[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
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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
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\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.
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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.
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\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.
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\3\ https://www.genusplc.com/rd/innovation-technologies/gene-
editing-ethical-commitments/.
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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\
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\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.
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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\
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\5\ USDA, Foreign Ag Service, Report Number: CA2020-009,
``Agricultural Biotechnology Annual'', January 5, 2021.
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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.'
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\1\ https://www.agshowcase.com/the-role-of-innovation-in-
transforming-the-global-food-system.
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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.
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\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.
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\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\
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\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\
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\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\
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\3\ https://www.bio.org/letters-testimony-comments/bio-submits-
comments-usda-highlighting-biotechs-role-tackling-climate.
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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.*
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* Editor's note: the report is retained in Committee file.
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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/.
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