, Mr. 
Costa, and others, and Mr. Johnson, as well as the full 
Committee, to make this a reality. Thank you so much, and for 
the time, and I yield back to Chairman Costa.
    Mr. Costa. Well, thank you very much, Chair Plaskett, for 
your comments. I couldn't agree with you more, and I too also 
want to thank the Ranking Members, and I think this has been a 
good use of time by both Subcommittee Members in working 
together on what really is an overlap of interests by both of 
our Subcommittees. The panel experts today provided not only 
important testimony, but I think did a very good job of 
answering the questions. I am sure there will be follow-up.
    One thing that has struck me in listening to today's 
testimony is the technological jump that I think is taking 
place not only in the last decade, but certainly in the next, 
and it has to be. It has to be, with the population growth that 
we have all talked about here, by the middle of the century it 
being almost ten billion people. We are over 7\1/2\ now at this 
point in time, and trying to produce more food for our nation, 
and for this planet, with less is, in light of climate change, 
a tall order, to say the least.
    And--so I think it is important that the takeaways from 
today's hearing is something that both Subcommittees will focus 
on, and our staff, on how we incentivize innovation in 
agriculture, deal with some of the larger threats that we are 
facing in terms of drought, extreme drought conditions that we 
find ourselves in, dealing with efforts that are--provide 
threats, and disease-resistant animals, and drought-tolerant 
crops, two things that are critical to our food supply chain, 
and technology is going to be a key part of how we make 
sustainability a greater part of our ability to produce food. 
Sustainability, frankly, has been a part of our success, but we 
need to do more. We have to do more.
    And I think, as you hear me say regularly, and I think most 
of the Members of the Committee share this thought, food is not 
only a national security issue, but a world security issue. 
Food and fiber that so many folks take for granted, that is on 
their dinner table every night, cannot happen unless we ensure 
that we have a robust and sustainable ability to produce that 
absolutely necessary nutrition for our sustenance, and it is 
important that, with the global dynamics changing, that we 
integrate new technologies into agriculture, and that we can 
prepare for that change.
    So once again I want to thank the witnesses, and the 
researchers, and the advocates that figure out how we can 
continue to build better efforts in terms of public-private 
partnerships with our universities throughout the country, and 
through the private-sector. It has been key on how we have done 
so well thus far, but obviously we need to do more, and have it 
scale neutral for new technologies for our agricultural 
producers. The bottom line is if we do this, we can address the 
challenges of the future for sustainability in the production 
of food and fiber not only for our nation, but for the world.
    So, with that, under the Rules of the Committee, the record 
of today's hearing will remain open for 10 calendar days to 
receive additional material and supplemental written responses 
from witnesses to any question posed by the Members. So, again, 
to our witnesses, who did a terrific job today, we may have 
follow-up questions for you by Members of the Committee, 
because we really want to ensure that the takeaways from this 
joint Subcommittees' hearing are something that we can build 
on, and that is what I hope will take place. So the joint 
hearing of the Subcommittee on Livestock and Foreign 
Agriculture and the Subcommittee on Biotechnology, 
Horticulture, and Research, with the support of my co-Chair, is 
now adjourned. Thank you very much.
    [Whereupon, at 12:43 p.m., the Subcommittees were 
adjourned.]
    [Material submitted for inclusion in the record follows:]
 Submitted Letter by Hon. Jim Costa, a Representative in Congress from 
 California; on Behalf of Sarah Gallo, Vice President, Agriculture and 
           Environment, Biotechnology Innovation Organization
October 26, 2021

 
 
 
Hon. David Scott,                    Hon. Glenn Thompson,
Chairman,                            Ranking Minority Member,
House Committee on Agriculture,      House Committee on Agriculture,
Washington, D.C.;                    Washington, D.C.;
 
Hon. Jim Costa,                      Hon. Dusty Johnson,
Chairman,                            Ranking Minority Member,
Subcommittee on Livestock and        Subcommittee on Livestock and
 Foreign Agriculture,                 Foreign Agriculture,
House Committee on Agriculture,      House Committee on Agriculture,
Washington, D.C.;                    Washington, D.C.;
 
Hon. Stacey E. Plaskett,             Hon. James R. Baird,
Chair,                               Ranking Minority Member,
Subcommittee on Biotechnology,       Subcommittee on Biotechnology,
 Horticulture, and Research,          Horticulture, and Research,
House Committee on Agriculture,      House Committee on Agriculture,
Washington, D.C.;                    Washington, D.C.
 

    Dear Chairman Scott, Chairman Costa, Chairwoman Plaskett, Ranking 
Member Thompson, Ranking Member Johnson, and Ranking Member Baird and 
Members of the Committee:

    The Biotechnology Innovation Organization (BIO) is pleased to 
submit a statement for the record to the United States House of 
Representatives Committee on Agriculture joint hybrid Subcommittee 
hearing, Agricultural Biotechnology: 21st Century Advancements and 
Applications.
Introduction
    BIO represents 1,000 members in a biotech ecosystem with a central 
mission--to advance public policy that supports a wide range of 
companies and academic research centers that are working to apply 
biology and technology in the energy, agriculture, manufacturing, and 
health sectors to improve the lives of people and the health of the 
planet. BIO is committed to speaking up for the millions of families 
around the globe who depend upon our success. We will drive a 
revolution that aims to cure patients, protect our climate, and nourish 
humanity.
Agricultural Biotechnology: 21st Century Advancements and Applications
    BIO applauds the Committee for examining the role of agricultural 
biotechnology in the 21st Century.
    To meet the challenges of a changing climate and sustainably 
increasing production to feed a growing world, it is crucial to lead 
with science and U.S. innovation. We must incentivize the adoption of 
innovative, sustainable technologies and practices; and streamline and 
expedite regulatory pathways for breakthrough technology solutions.
Adoption and Acceptance of Agricultural Biotechnology
    The adoption of biotechnology in agriculture and the development of 
biobased technologies has already contributed to food security, 
sustainability, and climate change solutions. The acceptance of 
biotechnology has enabled large shifts in agronomic practices that have 
led to significant and widespread environmental benefits.
    Ensuring policies and regulations continue to advance innovative 
breakthroughs will be critical. Increasing the use and acceptance of 
these technologies can reduce greenhouse gas emissions throughout 
agricultural supply chains and strengthen producers' resiliency to 
climate change while increasing production and helping tackling hunger 
by bringing more nutritious offerings to all tables.
    BIO understands that consumers want to know information about 
biotechnology in food and agriculture, and our members want to be the 
driver of that endeavor. A proactive approach to transparency stands to 
energize understanding, build trust, and foster an environment where 
innovators, companies, and consumers together can address our most 
pressing societal and environmental problems. BIO supports increased 
openness about products being developed and best practices developers 
use in advancing beneficial products to the commercial marketplace.
    The U.S. has led the way in developing these innovations due to 
thoughtful, bipartisan public policy. This has created a favorable 
climate in which to undertake the lengthy and risky job of investing 
and developing the next biotech breakthroughs; allowed producers to use 
new technologies; and ensured a pathway to market for new products. 
However, America's continued success and leadership are not guaranteed, 
and we should not take its global leadership for granted.
    COVID-19 has also exposed the vulnerabilities and inequalities in 
how communities are disproportionately impacted, our capacity to 
respond to crisis, our ability to maintain our supply chains, and to 
withstand an economic downturn. These challenges will only grow more 
prevalent and damaging because of climate change.
    To ensure America is able to respond to future challenges in 
cleaner, more efficient ways, maintain its global leadership, and allow 
its farmers, ranchers, sustainable fuel producers, and manufacturers to 
have access to cutting edge technologies, the United States must invest 
in new technologies and have risk-proportionate regulations that spur 
biological innovations.
    The government should also focus on removing barriers and assisting 
beginning and socially disadvantaged farmers and ranchers in accessing 
and utilizing these technologies, so all producers can adapt to the 
challenges ahead. By accelerating and deploying innovation, American 
agriculture can be resilient, self-sustaining, and strengthen our 
economy.
    To learn more about these technologies, our companies' innovative 
breakthroughs, and the policies that can allow American agriculture to 
thrive in the 21st Century, please see BIO's past comments to the 
Committee and the U.S. Department of Agriculture (USDA).

   BIO statement for the record to the United States House of 
        Representatives Committee on Agriculture hearing entitled, 
        Climate Change and the U.S. Agriculture and Forestry Sectors, 
        [available] here.\1\
---------------------------------------------------------------------------
    \1\ https://www.bio.org/letters-testimony-comments/bio-submits-
testimony-first-climate-hearing-new-house-agriculture.
    References annotated with  are retained in Committee file.

   BIO comments to USDA's Solicitation of Input from 
        Stakeholders on Agricultural Innovations, available here.\2\
---------------------------------------------------------------------------
    \2\ https://www.bio.org/letters-testimony-comments/bio-submits-
comments-usda-ag-innovation.

   BIO response to USDA's Request for Comments: Executive Order 
        on Tackling the Climate Crisis at Home and Abroad as USDA 
        develops a Climate-Smart Agriculture and Forestry Approach, 
        available here.\3\
---------------------------------------------------------------------------
    \3\ https://www.bio.org/letters-testimony-comments/bio-submits-
comments-usda-highlighting-biotechs-role-tackling-climate.
---------------------------------------------------------------------------
Conclusion
    With science we can return our nation and the world to health and 
prosperity. BIO is committed to working with the Committee, Congress, 
and the Administration to establish supportive policies and regulations 
to foster the rapid development and deployment of agricultural 
biotechnology to help American agriculture meet the challenges of the 
21st Century. We look forward to our continued partnership in this 
critical endeavor.
            Sincerely,
            
            
Sarah Gallo,
Vice President, Agriculture and Environment,
Biotechnology Innovation Organization.
                                 ______
                                 
  Submitted Letter by Hon. Stacey E. Plaskett, a Delegate in Congress 
 from Virgin Islands; on Behalf of Agricultural Retailers Association, 
                                 et al.
October 26, 2021

 
 
 
Hon. David Scott,                    Hon. Glenn Thompson,
Chairman,                            Ranking Minority Member,
House Committee on Agriculture,      House Committee on Agriculture,
Washington, D.C.;                    Washington, D.C.;
 

    Dear Chairman Scott and Ranking Member Thompson,

    On behalf of our nation's food and agricultural stakeholder 
community, we write to extend our appreciation for holding today's 
hearing on ``Agricultural Biotechnology: 21st Century Advancements and 
Applications.'' Biotechnology is an increasingly vital technology for 
the future productivity and sustainability of agriculture. As we work 
to posture these tools for greater future use, we welcome the Committee 
exploring important facets of the technology, including its underlying 
science, applications, and relevant policy matters. Moreover, we stand 
ready to assist the Committee in advancing policy improvements that 
will help these promising innovations address the challenges facing 
agriculture and our society.
    As mentioned, we believe this technology already has and will 
continue to play an important role in addressing many challenges facing 
our society. Historically, plant breeding has helped growers reduce 
their input needs and protect crops from devastating pests. In the last 
few decades, biotechnology has helped growers of certain crops, such as 
corn, soy, cotton, and sugar beets, even further, by facilitating 
adoption of vital conservation practices. Looking ahead, advancement in 
breeding innovation, such as genome editing, can play an even greater 
role in addressing countless issues in a broader variety of products, 
like specialty crops, cover crops, and livestock. We are already seeing 
important research and developments taking shape that can reduce food 
waste and put longer-lasting fresh produce in the hands of consumers; 
decrease livestock susceptibility to diseases, reducing producer losses 
and the need for antibiotics; and further cut greenhouse gas emissions 
and other environmental impacts of agricultural production.
    However, we would note that science and innovation are moving 
swiftly. To realize these important applications and their benefits, we 
must have Federal policies that are risk and science-based and will 
permit the meaningful adoption of these products by producers, supply 
chains, and consumers. For several years, the Federal Government has 
been involved in regulatory modernization efforts that will better 
facilitate the future use of these tools. We look forward to supporting 
continued work on these issues with the Committee and other 
policymakers to improve our regulatory landscape in a way that will 
allow these important innovations to come to fruition.
    Again, we thank you for your attention to these vitally important 
tools and stand ready to assist the Committee in efforts to ensure we 
can maximize the benefits these innovations can offer producers, 
consumers, and our society.
            Sincerely,


 
 
 
Agricultural Retailers Association   National Corn Growers Association
American Association of Veterinary   National Cotton Council
 Medical College
American Farm Bureau Federation      National Council of Farmer
                                      Cooperatives
American Seed Trade Association      National Milk Producers Federation
American Soybean Association         National Pork Producers Council
American Sugarbeet Growers           National Potato Council
 Association
Biological Products Industry         National Sorghum Producers
 Alliance
Biotechnology Innovation             National Turkey Federation
 Organization
Crop Science Society of America      Society of American Florists
National Association of State        U.S. Canola Association
 Departments of Agriculture          USA Rice
National Association of Wheat
 Growers
National Cattlemen's Beef
 Association
 
                                ______
                                 
   Supplementary Material Submitted by Jack A. Bobo, Chief Executive 
                           Officer, Futurity
Insert
          Mr. Bobo. . . . In Japan they are bringing a tomato that 
        lowers blood pressure, and they are selling seeds directly to 
        consumers so you can grow these heart-healthy tomatoes right at 
        home. . . .
          * * * * *
          Mr. Lawson. . . . Thank you. Mr. Chairman, I am going to 
        yield back, but, for the record, Mr. Chairman, I want to know 
        what kind of tomato that is going to lower blood pressure? And 
        so if you can get some information back, that will be 
        interesting.

    A genome-edited tomato produced using CRISPR-Cas9 technology have 
been sold on the open market in Japan since September 2021. The 
Sicilian Rouge tomatoes, which are genetically edited to contain high 
amounts of g-aminobutyric acid (GABA), are being sold directly to 
consumers by Tokyo-based Sanatech Seed. The company claims oral intake 
of GABA can help support lower blood pressure and promote relaxation.
References
    USDA FAS: Japan Determines Genome Edited Tomato Will Not be 
Regulated as GE https://apps.fas.usda.gov/newgainapi/api/Report/
DownloadReportByFileName
?fileName=Japan%20Determines%20Genome%20Edited%20Tomato%20Will%20Not
%20be%20Regulated%20as%20GE_Tokyo_Japan_12-10-2020.*
---------------------------------------------------------------------------
    * Editor's note: the report is retained in Committee file.
---------------------------------------------------------------------------
    GABA-enriched tomato is first CRISPR-edited food to enter market, 
December 14, 2021, https://www.nature.com/articles/d41587-021-00026-2.
    Sanatech Seed https://sanatech-seed.com/en/about-en/.

                                  [all]