[Senate Hearing 118-512]
[From the U.S. Government Publishing Office]
S. Hrg. 118-512
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND
DRUG ADMINISTRATION, AND RELATED AGEN-
CIES APPROPRIATIONS FOR FISCAL YEAR 2024
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HEARINGS
BEFORE A
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS
UNITED STATES SENATE
ONE HUNDRED EIGHTEENTH CONGRESS
FIRST SESSION
on
H.R. 4368/S. 2131
AN ACT MAKING APPROPRIATIONS FOR AGRICULTURE, RURAL DEVELOPMENT, FOOD
AND DRUG ADMINISTRATION, AND RELATED AGENCIES FOR THE FISCAL YEAR
ENDING SEPTEMBER 30, 2024, AND FOR OTHER PURPOSES
__________
Department of Agriculture
Department of Health and Human Services: Food and Drug Administration
__________
Printed for the use of the Committee on Appropriations
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: https://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
50-503 PDF WASHINGTON : 2025
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COMMITTEE ON APPROPRIATIONS
PATTY MURRAY, Washington, Chairman
DIANNE FEINSTEIN, California SUSAN M. COLLINS, Maine, Vice
RICHARD J. DURBIN, Illinois Chairman
JACK REED, Rhode Island MITCH McCONNELL, Kentucky
JON TESTER, Montana LISA MURKOWSKI, Alaska
JEANNE SHAHEEN, New Hampshire LINDSEY GRAHAM, South Carolina
JEFF MERKLEY, Oregon JERRY MORAN, Kansas
CHRISTOPHER A. COONS, Delaware JOHN HOEVEN, North Dakota
BRIAN SCHATZ, Hawaii JOHN BOOZMAN, Arkansas
TAMMY BALDWIN, Wisconsin SHELLEY MOORE CAPITO, West
CHRISTOPHER MURPHY, Connecticut Virginia
JOE MANCHIN, West Virginia JOHN KENNEDY, Louisiana
CHRIS VAN HOLLEN, Maryland CINDY HYDE-SMITH, Mississippi
MARTIN HEINRICH, New Mexico BILL HAGERTY, Tennessee
GARY PETERS, Michigan KATIE BRITT, Alabama
MARCO RUBIO, Florida
DEB FISCHER, Nebraska
Evan Schatz, Staff Director
Elizabeth McDonnell, Minority Staff Director
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Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies
MARTIN HEINRICH, New Mexico, Chairman
JON TESTER, Montana JOHN HOEVEN, North Dakota, Ranking
JEFF MERKLEY, Oregon MITCH McCONNELL, Kentucky
TAMMY BALDWIN, Wisconsin SUSAN M. COLLINS, Maine (ex
JOE MANCHIN, West Virginia officio)
GARY PETERS, Michigan JERRY MORAN, Kansas
KYRSTEN SINEMA, Arizona CINDY HYDE-SMITH, Mississippi
DEB FISCHER, Nebraska
Professional Staff
Dianne Nellor
Rachel Erlebacher
Hannah Chauvin
Angela Caalim
Morgan Ulmer (Minority)
Patrick Carroll (Minority)
Administrative Support
Alex Shultz (Minority)
C O N T E N T S
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hearings
Wednesday, March 29, 2023
Page
Department of Agriculture........................................ 1
Wednesday, April 19, 2023
Department of Health and Human Services: Food and Drug
Administration................................................. 51
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Nondepartmental Witnesses........................................ 87
back matter
List of Witnesses, Communications, and Prepared Statements....... 193
Subject Index:
Department of Agriculture.................................... 195
Department of Health and Human Services: Food and Drug
Administration............................................. 196
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2024
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WEDNESDAY, MARCH 29, 2023
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:01 a.m. in Room SD-192, Dirksen
Senate Office Building, Hon. Martin Heinrich (chairman)
presiding.
Present: Senators Heinrich, Murray, Tester, Merkley,
Baldwin, Manchin, Hoeven, Collins, Moran, Hyde-Smith, and
Fischer.
DEPARTMENT OF AGRICULTURE
STATEMENT OF HON. THOMAS J. VILSACK, SECRETARY
ACCOMPANIED BY:
MR. JOHN RAPP, DIRECTOR, OFFICE OF BUDGET AND PROGRAM ANALYSIS
opening statement of senator martin heinrich
Senator Heinrich. Good morning. This hearing of the
Agriculture Appropriations Subcommittee is now called to order.
And I would like to start by welcoming Secretary Vilsack.
Joining the Secretary is Mr. John Rapp, Budget Director for the
Department of Agriculture. And we welcome both of you here
today.
This is my first hearing as chairman of this subcommittee,
and I am looking forward to a good discussion on the fiscal
year 2024 Budget Request for the Department of Agriculture.
The programs and activities of this Department affect every
single American, from farmers, and rural communities, to
children and families who depend on healthy and nutritious
food.
This subcommittee must ensure that USDA has the resources
you need to fulfill your broad and absolutely critical mission.
The budget request for United States Department of Agriculture
(USDA) is ambitious, and it includes significant increases
across the board. The request totals $24.5 billion, which is an
increase of $2 billion.
I am pleased that the budget focuses on providing tools to
producers in rural communities to address the climate crisis,
and it calls for coordination of climate solutions across the
entire Department. I look forward to discussing some of these
initiatives and how this subcommittee can play a role in this
critical issue.
We also know that affordable housing is a major challenge,
not just in my home State of New Mexico, but really across the
Nation, and particularly in rural areas. The budget includes
much needed increases and innovative policy proposals to grow,
our affordable housing stock in rural communities, and ensure
that all Americans can access a safe and affordable place to
call home.
Another issue of great importance to both of us is ensuring
that our children can receive healthy and nutritious food,
without this our children simply do not learn as effectively;
do not thrive, so I am pleased to see increases to vital
nutrition programs.
It is clear that USDA has much work to do. And I look
forward to a robust discussion today. I am looking forward to
starting the appropriations process and working with all the
members of this subcommittee to draft an Agriculture Bill that
supports these vital programs.
I want to briefly reiterate the importance of reaching a
bipartisan top line agreement. We must invest in nondefense
programs if we want to move this country forward. We have
important work to do, and we need to come together to bring
back regular order. That will not be easy, but I stand ready to
work with every member as we continue to move this process
forward.
And with that, I will turn to our ranking member, Ranking
Member Hoeven, for any statement that he may have. And I would
just quickly add that I am looking forward to working with you,
and continuing the bipartisan tradition of this subcommittee.
statement of senator john hoeven
Senator Hoeven. Thanks Chairman Heinrich. Appreciate it. I
look forward to working with you as well.
Welcome back, Secretary Vilsack. I appreciate you being
here. We saw you on the Hill here a week or so ago, and
appreciate your diligence, and certainly respect your knowledge
of the Department of Agriculture having, you know, served 8
years prior, and back in the role. And of course I have had
opportunity to work with you through the years both in that
role and as governors.
The Department of Agriculture (Ag) affects every American
every day, our farmers and ranchers produce the highest
quality, low-cost food supply in the world that benefits every
single American, every single day. So what you do is incredibly
important, what we do here in Ag Appropriations is incredibly
important. And of course writing a good Farm Bill this year is
incredibly important.
There are always challenges, we have seen that, obviously,
with trade relations, with Coronavirus (COVID), with weather,
the supply chain issues, energy costs, all those things, are
challenges that our farmers and ranchers face every day, and
that is why it is so, so important that we have a good farm
policy.
Because when you look at our AG industry I think it is
absolutely remarkable. It is a remarkable industry where we
have been able to maintain a network of small businesses across
this country, unlike so many other industries where you have
seen incredible concentration, but we have got those small
businesses, family farms, and ranches, in many cases that have
been operating for, you know, decades and generations of
families. And we can't take that for granted.
Like I said, benefits every American because of this system
we have, and we can't treat it like when we walk in the room
and flip on the light that it is always going to be there for
us just the way it is. So I think it is incredibly important we
keep that in mind as we craft farm policy. And I know,
Secretary, you do.
This subcommittee has provided substantial support for our
farmers, ranchers, producers, and rural communities. Last year,
we provided critical base funding increase of 4 percent for
USDA research programs, 2.7 percent for Rural Development
programs, 5.6 for the Animal and Plant Health Inspection
Service (APHIS).
And you know, programs like that, again, are so important.
I think sometimes people don't even realize they are out there.
But we keep them healthy because of those inspection services
that make sure that that food gets to people and they can count
on it being, you know, healthy, and free of disease, and other
problems.
Again, things that, you know, the consumer takes for
granted. But food doesn't come just from the grocery store, it
comes from the farm and ranch, and there is a lot that goes
into making all that happen.
At the same time as we have provided more funds for these
programs, we have got to be careful because of the cost of the
overall farm program, the Farm Bill in total, the Supplemental
Nutrition Assistance Program (SNAP), all the different
components that go into this outstanding network of farming,
and ranching, and food supply that we have, we have got to
recognize that we have a real problem, overall, with the
budget, and we have got to be part of helping find solutions
that work. That has got to be an important part of what we do.
What I would submit to you, and I will be intrigued to hear
your comments on it, Secretary, when we get into the Q&A, is
that by doing a good job on crop insurance and the
countercyclical safety net, we make sure those farmers can
produce more food of the highest quality, with incredible
variety that keeps the food costs for the consumer as one of
the lowest percentage of their budgets of any country in the
world.
That is not only important to every American every day, but
when we look at the nutrition programs, it reduces the cost of
those nutrition programs, because more supply not only means,
you know, more availability of food, but lower costs.
So getting crop insurance and that safety net right
benefits every aspect of what we do, and it is critically
important, not only for this appropriations process, but as we
go into writing the Farm Bill.
Again, Chairman, thank you; I look forward to working with
you.
And Secretary, thanks for joining us today.
Senator Heinrich. Mr. Secretary.
summary statement of hon. thomas j. vilsack
Secretary Vilsack. Mr. Chairman, thank you very much for
the opportunity; and Senator Hoeven, thank you for the
opportunity, to appear before the committee today. And to the
Members of Committee, thank you for this opportunity.
This is an unusual budget, perhaps one that you have never
faced before, because you have to put it in the context of
everything else that is surrounding the Department of
Agriculture today. Whether it is the investments that are being
made in the American Rescue Plan (ARP), or the Bipartisan
Infrastructure Law (BIL), or the Inflation Reduction Act (IRA),
these are resources that complement and supplement, if you
will, the budget that we are presenting to you.
And the goal of this budget, frankly, is to invest in a
stronger America, and to expand our middle class, as the
President likes to say, from the bottom up and the middle out.
And there is no better opportunity to do that than within the
agricultural budget.
I would make one observation and one request of this
committee, that you take a look at the percentage increases of
this committee over time, and compare it to the percentage
increases of other Departments of Government. I think what you
are going to find, even in the nondiscretionary--nondefense
discretionary budget, the increases in this Department's budget
have been modest compared to other agencies.
So as you look at choices that have to be made, I hope that
that factor is taken into consideration, given the importance
of this Department, and the work of this Department, as both
the Chair and the Ranking Member have indicated.
When we look at making a stronger America and expanding the
middle class, there are things like the investments that we are
proposing in research surrounding clean energy and climate that
will help to create that middle class. Whether it is developing
a new industry, sustainable aviation fuel, or other bio-based
products, the idea here is to create not just better energy
sources, but also income sources for our farmers.
As Senator Hoeven knows, having listened to this before
during the Farm Bill Hearing at the Senate Ag Committee, that
we have had a record year in farm income in the last 2 years;
however, that that bounty has not been fully shared by all
farmers, nearly 50 percent of farmers during those record years
did not make any money, another 40 percent, or so, made money,
but the majority of money they made came from off-farm income.
So we had some farmers, those who sell more than $1,000,000
in product do very, very well in this economy, but I think we
still have a job to do for the other 90 percent. So investments
in research that create new opportunities; new income
opportunities, is a way of maintaining those small- and mid-
sized farming operations.
We are asking for increases in investment and staff at
Natural Resources Conservation Service (NRCS). Why? Because we
want to provide more technical assistance to farmers who are
embracing climate-smart practices, and we know that when they
do they can qualify for ecosystem service market opportunities,
which create another revenue source that is not currently
available to many farmers.
It is not just about asking for more money, it is also
about asking for legislative changes. We would like to be able
to open up more credit opportunities for beginning farmers. We
would like to take a look at the time and the number of times
farmers can come back to the Farm Service Agency (FSA) for
assistance and help so they can stay on the farm, extending the
number of years that they can borrow from the USDA.
It is proposed legislative changes in the Rural Development
to preserve rental assistance, we are facing a circumstance in
situation where a number of rental units could be lost as
mortgages get paid off, rental assistance units are lost, the
amount of vouchers that we provided, basically, take care of
about 35 projects each year. The circumstances today are that
we are losing about 80 projects per year. So we are losing
literally, potentially, tens of thousands of rental assistance
units in rural America at a time when we need affordable
housing.
It is protecting farmers from unfair practices in the
marketplace, which is why we are asking for continued support
for our packers and stockyards. There is a competing view,
obviously, to this budget that we have proposed. And that
competing view has suggested significant reductions across the
board, and I wanted you all to have an understanding of the
degree to which those budget cuts would impact and affect this
Department.
If those budget cuts, even the most conservative budget
cut, that is to say, putting it back to levels of several years
ago, would result, not in an increase in Special Supplemental
Nutrition Program for Women, Infants and Children (WIC)
participation, but perhaps as many as 250,000 participants in
WIC not being able to be provided that opportunity.
It would likely mean a loss of 40,000 rental assistance
units in rural America. It would mean 84,000 farmers couldn't
access the technical assistance they need to embrace
conservation practices. It would mean 6,600 farmers wouldn't
get the credit they need to continue farming operations. There
are real impacts to these reductions.
So that is the reason why I am here today, is to talk to
the committee about the importance of this Department's budget
relative to all other budgets, and to basically make the case
that in the context of what we are trying to do to create new
opportunities for farmers, new income sources for farmers
which, in turn, will create more job opportunities as well, in
rural America, and create a revival of the economy, this budget
is at a critical point, at a transformational point, in my
view, in rural America, and in agriculture.
And I look forward to the opportunity to respond to any
questions that the committee may have.
[The statement follows:]
Prepared Statement of Hon. Thomas J. Vilsack
Thank you, Chair Heinrich, Ranking Member Hoeven, and distinguished
members of this subcommittee, for the opportunity to come before you
today to discuss the Administration's priorities for the Department of
Agriculture (USDA) and to provide you an overview of the 2024
President's Budget.
We are at a pivotal moment for American agriculture and rural
communities with a decision to make about if, and how, agriculture will
meet the challenges of our time. One option is to maintain the status
quo. This path leads towards even more producers struggling to cover
their costs and often turning to off-farm income to support their
families; it leads to far too many rural communities languishing and
demonstrates the outdatedness of agricultural policies designed to
address challenges of the 1930s and 1970s, ones that reinforce systemic
inequities. This path works for a few who have done what American
agricultural economics has required of them: get big or get out. But
there is another path, one that prompts us to recognize the undeniable
challenges of climate change, the need for greater equity in our food
system, and that there are opportunities to seize as we seek to adapt
to a new course. This path draws on lessons from the COVID-19 pandemic,
which exposed vulnerabilities at every point in our food supply chain--
from the field to the factory to the grocery store--and compels us to
take transformative action so that this vital system is more resilient,
secure, and accessible to all. This path also draws strength from the
Interim Recommendations of the USDA Equity Commission \1\, because they
are a roadmap for ensuring USDA lives up to its name as the People's
Department for everyone. There is nothing more foundational to a
country's security and stability than its food supply; an inclusive
agriculture and rural life must be part of a shift to a bottom-up,
middle-out system if we want to create more opportunity in this
country.
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\1\ USDA Equity Commission. (2023). Interim Report 2023:
Recommendations made to the U.S. Department of Agriculture to Advance
equity for all. https://www.usda.gov/equity-commission/reports
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Through the fiscal Year 2024 Budget, the Biden-Harris
Administration and USDA have embraced a path where the future of
American agriculture is secure and where there is greater equity and
economic opportunity for agricultural and rural communities.
The 2024 USDA President's Budget also recognizes the historic
investments that Congress has made through the American Rescue Plan,
the Infrastructure Investment and Jobs Act, and the Inflation Reduction
Act. USDA is delivering on these investments, and the 2024 Budget
continues to confront challenges, rebuild the rural economy, and
support a new, innovative approach to the future of agriculture.
Agriculture is the foundation for fuel, fiber, and food; the
agricultural economy is more than just growing crops and selling them,
or raising livestock and selling them, or the products from them. The
food and agriculture industry contributes nearly $8 trillion to the
global economy, about a fifth of the economic activity of our country.
A strong agriculture sector is key to strong rural communities,
supporting over 21 million people and 11 percent of jobs in the
economy, providing access to essential services like housing, health
facilities, and fast reliable internet; it's how we ensure there's
safe, nutritious, affordable food on the table for everyone, supporting
the more than 10.2 percent of Americans that experience food insecurity
\2\; it's how we support and protect forests, grasslands, and farms--
nearly 50 percent of this nation's total land mass; and it's how we
provide for the communities that depend on them. The proposals in this
budget will address these challenges and spur new job creation and
opportunities in rural America; build resilience in the food supply
chain and restore America's advantage in agriculture; leverage USDA's
expertise to address climate change; and support a stronger nutrition
safety net. To make demonstrable progress toward addressing these real
issues, the 2024 President's Budget proposes $213.2 billion for USDA
programs, of which approximately $180.6 billion is mandatory funding
and $32.6 billion is discretionary funding.
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\2\ USDA, Economic Research Service using data from U.S. Department
of Commerce, Bureau of the Census, 2021 Current Population Survey Food
Security Supplement. https://www.ers.usda.gov/topics/food-nutrition-
assistance/food-security-in-the-u-s/key-statistics-graphics/
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research and innovation
This pivotal moment calls for additional investment in research and
innovation that influence every program we implement at USDA.
Agricultural research has a return on investment of $17 for every $1
invested. Between 1948 and 2019, total agricultural output in the
United States grew by 142 percent. This rise was not due to increases
in agricultural land or labor; in fact, both inputs declined over the
period. The productivity stemmed from the adoption of a whole suite of
innovations and technology transfer in crop and livestock breeding,
nutrient use, pest management, farm practices, and farm equipment and
structures. These innovations are the fruits of publicly funded
agricultural R&D that often have a less-told story, but we live and
reap the benefits of these investments every single day. Production
agriculture requires constant innovation and adaptation as farmers and
ranchers pursue climate-smart solutions to extreme weather, rural
businesses seek new markets, and underserved communities seek trusted
partners to tackle systemic concerns.
The budget proposes a $4.2 billion investment in our research,
education, and economics programs. The budget includes discretionary
funding of $1.9 billion for the National Institute of Food and
Agriculture (NIFA) of which $550 million is for the Agriculture and
Food Research Initiative (AFRI). Demand for AFRI's competitive funds
grows annually and the awards focus on promoting enhanced profitability
and productivity in U.S. agriculture, food and nutrition security, and
boosting rural prosperity through a circular economy with support for
clean energy technologies, climate-smart agriculture and forestry, and
education and workforce development. An additional $2 billion for the
Agricultural Research Service (ARS) includes increases of $20 million
in support of the Cancer Moonshot, $13 million for the operations and
maintenance of the new National Bio and Agro-Defense Facility, $83
million for clean energy, $88.5 million for climate science, $10
million for Climate Hubs and Climate Hub Fellows, and $14 million for
additional high priority investments. These funds enable ARS to find
solutions to agricultural problems that affect Americans every day from
field to table. This is done through the delivery of cutting-edge,
scientific tools and innovative solutions for American farmers,
producers, industry, and communities to support the nourishment and
well-being of all people; sustain our Nation's agroecosystems and
natural resources; and ensure the economic competitiveness and
excellence of our agriculture.
Science and research are the best defenses we have to protect our
resources against the climate crisis. The changes in our environment
have allowed invasive plants, pests, and diseases to move around the
world more easily and become established in new areas. Without the
tools and sufficient resources to protect ourselves against invasive
species and safeguard the health, welfare, and value of American
agriculture and natural resources, our farmers and our economy will
suffer. The budget calls for an investment of $6 million for the
Civilian Climate Corps within our Animal Plant Health Inspection
Service (APHIS) to identifying emerging invasive species threats and
expand efforts to develop and implement new surveillance methods to
detect incursions of invasive pests more quickly as well as develop new
mitigation methods to address those already present causing economic
and environmental damages.
tackling the climate crisis
Producers and land managers across the country are experiencing
real and increasing threats from climate change that have serious
implications-not just for farmers, ranchers, and forest landowners- but
also for surrounding communities and all Americans. In 2022, nearly 80
percent of the western region experienced extreme drought, wildfires
burned over 7.6 million acres of our forestland, and communities across
the country are dealing with the impacts of severe flooding and record
snow fall exacerbated by climate change. Agriculture has a critical
role in delivering climate change solutions and our Nations farmers,
ranchers, and foresters are already leading the way through the
adoption of voluntary and farmer friendly incentive-based climate-smart
agricultural and forestry practices. The budget proposes over $7
billion across the department in finding solutions to the climate
crisis through science, clean energy innovation, minimizing emissions
and greenhouse gases, building resilience, and supporting farmers and
producers as they adapt to the changing environment. Farmers, ranchers,
and forest landowners are ready, but they need USDA resources to help
mitigate their risk as they adopt these solutions.
The budget includes $904 million for Conservation Operations to
work with landowners and managers to develop conservation plans that
outline the specific practices needed to improve farm operations and
enhance farm environmental sustainability. The request includes an
increase of $23 million for Climate Smart Agriculture Implementation to
improve greenhouse gas monitoring, establish a soil health monitoring
network, and better understand the interrelationship between
conservation planning, practice implementation, and adaptation and
resilience to climate change. The budget proposes to enhance the
Conservation Technical Assistance Equity Conservation Cooperative
Agreements, begun in 2021, with an additional $50 million, bringing
total funding for this initiative to $100 million. The agreements are
2-year projects that expand the delivery of conservation assistance for
climate-smart agriculture and forestry to farmers and ranchers who are
beginning, limited resource, historically underserved and/or veterans.
The budget also proposes $20 million for the Healthy Forests Reserve
Program to enroll private lands and acreage owned by Indian Tribes for
the purpose of restoring, enhancing, and protecting forestland to
enhance carbon sequestration, improve plant and animal biodiversity,
and promote recovery of endangered and threatened species under the
Endangered Species Act. These efforts will allow for important outreach
and promotion of inclusive outcomes in farming practices, addressing
some of the historical inequities and working to build new levels of
trust with the People's Department.
The budget supports climate resiliency in a myriad of other ways
because the approach to the addressing the climate crisis must be taken
on multiple fronts. For example, USDA proposes to permanently authorize
the pandemic Cover Crop Incentive Program and apply the successful
model implemented with supplemental funding that provides a $5 per acre
premium subsidy for acres planted with cover crop. Cover cropping
systems benefit the environment by reducing soil erosion and
compaction, increase soil organic matter, and limit nutrient runoff.
Given the demand for this program in 2021 and 2022, USDA estimates a
15-million-acre enrollment in 2024 and that the program will grow 5
percent annually.
The budget provides $255 million in new funding to support clean
energy innovation, which includes an additional $155 million for
emissions mitigation deployment to help meet the Administration's goal
of zero carbon electricity by 2035. Specifically, grants and loans will
be used to expand rural clean energy, transform rural power production,
and create jobs. The budget requests an additional $30 million in
annual grant funding for the Rural Energy for America Program (REAP)
and will assist agricultural producers and rural small businesses to
purchase or install renewable energy systems or make energy efficiency
improvements. These increases will build tens of thousands of new
renewable energy systems and support small business owners in every
State.
creating more and better markets
While our policies and programs have ensured an increasingly
abundant food supply, growth in farm size and consolidation has put
extreme economic pressure on small and medium sized farms and our rural
communities. Most recently, the COVID-19 pandemic and the Russian
invasion of Ukraine, have roiled the supply chain, and exacerbated the
impacts of climate change, droughts, wildfires, other natural
disasters, and an especially widespread highly pathogenic avian
influenza (HPAI) outbreak. American agriculture has proven itself to be
extraordinarily efficient, but these crises have further revealed
hidden weaknesses in our production-optimized system. The challenges
presented today to our farms and rural communities requires a whole
systems approach to stay competitive and innovate the food and
agricultural system so that it works for everyone. In recent history,
there have been record setting farm income levels, but noting
approximately 80 percent of the value of agricultural production is
produced on farms that are midsized or larger. But nearly 50 percent of
our farmers have had negative farm income. Our data shows that 40
percent of farms are small and midsize farms where the primary
occupation of the household is farming, but most of their income that
was supporting their families came from off-farm sources. It's obvious
that the system needs to be revisited to find a way that the system
benefits the small and medium farms, expands opportunity, and values
their products. USDA currently has 141 Partnerships for Climate Smart
Commodities projects that are helping to make it less risky for farmers
to embrace climate-smart practices and link them to new markets that
value and reward them for their commitment to sustainability. These
opportunities for our farmers need Congress' support to build the
markets and show value to their customers.
The budget requests $80 million to support new supply chains and
markets that uplift small and mid-sized farmers through programs such
as the Local Agriculture Market Program, Dairy Business Innovation,
Farmers Market and Local Food Production, and Transportation and Market
Development. USDA is also expanding local food systems through urban
agriculture, supporting communities' capacity to gather, process, move
and store food in different geographic areas of the country. Urban
agriculture provides more options for producers to create value-added
products and sell locally to create new economic opportunities and job
creation in underserved communities. In 2024, USDA will invest over
$157 million in urban agriculture and innovation production initiatives
across the department, of which $13.5 million will go towards the Urban
Agriculture and Innovative Production Program, creating more grant
opportunities with a priority on supporting historically underserved
communities.
rebuilding rural america
It has been said that Rural Development can build a town from the
ground up. The essence of that statement is that USDA Rural
Development, when well-resourced and well-staffed, provides support
that is critical to improving quality of life in rural America--whether
it is through more affordable housing in underserved communities,
increased access to broadband service, or resilient wastewater
infrastructure. These are problems we can and must solve, and USDA is
committed to ensuring rural America has equitable access to essential
resources. To do so, we must have sufficient Rural Development staff to
deliver these vital programs. Over the last decade, RD's portfolio has
increased 85 percent, but its staffing levels decreased by 30 percent.
Increased staffing resources are desperately needed to ensure that we
meet the growing priorities in critical areas that have a direct effect
on our ability to be sustainable, relevant, and results- oriented in
delivering much-needed programs and services across rural America. The
budget proposal increases funding for Rural Development by $801 million
and includes critical increases for combatting climate change, and
improvements to rural communities' quality of life; these investments
attract new businesses, create greater sense of pride in communities,
and allow rural America to prosper.
In 2022 alone, USDA provided $548 million to the ReConnect program
and expanded access for 109,000 households, 14,520 farms, 5,900
businesses, 435 essential community facilities, 396 educational
facilities, and 51 health care facilities. The fiscal Year 2024 Budget
requests $400 million to reach even more communities, homes, and
businesses with reliable internet access which builds upon the $2
billion of funding provided by Congress in the Bipartisan
Infrastructure Law so that every community in America has access to
affordable, high-speed Internet.
It's estimated that 2.2 million people in America still lack indoor
plumbing and around 10 million homes still have poisonous lead pipes.
The President's Budget proposes $2.38 billion in the Water and
Wastewater program to provide additional grants and loans that will
improve water and waste disposal systems in rural areas and provide for
lead pipe replacement. This is an increase of $324 million over the
2023 enacted level and is a key investment in safe drinking water and
sanitary waste disposal systems, which are vital to achieving a high
quality of life for rural residents. Specifically, the budget provides
$1.6 billion in direct loans and $872 million in BA for water and
wastewater grants and loan subsidy. Within this funding, the Budget
targets $100M in grants for lead pipe replacement. In addition, the
Budget includes an increased loan level of $110 million for the 1
percent loan risk category, that targets the most rural and poor
communities.
Affordable housing has been a long-standing problem for low-income
residents in rural communities, one that is exacerbated by low energy
efficiency of the aging housing stock which means higher costs to
families. To help address this, the Budget includes a new proposal to
eliminate the existing low-income borrower penalty that requires
individuals to repay subsidy costs for Single-Family Direct loans-a
requirement that only exists for rural housing. Ending the
``recapture'' penalty promotes equity in rural communities, with
particular attention to those suffering from systemic racism and other
forms of discrimination. In addition, the budget includes the authority
to decouple rental assistance from USDA financed properties to help
ensure low- income rural tenants in USDA financed properties continue
to have access to affordable rents when projects reach loan maturity
and leave the portfolio. This proposal would allow vouchers when we
lose rental assisted properties, but these would be processed by HUD to
ensure that USDA is not funding vouchers that can leave rural areas.
The Budget also continues the 2023 Budget proposal to require climate
smart construction in USDA's rural housing programs. There are also
several new legislative changes designed to improve the disposal of
Real Estate Owned (REO) properties in shorter time frames and reduce
the costs associated with maintaining REO for longer periods; and
provide authority to standardize multifamily housing foreclosures
across States. The funding in the budget for these housing programs is
$2.2 billion, an increase of $459 million over 2023 Enacted.
To ensure that all rural communities are made aware of and are
encouraged to participate in USDA programs, this budget proposes $32
million to sustain and expand the Rural Partners Network (RPN)
authority. RPN provides targeted training, technical assistance, and
outreach to distressed communities in rural America through an all-of-
government approach to help rural and Tribal communities access Federal
funding and resources. This support is allowing for more strategic
community engagement, facilitating regional coordination among Federal
agencies to share best practices, braid Federal resources, and foster
collaboration with local and State partners. This work follows through
a commitment the President made when he came to office--we must invest
in America's heartland in a meaningful way. It is critical that we
ensure that our rural and Tribal communities can benefit from Federal
investments as the Biden-Harris Administration delivers unprecedented
resources through the American Rescue Plan, Bipartisan Infrastructure
Law, and Inflation Reduction Act. We can only expand this innovative
work of RPN into more rural communities and additional States if
Congress builds on the progress made over the last year and provides
additional funding for RPN.
supporting nutrition for the nation
USDA's core nutrition programs are the most far-reaching, powerful
tools available that ensure all Americans, regardless of race,
ethnicity, or background, have access to healthy, affordable food.
Across America, one in four individuals is served by one of USDA's 16
nutrition assistance programs over the course of the year. The budget
makes strategic investments to advance nutrition security through
education and evidence-based interventions, and to support the purchase
of nutritious and local foods.
We know that the Special Supplemental Nutrition Program for Women,
Infants, and Children (WIC) drives better health for infants and more
nutritious diets for children, and it is a key tool for addressing
disparities in maternal and child health outcomes. WIC serves about
half of all babies in the United States. After many years of decreasing
participation, WIC participation is now rising across all eligible
categories--women, children and infants. Continuing the bipartisan
commitment to full funding, the Budget requests $6.3 billion for WIC to
serve an estimated 6.5 million moms, infants, and young children per
month in 2024. It also proposes to continue the enhanced Cash Value
Benefits through 2024 to provide participants with increased benefits
to buy fresh fruits and vegetables which ensures that participating
women and children have access to scientific-based recommended levels
of fruits and vegetables.
The Supplemental Nutrition Assistance Program (SNAP) stretches the
food budget for many low- income people and research shows that
participation in SNAP reduces food insecurity and allows families to
have healthier diets. The budget request $122.1 billion for SNAP, a $32
billion decrease from 2023 primarily due to the expiration of emergency
allotment payments that were provided during fiscal years 2020 through
2022 and the 1.3 million participant decrease projected in enrollment
because of a recovering economy. As SNAP monthly benefits decline, USDA
anticipates that more eligible Tribal members will choose to
participate in the Food Distribution Program on Indian Reservations
(FDPIR) over SNAP, as it provides food packages to Indian Tribal
Organizations to improve nutrition and provide culturally appropriate
sustenance. The budget requests $165 million in 2024 to fund FDPIR food
and administrative costs, which supports participation at pre-pandemic
levels.
Child nutrition programs, such as the National School Lunch
Program, School Breakfast Program, Summer Food Service Program, and
Fresh Fruit and Vegetable Program, play a crucial role in ensuring that
children receive nutritious meals and snacks that promote health and
educational readiness. The meals children receive prepare them for
learning, foster healthy eating habits, and safeguard their health with
a goal of reducing the number of overweight and obese children. Thanks
to the 2023 Omnibus Appropriations Bill, a series of landmark
expansions for Child Nutrition Programs are now permanent. This
includes establishing a permanent Summer Electronic Benefit Transfer
Program for Children (Summer EBT) and adding a rural non-congregate
option in the Summer Food Service Program. Thanks to these changes by
Congress we know that we will see a permanent and positive impact on
how we meet the nutritional needs of children during the summer,
greatly improving equitable access to safe, healthy, and nutritious
food. The 2024 budget request expands on those important expansions of
child nutrition with a legislative proposal that would advance a
pathway to free school meals for an additional 9 million school
children through increased take up of the Community Eligibility
Provision among schools and States. This proposal is expected to cost
$234 million in 2024 and $15 billion over 10 years. During the COVID-19
pandemic, children had access to free meals resulting from temporary
flexibilities provided in the Families First Coronavirus Response Act,
and now many States are seeking ways to continue offering free school
meals for all students. Offering free meals to all children reduces
administrative burden, increases equitable access, reduces the stigma
associated with school meal participation, and allows schools to focus
on providing the highest quality meals.
The budget funds the child nutrition programs at a level that will
allow for the anticipated increases in participation, food cost
inflation, and implementation of new legislation. The budget projects
serving 5 billion lunches and snacks and 2.6 billion breakfasts in
schools, 1.9 billion meals in child and adult care programs, and 182
million meals through the Summer Food Service Program. The increases
will strengthen integrity controls, modernize food ordering and
inventory management systems, and provide critical staffing to enhance
FNS's ability to provide technical assistance and oversight of child
nutrition programs.
rebuilding usda through diversity, equity, and inclusion
Building a better USDA means bringing people of all backgrounds and
lived experiences to be a part of a healthy, safe, and inclusive
workplace. This includes ensuring we are recruiting the best and the
brightest across our great country, and investing in our employees
through recognition, wellness programs, and support to our employees.
Building a better America is about ensuring all have equal access to
USDA opportunities, which demands that we design and implement our
policies and programs with our diverse customers at the center. The
2024 budget focuses on building a USDA that is a model employer and
great place to work, proposes investments that remove barriers to
accessing USDA programs, and addresses historic gaps with respect to
who benefits from USDA programming.
It's an honor and a privilege to have the dedicated and talented
staff of over 100,000 employees supporting USDA. However, the historic
lack of investment throughout the Department over the years has
resulted in a decline in staffing that we still struggle to recover
from and has meant that we have not had the necessary resources to
modernize critical IT systems or make other improvements to the way we
do business here in USDA in support of rural Americans. Rebuilding our
workplace and workforce right will take time and focus over the course
of multiple years, but it couldn't be more important. In addition to
the programs that the public relies on and subcommittee and Congress
generously fund, I implore you to also concentrate on the critical
needs of organizational abilities and operations management that ensure
our staff are properly supported and our programs are delivered
efficiently, effectively, and with integrity.
There is currently 13 percent of the USDA workforce that is
eligible for retirement and in the next 4 years, another 13 percent
will become eligible for retirement. We need to focus on the future of
agriculture when rebuilding our workplace. Our workplace needs to
remain competitive, and the future of agriculture needs to reflect the
diversity across America and fight against historic inequities. USDA is
fostering collaboration between State, federal, and Tribal partners,
land-grant universities, Hispanic-serving institutions, Tribal
colleges, historically black colleges and universities, and other
strategic partners, to connect USDA programs and opportunities with the
communities they are intended to serve. Within this budget request,
over $370 million is dedicated to 1890 historically black land-grant
colleges and universities, 1994 Tribal land grant colleges and
universities, and Hispanic-serving institutions. These partnerships
with minority serving institutions support capacity building
initiatives that bolster education and pathways to employment for
students and faculty and help develop a strong pipeline of talented
individuals for USDA and USDA partner jobs. These investments in future
agricultural leaders will help USDA attract the best and brightest to
face the growing challenges of the agricultural economy.
conclusion
This budget is not a wish list; rather, it is a to do list to
fulfill the items that Congress and USDA have been talking about fixing
for decades. Moreover, this budget seeks to build the foundation for
innovation during this pivotal moment. It gives USDA the set of tools
to add to existing capabilities and develop new ways to address the
urgent challenges of our time-rebuild from the pandemic, respond to the
nutrition insecurity crisis, address the impacts of climate change,
invest in research and innovation, strengthen and build new markets and
opportunities for farmers and producers, rebuild the rural economy that
benefits all Americans, and ensure our services and programs are
accessible to everyone. It is a plan for what we need to do to continue
to get USDA back on track and to help the U.S. outcompete the rest of
the world. USDA needs the support of this subcommittee and of Congress
to make the much-needed investments called for in the President's
fiscal year 2024 Budget. I look forward to working with this
subcommittee and to answering any questions you may have about our
budget proposals.
Senator Heinrich. Thank you for that opening statement,
Secretary. We will start with five-minute rounds, or seven-
minute rounds of questions, I guess. Are we doing five or
seven? It keeps changing in front of me, sorry. We will just
get into the questions. How about that?
USDA programs are just playing an absolutely indispensable
role in the recovery from the Hermits Peak/Calf Canyon Fire in
New Mexico. The Emergency Watershed Protection Program, the
Emergency Forest Restoration Program, the Emergency
Conservation Programs are lifelines for families who are
working to get their properties back in condition, timberland
back in working condition, ranches, et cetera.
At the end of last year we passed nearly $1 billion dollars
in supplemental funding for these USDA emergency programs. And
I was just hoping you could give me a little bit of a progress
update on how you feel the implementation is going?
Secretary Vilsack. I am pleased with the fact that Chief
Cosby at NRCS has allocated $133 million from the conservation
programs, in a direct effort to try to address the nine
projects that are of significance and importance. And obviously
the Forest Service has been quite diligent in making sure that
resources are being provided to communities.
So I think the effort is underway. There is still more work
to be done, for sure. We are not going to forget about this, we
know we have an obligation to folks. I would say that I was
pleased with the opportunity that the Governor provided for us
to have kind of a--the equivalent of a job fair in New Mexico,
where we basically brought all of the various departments, for
all of the various entities, together in a gymnasium, and
basically gave people an opportunity to apply for various
programs.
So if there is something more that we need to do,
obviously, Mr. Chairman, I am more than happy to hear from you,
and from your staff, but we have certainly focused on this, and
understand the importance of it.
Senator Heinrich. I think it is important for people to
realize that these are not one-time emergencies. Because you
have the emergency, and in this case that fire lasted a really
long time people were out of their homes. And then you have the
floods that come afterwards.
Every year we have, you know, about half of our
precipitation in the late summer in what we call, the monsoon
season, and then you are just right back in emergency
situations once again. And so the coordination between all the
departments that are really helping with this recovery is much
appreciated, and we will continue that dialogue.
CHRONIC WASTING DISEASE
Chronic Wasting Disease (CWD) is an issue of particular
importance to both the Ranking Member and myself. We passed
some new authorities last year with the Chronic Wasting Disease
and Research Management Act. As you know, CWD is a fatal
disease that affects deer, elk, and moose.
Secretary, could you provide just a little bit of an update
on the Department's implementation of this legislation?
Secretary Vilsack. We are using the resources that you all
have provided, and the direction you have provided to enter
into cooperative agreements with states and tribes, in an
effort to try to focus on both wild and domestic herds.
Basically, we are splitting the resources between those two, I
think it is important.
We also are looking at the role of research trying to
determine exactly that--how this is transmitted from wild to
domestic, and domestic to wild, so that we get a better
understanding and appreciation for what we can do to mitigate
the consequences of this. And ultimately, potentially
hopefully, at some point in time, eradicate it, but we are
working on cooperative agreements right now.
Senator Heinrich. Do you think the Herd Certification
Program is working?
Secretary Vilsack. Well, we are in the process of seeking
public input to make sure that as we implement this, that we do
it in the right way, and that we do it consistent with what
people believe the certification program should provide. I
would say that I would be in a better position to respond to
your question in a month or two, after we have had that public
input, and we have given a sense of how to design this program.
PRESERVATION OF MULTI-FAMILY HOUSING
Senator Heinrich. Well, we will circle back on that for
sure. Rural housing I want to focus on your preservation
strategy for multi-family rental housing for a moment. For the
second year, the budget proposes decoupling two really
important programs financial assistance for affordable housing
rehabilitation, and construction and project-based rental
assistance.
These changes will help maintain and improve access to
safe, affordable housing for low-income Americans. And I was
really pleased that the fiscal year 2023 Senate Bill supported
this crucial policy solution absent this fix. More than 500
family in New Mexico alone, and 65,000 families across the
Nation, could lose access to affordable housing over the next
10 years.
So Secretary, can you tell us how USDA will implement those
changes if they are enacted?
Secretary Vilsack. Well, this is obviously a process which
will require us to go through a rule-making process, Senator,
but it is really critically important that we get this done.
Because as I said earlier, we have got a circumstance where
there are more mortgages getting paid off, as they get paid off
we lose those rental units unless there is a mechanism for
continuing them. And we have a voucher program, but the voucher
program is only providing resources to cover a portion of the
rental units that are lost.
And the reality in rural America is those rental units are
absolutely essential for small towns and communities. They are
just simply, they are necessary. So unless we decouple, unless
we figure out ways in which we can encourage reinvestment back
in these facilities, and continue to provide housing that is
affordable for folks, we are going to have a serious problem in
communities, which is why we continue to ask for the
decoupling, and ask for the assistance in making this happen.
Senator Heinrich. Yeah. I want to ask you as well, about
single-family housing recapture, and that proposal around the
balloon payments. But I am over my time. So I am going to turn
things over to the Ranking Member.
And then we will hear from the Chair of the entire
committee.
Senator Hoeven. Chairman, our Ranking Member is here, which
I appreciate very much. So I am going to defer to her for the
first round, if that is okay.
Senator Collins. Thank you very much. That is very gracious
of you, Senator Hoeven.
I am really pleased to see the leadership of this
subcommittee, as I know Chair Murray is, because I know that
you will work very well together.
SCHOOL MEALS PROPOSED RULE
Mr. Secretary, welcome. I very much appreciated your call
earlier this year to discuss with me, and to preview USDA's
proposed rule that would significantly change the nutritional
standards for foods that are served in the school lunch and
breakfast programs.
I think we can all agree on the need to have healthy,
nutritious foods served at school lunches and breakfasts. I
recently met with the Maine School Nutrition Association, and
they expressed some concerns about the proposed rule. I have
forwarded their letter to you, but I want to talk about them
here today.
First, let me point out that these are nutrition
professionals, many of them are registered dietitians, and
their concern is that students may simply refuse to eat foods
that have been reformulated to meet the standards in the
proposed rule. They point out that there are already sodium and
sugar requirements, and that they are already serving low-
sodium and low-sugar products.
So they say that with these additional requirements, to
further lower the sugar and sodium in these foods, that the
food begins to taste less and less like anything the students
have ever eaten, and that it will likely end up filling our
garbage cans.
Erin Dow, the school nutrition director from Freeport,
Durham, Maine, summed it up perfectly in our meeting when she
said, ``An uneaten meal, is not nutritious.''
My questions to you are this: First, has the Department
consulted with the frontline school nutrition directors about
this proposed rule? And second, how will USDA ensure that these
additional requirements do not result in fewer students eating
school meals?
Secretary Vilsack. Those are very good questions, Senator,
and I appreciate you asking them. First of all, we absolutely
have reached out to those who are the professionals, those who
were the heroes during the pandemic, who fed so many children
and families during the pandemic, and we are certainly
respectful of the role that they have played, and understand
the importance of the role they play now.
For that reason we have reached out to them, and we have
received input from them, and one of the things we attempted to
do with these rules was to provide a longer transition period.
The reality is these requirements don't go into effect
immediately, they are spaced in over a period of time, which I
think is important to note, because it gives people an
opportunity to make those adjustments, it gives the food
industry an opportunity to make those adjustments.
I would also point out that many of the reduced sugar
products that we are talking about, are already in the
marketplace, they are already available, and in fact they are
being used in schools today, especially when the adult and
child care program it is embracing, and with some degree of
success.
I would say that we are also providing grants, particularly
for rural schools, to make it a little bit easier for them to
respond. And we are understanding that there is a great deal of
interest in this, and so we are announcing this week a
transition or an expansion of, rather, an extension of the
comment period, so we are going to provide additional time for
people to comment.
And I would also point out, I am pretty proud of this, that
we actually made a $10 million award to the Full Plates and
Full Potential Program in Maine.
Senator Collins. A great program.
Secretary Vilsack. Yes. The purpose of that is to provide
help and assistance. So we are doing a lot in this space, and
we understand, at the end of the day I think we all as you say,
we have the same purpose which is to make sure our kids are fed
well.
POLYFLOUORINATED SUBSTANCES
Senator Collins. Thank you, in my little time remaining, I
also want to point out that we have had very good discussions
on Per- and Polyfluorinated Substances (PFAS). I know this is
of great interest to the Chairman as well, of that class of
forever chemicals that are being found in our soil, our water,
our animal feed, our crops, and our livestock.
In Maine, the presence of PFAS, and wastewater sludge
spread decades ago as fertilizer is preventing some of our
family farmers from being able to sell their products, causing
them significant financial harm, as we have discussed.
Well, Maine state agencies, agricultural service providers,
and academic researchers, are already undertaking research
relevant to the presence of PFAS, and the agricultural
landscape. Far more research is needed. I noticed in the budget
that this year your Department is requesting $20 million for
PFAS-related activities? How do you propose to use these funds?
And more broadly, what role do you see, for the Department, in
supporting research relevant to the PFAS challenge?
Secretary Vilsack. We needed to have a better
understanding, Senator, of the full extent of this challenge
that we face, and a better understanding of the impact of PFAS,
when it is found in soil, when it is found in anything that
impacts and affects our food supply. So first and foremost we
need to have better research to know precisely the extent of
what the challenge we are faced with.
Secondly, we need resources to be able to begin raising
awareness on the part of producers, now your producers in Maine
and those in New Mexico are fully aware of this, but I am not
sure that all of the producers around the country are aware of
it. So Natural Resources Conservation Service (NRCS), I think,
has a responsibility to raise awareness, to fill the knowledge
gaps, and to begin figuring out soil health practices that can
make a difference, potentially, in remediation.
We also need to take a look, creatively, at programs like
Conservation Reserve Program (CRP) and Conservation Reserve
Enhancement Program (CREP), just to determine whether or not
they can be a response to whatever we need to do to remediate
the soil. We need more research in terms of its impact on
animals and crops, and we also need to make sure that our food
safety folks are fully embracing and understanding of the need
to test, to make sure that as we are inspecting meat, poultry,
and processed eggs, that we know the impact, if any, of PFAS.
So there is a lot of work to do. $20 million is probably
not enough, but it is a start, and it is certainly more than
the $5 million we got last year.
Senator Collins. Thank you. Thank you, very much.
Senator Heinrich. Chair Murray.
Senator Murray. Well, thank you very much, Chair Heinrich,
and Ranking Member Hoeven, I do look forward to working with
both of you, and Vice Chair Collins, and everyone on this
subcommittee, as we return to regular order for the first time
in years.
And I will keep saying it, it is not going to be easy, but
we have to live up to our responsibility to pass these funding
bills in a timely, bipartisan way to keep our families strong,
and our economy strong, and our country competitive on the
world stage. And as this hearing should remind all of us that
requires a good deal more than just defense spending, after
all, at the most basic level we can't have strong communities
if people can't put food on the table.
RESEARCH INVESTMENTS IN FOOD SUPPLY
And that is as important as it is obvious. We have to make
sure that our food supply is secure, and that means protecting
our families from unsafe food. It means protecting them from
shortages, so avoiding, and mitigating supply chain
disruptions, addressing the climate crisis, like droughts,
which can threaten crops that all of us rely on.
And it also means addressing food insecurity, so the food
families need to stay safe and healthy, is available, and
accessible, and affordable. This is essential to keeping our
nation strong, not to mention competitive.
For one thing, and speaking as a grandmother and a former
preschool teacher, our kids cannot grow and thrive in body and
mind if they are not getting the nutrition they need. Which is
why the school lunch programs are so important, and why
fighting food insecurity, and getting family support, is a
priority of mine, as we negotiate the Farm Bill as well, this
year.
And as my colleagues know, agriculture is also a huge part
of our economy. In my state, every day, apples, and cherries,
and wheat, and potatoes, and pulse crops, and so many other
commodities, from Washington State, are shipped across the
world for people to enjoy. But we need to make sure that our
farmers, and our growers, are getting the support they need to
compete across the world as well, including through the
research happening at institutions like my alma mater,
Washington State University, and across the country, to address
our water shortages, and our improved yields, and reduce
inputs, and a lot more.
So I am really glad we have the opportunity now to assess
what we need to do to support our communities through the
important programs here at the Department of Agriculture. And
look forward to working with this committee as we put this bill
together.
So Mr. Secretary, I have a few questions for you, starting
with: The growers in Washington State and across the country
face a lot of challenges, extreme heat, wildfires, invasive
pests, plant diseases. And USDA's research has supported
American farmers and ranchers in adapting and responding to
these challenges so they can continue to produce a safe and
abundant food supply.
This research is often carried out in partnership with our
universities, like Washington State University, where students
and faculty work together on solutions to these challenges. Can
you speak to the importance of strong research investments in
our Nation's food supply?
Secretary Vilsack. Well, they are essential, Madam Chair.
And I would say that that this budget that we have proposed is
suggesting an increase in the Agriculture and Food Research
Initiative (AFRI) Program, which is the program that provides
that partnership between our land-grant universities, historic
Black colleges, minority serving institutions, to be able to
conduct that research.
I would say, frankly, that as a Nation we have underfunded
research in agriculture for far too long. When you compare it
to some of the other areas of our economy agriculture research
has been underfunded for a substantial amount of time. And I am
hopeful that we get the increase that we are seeking, because
it does bear fruit it does provide increased productivity,
greater resilience, adaptation and mitigation to climate, new
opportunities to use agricultural waste product to produce a
whole array of bio-based products that can improve job growth
and farm income. So it is essential, and we would certainly be
willing to talk to you in more detail about precisely where
those resources should be.
Senator Murray. So bottom line is, research saves money in
the future, and helps produce more food, and all the things we
need for our economy?
Secretary Vilsack. Every dollar of research generates
twenty dollars, or more, of economic opportunity.
CUTS TO FEDERAL FOOD ASSISTANCE
Senator Murray. Yes. Mr. Secretary, I am very concerned
about the House GOP calling for steep cuts to critical programs
like our Federal Food Assistance. My family relied on food
stamps when I was growing up, and my dad lost his job because
he got sick. And so I really understand how important this is
for people, and I am focused on making sure that we support
SNAP and the families who rely on it, in our Farm Bill this
year.
As appropriators, we also have a role to play in making
sure we have full funding for nutrition programs, WIC, school
meals, fresh fruit and vegetable program. Can you talk to us
about why it is so important that we fully fund the nutrition
programs?
Secretary Vilsack. Well, the research has shown that the
SNAP Program has a positive impact on reducing poverty, and for
children it also improves children's health if, in fact, the
benefits are meaningful. I think it is important for people to
know who is actually receiving SNAP. More than 80 percent of
SNAP recipients are either people with disabilities, senior
citizens who worked all their life, but are living on a fixed
income, or working moms and dads with children.
There is a lot of conversation about able-bodied adults
without dependents, but you need to know who those folks are.
There was a survey done in nine states, I think Washington
might have been one of those nine states, taking a look at who
those able-bodied folks were, and what they found was that they
were mostly men, and mostly homeless, mainly homeless. And I
suspect that many of them were probably homeless veterans.
And so I think as we look at the circumstances and
situations to try to assist, I think we should be spending more
time focusing on state's efforts with employment and training.
Your state, by the way, has one of the premier employment
and training efforts in terms of trying to connect people. If
you think about it, and Senator Hoeven, he knows this. States
know who the recipients are because they administer the SNAP
Program, and they also know where the jobs are, and they also
operate workforce development.
And the question is: Why we can't do a better job of
spending $100 million on employment and training, to basically
allow those things to connect so that the jobs that are
available, are linked to the people that need and can actually
do them?
CUTS TO CONSERVATION PROGRAMS
Senator Murray. Thank you very much for that. And finally,
in Washington State I have a lot of constituents working on
regionally important water storage projects in the Yakima and
Columbia basins. Those projects require ongoing technical
assistance, and support from local staff at the National
Resources Conservation Service. I often hear about how long it
takes to work with NRCS, or to get assistance.
Underfunded local staff are stretched really thin and it
would be an enormous mistake, I believe, to make things worse
by gutting these agencies working to conserve our vital
watersheds. Can you speak to what the risks are to our folks
who are working on these projects if we cut these budgets?
Secretary Vilsack. Well, the reality is that you will have
84,000--even the most--if you take not the most draconian
reduction that people are talking about, but the less draconian
version, it is 84,000 farmers who won't get the technical
assistance that they need in order to complete the planning, in
order to get the conservation benefit that they seek for their
operation.
So it is a very real impact, and we have made a concerted
effort to try to rebuild the workforce at NRCS, because when I
came back to this job there were 6,500 fewer people working at
USDA than before, and the morale was incredibly low. So we have
had a process of trying to rebuild both the workforce and the
morale.
Senator Murray. Thank you very much. I absolutely agree.
Thank you, Mr. Chairman.
Senator Heinrich. Ranking Member Hoeven.
Senator Hoeven. Thank you, Mr. Chairman.
CONCENTRATION OF SLAUGHTER INDUSTRY
Secretary, we have to do more to address the concentration
and the slaughter industry, particularly as regards to the
cattle industry, I know you share that belief and concern, and
there is a variety of things that we are doing, obviously we
have to continue to press on the practices of the large four
slaughterhouses, the processors, also, I think you are making
progress with alternatives, we are working hard on that, and I
am seeing that in our state and across, the country.
And I think that is very important and very beneficial, but
another thing that we have worked on--excuse me--is a cattle
contract library. And we allocated $2 million out of this
committee, and the authorization moved forward with a pilot
program. I think this is very valuable in terms of providing
more information to producers in regard to Agricultural
Marketing Agreement (AMA), and trying to promote more
transparency and competition. I know you got your rule out,
tell me where you are with it? How you think it is going? What
we need to do?
Secretary Vilsack. We put the rule out in January, and
began the process of putting stuff online. It is interesting,
our team believes, by virtue of what we knew before the rule
was proposed, and what we are seeing being provided by the
industry that adjustments have already been made to some
contracts in a positive way for producers.
Senator Hoeven. Good.
Secretary Vilsack. So I think the transparency, the
sunlight is an incredibly important tool. We are obviously
going to continue to do that, and to provide as much
information so people can make a comparative reaction, and a
comparative study of the contract that they are being offered,
versus what others have been.
Senator Hoeven. That program is important. The work you are
doing right now is really important, we will look to make it a
permanent program in the Farm Bill, and so we are learning--you
know, as you put it into play the experience that you gather
here is going to be really important, as we set up a permanent
authorization and funding for the program.
So we will be looking to that and drawing on the input, the
experience, and so forth that you pick up from the producers.
And it is really important because of the challenge of getting
the various associations to work together in cases like this
it--you know, is very beneficial that we are getting that done,
and that that experience you draw on is going to be very
valuable to us, how to have a good--the most effective program
going forward.
CATTLE IDENTIFICATION TAGS
Cattle identification tags, you have got your rule out for
public comment, I guess my concerns would be cost and any
mandatory nature of that, and how that is going to be handled
vis-`-vis our producers, it is like what, 30 bucks an animal,
roughly. And so that, you know, there is a cost, so I think
your original estimate is about $26 million, how are you going
to handle that, so that we are not putting a burden on our
producers out there?
Secretary Vilsack. Well, the benefit of this program is for
producers themselves, because if we have an incident and the
chances are that something will occur, the ability to be able
to identify where that incident occurs, and to be able to
contain it to a particular region, or a particular farm, is
going to be beneficial to trade.
Senator Hoeven. I agree on the benefit, I am just wondering
how you are going to handle the cost, and the mandatory nature,
you know, how our cowboys react to that stuff, so we want them
to see it as the beneficial tool it is.
Secretary Vilsack. Well, that is why we have been working
with the Cattlemen's Association, and other organizations, who
are in favor of this mandatory effort. I don't know that we
have, necessarily, had a conversation specifically. I haven't
had a conversation specifically about cost, but I am happy to
take that back to our team, and see what----
Senator Hoeven. Yeah. I hope you are working with the
associations on how you are going to handle that aspect of it.
And I do recognize the benefit of the tool, as do they.
CHRONIC WASTING DISEASE
Chronic Wasting Disease, the Chairman is an avid hunter, I
actually do enjoy hunting myself, and so we worked together on
the legislation for Chronic Wasting Disease, and he did a
tremendous job leading that effort. But really, one of the most
important aspects of it is, for the first time we actually have
domestic producers and the outdoorsmen working together rather
than jockeying against each other trying to get the funding,
and trying to get the research done that they want.
We finally brought them together in this initiative, and
that is critical, and we will, you know, obviously it is
authorized at $70 million, will work to increase funding, we
are already doing that, what is going to be most effective here
to advance the research in your opinion? And is there something
else we should be doing?
Secretary Vilsack. I think continuing to make sure that
there isn't appropriate division of those resources between
domestic and wild, that we don't seem to be favoring one or the
other recognizing, as you just mentioned, the need for these
folks to work together, and making sure that they see that this
program is benefiting all sides in a fairly appropriate way, I
think this is very important.
And then secondly, I think making sure that we have the
resources on the research side, to be able to really begin a
process of understanding, how does this get transmitted, and
what can we do from a domestic perspective to prevent
transmission. And we have got that issue frankly, and a lot of
other species as well.
Senator Hoeven. That is the breakthrough, that we have got
them working together, and then USDA working with the local--or
with the State Department of Ag, and their outdoor resources
people, I think can really help keep that cooperation going.
Secretary Vilsack. Absolutely.
Senator Hoeven. Thank you.
Senator Heinrich. Senator Manchin.
Senator Manchin. Thank you, Mr. Chairman.
Mr. Secretary, thank you, so much for all your service, and
feeding America, especially the children. I appreciate it more
than you know.
DEFINITION OF RURAL
I am going to switch gears just a little bit based on rural
America, and what we deal with. You and all of your staff and
everything, you do an awful lot more than just feed us. There
is an awful lot of economic activity that goes on, that
sometimes people aren't aware of, and myself, has not been,
until you and I spoke about what opportunities were out there.
Here is the problem we have, sir. The Economic Research
Service, I think was in your all, bailiwick, develops various
codes and criteria to help define rural America. The way I look
at it is about 66 million people living what I would consider
rural America. And currently, there is no code accurately that
captures the mountainous rural areas, which much difference;
the mountainous rural, versus agriculture rural, two different
things.
That is something we have not been able to see and it is
difficult for us to do anything as far as the building towers
to Internet, and all this, and delivering those services, are
so much more expensive. So the project was started in 2021, and
as of today we have not seen the Phase I published report. If
you could give us any update on that, if you have it? If not,
get back to me on that.
Secretary Vilsack. Well, I will have to get back to you on
it, Senator. But I would say this is an ongoing problem in
terms of the definition of ``rural''. There are multiple
definitions which creates a lot of confusion and a lot of
uncertainty.
Senator Manchin. Oh, I know.
Secretary Vilsack. So I will be happy to work with you on
that.
Senator Manchin. As a former Governor in serving, and
yourself, and I, we serve together. But as a former Governor
you have a lot of rule, at least in Iowa, you know--the problem
that happens, I have seen it since I have been here 12 years,
is when money is disbursed, whether it is in education, whether
it is in health care, whether it is in agriculture, whatever it
is, the rural areas do not get their proportion of shares.
So if there is 20 percent of the population that is
classified ``living in a rural area'', in my state, I don't
have one town, I don't have one city bigger than 50,000 people.
So I am a state of towns; 1.8 million people in a state of
towns, but it is as rural as it gets. And it is as wonderful,
it is just wild and wonderful, it is as wonderful as it gets,
but they get left out. When we look at the national money that
goes to rural America, it is only about 7-, 8-, 9 percent of
Federal funding.
Because I guess showing the biggest bang for your buck, it
is better if you have the 1,000,000 people, versus 50,000
people, but the services are just as needed. That is the
problem we are running into.
Secretary Vilsack. They are, but there is also a
contribution that rural America makes, a disproportionate
contribution that speaks to our military.
Senator Manchin. Oh.
Secretary Vilsack. People often forget that
disproportionate number of our military come from those small
towns in West Virginia and Iowa.
RECONNECT
Senator Manchin. And Appalachia, I mean Appalachia
especially. Let me go into this one here. President Biden
requested another 400 million of the ReConnect Program, in his
fiscal year 2024 Budget that he just put out. That is in
addition to the $348 million we had in the last budget, and
that is on top of the $2 billion in the Bipartisan
Infrastructure Law (BIL).
So have we put billions of dollars out there, and what we
are concerned about is, it is mammoth for you all I know that,
but coordinating that effort to be able to administer working
with Federal Communications Commission (FCC), National
Telecommunications and Information Administration (NTIA), and
Treasury. How is that going or where is the stumbling block?
Secretary Vilsack. I am pleased to tell you that by this
summer we will have all of the BIL money, the Infrastructure
money obligated, and the reason for that we really have spent a
lot of time trying to do this, so that it will complement the
work that will come next by NTIA and the Commerce Department,
and the FCC, because we want to basically use our resources to
upgrade, as best we can, the unserved and underserved areas so
that they have meaningful broadband.
And then as the mapping gets completed, we will then know
where the real serious gaps are which then will provide the
resources under the infrastructure law for commerce, and so
forth, to be able to invest through states. So we are
coordinating. We are making sure they know where we are
investing the money so that we are not overbuilding, and not
duplicating.
Senator Manchin. Well, let me just say, in closing, I
sincerely--in my lifetime I have never seen anyone has as much
knowledge as you, and as much experience in this job, coming
from where you came from, and also the states you represented,
to being in this position, and the amount of years you were
before, and one and done was not enough for the public service
you are giving, and I just thank you, because you can help us
so much, every one of you all.
I call him Tom, but I call him Governor, and I call him my
friend, he knows more about how to help your areas as far as in
getting other, than just the feeding of America, but basically
economic development. There is so much that they can offer in
that office, that we are not--we are just not accessing. So
thank you. Thank you, my friend.
Secretary Vilsack. I appreciate it.
Senator Heinrich. Well said, Senator Manchin.
Senator Hyde-Smith.
DISASTER ASSISTANCE
Senator Hyde-Smith. Thank you, Mr. Chairman, and I
certainly appreciate the opportunity to do this, and thank you
for being here. But first of all, I want to tell you how much I
appreciate your staff reaching out to us over the weekend with
the Mississippi tornadoes. Within hours after the storm they
were reaching out to the Mississippi delegation. And I
certainly appreciate that.
And seeing the devastation first-hand, you know, we have
just gone into that mode of trying to help these people as much
as we can. Most of this area is farming area, the Mississippi
Delta, and other areas as well. But you know, I just was up
there after the storm, and the day after that. And seeing the
devastation, you know, as resilient as we are, before we dive
into the details of the funding, I was just hoping that you
could kind of offer some information for the rural communities
that were affected.
For instance USDA's recent press release following these
tornadoes stated: Food Safety and Inspection Services (FSTS)
helping affected residents reduce their risk of food-borne
illnesses. Due to the power outages that we are looking at, the
Risk Management Agency offers several risk protection tools to
offset crop production and tree losses for certain crop
insurance products.
But the Farm Service Agency offers the Livestock Indemnity
Program, and the Tree Assistance Program, and the Emergency
Conservation Program, several things there, and NRCS can help
address natural resources concern, by providing the cost
assistance for work such as debris removal. But would you,
please, elaborate a little bit on the areas of assistance
offered, and how they can access this?
Secretary Vilsack. Well, first of all, I would encourage
you to take a look at the Farmers.gov website, which has this
document on it, which basically contains many of the programs
that you just mentioned but more than the ones that you
mentioned, and basically the kind of disaster they cover, and
the kind of assistance that they can provide, and the
information necessary. That would be the first order of
business.
The second order of business is making sure that state
officials and your staff reach out to the State Rural
Development Director for the State of Mississippi. I mean our
heart goes out. As a former governor, I have toured many
tornado damaged sites, and it is absolutely devastating to
people. They lose their home in a matter of seconds, and
unfortunately, in your state, loss of life as well.
But the Rural Development folks can be there to begin the
process of figuring out: How do we rebuild? How do we create
the opportunities for housing for the community facilities that
have been damaged or destroyed? What kind of resources could be
available?
And the Farm Service folks are there, obviously, to begin
the process of assessing the level of damage, so that crop
insurance and any risk management tools, as you well know from
your experience as commissioner down there, agriculture; that
we provide as quickly, a response to the loss of production as
possible.
So Farmers.gov, State Rural Development Director, and
working with the local FSA Office, I think would be where I
would start.
Senator Hyde-Smith. Well, I certainly appreciate that
because so much equipment got destroyed. You know, we are in
the middle of planting corn, and the equipment is just gone.
Secretary Vilsack. There is also a Disaster SNAP Program
that basically makes it a little bit easy for people who may
have lost their SNAP Card, because the tornado destroyed their
home.
Senator Hyde-Smith. Yeah. They don't even have vehicles.
Secretary Vilsack. Right.
Senator Hyde-Smith. You know, they have no way--no mode of
transportation right now to even--to get somewhere, but we are
going to recover, there is no doubt. We have some great folks
there. But I just wanted to tell you how much I appreciated
that.
HIGHLY PATHOGENIC AVIAN INFLUENZA
One thing I want to mention, I only have a little time
left. The 2022-2023 Highly Pathogenic Avian Influenza (HPAI),
the outbreak is the worst health crisis emergency in U.S.
history. As Ag Commissioner, this kept me awake at night, no
doubt. But paired with critical shortages of veterinarians in
rural, food, animal, and public practice, this outbreak has
been devastating for the poultry, turkey, and egg industries,
which we are a huge poultry state and egg state.
But it has also directly affected millions of families who
are struggling to keep up with the resulting rising cost of
poultry and eggs. But I recognize and appreciate that the
Animal and Plant Health Inspection Service, APHIS, is working
tirelessly to control Avian Influenza. But it seems as though
having more food animal veterinarians, and more vets in APHIS
would be helpful for current and future mitigation efforts.
But I also noticed that your budget includes $3 million for
incentives to recruit and retain public health veterinarians
for food, and safety, and inspection, services. So clearly USDA
understands the great need for veterinarians working in areas
besides small, animal practice, which is great, we all love,
and we have to have but, you know, it is just so much more
attractive and lucrative.
But the Veterinary Medicine Loan Repayment Program, which
your budget includes, helps alleviate veterinary shortages in
rural, and Food Animal Practice Government agencies like APHIS
and FSIS, by providing money towards the educational loans.
So you know, this subcommittee allocates the funds to this
program, and a major portion of those funds go right back to
the Federal Government because of the 39 percent Federal
withholding tax, which is just incredible on that program, at
its tax, 39 percent.
So only $6.1 million of the $10 million provided by
Congress for this program, in fiscal 2023, will actually be put
toward the educational loans of the veterinarians, and to
address these critical veterinary shortages.
Can you respond to that to help prevent animal health
emergencies, and what actions we can take to address this--
shortages in both private Food Animal Practice, and in state,
Federal Government, that 39 percent just blows me away.
Secretary Vilsack. Well, I am happy to take a look at that,
Senator. But I will tell you, the biggest problem we have is
retaining folks that we actually do get. They actually end up
starting at APHIS, they are excited about their job, they do an
amazing job for a year or two, and then someone basically says
to them: Hey, in the private sector you can make 10-, 20-,
25,000, $50,000 more, why don't you come over to the private
practice? And that, that is the challenge.
Our compensation system has got to be looked at from--and
when I say ``our'' I mean the Federal compensation system--so
it is competitive. And we have to have more flexibility in
terms of the ability to use retention resources to be able to
retain these folks, because we can get them in the door we
just, we are having a hard time keeping them.
The loan repayment is one aspect of it, but there are many,
many other aspects in terms of lack of competitive nature of
our compensation system.
Senator Hyde-Smith. I would really appreciate some help
with trying to offset that system.
I am sorry for going over my time, Mr. Chairman.
Senator Heinrich. Senator Merkley.
Senator Merkley. Thank you, Mr. Chairman.
DROUGHT IN THE WEST
And Mr. Secretary, good to see you; and I want to talk a
little bit about drought in the west.
And in the eastern part and southern part of my state we
have had droughts that have gone on year-after-year, it is also
associated with the lower snowpack we have in the Cascades. I
was just up at Crater Lake where they showed that they have
lost 240 inches of average snowpack over the last 90 years,
complicating the lack of rainfall during the spring and summer.
And the irrigation districts are responding by, one,
changing their practices on the farm to get more crop with less
water, but then also by piping their canals. And this piping
has been essential because of the massive amount of water that
is lost in open ditches, through evaporation and groundwater.
And that effort has been explored in an article, The
Washington Post, ``The Future of the American West is in
Central Oregon'', which is about that vast effort to pipe to
save our agriculture and I want to submit it for the record
Senator Heinrich. Without objection.
[The website link for the article follows:]
https://www.bloomberg.com/opinion/articles/2022-08-28/central-
oregon-is-the-future-of-the-american-west?embedded-checkout=true
Senator Merkley. Thank you. So this effort has been
recognized in the Western Water and Working Lands Framework,
and that NRCS philosophy notes that water management is
essential or we lose agriculture across a broad swath of the
West. Are you familiar with that NRCS Framework, and do you
support that?
Secretary Vilsack. I am very familiar. The six challenges
and thirteen strategies, and the $25 million that we have
allocated to the Department of Interior WaterSMART Project?
Senator Merkley. Thank you.
Secretary Vilsack. Yes, I am.
Senator Merkley. I knew you would know every nuance of it.
But I asked that simply because there is a tool that was
incredibly effective that I worked to revitalize, with Senator
Cochran, the 566 Program which had basically gone out of
existence. And that program was being used to help with the
piping of the irrigation districts in the West.
And over the last couple years the Administration has
shifted that 566 money away from helping with piping in the
West, and I am basically here to say: Can we recognize that
this is an incredibly powerful tool to help address the goals
in the Western Water and Working Lands Framework, and can we
move some of that funding back into the direction of helping
the Western Irrigation projects with their piping challenges?
Secretary Vilsack. It seems as if that would be consistent
with one or more of the strategies to modernize the water
infrastructure and the complete watershed projects; and also to
do a better job of water management. So it would seem to fit
within the strategies that the framework has called for.
Senator Merkley. It definitely fits. And I would appreciate
any help that we can get. We have been able, through our
community initiated projects, to direct a small amount of
money. This is, if you will, the congressionally directed
spending, which in Oregon we call ``community initiated''. And
I can tell you the irrigation districts are all completing
watershed plans to be eligible for this program.
And well, I am doing all I can to help them survive a very
difficult changing climate where water efficiency will help
save them, but piping is essential, and for that piping 566, is
essential so I ask for your help in shifting some of those
resources.
Secretary Vilsack. So I will take a look at it, Senator.
Senator Merkley. Thank you very much.
Senator Heinrich. Senator Moran.
Senator Moran. Chairman, thank you.
Mr. Secretary, thank you, for being here. Thank you for
your service to farmers and ranchers across the country, and in
Kansas, in particular. You and I are about to have a high-five
moment.
Secretary Vilsack. Yeah.
NATIONAL BIO AGRO-SCIENCE FACILITY
Senator Moran. Thank you for working with me to pick a date
for you to be in Kansas, and I want to take several moments,
but want to give you a moment to highlight a development that
began a long time ago as a result of the 9/11 Commission.
The Secretary will be in Kansas to cut a ribbon on, the
National Bio Agro-Science Facility (NBAF), designed to protect
public health and our food safety, managed by USDA,
Agricultural Research Service (ARS), and APHIS, and it will
contain the BL-4 Biocontainment Laboratory.
You were there, Mr. Secretary, in May of 2015, now 8 years
ago, a long time coming, but a very important facility and
asset for the Department of Agriculture, American farmers and
ranchers, and in fact every American citizen, and around the
globe.
I would be glad to have you highlight why you think this--
if you do, why you think this is a benefit to the American
people?
Secretary Vilsack. Well, Senator, it absolutely is. It
modernizes our process and our ability to investigate and to
research some of the major challenges and threats to American
agriculture, whether it is African Swine Fever, or Foot-and-
Mouth Disease, or some of the other seven critical diseases
that could cripple our livestock industry which, obviously,
would impact and affect our entire economy and our food
security.
In addition, this facility will also be where the Vaccine
Bank is housed, and as we develop vaccines to try to deal with
some of these threats, obviously being able to stockpile
appropriately and safely, those vaccines are incredibly
important. There are also, a great deal of research is going to
be done on the countermeasures, the biosecurity initiatives
that are a part of protecting our livestock industry.
So this is critically important. And the fact it has taken
as long as it has, is because of the minute nature of the
protections and security that is required as we move from Plum
Island to Manhattan, Kansas.
So I am looking forward to welcoming, and to cutting that
ribbon. And I am sure that you will have a pair of scissors,
and I am pretty sure Senator Roberts will have a pair of
scissors.
Senator Moran. I appreciate you being there, and I look
forward to seeing you in Kansas on May the 24th. Thank you.
Secretary Vilsack. Looking forward to it.
GENETICALLY MODIFIED ORGANISM CORN
Senator Moran. Mr. Secretary, I was in Mexico City, I met
with President Obrador may be a week ago Sunday. Maybe in your
answer to my question you can explain your smile. I raised my
concerns about the efforts to ban genetically modified organism
(GMO) corn, I was encouraged to hear what I thought was said,
which was that the matter could be resolved in the consultation
stage, rather than reach dispute settlement.
That was then followed by the suggestion that the United
States and Mexico ought to do an additional study about the
safety of GMO. Does the USDA continue to believe that the
science on this matter is conclusive, and will it continue to
fight to ensure full and fair access to the Mexican market?
Secretary Vilsack. Senator, and the reason I smiled is
because I have had two such meetings with President Obrador,
and I am fairly certain that what he told me on those occasions
is exactly what he told you. And the reality is that we don't
need another study, there are literally hundreds of studies
about the safety of this technology, and that has been
explained to the President. It has also been explained to the
President that 66 percent of his feed needs for his livestock
industry come from biotech corn that is grown and raised in the
United States.
The challenge is that he is very--as you probably found
out--very proud of the white corn that is produced, the maize
that is produced in Mexico. And I think he has put himself in a
situation, a political situation that is very hard for him to
move out of.
At the same time, by virtue of banning the ability to have
white corn from Nebraska, or other states come into Mexico we
are--he is asking us to acknowledge a non-scientific basis for
such a ban, and we can't do that. It is fundamental to our
trade strategy and philosophy, and our approach to the rest of
the world that we want a science-based system, and we believe
in the safety of biotech products, we believe in the science
behind it, and that has been explained to the President,
politely, on a number of occasions.
Senator Moran. Is there any question about what our trade
agreement is between Canada, and Mexico, and the United States.
Secretary Vilsack. Not in our view.
Senator Moran. Thank you. Mr. Chairman, I would conclude
just by telling that--I would feel guilty if I didn't say this.
Mr. Secretary, you and I have worked in your previous time
at USDA on trying to export and increase trade around the
world, I would encourage you and the administration that you
work in, to look for opportunities to reach agreements with
other nations, singular and then collectively, trade is hugely
important, and while we face challenges in making sure that we
do trade agreements right and they are enforced, farmers in
Kansas, and across the country depend upon the ability to
export what they do, around the globe.
Secretary Vilsack. Well, the good news is that we have had
over $15 billion of additional opportunities in market access
created in the last 2 years. So we will continue to do that.
Senator Moran. Thank you.
Senator Heinrich. Senator Fischer.
Senator Fischer. Thank you, Mr. Chairman.
PRECISION AGRICULTURE
Mr. Secretary, so nice to see you again. A couple of weeks
ago we had the opportunity to talk about the importance of
precision agriculture, and I would like to talk about an
exciting opportunity from USDA AG Research Service.
As you know, over the past couple of years Congress has
appropriated $31.2 million to begin construction on a new USDA-
ARS National Center for Resilient and Regenerative Precision
Agriculture, co-located at the University of Nebraska-Lincoln.
Those already-appropriated funds are going to allow
construction of a research greenhouse to begin on that project.
And I was glad to see in the fiscal year 2024 request for an
additional 60 USDA-ARS employees to Lincoln.
Can you discuss the need for those additional ARS
employees, and the vital research that the National Center for
Resilient and Regenerative Precision Agriculture will perform?
Secretary Vilsack. This is a process of rebuilding the
workforce at ARS, and providing a complement to the research it
has done through the AFRI Program, which is the grant program
to land-grant universities.
We are very proud of the work that we do at ARS, but we
just need more people, we need more bodies, and we need the
ability to recruit bright young people to make sure that we
have a constant stream of bright people. We have proposed this
because we like working with the University of Nebraska. We
think that they have a concept and a vision that is incredibly
important to the future of agriculture as it relates to our
response to climate.
We are going to have to produce more with less, and the
only way you can do that is by better understanding how to use
the inputs that you have in the most effective way, how you can
have seed technologies that are more beneficial and more
efficient in how they use the inputs. And then be able to
provide the information to farmers so that they can utilize
that information in the best possible way to improve their
productivity and their profitability.
So this is an important enterprise, which is why we
proposed additional investments, not only of people, but also
money.
Senator Fischer. And I hope that Congress is going to
quickly provide Appropriations so we can see the construction
of the facility as well.
IRA CONSERVATION FUNDING
In the Inflation Reduction Act it provided an addition of
$19.5 billion to several USDA conservation programs, text of
the IRA departed from the resource concerns agreed to in the
Bipartisan 2018 Farm Bill, and it restricted how these funds
could be used to improving soil carbon, reducing nitrogen
losses, or to reduce capture, avoid or sequester carbon
dioxide, methane, or nitrous oxide emissions associated with
agricultural production.
How is the USDA interpreting that restriction placed on IRA
conservation funds? For example, how will you look at a
producer who wants to use Environmental Quality Incentives
Programs (EQIP) cost-share funding to upgrade their irrigation
pivot, for example, so they can optimize their water usage?
Would that, or would they be at a disadvantage under the IRA
funding?
Secretary Vilsack. What I can tell you, Senator, and I will
get a specific answer to that hypothetical. I can tell you that
the NRCS is focused on utilizing the climate-smart practices
that we have identified that we are currently funding under the
EQIP Program and using the IRA resources to basically ensure
that those practices are targeted or benefited. I mean, the
reality is, I think it is--there are 45 of them, so there is
quite a broad range and the goal here is to try to encourage
more of that. But I will ask our team to get back to you on the
specific hypothetical you have provided.
Senator Fischer. Yeah. That would be great. I am new on
this committee, and I am excited to be on this committee
because I want to be able to make sure that we are funding
programs that work, and the producers use, where they are able
to have fewer inputs, and also be more profitable. And I have I
think if we can make those determinations that really work on
the ground, it is going to help not just rural America, it is
going to help our conservation methods as well.
Last question: The livestock is the biggest sector in
Nebraska, we always talk about that. It is a huge economic
engine. We have a Meat Animal Research Center in Clay Center.
And I was glad to see the budget request included an addition
of 15 employees at U.S. Meat Animal Research Center (MARC), as
well as an increase in ARS funding for their Livestock
Production Program. How would increased staff at MARC help
carry out research related to critical livestock industry
priorities, including increased environmental sustainability,
improved production efficiencies, and really optimize the use
of our natural resources?
Secretary Vilsack. Well, I think we are going to learn
quite a bit, not only for the work that is specifically done at
that Center, but also as we institute our partnership for
climate-smart commodities there is going to be a significant
amount of measurement, monitoring, verification, and
accumulation of data.
Senator Fischer. Mm-hmm.
Secretary Vilsack. That in turn can be provided to ARS
facilities, into other facilities, in terms of being able to
educate them about what we know works, and frankly we are going
to find out stuff that doesn't work. And we want to make sure
that we are not funding that, or we are not targeting resources
to what doesn't work.
So I think it is a combination of the research that they
would normally do, but it is also learning from the experience
in virtually every commodity including livestock, there are a
number of livestock projects in that Climate-Smart. So I think
you are going to learn a lot from that.
Senator Fischer. Okay. Great. I know specifically of one
Ph.D. student who is doing research at the University of
Nebraska, who has been conducting it, she has for over 5 years,
to look at livestock emissions. And I think that is going to
change the perception out there greatly, by the public, and
really look at the benefits of livestock to the environment.
Secretary Vilsack. We need to reduce methane, and we can.
There are strategies, and we also need to capture it and
convert it.
Senator Fischer. Yeah, thanks.
Senator Heinrich. Senator Tester.
Senator Tester. Thank you, Mr. Chair. I want to thank you
and the Ranking Member for having this hearing.
FARM SERVICE AGENCY STAFFING
I want to thank you for being here, Secretary Vilsack, I
appreciate it. You know, I have had a number of Farm Bill
listening sessions since this is a Farm Bill year, and these
haven't been invitation, this has been opening the doors and
let folks in to speak their mind. And we have heard things that
you have heard, like the reference price needs to go up because
of inflation. We have heard things like conservation programs,
like EQIP, need more flexibility, because we don't have enough
well drillers or dirt movers to get these jobs done within
timeframes.
We have heard things like the Crop Insurance Program,
especially with the push of cover crops needs to be increased
to cover a lot of those. We have heard a lot about food
security because we both know that democracies don't work very
well when you have a population that is hungry.
One of the things that I have heard about that I didn't
expect to hear about, but I have heard it at every one of them,
is that it is really hard to hire people in our FSA offices. We
have got 236 total FSA positions in Montana, roughly 40 of them
are vacant on any given day. Part of the problem is competitive
salaries. The starting salary in Montana is $33,700 if you
don't have a degree, $37,700 if you do.
I can tell you. And you know this, you know this, Mr.
Secretary, you can probably make money doing damn near anything
else but being a school teacher. Okay, that is probably the
only thing you couldn't do. We do not have locality pay in
Montana, and so a place like Bozeman, which is where our state
office is, where the cost of a house is equivalent to a house
in San Francisco, you are just not going to get people to work,
you just aren't going to get people to work at those wages.
So my question is, in your budget do you have adequate
dollars so that we can recruit some people; because it truly is
a crisis situation? I use our office in Chouteau County and
they felt the turnover, but in some of these offices it has
been devastating. And you know very well, we can do the best
job putting a Farm Bill up, and you can do the best job
implementing it, if you don't have people on the ground we are
screwed.
Secretary Vilsack. Senator, I couldn't agree with you more.
And this isn't just your FSA office issue, it is an issue
across FSA, it is not just an FSA issue, it is an issue across
all of our mission areas. And it is, in part, a result of the
overall Federal system that is in place, and we are trying to
work with the Office of Personnel Management (OPM) to get a
better understanding of how we might be able to reclassify
people, and figure out ways in which we can provide more
resources, and more incentives for people to work at USDA.
Senator Tester. So I am willing to work with you at the
OPM. You are right. It is a system-wide problem within Ag,
within the Veterans Affairs (VA), a number of other agencies,
if not every other agency. But let us say we get OPM to do that
reclassification, will this budget support it?
Secretary Vilsack. I believe it will. I mean, we are we are
asking for more resources so that we can hire more people. So I
think we have the capacity. The challenge isn't just simply
getting people, Senator, it is also retaining them.
Senator Tester. Yes. That is correct.
Secretary Vilsack. That is actually, to a certain extent,
that is an even greater problem, because as soon as they start
working somebody--here is what happens in these FSA offices,
the loan officers in particular, they get trained by us, get
trained well.
Senator Tester. Go to the bank.
Secretary Vilsack. And then a bank comes in and says: Hey,
you can we can make $5,000 more. And off they go. So we have
the capacity I think in our budget to do some retention stuff,
but we need, we need more permission.
Senator Tester. Well, I think it is a problem, and I would
have heard about it, at every group I went to. I mean these
folks, they didn't get together and plan this, I didn't give
them talking points. They came in, it came up organically. It
is an important problem.
Secretary Vilsack. Yes.
BRAZILIAN BEEF
Senator Tester. I want to talk about something else that
isn't nearly as pleasant as not being able to hire or keep
employees, believe it or not. And that is Brazilian beef. So I
have just got to tell you, I have had bills to ban it, I think
it is a bipartisan concern. Earlier this year Brazil had
another case of bovine spongiform encephalopathy (BSE) it took
them, it took them 35 days to report it. I would hope it
doesn't take us 35 days to report if we have it here, although
we don't, which is an issue that if we get it here it raises
hell with our beef industry.
My question is, does it take an act of Congress to ban
Brazilian beef, or can you do it? And if you can, why not do
it?
Secretary Vilsack. This was an atypical case, Senator, and
it is sort of like: Do you do you believe in the Golden Rule?
Because if you do it to Brazil, Brazil can do it to us; we
actually have had atypical BSE cases. And if you want the rest
of the world to ban our beef, for an atypical case, which is
not recognized as a bankable event by the World Health
Organization (WHO), and the animal health organizations, that
is the challenge, all right.
We have communicated to Brazil our unhappiness about the
tardiness and the lateness with which they have identified
this. We are happy to help them with their testing to make sure
that they get information to us quickly as possible. But I
think for an atypical case I think you are going down a road
that is pretty slippery, and I don't think we have the
authority to do it.
Senator Tester. And I am over time. So here is the issue. I
don't think you would disagree with the fact, that we raise the
best beef in the world, we raise the best Ag products in the
world. And that is not brag. I believe that is absolute
unequivocal fact. When we have a situation where we are having
a generation of ranchers go broke because of an issue that you
and I agree on, the amount of consolidation in the industry,
and the processing industry, and one of those processors is
JBS, which is a Brazilian company, I think we ought to do our
level best not only to hold them accountable to make sure they
are following the Packers and Stockyards Act, but hold them to
extremely high standards, when it comes to bringing in
Brazilian beef, because I think that is where most of it is
coming through.
Secretary Vilsack. It is certainly fair, that they should
be held to a high standard in terms of the safety of the
product.
Senator Tester. Okay. Thank you.
Senator Heinrich. Secretary, we are going to try to do a
quick second round, if you are amenable to that?
Secretary Vilsack. I didn't know I had a choice.
Senator Heinrich. You seem to be doing fine so far, so we
are not letting you off the hook just yet.
SINGLE-FAMILY HOUSING RECAPTURE
I mentioned the single-family housing recapture proposal
and, you know, the challenge with those balloon payments. Can
you just talk a little bit about how important this initiative
is, and how it would improve access to affordable housing in
rural America?
Secretary Vilsack. If you want to create distrust in
government, continue this process. People, basically, they sign
a loan document, they don't quite understand you are getting a
loan, interest subsidy, and you know, interest rates going to
be lower but, boy, you know, 20 years from now when you sell
it, or when your heirs sell it, you are going to have a--you
know, you are going to have a bill that you are going to have
to pay, and it is going to be pretty substantial.
Senator Heinrich. Yeah.
Secretary Vilsack. It is an outrage--I mean, to me, it is
an outrageous process because it comes as a tremendous
surprise, especially when ``mom'' and ``dad'' are gone, and the
kids are selling the house, and then they are set--good news is
you sold the house, the bad news is, you owe the Government
$27,000, and they go--that is not what we should be doing.
Senator Heinrich. I don't know how we got here, but we need
to fix it.
Secretary Vilsack. I don't know either, I don't know, and
there may have been a rationale behind it, but it undercuts
trust in government and to me that is the principal reason for
getting rid of it, and to do it retroactively so that we don't
surprise any more folks.
PROCESSING OPPORTUNITIES FOR BISON
Senator Heinrich. Thank you. Both the Ranking Member and I
have a special interest in bison. We actually designated bison
the ``National Mammal'' a few years ago.
We have a lot of interest in bison production in New
Mexico, particularly with some of our tribes, and Pueblo
producers. What do you see as the USDA's role in aiding
producers, and in particular like expanding access to
processing opportunities for those producers?
Secretary Vilsack. Well, we have had two initiatives, one
basically taking a look at existing processing facilities, and
giving them resources to be able to expand their market
capacity, and market reach, two bison operations have received
those Meat and Poultry Inspection Readiness Grants.
I think--if you are patient with us--within the next month
or two you will see there will be a specific effort to provide
additional resources for tribal processing, which obviously
will be focused a great deal on bison. We have also, as part of
our effort on food sovereignty, with tribes we have tried to
integrate more bison purchasing, and more bison in some of our
feeding programs.
And also I am pleased to note that the Partnership for
Climate-Smart Agriculture Commodities included several bison
projects as well, so there is a great deal of effort, both in
terms of creating market opportunities, expanding processing
capacity, and being able to incorporate bison into any climate-
smart initiatives that we are developing.
Senator Heinrich. And I appreciate your focus on it. I
would mention, as you are looking at that production side, the
concept of shared resources for mobile processing is something
there is an awful lot of interest in and something to bear some
focus.
Secretary Vilsack. There is a loan guarantee program that
we have that is basically providing resources for mobile
slaughter and processing, it is a loan program, but it is a
guaranteed program with lower interest rates. That is something
that folks could look at as well.
POLLINATORS
Senator Heinrich. Great. Thank you. We have had a lot of
challenges with pollinators in recent years, and an enormous
amount of our agricultural production is directly dependent on
pollinators, what are we doing in this budget around ensuring
the long-term success of a whole range of pollinators that
agriculture depends on?
Secretary Vilsack. Well, we have a specific CRP aspect to
pollinator, which isn't necessarily specific to this budget,
but it is obviously specific to the Department. There are
research initiatives that are also focused on pollinator
health, Utah State. For example, has a fairly significant
initiative when it comes to pollinators.
I didn't know that there were like, you know, 4,000
different kinds of bees in the United States, and 20,000
internationally, but now I do know that, in part, because of
their program. So we fund research, and we provide habitat,
expanded investment in habitat.
Senator Heinrich. Great. I am going to pass things off to
the Ranking Member.
Senator Hoeven. Thanks, Mr. Chairman.
DISASTER ASSISTANCE
A number of things that Senator Tester mentioned, I think
are really important. I won't go back into them, but the FSA
staffing is very important obviously. We want to work with you
to address that. He also emphasized the importance of crop
insurance and safety net as I did in my opening comment. Do you
agree that those have to be absolute priorities in the in the
upcoming Farm Bill?
Secretary Vilsack. Yes.
Senator Hoeven. Updating those?
Secretary Vilsack. Yes.
Senator Hoeven. Okay. The emergency--we put together the
Wildfires Hurricanes Indemnity Program+ (WHIP+), and then
utilized it, and then came back, and utilized it again. You
brought it out and called it Emergency Relief Program (ERP).
Phase 1 worked very well, we are very pleased with that. Phase
II, as you know, we weren't quite as pleased with, in terms of
how you formulated it. My request to you, going forward, is
that you would work with us if we utilized that WHIP+ Program,
or as you call it, ERP, and the Livestock Risk Protection
(LRP), again, I think you did a lot of good, but we would like
to coordinate with you on how it is implemented, if utilized
going forward.
Secretary Vilsack. Do you want me to respond to that,
Senator?
Senator Hoeven. Yes.
Secretary Vilsack. There are three groups of people that we
are dealing with when it comes to ERP. There is the group that
has Crop insurance or Noninsured Corp Disaster Assistance
Program (NAP) coverage, where they have information and data
that was provided to us and we pre-populated the application,
tried to reduce the time to get resources satisfied.
Senator Hoeven. Yeah. Mm-hmm.
Secretary Vilsack. That is Phase I. Phase II was focused on
the people that did not have. That there are people that are
greatest at risk, that don't have any of those protections. Try
to get them into that system. If there is money left over from
Phase II, our expectation is to take a look at the other group,
which is the group that, because of their losses were pretty--
didn't trigger an indemnity under crop insurance, that they
would then be in a position to be able to receive resources.
And we are learning from this experience, and I would
expect and anticipate that we need to look at that in terms of
this year's ERP Program.
Senator Hoeven. Yes.
Secretary Vilsack. Having said that, Senator, there is not
enough money in that program.
Senator Hoeven. I know. And that was part of it, which is
why I registered concerns but left it at that.
Secretary Vilsack. Okay.
Senator Hoeven. But no, that is what I hope you would say,
and that is good. We will work with you going forward. Also I
think again, as far as that countercyclical safety net that,
you know, getting that right and crop insurance right, updating
it like we are talking about, will help diminish the need for
some of these other disaster assistance programs, so again,
incredibly important.
And one of the areas, also, I want to ask about, is the
Pest Management policies, you know, some of the issues we have
seen with glyphosate, chlorpyrifos, some of those products that
our farmers and ranchers have been using for years, and years,
and years now are being taken off the market. Not necessarily
through your actions, but through court actions, that can be
kind of state by state. It is creating a difficult patchwork
for our producers out there.
What can we do about that? And it is also creating a lot of
uncertainty for them. I mean they are they are buying these
products, and then they can't use them. I mean, it really is
getting to be an issue that USDA needs to take the leadership
role in terms of helping our farmers and ranchers from the
standpoint of understanding what they do, and the certainty
they need as they run their operations?
Secretary Vilsack. Well, I would say a couple things on
that. I think, first of all, you are right. We need to be
making sure that as other agencies of government make decisions
that could impact and affect producers, that we have done a
good enough job of educating them about the impact on
producers. And I am fairly confident that our Pest Management
folks are doing that at USDA. That they are providing the
technical, and scientific, and detailed information about the
impact and effect of what Environmental Protection Agency (EPA)
may be considering.
Then secondly, to the extent that we can work with the
industry to make sure that as things are restricted in some
way, that the labeling is what it needs to be, to be able to
provide clear understanding of when, and under what
circumstances certain things can, in fact, be used.
And then third, if there is a way in which our NRCS
capacities can be used in a way to mitigate the consequences of
some of this, we ought to be, obviously, directing our
resources to do so. And I think our research folks also have a
responsibility to ask the question: Are there ways in which we
can, if we can't use this, what is the alternative; and we need
to provide that alternative to our producers through extension?
TRANSITIONING NEXT GENERATION FARMERS
Senator Hoeven. Like-kind exchanges. The average age of a
farmer nowadays is about 60 years old, which of course I think
is remarkably young, but for most people 60 years old is, you
know--we have got to get this next generation into farming. One
of the tools they use is 1031 like-kind exchanges, and the
administration has come out proposing limitations on 1031 like-
kind exchanges. But you know the capital barriers to getting
into production agriculture. We have got to help this next
generation get into farming; that is an important tool.
Secretary Vilsack. Well, I would say that that is one of
the reasons why we have asked for greater flexibility on our
loan programs, so that we are in a position to help.
Senator Hoeven. Agreed. Yeah, we need to do more with the
beginning farmer, and the other loan programs as well. But you
would agree, those are important tools that our--and that it is
an important part of transitioning this next generation into
agriculture.
Secretary Vilsack. It is Senator, but the reality is that
there are so many needs, I mean we have to take a look at:
Where does the resource come from to do all the stuff that we
want done, that we have all talked about here in this
committee? And that we are talking about in our budget? I mean,
it is a balance.
Senator Hoeven. Yeah. No, I understand. We have to we have
to figure out good commonsense ways to accomplish it.
Again, thank you, for being here today; and for your work.
Secretary Vilsack. You bet.
Senator Heinrich. Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman.
DAIRY BUSINESS INNOVATION INITIATIVE
Secretary Vilsack, it is great to have you back before the
committee today. Before I get to my questions, I would like to
just thank you for prioritizing the Dairy Business Innovation
Initiative in your budget. In the time since its inclusion in
the 2018 Farm Bill, millions of have gone to Dairy Producers
including those in Wisconsin, enabling businesses to expand
their product lines, and increase their market share.
These small dollar grants have been incredibly meaningful
to my state's world-renowned dairy and cheese industry. So we
appreciate that prioritization.
Wisconsin dairy farmers have also led the way in
implementing managed grazing to sustain herds. This practice,
when done right, can go a long way in improving soil health,
plant diversity, and water quality. For years, Wisconsin
grazers and those interested in pursuing managed grazing have
made it clear to me that the success of their operation is
significantly improved when they are able to consult a grazing
expert.
Specifically a knowledgeable technician who can help
address the unique needs of their operation, and can save
farmers valuable time and get them on an expedited path to
profitability, improved water quality, and climate resilience.
GRAZING LANDS CONERVATION INITIATIVE
I was able to secure funding for the Grazing Lands
Conservation Initiative in the fiscal years 2022 and 2023. And
this funding was intended to begin meeting the needs for
grazing technical assistance for the first time in over a
decade.
So Secretary Vilsack, could you share with me the Agency's
plan to allocate these funds so that technical assistance can
be made available? But additionally, I would note that funds
were not included in the fiscal year 2024 Budget, and so I am
curious to know how the USDA plans to sustain this operation?
Secretary Vilsack. Senator, I may stand to be corrected in
the answer I am about to give you. So bear with me if I am
misstating something. NRCS has basically outlined a variety of
factors that we want to, basically, invest our conservation
resources in. And one of them has to do with grazing, and one
of them has to do with rotational grazing and proper
management, as part of their climate-smart practices.
And so I think, from a standpoint of NRCS, we see this as
kind of already included in the suite of 45 practices that we
have identified, that we want to target our resources, we want
to direct IRA resources towards, based on the requests from
farmers that we get. There is a significant backlog. I suspect
that there are some producers in Wisconsin that are waiting
for, they have a plan they are waiting for the resources from
NRCS. And we are really trying to focus on reducing that
backlog, and then basically making sure that the EQIP,
Conservation Stewardship Program (CSP), all of those resources
are effectively invested in climate-smart practices.
CLIMATE-SMART COMMODITY PARTNERSHIP INITIATIVE
That is in addition to the fact that many Wisconsin
producers will also be engaged and involved in the Climate-
Smart Commodity Partnership Initiative, and I know that there
are management practices included in many of the projects that
we sponsor, and will be sponsoring in Wisconsin. So you will
also have opportunities within that partnership initiative to
also see significant investment in those practices.
Senator Baldwin. Okay. I will certainly want to follow up,
and be able to track this with some granularity.
I would like to next ask about Avian Influenza, which has
contributed to major increases in egg prices this year; the
Animal and Plant Health Inspection Service Line for the
Emergency Preparedness and Response Initiatives, so a minor
increase in your budget.
How will this budget proposal ensure that needs are met to
fully address the spread of Avian Influenza, including
providing quarantine and inspection services to producers, and
funding for state agencies and universities that are conducting
Avian Influenza testing?
Secretary Vilsack. This is a great question, and I
appreciate you raising it. Because it basically allows me to
indicate that there are a number of tools that we are bringing
to the HPAI fight, and one of those tools is the Commodity
Credit Corporation (CCC). So APHIS is receiving additional
resources from the CCC Fund, which is essentially providing
resources to allow us to help farmers deal with the detection,
eradication, and restoration of their facilities.
And so there is a complement there, as you just can't look
at the four corners of the budget, you have to look at also the
additional resources that we are providing.
In addition, when we basically create resources for
research there are a number of research projects that involve
this that are underway at universities at are getting--they
aren't specifically on a line item, but they are involved,
potentially, in an AFRI effort.
We are also meeting with the industry and, you know, I
think there is more work to be done here in terms of
encouraging, not just the development of biosecurity plans, but
the implementation of those plans, our producers, our
commercial operations have done a much, much, much better job
than they did in 2014/2015, because we didn't see quite the
spread from commercial operations that we did.
But we need to continue to be very vigilant about that, we
need to take a look at the design of these facilities in terms
of the transmission, airflow which can potentially complicate
things. We need to make sure that we continue our research on
vaccines, with the understanding that we are not there yet, we
are not even close to being there yet. We don't have a
commercial operation willing to produce the vaccine, we haven't
matched it identically to the issue that we have got right now,
and there are trade complications as a result of the use of
vaccine.
So it is really complicated. Some people like to simplify
it, but it is very, very complicated. So all of that is in the
budget in various pieces, it may not be specifically identified
as such, but it is all in the budget.
Senator Baldwin. Thank you. I yield back.
Senator Heinrich. I want to thank you, Secretary Vilsack;
and you Mr. Rapp, for being here today.
ADDITIONAL COMMITTEE QUESTIONS
Questions for the record are due by next Wednesday, April
5th, and we would appreciate responses back from USDA within
the next 30 days.
Questions Submitted by Senator Dianne Feinstein
deferred maintenance for research facilities
Question. Secretary Vilsack, as you may know, a March 2021 study
found that there is at least $11.5 billion of deferred maintenance for
university agricultural research facilities nationwide, and that 69
percent of infrastructure at these facilities is more than 25 years
old. In Fiscal Year 2023, Congress provided $2 million towards Research
Facilities Act competitive grants. Absent a sustained Federal effort to
upgrade aging or obsolete infrastructure, I am concerned that the
United States' ability to conduct world-leading research will suffer.
Secretary Vilsack, what actions is the U.S. Department of
Agriculture (USDA) currently taking to improve research infrastructure
and support the next generation of agricultural researchers? How is
USDA utilizing the $2 million provided by Congress for Research
Facilities Act grants in Fiscal Year 2023? How should USDA's efforts be
scaled to better meet the needs of research institutions across the
country?
Answer. USDA currently provides research facilities funding through
multiple programs including the 1890 Facilities Grants Program, the
Agriculture and Food Sciences Facilities and Equipment Program for
Insular Areas and, most recently in fiscal year 2023, the Research
Facilities Act Grant Program (RFAP). Through RFAP, USDA National
Institute of Food and Agriculture (NIFA) will provide funding to assist
in the construction, alteration, acquisition, modernization,
renovation, or remodeling of agricultural research facilities. RFAP
prioritizes facilities that are located at or primarily benefit
minority-serving institutions in accordance with the Joint Explanatory
Statement, which accompanied the Consolidated Appropriations Act, 2023.
NIFA will host a virtual listening session on April 13, 2023, to
receive input from stakeholders, customers, and partners that will
facilitate the development of the Research Facilities Act Program
Request for Applications (RFA). Once the publication date for the RFA
is finalized, NIFA will host a technical assistance webinar to provide
information and assist stakeholders in applying to RFAP.
NIFA's current research infrastructure programs support both
fundamental and applied research across diverse institutions serving
different communities. This investment in research infrastructure
allows for more institutions, including minority-serving institutions,
to improve their agricultural research facilities with multiple
benefits including greater output of cutting- edge research that
addresses current and future priority issues, improved training of a
more diverse and well-trained workforce, and enhanced competition with
global competitors. Among the multiple beneficiaries of investments in
research facilities are limited resource farmers and ranchers since it
can help them access new technologies, methods, and knowledge that will
improve productivity, efficiency, and profitability. Consumers also
benefit because improved and advanced research facilities can lead to
the development of new and better products, such as healthier, safer,
and more sustainable food choices. Finally, investments in research
facilities can improve opportunities for students to gain firsthand
experience leading to a better trained workforce in food and
agricultural sciences. USDA stands ready to scale such efforts to
better meet the needs of research institutions across the country.
labor costs
Question. Secretary Vilsack, labor costs account for 39 percent of
the total cash expenses for specialty crop producers, three times more
than other types of farms. In a report required by the 2018 Farm Bill
on automation research efforts, USDA found that specialty crop
automation and mechanization research at Agricultural Marketing
Service, Agricultural Research Service, and National Institute of Food
and Agriculture represented 2 percent, 1 percent, and 3 percent of
specialty crop research funding, respectively, from 2008 through 2018.
Secretary Vilsack, how can USDA better utilize existing programs to
support automation and mechanization for specialty crops? Would USDA
support a new standalone grant program to facilitate the development of
labor-saving tools and support training and retraining of impacted
workers?
Answer. Despite tremendous progress and advances made by existing
USDA programs to support automation and mechanization for specialty
crops, there remains a huge unmet need for USDA to expand and
accelerate its support for the research, development, and use of next
generation automation, sensors, robotics, and AI-powered (artificial
intelligence) analytics in the production, harvesting, and processing
of specialty crops that will result in new labor- and cost- saving
tools, high-paying technical jobs, and support the training and
retraining of impacted workers.
Based on the 2020 report to Congress, ``Developing Automation and
Mechanization for Specialty Crops: A Review of U.S. Department of
Agriculture Programs'' prepared by the Economic Research Service, USDA
has six programs in the Agricultural Marketing Service (AMS), the
Agricultural Research Service (ARS), and the National Institute of Food
and Agriculture (NIFA) that, among other objectives, support the
development and use of automation or mechanization in the production
and processing of U.S. specialty crops. The programs are: 1) AMS
Specialty Crop Block Grant Program; 2) ARS Crop Production National
Program and Product Quality and New Uses National Program; and 3) NIFA
Specialty Crops Research Initiative (SCRI), Small Business Innovation
Research (SBIR), and Agriculture and Food Research Initiative (AFRI).
From 2008 to 2018, these programs funded $288 million ($28 million per
year) toward 213 projects to develop and enhance the use of automation
or mechanization in specialty crop production and processing. The
projects included job aid/machinery automation, machine learning/data
analysis, mechanical harvesting/processing, precision agriculture,
remote sensing/drones, and sensors, and covered a variety of specialty
crops (almonds, apples, avocados, beets, blueberries, broccoli,
cabbage, carrots, cauliflower, celery, cherries, chestnuts, chickpeas,
chili peppers, citrus, cranberries, currants, elderberry, table and
wine grapes, hazelnuts, hops, lettuce, maple syrup, mushrooms, nursery
crops, olives, onions, ornamentals, pecans, peaches, pears, peas,
peonies, pistachios, potatoes, pumpkin seeds, raspberries, sod,
strawberries, sweet corn, sweet potatoes, tea, tomatoes, and walnuts).
As more data is collected and USDA becomes more informed, resources
could be used to address climate-smart agriculture of the future, in
respect to novel scalable implementation of workforce development and
in leveraging of resilient food systems transitions for broadening
agricultural workforce participation across all sectors of society and
ages.
There is a need for continued support regarding long-term data
curation and sustainability of automation and mechanization projects,
databases, and software. However, the focus of many new proposals
center on novel ideas and tools, rather than continued maintenance and
update of systems which is needed. USDA's support of open-source
projects helps encourage collaboration, reduces costs and time
associated with project initiation and database development, and may
decrease barriers associated with farmer concerns regarding for-profit
data collection and use.
USDA stands ready to implement and support all existing and any new
programs intended to support the development of labor-saving tools and
support training and retraining of impacted workers.
crop loss from natural disasters
Question. Since 2018, Congress has appropriated funds four times to
support producers that experienced crop loss and damage due to natural
disasters. These supplemental appropriations have included shifting
requirements for USDA and producers, leading to the creation of several
programs at USDA-the Wildfires and Hurricanes Indemnity Program in
2017, the Wildfire and Hurricane Indemnity Program Plus in 2018 and
2019, and the Emergency Relief Program in 2020 and 2021. Although,
these programs provided much-needed assistance, the changing
regulations confused producers and delayed payments. Beyond that, the
impact of disasters can extend beyond the farm and into agricultural
support industries-like processors-which may be devastated if there are
no crops planted or harvested.
Secretary Vilsack, would a permanently authorized disaster program
modeled on the Emergency Relief Program (ERP) improve USDA's ability to
quickly disseminate funds to disaster-affected producers following
supplemental appropriations? How could assistance be extended to
agribusinesses that also experience significant loss after natural
disasters?
Answer. USDA offers subsidized crop insurance, has permanent
disaster programs, and is working to implement the current ad-hoc
disaster program that Congress has authorized as a $3.74B disaster
assistance funding in the Consolidated Appropriations Act, 2023 (Div.
N), which supplemented and extended provisions in the Emergency Relief
Program/Emergency Livestock Relief Program from the Extending
Government Funding and Delivering Emergency Assistance Act (Public Law
117-43) . A permanently authorized disaster program may improve USDA's
ability to quickly disseminate funds to eligible producers, although
the full costs and benefits of a permanently authorized disaster
program are unknown at this time. There is time needed after
legislation is passed to develop policy and software for program
implementation; however, after initial program implementation, future
years can be close to seamless and allow USDA to respond to disasters
in real-time, when funded.
Current and past ad-hoc disaster programs are tied to the loss of
crops; with a 2-year linkage requirement to purchase crop insurance
where crop insurance is available or Noninsured Crop Disaster
Assistance Program (NAP) coverage for those commodities for which crop
insurance is not available.
Agribusinesses are not eligible for current and past ad-hoc
disaster programs, nor are they part of the permanent disaster
programs, as agribusinesses are not the owners or shareholders of the
crops. However, there are commercial insurance products that
agribusinesses could choose to option as part of their risk management
strategies. If Congress were to consider inclusion of agribusinesses it
would require legislative guidance to change or further clarify the
definition of loss and/or eligible producer.
crop insurance for specialty growers
Question. Secretary Vilsack, I appreciate USDA's efforts to expand
access to crop insurance for specialty crop growers, but I remain
concerned that many growers have inadequate insurance options and are
forced to rely on policies that only cover catastrophic loss or leave
significant acreage uncovered.
Secretary Vilsack, how can USDA improve crop insurance options for
specialty crop producers, especially those who have historically not
purchased insurance policies or relied solely on coverage for
catastrophic losses?
Answer. Expanding crop insurance to specialty crops and smaller
farmers is a priority for this Administration. The USDA Risk Management
Agency (RMA) made tremendous progress on expanding options for
specialty crop growers, and we know there is still more work to be
done. We've doubled the eligibility for Whole Farm and tripled the
eligibility for Micro Farm, which helps smaller farmers.
We undertook an effort last winter to meet farmers and insurance
professionals throughout the country to promote Whole Farm and Micro
Farm. To date, we've had over 8,000 attendees. We've learned a great
deal and so have the attendees. We hope to use this as a model to
promote and educate about new products. RMA has a specialty crop
liaison in every regional office and a national employee devoted to
this effort. We would be glad to engage and discuss any specific ideas
your office has on enhancing coverage.
On the outreach and education front, since 2021, the RMA has
invested more than $6.4 million in partnerships with 27 entities to
expand outreach and education on crop insurance, which embodies the
diversity of agriculture including Hispanic/Latino, Native Americans,
African American, Beginning, Women, Veteran and Historically
Underserved farmers, with additional emphasis on those producers who
are growing and producing specialty crops, livestock, organic-certified
or transitioning, sustainable/regenerative crops and/or small farms and
ranches.
captive marine mammal care
Question. Secretary Vilsack, the USDA last updated key elements of
its standards for the handling and care of captive marine mammals in
1984, nearly 40 years ago. Since that time, significant progress has
been made in marine mammal biology and ecology research. You were also
the Secretary of Agriculture in 2016 under President Obama, when a
proposed rule was released that would have finally updated these
standards. Unfortunately, that rule was never finalized, and it was
withdrawn in 2021 because it was outdated.
Secretary Vilsack, do you agree that the captive marine mammal
standards of care are outdated? What efforts is USDA undertaking to
examine the standards and space requirements of marine mammals?
Answer. USDA takes the health and welfare of every animal covered
under the Animal Welfare Act seriously, including marine mammal
populations. The Animal Welfare Act sets basic standards for humane
care and treatment that must be provided for certain animals used in
certain activities. USDA's focus is specific to those marine mammals
used for public exhibition or biomedical research. Research surrounding
captive marine mammals continues to evolve, including since the 2016
proposed rule was drafted. We will review the newly available research,
as well as consider opportunities to engage with members of the marine
mammal community, as we consider options for future rule making.
______
Questions Submitted by Senator Tammy Baldwin
regional conservation partnership program
Question. The Regional Conservation Partnership Program (RCPP) has
shown significant promise as a flexible and partner driven conservation
program but has had a troubled implementation and rollout since the
2018 Farm Bill. Given the U.S. Department of Agriculture's wide
discretion in implementing this program, what steps has the agency
taken to improve RCPP implementation? In particular, how is the agency:
reducing paperwork burdens; ensuring efficient easement appraisal
processes; streamlining easement and land management project
implementation; and ensuring sufficient and consistent agency
staffing--both at NRCS Headquarters and in State offices--to guarantee
that Federal funds and partner resources are effectively delivered to
America's farmers?
Answer. The USDA National Resource Conservation Service (NRCS) is
evaluating the flexibilities to ensure appropriate use of RCPP funding,
while listening to the challenges of our customers. We are leaning in
on certified entities for easement transactions and internal training
of our RCPP coordinators to ensure consistent interpretations of
policies and procedures for success. We expect to make an initial
public announcement in Spring of 2023 on the first set of flexibilities
and are working towards additional improvements and efficiencies.
conservation technical assistance
Question. The Natural Resource Conservation Service (NRCS) has the
ability to use Conservation Technical Assistance (CTA) funding to hire
grazing technicians across the country, both within NRCS and at third
party organizations, via the Grazing Lands Conservation Initiative
(GLCI). With the passage of the Inflation Reduction Act (IRA), more CTA
funding is available to NRCS than ever before, making now an ideal time
to ensure dedicated funding for GCLI. Yet the recent President's Budget
Request notes USDA's intention to spend $0 through GLCI in FY24. Why is
USDA opting to withhold funding that could support access to grazing
technicians for producers across the country?
Answer. NRCS continues to prioritize hiring and focus on
recruitment and retention of qualified technical staff. We are
increasing staffing numbers and working with Land Grant Universities
and other institutions to produce USDA qualified applicants, including
grazing technicians. We are also seeking opportunities to partner with
other technical organizations and agencies to onboard staff.
conservation stewardship program
Question. Secretary Vilsack noted during the March 29th Senate
Appropriations subcommittee hearing on Agriculture, Rural Development,
food and Drug Administration, and Related Agencies, that IRA spending
within the Conservation Stewardship Program (CSP) and the Environmental
Stewardship Program (EQIP) will be used to contract with producers
implementing sustainable grazing practices already available within
each program. However, contracting with a producer to implement a
practice does not guarantee that that practices will create an overall
benefit for farm, and targeted technical assistance is often needed to
ensure practices have both an environmental benefit and an agronomic
benefit. When both are realized, producers are more likely to maintain
and improve upon practices over the long term. Given the importance of
technical assistance in ensuring the success of sustainable grazing
practices on farms, why hasn't USDA committed to ensuring that
increased GLCI funding accompanies IRA spending in CSP and EQIP,
helping to provide increased grazing TA simultaneously with increased
funding for practice implementation?
Answer. The USDA National Resource Conservation Service (NRCS) is
committed to this work and continues to seek out qualified applicants
to join the technical teams across the country in our field offices.
Grazing lands are a key component of soil health and climate solutions.
Using a systems approach to addressing climate smart resource concerns
and the co-benefits of a grazing system are a primary focus of the
Inflation Reduction Act (IRA) implementation.
business and industry program
Question. Last year, USDA proposed--and the Committees accepted--an
interchange in budget authority that increased the lending authority of
the Business and Industry Program. The program, again, faces a shortage
of loan authority. Of the loans that have currently been obligated and
the dollar value of those in the pipeline, there will be a deficit in
the program in excess of $250 million. To avoid the denial of qualified
loans, would the agency consider supporting another interchange of
unobligated funds to enable lending in the Business and Industry
Program?
Answer. The Department is exploring options for continuing support
of the Business and Industry Guaranteed Loan program above the level
that Congress provided in order to meet demand. An interchange of
unobligated funds is one of the options but in the interim the
Department continues making any funding available from this program's
recoveries.
______
Questions Submitted by Senator Joe Manchin
usda staffing needs
Question. Is the Department of Agriculture able to adequately meet
its staffing needs and is the agency able to fill key positions with
qualified employees?
Answer. The Department is working diligently to maximize the
effectiveness of the funding provided by Congress to meet our staffing
needs across the country. At this time, yes, the Department believes
that we are able to adequately meet our staffing needs. Our leadership
team continues to look closely at staffing needs as they arise, whether
within a headquarters unit or in a field office, to ensure that our
staffing resources are ultimately aligned to address the needs of
USDA's customers.
Question. Related, what percentage of USDA employees are back in
the office full time nationwide?
Answer. Throughout the public health emergency, tens of thousands
of USDA employees continued to work in-person to meet the Nation's
needs for critical public services such as meat and poultry inspections
and wildland firefighting. As the Department continues to analyze the
data and evidence, we are focused on ensuring that our customers
continue to get the support necessary from our workforce to meet their
expectations and to meet their daily needs for support from USDA. When
the Department concludes its analysis and finalizes its plans for
maximizing the customer experience, we will share that information with
you and the Committee.
difficult terrain and access to urban area project
Question. The USDA Economic Research Service (ERS) has been working
on the ``Difficult Terrain and Access to Urban Area'' project. This
project was started in 2021, and as of 2023 my office has not seen the
Phase I published report, due to ``unanticipated delays''. Can you
provide an update on the status and publication of this project? Will
the ERS commit to visiting West Virginia to better understand our
mountainous and difficult terrain areas?
Answer. Yes, USDA is committed to visiting West Virginia to gain
greater insights into the mountainous and difficult terrain areas. The
ERS researchers are in the process of incorporating comments and
conducting additional analysis of the data based on the comments on the
peer review manuscript. In addition, ERS met with the Federal Office of
Rural Health Policy in February to discuss the progress of this
project. ERS plans on providing the office with the data needed for the
next cycle of grant announcements. USDA is on track to publish the
report by this summer.
broadband coordination
Question. With tens of billions in Federal funding directed to
broadband in the last 5 years, how is USDA coordinating with other
broadband deployment programs--such as those administered by the FCC,
NTIA, and Treasury?
Answer. USDA meets regularly and on an ad hoc basis with the
Federal Communications Commission (FCC), the National
Telecommunications and Information Administration (NTIA) and the U.S.
Treasury to ensure that Federal dollars are spent in the most efficient
way possible. Additionally, USDA shares information with our Federal
partners regarding the awards made under our programs to enable other
agencies to take those awards into consideration to ensure projects do
not overlap or overbuild existing services already made available.
______
Questions Submitted by Senator Susan M. Collins
remote work and upgrades to usda headquarters
Question. During the COVID-19 pandemic, many Federal employees were
given the opportunity to work from home. While most have returned to
the office, it is my understanding that many USDA employees are now
permanently working from home with no intention to return. What is your
plan for the South Building and to return staffing in the building to
pre- pandemic levels so that taxpayers aren't asked to fund
refurbishment of empty workspace?
The FY2024 budget proposes an increase of $84 M for Agriculture
Buildings and Facilities, $46.8 M of which is specifically designated
for modernization of the USDA South Building. The USDA South Building
modification has been an ongoing endeavor since well before the
pandemic. The Committee has requested a plan for how these funds will
be used and prioritized, and we have yet to see one.
Answer. The Department recently submitted its response to OMB-M-23-
15, the next step in reviewing USDA's Future of Work policies while
maintaining laser focus on service delivery. USDA has been on a journey
to modernize and transform our culture and workplace to become one of
the ``Best Places to Work in the Federal Government.'' A core value of
our Future of Work approach is the importance of making data-driven
decisions and ensuring our employees have a voice in the policies that
impact their lives. We are committed to continuing to refine
performance measures and benchmarks, use data to ensure we have a
warning system in place to alert us if performance starts to wane under
the current policies, and have data that will give the Department a
better chance to make any telework policy changes without causing any
drastic short-term performance and morale losses.
The South Building is a critical component of the Department's real
property portfolio in the National Capital Region (NCR) and is home to
the headquarters for many of the Department's program agencies and
staff offices. The building, originally built in the 1930s, still
includes many original systems which have been well maintained but the
building has only been partially upgraded in recent years. A continued
investment in the renovation of the South Building will enable the
Department to address significant life and health safety challenges
that exist throughout the facility due to the relative age of the
structure and systems. These renovations will also create opportunities
for the Department to make strategic decisions on the continued use of
leased facilities throughout the NCR. Without continued investments in
building modernization, the Department will likely need to maintain a
significant portfolio of leased facilities in the NCR that cost over
$10 million per year in rental payments.
______
Questions Submitted by Senator Jerry Moran
international market access
Question. As major exporters of beef, wheat, and oil seed, Kansas
farmers know how crucial international market access is to their
prosperity. The Department's budget request also recognizes foreign
trade as essential for the vitality of the U.S. agricultural industry.
However, I'm increasingly concerned that the Biden Administration
is instead opting out of free trade agreements that facilitate
agricultural exports in favor of loosely-defined frameworks that do not
benefit our farmers.
How does USDA reconcile the importance of agricultural trade with
the administration's opposition to pursuing free trade agreements?
Answer. USDA is working alongside the United States Trade
Representative (USTR) within the parameters of the Biden Administration
to advance trade policy. One challenge that USDA and USTR currently
face is to build trust in this country on trade. USDA and USTR must,
therefore, work to secure wins by creating new or expanded market
access, enforcing existing agreements, and restoring trust in trade.
There are a multitude of ways in which USDA is making a difference in
terms of trade without necessarily focusing solely on free trade
agreements. We must continue to expand trade missions, provide support
to foreign market development programs that help drive exports, and
always look for opportunities to break down barriers to trade.
We will therefore continue to work with USTR, the Department of
Commerce, and other U.S. government partners on the U.S.-Kenya
Strategic Trade and Investment Partnership (STIP), the 21st Century
Taiwan Trade Initiative, and the Indo-Pacific Economic Framework for
Prosperity (IPEF). The IPEF, for instance, can serve to increase U.S.
agricultural exports to an area of the world where both the middle
class and the demand for high-quality, trusted, sustainably produced
agricultural products are growing. The IPEF Trade Pillar seeks to
emphasize agricultural sustainability and agricultural biotechnology,
enhancing agricultural supply chain resilience, improving transparency
on regulatory measures, and promoting science- based decision-making to
protect human, animal, and plant life. In doing so, markets can be
created or opened to the type of high-quality, high-value products our
farmers, ranchers, and producers are already producing.
USDA has also sponsored numerous Agribusiness Trade Missions
(ATMs). In calendar year (CY) 2022, ATMs provided small and medium-
sized U.S. exporters opportunities in markets including the United Arab
Emirates, United Kingdom, Philippines, Kenya, Tanzania, Spain, and
Portugal. During these missions, participants engaged directly with
potential buyers, resulting in a total of 125 U.S. agribusinesses
participating in 1,310 business-to-business meetings reporting $42.2
million in 12-month projected sales. Our work to expand ATMs provides
U.S. exporters with additional opportunities to increase their market
presence overseas and generate sales, while providing senior-level USDA
officials with a platform to advance U.S. agricultural trade priorities
directly with foreign counterparts. Regarding CY 2023, USDA has
executed or is in the process of executing trade missions to Panama,
the Netherlands, Japan, Chile, Malaysia, and Angola.
The United States continues to implement agricultural trade
policies in a manner consistent with its free trade agreement
obligations and expects our trading partners to do the same while
working to maintain open and predictable markets for American farmers
and producers. Policy discussions with the European Union (EU) on
several agricultural trade issues are ongoing to address market access
issues such as overly restrictive maximum residue levels (MRL),
unpredictable animal health certificate policies, lack of recognition
of common food names, and deforestation-free supply chain regulations,
to name a few.
Additionally, USDA continues to work in close coordination with
USTR on dispute settlement efforts regarding Canada's tariff-rate quota
allocation measures for dairy products under the U.S.-Mexico-Canada
Agreement (USMCA). The United States' priority remains ensuring that
U.S. workers, processors, farmers, and exporters benefit from the
market access Canada committed to through the USMCA. USDA and USTR also
continue to engage with Mexican officials at all levels to convey our
serious concerns about Mexico's treatment of agricultural
biotechnology. It is critical that Mexico fully complies with its USMCA
commitments and that it returns to a science- and risk-based regulatory
approach for all biotech products. Mexico is a valued trading partner,
and USDA is committed to working with it to resolve these biotech
issues and avoid any disruption of trade in corn or other agricultural
products.
Specifically for beef, tariff reductions that came about under the
U.S.-Japan Trade Agreement that went into effect in 2020 have helped
the United States become Japan's top beef supplier for the first time
in more than two decades. The revision of the beef safeguard,
negotiated in 2022, will ensure that U.S. beef exports to Japan can
continue to grow. For soybeans, the U.S. exported a record $33.3
billion in product in 2022, and we will continue to fight any barriers
that impede their export to global markets.
USDA advocates for U.S. agriculture around the world through
diverse mechanisms to secure tariff reductions, improve the environment
for exporting U.S. agricultural products, and increase predictability
and transparency in trade regulation. Under this administration, USDA
engagement was critical to delivering roughly $15 billion in new or
preserved market access through active policy intervention with foreign
governments. By leveraging creative trade policy tools, and working in
concert with USTR, USDA remains committed to making significant gains
and expanding market access for farmers and ranchers throughout the
United States.
reconnect deployment
Question. Secretary Vilsack, the FY2024 budget requests another
$400 million for the ReConnect broadband deployment program. With more
than $175 billion in Federal funding directed to broadband in the last
5 years, I am concerned about keeping this program focused on unserved
areas in rural America and ensuring Federal broadband deployment
resources are efficiently utilized.
Does the Memorandum of Understanding (MOU) that USDA, NTIA, FCC,
and Treasury signed in May 2022 ensure that ReConnect funds will not
duplicate other Federal broadband deployment investments?
Answer. USDA meets regularly and on an ad hoc basis with the
Federal Communications Commission (FCC), the National
Telecommunications and Information Administration (NTIA), and the U.S.
Treasury to ensure that Federal dollars are spent in the most efficient
way possible. Under the Memorandum of Understanding that is in place,
USDA shares information with our Federal partners regarding the awards
made under our programs to enable other agencies to take those awards
into consideration to ensure projects do not overlap or overbuild
existing services already made available.
Question. If not, what more needs to be done to ensure Federal
funds are not being duplicated, while unserved areas still exist?
Answer. The MOU signed in May 2022 is helping to ensure that
duplication will not occur.
farm service agency loan officers
Question. Secretary Vilsack, as you are aware, USDA Farm Service
Agency staff performs a crucial role in facilitating the investments in
our agricultural communities and the rural towns they support we
advocate for. My understanding is that about 40 percent of the FSA loan
officers are retirement eligible in the next 5 years and that it takes
2 years to train a new loan officer.
What steps is the department taking to recruit and retain loan
officers?
Answer. The USDA Farm Service Agency (FSA) continues to be
challenged in the recruitment and retention of employees. In Farm Loan
Programs, for example, 42 percent of loan officers and supervisors are
eligible for retirement between now and fiscal year 2027. In addition
to attrition through retirements, challenges include hiring and
retaining new staff due to Federal pay scales that are not competitive
with the private sector, high workload demands, and business processes
that are manual and paper based compared to other financial industry
employers.
FSA has taken several steps to address these challenges and to
recruit and retain Loan Officers. Over the last couple of years, FSA
has increased use of the Pathways Program to bring college students and
recent graduates into the Agency, as well as increasing use of the 1890
Scholars Program and other internship programs. FSA has modified the
required experience for the Loan Officer positions to include not only
FSA loan approval authority but also private sector agricultural loan
experience, thus expanding the Agency's recruitment reach. FSA is also
encouraging States to make more use of the Loan Analyst position; loan
analysts complete the first year of the Farm Loan Officer Training
program, building a workforce that is readily available to step into
the Loan Officer role more quickly.
FSA has also increased utilization of recruitment, relocation, and
retention incentives for farm loan employees. In fiscal Year 2022, FSA
issued over $620,000 in student loan repayments to 69 farm loan
employees. In exchange for receiving loan repayments, employees signed
a 3-year service agreement. FSA plans to utilize student loan
repayments for these series again in fiscal Year 2023. In addition,
since February 2022, FSA has approved 38 relocation and recruitment
incentives in these series. FSA continues to explore all options to
improve recruitment and retention.
Question. For example, will you be seeking direct hiring authority
from the Office of Personnel Management for these critical positions?
Answer. The FSA is looking at leveraging various authorities that
exist including OPM waivers for direct hire authority.
select agent registration
Question. Can you please provide an update on the status of the
select agent registration activities including a program schedule, it
is my understanding that this is currently running slightly behind the
initial planned schedule.
Answer. Delays in facility construction, commissioning schedule,
and receipt of commissioning documents have impacted our initial Select
Agent Registration schedule, yet personnel at the National Bio and
Agro-Defense Facility (NBAF) have been proactive in the registration
process and have been working with the Federal Select Agent Program
(FSAP) on registration and approval for all activities with Select
Agents necessary to transfer the mission from the Plum Island Animal
Disease Center (PIADC) to NBAF.
NBAF personnel are in constant contact with FSAP regarding document
submission and are coordinating with FSAP on planning inspection dates,
with the goal of having a first inspection in Fall 2023.
NBAF and USDA leadership have developed a tiered science transition
strategy, to begin laboratory work with non-infectious materials,
progressing to low risk agents, and then eventual work with Select
Agents after full FSAP approval is received. They will not work with
any Select Agents until approved by the FSAP. The goal of completing
full registration of the facility by Fall 2024, pending any unforeseen
circumstances, remains the same.
Question. Please provide a crosswalk of the funds in the budget
request for NBAF and related science at both ARS and APHIS.
Answer. The fiscal year 2024 President's budget requested an
increase of $23.9 million over the fiscal Year 2023 enacted level. This
proposed increase consists of $13 million in operations for contracts
(facilities, security, supplies, and services), an additional $10.6
million for capital improvements in the USDA Agricultural Research
Service (ARS) Buildings and facilities account, and an increase of $300
thousand to cover the anticipated increase in pay costs. There is no
change in the proposed research and science budgets at ARS or the
Animal and Plant Health Inspection Service (APHIS).
Question. Please explain USDA's plan to obtain sufficient BSL-2
space needed to house animals prior to the beginning of a specific
experiment. If additional funds were provided in FY24 to address these
needs, please provide budget details for funds would be executed.
Answer. While we recognize that BSL-2 space at NBAF is limited,
there are no current plans for expanding animal holding capacity.
collaboration with university partners
Question. If additional funds were available in FY24 to enhance
collaboration with university partners, what would be most helpful in
either equipment or curriculum development to make enduring progress on
the important educating and training students for the future workforce?
Answer. The partnership and workforce development funds provided
have enabled considerable education and training initiatives for USDA
ARS and APHIS to meet their specific mission needs. Additional
investment in the NBAF Agrosecurity Partnerships for Innovative
Research (ASPIRE) program would further strengthen the framework by
which NBAF will enhance America's agricultural biosecurity by forming
strategic partnerships with universities, industry, and other Federal
agencies to support the NBAF Strategic Plan and National Biodefense
Strategy.
Through ASPIRE, USDA is partnering with the Research Corporation
for Science Advancement (RCSA) to launch a Scialog, pairing ``science
and dialogue'' around fundamental scientific challenges, on Mitigating
Zoonotic Threats. The Scialog fellows include around 50 early career
faculty and scientists from across the U.S. with varied disciplinary
expertise who work together for over 3 years to innovate around current
best ideas and build an innovation network that will extend over the
next 30+ years of their careers. ARS and APHIS have several of their
early career scientists within this cohort.
Other key partnerships include the Research Alliance for Veterinary
Science and Biodefense BSL-3 Network 'RAV3N' funded by USDA, which is a
collaborative community of 18 U.S. academic and Federal institutions.
The Network aims to establish strategic and coordinated approaches for
collective large-animal biocontainment infrastructure and science
capacity to improve bio-surveillance, diagnostics, and countermeasure
developments against high- consequence pathogens of veterinary
importance.
Recognizing the competitiveness of the workplace for research,
diagnostic, and operational staff for high containment facilities, USDA
has developed programs to help supply the scientific and operational
pipeline and provide awareness of career opportunities at NBAF. For
example, ARS has trained more than 20 students from 5 different
universities and trained an additional 18 post-docs. In fiscal Year
2022, a new partnership was established with Indiana University of
Pennsylvania to create a biosafety certificate program to increase the
workforce pipeline for work in high containment facilities. APHIS is
developing the next generation of subject matter experts and laboratory
staff at NBAF through its NBAF Scientist Training Program (NSTP) and
the NBAF Laboratorian Training Program (NLTP). The NSTP has supported
26 students from 15 universities with 10 now transferred to permanent
Federal positions at NBAF and already contributing to science
transition planning. The NLTP has trained 39 undergraduate students
between programs at Kansas State University and Texas Tech University
and will continue to do so.
Question. If additional funds were available in FY24, what
activities and in what amount would be useful to the Department's
future plan to house a Biologics Development Module at NBAF? Are there
opportunities for university partners to contribute to the production
of standardized biological reagents?
Answer. The Biologics Development Module (BDM) has filled several
key positions and is developing a prioritization of projects to begin
as the facility comes online. USDA will hold a BDM Stakeholder meeting
on June 21-22, 2023, in Manhattan, Kansas. A primary goal for this
meeting is to identify key contacts among industry, academia, and other
Federal agencies who will be instrumental in successfully establishing
collaborations and partnerships with the BDM. In addition, USDA will
introduce stakeholders to the BDM personnel and describe its
capabilities and solicit feedback from stakeholders regarding past
experience with public private partnerships and lessons learned, and
the potential to partner with universities on the production of
standardized biological reagents.
______
Questions Submitted by Senator Deb Fischer
unobligated covid funding
Question. The President has stated that the pandemic is over, and
the National emergency is set to end in May. Since 2020, USDA has
received billions of dollars through the CARES Act, the Consolidated
Appropriations of '21, and the American Rescue Plan Act to administer
as emergency assistance, to help farmers and ranchers, consumers and
rural communities withstand the impacts of the pandemic.
Can you provide to this subcommittee an accounting of the funds
that remain unobligated and unspent under these authorities?
Answer. USDA submits a monthly accounting of the funds that remain
unobligated and unspent under funding received through the CARES Act,
the Consolidated Appropriations of 2021, and the American Rescue Plan
Act to administer as emergency assistance, to help farmers and
ranchers, consumers, and rural communities withstand the impacts of the
pandemic. The latest report was sent March 14, 2023.
reconnect
Question. Can you provide the subcommittee with the latest outlays
for ReConnect from the funding included in the Bipartisan
Infrastructure Law?
Answer. USDA is working diligently to expedite all funding made
available under the Bipartisan Infrastructure Law. The agency has
already awarded over $540 million in funds under our 3rd funding window
and we are on-track to obligate the remaining ReConnect funding under
our 4th window and expect to obligate approximately $1.9 billion in
awards by leveraging both loan and grant funding. As of today, there
have not been any outlays, but Rural Development expects that outlays
will begin this fiscal year and continue in the next 7 years, in line
with the normal outlay patterns for the program.
Question. Would you be able to clarify your position about the
program's goal, and whether you feel it should help unserved Americans
without any broadband access in rural America?
Answer. The ReConnect Program is focused on extending affordable,
reliable high-speed broadband service in rural unserved and underserved
communities. Priority is given to unserved communities, but the program
does make funding available to eligible underserved communities as
well.
water quality and quantity
Question. The legislative text of IRA departed from the resource
concerns agreed to in the bipartisan 2018 Farm Bill and restricted
those funds use to address ``improving soil carbon, reducing nitrogen
losses or to reduce, capture, avoid, or sequester carbon dioxide,
methane, or nitrous oxide emissions, associated with agricultural
production.'' Water quantity and water quality remain top local
resource concerns in Nebraska. How will USDA interpret the restriction
placed on IRA conservation funds?
For example, how will USDA look at a producer wanting to use EQIP
cost share funding to upgrade their irrigation pivot to optimize water
use? Would they be at a disadvantage with IRA funding?
Answer. Investments from the Inflation Reduction Act (IRA) are
investments to help farmers, ranchers, and forest owners implement new
or additional conservation activities on their lands, with a focus on
Climate-Smart mitigation activities that can increase storage of carbon
and reduce greenhouse gas emissions and may also help to address
drought and other climate-related stressors. We realize that
conservation practices build upon each other, and the solutions include
co-benefits. Applicants who want to address resource concerns related
to climate smart agriculture and forestry are able to apply for all
conservation programs regardless of funding source. State Technical
Committees provide the guidance to the State Conservationist for
funding priorities. In addition, NRCS recently announced the Western
Water and Working Land Framework, of which Nebraska is included in the
17 States. In the Framework, NRCS identifies six major water and land
resource management challenges, guidelines for identifying vulnerable
agricultural landscapes and 13 strategies for NRCS leaders in western
States to use now to collaborate with partners, water resource managers
and producers. The goal is to help secure clean and available water
supplies, healthy soils, resilient landscapes, and thriving
agricultural communities, now and in the future.
Question. The IRA also removed a Farm Bill requirement that 50
percent of EQIP funds are used for livestock production. Without that
requirement, does USDA anticipate a significant shift in the
distribution of EQIP funds?
Answer. Livestock production will continue to be a significant
piece of NRCS Farm Bill Environmental Quality Incentives Program (EQIP)
distribution based on locally driven priority resource concerns. While
IRA does not require a minimum, we continue to use EQIP Farm Bill funds
with the 50 percent requirement.
precision agriculture
Question. As you know our Nation is at a critical juncture in
advancing precision agriculture technology and related artificial
intelligence. To ensure producers have access to safe digital tools to
guide and enhance management and production options, Congress provided
US Department of Agriculture (UDSA) Agriculture Research Service with
the initial planning funding to co-locate and establish a national
center for resilient and regenerative precision agriculture in Lincoln
at the Nebraska Innovation Campus. This facility is envisioned to serve
as the anchor of a national network comprised of USDA and land-grant
universities and their Cooperative Extension arms to equip America's
farmers and ranchers with 21st century precision technologies to meet
present-day and future challenges.
Can you provide the Committee with an update on steps USDA taken to
help expedite planning surrounding the implementation of initial
funding provided by Congress and support moving forward?
Answer. The strategic plan for the new National Center for
Resilient and Regenerative Precision Agriculture (NCRRPA) will more
than double ARS personnel at the location, expand research capacity,
catalyze collaborations with University of Nebraska-Lincoln (UNL), and
add new Agricultural Research Service (ARS) buildings to the existing
ARS presence in Lincoln. The project is progressing. There will be two
construction projects: one is a new headhouse and greenhouse (HH/GH)
and one is a new lab/office building (LOB). ARS currently has $11.2
million appropriated for planning and design and $20 million for
construction. ARS is actively planning and designing both buildings and
will build the HH/GH first with funds already appropriated. The
Architect and Engineering firm submitted the Program of Requirement for
ARS review in December 2022. In March 2023, the 35 percent design for
the LOB was provided to ARS. USDA ARS will adapt the HH/GH space into a
Plant Growth Facility that will be a hybrid HH/GH plus grow house.
Integrating a climate-controlled grow house reduces overall operating
costs to meet current and future research mission needs. The hybrid
Plant Growth Facility will still occupy 25,140 square feet and follows
the Nebraska Innovation Campus building guidelines.
Question. What research and technology gaps has USDA identified
that could be addressed by a National Center for Regenerative Precision
Agriculture for the development of enhanced digital tools to meet
president day and future challenges?
Answer. A key priority for the National Center for Regenerative
Precision Agriculture (NCRPA) will be to develop and enable precision
agriculture for producers of all sizes, of all crop and livestock
systems, and in all parts of the U.S. Since data drives precision
agriculture, this will require Big Data and High-Performance Computing
capacity as well as data capture, integration and standardization
efficiencies. USDA Agricultural Research Service (ARS) has worked to
identify key data, infrastructure and technology gaps that are
bottlenecks to providing all producers with meaningful and helpful
precision agriculture tools and capacity.
As part of this, ARS has allocated most of the funding appropriated
in fiscal year 2023 for Measurement and Monitoring Innovation to
strategically catalyze innovation in sensors, Internet of Things (IoT)
technologies and data capture, automation, standardization and
integration. In deploying these funds to a new project in Lincoln, ARS
has directed the team there to establish collaborations with UNL around
data integration and with North Dakota State University around sensor,
electronics and computer engineering and design. In addition to these
strategic new collaborations, the project will seek to link well
aligned sensor, IoT and data integration research efforts at other ARS
research locations (including Clay Center, Nebraska; Stillwater,
Oklahoma; Mandan, North Dakota; Fort Collins, Colorado; Beltsville,
Maryland; Mississippi State, Mississippi; Columbia, Missouri; and
others) and university collaborators (including University of Nebraska-
Lincoln, North Dakota State University, Colorado State University,
Oklahoma State University, University of Missouri, North Carolina State
University, and others).
Additionally, the fiscal Year 2024 President's Budget includes, as
part of the ARS Climate Science request, the creation of a focused and
coordinated climate change adaptation and mitigation modeling, data
management and tool development project that serves as an ARS center of
excellence to strengthen and support research across ARS and regional
engagement of the Climate Hubs. If funded, this new Climate Science
center of excellence will likely be located at NCRRPA and will increase
the impact of ARS climate change mitigation and adaptation research
efforts such as Long-Term Agroecosystem Research (LTAR), Breeding
Insights, ARS Grand Challenges Synergies, and others. This new project
will catalyze a data-driven and precision agriculture focus on climate
change adaptation and mitigation. It will support and enhance other
precision agriculture efforts already underway at ARS as well as the
new precision livestock management effort at nearby Clay Center,
University of Nebraska-Lincoln and other locations. Building on the
current collaborations and common research framework of LTAR, the
Climate Hubs, and others, these funds will increase focus specifically
on climate smart practices, data, tools, and technologies that are
relevant both regionally and nationally, and that can lead to
greenhouse gas mitigation, producer participation in carbon and
ecosystem markets, resilience to weather extremes, and adaptation to
regional expected climatic conditions of the future. The effort will
leverage ARS's Partnerships for Data Innovations, SciNet infrastructure
for Big Data, Artificial Intelligence and Machine Learning processing
and analytics, Life Cycle Analysis and strengthen data and modeling
collaborations with other Agencies and Departments such as the National
Oceanic and Atmospheric Administration, the National Aeronautics and
Space Administration, and the Department of the Interior.
Question. Outside of funding, are there any barriers that would
hinder the construction and establishment of the proposed ARS co-
located facility?
Answer. ARS notes that significant progress is being made and no
other significant barriers have been identified at this time.
extreme drought
Question. The extreme drought that persists across the western U.S.
and shows signs of intensifying has wreaked havoc on farming
communities, towns, and municipalities across the Western U.S. and some
areas east of the Mississippi. One essential tool that USDA and U.S.
agriculture producers have benefited from since 1999 is the U.S.
Drought Monitor (USDM), produced weekly by the National Drought
Mitigation Center (NDMC) at the University of Nebraska Lincoln. Can
USDA provide the Committee with the current USDA programs and other
Federal and State agencies that use the USDM and early warning science-
based NDMC products to inform drought-related decisions?
Answer. While USDA cannot speak to USDM usage by other Federal
agencies, several States have official drought plans incorporating
information provided by the NDMC, including the weekly USDM map and
associated statistics. These plans can be found here: https://
drought.unl.edu/planning/DroughtPlans/StatePlans.aspx.
Congress has also mandated its use as a trigger for the Livestock
Forage Disaster Program in the Food, Conservation, and Energy Act of
2008. Other USDA programs that use the USDM as a determinant of
eligibility are:
--The Emergency Assistance for Livestock, Honeybees, and Farm Raised
Fish Program;
--Fast Track USDA Disaster Designations;
--Emergency Farm Loans; and
--Emergency Haying and Grazing under the Conservation Reserve
Program.
A summary of these and other programs providing relief from drought
and other natural disasters is here: https://www.farmers.gov/sites/
default/files/2021-10/fsa-usdroughtmonitor- factsheet-21-101521.pdf.
pork processing capacity
Question. I am glad the Department avoided a lapse in the NSIS
time-limited trial and subsequent loss in pork processing capacity this
spring. I appreciate the efforts you have taken to make gains in meat
and poultry processing capacity. I'd urge you to establish the NSIS
which allows plants to process hogs at the higher line speed
permanently. These plants have been operating in this way for decades
now, safely and efficiently. Do you agree we need a permanent solution
to ensuring pork line speed? Can you share with us the timing and
process for re- establishing this program permanently?
Answer. FSIS has contracted with a team of worker safety experts to
study the impact of increased line speeds on worker safety at poultry
establishments. The agency was able to expand the contract to include
swine establishments. In early March 2023, FSIS announced that it was
extending the duration of the swine ``Time-Limited Trials'' (TLT's)
until November 30, 2023. This extension will allow the contractors to
finalize their report on the swine establishments data, enable the
agency to assess the report's findings and conclusions, and to
determine future actions, including a potential rulemaking on line
speed.
Question. Are there funding needs from the Department to ensure a
permanent program?
Answer. There are no additional funding needs at this time.
SUBCOMMITTEE RECESS
Senator Heinrich. And thank you. Thank you both.
And with that, this hearing is adjourned.
[Whereupon, at 11:35 a.m., Wednesday, March 29, the hearing
was adjourned, and the subcommittee was recessed, to reconvene
at a time subject to the call of the Chair.]
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2024
----------
WEDNESDAY, APRIL 19, 2023
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 2:15 p.m. in Room SD-124, Dirksen
Senate Office Building, Hon. Martin Heinrich (chairman)
presiding.
Present: Senators Heinrich, Murray, Tester, Manchin,
Peters, Hoeven, Collins, and Hyde-Smith.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
STATEMENT OF HON. DR. ROBERT CALIFF, M.D., COMMISSIONER
OPENING STATEMENT OF SENATOR MARTIN HEINRICH
Senator Heinrich. Good afternoon. This hearing of the
Agricultural Appropriations Subcommittee is now called to
order, and I'd like to begin by welcoming FDA Commissioner Dr.
Robert Califf to this hearing. Thank you for being here today.
Very much looking forward to discussing the fiscal year 2024
Budget Request for the Food and Drug Administration.
The responsibilities of the FDA are extensive and they
impact every single American. Last year this committee provided
historic funding for this agency but there is much more work
that needs to be done and that begins with the budget request
in front of us today.
This request for FDA includes the discretionary increase of
$372 million. This increase touches on a wide array of
activities at the FDA, from enhancing food safety to advancing
safe and effective medical products as well as continuing to
address the ongoing Opioid crisis.
We must ensure that the vast number of products FDA
regulates are safe while also not slowing down important
advancements in research and technology. These are not easy
tasks, but this committee stands ready to work to support the
FDA and the critical work that is done there.
The decisions the FDA makes, whether approving a medical
device or approving a new drug, must be guided by science and
data, not by political pressure.
Dr. Califf, with your long and distinguished career in
science, I suspect you must feel the same way and that
precisely is why a recent decision by a Federal judge in Texas
is so disturbing to me.
This judge has replaced his political agenda for the data-
driven process used by the FDA. He has undermined the FDA's
safety and efficacy determination of Mifepristone and with it
he has undermined the FDA's authority to determine the safety
and efficacy of all medications, from insulin to cancer
treatments.
I know we're going to discuss this shortly and I'm
interested to hear your thoughts, Dr. Califf, but first I look
forward to hearing your testimony and having a robust
discussion on this year's budget request, and I'll now turn the
time over to Ranking Member Hoeven for any opening statements
that he may have.
Thank you, Member Hoeven.
STATEMENT OF SENATOR JOHN HOEVEN
Senator Hoeven. Thank you, Chairman Heinrich, appreciate
it.
I'm also pleased that our Ranking Member for the Full
Appropriations Committee, Senator Collins, is here. Thanks for
joining us, appreciate it very much, and, Dr. Califf, thanks
for being here, appreciate it very much.
Last year when you returned to reprise your role as
Commissioner, we were at the beginning stages of the infant
formula crisis. During both the budget hearing and subsequent
food safety hearing, we had frank discussions on the need for
sustained leadership in the agency, and I expressed to you at
that time, you know, that we had seven commissioners in the
past decade and that we need some stability in the FDA. I'm
pleased that you're back and I know you're working hard to try
to provide that stability. I think it's important and I
appreciate your efforts.
Obviously FDA plays a critical role in the safety and
prosperity of our nation. Your agency actually has some aspect
of authority over approximately 20 cents of every dollar spent
in America. You knew that, right? Pretty remarkable.
Americans expect the food that they eat and the drugs they
take will be safe and effective. So your reach is vast. You
have authority over more than a 160,000 foreign establishments
and a 135,000 domestic establishments, ranging from food
processing plants to facilities that manufacture life-saving
medications.
In addition, FDA's tasked with the regulatory
responsibility not only for the facilities but the individual
products. So obviously that role is incredibly important, one
that we can't take for granted, one that FDA has to get right.
In delivering these regulatory responsibilities, it's very
important that you have transparency and certainty and
particularly when we look at small businesses as well as ag
producers, like we have in my state of North Dakota, you know,
their overwhelming concern is that the Federal Government in
terms of that regulatory burden is reasonable, that common
sense is applied, transparent and predictable, and so all of
these things are vitally important to encourage the type of
innovation and so forth that we need to continue to advance our
economy and do it safely and well.
So again I think as we pursue these solutions and I know
you're involved in this and rightly so, this reorganization
effort, we've got to avoid a one size fits all and we've got to
use common sense. We've got to appreciate and understand the
incredible role that small business plays in our economy, truly
the back bone of our economy, and make sure that as you do
these things that we don't get overly bureaucratic burdensome
and so forth but in fact find ways to do things as effectively
as possible and in a way that provides certainty to people
across this country in all different aspects of the things that
you do which are so critically important to our nation.
Thank you for being here today with us, appreciate it.
Senator Heinrich. Dr. Califf.
SUMMARY STATEMENT OF DR. ROBERT CALIFF
Dr. Califf. Thank you, Chair Heinrich, Ranking Member
Hoeven, and Members of the Subcommittee. Thanks for the chance
to be here today.
I'd like to start by thanking the Subcommittee for your
continued support of FDA, especially over the last few years,
as the agency has worked tirelessly to turn the corner on
COVID-19, ensure a safe and nutritious food supply, and prepare
for the emerging challenges of an expanding and changing
landscape of food, medical, and tobacco products.
This has been possible due to the vital and never-ending
work of our dedicated FDA staff across the country and the
world. To continue supporting their work, the budget I present
to you today requests a total of $7.2 billion, a 7.8 percent
increase in funding for the FDA.
This significant increase in funding will have an immediate
impact on optimizing the health benefits of safe and nutritious
food, reducing harm from tobacco products, and ensuring the
availability of safe and effective medical products.
This funding will also enable the agency to continue to
leverage new and emerging technologies, improve the recruitment
and support of a highly skilled workforce, and adapt to new
production and business models in the industries that we
regulate.
I want all of you to know as well as the American people
that I, along with the leadership at FDA, will continue to make
the long- and short-term strategic organizational changes and
investments to ensure this agency is best positioned for future
public health and regulatory challenges and opportunities.
Since rejoining the agency I have consistently heard from
industry, Congress, and other stakeholders that the Human Foods
Program needed more attention and support. I don't have to tell
you that the infant formula shortage highlighted many of these
issues.
We've begun the exciting process of implementing a
revitalized and forward-looking FDA Human Foods Program,
including a new model for the Office of Regulatory Affairs.
We've announced a search for a Deputy Commissioner of Human
Foods who will report directly to the Commissioner and will
have clear authority over the organization's strategy and
resource allocation of the Human Foods Program.
As we embark on these changes, I want to be clear, our food
is already the safest it has ever been and no other country has
safer food, but that doesn't mean we can't improve; and while
most public discussion has been about preventing food
contamination, America has a critical need to improve its
nutritional status and better understand and reduce the
chemicals that put our food supply at risk.
In addition to our focus on food, tobacco product
regulation and enforcement remains one of our greatest
opportunities to save lives.
Although tobacco use is declining and vaping has been
modestly declining in youth, we will lose almost 500,000
Americans this year and millions of teenagers are already
addicted to nicotine with many new users each day.
That's why our budget requests an additional $100 million
in user fees and authority to include manufacturers and
importers of all deemed products, including electronic nicotine
delivery systems or vaping products, among the tobacco product
classes for which FDA assesses tobacco user fees.
No one anticipated we'd be inundated with almost 27 million
applications for vaping products. It's time for this industry
to pay its fair share as we grapple with the ongoing ravages of
tobacco and nicotine addiction.
The U.S. continues to lead the world in medical product
innovation but additional resources are needed to focus on key
areas presenting new challenges. The ongoing Opioid overdose
crisis, supply chain issues leading to a host of critical
product shortages, increasing needs for post-market evaluation,
and opportunities for amazing progress in battling cancer and
neurodegenerative diseases.
Finally, we also need to ensure continuity of the agency's
modernization of our IT infrastructure and data processes. This
isn't just making sure our computers are the latest model or
that the Wi-Fi works consistently, although that is important.
We need the ability to create systems that allow us to keep
up with the complexities of the industries and products we
regulate with the immense consequences for the health of all
Americans.
Finally, we need to be prepared for the next pandemic
threat. We've learned a lot over the course of the COVID
pandemic and need to assure the public that we're ready for the
next event.
I'd like to close by thanking the Subcommittee again for
your continued support of the agency. As the gold standard for
protecting health, FDA is trusted by Americans and relied upon
around the world for our work, ensuring the safety, efficacy,
and security of our nation's medical products and food supply.
Once again, thanks for inviting me to testify before you
today and I look forward to answering your questions.
[The statement follows:]
Prepared Statement of Dr. Robert M. Califf, M.D.
Chairman Heinrich, Ranking Member Hoeven, and Members of the
Subcommittee, thank you for the opportunity to appear before you today
to discuss the President's Fiscal Year 2024 Budget request for the Food
and Drug Administration (FDA or the Agency).
I would like to start by thanking the Subcommittee for your
continued support of FDA. The Agency greatly appreciates the funding
increases provided by the Subcommittee in the FY 2023 omnibus, as well
as the expanded and new regulatory authorities included in the
legislation to address cosmetics and medical device cybersecurity. Your
continued partnership is critical as we further our mission to protect
and promote the public health. FDA's talented and dedicated workforce
has worked around the clock for the past three-plus years to respond to
the COVID-19 pandemic, confront related challenges, and ultimately
strengthen our nation's response to future outbreaks. We appreciate
your ongoing support on a variety of programs and initiatives,
including the dedicated resources in several critical areas that
support our personnel and efforts, including employee pay costs,
infrastructure, and data-modernization to ensure continuity of our
vital work.
The COVID-19 pandemic has underscored the need for a swift, unified
governmental response with collaboration across Federal agencies,
state, local, tribal, and territorial governments, industry, and the
private sector. As we collectively work together as a nation to turn
the corner on COVID, the Agency is using the lessons learned to
continue our core mission while we pursue new ways to better prepare
for future threats and confront new challenges posed from an ever-
expanding marketplace of food, tobacco products, and medical products.
For example, in the foods area, the Agency has remained laser-
focused on a variety of critical efforts, including stabilizing the
supply chain for critical products such as infant formula, mitigating
the risk of potential exposure to certain chemicals, toxic elements,
and allergens, and facilitating consumer education regarding healthy
foods through the development of updated and more accessible food
labeling. Furthermore, with a Human Foods Program that regulates
approximately 80% of foods consumed by Americans, including those
bought in grocery stores, restaurants, and cafeterias, we are actively
working towards a new, transformative vision for the program that is
forward-thinking, proactive, and adaptive to an ever-changing and
evolving landscape. FDA is taking steps, in line with the
recommendations of the external evaluation conducted by the Reagan-
Udall Foundation, to ensure that our customers, the American public,
can remain as fully confident in the food they eat as they are in the
medical products they rely on to support their health; our FY 2024
Budget places us firmly on the steps towards this path.
The funding requested in the President's FY 2024 Budget request
builds upon funding provided in the FY 2023 omnibus for foods and other
product areas, while also acknowledging additional future needs and
challenges. Our FY 2024 program level request totals $7.2 billion,
which represents an overall increase of approximately $521.4 million in
annual funding above the FY 2023 Enacted level. Of this total, $3.3
billion is for user fees, which is an increase of approximately $149.5
million above the FY 2023 Enacted level. As part of the total program
level, the Budget also requests $3.96 billion in budget authority,
which is an increase of approximately $372 million above the FY 2023
Enacted level. These increases are organized into five critical areas
that advance the Agency's activities in support of protecting and
promoting human and animal health: (1) enhancing food safety,
nutrition, and cosmetics oversight; (2) advancing medical product
safety; (3) investing in core operations; (4) modernizing
infrastructure, buildings and facilities; and (5) tobacco user fees.
The Budget also provides $670 million of mandatory funding to advance
the goals of HHS's Pandemic Preparedness Plan.
enhancing food safety, nutrition, and cosmetics oversight
FDA's Budget request provides a historic investment in FDA's Foods
Program with $1.7 billion for food safety, nutrition, and cosmetics, an
increase of $210.6 million above FY 2023 levels, to support our
continual efforts and commitment to strengthening FDA's food safety and
nutrition capacity. This funding will help to ensure our human and
animal food supply is safe, sanitary, wholesome, and accurately
labeled, as well as ensure that FDA can start to implement new
authorities given by Congress to provide oversight of the safety and
proper labeling of cosmetic products. Additionally, this Budget will
increase FDA's inspectional capabilities, which include the risk-based
oversight of food facilities subject to FDA's food safety regulations
and help ensure a reliable and safe food supply chain.
New Era of Smarter Food Safety
As a nation, our food supply is the safest it has ever been--but
that does not mean we can't improve upon it. Specifically, as part of
the total $1.7 billion request for FDA's Foods Program, the FY 2024
Budget includes an increase of $37 million for our New Era of Smarter
Food Safety initiative. This approach aims to bend the curve of
foodborne illness by strengthening data access and analysis
capabilities, as well as bolstering capacity and food safety
inspectional efforts.
Healthy and Safe Food for All
Within these requested Foods Program investments, FDA is also
seeking resources for our ongoing efforts to provide safe food to the
American public, with a renewed emphasis on the availability of healthy
food options. The infant formula shortage from the last year serves as
a stark example of the need for continued attention to the critical
issues of food safety and security, the importance of quality
nutrition, and the need for a safe and accessible supply of food
products. To meet this goal, FDA is requesting an increase of $64
million to modernize oversight of infant formula, empower consumers to
make healthier food choices, and reduce exposure to toxic elements in
the food supply. We are further requesting an increase of $5 million in
order to improve FDA's ability to assess and track certain elements of
the food supply chain and industry capacity in order to help minimize
supply chain disruptions and enable a more resilient food system.
White House Commitment to Nutrition and Food Labeling
Finally, I would note that as a cardiologist, I've seen firsthand
the result of poor nutrition and diet, often stemming from childhood,
and the long-term impacts from diet-related chronic disease that can
occur. One of the first steps to addressing this often-neglected issue
is to ensure consumers have adequate and necessary information on the
food they eat. To advance these efforts, our budget also requests an
increase of $12 million to strengthen nutrition and labeling work in
alignment with the White House's National Strategy on Hunger,
Nutrition, and Health.
advancing medical product safety
In addition to ensuring a safe and healthy food supply, FDA's FY
2024 Budget request includes $4.6 billion for strengthening human and
animal health efforts across FDA's medical product centers, an increase
of $199.9 million above the FY 2023 Enacted level.
Device Shortages and Supply Chain
For example, as part of FDA's total medical product safety
investments, this budget requests an increase of $11.6 million, for a
total of $21.6 million, to continue building capabilities for FDA's
Resilient Supply Chain and Shortages Program for medical devices, and
for recruiting data science, supply chain, and medical device experts
to properly staff the program. These resources support our efforts to
help prevent and mitigate shortages of critical medical devices,
improve our ability to work proactively with medical device
stakeholders to assess vulnerabilities and enhance resiliency, and
ultimately safeguard the availability of life- saving technologies that
are most often needed by vulnerable populations.
ALS (ACT for ALS)
In addition to maintaining access to current devices and other
existing medical products, FDA also continues its focus on promoting
the innovation and scientific advancement of new medical products,
including products to address critical and rare diseases. Our medical
products request therefore includes an increase of $2.5 million for
staffing to implement the ACT for ALS Act and to help facilitate access
to therapies for neurodegenerative diseases such as amyotrophic lateral
sclerosis (ALS). Additionally, this funding will help to expand the
related development of new scientific approaches and tools that are
available for the development of effective new medical products to
prevent, diagnose, mitigate, and treat rare neurodegenerative diseases.
Combating the Overdose Crisis
Finally, in addition to the ongoing efforts at the Agency to
promote medical product access and innovation, I also remain deeply
involved in efforts to address an issue that has devastated countless
families across our country, the overdose crisis. FDA's Budget request
includes a proposed increase of $23 million, for a total of $102.5
million, to support the continued development of overdose reversal
treatments, as well as treatments for Opioid Use Disorder (OUD). This
funding will also support preventative methods and tools which involve
establishing satellite labs at International Mail Facilities with
permanent staffing of scientists and investigators, along with
expanding FDA's use of analytical tools for screening entries of
potentially illicit products before they can enter our country. In
addition, this funding will help advance the development, evaluation,
and market authorization of digital health medical devices for further
monitoring and addressing OUD inclusive of the patient perspective.
Addressing this crisis is largely dependent on collaboration across the
country, and utilizing real-time data to take effective and evidence-
based approaches on this issue remains crucial to our next steps to
turning the corner on this epidemic.
Cancer Moonshot
Further, FDA's Budget provides $50 million for FDA to advance the
President's Cancer Moonshot goals. These funds will enhance Agency-wide
efforts to improve evidence generation for underrepresented subgroups
in oncology clinical trials, as well as to support pragmatic,
decentralized trials and the development of sources of evidence that
incorporate patient- generated data and real-world evidence.
Additionally, these resources will assist in the expansion of FDA's
efforts to facilitate the approvals of innovative and new cancer
treatments by international regulatory authorities at the time of FDA
approval and will foster collaboration on cancer treatments with other
countries with standards comparable to the U.S. standard of care.
investing in core operations
As highlighted in earlier portions of this testimony, our nation
relies on FDA to provide rigorous and transparent scientific review, a
predictable and responsive regulatory structure, a strong inspectorate,
and expert staff to provide support for these activities. To meet these
needs, as part of our total program level, our FY 2024 Budget requests
$131.1 million above FY 2023 levels to continue to strengthen and
support FDA's core operations and pursue new areas of improvement and
innovation. In order to support further efforts, the Agency needs a
strong framework for our programs, and for us that begins with data.
Core operations also include initiatives such as advancing lab safety,
information technology, and support services to help ensure FDA's
ability to carry out its programmatic responsibilities.
Data Modernization and Enhanced Technologies
FDA's core operations request includes an increase of $10 million
for Data and IT Modernization to build new tools and greater capacity
to analyze real-time information. To meet the challenges of emerging
threats and the need for real-time evaluation, FDA relies on the
ability to rapidly and continuously access, analyze, and aggregate
multiple sources of information. From the COVID-19 pandemic to import
alerts and domestic recalls, continual modernization of FDA's IT
infrastructure has become increasingly more vital in order to keep pace
with the evolution of outbreaks and disease. With these resources, FDA
will continue to further build our centralized enterprise data
modernization capabilities and strengthen the Agency's common data
infrastructure, data exchange, and IT analytic services, talent, and
tools. Investments in these critical areas will enable FDA to directly
meet the challenges of our modern data-driven world, and continue to
operate as the gold standard for product regulation and oversight.
modernizing infrastructure, buildings & facilities
In addition to necessary investments in our core operations,
including digital infrastructure, the continuity of the Agency's
critical work also requires funding to complete projects that will
improve the condition of FDA's owned buildings and physical site
infrastructure. As part of our overarching FY 2024 Budget, FDA's
request provides a total of $395.9 million for infrastructure,
buildings, and facilities. This funding will help to ensure that FDA's
offices and labs across the country are optimally functioning. This
funding will also directly support the Agency's priorities across the
country by providing secure, modern, reliable, and cost-effective
office and laboratory space that empowers FDA's workforce to protect
and promote the safety and health of American families. By investing
resources in FDA's facilities, the Agency will be able to continue to
provide the high-quality infrastructure and facilities needed for FDA
employees to work to ensure FDA can achieve its strategic priorities
across the country and the world.
tobacco regulation
As one of these strategic priorities, tobacco product regulation
represents one of FDA's greatest opportunities to save lives. The
Tobacco Control Act gave FDA immediate authority to regulate
cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless
tobacco. FDA finalized the Deeming rule in 2016, which extended FDA's
tobacco authorities to all tobacco products, including cigars, hookah
(waterpipe) tobacco, pipe tobacco, nicotine gels, and electronic
nicotine delivery systems (ENDS) such as e-cigarettes. In 2022, a new
Federal law went into effect clarifying FDA's authority to regulate
tobacco products containing nicotine from any source, including
synthetic or non-tobacco nicotine (NTN). FDA regulates the manufacture,
marketing, and distribution of tobacco products. Key areas of focus
include policy and rulemaking, compliance and enforcement, premarket
review, research support, and public education campaigns.
In addition to the priorities mentioned earlier across foods,
medical products, core operations, and infrastructure, the Budget also
requests an additional $100 million in user fees and requests authority
to include manufacturers and importers of all deemed products--
including ENDS--among the tobacco product classes for which FDA
assesses tobacco user fees. These products represent an increasing
share of FDA's tobacco regulatory activities. The additional funding
will support hiring more staff, help FDA bolster compliance and
enforcement efforts for all tobacco products, and expand public
education campaigns and science and research programs, as we work to
mitigate harms and to protect consumers from the dangers of tobacco
use. To ensure that resources keep up with new tobacco products, the
proposal would also index future collections to inflation. This
proposal would ensure that FDA has the resources to address all
regulated tobacco products, including ENDS, which currently have high
rates of youth use, as well as future novel products.
pandemic preparedness
Finally, as we advance towards regular operations across our
product centers, FDA remains aware that there is work yet to be done in
our response to COVID-19, and it is critical that we learn from both
our successes and the challenges we experienced to best improve our
operations moving forward. Lessons learned from the COVID-19 pandemic
have reiterated the need to proactively plan for the next public health
emergency by ensuring FDA has the resources and capacity in place to
fully respond. FDA plays a unique and central role to the whole-of-
government response to protect and promote the public health, and in
turn, we are requesting funding to improve FDA's core capabilities to
help ensure there is the appropriate level of regulatory capacity to
respond rapidly and effectively to any future pandemic or high
consequence biological threat.
Separate from our aforementioned requests for discretionary budget
authority, FDA's Budget includes a request for $670 million in new
mandatory resources available over 5 years to advance activities to
better prepare FDA for the next pandemic. These funds would support the
Agency's biodefense efforts, domestic and globally, by bolstering FDA's
cadre of medical product reviewers and strengthening foundational
processes. It would also increase FDA's capacity to leverage a One
Health approach to respond to emerging threats. And lastly, these
resources would help strengthen underlying technology platforms to
improve electronic information exchange among stakeholders and bolster
central coordinating capacity within the Office of the Commissioner.
With these resources, FDA will have the opportunity now to build on
lessons learned from previous responses and provide transformational
investments to help ensure that FDA can respond quickly and effectively
in times of a public health crisis.
conclusion
This last year has presented some defining moments for the Agency
and ample opportunities to bring the Agency into a new chapter. This
Budget will help FDA maintain and expand on our current efforts, pursue
new innovative strategies and methods, and provide a renewed focus on,
and investment in, a variety of endeavors in the interest of public
health for both humans and animals. I would like to close by thanking
the Subcommittee again for your continued support of the Agency. I look
forward to answering your questions today, and FDA looks forward to our
collaboration and work together.
Senator Heinrich. Thank you for your testimony this
morning, Doctor.
As you know and I mentioned in my introduction earlier this
month, U.S. District Judge in Texas ruled that FDA's approval
of Mifepristone more than 20 years ago was improper and issued
a nationwide injunction to halt it.
This sets an incredibly dangerous precedent in terms of
both women's reproductive rights but also the FDA's review of
drugs.
Doctor, I'd like to give you the opportunity to speak about
what impact this ruling could have on other FDA-approved drugs.
Dr. Califf. Well, as you know, Senator, that matter's
currently pending before the Supreme Court. So, I have to be
brief and concise, but I will say that we are concerned about
the potential future impacts of this case as reflected in the
extensive briefs that have been filed by the Department of
Justice on our behalf.
This includes a wide range of concerns ranging from the
well-being of patients, including women who need access to this
drug, the pharmaceutical industry, and our ability to implement
our statutory authority. So, the considerations are extensive.
Senator Heinrich. Switching gears just a little bit, Opioid
and fentanyl use is having dire impacts in communities across
the country, including my home state where two-thirds of drug
overdose deaths involve an Opioid.
With Naloxone approved by the FDA and now available over
the counter, what else is the FDA doing to continue addressing
the Opioid epidemic broadly?
Dr. Califf. Really appreciate the chance to address this
and we should all be concerned because the nature of the
epidemic is changing significantly from just the prescription
misuse to now cartels driving fentanyl being delivered by mail
to American homes with unsuspecting parents finding teenagers
dead, in addition to the other problems that we've seen.
Having said that, we have a major report that's out with a
whole host of things that we're doing, but just to name a few.
We recently are requiring now a mail-back system to be employed
by all the manufacturers of opioids so that when people finish
their supplies rather than having them sit in the medicine
cabinet, they can be mailed back to the pharmacy. We also just
changed the labeling of long-acting opioids just last week,
taking into account that we still don't have the data we need
about long-term benefits. In fact, there's a hearing going--I
mean, an advisory committee going on today to talk about that.
We have a number of other things that we think are
important in the future. One that I'll mention that's very
important to us is we'd like to have the authority to require
that any new opioid company attempting to bring an opioid to
the market must show that the new one has superiority to the
old ones in terms of safety.
Right now, by law we don't have the authority to make that
decision. It would really help us if we had that authority.
This is a carve-out, an exception. It's not pertinent. A lot of
times the second drug along in a class turns out to have
advantages that were unanticipated, but this is a case where
for opioids we really need help.
I can go on much longer, but I know we have limited time.
Senator Heinrich. Do you want to touch on--there's a $23
million increase in the budget specific to this. Do you want to
touch on your plans for that increased funding?
Dr. Califf. Sure. A lot of it has to do with the data
systems that we need and the testing that we need to do in
proximity to where the opioids are coming into the market.
If you ever want to have an interesting field trip, go to
our International Mail Facility at JFK and see the Labrador
retrievers. Senator Baldwin made that trip, but it's just an
enormous amount of stuff coming in that Americans are getting
over the Internet, I think not realizing that often they're
getting really bad stuff.
So, we've got to invest in the testing to intercept this
right at the border, have the data systems and the artificial
intelligence to screen just as we do when people come into our
airports to sort the bad guys from the good guys, and then
we're hoping that there's going to be development of non-
addictive pain medicines. It's a place where, in my view, the
industry has let us down.
I say that having been on the industry side in part of my
career. It's a tough job, but we're not succeeding in seeing
non-addictive pain medicines coming through the pipeline. So,
we need to do everything we can to push the industry and work
with the NIH to make this happen.
Senator Heinrich. The accelerated drug approval process at
FDA can often be a game-changer for patients with serious
medical conditions. It's a process that's important to myself,
many advocates actually, yet many of these drugs approved
through that process are not then reimbursed by the Centers for
Medicare and Medicaid Services (CMS).
Doctor, what is the FDA doing to coordinate with CMS on
drugs that are approved specifically through the accelerated
process?
Dr. Califf. Well, you may remember when I came in this
time, you know, I likened it to a relay race where we run the
first lap and then we hand off the baton to the payers, the
private payers and CMS. What we're doing is try to make sure
the information is much more seamless, that we have the
clinical trials that are relevant to what they need, but it's
also abundantly critical CMS does not influence our decisions
about safety and effectiveness and we don't have any authority
to influence CMS's decisions about the reasonable and necessary
criteria and what we want to do is to make sure people have the
right information so that CMS can make the best decisions it
can, that it understands what we were looking at when we made
our decisions.
I think this is an area in American medicine where there's
a lot more work to be done and we can maybe later in the
session we can talk about.
Senator Heinrich. Okay. Ranking Member Hoeven.
Senator Hoeven. Mr. Chairman, I'm going to defer to our
Appropriations Ranking Member Senator Collins for the first
round. I always appreciate when she joins us.
Senator Collins. Thank you very much.
Dr. Califf, I have a series of questions that go to the
heart of the recent court decision in Texas on Mifepristone.
First, are FDA's regulatory decisions based on sound
science?
Dr. Califf. Yes, the latest available science with the best
methods that we can find by civil servants who have no
financial conflicts.
Senator Collins. Second, are political or economic
considerations weighed in your drug approval process?
Dr. Califf. No. Of course, we're all human beings. We're
aware of the discussions that go on, but that decisionmaking
process is protected. Political appointees, even the
Commissioner, me, I'm a political appointee, I think of myself
as a doctor, but I'm politically appointed, we don't influence
those decisions or intercede, except in very rare
circumstances.
Senator Collins. Third, has this abortion drug been on the
market for more than two decades?
Dr. Califf. Yes, 23 years, I think.
Senator Collins. And has it been used by millions of women
during that period?
Dr. Califf. Many millions.
Senator Collins. Let me read you a quote that was included
in a filing by some physicians who were challenging the process
by which the FDA approved this drug. These doctors say, ``For
nearly a quarter century the FDA and the manufacturer have
brazenly flouted the law and applicable regulations,
disregarded holes and red flags and their own safety data,
intentionally evaded judicial review, and continually placed
politics above women's health.''
Could you comment on that statement?
Dr. Califf. Well, as I've said, we use the latest science,
the best data to make our decisions, and these sorts of
influences you're describing are protected within the FDA by
the system for all drugs, not just this one.
Senator Collins. And I appreciate those answers. I consider
the FDA to be the gold standard globally in approving drugs and
I find this court ruling to be more reflective of the judge's
personal views rather than a fair and impartial analysis of the
facts of the case.
I do want to pick up on the issue that the Chairman raised
because just as I question the court's decision in this case, I
also question CMS's decision to deny Medicare patients access
to two Alzheimer's drugs that have been approved by the FDA.
My view is CMS should stay in its lane, the FDA should stay
in its lane, and we've talked about that. So I'm not going to
ask you to comment today because I want to quickly get in one
other issue, and it has to do with cell and gene therapy
approvals.
Almost 5 years ago the FDA issued a forward-looking
statement on the future of cell and gene therapy approvals and
new policies to advance their development. The FDA stated its
intent to maximize use of expedited programs, including
accelerated approval to review gene therapies for serious life-
threatening diseases, and this subcommittee's bill included
language last year to further encourage FDA to bring urgency to
the gene therapy.
In 2021 you stated that you are a fan of accelerated
approval for the right conditions and as we've also talked, I
believe that you are sincere in your belief that there's great
promise here.
However, what I am frequently hearing is that the FDA's
Center on Biologics has put clinical holds without explanation
on some promising cell therapy developments.
Do you agree that there is a problem there?
Dr. Califf. I want to acknowledge that I think there are
some issues there that need to be worked out. This was
recognized in the User Fee Agreements that were just concluded
and you all passed just last year which are now going into
effect.
We're going to be hiring 150 to 200 people in this area
under the leadership of Dr. Marks, who I think you'd agree has
done a remarkable job with vaccines and now this is going to be
a big focus of attention.
I would emphasize when it comes to clinical holds, it's not
just it's something that's going wrong with a patient. Often it
has to do with the integration of manufacturing and a lot of
the companies are start-ups without robust manufacturing
facilities. So, there's a lot of work to go on, but we agree
that this is an area we've got to move along more quickly.
I know like everyone else you all talk about FDA approvals.
I always feel like I need to emphasize we also don't approve a
lot of things if they aren't safe and effective. If the risks
outweigh the benefits, it's our job to stop those, but I do
acknowledge that there's an issue here that we're addressing.
Senator Collins. Thank you. Thank you, Mr. Chairman.
Senator Heinrich. Senator Peters.
Senator Peters. Thank you, Mr. Chairman.
Dr. Califf, last month, as the Chair of the Senate Homeland
Security and Government Affairs Committee, I released an
investigative report that found that there were major blind
spots in our ability to accurately assess vulnerabilities in
our drug supply chain.
From both a national and a homeland security standpoint,
I'm particularly concerned about shortfalls in the FDA's
ability to use data analytics to effectively assess our
reliance on foreign sources, especially in countries with
rising geopolitical risk, like China.
The Defense Department, of course, relies on the same
international market to provide drugs for our service members.
So my question for you, sir, do you agree that the FDA does
not have sufficient visibility to identify some of the risks
that could lead to supply shortages and if that is the case
what are some of your top challenges to assess this risk?
Dr. Califf. Thanks for raising this issue. It's taking up a
large amount of my time right now and just a couple of preface
statements.
We're seeing shortages in every commodity we regulate,
including food, devices, drugs, and biologics. The only one
we're not seeing it in is tobacco, oddly enough, the one I
might prefer there was a shortage, it's not occurring. They
seem to have figured it out.
The second preface point that I would make is that I was on
the National Academy of Medicine's Supply Chain Committee just
before being nominated and spent a lot of time working on it
then and the report that you put out is very consistent. I
think there are five different reports now that make this
point.
If FDA is looking through a windshield, we got mud on our
windshield because we can see some things but there's a lot
that we can't see because we don't have requirements of the
industry to give us the data that we need and we don't have
funding for the data systems and analytics that we need, and,
if you wish, I'm glad to go into any amount of detail.
The one other point I want to make in general is that
there's an element of this, that is clearly in FDA's lane, and
there's an element which is more of an all of government; that
is, when we see a problem, many of the levers that are really
important to pull exist outside the FDA when it comes to things
like tariffs or investments in manufacturing facilities in the
U.S. with funding which are two of the areas I think we've got
to look at.
Senator Peters. Well, great. Well, I guess in further
conversations we've had a follow-up report, two reports now,
one we did prior to the pandemic and since then it's gotten
worse, not better, and we've got a number of ideas how to
address it but love to have your thoughts and meet with you at
some point in the near future.
Dr. Califf. I'd like to, and your point about insecure
countries that we're dependent on is really critical right now.
Senator Peters. Right, absolutely. Thank you.
Sir, I'd also like to follow up with you on the FDA's work
to restore confidence in our nation's infant formula supply.
As you're well aware, in Michigan we witnessed the
devastating harm that can come from bacterial contamination of
infant formula that families rely on, and it's clear,
absolutely clear that we have a lot more work to do. In the
most recent Michigan case, once again contaminated formula was
recalled only long after it was already distributed, sold, and
consumed. This put vulnerable infants at risk and once again in
response the FDA asked manufacturers to voluntarily notify the
FDA of any time a product sample is found to be positive for
Cronobacter or Salmonella, even if the affected lots have not
yet been distributed.
So my question is are you confident the industry will
consistently volunteer accurate and verifiable information to
the FDA or do you think we're going to need to be thinking of
legislative change to require earlier industry reporting, if
necessary?
Dr. Califf. I am confident the majority of the industry
will comply, but I would prefer it if the things that are
really needed are written into law. It's a lesson I've learned
this year.
You know, it's like anything in America. Most people want
to do the right thing and they do it but you have outliers. In
the case of the infant formula situation, it's a concentrated
industry. So one entity not doing the right thing can create a
problem.
I do want to point out the recent case you talk about, we
changed the standards and this particular entity got caught in
the middle of it, didn't meet what we expected them to do. I
think the whole industry is moving to the standard of
notification and better bracketing of products, but still I
think having the authority is so much better.
I've been on the industry side and when the industry is
told you must do something, it actually does it because the
penalties are very different than in a voluntary situation.
Senator Peters. Right. Well, thank you. Thank you, Mr.
Chairman.
Senator Heinrich. Thank you.
Ranking Member Hoeven.
Senator Hoeven. Dr. Califf, as you and I have discussed, I
am concerned about FDA decisions to allow Mifepristone to be
distributed by mail and without physician supervision.
So my question to you is will you commit to following the
decision of the courts with respect to the drug and how it's
handled?
Dr. Califf. I'll just say the FDA intends to comply with
any court orders.
Senator Hoeven. Thank you.
And I would like to follow up on the infant formula supply.
Talk about supply--we're still getting reports in some cases of
supply of certain types of brands. Where are we at with the
supply of infant formula and what else are you doing to make
sure it's available?
Dr. Califf. You know, I've tried to stay understated on
this because, you know, the day of the Abbott recall was the
day I was confirmed and I discovered all these problems inside
the FDA that needed to be fixed. We could have a long
discussion about how much those problems actually affected
infant formulas specifically I don't think as much as people
think, but that doesn't change the fact that we needed to fix
our own house internally.
But, I am pleased to say today we're over 90 percent in
stock which is higher than it was before the recall. So there's
plenty of formula out there and March 28th we put out our
Stability Report with a whole host of things that we've done,
but I also want to say that while we're stable at this point
and probably a little better off than we were before the
recall, there are four or five key things that are beyond the
FDA that need to be fixed.
It's a concentrated industry. We don't have enough
variation in the suppliers. Putting up a new infant formula
plant takes years and, in fact, Abbott has decided to put up a
new one. It's going to take a couple years for them to do it
and they have the most capacity in the industry already, but
you've got to get 30 ingredients right, the quality has to be
there. So, this is not a trivial thing for start-ups to begin
to do.
So, there's a lot of work to do to diversify the industry
to assure that if there's a bad lot event like the major flood
that occurred in Michigan, you know, one in a hundred-year
flood, that the whole thing doesn't become short again. So, I
don't want to appear complacent. We still have work to do. It's
very much there in our report.
Senator Hoeven. So I think that answer is helpful. I think
it reassures people that supply is out there and that you're
working on it and I think in your leadership role that's the
kind of thing that both in terms of the information and action
that can help address this type of situation. So I appreciate
that.
Dr. Califf. If I may mention, I know you're particularly
concerned about rural areas, I'll just say in everything that
we're currently regulating, rural areas are in need of better
support.
Now, you know, FDA can measure these things but we can't
necessarily fix it, but in infant formula I know that's still a
bit of an issue as the supply's up overall but it tends to be
centrally distributed to start with. So, we're very much
working on that every day. I just wanted to make sure that was
noted.
Senator Hoeven. Right. Particularly when you're looking for
certain size and certain brands, certain types, you know,
obviously it's there in the urban center and the big store but
that's exactly right and so I appreciate that.
In regard to the traceability rule, this goes back to my
opening comments, and I'm concerned about the size and scope of
the traceability rule and, you know, the workability.
So, I mean, do you have a comprehensive list of the
products that you're going to cover under the rule? Who's going
to have the burden of maintaining records, the entity, the
business, or the industry, or FDA, or both, and then are you
going to allow exceptions again for small business, family-
owned business kind of thing?
Dr. Califf. Sure. As we've discussed before, we've got to
be sensitive to the needs of small organizations and we already
have exceptions for, for example, family farms and for retail
establishments that are small. There are exceptions, but, you
know, there's a phrase used in the industry ``educate before
you regulate'' and what we want to do, if we look 10 years
ahead, we hope the entire supply chain will be digitized,
right, so that we can distribute the right stuff to the right
place regardless of where it is in America, but for smaller
companies to get there, they're going to need help and support.
We recognize that and it'll be shown in our adaptive
approach to regulation.
Senator Hoeven. The exception is very important and that
rule can get away from you. So I'm glad you're watching it
closely.
My last question is regarding the Medicare and Medicaid
coverage of Alzheimer's drugs. I joined with 19 of my
colleagues, including Senator Collins, in sending a letter to
CMS expressing our dismay for the agency's coverage termination
on Alzheimer's drug.
AS Commissioner and a physician, are you concerned with CMS
choosing not to cover some of those FDA-approved Alzheimer's
drugs?
Dr. Califf. Senator, you know I can't comment on CMS's
decision.
Senator Hoeven. Sure you can.
Dr. Califf. All I can say is we evaluated and considered it
safe and effective.
I'll just point this is an amazing area of biology that is
still a problem.
Senator Hoeven. That's the good comment for a non-comment.
Dr. Califf. Okay.
Senator Hoeven. You determined them to be safe and
effective.
Dr. Califf. But that's different than reasonable and
necessary which is the CMS standard. I just got--you know, we
have family involvement with this disease. It affects my family
greatly. So, I'm very much hoping the biology works out.
There's a whole bunch of new clinical trials about to come
in. I think this will--I'm actually very confident having
talked with CMS we'll get this resolved in a positive way and
let's see the data as it comes in.
Senator Hoeven. I appreciate that.
Senator Heinrich. Chair Murray.
Senator Murray. Well, thank you very much, Chair Heinrich
and Ranking Member Hoeven.
You know, families back home are really counting on us to
work in this committee and across the Appropriations in a
timely bipartisan way so we can pass our funding bills that
keep them safe and our country strong. So I'm really glad this
committee is continuing full steam ahead with return to regular
order and talking about making sure that FDA has the resources
it needs to live up to its really critical mission because make
no mistake protecting our families is not just about how strong
our military is, it is about how safe our food or drugs or our
medical devices are, not to mention how smooth our supply
chains are to ensure that families get what they need.
We've had some tough reminders of that over the years,
whether it's the medical supply shortages during the pandemic
or the agency's important work to quickly, safely review COVID
treatments and vaccines, or, as we've talked about here, the
inexcusable baby formula shortage.
That is really why I pressed very hard to make sure our end
of the year package last year included some really important
reforms to FDA, but we have more work to do, including on this
subcommittee, to make sure we provide the resources for all
this, as well, because there is a direct line between FDA
having the resources it needs and the safety of American
families.
Every time families back in Washington State go to the
grocery store or gather around the dinner table or fill a
prescription or rely on a medical device, they're really
putting their trust in FDA and their experts to uphold the gold
standard of safety and effectiveness, and let me just say once
again, especially in light of recent events, the determination
about whether drugs are safe and effective needs to be left to
the experts at FDA, not politicians and certainly not judges.
We got a stark reminder of this in the recent weeks when
extreme, poorly reasoned, and dangerous rulings of judges
undermined FDA's authority to review and approve drugs by
declaring themselves to know better than FDA's experts about
medication abortion.
FDA has an enormous responsibility and some hard work ahead
to make sure it is living up to that responsibility. The last
thing our families need at this critical moment is for
politicians to undermine its authority or shortchange its
efforts.
So I'm really glad today, Dr. Califf, to have you before
this committee to talk about what the agency is doing and what
it requires to tackle the challenges you have ahead, and I do
want to start out with the Mifepristone issue.
As you know, the Supreme Court is going to decide a case
that really threatens access to medication abortion nationwide
and seeks to undermine the FDA's authorities to approve and
regulate medicine.
Let me ask the question this way. Commissioner Califf,
would you speak to the implications of this case on the drug
approval process and the scientific rigor with which the agency
approaches drug applications?
Dr. Califf. As we discussed already today, our decisions
are based on the latest science, the best data we can find, the
weighing of risks and benefits by our professionals who are
full-time civil servants without financial conflict, and there
is concern in this case about the impact on a wide variety of
things, including patients, women in need of access to a drug
which is approved, the pharmaceutical industry itself because
of the threat to the separation of this decision about what's
approval and what's not sequestered away from political
influence. So, these are all concerns that we have.
Senator Murray. So I take from your answer that this, of
course, could have an implication on Mifepristone but also on
the process that all of the drugs and tools that are going
through the FDA?
Dr. Califf. This is well reflected in the extensive briefs
that the Justice Department has filed on our behalf and are
publicly available.
Senator Murray. Thank you very much.
Dr. Califf, at the end of last year, as you know, I
negotiated and passed the Modernization of Cosmetics Regulation
Act of 2022 which Senator Collins, who just left, was a
critical part of. It provided new authority to your agency to
make sure that cosmetics are safe for the people who use them.
The FDA finally, after many years, will know who is making
and marketing what products and where and what ingredients are
being used and when there is an adverse event, like severe
rashes or hair falling out or worse. This is the first time and
I'm very excited that you now have the authority to regulate
this. I can't tell you how many people I've talked to didn't
even know they weren't regulated before. So very important
step. You will now have the power to take products off the
shelves if they're not safe.
Can you provide us with an update about how you're moving
forward with this new authority and, importantly for this
committee, what resources you will need to implement them?
Dr. Califf. Sure. I'm still stunned by the average of 12
cosmetics a day for women and six cosmetics a day for men,
something I hadn't really considered before, but I am pleased
to say that we're on track and I'm really excited that we've
moved this under the auspices of Dr. Namandje' N. Bumpus, who's
our Chief Scientist.
If you all have not met her, I would urge you to meet with
her. She was the Chair of a Department of Pharmacology at
Hopkins and I tried to talk her out of coming to FDA because
she had a good life as an endowed professor, but she's a great
civil servant, a preeminent scientist in that role.
We're moving along well with the registration issues that
are part of this, developing the adverse event system. We've
asked for $5 million for next year which is a very important
part of the budget. Our estimate for the overall dealing with
this $70 billion a year industry is about $40 million to get us
where we need to be over time and we'll phase that in so that
we can show progress.
I know I've learned we need to show that in order to get
people interested, but there are real safety issues that we're
encountering. So, I'm glad we have that opportunity.
Senator Murray. Okay. Thank you very much. Thank you, Mr.
Chairman.
Senator Heinrich. Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Mr. Chairman, and thank you,
Dr. Califf, for being here today before the committee because I
certainly look forward to your questions.
I just find it extremely concerning that under your watch
the FDA allowed the dangerous life-ending, because they do kill
the baby, chemical abortion drugs to be ordered by consumers
through mail or purchased in retail pharmacies without ever
seeing a doctor in person, I think that's the concern of many,
many people. In 2016, as you know, the risk evaluation and
mitigation strategies were changed to eliminate the
requirements that non-fatal adverse events would even have to
be reported to FDA.
So that's been 7 years that if the woman almost died, it
was not reported. It was only reported if there were fatal
cases. The FDA that claimed this drug to be safe in part based
on the lack of reports of non-fatal adverse events. I agree
with the fifth circuit's description of this deeply disturbing
this of really-not-looking-at-it or the head-in-the-sand
approach. Because of the lackluster approach to safety, women
seeking to use these drugs do so without the chance to be
screened by an ultrasound for complications. My main concern is
an ectopic pregnancy that if the baby is not positioned which
is deadly, or if she's further along that she's saying that she
is, I'm truly grateful that the two Federal courts have ruled
that the FDA's most recent action failed to meet its legal
obligation.
So that's what the lawsuit is about, not judging if the
drug is safe or unsafe but that the FDA failed to meet its
legal obligation to protect the safety of women and girls and
that it also directly violated longstanding Federal criminal
laws that expressly prohibited the mailing and interstate
shipping of abortion drugs.
So the FDA, it's more of a legal issue of the procedure
that happened than a safety issue of determining what drug is
safe. If the Supreme Court allows the lower court rulings to go
into effect, will the FDA fully comply with the decision
without delay and not attempt to flout the ruling under the
guise of some kind of enforcement discretion? Would you apply
immediately?
Dr. Califf. First, let me just reply to one small thing
that you said, not such a small thing, but I do want to offer a
different viewpoint on the adverse event reporting.
Adverse event reporting is required of all drugs, including
this one. The reporting of adverse events is not being ignored
in this case. It's required just like with all drugs. What was
done was to take away a separate form that's different from all
the rest of the drugs.
But with regard to your question, we're confident the law's
on our side. We've appealed the District Court's decision to
the Supreme Court and have sought a stay pending that appeal,
but FDA, as I've said already, does intend to comply with any
court orders.
Senator Hyde-Smith. Okay. In making its decision to
eliminate the in-person dispensing requirement, none of the
studies the FDA cited, which were largely conducted by abortion
activists, studied the drugs under the new no-test tele-
abortion regime.
Despite this, the FDA concluded that it was safe, but even
the FDA admitted that this decision would increase emergency
room visits for pregnant women taking the drugs.
How comfortable is the FDA in recommending practices that
have not yet been fully tested for safety?
Dr. Califf. Senator, since that's before the Supreme Court,
I have to refer you to the briefs that have been filed by the
Justice Department on our behalf. The answers to these
questions are discussed in detail there.
Senator Hyde-Smith. Okay. And how many studies has FDA
considered that studied the effects of abortion drugs on young
girls as required by law?
Dr. Califf. Again, I'd have to refer you to the briefs that
have been filed by the Justice Department.
Senator Hyde-Smith. Okay. And the law also requires the FDA
to respond to petitions within a 180 days, but the FDA waited
roughly 14 years and nearly 3 years to respond to citizens'
petitions challenging FDA approval and deregulation of chemical
abortion drugs.
Can you speak to that?
Dr. Califf. I'll just say again this is discussed in the
briefs that are filed by the Justice Department and it would
take a long answer.
Senator Hyde-Smith. Okay. My time is up.
Senator Heinrich. Senator Tester.
Senator Tester. Thank you, Mr. Chairman, Ranking Member,
for having this hearing.
I want to thank you for being here, Dr. Califf. I think you
guys have been the gold standard. I appreciate the fact that
you're in the position that you're in and I want to thank you
for your work.
I'm not going to get into the activist judges. I'm not
going to get into any of that stuff. The fact of the matter is,
is that the FDA has done a great job and have done it for a
long time and it continues under your watch.
I come from Rural America. You touched on it a little bit
with the Ranking Member, but when we spoke last year we talked
about the importance of ensuring good health outcomes in Rural
America.
Given your background as a clinical researcher, we can talk
about the clinical trials for new and innovative medical
treatments and how they work for Rural America.
So clinical trials are critical, you know that, for drug
development. Montana's rural population face many challenges in
assessing and accessing clinical trials for innovative
pharmaceuticals.
So the question is this. Can you explain how the FDA's
budget allocation supports the expansion of clinical trials to
rural areas, including efforts to increase diversity in
clinical research participants and ensuring safety and efficacy
of the drugs for all Americans, regardless of geographic
location?
Dr. Califf. Sure. Thanks for the question.
I think it's critically important. I can't resist making
one comment which is that we can't ask clinical trials to fix a
structural issue with our health care system in general, but
having said that, we got to do everything we can for the
clinical trials.
We have an office essentially charged with dealing with
diversity across the board, including clinical trials. There's
a cross-agency task force working on this. We have several
guidance that have come out and, of course, our increasing
encouragement of adoption of the use of telehealth in clinical
trials is a big part of this.
Here, I'd also emphasize that we've got to get broadband
out to the rural communities. The money allocated for that as I
understand it. So we can't use that technology unless someone
is wired up in order to be able to use it, and I can't
emphasize enough let's say you have a significant cancer
driving three hours to get your experimental treatment,
something a lot of people just can't do, and so we've got to
set up these systems that can efficiently get the clinical
trials done.
Finally, I'd just say the real-world evidence which has
been a big part of my career that is using data that's all part
of the health care system and then doing the trials more
virtually is a rapidly growing method that we're very much in
favor of.
So, all these things are in play, but I'm not going to
argue we're there yet. We've got a ways to go in this regard.
Senator Tester. So in that regard of broadband, I can tell
you the gentleman to my right, Senator Manchin and myself
worked on a bill called The Bipartisan Infrastructure Package.
It'll get these folks wired up as soon as we get that money out
the door and get the cable in the ground.
Dr. Califf. I had a flat tire in West Virginia and I
couldn't even use my cell phone. It was not a pleasant night.
Senator Tester. That's Manchin's fault.
[Laughter.]
Senator Tester. Let me get you his phone number.
Dr. Califf. There was no way to call. I had to wait for a
passerby to come by.
Senator Tester. I want to talk a little bit not because I
have an agenda on this, I'm just curious. You talked about
approvals and you also talked about disapprovals.
Can you give me a number of the drugs that you guys take a
look at? Is it a fairly static number that you disapprove
compared to what you approve?
Dr. Califf. I would say it's really hard, Senator, because
this all starts when a scientist has an idea and it's like one
out of a thousand ideas get into human clinical trials because
to get to human clinical trial, you got to have the money
invested, an IRB has to be approved, the FDA has to approve it.
Out of those that get into the first human clinical trial,
about 90 percent don't make it to the market.
Senator Tester. Okay.
Dr. Califf. Now the big change that's happened is we meet
with the companies all the time. It used to be there were a lot
of applications submitted that had no hope. Now the only
applications that go in are the ones that have gotten all the
way to the end of the game. We get rid of all the others. Very
efficient financially but also protects patients who are being
enrolled in clinical trials for drugs that aren't going to
work.
Senator Tester. So you just talked about the lengths, so
that gets into timeliness.
As a doctor, how do you think the FDA's doing on
timeliness, and this is being somewhat self-critical or pat
yourself on the back?
Dr. Califf. I think we're the fastest in the world at high
quality. Now there's some countries that don't have much of a
regulatory system at all. That's different. We're the fastest
in the world, but we're also the most thorough and we're the
only regulatory entity that does an independent analysis of the
data.
I'm pleased to say as of today we're meeting a hundred
percent of our user fee agreement requirements. Remember
industry comes in and the user fees negotiates with us and the
primary thing that they measure is whether we're meeting our
timeframes that are required and even in the midst of this
recovering from the pandemic we're now meeting all of our
requirements for timeliness.
We just discussed earlier in the area of biologics with
gene editing. That's an area that we're emphasizing where we've
got to do some work.
Senator Tester. Thank you, Dr. Califf. Keep up the good
work.
Senator Heinrich. Thank you, Senator Tester.
Senator Manchin, did you want to share yourself on with the
Doctor?
Senator Manchin. As soon as we get that tower up, you'll be
in good shape.
You and I talked briefly and I want to go over some of the
things we talked about. The FDA is holding an advisory
committee meeting on opiates today in particular on the
questionable clinical trial practice known as enriched
enrollment. The agenda today has a majority of the speakers who
attended the very questionable IMPACT Meetings that we spoke
about and I previously expressed concerns and I think most of
you all know about the IMPACT meetings. That was the
questionable pay to play where they would pay to present
themselves before the FDA advisory committees.
The speakers today have not been disclosed, have not even,
I don't think, disclosed their involvement with IMPACT if they
had been partaking in those before. I find it imperative that
this advisory committee has non-ideological presenters to avoid
the appearance of industry influence on the agency's
decisionmaking. As it stands, this very much appears there will
be heavy influence on today's advisory committee.
Let me tell you what I'm speaking about. We got more and
more opiates coming on the market. My state is ground zero. All
of you all have--every state has problems and you and I talked
about this. So there shouldn't be--to put a new opiate on the
market, some manufacturer coming to you, there has to be
something that it's replacing, something that's not doing--and
this is a better, more improved.
We take nothing off. Everything stays on the market as you
bring more on, and if you can explain that to me and what we
can do to make sure we're passing legislation that allows you
to remove when you find approving drug, if you can explain that
to us, it'd be appreciated.
Dr. Califf. Yes. So, first, we'll get back to you on the
advisory committee meeting, but the issue that you raise, we
discussed this earlier before you came in, but to be clear
about it, the most important thing I think you can do is give
us the statutory authority in the area of opioids to require
that anything new that attempts to come on the market has to
demonstrate clear superiority in terms of safety to the all
drug.
Now whatever else you want to attach to that, we talked a
bit yesterday, it was pretty much the same conversation we had
in 2016, as I recall. So it could really help us move more
quickly and accomplish the common goals that we have.
Senator Manchin. Are your staff, are they aware of the
EFFECTIVE Act?
Dr. Califf. Yes.
Senator Manchin. Okay. Is there some ways that you think we
could improve that to give you more authority?
Dr. Califf. We'd like to work with you on that.
Senator Manchin. Okay.
Dr. Califf. And inviting your staff to come out to FDA and
we'll come to you.
Senator Manchin. We'll do that. I think she's working with
your staff to make an appearance there and sit down and work
with you all.
Let me ask this. With today's meeting, what additional
stakeholders have you invited? Did you make any adjustments so
it'll be more of a----
Dr. Califf. We only had that conversation last night. So
there wasn't time to adjust the meeting, but there was an open
session. The gentleman you brought up, Dr. Kolodney, was the
second public speaker and I think, you know, as you pointed
out, it wasn't two--he got five minutes but I know you'd like
for him to get more time.
Senator Manchin. Well, the person that I'm saying was
basically important to the IMPACT before is the person who got
all the time, you know, and he was definitely tied to the
industry.
If the pharmaceutical--I mean, you talk about the fox in
the henhouse, that's our problem. It's just killing our state.
It just has done irreparable damage.
Let me ask you this. On the recommendation of external
review of the FDA Regulations of Opiates Report that you
ordered was to ensure the FDA be as transparent as possible
regarding decisionmaking. Advisory committees present complex
scientific reviews of safety and efficacy of medicines most
patients and general public really don't have a background to
fully understand the scientific studies discussed in these
settings.
Dr. Califf, you recently have been pushing to reduce voting
in the FDA's advisory committees, even stating in a Med page
Today interview that ``voting doesn't matter,'' but they're the
ones that do have the expertise, the public does not, and how
does ending voting for the advisory committee meetings improve
the transparency and the public trust that you advocated for?
Dr. Califf. To be clear about what I said and what I
believe,----
Senator Manchin. It wasn't taken out of content, was it,
sir, because we never would do that.
Dr. Califf. A little bit, but generally--so what I'd say,
we're pushing to have advisory committees, not less.
Senator Manchin. Yeah.
Dr. Califf. The point I was making is that people focus on
the vote, but its' the FDA that has to make the decision, not
the advisory committee. What the FDA employees and leaders want
out of the advisory committee is deep knowledge about the
thinking from multiple points of view.
What is it that is driving their thinking and because it is
advisory, people tend to focus on like if it's an eight to five
vote----
Senator Manchin. Well, here is the thing. You know, you
know the one I'm talking about. It's 11 to two.
Dr. Califf. Yeah.
Senator Manchin. Please don't put this drug on the market.
They overrule and you all put it on the market. You weren't
there. They put it on the market anyway. We begged them not to.
Then they had the--finally the company pulled it off themselves
but it was just horrific. I mean, I'm saying these are the
people that have knowledge thinking it was dangerous to put it
on the market.
Dr. Califf. I hear you. What I want is much more public
discussion about the issues, less focus on like a cage match of
who's voting for what and rushing out the door.
Senator Manchin. Just a number of states have been affected
beyond anybody's imagination.
Dr. Califf. Senator, as I told you yesterday, I helped
start a not-for-profit in Dayton, Ohio, which is right there
with West Virginia, as you know, in terms of death rates and
other problems. I have a deep sense of what this is about and
we're going to work on it as hard as we can. I'm not pretending
we got everything right. So, I appreciate your concern.
Senator Manchin. We need help on that. I was alarmed to see
that the meeting that was going on today and how it was put
together and the presenters and who had the time to do that. It
just didn't seem like it was very balanced.
Dr. Califf. I hear you.
Senator Manchin. Thank you, sir.
Senator Heinrich. I want to thank Commissioner Califf for
being here today.
ADDITIONAL COMMITTEE QUESTIONS
Questions for the record are due by next Wednesday, April
26th and we'd certainly appreciate responses back from FDA
within 30 days.
Questions Submitted by Senator Martin Heinrich
Question. Last December, the Reagan-dall Foundation released its
evaluation of the FDA's human foods program and highlighted serious
organizational challenges within the agency.
Since that report was issued, several senior staff within FDA
announced their departure from the agency. How will FDA continue to
move forward and address the challenges identified within the
Foundation report with such a significant change in senior leadership?
Answer. Following the release of Reagan-Udall Foundation's
Operational Evaluation of FDA's Human Foods Program, Commissioner
Califf announced a proposal for a unified Human Foods Program (HFP) and
a new model for the Office of Regulatory Affairs (ORA). Since the
announcement, the Agency has made significant progress to implement the
vision, including initiating a competitive national search for a new
Deputy Commissioner for Human Foods who will report directly to the
Commissioner and provide leadership and expertise for FDA's entire
nutrition and food safety programs. The Commissioner has identified
competent and capable FDA senior leaders to fill the leadership roles
in ORA, the Center for Food Safety and Applied Nutrition (CFSAN), and
the Office of Food Policy and Response (OFPR) during the transition,
while the Agency is also working to address the challenges identified
in the Reagan-Udall report through an Agency-wide approach. FDA has
created an internal Implementation and Change Management Group--
comprising current and future leaders from all components of the Human
Foods Program and from other Centers--to develop a detailed plan to
ensure the successful execution of a unified Human Foods Program and to
restructure ORA into an enterprise-wide organization supporting the
priorities of the Human Foods Program and the Centers, while focusing
on the core functions of inspections, import operations, sampling,
laboratory analysis, and investigations.
Question. Where is the agency on hiring a Deputy Commissioner for
Human Foods?
Answer. The Agency's search for a Deputy Commissioner for Human
Foods commenced in late February through a vacancy announcement under
our Title 21 hiring authority (granted to us by the 21st Century Cures
Act). FDA is currently in the process of interviewing several qualified
candidates and hopes to make a selection for this important position as
soon as possible. This is a critical role and the Agency is moving as
quickly as possible, although we need to follow the necessary legal
processes. The Agency looks forward to keeping you apprised of our
progress.
Question. Your budget requests an additional $11.6 million to
continue building capabilities for FDA's Resilient Supply Chain and
Shortages Program for medical devices. With supplemental funding ending
in 2025, how does the FDA plan to manage this program for the long
term?
Answer. FDA appreciates the funds Congress has provided thus far--
the $10 million total provided across FY 2022 and FY 2023 were the
first funds provided to FDA's base for medical device supply chain
efforts, and we have been able to transition some staff and
capabilities funded by the COVID-19 supplementals to start building a
permanent, serviceable program. The Agency is still in a building
stage, however--having essentially started building from scratch during
the pandemic, FDA has had to develop infrastructure where it did not
exist, recruit expertise it did not have, and start building
capabilities and a program where none had existed.
What FDA has today remains a largely reactive program. It is making
a huge difference for the domestic supply chain, but major
vulnerabilities continue to put the nation's supply chain and the
U.S. healthcare system as a whole, at risk. Medical device
shortages most often impact vulnerable and underserved populations,
such as children, rural communities, and veterans. The Agency is also
aware that China accounts for approximately 45% of finished medical
devices imported into the U.S., and that the U.S. remains heavily
dependent on China for raw materials and components that are used to
make medical devices. Patient safety and national security depend on
having preventative capabilities. FDA seeks to get out of ``response
mode'' by focusing on what is needed for a serviceable, sustainable
program where the Agency can intervene and help prevent shortages from
happening in the first place.
The request for an additional $11.6 million is the difference
between a such a reactive program and transitioning to a proactive
program that is preventive--so regardless of the situation, whether it
is a massive pandemic or a spot shortage in one part of the country,
FDA is not left scrambling and playing catch up. Without these
additional funds in FY 2024, FDA will need to start scaling back the
existing program capabilities as COVID supplemental funding runs out.
Question. How does FDA view shortages in medical devices from a
national security perspective?
Answer. Medical product supply chains are critical to U.S. national
security, and preventing shortages and interruptions depend, in part,
on FDA having the resources and the authorities to establish a
proactive supply chain program to prevent these problems from happening
before they occur, particularly in the face of global threats and
cybersecurity attacks. Simply stated, health security is national
security.
The nation's continued dependence on China for critical devices and
the raw materials and components used to manufacture them is one of the
largest threats to health security and infrastructure. This was evident
during the early phases of the pandemic, China held products hostage
and did not allow the U.S. to get them out of that country. There also
continue to be cybersecurity threats that could force manufacturers to
go offline.
In order to build a strong healthcare structure that is resilient
to these national security challenges, FDA needs the resources to have
visibility into the supply chain and get information as early as
possible. The Agency also needs critical authorities, including the
removal of the temporal limitation of ``during, or in advance of'' a
public health emergency for notifications of manufacturing disruptions
to the FDA. Additionally, FDA needs the authority to require
manufacturers to maintain and share Risk Management Plans.
Having a proactive system and information to help better understand
vulnerabilities and risks, and to work with manufacturers to prevent
potential supply chain shortages before harm comes to patients and
healthcare providers strengthens national security.
Question. The infant formula crisis the country experienced
highlighted the importance of moving away from a few large
manufacturers to allowing smaller facilities more capacity. How is FDA
working with smaller infant formula companies to expand their capacity?
Answer. Recognizing the importance of a resilient and diversified
supply chain, FDA has taken numerous steps to help all producers,
regardless of size, have the ability to access and support the U.S.
market for infant formula. In May 2022, to help address the infant
formula shortage, FDA issued the ``Guidance for Industry: Infant
Formula Enforcement Discretion Policy''\1\ to describe considerations
for firms and formulas entering the market temporarily under FDA's
exercise of enforcement discretion. During the initial period of
enforcement discretion, when supply chain concerns were at their peak,
FDA developed webpages about the new formulas that were entering the
market under FDA's exercise of enforcement discretion, with information
about how to safely switch to those formulas, if needed. Subsequently,
in September 2022, FDA issued the ``Guidance for Industry: Infant
Formula Transition Plan for Exercise of Enforcement Discretion''\2\ to
outline a path for interested firms marketing products in the U.S.
under the exercise of enforcement discretion to bring those products
into compliance with all U.S. requirements to facilitate longer-term
availability of those products in the market.
---------------------------------------------------------------------------
\1\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-infant-formula- enforcement-discretion-
policy
\2\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-infant-formula- transition-plan-exercise-
enforcement-discretion
---------------------------------------------------------------------------
Additionally, FDA hosted multiple webinars in autumn 2022 to
support infant formula firms interested in marketing their products in
the U.S., including those marketing as part of the transition plan and
new market entrants more generally. Topics of the webinars included:
the Infant Formula Transition Plan guidance, FDA's requirements and
recommendations for new infant formula submissions, protein efficiency
ratio (PER) studies, and growth monitoring studies (GMS). Following
these webinars, in February 2023, FDA issued ``Draft Guidance for
Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to
Demonstrate that a New Infant Formula Supports the Quality Factor of
Sufficient Biological Quality of Protein,'' \3\ with more information
relating to a key component of a new infant formula submission. Most
recently, FDA has announced two additional webinars to be held on
Wednesday, May 24, 2023, and Wednesday, June 7, 2023, to provide
stakeholders with information on regulatory requirements and
considerations for infant formula ingredients and packaging.
---------------------------------------------------------------------------
\3\ https://www.fa.gov/regulatory-information/search-fda-guidance-
documents/draft-guidance-industry-protein- efficiency-ratio-rat-
bioassay-studies-demonstrate-new-infant-formula
---------------------------------------------------------------------------
More broadly, on March 28, 2023, FDA published the Immediate
National Strategy to Increase the Resiliency of the U.S. Infant Formula
Market.
---------------------------------------------------------------------------
*ERR14*\3\ The strategy describes immediate actions FDA took to
address the shortage and details the Agency's plans for improving the
resiliency of the infant formula market, while noting multiple issues
that are beyond the purview of FDA. The immediate strategy represents a
first step toward issuing, with input from the National Academy of
Science, Engineering and Medicine, a long-term national strategy in
2024 to improve preparedness against infant formula shortages by
outlining methods to improve information-sharing, recommending measures
for protecting the integrity of the infant formula supply chain, and
preventing contamination. The longer-term strategy will explore new
approaches to help facilitate entry of new infant formula manufacturers
to increase supply and mitigate future shortages and assess whether
additional regulatory authorities are needed to gain insight into the
supply chain and risks for shortages.
\4\ https://www.fda.gov/food/infant-formula-guidance-documents-
regulatory-information/immediate-national- strategy-increase-
resiliency-us-infant-formula-market
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*ERR14*Question. Can you update the Committee on FDA's efforts
ensure such a crisis never happens again?
Answer. FDA has taken a great number of measures to reduce the
potential of a similar incident occurring in the future. However, it
should be noted that it is not possible to completely prevent all
outbreaks, and the infant formula industry remains concentrated in the
U.S. Further, the industry ultimately has the primary responsibility to
produce safe, nutritious, and high-quality infant formula.
Since February 2022, the Agency has had ongoing and extensive
engagement with the infant formula industry to identify and implement
opportunities to strengthen preventive control practices and engage on
the development and refinement of the FDA's Strategy to Help Prevent
Cronobacter sakazakii Illnesses Associated with Consumption of Powdered
Infant Formula (released November 15, 2022). FDA food safety experts
have engaged with industry, state, international, and other partners
to: explore environmental factors that may contribute to contamination
in facilities; review issues related to specific foodborne hazards to
identify potential mitigation measures or knowledge gaps; review
regulations to identify provisions that may be strengthened; identify
prevention measures that can be taken to reduce future incidences of
foodborne illness; and identify knowledge gaps to expand our
understanding of food safety issues and limit recurrences of underlying
root causes responsible for contamination.
Already, the Agency is seeing actions advanced through the
prevention strategy that will help to prevent recurrence of
contamination. FDA food safety experts have advanced a charge through
the National Advisory Committee on Microbiological Criteria for Foods
(NACMCF) to gain scientific insight on possible industry and public
health interventions to address Cronobacter infections associated with
powdered infant formula. In addition, the Agency has engaged with the
National Academy of Science, Engineering and Medicine (NASEM) to
examine and report on challenges in the supply, market competition, and
regulation of infant formula in the U.S.
Furthermore, on March 28, 2023, FDA published an immediate national
strategy\5\ to increase the resiliency of the U.S. infant formula
supply chain, protect against future contamination and other potential
causes of shortages, and ensure parents and caregivers have access to
infant formula and the information they need. The strategy describes
immediate actions FDA took to address the shortage and details the
Agency's plans for improving the resiliency of the infant formula
market, while noting multiple issues that are beyond the purview of
FDA. It also traces the events that led up to and followed the
voluntary recall of infant formula by Abbott Nutrition in February
2022, the temporary pause in production at the Abbott Nutrition
facility in Sturgis, Michigan, as well as numerous other factors that
contributed to and exacerbated the shortage. The immediate strategy
represents a first step toward issuing, with input from NASEM, a long-
term national strategy in 2024 to improve preparedness and explore new
approaches to help facilitate entry of new manufacturers to increase
supply and mitigate future potential shortages.
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\5\ https://www.fda.gov/food/infant-formula-guidance-documents-
regulatory-information/immediate-national- strategy-increase-
resiliency-us-infant-formula-market
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To specifically ensure the issues encountered at Abbott Nutrition's
Sturgis, MI, facility will not be repeated, FDA negotiated a consent
decree with Abbott Nutrition, which was entered by the U.S. District
Court for the Western District of Michigan on May 16, 2022. This
consent decree requires Abbott to take steps necessary to safely
produce infant formula in close coordination with FDA and under our
oversight of its manufacturing and food safety processes. More broadly,
FDA is committed to conducting surveillance food safety inspections of
all infant formula manufacturers at least annually and to use remote
regulatory assessments, as needed. Work is also underway to
significantly expand and improve infant formula training for
investigators and other appropriate staff to ensure every infant
formula inspection is robust, thorough, and focused on the most
critical aspects of the infant formula manufacturing process.
FDA is also working to monitor the infant formula supply and supply
chain to assess general market health and current and future demand,
and identify potential signs of production and supply chain challenges
by analyzing industry production data, in-stock rates, sales data, and
information on key supply chain characteristics. Much of the work on
infant formula will be coordinated through the creation of a new Office
of Critical Foods responsible for oversight, coordination, and other
activities related to critical foods, which is defined to include
infant formula and medical foods. FDA will continue to build on these
efforts throughout FY 2023 as a result of $7.5 million in additional
funding provided by Congress for infant formula-related activities.
This is enabling the Agency to hire 16 new full-time equivalents (FTE)
in the Center for Food Safety and Applied Nutrition. FDA's FY 2024
request contains an additional $21 million to further expand its work
in this area.
However, the infant formula industry needs to take its
responsibility to produce safe food more seriously. FDA has reviewed
conditions during recent inspections of powdered infant formula
manufacturers and has identified numerous areas for improvement across
the infant formula industry. The Agency outlined these areas for
improvement in a March 8, 2023, letter, which was a call to action for
all members of the infant formula industry to help protect our most
vulnerable population by, among other things, evaluating established
systems of production and in-process controls and ensuring that
appropriate controls are implemented at any point, step, or stage in
the production process where control is necessary to prevent
adulteration of infant formula. In addition, the infant formula
industry is now required to establish and implement risk redundancy
plans to minimize the impact of any future disruptions in production.
Industry must ensure they are producing formula consistent with high
U.S. food safety standards and maintaining their facilities so recalls
and shutdowns are minimized.
Question. The recent White House National Strategy on Hunger,
Nutrition, and Health highlighted the need to empower consumers to make
healthier food choices. The budget is requesting an additional $12
million to strengthen the FDA's work on nutrition and labeling. Can you
detail how this additional funding will be used?
Answer. The additional requested funding of $12 million, which
includes 19 FTE, will be used to enhance and strengthen the nutrition
and labeling work performed by FDA. This includes the development of a
standardized, science-based, front-of-package labeling scheme that
would help consumers, particularly those with lower nutrition literacy,
quickly and easily identify foods that can help them build a healthy
dietary pattern. Front-of-package labeling would complement the
Nutrition Facts label by displaying simplified, at-a-glance nutrition
information and giving consumers additional context to help them
quickly make more informed food selections.
FDA will also continue to examine the use of the nutrient content
claim, ``healthy,'' in food labeling to ensure that it aligns with
current nutrition science and the Dietary Guidelines for Americans. FDA
will continue its rulemaking effort to update the nutrition criteria
for when the ``healthy'' nutrient content claim can be put on a
product, which will help to provide consumers with information to make
more informed dietary choices. FDA will also continue its work to
develop a symbol companies can use on food packages to depict the
nutrient content claim, ``healthy.'' In addition, FDA will work to
finalize a guidance on using Dietary Guidance Statements on food
labeling in order to help consumers understand how a particular food
can contribute to a healthy eating pattern. Additional funding will
also go towards advances in e- commerce, such as gathering additional
public input to inform a possible guidance for the food industry on
nutrition, ingredient, and allergen information that should be
available for groceries sold online.
FDA will also assess progress in reducing sodium in processed
packaged and prepared foods and begin the process to develop revised,
voluntary sodium reduction targets as part of the Agency's broad and
continued approach to facilitating the reduction of sodium intake, as
outlined in the White House National Strategy. In October 2021, the
Agency issued voluntary, short-term (2.5 year) sodium reduction
targets. The request will support FDA in finalizing a regulation that
will provide companies with additional flexibility in the use of safe
and suitable salt substitutes in standardized foods, for which salt is
an optional or required ingredient, giving industry additional tools to
produce foods lower in sodium content.
Question. The Drug Supply Chain Security Act (DSCSA) of 2013
established a uniform, interoperable framework for tracing
pharmaceutical products throughout the supply chain. On the DSCSA's
final implementation deadline of November 27, 2023, supply chain
trading partners will be required to provide and receive serialized
transaction data along with serialized product upon a change of
ownership. The supply chain is at a critical point and it appears that
industry may not be fully ready which could lead to supply chain
challenges.
The pandemic brought to light many issues in the drug supply chain.
To this day we still struggle with shortages of drugs including
Adderall and Albuterol, among others. If the DSCSA is not properly
implemented, it could cause more shortages. Is the FDA concerned about
drug shortages if product is not able to move through the supply chain?
Answer. The DSCSA program is critical to improve the detection and
removal of potentially dangerous drugs from the supply chain and help
protect patients from receiving a drug that may be counterfeit, stolen,
contaminated, or otherwise harmful. The Agency has heard from trading
partners and other stakeholders about implementation challenges,
particularly related to data and data exchange issues, and concerns
that not everyone in the supply chain will have their systems and
processes in place to meet the November 2023 requirements. FDA
considers all stakeholder concerns and examines all available
regulatory options to minimize the chance of supply chain disruptions.
Question. If manufacturers aren't ready, how will that affect
pharmacies and patients?
Answer. FDA has heard that while there has been industry progress
towards enhanced drug distribution security requirements, stakeholders
are concerned about the current status of readiness of trading partners
in the supply chain and implementation challenges. Stakeholders
indicated that some of these challenges may lead to supply chain
issues, potentially affecting the distribution and availability of
certain prescription drugs. The Agency is actively continuing
stakeholder outreach and engagement on these issues. In addition, FDA
will be conducting a small dispenser assessment that will examine
necessary software and hardware accessibility, and the cost to obtain,
install, maintain, and integrate them into business practices. The
assessment will help FDA identify and consider compliance challenges
faced by small dispensers (i.e. small pharmacies).
______
Questions Submitted by Senator Tammy Baldwin
Question. How is the agency considering the widespread concern from
consumers, farmers and producers over FDA not enforcing dairy standards
of identity?
Answer. FDA establishes food standards of identity to promote
honesty and fair dealing in the interest of consumers, and this remains
an Agency priority. The Agency recognizes that there has been
significant development and commercial activity in the area of plant-
based alternatives to traditional food products, including plant-based
beverages labeled with names that include the terms of dairy standards
of identity, such as ``milk.'' In February 2023, FDA issued a draft
guidance\6\ entitled ``Labeling of Plant-Based Milk Alternatives and
Voluntary Nutrient Statements.'' This draft guidance explains that,
while plant-based milk alternatives are not permitted to be offered for
sale as ``milk,'' the use of the term ``milk'' as part of the name of
plant- based milk alternatives does not mean that such products are
represented as ``milk'' as defined in FDA regulations. The draft
guidance also provides recommendations for labeling plant-based
beverages with additional nutrition information to help consumers
compare these products to milk and make informed dietary choices.
Empowering consumers with nutrition information they can use to
identify healthier choices more easily is a priority under FDA's
Nutrition Initiatives. FDA is interested in hearing from stakeholders
and encourages all interested persons to submit comments to the draft
guidance docket by July 31, 2023.
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\6\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/draft-guidance-industry-labeling- plant-based-milk-
alternatives-and-voluntary-nutrient-statements
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Question. How will these concerns be implemented into the final
Guidance for Industry: Labeling of Plant-Based Milk Alternatives and
Voluntary Nutrient Statements?
Answer. On May 1, 2023, FDA reopened the public comment period for
90 more days to allow additional time for interested persons to develop
and submit comments to the draft guidance. The deadline for comments is
July 31, 2023. The Agency welcomes comments on any aspect of the draft
guidance. This topic is of great interest to a variety of stakeholders
with differing perspectives and FDA anticipates receiving useful
information from comments. All comments, data, and research timely
submitted to the docket will be reviewed and considered before
beginning work on a final guidance.
Question. How does the FDA plan to evaluate animal feed additives
with environmental claims, such as those intended to target enteric
methane emissions, in a safe and timely manner?
Answer. FDA understands Congress's and stakeholders' interest in a
robust and timely pathway for environmentally beneficial products to
enter the market for use in animal food.
The Federal Food, Drug, and Cosmetic Act sets the regulatory
paradigm to which products used in animal food are subject. Articles
(other than food) intended to affect the structure or function of the
body of an animal are drugs under the Act. Some products with
environmental claims, such as those non-nutritive substances that
affect an animal's function to reduce methane emissions, meet the
definition of a drug.
FDA remains engaged with Congress and stakeholders to consider
potential solutions. The Agency is also considering alternative
approaches for the regulation of these products in the absence of
legislation. In the interim, FDA is working with sponsors to identify
alternative pathways to market, where appropriate, on a case-by-case
basis.
Question. The FDA is now 19 months past a court ordered deadline to
finish its review of e- cigarette applications, and 8 months past a
deadline set by Congress to review applications of synthetic nicotine
products. Unauthorized vaping products remain on the market. Why have
these products been allowed to stay on the market, and what is the
current backlog of applications?
Answer. FDA continues to make significant progress on reviewing
applications despite their sheer volume and the rapidly evolving
tobacco product landscape. To date, FDA has received premarket tobacco
product applications for 26 million products, the vast majority of
which are for e- cigarettes, and has successfully completed its review
of 99 percent of them. This includes one million applications for non-
tobacco nicotine products, including synthetic nicotine--for which FDA
has successfully completed review of 99.5% of applications. FDA has
been working diligently to ensure we are processing applications as
quickly as possible while also ensuring the decisions are
scientifically accurate, legally defensible, and aligned with the
authorities granted by Congress.
FDA has been clear that all new tobacco products on the market
without the statutorily required premarket authorization are marketed
unlawfully and are subject to enforcement by FDA. We will continue to
closely monitor the marketplace and take compliance and enforcement
actions on a case-by-case basis according to our enforcement priorities
and the individual circumstances. Compliance and enforcement actions
include: warning letters, civil money penalties, seizures, and
injunctions, among others. Importantly, FDA does not have independent
litigation authority. Therefore, we work with the U.S. Department of
Justice (DOJ) to inform our enforcement actions. The DOJ must evaluate
the legal risks of pursuing particular actions and decide whether to
litigate cases on our behalf.
Question. On April 26, 2022, the Director of the Center of Drug
Evaluation and Research testified under oath at a Senate HELP Committee
hearing that ``The Center for Drugs currently does not have a contract
with McKinsey and across FDA. [W]e anticipate that further contracts
will not be issued pending the outcome of the investigations.'' This
followed a 2022 congressional investigation that found that at least 22
McKinsey consultants worked for both FDA and opioid manufacturers on
related topics, including at the same time. Can you confirm that over
the last year, McKinsey has not been hired by the FDA and will not be
hired in the future?
Answer. FDA does not have any active contracts with McKinsey. Due
to rules governing competition, it would be inappropriate to comment on
future plans absent an explicit prohibition or debarment of McKinsey.
The Federal Acquisition Regulation (FAR), particularly Part 6,
prescribes policies and procedures to promote full and open competition
in the acquisition process.
______
Questions Submitted by Senator Joe Manchin
Question. The enriched enrollment or EERW process has made it
significantly easier for the FDA to approve opioids and allow for broad
marketing to the public. The process removes patients with pre-existing
opioid sensitives from clinical trials, instead of sticking with
traditional double-blind studies. This has skewed results and seriously
underestimates risks associated with the proposed drug involved in the
clinical trial.
The External Report of FDA Regulations of Opioid Analgesics notes
that ``there are several limitations of EERW design that warrant
additional consideration for opioid[s]''.
--Will the FDA commit to following the recommendations of the report
and hold another Advisory Committee meeting focused on FDA's
use of enriched enrollment for opioid approvals?
Answer. The Agency understands your concern with enriched
enrollment randomized withdrawal (EERW) trials. As you know, the Agency
recently held an Advisory Committee meeting with the Drug Safety and
Risk Management Advisory Committee to review EERW trial design.\14\
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\14\ April 19, 2023: Meeting of the Anesthetic and Analgesic Drug
Products Advisory Committee Meeting Announcement and Materials
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The Agency is reviewing the discussion from the Advisory Committee
and if there is further need to obtain independent expert advice on
scientific, technical, and policy matters related to EERW design FDA
will at that time consider the need for an additional Advisory
Committee meeting regarding EERW design.
Question. The Fiscal Year 2022 Consolidated Appropriations report
included language directing the FDA to ``conduct a study to review EERW
study designs used in the approval of new prescription opioids for
chronic pain.'' This study is intended to specifically look at the use
of EERWs use to approve new opioids. Will the FDA commit to completing
this study?
Answer. As noted in Question 1, the Agency is conducting an ongoing
review of the use of EERW trial design. An element of the review was
the Advisory Committee held on April 19th, 2023.\15\
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\15\ April 19, 2023: Meeting of the Anesthetic and Analgesic Drug
Products Advisory Committee Meeting Announcement and Materials
---------------------------------------------------------------------------
Question. I introduced the FDA Accountability for Public Safety Act
to ensure Advisory Committees are properly used. Specifically, if a
Committee votes against approval and you decide to go against this
vote, you must submit a report to Congress that includes the medical
and scientific evidence to justify its approval. How will the FDA
ensure Advisory Committee discussions are clear and transparent?
Answer. FDA's advisory committee meetings are conducted in
accordance with the Federal Advisory Committee Act, which requires that
timely notice of advisory committee meetings be published in the
Federal Register, that the meetings generally be open to the public,
and that records of all meetings be maintained and available to the
public, subject to limited exceptions. To that end, and to be as
transparent as possible, FDA maintains a public website for each of its
advisory committees that includes agendas, presentation materials,
minutes, and transcripts of all meetings of the committee. FDA's
advisory committee meetings can also be viewed live via webcast and
when meetings are held on FDA's campus or at other locations, members
of the public and press are able to attend in person. Advisory
committees make non-binding recommendations to the FDA, which generally
follows the recommendations, but is not legally bound to do so. The
available science and data guide the Agency's decisionmaking.
Question. Between November 2021 and November 2022, the CDC reported
that over 78,000 people died of an opioid related overdose. While we
know opioids can be prescribed with legitimate prescriptions to treat
pain, we also know that even with prescriptions, opioids can kill.
These pills kill via respiratory depression, essentially, they make you
go to sleep and forget to breathe. However, we do know of several non-
opioid treatments to treat pain that don't result in respiratory
depression. What is the FDA doing to speed up approval of non-opioid
treatments for pain?
Answer. Addressing the overdose crisis continues to be one of FDA's
top public health priorities, and the Agency agrees that there is still
much work to do as deaths from drug overdoses remain at historically
high levels. One of FDA's four Overdose Prevention Priorities under our
Overdose Prevention Framework \16\ is supporting primary prevention by
eliminating unnecessary initial prescription drug exposure and
inappropriate prolonged prescribing. A key activity under this priority
is the development of novel, non-opioid pain therapies, which the
Agency believes will ultimately help prevent new cases of overdose and
reduce deaths. FDA is committed to doing its part to help spur this
development. To support such developments, the Agency recently
published draft guidances titled ``Development of Non-Opioid Analgesics
for Acute Pain''\17\ (February 2022) and ``Development of Local
Anesthetic Drug Products With Prolonged Duration of Effect'' (March
2023). These guidances are intended to assist sponsors in the
development of alternatives to opioids for the management of pain.
Additionally, FDA is developing a guidance for industry on the
development of non-addictive medical products for the management of
chronic pain, as stated on the 2023 CDER guidance agenda.
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\16\ https://www.fda.gov/drugs/drug-safety-and-availability/food-
and-drug-administration-overdose-prevention- framework
\17\ Development of Non-Opioid Analgesics for Acute Pain
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Questions Submitted by Senator John Hoeven
Question. In fiscal year (FY) 2023, Congress provided $5 million in
new funding to implement an FDA-wide New Alternative Methods (NAMs)
Program with the goal of advancing the development, qualification, and
implementation of NAMs for product testing. It is important that the
funds are used to provide regulatory clarity to sponsors and the
community as to what constitutes a ``regulatory-grade'' NAM. Please
provide an update on the implementation plan for the NAMs program.
Answer. FDA appreciates that Congress provided $5 million in new
funding in FY 2023 to implement an FDA-wide New Alternative Methods
(NAMs) Program. With dedicated resources for alternative methods, FDA
is beginning to implement a program to evaluate the suitability and
validity of these methods to best inform the Agency's regulatory
decisionmaking process. Centrally coordinated and managed by FDA's
Office of the Chief Scientist, this core program focuses on
establishing cohesive and comprehensive strategies to advance the
development, qualification, and implementation of NAMs for regulatory
use. The program broadens and complements longstanding work led by FDA
Centers and Offices, including specific programmatic objectives such as
expanding capacity to qualify alternative methods and filling
information gaps with applied research to support new policy and
guidance development.
The FY 2024 President's Budget builds on the FY 2023 Budget by
requesting an additional $1.5 million in funding within the Office of
the Chief Scientist to further support the NAMs Program by providing
strategic coordination, implementation, and oversight, as well as to
develop a qualification process to assess NAMs for regulatory use.
As follow up to a presentation for the Science Board to FDA at its
June 2022 meeting,\7\ the Agency is working to establish a Science
Board subcommittee that will be charged with continued discussion on
the topic of NAMs and will look to consider the board's recommendations
as part of the overarching efforts for continued progress. The Agency
is also assessing its current activities to identify capabilities,
critical gaps, and potential actions that could be taken to continue
and enhance ongoing efforts to advance development and adoption of
alternative methods.
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\7\ https://www.fda.gov/advisory-committees/committees-and-meeting-
materials/2022-meeting-announcement- science-board-fda-06142022
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Question. It is my understanding that Canada just updated their
Listeria monocytogenes (Lm) policy and continue to base their policy on
whether foods support or do not support growth of the pathogen. Will
FDA also incorporate a risk-based approach that is reflective of the
current scientific evidence?
Answer. FDA is developing three guidance documents on the following
topics:
--The Agency's enforcement policy for Listeria monocytogenes (Lm) in
foods.
--Classifying food as ready to eat (RTE) or not ready to eat (NRTE).
--Control of Listeria monocytogenes in RTE foods.
In the development of these documents, FDA is considering updated
scientific information, including current thinking regarding the
enforcement policy for foods based on whether foods support the growth
of Lm. All three documents are a priority for FDA, and the CPG and
guidance on classifying food as RTE or NRTE are on FDA's 2023 ``Foods
Program Guidance Documents Under Development.''8 The Agency's goal is
to issue Listeria policies that are grounded in the best available
science, protective of public health, and practical for industry to
implement.
8 https://www.fda.gov/food/guidance-documents-regulatory-
information-topic-food-and-dietary-supplements/foods- program-guidance-
under-development
Question. The Reagan-Udall Foundation evaluation on the tobacco
program raised significant questions about the lack of a cohesive plan
at the Center for Tobacco Products (CTP), finding, ``the lack of
clarity about CTP's direction, its priorities and its near-term and
longer-term goals and objectives, hinders CTP's ability to effectively
carry out its mission establish efficient programs to accomplish its
goals and objectives, and set appropriate metrics to assess outcomes.''
For fiscal year (FY) 2024, the President's budget requests a $100
million increase for tobacco user-fees. How would this additional
funding be employed, and does the agency have a plan to address the
issues raised in the Reagan-Udall Foundation's Evaluation Report?
Answer. FDA welcomed the opportunity for the independent external
review by the Reagan-Udall Foundation and is committed to addressing
all the recommendations outlined in its evaluation report as
expeditiously as possible. In February 2023, FDA announced the Center
for Tobacco Products' (CTP's) plans for addressing the
recommendations.\9\ FDA also developed a new webpage\10\ describing
CTP's activities to address the recommendations, by topic area, that
will be updated routinely to reflect progress.
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\9\ https://www.fda.gov/tobacco-products/ctp-newsroom/all-center-
approach-ctps-response-reagan-udall-foundation- evaluation-report
\10\ https://www.fda.gov/tobacco-products/about-center-tobacco-
products-ctp/actions-address-recommendations- reagan-udall-evaluation-
ctp
---------------------------------------------------------------------------
A key recommendation of the report was that CTP create and
implement a new strategic plan that identifies the Center's strategic
objectives and plots an operational roadmap of the steps CTP will take
over the next 5 years to achieve those objectives. Development of the
strategic plan commenced in February 2023, and will build upon prior
strategic plans the Center has created and implemented since its
inception. For the new strategic plan, CTP will engage with both
internal and external stakeholders during development. We anticipate
release of the plan no later than December 2023.
The Reagan-Udall Foundation report also specifically recommended
that ``additional resources should be sought, particularly to provide
some parity among the tobacco sectors assessed under user fees for the
Center's work.'' Currently, FDA is only authorized to assess user fees
on tobacco products that fall within six product classes.\11\ The
authorized collection amount is fixed and is not indexed to
inflation.\12\ FDA believes that an additional $100 million in user
fees, indexed to inflation, represents an appropriate increase in
resources to ensure comprehensive regulation of the changing tobacco
product marketplace. An additional $100 million will enable FDA to
expand much-needed activities for the newly regulated products, with
three-quarters of the additional resources being dedicated to
compliance and enforcement and product review; the remaining resources
would be allocated to scientific research, regulation and guidance
development, and public education.
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\11\ Per section 919 of the Federal Food, Drug, and Cosmetic Act,
these six classes are: cigars, pipe tobacco, cigarettes, snuff, chewing
tobacco, and roll-your-own tobacco. FDA does not currently have
authority to assess and collect user fees for ENDS products.
\12\ Section 919 authorizes the total amount of user fees FDA must
assess and collect each year. For the first 10 years of the FDA tobacco
program, the total amount of user fee collections increased each year.
Beginning in FY2019, the authorized amount is fixed at $712 million.
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Question. The issue of access to compounded hormones remains a
concern for millions of patients who rely on access to compounded
therapies. In response to a question for the record I posed last year,
the agency cited the National Academies of Sciences, Engineering, and
Medicine's (NASEM) report stating, ``FDA intends to consider the
information in the NASEM report.'' The FDA did not mention any other
scientific studies on this topic in its response.
Will FDA review all relevant stakeholder comments and consider
additional peer-reviewed scientific studies as part of the agency's
review of the NASEM report and its recommendations?
Answer. When developing Agency policies, FDA intends to consider
all relevant information, including the NASEM report and stakeholder
comments and submissions, while taking into account patient access
concerns. Moreover, before implementing a new policy, the Agency
generally provides an opportunity for public comment, whether the
policy is announced through a draft guidance, Federal Register Notice,
or proposed rulemaking.
As background, compounded ``bioidentical hormone replacement
therapy'' (cBHRT) products are not FDA-approved, which means these
products have not undergone an FDA assessment of safety, effectiveness,
or quality prior to marketing.
To help inform the public and the FDA's policies regarding cBHRT,
the Agency entered into an agreement with the National Academies of
Sciences, Engineering, and Medicine (NASEM) to convene an ad hoc
committee to conduct a study on the clinical utility of cBHRT drug
products. The committee also reviewed which populations may benefit
from the use of these preparations and considered whether the available
evidence supports their use to treat patients. The committee issued its
report, ``The Clinical Utility of Compounded Bioidentical Hormone
Therapy,'' on July 1, 2020.\13\
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\13\ https://www.nationalacademies.org/our-work/clinical-utility-
of-treating-patients-with-compounded-bioidentical- hormone-replacement-
therapy
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Reports published by NASEM aim to provide independent, objective
expert advice. With regard to cBHRT, NASEM held six open session
meetings for the Committee on Clinical Utility of Treating Patients
with Compounded Bioidentical Hormone Replacement Therapy. According to
NASEM, these meetings provided an opportunity for the committee to
gather data and contextual information from relevant BHRT compounders
and BHRT medical professionals.
The NASEM report discusses some of the uncertainties of the
potential benefits and safety risks associated with the use of these
compounded products. FDA believes the results of NASEM's research
provide important information that will increase public understanding
regarding cBHRT products.
______
Questions Submitted by Senator Susan M. Collins
Question. Clinical Holds. I wanted to follow up on the issue of
clinical holds, which I raised during the hearing. Clinical holds can
be an important and appropriate tool for the Agency to utilize when a
potential concern with an application has surfaced, but they are not a
substitute for timely, constructive, and clear communication to
sponsors. Further, when clinical holds are imposed for an ongoing
development program, there should be urgency brought to resolving it.
The anecdotal evidence suggests that the review process for cell
and gene therapy is becoming more protracted, and I am concerned that
the lack of face-to-face meetings may be negatively affecting the FDA's
ability to keep pace and retain its scientific and regulatory stature
as the gold standard.
How many clinical holds have been issued in the past year? What
percentage of cell and gene therapy applications have been subject to a
clinical hold? Please include whether the Agency either sought or
granted live meetings to discuss and potentially resolve the Agency's
questions that led to the clinical hold.
Answer. Of the 262 cell and gene therapy Investigational New Drug
applications (INDs) received in calendar year 2022, 54 (20.6%) were
placed on clinical hold in the initial 30 days after receiving the
application. The Center for Biologics Evaluation and Research (CBER)
and the Center for Drug Evaluation and Research (CDER) began accepting
requests for in-person, face-to-face industry meetings on February 13,
2023, for certain meeting types. As such, no in-person, face- to-face
meetings were held for INDs put on clinical hold within CY 2022.
However, throughout that time, FDA has continued to hold ``live''
meetings (e.g., via teleconference) when appropriate.
It is important to note that the likelihood an IND application will
be allowed to proceed is related to the quality and completeness of
each IND section (Chemistry, Manufacturing and Controls (CMC),
Pharmacology and Toxicology (P/T), and Clinical), whether all the
identified safety risks are adequately addressed, and whether the
sponsor provides timely responses to Agency information requests. There
may be additional challenges encountered by the review team during the
review of an original IND, which may include:
--Grossly inadequate or missing sections of the IND for CMC, P/T or
Clinical review.
--Inadequate donor eligibility information.
--Inclusion of a device (e.g., delivery device, companion
diagnostic), human factors study, or combination product
classification that requires a consultative review(s) from
another Center. Based on our experience, oftentimes such
inclusions are inadequately or poorly addressed in submissions.
--Requirement for clinical subspecialty review from another Center.
--Cross reference of a Master File or IND in another product Office
within the Center or another Center, requiring a consultative
review.
FDA remains committed to working with all sponsors to resolve
issues and help speed development of new products, while maintaining
high, scientifically based safety and efficacy standards.
Question. Written Responses. I remain interested in the Agency's
progress towards restoring face-to-face (FTF) meetings with sponsors
and relying less on Written Response Only (WRO) communications. While I
am pleased that FDA announced on January 30, 2023, that is was
restoring some FTF meetings, the Agency has not expanded the FTF option
for all types of meetings. The opportunity for critical discussion and
meaningful scientific exchange are diminished under a WRO. FDA needs to
preserve WRO as a tool for routine exchanges and clarifying responses
to sponsors, but should otherwise be working to restore live options
for most types of meetings and requests.
What is the current timeline for full restoration of FTF
interactions across each meeting type?
Answer. The Agency understands the desire to conduct face-to-face
(FTF) meetings. There are three formats for formal meetings with FDA,
namely FTF (can be either in-person or virtual), Teleconference, and
Written Response Only (WRO). As noted, WROs are one of these meeting
formats and are an important and efficient tool under the appropriate
circumstances. For each meeting request, the Agency carefully considers
the specific questions posed by the drug developer, as well as the
context (e.g., stage of development, product complexity, clinical
indication and unmet need). When the Agency expects that our responses
will be straightforward (e.g., referral to content of a specific
guidance document) or will reiterate points made in previous
discussions with the sponsor, then FDA has commonly provided written
responses. When the questions are complex, for example with a product
that raises new scientific questions, or an innovative trial design,
the Agency has been more likely to offer a FTF meeting via
videoconference or in-person.
While WROs have been and will continue to be an important tool, FDA
has continued to hold ``live'' meetings (e.g., discussion via
teleconference or virtual face-to-face) with sponsors and applicants
over the past 3 years for any meeting type when appropriate. The
announcement on January 30 provided new information about the
reintroduction of in-person FTF meetings, which were precluded during
the pandemic. The reintroduced in-person FTF meetings (which will
include a hybrid component to allow broader participation) will
continue to expand until all meeting types are included.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. Over a million patients a day use medical gases under the
supervision of healthcare professionals across the country. We
congratulate the FDA for releasing a notice of proposed rulemaking for
medical gases on May 23, 2022. However, the FY 2017 Consolidated
Appropriations Act required a final rule to be issued by July 15,
2017--nearly 6 years ago. The public comment period ended on August 23,
2022 and FDA received a total of 4 public comments on the proposed
rule. I was dismayed to see in the Fall 2022 Unified Agenda that FDA
had put the rulemaking on the backburner, listing it as a long-term
action with a projected publication date of October 2024. That means
FDA is projecting it needs 29 months to respond to four public comments
to finalize the medical gas rulemaking.
It is deeply frustrating that the subcommittee is being told--six
years after a statutory deadline--that it will be another year before
FDA issues a final rule on medical gases. The FY 2023 Joint Explanatory
Statement requires the FDA to produce quarterly reports on progress
until the final rule is published. We would rather have the final rule
rather than make you produce more reports. Can you commit to this
Committee that you will accelerate the final rule and publish it in
2023?
Answer. FDA is working in earnest to finalize and publish the
medical gas final rule by the projected publication date, but we cannot
guarantee publication on a given timeline because certain aspects of
the rulemaking and clearance process are outside of FDA's control. This
rulemaking is large and complex because it is intended to address a
wide range of topics and is anticipated to include changes to existing
regulations as well as the addition of entirely new regulations.
Developing this rule has also required coordination across numerous
Agency components, given the range of subjects involved, including
labeling, current good manufacturing practice, certification, and
safety reporting. In making changes based on the comments we received
to the proposed rule, we must also ensure that any revisions do not
create issues for other regulatory areas. We would be happy to provide
updates, as appropriate.
______
Questions Submitted by Senator Deb Fischer
Question. Feed additives can include enzymes, vitamins, and
minerals that help livestock to increase feed efficiencies and reduce
environmental impact. However, slow approvals prevent advancements in
these additives and their benefits. Can you discuss how additional
resources in the past few years have helped the Center for Veterinary
Medicine speed up the review process?
Answer. FDA received an additional $5 million in FY 2020 and an
additional $1 million in FY 2022 for animal food ingredient reviews,
which allowed the Center for Veterinary Medicine (CVM) to successfully
hire more staff and improve timeliness for pre-market review of
multifaceted and innovative new animal food ingredients. The animal
food ingredient industry is rapidly evolving and submissions of
innovative new animal food ingredients have become more complex and
contain more scientific data for CVM to analyze. Since receiving these
increased resources, FDA has increased its on-time rate from 44% of
reviews to 73% of reviews this past year, all while moving over twice
as many reviews through the system. Additionally, CVM's Office of
Surveillance and Compliance underwent a reorganization in 2022 to more
fully align its resources and work, which included establishing the
Division of Animal Food Ingredients (DAFI). All 36 FTEs in DAFI are
focused on work related to the pre-market review of new animal food
ingredients, which includes reviewing new submissions, developing
policy, evaluating science, and administering functions associated with
the pre-market animal food ingredient processes.
Question. I also understand the Center for Veterinary Medicine is
working to update their policy manual to better address innovative new
products in the feed industry. How is that going and are there other
items that the Center for Veterinary Medicine is doing to improve the
animal food ingredient review process?
Answer. CVM is reviewing its Policy and Procedures Manual (PPM)
Guide 1240.3605, Regulating Animal Foods with Drug Claims, in part to
keep pace with innovative uses of substances in food for animals. In
October 2022, the Center held a public listening session to gain
stakeholder input on potential changes resulting from this review.
Substances that benefit animal production, the environment, human food
safety, or the animal's microbiome, and positively impact animal
agriculture are a part of the discussions as to the best way to
regulate them to ensure safety, effectiveness, and provide innovative
products to animal producers.
At this point in FDA's evaluation, the Agency believes it will
issue an updated Guidance for Industry. However, it should be noted
that evaluating claims about the effects of food ingredients will
increase the workload for the ingredient review staff and new claims
will also present the need for new expertise for their evaluation. To
prepare for the anticipated additional workload, CVM continues to
update and streamline operating processes and procedures. CVM is also
engaging and training the animal food industry on effective ways to
submit data to expedite the review process.
Question. In the FY24 Budget Request, you noted that FDA will
develop a standardized system to help consumers quickly and easily
identify foods that are part of a healthy eating pattern. FDA will also
make sure ``healthy'' labeling aligns with current nutrition science
and the Dietary Guidelines for Americans with a proposal to update the
nutrition standards for when ``healthy'' claims can be put on products,
and will also develop a symbol to be used to depict and easily
communicate a food as ``healthy.'' Can you discuss what coordination
has been done with USDA in regards to the healthy label? Specifically,
how would meat products under USDA labeling jurisdiction be treated by
FDA's proposed rule?
Answer. The proposed rule developed by FDA was shared with USDA,
which reviewed it and engaged with FDA throughout the clearance
process. FDA carefully considered USDA's input before publishing the
proposed rule. The proposed rule only applies to foods subject to FDA's
labeling regulations. This includes the meat products that are
regulated by FDA, specifically game meat and seafood. Meat and poultry
products under USDA jurisdiction are subject to the regulations set
forth by USDA. However, the definitions for nutrient content claims for
FDA and USDA are typically identical or very similar due to our inter-
departmental collaborative efforts.
Question. What assurances has the agency provided to food
manufacturers to avoid potential lawsuits for being out of compliance
with the updated ``healthy'' definition during the proposed compliance
period after a new definition is updated?
Answer. Even after any new requirements for the definition of the
nutrient content claim ``healthy'' are in effect, manufacturers may
begin to comply with the new requirements or they may continue to use
the old definition of ``healthy'' until the compliance date arrives.
FDA notes that manufacturers would not be required to comply with
requirements of the final rule until the compliance date. The Agency
has proposed an effective date 60 days after the date of publication of
the final rule in the Federal Register, with a proposed compliance date
3 years after the effective date. This timeframe would provide industry
time to revise labeling to come into compliance with the new
requirements.
SUBCOMMITTEE RECESS
Senator Heinrich. With that, this hearing is adjourned.
Dr. Califf. Thank you.
Senator Heinrich. [Whereupon, at 3:14 p.m., Wednesday,
April 19, the subcommittee was recessed, to reconvene subject
to the call of the Chair.]
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2024
----------
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
NONDEPARTMENTAL WITNESSES
[The following testimonies were received by the
Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies for inclusion in the
record. The submitted materials relate to the fiscal year 2024
budget request for programs within the subcommittee's
jurisdiction.]
Prepared Statement of the Alliance for a Stronger FDA
The Alliance for a Stronger FDA thanks the subcommittee for its
continuing support of the Food and Drug Administration (FDA). The
resources you have provided FDA serve the American people, assure a
safe food supply and help deliver safe and effective medical products.
We support the Administration's request for $3.914 billion in BA
funding for FDA in fiscal Year 24. As you evaluate the merits of this
request, we ask that you keep these three thoughts in mind:
FDA has a uniquely difficult mission while providing a core
function of government:
--Few (if any) Federal agencies have a broader range of
responsibilities than the FDA.
--No Federal agency's mission and responsibilities are more affected
by changes in science, technology, innovation, commerce, and
social trends than the FDA.
FDA needs more resources each year because of its expanding mission
and growing responsibilities:
--Increased complexity and progress in science, technology, and
innovation;
--Continued growth of FDA-regulated industries, including
globalization;
--FDA's responsibilities regularly increase, including with unfunded
mandates; and
--Likelihood of unexpected public health and scientific needs/
challenges every year
FDA's mission and responsibilities are incredibly consequential and
visible:
--Every day, thousands of tasks are completed successfully and
uneventfully by the FDA.
--FDA's dedicated employees (largely unseen) devote millions of hours
each year to successfully maintaining FDA's high standards for
safe food and safe and effective medical products.
--Problems should be addressed; often that requires additional
resources and authorities.
background
The Alliance for a Stronger FDA includes 150 stakeholder
organizations that advocate for FDA resources commensurate with its
growing responsibilities. Our members are consumer and patient groups,
research advocates, health professional societies, trade groups,
companies, and individuals.
We believe that the primary beneficiary of FDA's activities is the
American public. Accordingly, it is critical that the public remains
the largest source of FDA funding.
Our request for fiscal Year 24 funding focuses exclusively on
appropriations that come from monies paid by taxpayers (BA) and
intentionally does not include user fees and mandated funding (e.g.,
Cures monies transferred from the National Institutes of Health).
However, we urge Congress to fully fund those programs, as well.
FDA's jurisdiction includes responsibility for more than 80 percent
of the food supply and all drugs, medical devices, biologics, vaccines,
veterinary food/medicine, dietary supplements, and cosmetics.
Altogether, the agency oversees products that represent 20 percent of
all consumer spending ($2.8 trillion) and touch the American public
multiple times each day.
Because the FDA's mission continues to grow and its vital
activities have become more sophisticated and complex, the Alliance
supports the Administration's budget authority (BA) request of $3.914
billion for FY24. This provides for an increase of $366 million in BA
salary and expenses (S&E) and an increase of $6 million in BA buildings
and facilities (B&F).
The Alliance encourages FDA to increase transparency and
accountability in its use of funding.
fda needs funding to meet 21st century challenges
We support strengthening the scientific capabilities of FDA
throughout the five Centers, ORA, NCTR, and the Office of the
Commissioner. This includes personnel capable of conducting FDA's
ongoing responsibilities while looking for innovative ways to meet
future demands. To support science-based decision-making and keep up
with innovation in both food and medical products, the FDA needs more
scientific and technical staff, and better analytical tools.
The growing complexity of science, interwoven with new advances in
technology, is a challenge across the agency. In food safety, this
means the use of artificial intelligence, whole genome sequencing, and
enhanced electronic recordkeeping that will contribute to a safer food
supply. In medical products, this means new tools to evaluate medical
products that incorporate cell and gene therapy, digital health,
artificial intelligence, and real-world evidence. Addressing
cybersecurity concerns is a priority.
areas of need and opportunity
The Administration's request, which the Alliance supports, has four
components, to which we have added the Alliance's comments.
enhancing food safety, nutrition and cosmetics
--$128.2 million in investments in food safety and nutrition
modernization, including food labeling and animal food safety
oversight. While the agency is in the process of defining its
future vision for the Human Foods Program, there is significant
need for additional resources to strengthen its foundational
food safety and nutrition capacity.
Alliance comment: The fiscal Year 24 FDA budget request places a
strong emphasis on strengthening food and nutrition programs. The
request is based on needs-based assessments made last summer and
represents steps that can and should be supported in fiscal Year 24.
Priorities should include: more robust and rapid implementation of
the Food Safety Modernization Act (FSMA); a strong start on initiatives
in the agency's New Era of Smarter Food Safety; finalization of
guidances; a focus on produce safety, import safety, and training/
education; enhanced funding of systems for surveillance of foodborne
illnesses and outbreak response; and strengthening the scientific
capabilities of CFSAN/CVM/NCTR.
FDA's BA appropriation should include increased support and
predictability for the agency's extremely valuable cooperative
relationships with State and local regulatory programs (including
public health laboratories).
--$5 million toward modernizing oversight of cosmetics. The budget
includes new funding for the development of regulations,
compliance policies, product registration and listing
platforms, adverse event reporting and other activities.
Alliance comment: This past December, Congress passed The
Modernization of Cosmetics Regulation Act of 2022, a major overhaul of
the regulation of cosmetics, amending a law that was passed in 1938.
There is no money in the fiscal Year 23 (current year) appropriation to
pay for implementation. The President's request for $5 million in
fiscal Year 24 is a good start. Congress should recognize that more
money will be needed.
advancing access to safe and effective medical products
--$23 million in additional funds to advance the goal of ending the
opioid crisis. Funding will support broader development of
treatments for substance use disorders and enhance regulatory
oversight, expand compliance, enforcement, and laboratory
support.
--$11.6 million increase toward improving the medical device supply
chain and shortage programs. The agency will continue to build
its capabilities to ensure patients have access to medical
devices at all times.
--$2.5 million to implement ACT for ALS to foster development of
treatments for ALS and other rare neurodegenerative diseases.
To help the FDA implement the ACT for ALS Act.
Alliance comment: These proposed investments are responses to
important problems, and we support the Administration's request for
each. The medical device supply chain is especially pressing. The
request for ACT for ALS responds to newly enacted legislation and
reflects the particular difficulties in evaluating treatments for
neurodegenerative diseases.
We expect that FDA will be continuing a number of similar medical
products initiatives funded in prior fiscal years, including programs
targeted at advanced manufacturing, outsourcing, real-world evidence,
compounding, generics, and rare diseases.
reigniting cancer moonshot
--$50 million to advance the President's Cancer Moonshot goals. This
funding will advance the President's Cancer Moonshot.
Alliance comment: Our nation's investment in prevention, diagnosis,
treatment, and cure of cancer has produced remarkable advances. FDA
plays an essential role as the intermediary between research and
clinical practice. With more funding, FDA will be able to do more to
improve the outlook for cancer patients and their families.
strengthening public health and mission support capacity (agency-wide
impact)
--$10 million in further investments in enterprise data and IT
modernization. The budget will expand data exchange
capabilities and underlying technology platforms to better meet
the challenges of the FDA's programs and mission-critical
responsibilities.
--$16 million for regulatory and mission support functions within the
Office of the Commissioner. These resources will enable the FDA
to provide the appropriate crosscutting strategic direction,
policy coordination, and business services to ensure that the
FDA's programs operate effectively, efficiently, and are well
coordinated.
--$9.4 million for FDA buildings, facilities, and infrastructure
improvements. The budget includes additional funding to help
ensure that the FDA's offices and laboratories across the
country are secure, modern, reliable, and cost-effective.
--$105.3 million for cost-of-living salary increases for fiscal Year
23 and fiscal Year 24.
Alliance comment: Science-based decision making requires
infrastructure, integrated databases, and program coordination.
Investments in these areas have not kept pace with the agency's needs.
We earlier commented on the challenges of recruiting and maintaining a
scientific workforce. Paying for the salary increases outright, rather
than subtracting them from existing programs, is an important budgeting
advance.
conclusion
We urge Congress to recognize the multiple opportunities for FDA to
be a more effective protector of public health, as well as a fair and
efficient regulator. Additional investment in FDA will result in
substantial added value to the American public.
The Alliance again thanks the subcommittee for its support of the
agency and looks forward to working with Members of Congress and staff
on fiscal Year 24 appropriations for FDA.
[This statement was submitted by Steven A. Grossmanm, Executive
Director, Alliance for a Stronger FDA.]
______
Prepared Statement of American Brain Coalition
Chair Heinrich and Ranking Member Hoeven, on behalf of the (ABC)
thank you for the opportunity to submit testimony in support of our
request for $3 million in Fiscal Year 2024 funding for the Neurology
Drug Program at the Food and Drug Administration (FDA).
My name is Dr. Matthew Rizzo, I am a physician, a researcher, a
neurologist, and a professor. I am also a husband, son, father, and
friend. I sincerely appreciate the opportunity to submit this testimony
on an issue of great professional interest and great personal
importance to me and so many other Americans.
I currently serve as the Frances & Edgar Reynolds Chair & Professor
of the Department of Neurological Sciences, Director of Neurosciences
Services, and Co-Director of the Center for Integrative and
Translational Neuroscience at the University of Nebraska Medical
Center, as well as Director of the National Institutes of Health/
National Institute of General Medical Sciences Great Plains IDeA-
Clinical and Translational Research network. I received my medical
training at Johns Hopkins University School of Medicine and completed
my residency in Neurology and fellowship in Behavioral Neurology and
Cognitive Neuroscience at the University of Iowa. Prior to joining the
University of Nebraska Medical Center, I served as a Professor of
Neurology at the University of Iowa College of Medicine; Vice Chair of
Transitional and Clinical Research, Department of Neurology at the
University of Iowa College of Medicine, and as the Director of the
Aging Brain and Mind Initiative at the University of Iowa. They do
research and provide care for patients with memory disorders,
particularly focusing on addressing behavioral consequences of aging
and neurological disorders.
I am also honored to serve as the Chair of the American Brain
Coalition (ABC). The ABC is a nonprofit organization comprised of
nearly 150 of the Nation's leading professional neurological,
psychological, and psychiatric associations and patient organizations.
Together, the ABC seeks to advance the understanding the brain and
reduce the burden of brain disorders for the millions of Americans who
suffer from diseases affecting the brain and central nervous system
(CNS).
We are grateful that Congress first funded the Neurology Drug
Program in fiscal Year 2023. This initial funding will allow FDA to
gain the expertise to develop policies and guidance that keep pace with
emerging brain science. We look forward to the resulting advances from
the Neurology Drug Program that encompass all areas of brain health
including neurodevelopmental, neurodegenerative, psychiatric, brain
injuries and more.
Brain diseases, including neurological, psychiatric, and CNS
disorders, impose staggering personal and financial costs on Americans.
Nearly one in five U.S. adults live with a mental illness.
Neuropsychiatric disorders are also the leading cause of disability in
the Nation, making up 18.7 percent of years lost to disability and
premature death.\1\ Neurological conditions are troublingly prevalent
as well--twenty million Americans suffer from a neurological condition,
with 16 percent of households including an individual with a brain
impairment.\2\ Brain and CNS diseases also harm older Americans, with
more than one in nine people over age 65 having Alzheimer's
dementia.\3\
---------------------------------------------------------------------------
\1\ Office of Disease Prevention and Health Promotion, Mental
Health and Mental Disorders, at: https://www.healthypeople.gov/2020/
topics-objectives/topic/mental-health-and-mental-disorders.
\2\ S. Pal, Incidence and Prevalence of Major Neurologic Disorders.
US Pharm, at: https://www.uspharmacist.com/article/incidence-and-
prevalence-of-major-neurologic-disorders
\3\ Alzheimer's Association, Facts and Figures, at: https://
www.alz.org/alzheimers-dementia/facts-figures.
---------------------------------------------------------------------------
The enormous personal costs of brain and CNS conditions also
translate to financial hardship for patients and their families and
burden the U.S. economy. Brain disorders and diseases cost the U.S.
more than $1.5 trillion per year,\4\ a significant portion of which is
borne by the Medicare program. Seven of the twenty-one chronic
conditions tracked by the Centers for Medicare & Medicaid Services are
related to the brain, representing an average annual cost of $23,325
per Medicare beneficiary--higher than the average cost for all other
chronic conditions.\5\
---------------------------------------------------------------------------
\4\ Information Technology & Innovation Foundation, A Trillion-
Dollar Opportunity: How Brain Research Can Drive Health and Prosperity,
at: http://www2.itif.org/2016-trillion-dollar-opportunity.pdf?--
ga=2.209915987.77733799.1607703298-1777725734.1607703298.
\5\ Center for Medicare & Medicaid Services Chronic Conditions
Utilization/Spending State Level: All Beneficiaries 2017. The average
per capita spending for a chronic condition is $22,099.
---------------------------------------------------------------------------
The high prevalence of these diseases means that nearly every
family in the U.S. has either personally experienced a brain disease or
watched a loved one struggle with the effects of diseases like
substance use disorder, schizophrenia, multiple sclerosis, Alzheimer's
disease, and hundreds of other diseases that impact the brain.
Despite the prevalence and impact of these diseases, few effective
treatments are available for many brain diseases and disorders. While
product development is difficult for any condition, treatment
development for brain disease is uniquely challenging. In particular:
--Clinical trials for brain and CNS conditions fail more often and
are frequently more costly than clinical trials for other
conditions.\6\
---------------------------------------------------------------------------
\6\ J.A. Dimasi, CNS drugs take 20 percent longer to develop and to
approve vs. non-CNS drugs. Tufts Center for the Study of Drug
Development.
--Brain-targeting drugs, devices, and other therapeutics reviewed by
the FDA are approved at a much lower rate than those for other
disease areas, with one recent study finding that the mean
approval phase time for CNS compared to non-CNS was an
astonishing 57 percent longer.\7\
---------------------------------------------------------------------------
\7\ See Bio, Clinical Development Success Rates and Contributing
Factors 2011-2020, at: https://www.bio.org/clinical-development-
success-rates-and-contributing-factors-2011-2020; J.A. Dimasi, CNS
drugs take 20 percent longer to develop and to approve vs. non-CNS
drugs. Tufts Center for the Study of Drug Development.
--A recent report indicated that the probability of a drug
successfully making its way through a Phase 1 clinical trial to
the point of approval is only 15 percent for brain and CNS
treatments -compared to 32 percent for ophthalmology, 25
percent for cardiovascular problems, and 25 percent for
infectious disease.\8\
---------------------------------------------------------------------------
\8\ C. Heem Wong, et al. Estimation of clinical trial success rates
and related parameters. Biostatistics, kxx069.
These delays compound the fact that not enough treatments exist--
every extra expense and every delay means more time that our families,
friends, and neighbors suffer from the frequently debilitating effects
of these diseases.
The lack of safe and effective treatments for brain disease is
particularly frustrating given the incredible neuroscience discoveries
made in the past decade. In addition to private investment, robust
public investment in the National Institutes of Health (NIH) and the
BRAIN Initiative, we are building the knowledge base that will allow us
to finally deliver treatments to patients that need them.
Ambitious engineers hope to extract human consciousness and put it
in artificial processors able to hold the experience and unique
processing capacity that form our individuality. The sheer number of
brain cells (about 200 million, half of them neurons) and connections
(up to 10,000 per neuron), and ignorance of relevant systems science
and minimal requirements to generate any kind of consciousness, put
this dream out of reach so far.\9\ Others hope to understand the
restorative capacity of the brain and the potential to regenerate,
replace and integrate elements as they die, or to delay the demise of
neurons so that they last as long as our bodies last. These approaches
include attempts to delay mental decline before it becomes clinically
significant through increased mental and physical activity and caloric
restriction.
---------------------------------------------------------------------------
\9\ https://www.nimh.nih.gov/news/science-news/2021/nih-brain-
initiative-unveils-detailed-atlas-of-the-mammalian-primary-motor-cortex
---------------------------------------------------------------------------
For example, ongoing work aims to discern and delay different
phases of Alzheimer's disease (AD), associated with declines in
vasculature, lipid metabolism, and neurotransmitters. Phases of decline
preceding cell death in AD and related disorders are biochemical,
cellular, and clinical, and may antedate diagnosis by decades. The
biochemical phase begins decades before the cellular phase, which in
turn begins years before clinical diagnosis. AD builds up slowly, long
before it becomes clinically apparent and does not simply ``happen''
all at once, later in life. Understanding these early phases of a
disease that devaStates so many older Americans is critical. Early
diagnosis could allow early intervention to halt disease progression in
its tracks, before it is too late to matter.
To respond to the unique challenges in the discovery and
development of treatments for brain disease, and allow more
neuroscience discoveries to directly benefit patients, it is vital that
the Federal Government prepare the brain-specific regulatory tools and
guidelines needed for fast, well-structured, transparent, and
predictable product review. To support this aim, ABC and the brain
community are advocating for Congress to increase funding for the
Neurology Drug Program at the FDA. This program would allow FDA to
develop policies and guidance that keep pace with emerging brain
science. By appropriating the necessary resources dedicated to meet the
challenges I have outlined, FDA will be positioned to issue guidance
and eventually bring safe and effective brain-targeting treatments to
market.
A problem like brain disease requires a focused, urgent response
that takes seriously the incredible burden borne by patients who often
face poor prognoses and have access to too few treatments. Every day
that a safe and effective treatment for a brain disease or disorder is
delayed unnecessarily is another day that millions of patients suffer
from potentially debilitating diseases. ABC urges the subcommittee to
provide $3 million in fiscal Year 2024 to for the Neurology Drug
Program to provide better guidance to researchers and product
developers for detection and treatment of neurological disorders.
Thank you for the opportunity to provide this testimony. The ABC
looks forward to continuing this dialogue and identifying creative
solutions to bring more treatments and cures to patients with
neurological and psychiatric disease.
[This statement was submitted by Matthew Rizzo, MD, FAAN, Chair,
American Brain Coalition.]
______
Prepared Statement of American Commodity Distribution Association
On behalf of the American Commodity Distribution Association
(ACDA), I respectfully submit this statement regarding the FY 2024
budget request of the Food and Nutrition Service for inclusion in the
Subcommittee's official record. ACDA members appreciate the
Subcommittee's support for these vital programs.
ACDA members involved in school food programs and household
programs continue to do all that they can to provide USDA Foods in a
variety of settings. We have dealt with supply chain challenges,
different demands across different programs, and concerns about the
potential for increased needs particularly in household programs in the
coming year.
We continue to thank our partners at the Agricultural Marketing
Service and the Food and Nutrition Service who have responded using the
authorities available to them. We also continue to maintain the
specific concerns we have regarding donated food support for both
schools and food banks. While efforts are being made to return to
``normal'', it is a transition. Food prices have not returned to
``normal'', and are a significant problem. We continue to ask that you
fully fund administrative expense funding for TEFAP at $100 million;
provide the requested $390,000,000 for the Commodity Supplemental Food
Program (CSFP) to maintain the current caseload and to allow for
requested expansion; and to increase funding for the school food
equipment grant program.
ACDA is a non-profit professional trade association, dedicated
since 1974 to the growth and improvement of USDA's Commodity Food
Distribution Program. ACDA members include state agencies that
distribute USDA-purchased foods; agricultural organizations; industry;
associate members; recipient agencies, such as schools and soup
kitchens; and allied organizations, such as anti-hunger groups. ACDA
members this past year distributed more than 3 billion pounds of
domestically produced commodities this past year to programs including
the National School Lunch and Breakfast Programs, the Emergency Food
Assistance Program, the Summer Food Service Program, the Commodity
Supplemental Food Program, and the Child and Adult Care Food Program.
usda foods face challenges
ACDA supports the budget request of $468,752,000 for the purchase
of TEFAP commodities and supports the Secretary's ability to procure
additional foods as needed using the authority of the Commodity Credit
Corporation (CCC). The $517,000,000 in FY 2022 bonus commodities was
very helpful in meeting the needs faced by food banks, and we urge the
Subcommittee to monitor available food supplies to recognize that both
bonuses and supplemental funding may be needed to meet needs. We are
anticipating a higher demand on food banks with the loss of higher SNAP
benefits.
As we have done previously, we highlight section 4205 of the
Agricultural Act of 2014 which established a multiagency task force to
evaluate and monitor the commodity programs to ensure that they meet
the mission of the Department. There has not been such a report in the
past year, so we urge the Subcommittee to direct the prompt provision
of such a report, and to include both food vendors and recipient
agencies to secure their views.
We also ask the Subcommittee to solicit a study on the impact of
fees on USDA Foods utilization in the National School Lunch Program. We
also urge the Subcommittee call for a study on the challenges faced by
rural and remote schools face including the absence of distributors,
the complexity of deliveries, and their smaller scale.
nutrition standards going forward
In February FNS published its proposed rule establishing school
meal nutrition standards for SY 2024-2025 and beyond. The public
comment period is open through April 10, and ACDA has urged the
Secretary to extend the comment period given the significance of this
proposed rule. ACDA will submit comments reflecting our members' views,
and will continue to work on this issue.
As we said last year, ACDA supports responsible meal standards that
provide quality meals to students. Any such rule should meet standards
of affordability, availability, acceptability, and administrative
achievability. The ability to offer a quality school meal program is
directly linked to the ability to pay the costs associated with the
program's operation. Any more stringent nutrition standard needs to be
both realistic and phased in over time. The Department should keep in
mind the challenges that manufacturers face in developing new products,
the costs associated with a schedule of revising products to meet
standards, and the challenges that school food authorities face in
providing nutritious meals that are desired by students. It is
important that the dialogue encouraged by comments on the rule proceed
so that meaningful and measured action can be achieved.
fully fund tefap administrative funds at $100 million
ACDA strongly supports the President's proposal to fully fund TEFAP
Administrative Funds at $100 million. ACDA has consistently urged full
funding and appreciates the level of support provided by the
Subcommittee in the past. Food banks are making every effort to control
costs, but operating expenses are increasing further demonstrating the
justification for full funding.
As we have told the Subcommittee in the past, food banks, Community
Action Agencies, and other TEFAP operators continue to find that they
have had little choice but to convert food dollars to administrative
expense funds to maintain their operations. Using food dollars,
particularly when programs face higher food costs, for operating
expenses reduces the ability of these operators to provide food
assistance to more individuals and families who continue to face
difficult times.
school food equipment grants
ACDA supports increasing School Food Equipment Grants to $35
million, an increase of $5 million over the budget request, and opposes
the proposal to decrease School Breakfast Equipment Grants by
$3,000,000. The ability to provide quality meals is directly linked to
school food equipment. Many more school food authorities need this type
of assistance, meriting expanding these programs and not reducing them.
ACDA continues to support emphasizing the importance of fruits and
vegetables in all forms--fresh, canned, dried, and frozen--as noted in
the 2020-2025 Dietary Guidelines for Americans. However, we remain
concerned about mandating not just what children are offered in school
meals but what they must take, whether they intend to eat it or not.
Increasing flexibility to program sponsors in planning menus that meet
high nutrition standards but still are within cost targets is of
critical importance and will help reduce waste resulting from this
mandate.
buy american
ACDA appreciates the efforts of America's farmers and ranchers to
provide wholesome product for various feeding programs, in addition to
the important role they make in supporting American consumers.
Producers continue to see product coming into the United States that
disrupt domestic sales and result in the need for Bonus Buys. Buy
American provisions are included in the proposed school meals standard
rule. ACDA continues to stand by the recommendations we made last year.
First, ACDA urges FNS to work to reduce the administrative burden of
repetitive exemption forms. State agencies need better guidance to
permit longer-term exemptions when supply issues are well known.
Second, help clarify what products should/should not be sold to School
Food Authorities (SFAs) while supporting domestic suppliers that
provide our most essential needs. Third, exemptions of commodity
reprocessed products sold in the National School Lunch Program (NSLP)
and School Breakfast Program (SBP) would benefit both processors and
Recipient Agencies by reducing audit paperwork while supporting
domestic farmers and industry stakeholders. Fourth, FNS should provide
guidance and best practices to vendors/distributors, particularly
national and multi-state operations, as to how to identify the point of
origin on products being offered for sale. Fifth, several SFAs have
limited options when it comes to vendors who are willing to supply
their programs. FNS should consider some type of incentive program for
vendors to provide supplies to limited-service areas which could
provide additional competition that would help both with price and
product availability.
ACDA thanks the Subcommittee for its support over the years and
looks forward to continuing to work with you as the FY 2024
Appropriation moves ahead.
[This statement was submitted by Noelle Sanchez, President,
American Commodity Distribution Association]
______
Prepared Statement of American Farm Bureau Federation
Chairman Heinrich, Ranking Member Hoeven and members of the
Committee:
On behalf of the American Farm Bureau Federation (AFBF), the
Nation's largest general farm organization, I commend the committee's
steadfast support of agriculture, our Nation's food supply, and the
well-being of rural America. The funding priorities for our
organization are outlined below.
AFBF supports increasing spending levels above FY23 enacted levels
for the following programs:
Agricultural Research: USDA's Agricultural Research Service,
National Institute of Food and Agriculture, including the Agriculture
and Food Research Initiative, Economic Research Service, and National
Agricultural Statistics Service which provide research, data, and
statistical analysis critical for addressing challenges faced by the
agriculture community.
Crop Protection: Office of Pesticide Management Policy, which
promotes the development of new pest management approaches and is
critical for crop protection. USDA's Minor Crop Pest Management Program
(IR-4) ensures safe and effective agrichemicals and biopesticides are
available for small, specialty crop markets.
Farm Programs: AFBF urges the committee to protect programs that
ensure U.S. farmers and ranchers are able to continue to produce food,
fiber and fuel as they battle high input prices, labor challenges, and
natural disasters. AFBF supports increased funding for risk management
tools, which include Federal crop insurance and commodity programs, as
well as Federal conservation programs, which preserve environmental
benefits. AFBF supports prioritizing working lands conservation
programs over retirement land programs. Additionally, increased funding
for the Farm Service Agency (FSA) loan guarantee programs will ensure
availability to farmers eligible under current authorities and the FSA
Agricultural Mediation Program.
In addition, adequate funding should be provided for personnel and
technology upgrades to effectively serve farmers and ranchers utilizing
these programs.
Food Safety: Increase funding for food protection at the Food and
Drug Administration and Food Safety and Inspection Service (FSIS)
directed to increase education and training of inspectors and other
relevant staff.
International Programs: The Market Access Program and the Foreign
Market Development Program to increase demand for U.S. agriculture and
food products in foreign markets. The McGovern-Dole International Food
for Education and Child Nutrition Program, which effectively delivers
both food aid and educational assistance. Public Law 480 programs,
which provide foreign food aid by purchasing U.S. commodities.
AFBF supports funding the following programs at the authorized
spending level:
Agriculture Advanced Research and Development Authority (AgARDA):
This pilot program was authorized in the 2018 Farm Bill to leverage
successful public-private partnerships to improve efficiency and
accelerate research and development in pursuit of overcoming long-term
and high-risk agricultural and food-related research and development
challenges.
animal health
--Animal and Plant Health Inspection Service (APHIS) Antimicrobial
Resistance Action Plan.
--The Veterinary Medicine Loan Repayment Program and the Veterinary
Services Grant Program, which allow veterinarians to ensure
animal health and welfare while protecting the Nation's food
supply.
--The National Animal Health Laboratory Network, which provides an
early warning system for emerging animal diseases.
--Section 1433 Continuing Animal Health and Disease, Food Security,
and Stewardship Research, Education and Extension Programs to
address critical priorities in food security, zoonotic disease
and stewardship.
--The FDA's Center for Veterinary Medicine, which oversees the safety
of animal drugs, feed, and biotechnology-derived products.
--The availability of foot-and-mouth disease vaccines to meet
emergency response requirements.
Biotechnology Promotion: APHIS' Biotechnology Regulatory Services,
if there are appropriate levels of congressional oversight, to ensure
APHIS' regulatory considerations are science- and risk-based,
transparent and predictable, while promoting innovation in plant
breeding and facilitating trade.
Expanding International Markets and Safeguarding U.S. Agriculture:
--The Foreign Agricultural Service, Emerging Markets Program and
Technical Assistance for Specialty Crops Program, all of which
increase demand for U.S. agriculture and food products abroad.
--APHIS Plant Protection and Quarantine personnel and facilities.
--APHIS trade issues resolution and management activities that are
essential for an effective response when other countries raise
sanitary and phytosanitary measures related to American
products.
--The U.S. Codex Office, which is essential to improving the
harmonization of international science-based standards for the
safety of food and agriculture products.
Farm and Ranch Stress Assistance Network (FRSAN): The Farm and
Ranch Stress Assistance Network provides stress assistance programs
that address the increasing financial and mental stress impacting
farmers and ranchers.
Food Safety and Protection Funding for the Food & Drug
Administration in the following areas:
--Implementation of the Food Safety Modernization Act;
--Additional science-based inspection, targeted according to risk;
--Effective inspection of imported food and feed products;
--Research and development of scientifically based rapid-testing
procedures and tools;
--Accurate and timely response to outbreaks that identify
contaminated products, remove them from the market and minimize
disruption to producers; and
--Indemnification for producers who suffer marketing losses due to
inaccurate government- advised recalls or warnings.
--Funding for USDA food protection programs in the following areas:
The National Antimicrobial Residue Monitoring System to detect
trends in antibiotic resistance in foodborne bacteria.
--The Food Animal Residue Avoidance Databank, through which
veterinarians establish science-based recommendations for drug
withdrawal intervals.
renewable energy
--Renewable Energy for America Program, which offers a combination of
grants and guaranteed loans for farmers to purchase renewable
energy systems.
--USDA's energy programs that improve the Nation's energy security
and economic development including: the Biobased Markets
Program, Biorefinery Assistance Program, Biomass Crop
Assistance Program, Biomass Research & Development Initiative,
Bioenergy Program for Advanced Biofuels, Biodiesel Fuel
Education Program, and Carbon Utilization and Biogas Education
Program.
strengthening rural communities
--Rural Utilities Service telecommunications programs, including the
ReConnect Loan and Grant Program the Distance Learning and
Telemedicine Program, and Community Connect Program which seek
to bring broadband to rural communities and improve access to
distance learning and telemedicine opportunities for rural
residents.
--Business and Industry Loan Program, Value-Added Producer Grant
Program, and the Rural Innovation Stronger Economy Program
which support business creation and growth in rural
communities.
--Community Facilities Direct Loan and Grant Program and Community
Facilities Loan Guarantee Program, which fund the construction
or improvement of essential community facilities.
--Agriculture in the Classroom which helps students gain greater
awareness of the role agriculture plays in the economy and
society.
Wildlife Services: Wildlife Services programs that prevent and
minimize wildlife damage, while protecting human health and safety from
conflicts with wildlife.
Thank you for your continued support for American agriculture. We
look forward to working with the subcommittee as the appropriations
process moves forward. Contact: Emily Buckman, Director, Government
Affairs, [email protected].
[This statement was submitted by Zippy Duvall, President.]
______
Prepared Statement of American Society for Microbiology
The American Society for Microbiology (ASM) appreciates the
opportunity to submit outside witness testimony for the Fiscal Year
2024 Agriculture appropriations bill in support of increased funding
for the Research, Education, and Economics research area.
ASM respectfully requests that Congress provide $4 billion for
research, education, and outreach at the U.S. Department of Agriculture
in Fiscal Year 2024. Specifically, we recommend
--$700 million for the Agriculture and Food Research Initiative
(AFRI),
--$1.9 billion for the Agricultural Research Service (ARS)
--$112 million for the National Bio and Agro-Defense Facility (NBAF),
--$100 million for the Advanced Agriculture Research and Development
Authority (AgARDA), and
--an increase of $85 million for antimicrobial resistance priorities
at USDA.
--$2.2 billion for the Animal and Plant Health Inspection Service
(APHIS)
ASM is one of the oldest and largest life science societies with
30,000 members in the U.S. and around the world. Our mission is to
promote and advance the microbial sciences, including programs and
initiatives funded by Federal Government departments and agencies, by
virtue of the integral role microorganisms play in human health and
society. Microbial science is a cross-cutting endeavor, and our
members' federally funded research is fundamental to advances in human
health, agriculture, energy, and the environment.
a strong investment in microbial research pays dividends
We thank Congress for its bipartisan support of agriculture
research and for its commitment to foundational microbiology research
at USDA. For every dollar invested in agriculture research, there is a
return on investment of $17. At one point in time, agriculture research
represented 4.3 percent of the overall non-defense research allocations
and appropriations for the Federal Government. Today, it is nearly half
that amount, which is concerning, considering Agricultural research is
the underpinning of all Titles within the Farm Bill.
ASM appreciates USDA's commitment to environmentally sound and
economically viable agricultural practices. As noted in the National
Academies report Science Breakthroughs to Advance Food and Agricultural
Research by 2030, further understanding of animal, soil, and plant
microbiomes will provide opportunities to improve crop production,
transform feed efficiency, and increase resilience to stress and
disease. To support these innovative technologies and practices, USDA
must increase investments in the microbial sciences.
Thanks to past investments in microbiology research through AFRI,
scientists are:
--Developing a voluntary framework for antimicrobial stewardship in
animals. This addresses a critical need, as widespread use of
antibiotics in animals and humans has led to increased
resistance and could render these medicines ineffective.
--Learning more about how soil and root microbiome can be altered to
improve plant productivity and soil health. This knowledge will
help ensure crop viability over the longer term.
--Studying the connection of the soil microbiome to human gut health
and related outcomes. This promising area of research will
become increasingly important as climate change alters crop
production and food availability.
--Learning more about the role that the bovine gut microbiome plays
in how cattle process feed. By deepening our understanding of
this complex ecosystem, scientists hope that better strategies
for sustainable beef production can be developed.
usda-funded research is needed to address climate change, antimicrobial
resistance, and food security
The challenges facing our Nation's producers and consumers are
growing. World food demand is expected to double in the next 25 years,
increasing the stress on the U.S. food and agricultural enterprise. In
addition, we continue to face a rapidly changing climate and
antimicrobial resistance (AMR), while recovering from the ongoing
pandemic and preparing for the next one. AMR is one of the most
daunting public health challenges facing the U.S. and the world. ASM
and its members are tackling AMR from a variety of angles-from health
care and clinical laboratory settings to agricultural and environmental
microbial research perspectives, in the U.S. and around the world. A
problem as complex as AMR requires multi-faceted approaches consistent
with the One Health model, recognizing that the health of people,
animals, and the environment are interdependent. Likewise, policy
solutions must be comprehensive and address AMR from multiple angles
and, when possible, with integrated strategies.
To combat AMR, we recommend an increase of at least $85 million for
antimicrobial resistance priorities at USDA, including a $25 million
increase in funding for the Animal and Plant Health Inspection Service
(APHIS) and the National Animal Health Laboratory Network (NAHLN). This
funding allows the agency to continue to promote agricultural
stewardship, including gathering and evaluating valuable information on
antibiotic use practices and identifying and characterizing injudicious
use on farms and other agricultural settings through the National
Animal Health Monitoring System (NAHMS) and other initiatives.
Tackling AMR will require increased investment in basic and applied
research into why microbes become resistant, how they persist in
ecological niches, and to develop novel countermeasures, including
continued support for Invasive Pest Emergencies and the National Animal
and Disease Preparedness and Response programs. This work also will
entail public-private partnerships through entities such as the
Advanced Research Projects Agency for Health and ideally its USDA
equivalent, AGARDA. Other policy approaches that are critical to
success include those that bolster AMR surveillance and laboratory
capacity, support programs dedicated to infection prevention and
control in healthcare and non-healthcare settings, policies to promote
access to AMR tools in low and middle resource countries that improve
diagnostics, microbiome modulators and antibiotic stewardship, and
broader application and integration of pathogen genomic sequencing
technologies.
Expanded funding for agricultural research including the National
Bio and Agro-Defense Facility through ARS will enable USDA
investigators and scientists to better protect the Nation's
agriculture, farmers and citizens against the threat and potential
impact of serious animal diseases and to understand the factors driving
the emergence of resistant pathogens, which are expected to become even
more common due to climate change. If we are to seize the current,
unparalleled scientific opportunities that exist in microbial research,
Congress must also support the deployment and use of technology and
practices to enhance microbial research data collection and utilization
to make our food and agricultural systems more efficient, resilient,
and sustainable.
As in human health, applications of the microbiome in animal health
are expanding rapidly, with exciting prospects for application in
domestic pets, farm animals, and conservation. Food production depends
on healthy microbiomes, and microbiome innovation can support the
agricultural sector as it works to meet the needs of a growing
population. To date, many studies have identified associations between
the microbiome, productivity, and management practices in various food
animal species; however, the specific organisms and metabolic pathways
involved remain to be determined. A coordinated effort to do so in the
main food producing animals could propel the industry to the next level
and support the pressing concerns of feeding the planet and combating
antimicrobial resistance.
Our nation's ability to meet the 21st century challenges of human
nutrition and food security, conservation of our Nation's resources,
and antimicrobial resistance will only be possible if Congress
continues its commitment to robust and sustained funding increases for
microbial, food, and agricultural research through AFRI, AgARDA, and
other USDA-funded research, education, and extension programs. ASM
recognizes the challenges facing our Nation and the difficult decisions
that must be made to ensure our Nation's fiscal health, and we believe
that funding cutting edge agricultural research will help our Nation's
farmers and ranchers succeed in the 21st century. Targeted acceleration
of innovative research through funding AgARDA, combined with meaningful
increases for USDA-funded research and FDA budget authority in fiscal
Year 2024 are essential for supporting microbial research to benefit
animal, human, and environmental health.
[This statement was submitted by Allen Segal, Chief Advocacy
Officer.]
______
Prepared Statement of American Society for Nutrition
The American Society for Nutrition (ASN) respectfully requests that
the U.S. Department of Agriculture (USDA)/National Institute of Food
and Agriculture/Agriculture and Food Research Initiative receive $550
million, and that the USDA/Agricultural Research Service receive $1.95
billion in fiscal year 2024. ASN has more than 8,000 members working
throughout academia, clinical practice, government, and industry, who
conduct research to advance our knowledge and application of nutrition.
agriculture and food research initiative
The USDA has been the lead nutrition agency and the most important
Federal agency to influence U.S. policies on dietary intake and food
patterns for years. Agricultural research is essential to address the
ever-increasing demand for a healthy, affordable, nutritious and
sustainable food supply. The Agriculture and Food Research Initiative
(AFRI) competitive grants program is charged with funding fundamental
and applied research, extension, and education in support of our
Nation's interconnected food and agricultural systems, which includes
human nutrition. AFRI has funded cutting-edge, nutrition research on
key issues of timely importance on a competitive, peer-reviewed basis
since its establishment in the 2008 Farm Bill.
ASN requests that AFRI be funded at $550 million in fiscal Year
2024, the same amount requested in the President's budget proposal.
$550 million would allow AFRI to support more competitive grants that
ensure a safe, sustainable, nutritious, affordable, adequate food
supply and bring AFRI closer to its fully authorized funding level of
$700 million/year. This funding level for AFRI is needed to invest in
crucial areas aimed at addressing our Nation's most urgent and pressing
food, agriculture, and public health challenges. AFRI-funded research
supports nutrition and wellness, equity across the food system, food
safety and traceability, supply chain resiliency, and a diverse
research workforce. Growing inflation and food insecurity have been
felt throughout the food and agriculture sector. However, AFRI is
uniquely suited to address many of these challenges through
transdisciplinary research, which allows researchers across disciplines
to examine issues in a systematic way rather than in silos. For
example, a total of $20 million is included in the AFRI budget proposal
to support the Cancer Moonshot efforts with funding for the Precision
Nutrition program at the National Institutes of Health (NIH). However,
despite incremental increases in AFRI funding, roughly 70 percent of
AFRI proposals that are deemed worthy by expert review panels are not
funded, simply because of insufficient funding. Agricultural and food
research funding at the USDA has unfortunately remained fairly flat
over the last fifty years.
Funding AFRI at $550 million in fiscal Year 2024 is critical to
provide a safe and nutritious food supply for the world's population,
to preserve the competitive position of U.S. agriculture in the global
marketplace, and to provide jobs and revenue crucial to support the
U.S. economy. Robust investment in USDA-supported research is also
needed to attract, retain, and develop the next generation of
scientists from diverse backgrounds to advance innovations benefiting
all Americans. In order to achieve those benefits, AFRI must be able to
support agricultural research and coordinate opportunities to build off
of these discoveries.
agricultural research service
The Agricultural Research Service (ARS) ensures high-quality, safe
food and other agricultural products; assesses the nutritional needs of
Americans; sustains a competitive agricultural economy; enhances the
natural resource base and the environment; and provides economic
opportunities for rural citizens, communities, and society as a whole.
ARS supports intramural and extramural research across four national
program areas including Nutrition, Food Safety and Quality. The ARS
Nutrition, Food Safety, and Quality National Program maintains a
healthy and safe food supply while improving the economic viability and
competitiveness of American agriculture. ASN requests that ARS receive
$1.95 billion in fiscal Year 2024 to ensure that ARS can respond to
food safety and nutrition security concerns, new plant and animal pests
and diseases, and weather-related and environmental stresses.
ARS's human nutrition research program includes six Human Nutrition
Research Centers (HNRCs) across the Nation that link producer and
consumer interests and form the core for building knowledge about food
and nutrition. HNRCs conduct unparalleled human nutrition research on
the role of food and dietary components in human health from conception
to advanced old age, and they provide authoritative, peer-reviewed,
science-based evidence that forms the basis of our Federal nutrition
policy and programs. HNRCs play an important role not only in
generating knowledge, but also in translating it for stakeholders.
Funding for ARS supports all of the USDA/HNRCs and ensures that these
research facilities have adequate funding to continue their unique
mission of improving the health of Americans through cutting-edge food,
nutrition and agricultural research. The President's budget request
seeks $1.979 billion for ARS and includes $41 to improve ARS buildings
and facilities.
Nutrition monitoring conducted by the USDA/ARS in partnership with
the Department of Health and Human Services (HHS) is a unique and
critically important surveillance function in which dietary intake,
nutritional status, and health status are evaluated in a rigorous and
standardized manner. ARS is responsible for food and nutrient databases
and the ``What We Eat in America'' dietary survey, while HHS tracks
nutritional status and health parameters. Nutrition monitoring findings
are essential for multiple government agencies, as well as the public
and private sector to track what Americans are eating, inform nutrition
and dietary guidance policy, evaluate the effectiveness and efficiency
of nutrition assistance programs, and study nutrition-related disease
outcomes. Because of past funding deficiencies, some food composition
database entries do not reflect the realities of the current food
supply, which may negatively impact programs and policies based on this
information. It is imperative that ARS continue to receive increased
support to update food and nutrient databases and to continue critical
surveillance of the Nation's nutritional status and the many benefits
it provides.
Thank you for the opportunity to submit testimony regarding fiscal
Year 2024 appropriations for the U.S. Department of Agriculture/
National Institute of Food and Agriculture/AFRI competitive grants
program and Agricultural Research Service. Please contact John E.
Courtney, Ph.D., Executive Officer, at [email protected] or 240-
428-3643, 9211 Corporate Boulevard, Suite 300, Rockville, MD 20850 if
ASN may provide further assistance.
[This statement was submitted by Martha A. Belury, PhD, RDN, 2022-
2023 President, American Society for Nutrition.]
______
Prepared Statement of the American Society for the Prevention of
Cruelty to Animals (ASPCA)
On behalf of The American Society for the Prevention of Cruelty to
Animals (ASPCA), the first humane organization in North America, and
our over 2 million supporters nationwide, thank you for the opportunity
to submit written testimony to the subcommittee. We ask that you please
consider the following provisions to benefit animal welfare as you
draft the FY2024 Agriculture Appropriations bill.
require aphis to properly enforce the animal welfare act
The USDA's Animal and Plant Health Inspection Service (APHIS)
continues to fail to enforce the Animal Welfare Act, despite having
adequate resources to do so. Rather than request additional funds for
the program to address problematic licensees and stop systemic animal
cruelty, the agency has proposed a decrease of $1.865 million and 32
FTEs for the program in FY2024. We are grateful that the enacted
Consolidated Appropriations Act, 2023 (Public Law 117-328) included
bill language preventing the use of funds for the non-recording of
observed violations of the AWA on inspection reports, finally ending
the agency's misguided ``Teachable Moments'' program, which allowed
non-compliant facilities to avoid having their violations recorded. The
House Agriculture Appropriations Report, which was incorporated into
the Joint Explanatory Statement by reference, also included a strong
directive to the agency to reform its licensing, inspection, and
enforcement scheme. However, despite this language, the agency
continues to fail to respond to violations of the law with appropriate
action, even in the worst cases. In early March 2023, Reuters published
a story revealing that high-ranking APHIS officials went to great
lengths to cover up ongoing AWA violations and animal suffering at the
beagle breeding and testing facility operated by Envigo in Cumberland,
Virginia-thwarting efforts by inspectors to intervene and alleviate the
suffering of thousands of dogs. The article includes details about
agency officials directing inspectors to delete content from their
reports, denying support for inspections to build a case against this
non-compliant licensee, and removing the team leader supervising the
investigation without explanation. This disturbing series of events
expose an agency that is more concerned about protecting licensed
businesses from repercussions than protecting animals. The ASPCA
requests that the subcommittee include the following bill language:
``Sec. X: None of the funds made available by this act or any other act
may be used to: (a) issue or renew the license of any licensed dealer
or exhibitor where agency personnel have previously recorded or
observed any violation of the Animal Welfare Act or its regulations,
other than administrative or record-keeping violations on inspection
reports; (b) conduct announced inspections (other than pre-license
inspections) or any announced ``courtesy'' or ``compliance'' visit; (c)
conduct any inspection of any dealer or exhibitor's facility without
the use of a body camera for all agency personnel present at the
inspection. The Secretary shall ensure that each inspection report and
all supporting records, including photographs and video recordings,
reflecting any violation of the law or regulations, other than
administrative or record keeping violations, are shared immediately,
and no later 24 hours after inspection, with State and local law
enforcement authorities of appropriate jurisdiction; (d) conduct more
than one pre-license inspection.'' Additionally, we request an increase
of $4,000,000 above the President's FY24 request for the Animal Welfare
program to ensure the proper enforcement of Federal standards, as well
as to cover the initial costs of body cameras for inspectors and the
necessary software to enable APHIS to share photographs and videos with
State and local law enforcement as necessary to assist with animal
cruelty investigations.
continue the current ban on federal funding for horse slaughterhouse
inspections
The Consolidated Appropriations Act, 2023 continues the
longstanding provision barring Federal funding for Food Safety and
Inspection Service (FSIS) inspections at domestic horse
slaughterhouses. Americans do not consume horse meat, we do not raise
horses for food, and national polling from 2021 \1\ indicates that 83
percent of American voters oppose the slaughter of horses for human
consumption. Cruelties associated with all stages of horse slaughter
are well-documented. Horses are at risk of suffering for prolonged
periods during transport to slaughter. Before this funding restriction
was in place, horses slaughtered in FSIS regulated plants endured
repeated blows, sometimes remaining conscious during dismemberment,
because the equipment used to slaughter horses is not designed for
their physiology.
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\1\ https://www.aspca.org/about-us/press-releases/new-research-
shows-overwhelming-majority-americans-oppose-horse-slaughter
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In addition to these intrinsic welfare concerns, consumption of
meat from American horses is a public safety gamble. A 2010 Food and
Chemical Toxicology Journal article detailed the ubiquitous use of
phenylbutazone in racehorses subsequently sent to auction and then to
slaughter only days after medication.\2\ Phenylbutazone is one of the
anti-inflammatory drugs most frequently administered to horses in the
United States regardless of discipline, and its use is prohibited for
animals raised for human consumption. Taxpayer dollars should not be
used to prop up an industry that disregards animal welfare and human
health. President Biden's FY24 Budget Proposal includes this
longstanding provision blocking Federal funding for horse
slaughterhouse inspections. The ASPCA requests that the subcommittee
continue the prohibition on Federal funding for domestic horse
slaughter by including the following bill language: ``None of the funds
made available by this or any other act in this or any fiscal year
hereafter may be used to pay the salaries or expenses of personnel- (1)
to inspect horses under section 3 of the Federal Meat Inspection Act
(21 U.S.C. 603); (2) to inspect horses under section 903 of the Federal
Agriculture Improvement and Reform Act of 1996 (7 U.S.C. 1901 note;
Public Law 104-127); or (3) to implement or enforce section 352.19 of
title 9, Code of Federal Regulations (or a successor regulation).''
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\2\ Dodman, N., Blondeau, N., Marini, A.M., ``Association of
Phenylbutazone Usage with Horses Bought for Slaughter: A Public Health
Risk.'' Food and Chemical Toxicology: May 2010.
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direct usda to report on costs and risks of animal depopulation
Concentrated Animal Feeding Operations (CAFOs) operate using a
``just in time'' model, meaning that CAFOs run according to a strict
timeline of animal rearing tied to specific slaughter dates at
predetermined slaughter facilities. Once one herd or flock is
transported off-site for slaughter, there is just enough time to prep
for the arrival of the next batch of animals. When an emergency occurs
and access to slaughter is reduced or eliminated, CAFOs are ill-
equipped to adjust and care for ``excess'' animals who can quickly
accumulate on farms. Without the space or resources to care for those
animals, they resort to ``intentional depopulation,'' which requires
killing entire flocks or herds of animals through various methods,
rather than through the regular slaughter process or humane euthanasia.
Some of the methods used to kill ``excess'' animals, like ventilation
shutdown, are particularly inhumane. To kill chickens and pigs using
ventilation shutdown, workers are forced to shut off barns' ventilation
systems--and often raise the heat--with animals sealed inside, where
they slowly die from overheating and suffocation. At this time, there
are no reporting requirements on the methods used to depopulate farm
animals. The ASPCA requests that the subcommittee include the following
bill language requesting a report on the current and future costs to
taxpayers and risks to national security, animals, rural communities,
and consumers associated with the mass depopulation of livestock and
poultry in CAFOs: ``Not later than 180 days after the date of enactment
of this act, the Secretary of Agriculture shall submit to the Committee
on Appropriations in both Houses of Congress a report detailing the
future costs to taxpayers and the risks to national security, animals,
rural communities, and consumers associated with the depopulation of
livestock and poultry in concentrated animal feeding operations, as
defined by 40 CFR 122.23.'' Additionally, we request the following
report language: ``The Committee understands that, in response to the
COVID pandemic, poultry and livestock producers that operate
concentrated animal feeding operations engaged in large scale
depopulation practices that included inhumane methods such as
ventilation shutdowns and water-based foam, and received USDA COVID-19
relief funds, resources, and other forms of support to accomplish this
depopulation. The Committee must fully understand the impact these
depopulation practices have on animals, consumers, taxpayers, and the
communities where these concentrated animal feeding operations exist.''
direct the gao to submit a report evaluating the 28-hour rule
The regular feeding, watering, and rest required for animals under
49 USC Sec. 80502 by animal carriers is not being effectively enforced
or may be waived by USDA inspectors; lack of enforcement or wavier of
the 28-hour rule causes undue stress on the animals being transported
and is counter to the intent of underlying statute. To acquire more
information about how the USDA is enforcing the 28-hour rule, the ASPCA
requests the following bill language: ``(a) Not later than 365 days
after the date of enactment of this act, the Government Accountability
Office (GAO) shall submit to the Committee on Agriculture of the House
of Representatives and the Committee on Agriculture, Nutrition, and
Forestry of the Senate a report evaluating the 28-hour rule, as defined
in 49 USC Sec. 80502, prohibiting the confinement of animals in a
vehicle or vessel for more than 28 consecutive hours without unloading
the animals for feeding, water, and rest. (b) The report shall
include--(1) An examination of the enforcement and waivers of the 28-
hour rule; and (2) An evaluation of- (a) The monitoring systems in
place for enforcement; (b) The number of waivers issued on a yearly
basis; (c) An evaluation of the roles of the Department of Agriculture,
Department of Transportation, and the Department of Justice in
enforcing the statute; (d) An evaluation of the funding of the agencies
authorized to enforce the statute; (e)Any concerns or problems with the
implementation of the statute; and (f) Any positive or negative impact
on the welfare of animals in transport related to the enforcement, or
lack thereof, and waiver process. (c) Reporting--Not later than 60 days
after the release of the GAO report, the Secretary of Agriculture, the
Secretary of Transportation and the Attorney General shall brief the
committees on a plan to address issues raised by the report issued
under this section.'' Additionally, we request the following report
language: ``The Committee is concerned that the regular feeding,
watering, and rest required under 49 USC Sec. 80502 by animal carriers
is not being effectively enforced or may be waived by USDA inspectors;
lack of enforcement or wavier of the 28-hour rule causes undue stress
on the animals being transported and is counter to the intent of
underlying statute. The Committee recognizes that millions of animals
that are regulated by this statute are transported every year, but the
lack of coordination by government agencies may be leading to the lack
of enforcement. The Committee is concerned that lack of enforcement and
waiving is due to inadequate monitoring systems and enforcement
authority for the three agencies involved in enforcement: the USDA,
DOJ, and DOT. The Committee directs the Secretary of Agriculture,
Secretary of Transportation, and the Attorney General to provide a
briefing to the Committee on a plan to address issues raised within 60
days of the release of the GAO report.''
require fsis to strengthen enforcement of the humane methods of
slaughter act
The Humane Methods of Slaughter Act (HMSA) is effectively the only
Federal law protecting farm animals from cruelty. It is vitally
important for animal welfare and food safety that FSIS enforce this law
and ensure that slaughterhouses follow related humane slaughter and
handling regulations. We urge the subcommittee to include the following
bill language to ensure HMSA enforcement is strengthened: ``No fewer
than 165 full-time equivalent positions shall be employed during fiscal
year 2024 for purposes dedicated solely to inspections and enforcement
related to the Humane Methods of Slaughter Act. This number is in
addition to the Humane Handling Enforcement Coordinator and District
Veterinary Medical Specialist positions.'' Additionally, we request the
following report language: ``The Food Safety and Inspection Service
(FSIS) shall ensure that all inspection personnel conducting humane
handling verification procedures receive robust initial training and
periodic refresher training on the FSIS humane handling and slaughter
regulations and directives. This includes handling of non-ambulatory
disabled animals, as well as proper use of the Humane Activities
Tracking System to ensure humane handling of animals as they arrive and
are offloaded and handled in ante-mortem holding pens, suspect pens,
chutes, stunning areas, and on the processing line. The Committee
directs the agency to continue preparation and online publication of
the Humane Handling Quarterly Reports, to include: (1) the number of
humane handling verification procedures performed, (2) the number of
administrative enforcement actions taken, (3) time spent on Humane
Handling Activities Tracking System activities, and (4) comparisons of
these measurements by plant size and FSIS district. The Committee
recognizes that the humane handling of birds at slaughter according to
Good Commercial Practices reduces the occurrence of adulterated poultry
products in the marketplace and can improve the treatment of birds at
slaughter. The Committee awaits the Department's briefing requested in
the fiscal year 2022 and 2023 reports on documented instances where
establishments lost control of their processes for handling birds, and
consequently were not operating in accordance with GCPs. Further, the
Committee directs the USDA to track the number of inspector hours spent
on GCP verification activities intended to reduce instances of
adulteration using its existing Humane Activities Tracking System or
other appropriate method.''
allocate funding for the value-added producer grant program
The USDA's Value-Added Producer Grant (VAPG) program helps farmers
participate in value-added farming activities to generate new products,
create and expand marketing opportunities and increase farmer income,
including those produced using more humane farming methods, such as
welfare-certified or pasture-raised products. The VAPG program is one
of the only Federal grant programs available to farmers raising animals
outside of the conventional confinement model and is a critical
resource for building a more humane food system. The enacted
Consolidated Appropriations Act, 2023 included $13 million in
discretionary funding for this program; the ASPCA requests the
subcommittee to meet or exceed this funding level in the FY2024 bill.
allocate funding for horse soring enforcement & urge usda to issue new
proposed hpa rule
APHIS is also charged with protecting horses through its
enforcement of the Horse Protection Act (HPA). We appreciate that
Congress provided $4.096 million in fiscal year 2023 for USDA to
strengthen enforcement of the HPA. The ASPCA requests no less than the
fiscal year 2023 enacted level of $4.096 million in the bill to support
needed enforcement of the HPA. Additionally, we request the following
report language: ``The Committee provides $4,096,000 for enforcement of
the Horse Protection Act of 1970, as amended (15 U.S.C. 1831), and
reminds the Secretary that Congress granted the agency primary
responsibility to enforce this law. The Committee urges the Secretary
to issue the new proposed HPA rule expeditiously, consistent with the
agency's announced intentions in December 2021, and to finalize and
publish the new final rule by December 31, 2023. The Committee further
urges the Secretary to ensure that the new rule includes at a minimum
all the key elements of the final rule, ``Horse Protection; Licensing
of Designated Qualified Persons and Other Amendments'' [Docket No.
APHIS-2011-0009], that was finalized and displayed in advance public
notice in the Federal Register on January 19, 2017.''
provide funding for usda to implement the pet and women safety act
grant program
We appreciate that Congress provided $3 million in fiscal year 2023
to continue implementing Section 12502 of the 2018 Farm Bill (Public
Law 115-334), which incorporated the language of the Pet and Women
Safety (PAWS) Act to authorize a grant program to provide emergency and
transitional shelter options for domestic violence survivors with
companion animals. Research shows that abusers often threaten or
inflict violence on pets to intimidate or exert control over their
partners and prevent them from leaving. This program will ensure that
more domestic violence service providers are able to accommodate pets
or arrange for pet shelter. The ASPCA urges the subcommittee to include
$3,000,000 in the FY2024 Agriculture Appropriations Bill to continue
implementing the PAWS grant program as authorized in Section 12502 of
Public Law 115-334. The ASPCA also requests the subcommittee to include
the following Report Language: ``The Committee directs the Secretary of
Agriculture to continue coordinating with the Departments of Justice,
Housing and Urban Development, and Health and Human Services to
efficiently implement the grant program for providing emergency and
transitional shelter options for domestic violence survivors with
companion animals.''
[This statement was submitted by Ingrid Seggerman, Senior Director
of Federal Affairs, ASPCA.]
______
Prepared Statement of Animal Health Institute
On behalf of the Animal Health Institute (AHI), I write today to
request that you include funding for priorities important to human and
animal health in the Fiscal Year 2024 Agriculture, Rural Development,
Food and Drug Administrations and Related Agencies Appropriations Bill.
Funding of these programs protects animal health and human health by
providing safe and effective products to prevent and treat disease in
animals.
AHI is appreciative to Congress for providing $21.48 million for
the Center for Veterinary Biologics (CVB) in last year's spending bill.
We request Congress maintain this funding level for the Center to
continue to review and approve veterinary biologics in a timely manner,
help compensate for the coming wave of retirements by experienced CVB
staffers and continue to bring current vaccines and new and innovative
technologies to market.
We request the user fees established by the Animal Drug User Fee
Act (ADUFA) of $33.500 million be included in the fiscal Year 2024
appropriations bill. ADUFA provides a system of performance standards
and user fees to improve the new animal drug review process at the U.S.
Food and Drug Administration's (FDA) Center for Veterinary Medicine
(CVM). Predictability of the review process has improved as FDA CVM has
met the agreed-upon performance standards. To maintain this success, we
request that the fees be integrated into this year's appropriation
bill. The appropriation is entirely budget neutral as the money will be
provided by the animal health companies.
The FDA CVM issued final guidance #256, Compounding Animal Drugs
from Bulk Drug Substances, in 2022, to provide regulatory certainty
about animal drug compounding from bulk drug substances. The guidance
alone will not end current abusive practices that threaten animal
health unless vigorously enforced. We request Congress provide $2
million to support the CVM in fully and properly enforcing guidance
#256 to protect animal health.
Another area of importance within animal and public health is the
control of ectoparasites in pets, livestock, and the environment. In
order to ensure timely approval of new preventative medications for
controlling fleas, ticks, and other ectoparasites in animals, AHI
requests the Environmental Protection Agency's (EPA) pesticide
registration activities be appropriated $166 million for the fiscal
Year 2024. This will help ensure that much needed improvements to the
EPA registration process are possible and the agency can decrease the
time currently required for review and approval of new products.
AHI respectfully requests $33 million for the USDA-APHIS Wildlife
Services National Rabies Management Program (NRMP). The program is
critical to decreasing the spread of rabies and is protective of human
and animal health.
Thank you for your consideration. Please do not hesitate to contact
me if you have any questions or need additional information.
Sincerely,
Ronald B. Phillips
Senior Vice President, Policy
______
Prepared Statement of Animal Welfare Institute
The Animal Welfare Institute, a nonprofit national animal welfare
advocacy organization, thanks the subcommittee for its ongoing and
robust efforts to ensure strong enforcement of the Animal Welfare Act
and to provide resources to assist domestic violence survivors and
their pets. We respectfully ask the subcommittee to maintain these
efforts in FY24 as its leadership and oversight continue to be urgently
needed.
Meaningful animal welfare laws are essential both for humane and
human reasons. These laws-and the steps Congress takes to improve their
enforcement-decrease the sale of sick pets by commercial breeders,
improve the integrity of animal-based research, reduce risks of disease
transmission and dangerous encounters involving animals and the public,
protect pet owners from the theft of their companion animals by
unscrupulous dealers, assure food safety for consumers, and improve
slaughterhouse conditions for both workers and animals. Most
importantly, they are intended to assure humane treatment of animals
used in commercial activities throughout the country.
aphis/animal care/animal welfare act enforcement
Bill Language Request: ``The Secretary shall ensure that
appropriate enforcement action in the form of penalties or case
referral to the Office of General Counsel or the Department of Justice,
or both, is taken when a regulated facility violates the Animal Welfare
Act (7 U.SC. Sec. Sec. 2131-2159), as documented on an inspection
report, with due consideration to the appropriateness of the penalty
with respect to the size of the business of the person involved, the
gravity of the violation, the person's good faith, and the history of
previous violations, as provided in 7 U.S.C. Sec. 2149(b).
``The Secretary shall ensure that any interference with or
failure to allow access for an inspection under the Animal Welfare Act,
7 U.S.C. Sec. Sec. 2131-2159, is documented on an inspection report.
``The Secretary shall ensure that all dealers selling dogs,
cats, and other covered animals online have the necessary license
pursuant to Animal Welfare Act, 7 U.S.C. Sec. Sec. 2131-2159, as
required under 78 Fed. Reg. 57227.
``The Secretary of Agriculture shall enter into a memorandum of
understanding with the U.S. Attorney General to encourage greater
collaboration on Animal Welfare Act enforcement and ensure that the
Department of Justice has access to evidence needed to initiate
cases.''
Report Language Request: ``Case Referrals for Animal Welfare Act
(AWA) Violations.--The Committee is concerned that USDA is not fully
utilizing its enforcement capabilities, particularly for chronic
violators of the AWA. There has been an overall decline in AWA
enforcement since 2010, when USDA initiated 874 cases and 74 stipulated
penalties. By 2021, enforcement had dropped to 262 initiated cases, of
which 18 resulted in settlements and 17 in administrative orders. The
Committee directs USDA to use its full enforcement capabilities under
the AWA, including referring cases to the Office of General Counsel,
the Department of Justice, or both, when appropriate according to the
factors the agency must consider under 7 U.S.C. Sec. 2149(b).''
Justification: The AWA is the chief Federal law for the protection
of animals. We are concerned about USDA's oversight of regulated
industries in recent years. While we acknowledge some improvements in
2021 compared to the previous 4 years, overall there has been a decline
in AWA enforcement, with far fewer cases initiated, warnings issued,
and official complaints filed in recent years. In fiscal Year 2021,
APHIS opened 118 new enforcement cases, which was an improvement
compared to 2020, but still a decline of more than 50 percent compared
to the 252 cases opened in fiscal Year 2014. Lower-level actions like
official warnings were also issued sparingly; in fiscal Year 2016, the
agency issued almost 200 warnings, but in fiscal Year 2021, it issued
only 58. It should be noted that this is improved from fiscal Year
2019, when it issued only two, and in fiscal Year 2020, when it did not
issue a single one.
Problems are present throughout the system. In 2018, inspectors
were issued guidance that allows ailing animals to be diagnosed over
the phone without a physical veterinary examination or testing, which
denies animals necessary care and puts the public at risk. These
guidelines no longer require that euthanasia be carried out according
to the American Veterinary Medical Association's Guidelines for
Euthanasia of Animals, which can lead to horrific cases such as a
Kansas breeder who fatally shot 24 dogs, resulting in a suspension of
their state license but no penalty from USDA. We are also aware of
licensees who have repeatedly denied access to their facilities for
inspections (even before the pandemic) or interfered with USDA's
collection of information, and have not been cited. There also continue
to be cases where significant violations have been documented, but USDA
has opted not to take any enforcement action. One look no further than
the Envigo case in Virginia, where years of documented noncompliances
went unaddressed until DOJ took the extraordinary step of seeking
injunctive relief. At the same time as 4,000 dogs were being removed
from horrendous conditions to be placed in loving homes, USDA was
renewing the license of Envigo's parent company. While the scale is
enormous, this is by no means an isolated case.
In 2013, USDA issued a rule intended to close loopholes that
allowed dog breeders to sell puppies online without a USDA license, but
enforcement with respect to online dealers has been lackluster. As a
result, many online operations continue to sell puppies sight unseen to
consumers without the necessary USDA licensing and oversight.
We are grateful to the Committee and Congress for directing Animal
Care to document every observed AWA violation on official inspection
reports and that, as a result, Animal Care finally put an end to its
``Teachable Moments'' program.
aphis/animal care/protecting animals with shelter (paws) funding
Requested Funding: We request that Congress again provide the full
authorized appropriation of $3 million to continue implementing the
PAWS grant program as authorized by Section 12502 of Public Law 115-
334. (It should be noted that the program is set up as a pass-through,
with funds going initially to USDA but the grants being administered by
DOJ.)
Requested Report Language: ``The Committee directs the Secretary of
Agriculture to continue coordinating with the Departments of Justice,
Housing and Urban Development, and Health and Human Services to
efficiently implement the grant program for providing emergency and
transitional shelter options for domestic violence survivors with
companion animals.''
Justification: We appreciate that Congress provided $3 million in
fiscal Year 2023 to continue implementing Section 12502 of the 2018
Farm Bill (Public Law 115-334), which authorized a new grant program to
provide emergency and transitional housing options for domestic
violence survivors with companion animals. Research shows that abusers
often threaten or inflict violence on pets as a way to intimidate or
exert control over their partners and prevent them from leaving. In
fact, nearly half of domestic violence survivors report staying with
their abuser for fear of what would happen to their pets if they leave.
This program is successfully ensuring that more survivors feel they can
leave because safekeeping for their pets is available. The programs
that have been funded so far represent diversity in geographic areas
and populations served, as well as in their solutions to the problem of
how best to assist domestic violence survivors who have companion
animals. The common thread through them all is the level of excitement
at being able to reach this highly underserved population of survivors
and to increase community awareness about this long-standing oversight,
which would not have been possible with these grants. But there has
been more demand for grants than the program has been able to meet: For
FY20 through FY22, 23 grants were awarded, but 81 applications had been
received. Continued funding is essential.
usda/office of inspector general/animal fighting enforcement
Requested Report Language: ``The Committee is concerned about
illegal animal fighting activity that subjects animals to cruel
conditions and has the potential to spread illnesses such as virulent
Newcastle disease and avian flu. The OIG is encouraged to increase its
enforcement efforts in the States and territories and to pursue animal
fighting cases even if related concerns, such as money laundering and
illegal weapons, have not yet been determined to be at issue before an
investigation is opened. OIG is also encouraged to work with USPS and
DoJ to examine the prevalence of the illegal shipment of game-fowl used
in cockfighting. The Committee also encourages the OIG to audit and
investigate USDA enforcement of the Animal Welfare Act and the Horse
Protection Act to help improve compliance with these important laws.
This should include finalizing the reopening of the audit of the Animal
Care Program Oversight of Dog Breeders to allow completion of in-person
visits. Additionally, the Committee is concerned about the lack of
meaningful enforcement of the AWA and HPA and requests that these
audits should also examine what barriers exist to full enforcement of
both Acts, and what if any steps can be taken within APHIS' Animal Care
and Investigative and Enforcement Services programs to ensure that the
regulated community is held accountable for violations of these Acts.''
aphis/animal care/emergency preparedness and response
Requested Funding: We request $1.45 million for Animal Care under
APHIS' Emergency Preparedness and Response line item.
Background: APHIS Emergency Preparedness and Response funds enable
the Animal Care program to support a cooperative agreement on hazard
preparedness and response for zoos and aquariums, facilitate networking
efforts for state emergency agriculture officials, update Best
Practices Documents for animal emergency management, conduct outreach,
and implement the final rule issued in December 2021 following a
directive in the fiscal Year 2021 omnibus (86 Fed Reg 68533), which
requires emergency contingency plans for all facilities regulated under
the Animal Welfare Act.
food and drug administration/reducing animal testing and advancing
nonanimal methods
Requested Funding: We request no less than the fiscal year 2023
level of $5 million.
Requested Report Language: ``The Committee directs FDA to
efficiently and expeditiously utilize existing funds to reduce animal
testing and advance alternative methods in a measurable and impactful
way. The agency is further directed to provide a report to the
Committee within 90 days of enactment that provides details on the
status of forming the New Alternative Methods Program in the
Commissioner's office, including but not limited to a description of
program goals and staffing levels by position classification; FDA's
priority areas for reducing animal use and advancing alternatives,
including goals, timelines, and funding associated with each of these
identified priorities; metrics the agency will sue to measure impact,
and how the agency will communicate information regarding acceptance of
alternative methods to the regulated community. The agency should not
use funding to carry out new animal testing, including to compare the
use of animals to alternative methods, but instead use existing animal
data.''
aphis/animal care/marine mammals in captivity
Requested Report Language: ``Last year, the Committee directed USDA
to prioritize and reissue a proposed rulemaking to update regulations
for the handling and care of marine mammals in captivity. This has not
happened yet. The Committee continues to be concerned that USDA's
handling, care, treatment, and transportation standards for marine
mammals in captivity are seriously outdated. Marine mammal science has
progressed significantly in the almost 40 years since the most
important of these regulations were last updated, and the current
standards do not adequately protect the welfare of captive marine
mammals. An effort to modernize these standards that began in 2002
ended in 2021 when a proposed rule published in 2016 was withdrawn,
recognizing it was now outdated. The Committee reminds APHIS that it
expects it to prioritize developing and finalizing a humane and
science-based rule to modernize its marine mammal regulations and
directs the agency to report back within 6 months on its progress in
achieving that goal.''
Justification: It was 1984 when the USDA last updated key elements
of the handling and care standards for marine mammals. In those nearly
40 years, significant progress has been made in marine mammal biology
and ecology research, the results of which should inform Federal care
regulations, such as increasing minimum space requirements,
establishing species-specific ambient temperature ranges, and
mitigating the effects of noise. An effort to modernize these standards
that began in 2002 ended in 2021 when a proposed rule (81 FR 5629)
published in 2016 was withdrawn ``due to the age of the analyses on
which it relies.'' Updating the minimum space requirements is
especially critical to improve the welfare of captive marine mammals.
Research within the past 20 years indicates that marine mammals in the
wild move far more widely than was previously understood, including
diving to astounding depths. For example, a 2015 study by researchers
at the University of Alaska Fairbanks and University of Washington
Seattle found that belugas routinely dive to 2,000 feet, yet the
current minimum required depth for this species in captivity is only 7
feet (half the average body length of the species).
[This statement was submitted by Nancy Blaney, Director, Government
Affairs.]
______
Prepared Statement of Animal Welfare Institute
The Animal Welfare Institute appreciates the opportunity to submit
testimony on FY2024 spending priorities for the U.S. Department of
Agriculture's Animal and Plant Health Inspection Service's Wildlife
Services program. AWI is grateful to Congress for the actions it has
taken over the past several years to encourage Wildlife Services to
invest in developing and transitioning to nonlethal methods of
responding to human-wildlife conflict. While the agency has taken small
steps towards implementing nonlethal methods, leadership from the
Committee is still needed to ensure this remains a priority for the
agency because it continues to use inhumane methods, such as M-44
sodium cyanide devices, that pose a risk to millions of animals, the
environment, and the public.
chemical poisons
Report language request: ``No Federal funds shall be expended or
committed for the manufacture, import, purchase, sale, distribution,
preparation, placement, deployment, training in the use of, or
authorization for use by third parties, of M-44 sodium cyanide ejector
devices ('M-44s'), including any of the device's components or parts.
This prohibition extends to use of Wildlife Services staff time and
resources in connection with the use of M-44s, including where such
actions are undertaken in connection with a cooperative agreement,
except for activities directly related to the removal of M-44s that
have been placed on federal, Tribal, State, and private land. Nor shall
Federal funds be expended or committed for the manufacture, import,
purchase, sale, distribution, preparation, placement, deployment,
training in the use of, or authorization for use by third parties of
sodium fluoroacetate ('Compound 1080'), including for livestock
protection collars.
``Exposure to sodium cyanide and Compound 1080 can cause severe,
unjustifiable suffering and often results in painful, protracted deaths
for wildlife and family pets, including many non-target animals and
even people. Use of M-44s and Compound 1080 for wildlife 'control'
purposes is unsafe for people and animals alike and is an ineffective
approach to sustainably reducing and preventing human-wildlife conflict
and livestock losses. The Committee urges Wildlife Services to
reallocate resources to the provision of technical assistance and
education to promote, incentivize, implement, and sustain the use of
nonlethal methods of predator control and coexistence, which can be
less costly, more effective, and less dangerous to non-target species
relative to M-44s and Compound 1080.
``Just as Federal funds may not be allocated to the use of M-44s or
Compound 1080, Federal funds may not be used to develop, introduce, or
reintroduce other chemical poisons, including but not limited to
alternative delivery mechanisms for sodium cyanide, Compound 1080, and
other pesticides, for purposes of lethal predator control. This
prohibition extends to the use of Federal funds to initiate or continue
research, development, testing, registration, manufacture, preparation,
or investigation of any chemical poisons or pesticides that may be used
for lethal predator control.''
Justification: Lethal animal control devices such as M-44s or
Compound 1080 cause severe, unnecessary pain and suffering and often
result in painful deaths of wild animals and family pets. In 2022,
Wildlife Services killed over 6,000 animals with M-44s, 152 of whom
were killed unintentionally. These devices have killed family pets and
have caused severe, irreparable harm to people who have been exposed.
Sodium cyanide, used in M-44s, and Compound 1080 (sodium
fluoroacetate), used in livestock collars, are two of the world's
deadliest poisons and present threats to public health, the
environment, and national security. With an assortment of safer and
more effective nonlethal options available, Wildlife Services should no
longer employ M-44s or Compound 1080 as a means of predator control.
nonlethal methods development
Report language request: ``The Committee is aware that Wildlife
Services, according to the program's informational materials, has
worked with landowners to deploy nonlethal predator management
strategies such as fladry, electric fencing, and livestock guardian
dogs. However, these efforts have been insufficient, and millions of
animals continue to be inhumanely killed each year, including thousands
of nontarget animals. Wildlife Services must implement and prioritize
nonlethal strategies through the following: (1) promoting and
implementing nonlethal livestock-predator conflict deterrence and
mitigation techniques, including but not limited to use of barriers and
fencing, fladry and turbo-fladry, visual and auditory deterrents,
livestock protection animals, appropriate husbandry practices, night
corralling, shed lambing, attractant and carcass removal, livestock
herding, and human presence; (2) providing training in selection,
implementation, monitoring, and adaptation of nonlethal techniques for
agricultural producers, landowners, Federal and State agency personnel,
and others; and (3) collaborating with the National Wildlife Research
Center to advance and improve nonlethal predator coexistence methods,
conduct research on monitoring methods for efficacy of nonlethal
control methods implemented to reduce predation, and establish clear
documentation protocols for nonlethal approaches implemented in advance
of lethal control measures where applicable.
``The Committee directs Wildlife Services to fund nonlethal
predator control activities from a percentage of the United States
Department of Agriculture's total budget. No less than $5,000,000 of
existing funds must be allocated towards nonlethal strategies. In FY23,
the Committee allocated funding specific to nonlethal measures.
Wildlife Services is directed to provide a report detailing how these
additional funds were dispersed-including regional distribution, wild
and domestic species affected, number and size of livestock/
agricultural operations affected, nonlethal tools and methods
implemented and supported, and efficacy evaluation methods and
outcomes- within 45 days of the enactment of this act. Wildlife
Services is also directed to document all work on nonlethal strategies
development and submit a report demonstrating progress in this area
within 180 days of the enactment of this act.''
Justification: It is estimated that USDA's Wildlife Services has
killed over 34 million animals over the last decade. In 2022, 383,731
native animals were killed by the agency-more than 2,600 of whom were
killed unintentionally. The death toll included more than 56,000
coyotes, 26,000 beavers, 2,400 foxes, and hundreds of gray wolves,
black bears, mountain lions, and badgers, among many other species.
These animals were killed using a variety of inhumane methods, such as
M-44 devices, snares, body-gripping traps, leghold traps, and firearms.
Lethal predator control methods, often employed to benefit the
agriculture industry, are proven to be ineffective and inhumane and to
pose safety risks to both humans and pets, and are more costly than
nonlethal methods. Predator species are a critical part of healthy
ecosystems. Employing nonlethal predator control methods will establish
sustainable coexistence and benefit both the agricultural community and
the environment.
trapping
Report language request: ``The Committee directs the Secretary to
allocate $300,000 to institute a 3-year pilot program to replace the
use of body-gripping traps by agency personnel with non-lethal methods
and equipment, with the following exceptions:
--When the body-gripping trap is used to (i) control documented
invasive species to achieve resource management objectives
where alternative methods have failed; or (ii) protect a
species that is (I) listed as an endangered species or
threatened species under the Endangered Species Act of 1973 (16
U.S.C. 1531 et seq.); or (II) treated by the Forest Service as
a sensitive species.
--Exception only applies when: (i) such use of a body-gripping trap
is in accordance with applicable State and Federal law; (ii)
prior to use of a body-gripping trap, all available and viable
nonlethal methods for such control or protection, respectively,
are attempted; and (iii) such attempts are documented in
writing, and such documentation is maintained at the
headquarters of the department that employs the individual
engaging in such attempt.''
Justification: Body-gripping traps, such as snares, Conibear traps,
and steel-jaw leghold traps, are inhumane and inherently nonselective.
The nontarget animals caught in these traps include threatened and
endangered species, as well as family pets. These traps do not belong
on public lands where families go to enjoy spending time outdoors, and
where anyone who trips a trap can become a victim.
Based on funding levels for other predator control programs,
$300,000 over 3 years would be a reasonable amount to fund a pilot
program for replacing agency use of body-gripping traps with nonlethal
methods. The Fish and Wildlife Service's Endangered Species
Conservation-Wolf Livestock Loss Compensation and Prevention fund tends
to give $50,000-$100,000 to each recipient. The FWS Fish and Wildlife
Coordination and Assistance fund was appropriated $150,000 in FY16 (the
most recent year with data) to award grants to conservation and/or
environmental projects. Wildlife Services gave Colorado State
University a $50,028 grant to study nonlethal management of coyote
predation. This paints a picture of $50,000-150,000 per year for a
small predator management program, and a 3-year program is advisable to
obtain meaningful results.
Thank you for your consideration of our recommendations for how the
Committee can ensure Wildlife Services prioritizes a transition to
safer, effective nonlethal methods.
[This statement was submitted by Ericca Gandolfo, Policy Advisor,
Government Affairs, Animal Welfare Institute.]
______
Prepared Statement of the Animal Welfare Institute
Thank you for the opportunity to submit testimony on Fiscal Year
2024 funding priorities for the U.S. Department of Agriculture. Below
are some of the Animal Welfare Institute's top priorities that fall
under the Food Safety and Inspection Service, Farm Service Agency, and
Animal and Plant Health Inspection Service pertaining to the humane
treatment of farmed animals and equines.
food safety and inspection service--humane methods of slaughter act
enforcement
Effective enforcement of the Humane Methods of Slaughter Act can
prevent abuses like those documented in undercover investigations and
reduce the chance of associated food safety risks and costly recalls of
meat and egg products. The number of FTEs required under annual
appropriations for enforcement of the HMSA has remained at 148 since
FY12, despite the fact that actual staffing levels have consistently
been above this number for the past decade. To more accurately reflect
previous staffing levels that have proven to increase the number of
humane handling verification procedures performed and align with the
agency's staffing commitments, 165 FTEs should be appropriated. We also
request that the agency continue publishing the Humane Handling
Quarterly Reports--as previously directed by the FY21, FY22 and FY23
agriculture appropriations reports--to allow for timely and efficient
access to information pertinent to monitoring HMSA enforcement. AWI
greatly appreciates the Committee's attention to this matter given that
Humane Handling Quarterly Reports provide critical information that
promotes transparency and public trust in FSIS's oversight of the
treatment of animals slaughtered at USDA inspected facilities.
Bill language request: No fewer than 165 full-time equivalent
positions shall be employed during fiscal year 2024 for purposes
dedicated solely to inspections and enforcement related to the Humane
Methods of Slaughter Act. This number is in addition to the Humane
Handling Enforcement Coordinator and District Veterinary Medical
Specialist positions.
Report language request: FSIS shall ensure that all inspection
personnel conducting humane handling verification procedures receive
robust initial training and periodic refresher training on the FSIS
humane handling and slaughter regulations and directives. This includes
handling of non-ambulatory disabled animals, as well as proper use of
the Humane Activities Tracking System to ensure humane handling of
animals as they arrive and are offloaded and handled in ante-mortem
holding pens, suspect pens, chutes, stunning areas, and on the
processing line. The Committee directs the agency to continue
preparation and online publication of the Humane Handling Quarterly
Reports, to include: (1) the number of humane handling verification
procedures performed, (2) the number of administrative enforcement
actions taken, (3) time spent on Humane Handling Activities Tracking
System activities, and (4) comparisons of these measurements by plant
size and FSIS district.
food safety and inspection service--poultry slaughter good commercial
practices
USDA has documented a variety of serious humane handling problems
at poultry slaughter plants, including birds drowning in scalding
tanks, disposal of live birds under piles of dead birds, birds dying
due to suffocation and/or prolonged exposure to extreme weather, and
mechanical problems resulting in injury and death. In 2005, USDA issued
a notice to slaughter establishments that acknowledged the link between
inhumane treatment of birds and adulterated poultry products, and
referenced industry ``Good Commercial Practices'' for bird handling.
Subsequently, USDA inspectors began conducting verification of these
requirements for live bird handling in every federally inspected plant.
However, inspector oversight appears to vary widely at poultry
slaughter establishments. According to USDA enforcement records,
between 2018 and 2020, nearly one-half (42 percent) of federally
inspected poultry plants were not issued any enforcement records
documenting GCP compliance. In order to determine why the reporting of
GCP compliance varies so dramatically among inspection personnel, USDA
should begin tracking the time inspectors spend on GCP-related
activities. Information gained from this monitoring will also assist
USDA and Congress in determining the level of inspector oversight
needed to prevent repeated incidents of bird mistreatment that has the
potential to result in poultry product adulteration.
Report language request: The Committee recognizes that the humane
handling of birds at slaughter according to Good Commercial Practices
(GCPs) reduces the occurrence of adulterated poultry products in the
marketplace and can improve the treatment of birds at slaughter. The
Committee awaits the Department's briefing requested in the fiscal year
2022 and 2023 reports on documented instances where establishments lost
control of their processes for handling birds, and consequently were
not operating in accordance with GCPs. Further, the Committee directs
the USDA to track the number of inspector hours spent on GCP
verification activities intended to reduce instances of adulteration
using its existing Humane Activities Tracking System or other
appropriate method.
farm service agency--livestock indemnity program
The Livestock Indemnity Program compensates producers for farmed
animal injuries and deaths caused by adverse weather and natural
disasters. The number of farmed animals that die from adverse weather
events is immense--as is the amount of Federal funds disbursed under
LIP. According to data from the USDA Economic Research Service,
USAspending.gov, and public records obtained via FOIA, LIP payments
have totaled over $500 million since 2008. However, producers are not
required to demonstrate that they provide animals with basic
protections from extreme weather or that they have disaster plans in
place before receiving taxpayer dollars under LIP. Disaster
preparedness plans are widely supported by agriculture industry groups
and are recommended by both the American Veterinary Medical Association
and the USDA. To save taxpayer dollars and mitigate losses, USDA should
require that producers have disaster preparedness plans for the
issuance of payments under LIP.
Bill language request: Livestock Indemnity Payments for Adverse
Weather. For expenses involved in making indemnity payments to eligible
livestock owners or contract growers, such sums as may be necessary:
Provided, That the Secretary shall ensure that no funds are used for
issuing payments under the program, unless the applicant offers 1) a
disaster preparedness plan that is specific to the species of animal(s)
and region of the country, and 2) a description of how the plan was
executed to prevent livestock injuries or deaths.
Report language request: Disaster Preparedness.--The Committee
recognizes that millions of farmed animals die each year due to the
effects of adverse weather, and extreme weather events are occurring at
increased frequency, putting additional livestock at risk of injury and
death. The committee also is cognizant that veterinary and agricultural
trade associations recognize the importance of disaster planning in
preventing the extent of livestock deaths. Therefore, the Committee
directs USDA to require written disaster preparedness plans for the
issuance of payments under the Livestock Indemnity Program.
food safety and inspection service and animal and plant health
inspection service--enforcement of the twenty-eight hour law
The Twenty-Eight Hour Law is the only Federal law aimed at
providing basic protections for farmed animals transported across the
United States; unfortunately, oversight of compliance is virtually
nonexistent even though available evidence and investigations have
revealed numerous instances where animals were transported in excess of
28 hours without food, water, or rest. Given that the statute is not
actively enforced by any of the agencies responsible for doing so,
report language should direct USDA and DOT to develop a mechanism
(e.g., through guidance, policies, or regulations) to monitor
compliance (e.g., by integrating checks into routine roadside
inspections that are already being conducted by DOT, during humane
handling verifications conducted by FSIS at federally inspected
livestock slaughter establishments, and/or during live animal export
inspections conducted by APHIS). Transport can be very stressful for
animals, as they are subjected to increased handling, exposure to
temperature extremes, and long journeys involving overcrowding and food
and water deprivation. At a bare minimum, ensuring that the Twenty-
Eight Hour Law is being followed would vastly improve conditions.
Moreover, better protecting the health and welfare of these animals
helps to prevent the spread of disease and reduce incidences of injury,
infection, and mortality due to the stresses associated with transport.
Report language request: Enforcement of the Twenty-Eight Hour Law.-
Not later than 180 days after the date of enactment of this act, the
Secretary of Agriculture, in consultation with the Secretary of
Transportation, shall develop a mechanism for conducting investigations
or inspections, including but not limited to inspection of any vehicle
or vessel transporting animals or any written or electronic records
associated with such transport of animals, to determine whether any
rail carrier, express carrier, or common carrier, a receiver, trustee,
or lessee of one of those carriers, or an owner or master of a vessel
transporting animals has violated or is violating the Twenty-Eight Hour
Law (Section 80502 of title 49, United States Code).
food safety and inspection service--horse slaughter facility
inspections
Horse slaughter does not occur in the United States due to the
inclusion of annual appropriations language blocking the use of Federal
funds to inspect horse slaughter facilities, thereby preventing these
facilities from legally operating on U.S. soil. Before horse slaughter
facilities closed in the United States, USDA itself documented horrific
incidents of cruelty. Horses--which serve as companion, working, and
performance animals--have a strong fight-or-flight reflex and
instinctively thrash their long necks when panicked. Rendering horses
unconscious prior to slaughter can be extremely difficult as stunning
them often requires repeated blows to the head. In addition to well-
documented animal abuse within the predatory horse slaughter industry,
the consumption of horse meat presents a significant food safety
concern. Horses are not raised for human consumption in the United
States and are regularly administered a wide range of drugs that are
expressly prohibited by the Food and Drug Administration for use in
food animals.
Bill language request: Hereafter, none of the funds made available
by this act or any other act may be used to pay the salaries or
expenses of personnel- 1) to inspect horses under section 3 of the
Federal Meat Inspection Act (21 U.S.C 603); (2) to inspect horses under
section 903 of the Federal Agriculture Improvement and Reform Act of
1996 (7 U.S.C. 1901 note; Public Law 104-127); or (3) to implement or
enforce section 352.19 of title 9, Code of Federal Regulations (or a
successor regulation).
Report language request: Nearly every year since 2005, Congress has
prohibited equines from being slaughtered for human consumption in the
United States by restricting the USDA's use of funds for slaughter
inspections. Despite Congressional intent to shutter the horse
slaughter industry through this prohibition, thousands of equines
continue to be exported to foreign abattoirs annually. The Committee is
deeply concerned with the welfare of American horses caught in the
slaughter pipeline and the economic impacts that this practice has on
the American equine community. Therefore, the Committee directs the
USDA to cease all activities that allow, facilitate, or otherwise
support the horse slaughter industry, including the transport or export
of American equines for human consumption.
animal and plant health inspection service--horse protection act
enforcement
We appreciate Congress providing $$4.096 million in FY23 for USDA
to improve enforcement of the Horse Protection Act and combat the
abusive practices associated with soring. A 2010 Office of Inspector
report outlined serious conflicts of interest with the industry self-
monitoring system by Horse Industry Organizations on which USDA still
relies. In 2021, the National Academies of Sciences, Engineering, and
Medicine issued a report that echoed OIG's findings and called for an
end to the industry self-policing system. But although USDA announced
final regulations in 2017 to eliminate industry self-policing and
institute other reforms to end soring, these widely supported
regulations were frozen by the last administration. We appreciate
Congress's past inclusion of language directing USDA to finalize a long
overdue rulemaking that would substantially improve HPA enforcement.
Report language request: The Committee provides $4,096,000 for
enforcement of the Horse Protection Act of 1970, as amended (15 U.S.C.
1831), and reminds the Secretary that Congress granted the agency
primary responsibility to enforce this law, including the training of
all inspectors. The Committee urges the Secretary to issue the new
proposed HPA rule expeditiously, consistent with the agency's announced
intentions in December 2021, and to finalize and publish the new final
rule by December 31, 2023. The Committee further urges the Secretary to
ensure that the new rule includes at a minimum all the key elements of
the final rule, ``Horse Protection; Licensing of Designated Qualified
Persons and Other Amendments'' [Docket No. APHIS-2011-0009], that was
finalized and displayed in advance public notice in the Federal
Register on January 19, 2017.
[This statement was submitted by Dena Jones, Director, Farm Animal
Program and Joanna Grossman, PhD, Equine Program Director and Senior
Advisor.]
______
Prepared Statement of Animal Welfare Institute
The Animal Welfare Institute, a national nonprofit animal welfare
advocacy organization, respectfully asks the Committee to allocate
$500,000 for the U.S. Department of Agriculture's National Agricultural
Statistics Service to expand the scope of its annual mink survey to
collect and publish additional data about mink farms, and to collect
data about other types of fur farms. This will increase transparency
regarding the total number of animals bred and killed for fur in the
U.S., and whether public safety measures are enforced to curb disease
transmission.
mink farms pose a public health risk
Mink on fur farms incubate and transmit diseases such as COVID-19
and avian influenza, creating circumstances that threaten to worsen the
current pandemic and usher in the next one. Mink pose a high risk to
humans because their upper respiratory tract is exceptionally well
suited to be a conduit to ours, making them effective ``mixing
vessels'' to create novel pandemic viruses.\1\ Furthermore, fur farms
house mink in crowded environments that create an ideal setting for
pathogens to circulate among and across species.\2\ Wire cages are
packed together and may be stacked on top of each other so that urine
and excrement falls on the animals below. Given the conditions of
confinement, these animals are highly stressed and thus
immunocompromised, making them more susceptible to infection. The
absence of legal requirements for veterinary care only compounds the
problem.
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\1\ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7993395/
\2\ https://www.hsvma.org/
index.php?option=com_content&view=article&id=1179:fur_riskofdisease
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Mink are highly susceptible to COVID-19, which has infected tens of
thousands of mink in the U.S.\3\ and millions more internationally.
Even more alarmingly, they are capable of passing a mutated form of the
virus back to humans. Mink to human transmission of the virus has been
reported in the Netherlands, Denmark, and Poland, and the U.S. Four
people in Michigan were infected with a unique COVID-19 strain traced
back to mink.\4\ Spillback from mink farms to humans could introduce
new variants, undermining the effectiveness of vaccines and
jeopardizing efforts to contain the pandemic.\5\ Like humans, mink can
become infected with COVID-19 without showing symptoms, thus
potentially serving as an undetected reservoir of the disease. Escapees
from these farms can also transmit the virus to wild populations,
potentially fostering reservoirs of the virus off the farms. In
December 2020, a wild mink captured near a mink farm in Utah tested
positive for a variant of COVID-19 indistinguishable from the virus
found in nearby infected farmed mink--demonstrating the broader dangers
posed.\6\
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\3\ https://www.rochesterfirst.com/news/coronavirus-confirmed-in-
mink-at-oregon-fur-farm/
\4\ https://www.freep.com/story/news/health/2022/04/17/michigan-
covid-cases-tied-to-mink-human-spillover/7338784001/
\5\ https://www.who.int/news/item/07-03-2022-joint-statement-on-
the-prioritization-of-monitoring-sars-cov-2-infection-in-wildlife-and-
preventing-the-formation-of-animal-reservoirs
\6\ https://www.sciencenews.org/article/covid-19-coronavirus-mink-
utah-first-wild-animal-test-positive
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In addition, a deadly avian influenza virus (H5N1) infected mink on
a fur farm in Spain in October 2022. Before this outbreak, the virus
spread primarily through contact with infected birds, not between
mammals. However, in Spain it spread from mink to mink and gained at
least one mutation that favors mammal-to-mammal spread.\7\ H5N1, which
has spread swiftly among birds around the world since 2020, could
infect other mink farms and mutate to become transmissible between
humans.\8\ Scientists are sounding the alarm on this H5N1 outbreak in
Spain, calling it a ``clear mechanism for an H5 pandemic to start'' and
``a warning bell.''
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\7\ https://www.eurosurveillance.org/content/10.2807/1560-
7917.ES.2023.28.3.2300001
\8\ https://www.science.org/content/article/incredibly-concerning-
bird-flu-outbreak-spanish-mink-farm-triggers-pandemic-fears
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annual mink farm survey
It is vital that the USDA heed the recommendations of the World
Health Organization,\9\ the Food and Agriculture Organization of the
United Nations,\10\ and other global health and food safety
organizations that recommend monitoring fur farms more closely.
Implementing these recommendations will require the agency to collect
more data than it currently does.
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\9\ https://www.who.int/emergencies/diseases/novel-coronavirus-
2019/origins-of-the-virus
\10\ https://www.fao.org/publications/card/en/c/CB3368EN/
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There is no way to know the total number of animals bred and killed
on fur farms in the U.S. each year, and there are no Federal
regulations governing the operation of fur farms. There is little
transparency regarding what, if, or how public safety measures are
implemented on these farms to curb disease transmission. A small amount
of data on mink farms is compiled by the USDA in an annual market
report as part of its reporting on agricultural commodities.\11\
However, no data are collected on fox, lynx, bobcat, or other animals
farmed for fur.
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\11\ https://www.nass.usda.gov/Surveys/Guide_to_NASS_Surveys/Mink/
index.php
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Not only does the lack of meaningful Federal or state oversight
mean that animals can be bred, housed, and killed in inhumane ways, but
it also means that it is impossible to easily monitor the potential
infectious diseases incubated or spread at these farms.
Thus, AWI recommends an additional $500,000 for the National
Agricultural Statistics Service to expand the scope of its annual mink
survey to collect and publish additional data about mink farms, and to
collect data about other types of fur farms.
Accompanying this funding, AWI urges the inclusion of a directive
outlining the information to be gathered and published in this survey,
including at minimum: the full contact information for all fur farm
owners and operators; the address for each place of business where a
fur farm conducted business; the legal descriptions of any lands upon
which the fur farm conducted business; all trade names under which the
fur farm conducted business; the number of individuals who worked on
each farm; the number and sex of individual animals raised for fur; the
source of each individual animal raised for fur; a detailed description
of how the animals were transported, including the route taken, if
applicable; the number of individual animals purchased, transferred, or
sold and the name of each person or entity to whom or from whom such
animals were purchased, transferred, or sold; a description of the
size, number, and type of the fur farm's pens, cages, or other such
enclosures; a description of the barrier(s) used to contain the animals
raised for fur on the farm, as well as the barriers used to prevent
other animals from gaining access to the farm; a description of the
procedures the fur farm uses to dispose of manure, carcasses and any
parts thereof; a description of the practices and procedures used by
the fur farm to ensure the health and safety of farm workers, the
public, and animals on and around the farm; the number of animals
raised for fur that died or were killed, the cause of death, and, if
killed by humans, the reason each was killed and the method used; a
description of the measures the fur farm adhered to in compliance with
the current American Veterinary Medical Association guidelines relevant
to fur farm operations, including euthanasia and depopulation; and a
description of the measures the fur farm adhered to in compliance with
the latest guidelines and recommendations developed by the USDA, the
CDC, and any other Federal agencies, in order to prevent the
transmission of COVID-19 or other diseases to other captive furbearing
animals or to wildlife, fur farm workers, and the public.
To help curb the current pandemic-and to prevent the next one-we
must gain a better understanding of fur farms in the U.S. Thank you for
your consideration of our recommendations for how the Committee can
direct the USDA to provide this information to Congress and to the
public.
[This statement was submitted by Kate Dylewsky, Assistant Director
of Government Affairs.]
______
Prepared Statement of the Campaign for Contract Agriculture Reform
I am submitting this testimony on behalf of the Campaign for
Contract Agriculture Reform (CCAR) regarding our fiscal year 2024
funding requests for USDA programs.
The Campaign for Contract Agriculture Reform (CCAR) is a national
alliance of organizations working to provide a voice for farmers and
ranchers involved in contract agriculture, as well as the communities
in which they live. The member organizations of CCAR include Farm Aid,
Farm and Ranch Freedom Alliance, Food Integrity Campaign, National
Family Farm Coalition, National Farmers Union, National Sustainable
Agriculture Coalition, R-CALF USA, Rural Advancement Foundation
International and Western Organization of Resource Councils.
usda/agricultural marketing service (ams)
Packers and Stockyards Act Oversight and Enforcement
Packers and Stockyards Program--$35 million
We commend the Subcommittee for its strong support for Packers and
Stockyards Act oversight and enforcement in the Fiscal Year 2023
Omnibus Appropriations bill, and in the preliminary Agriculture
Appropriations bill and report that informed the final bill.
The Packers and Stockyard Act is a strong statute that provides
broad protections for farmers against unfair, deceptive,
discriminatory, and unduly preferential or prejudicial practices of
livestock and poultry companies. Unfortunately, the lack of clear
regulations to define the terms of the statute and provide clarity
about USDA interpretation of those protections has hindered
enforcement, to the detriment of poultry growers and livestock farmers
and ranchers.
When the Packers and Stockyards Act (PSA) was passed in 1921, it
came at a time of great concern by Americans about the concentration
and related market power of meatpackers and other agricultural
processors. Congress passed the PSA because it realized that while
existing antitrust laws (Sherman Act, Federal Trade Commission Act, and
the Clayton Antitrust Act) address mergers, acquisition, and business
practices that unlawfully harm competition in the marketplace, those
statutes do not address harms to individual farmers and ranchers caused
by unlawful practices of powerful meatpackers and poultry companies.
Indeed, the primary focus of Congress in passing the PSA and its
amendments was to ensure that USDA could address meatpacker and poultry
company actions that harm farmers and ranchers individually. In fact,
the primary farmer and rancher protection provisions of the Packers and
Stockyards Act [Section 202(a) and (b)] focus on meatpacker and poultry
company harms to farmers and ranchers, without establishing any
requirement for farmers or USDA to prove that those practices have also
harmed competition in the marketplace broadly.
While market consolidation and the power of meatpackers in 1921 was
a major impetus for Congress to pass the Packers and Stockyards Act,
it's important to note that meat and poultry markets are even more
consolidated now than they were in 1921. In addition, more recent
vertical integration structures through poultry and hog contracting
practices, and certain cattle contracting practices, have allowed those
firms to shift economic risks onto the backs of the farmers and
ranchers with whom they contract. The current market conditions for
livestock and poultry make PSA enforcement, and the regulatory updates
to support that enforcement, more important now than ever.
Therefore, CCAR is supporting the request in the President's budget
for $35 million for the Packers and Stockyards program within the
Agricultural Marketing Service. We would also strongly oppose any
efforts by Congress to place limitations on USDA's authority to
finalize Packers and Stockyards Act regulatory updates.
In addition, CCAR requests the inclusion of the following report
language to address these issues:
The Committee recognizes that consolidation in
agribusiness can be detrimental to farmers, consumers,
workers, and the environment. The Committee considers
enforcement of the Packers and Stockyards Act a top
priority and directs the Department to continue
enforcing the Act to the fullest extent of the law.
Further, the Committee urges the USDA Agricultural
Marketing Service (AMS) and other agencies and mission
areas to fully incorporate fair and competitive markets
priorities across relevant programs and operations.
Thank you for the opportunity to provide this testimony about the
Fiscal Year 2024 Agriculture Appropriations process.
[This statement was submitted by Steven Etka, Policy Director,
Campaign for Contract Agriculture Reform]
______
Prepared Statement of the Campaign for Family Farms and the Environment
u.s. department of agriculture, agricultural marketing service
The Campaign for Family Farms and the Environment (CFFE) is a
coalition of State and national organizations, including Dakota Rural
Action, Iowa Citizens for Community Improvement, Land Stewardship
Project, Missouri Rural Crisis Center, Food & Water Watch and Institute
for Agriculture and Trade Policy. Our organizations work together to
change policies that promote consolidation in animal agriculture at the
expense of independent family farms, rural and urban economies, workers
and public health.
competitive markets for livestock and poultry
It has been clear for decades that lack of enforcement of the
Packers and Stockyards Act (PSA), along with unchecked mergers of meat
and poultry companies, has allowed large buyers to exercise extreme
market power at the expense of livestock producers and contract
growers. This has led to devastating changes in the structure of
livestock and poultry markets around the country, and removed any
chance for economic viability for many independent producers.
CFFE members have lived through this transition, particularly in
hog markets, which in the 1980s offered small independent producers in
the Midwest flexibility and the potential for profitability by
including livestock in their farming operations. But by the mid-1990's,
Midwestern farmers saw the rise of buyer power by the largest packers
shift the market away from cash sales and limit or eliminate market
access for smaller sellers. Producers who lived through the upheaval of
the hog market collapse in the late 1990's describe how the buying
stations they depended on to purchase hogs disappeared, leaving them to
deal directly with very large packers who openly stated that they would
pay producers with smaller herds less per head. This drove out
independent producers, to be replaced with large, industrialized
operations raising contracted hogs, to devastating effect for rural
communities. Now, there is essentially no cash market for hogs. As a
recent USDA proposed rule points out, today, ``in effect, the only
production/marketing choice for a hog producer is to enter a
contract.'' \1\
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\1\ Agricultural Marketing Service, U.S. Department of Agriculture.
Proposed Rule. ``Inclusive Competition and Market Integrity Under the
Packers and Stockyards Act.'' October 23, 2022. Federal Register. Pg.
60040.
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While structural changes in cattle markets have not yet driven
independent producers completely out of the market as happened in the
hog sector, the same trends are developing on a longer timeline. The
USDA notes that for cattle ``there are commonly only one or two buyers
in some local geographic markets, and few sellers have the option of
selling fed cattle to more than three or four packers.'' \2\ And that
``since 2005, negotiated cash trades have declined from 65 percent to
about 27 percent today.'' \3\ This transition replaced cash trades with
contracts and alternative marketing arrangements that not only
eliminate producers' access to cash markets, but also eliminate
opportunities for price discovery and create another avenue for packers
to advantage some producers over others.
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\2\ Agricultural Marketing Service. Pg. 60011.
\3\ Agricultural Marketing Service. Pg. 60012.
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There are many reforms needed to address the stranglehold that a
handful of multinational corporations have on each step of the
livestock and protein supply chain. CFFE appreciates the committee's
recognition of these issues in the FY23 funding bill with the inclusion
of report language and funding for enforcement of the PSA. We urge you
to continue to include following report language in fiscal Year 2024:
The Committee recognizes that consolidation in
agribusiness can be detrimental to farmers, consumers,
workers, and the environment. The Committee considers
enforcement of the Packers and Stockyards Act a top
priority and directs the Department to continue
enforcing the act to the fullest extent of the law.
Further, the Committee urges the USDA Agricultural
Marketing Service (AMS) and other agencies and mission
areas to fully incorporate fair and competitive markets
priorities across relevant programs and operations.
enforcement of the packers and stockyards act
Livestock and poultry markets are based on asymmetric information,
limited or nonexistent price discovery, extreme buyer power at the
regional level, and widespread retaliation and deception in many forms.
To address these systemic problems, producers need a comprehensive set
of regulations, along with a strategy for robust enforcement by the
USDA. CFFE supports the regulatory updates and clarifications to the
PSA currently being promulgated by the Agricultural Marketing Service's
Packers and Stockyards Division.
In addition to providing a long overdue update to improve
enforcement of the PSA, these rules will serve as an important
complement to the USDA's plans to invest significant resources into new
and expanded meat and poultry processing infrastructure. If the USDA
does not also prioritize robust enforcement of antitrust laws to level
the playing field in these markets, these investments will not create
processing capacity that is economically viable in the long-term.
We oppose any efforts to interfere with the USDA's rulemaking
authority and the ongoing Packers and Stockyards Act rulemakings in the
appropriations process or other legislation. Additionally, we request
that the Committee provide AMS with additional funding for Packers and
Stockyards Act enforcement at the $35 million level.
cattle contracts library
We encourage the Committee to renew the Cattle Contracts Library
pilot program that was first appropriated in FY23. This pilot program
has just begun to provide information to producers and others, and
needs more time to provide desperately needed transparency about what
types of contracts are being offered by large meatpackers to cattle
producers.
[This statement was submitted by Patty Lovera, Policy Advisor,
Campaign for Family Farms and the Environment.]
______
Prepared Statement of Central Arizona Water Conservation District
On behalf of the Central Arizona Water Conservation District
(CAWCD), I am writing to ask that you include $12.2 million in the U.S.
Department of Agriculture's Environmental Quality Incentives Program
Financial Assistance (EQIP FA) for the Colorado River Basin Salinity
Control Program in the Fiscal Year 2024 Appropriation bill. The
salinity control funding under EQIP FA will help protect the water
quality of the Colorado River that is used by approximately 40 million
people for municipal and industrial purposes and used to irrigate
approximately 5.5 million acres in the United States.
The CAWCD manages the Central Arizona Project (CAP), a multi-
purpose water resource development and management project that delivers
Colorado River water into central and southern Arizona. The largest
supplier of renewable water in Arizona, CAP delivers up to 1.5 million
acre-feet of Arizona's 2.8-million-acre-foot Colorado River entitlement
each year to municipal and industrial users, agricultural irrigation
districts, and Indian communities.
Our goal at CAWCD is to provide an affordable, reliable and
sustainable supply of Colorado River water to a service area that
includes more than 80 percent of Arizona's population.
These renewable water supplies are critical to Arizona's economy
and to the economies of Native American communities throughout the
state. Nearly 90 percent of economic activity in the State of Arizona
occurs within CAP's service area. The canal provides an economic
benefit of $100 billion annually, accounting for one-third of the
entire Arizona gross state product. CAP also helps the State of Arizona
meet its water management and regulatory objectives of reducing
groundwater use and ensuring availability of groundwater as a
supplemental water supply during future droughts. Achieving and
maintaining these water management objectives is critical to the long-
term sustainability of a State as arid as Arizona.
negative impacts of concentrated salts
Natural and man-induced salt loading to the Colorado River creates
environmental and economic damages. EPA has identified that more than
60 percent of the salt load of the Colorado River comes from natural
sources. With the significant Federal ownership in the Basin, most of
this comes from federally administered lands. Human activity,
principally irrigation, adds to the salt load of the Colorado River.
Further, natural and human activities concentrate the dissolved salts
in the River.
The U.S. Bureau of Reclamation (Reclamation) has estimated
quantifiable damages at about $354 million per year. Modeling by
Reclamation indicates that damages will rise to approximately $671
million per year by 2040 without continuation of the Program. These
damages include:
--A reduction in the ability to reclaim and reuse water for
beneficial uses, including drinking water and irrigation water
supplies, due to high salinities in the water delivered to
water treatment and reclamation facilities;
--A reduction in the yield of salt sensitive crops and increased
water use to meet the leaching requirements in the agricultural
sector;
--Increased use of imported water and cost of desalination and brine
disposal for recycling water in the municipal sector;
--An increase in the use of water and the cost of water treatment,
and an increase in sewer fees in the industrial sector;
--An increase in the cost of cooling operations and the cost of water
softening, and a decrease in equipment service life in the
commercial sector;
--A reduction in the useful life of galvanized water pipe systems,
water heaters, faucets, garbage disposals, clothes washers, and
dishwashers, and increased use of bottled water and water
softeners in the household sector;
--A decrease in the life of treatment facilities and pipelines in the
utility sector, and
--Difficulty in meeting wastewater discharge requirements to comply
with National Pollutant Discharge Elimination System permit
terms and conditions, and an increase in desalination and brine
disposal costs due to accumulation of salts in groundwater
basins.
The threat of salinity continues to be a concern between the United
States and Mexico. Since the agreement of Minute 242 in 1973 to the
1944 Water Treaty, the United States has taken several actions to
improve the quality of water delivered to Mexico, including operating
and maintaining the Main Outlet Drain Extension (MODE). More recently,
on November 20, 2012, a 5-year agreement, known as Minute 319, was
signed between the U.S. and Mexico to guide future management of the
Colorado River. Among the key issues addressed in Minute 319 included
an agreement to maintain current salinity management and existing
salinity standards. The United States, Mexico, and key water users,
including CAWCD, worked since 2015 to develop a successor agreement,
Minute 323, which was finalized on September 27, 2017. Minute 323
continues collaboration and cooperation among the United States and
Mexico with respect to salinity control in the Colorado River system.
The CAWCD and other key water providers are committed to meeting these
goals.
Adequate funding for salinity control will prevent the water
quality of the Colorado River from further degradation and avoid
significant increases in economic damages to municipal, industrial and
irrigation users.
conclusion
Implementation of salinity control practices through EQIP has
proven to be a very cost-effective method of controlling the salinity
in the Colorado River. CAWCD urges the subcommittee to include $12.2
million from the USDA's Environmental Quality Incentive Program
Financial Assistance for the Colorado River Basin Salinity Control
Program in the Fiscal Year 2024 Appropriation bill. Additionally, there
is needed sufficient Technical Assistance dollars to adequately
implement the program. The funding level will prevent the further
degradation of water quality of the Colorado River, and significantly
increased damages from the higher salt concentrations to municipal,
industrial and irrigation users.
[This statement was submitted by Brenda Burman, General Manager.]
______
Prepared Statement of the Center for Invasive Species Prevention
The Center for Invasive Species Prevention (CISP) and the Vermont
Woodlands Association (VWA) urge continued support by the subcommittee
on Agriculture and related agencies for a Federal program that is key
to protecting America's urban and rural forests from pest-caused
mortality: the USDA Animal and Plant Health Inspection Service (APHIS).
APHIS is responsible for preventing introduction and spread of pests
that harm agriculture, including forests. While most port inspections
are carried out by the Department of Homeland Security Bureau of
Customs and Border Protection, APHIS sets the policy guidance. APHIS
also inspects imports of living plants.
----------------------------------------------------------------------------------------------------------------
FY 2024 Pres'
Program FY 2022 (millions) FY 2023 (millions) request (millions) Our ask (millions)
----------------------------------------------------------------------------------------------------------------
Tree & Wood Pests............... $61 $63 $64 $65
Specialty Crops................. $210 $216 $222 $222
Pest Detection.................. $28 $29 $30 $30
Methods Development............. $21 $23 $23 $25
----------------------------------------------------------------------------------------------------------------
We thank you for recent incremental funding increases for these
programs. We welcome the additional increases proposed by the
Administration. Unfortunately, more substantial investments are needed.
Introduced pests threaten many forest products and services
benefitting all Americans. These include wood products; wildlife
habitat; carbon sequestration; clean water and air; storm water
management; lower energy costs; improved health; aesthetic enjoyment;
and jobs. Already, the 15 most damaging non-native pests threaten at
least 41 percent of forest biomass in the ``lower 48'' States. These 15
species have caused an additional annual conversion of live biomass to
dead wood at a rate similar in magnitude to that attributed to fire
(5.53 TgC per year for pests v. 5.4 to 14.2 TgC per year for fire).\1\
---------------------------------------------------------------------------
\1\ Fei, S., R.S. Morin, C.M. Oswalt, and A.M. 2019. Biomass losses
resulting from insect and disease invasions in United States forests.
PNAS August 27, 2019. Vol. 116 No. 35 17371-17376
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These pests also impose significant costs that are borne
principally by municipal governments and homeowners. As more pests have
been accidentally introduced, these costs have risen. By 2050,\2\ 1.4
million street trees in urban areas and communities will probably be
killed by introduced insect pests. High costs will be seen in Milwaukee
and Madison Wisconsin; the Chicago area; Cleveland; and Baltimore,
Towson, and Salisbury, Maryland. Removing and replacing these trees is
projected to cost cities $30 million per year. Additional trees in
parks, on homeowners' properties, and in urban woodlands--will also die
and require removal and replacement.
---------------------------------------------------------------------------
\2\ Hudgins, E.J., F.H. Koch, M.J. Ambrose, and B. Leung. 2022.
Hotspots of pest-induced US urban tree death, 2020-2050. Journal of
Applied Ecology
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Tree-killing pests are linked to the international supply chain.
Many pests-especially the highly damaging wood-borers-arrive in
inadequately treated crates and pallets made of wood.
Imports from Asia transport the most damaging pests, e.g., Asian
longhorned beetle, emerald ash borer, redbay ambrosia beetle, and the
invasive shot hole borers. U.S. imports from Asia involve an estimated
20 million shipping containers annually. At least 33,000 of these
containers, perhaps twice that number,\3\ probably carry a tree-killing
pest. If an Asian wood-boring insect that attacks maples or oaks were
introduced, it could kill 6.1 million trees and cost American cities
$4.9 billion over 30 years.\4\ The risk would be highest if this pest
were introduced to the South--a growing likelihood given rising direct
shipments from Asia following the expansion of the Panama Canal in
2016.
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\3\ Haack RA, Hardin JA, Caton BP and Petrice TR (2022) Wood borer
detection rates on wood packaging materials entering the United States
during different phases of ISPM#15 implementation and regulatory
changes. Front. For. Glob. Change 5:1069117. doi: 10.3389/
ffgc.2022.1069117
\4\ Hudgins, et al. op. cit.
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Since 2006, all countries shipping goods to North America must
treat their wood packaging according to specified protocols in the
International Standard for Phytosanitary Measures (ISPM) #15. However,
as of 2020, 0.22 percent [1/5th of 1 percent] of the shipping
containers entering the U.S. were infested by a tree-killing insect.\5\
This equates to tens of thousands of containers harboring tree-killing
insects.
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\5\ Haack et al. op cit.
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Worse, trade partners' compliance with the rules has deteriorated;
the ``approach rate'' of pest-infested wood packaging fell in 2005-
2006, but has since gone back up. The most troubling of offenders is
China. China has been required to treat its wood packaging since
December 1998. Nevertheless, in the 2010-2020 period, 0.73 percent [or
3/4 of 1 percent] of its wood packaging contained a tree-killing pest.
This is three times the global average for the period. China supplied
40.7 percent of U.S. imports in 2022,\6\ (5,655,000 containers), so it
alone might be sending to our shores 30,000 containers infested with
tree-killing insects. These pests threaten all our forests and the
ecosystem services they provide.
---------------------------------------------------------------------------
\6\ Szakonyi, M. 2023. Sourcing shift from China pulls US import
share to more than a decade low.
---------------------------------------------------------------------------
We suggest that the subcommittee ask APHIS what steps it will take
to end China's noncompliance. (The Department of Homeland Security's
Bureau of Customs and Border Protection has twice strengthened its
enforcement of wood packaging rules. In 2017 it began penalizing
importers of non-compliant wood packaging under Title 19 of the United
States Code. In 2021, it incorporated the wood packaging requirements
into its voluntary C-TPAC program.)
ISPM#15 per se is falling short at the global level. The presence
of the mark indicating that a crate or pallet complies with ISPM#15 is
not reliable. Therefore we suggest further that the subcommittee ask
APHIS what steps it is taking at the global level to improve the
efficacy of ISPM#15--or to replace it if necessary to ensure that pests
are not being introduced.
Other pests-especially plant diseases and sap sucking insects-come
on imported plants. The U.S. imported about 5 billion plants in
2021.\7\ Recent introductions probably via this pathway include several
pathogens-e.g. rapid ?ohi?a death in Hawai`i, beech leaf disease
(established from Ohio to Maine), and boxwood blight. Insects have also
been introduced on imported plants recently; one example is the elm
zigzag sawfly (present in North Carolina, Virginia, and New York).
---------------------------------------------------------------------------
\7\ MacLachlan, M.J., A. M. Liebhold, T. Yamanaka, M. R.
Springborn. 2022. Hidden patterns of insect establishment risk revealed
from two centuries of alien species discoveries. Sci. Adv. 7, eabj1012
(2021).
---------------------------------------------------------------------------
In 2009,\8\ approximately 12 percent of plant shipments were
infested by a pest. This pest approach rate is more than 50 times
higher than the 0.22 percent approach rate for wood packaging. APHIS
has adopted several changes to its phytosanitary system for imported
plants in the decade since 2009. The few analyses published have not
considered pathogens. We suggest that the subcommittee ask APHIS to
facilitate an independent analysis of the efficacy of the agency's
current phytosanitary programs to prevent introductions of pests on
important plants, with an emphasis on introductions of plant pathogens.
---------------------------------------------------------------------------
\8\ Liebhold, A.M., E.G. Brockerhoff, L.J. Garrett, J.L. Parke, and
K.O. Britton. 2012. Live Plant Imports: the Major Pathway for Forest
Insect and Pathogen Invasions of the US. Frontiers in Ecology.
---------------------------------------------------------------------------
Once introduced, invasive pests do not stay in the cities where
they first arrived. Instead, they proliferate and spread--often
facilitated by movement of firewood, plants, and outdoor household
goods such as patio furniture.
APHIS is responsible for preventing spread of the sudden oak death
pathogen, Phytophthora ramorum, through trade in nursery plants. In
recent years California has had few detections in nurseries and little
expansion in forests--probably because the drought suppressed the
fungus. This year's very wet winter will probably lead to a new disease
outbreaks. In cooler, wetter conditions in Oregon and Washington,
detections in nurseries and in the forest or plantings continue.
In 2022, P. ramorum was detected at 18 establishment, 12 of which
were first-time detections. We believe reduced funding in support for
the California nursery regulatory program are unwise given the increase
in outbreaks likely to result from the wet 2022-2023 winter. Oregon and
Washington continue to detect infestations in additional retailers
brought in by plants bought from other nurseries. Washington responded
to several ``trace forward'' incidents, one involving more than 160
residential sites. APHIS' program is not succeeding in eradicating P.
ramorum from nurseries. We suggest that the subcommittee ask APHIS what
steps it is taking to improve the efficacy of the SOD program.
In the East, P. ramorum was found in three of 65 streams sampled in
10 primarily southeastern States. Most troubling is the first-time
detection in South Carolina. P. ramorum has now been detected from
eight streams in four States, Alabama, Mississippi, North Carolina, and
now South Carolina. The pathogen has been present in some of these
streams for more than 10 years. Is it established?
Oregon faces particularly high risks because three of the four
known genetic strains of Phytopthora ramorum are established in the
State's forests. This proliferation is likely to promote more
aggressive infections, so exacerbating the disease. How did these three
strains enter the U.S.?
Beech trees so important to wildlife conservation in the Northeast
are under attack by two pathogens and at risk to an insect. Most
alarming is the rapid spread of beech leaf disease from Ohio to Maine.
A leaf-feeding weevil is spreading south in eastern Canada. We suggest
that the subcommittee ask APHIS what steps it is taking to prevent its
introduction to the U.S.
'Ohi'a trees make up 80 percent of the biomass of forests across
the Hawaiian archipelago. They are under attack by two introduced
diseases first detected in 2010. How is APHIS helping to protect these
forests-so important to biodiversity and other ecosystem services,
including water supplies?
aphis funding levels
To respond effectively to these pests and to the others that will
be introduced in coming years, the key APHIS programs identified above
must have adequate funds--even in this time of budgetary constraints.
For this reason, we thank the Congress for increasing funding for
APHIS' Tree and Wood Pests program to $64 million in fiscal year 2023
and ask that you raise it to $65 million in FY2024.
The Tree and Wood Pests account supports eradication and control
efforts targeting principally the Asian longhorned beetle (ALB) and
spongy (formerly gypsy) moth. Eradicating the ALB normally receives
about two-thirds of the funds. The programs in Massachusetts, New York,
Ohio, and South Carolina must continue until eradication succeeds.
Oregon detected the emerald ash borer (EAB) near Portland in 2022.
More than 9,000 ash trees along Portland's streets and thousands more
in parks will probably die. In wetlands of the Willamette Valley, ash
constitutes almost 100 percent of the forest trees. Washington and
California also face risks. Indeed, the Hudgins study identified
Seattle and Takoma as likely to lose thousands of ash trees. The
numerous ash in riparian forests, windbreaks, and towns of North Dakota
are also at risk since EAB is established in South Dakota, Minnesota,
and Manitoba. We suggest that the Committee ask APHIS what it has
learned from the EAB program's failure and how it will apply that
lesson to other programs.
We have described failures of the Specialty Crops program to
prevent spread of the sudden oak death pathogen through the interstate
trade in nursery plants. We support the Administration's request for
$222 million for this program. However, we ask that the Committee
ensure that APHIS allots adequate funding under this budget line to
management of sudden oak death, and such new invaders as rapid 'ohi'a
death in Hawai`i, and beech leaf disease and elm zig-zag sawfly in the
East.
We support the Administration's request for the Pest Detection
program. This program is key to the prompt detection of newly
introduced pests that is critical to successful pest eradication or
containment. However, we ask for a small increase for the ``Methods
Development'' program, which enables APHIS to improve development of
essential detection and eradication tools.
We note that the current $1 million emergency fund is far below the
level needed to respond when a new pest is discovered. Funding
constraints have hampered APHIS' response to past pest incursions.
[This statement was submitted by Faith T. Campbell, President,
Center for Invasive Species Prevention.]
______
Prepared Statement of the Colorado River Board of California (Board)
This testimony is provided by the Colorado River Board of
California (Board) and is in support of Fiscal-Year 2024 funding for
the U.S. Department of Agriculture (USDA) associated with those
activities that assist in the implementation of Title II of the
Colorado River Basin Salinity Control Act of 1974 (Public Law 93-320),
as amended. This long-standing and cost-effective salinity control
program in the Colorado River Basin is being carried out pursuant to
the Colorado River Basin Salinity Control Act and the Clean Water Act
(Public Law 92-500). Congress authorized the Colorado River Basin
Salinity Control Program (Program) in 1974 to offset increased damages
caused by continued development and use of the waters of the Colorado
River. The USDA portion of the Program, as authorized by Congress and
funded and administered by the Natural Resources Conservation Service
(NRCS) under the Environmental Quality Incentives Program (EQIP), is an
essential part of the overall effort. A funding level of at least $12.2
million in EQIP Financial Assistance (FA) is required annually to
prevent further degradation of the quality of the Colorado River and
increased downstream environmental and economic damages.
The Board is the state agency charged with protecting California's
interests and rights in the water and power resources of the Colorado
River system. In this capacity, California participates along with the
other six Colorado River Basin States in the Colorado River Basin
Salinity Control Forum (Forum), the interstate organization responsible
for coordinating the Basin States' salinity control efforts. In close
cooperation with the U. S. Environmental Protection Agency (EPA) and
pursuant to requirements of the Clean Water Act, the Forum is charged
with reviewing the Colorado River's water quality standards every 3
years. The Forum adopts a Plan of Implementation consistent with these
water quality standards. The level of appropriation being supported in
this testimony is consistent with the Forum's 2020 Plan of
Implementation. The Forum's 2020 Plan of Implementation can be found on
this website: https://coloradoriversalinity.org/docs/
2020%20REVIEW%20Final percent20w percent20appendices.pdf. If adequate
funds are not appropriated, significant damages associated with
increasing salinity concentrations of Colorado River water would become
more widespread in the United States and Mexico.
The Program benefits both the Upper Basin water users through more
efficient water management and Lower Basin water users through reduced
salinity concentration of Colorado River water. The salinity of
Colorado River waters increases from about 50 mg/L at its headwaters to
more than 700 mg/L in the Lower Basin. There are very significant
economic damages caused downstream by high salt levels in the water.
There are also local benefits in the Upper Colorado River Basin from
the Program in the form of soil and environmental benefits, improved
agricultural production, improved water efficiencies, reduced
fertilizer use and labor costs, and water distribution and
infrastructure improvements. Local producers submit cost-effective
applications under EQIP in Colorado, Utah, and Wyoming and offer to
cost-share in the acquisition of new irrigation equipment. The mix of
funding under EQIP, cost-share from the Basin States and efforts and
cost-share brought forward by local producers has created a most
remarkable and successful partnership.
At the urging of the States and directives from Congress, NRCS
recognized that the Program is different than small watershed
enhancement efforts common to EQIP. In the case of Colorado River
salinity control efforts, the watershed being managed stretches more
than 1,400 miles from the Colorado River's headwaters in the Rocky
Mountains to the Colorado River's terminus in the Gulf of California in
Mexico. Each year, NRCS State Conservationists in Colorado, Utah and
Wyoming prepare a 3-year funding plan for the salinity control efforts
under EQIP. The Board supports this funding plan which recognizes the
need for $12.2 million in EQIP Financial Assistance (FA) allocations in
fiscal Year 2024. Additionally, there is still a need for sufficient
Technical Assistance (TA) dollars to adequately implement the Program.
It has been over forty-nine years since the passage of the Colorado
River Basin Salinity Control Act and much has been learned about the
impact of salts in the Colorado River system. Currently, the salinity
concentration of Colorado River water causes about $354 million in
quantifiable damages in the United States annually. Economic and
hydrologic modeling by Reclamation indicates that the quantifiable
damages could rise to nearly $671 million by the year 2040 without the
continuation of the Program. For example, damages can be incurred
related to the following activities:
--A reduction in the ability and increased costs to re-claim and
reuse water due to high salinities in the water delivered to
water treatment and reclamation facilities;
--A reduction in the yield of salt sensitive crops and increased
water use to meet the leaching requirements in the agricultural
sector;
--Increases in the volumes of imported water required;
--Increased costs of desalination and brine disposal for recycling
water in the municipal and industrial sectors;
--A reduction in the useful life of galvanized water pipe systems,
water heaters, faucets, garbage disposals, clothes washers, and
dishwashers, and increased use of bottled water and water
softeners in the household sector;
--An increase in the cost of cooling operations and the cost of water
softening, and a decrease in equipment service life in the
commercial sectors;
--An increase in the use of water and the cost of water treatment,
and an increase in sewer fees in the industrial sectors;
--A decrease in the life of treatment facilities and pipelines in the
utility sectors;
--Difficulty in meeting wastewater discharge requirements to comply
with National Pollutant Discharge Elimination System permit
terms and conditions; and
--An increase in desalination and brine disposal costs due to
accumulation of salts in groundwater basins.
The Colorado River is, and will continue to be, a major and vital
water resource to the nearly 20 million residents and 860,000 acres of
irrigated agriculture within southern California, including municipal,
industrial, and agricultural water users in Imperial, Los Angeles,
Orange, Riverside, San Bernardino, San Diego, and Ventura Counties. The
protection and improvement of Colorado River water quality through the
continuation and expansion of an effective salinity control program
avoids additional economic and environmental damages to Mexico,
California and the other States that rely on Colorado River water
resources.
Thank you for your consideration of this testimony.
[This statement was submitted by Christopher S. Harris, Executive
Director, Colorado River Board of California.]
______
Prepared Statement of the Colorado River Basin Salinity Control Program
Congress authorized the Colorado River Basin Salinity Control
Program (Program) through the Colorado River Basin Salinity Control Act
(Act) in 1974 to offset increased damages caused by continued
development and use of the waters of the Colorado River. Congress has
directed the Secretary of Agriculture to participate in the
implementation of the Program. The USDA portion of the Program, as
authorized by Congress and funded and administered by the Natural
Resources Conservation Service (NRCS) under the Environmental Quality
Incentives Program (EQIP), is an essential part of the overall effort.
A funding level of $12.2 Million in EQIP Financial Assistance (FA) in
2024 is consistent with the Program's Plan of Implementation and is
required to prevent further degradation of the quality of the Colorado
River and commensurate increases in economic damages to water users.
The Program is currently funded under NRCS's EQIP and under the
Bureau of Reclamation's Basinwide Program. Recognizing that
agricultural improvements are some of the most cost-effective
strategies, Congress passed several Acts to authorize and fund the
United States Departments of Agriculture and Interior to establish a
voluntary, cooperative program with irrigators to improve water
management and reduce watershed erosion:
--1984 amendment of the Salinity Control Act
--1996 Federal Agriculture Improvement and Reform Act
--2002 Farm Security and Rural Investment Act (FSRIA)
--2008 Food, Conservation and Energy Act (FCEA)
--2018 Agricultural Improvement Act
The Program, as set forth in the act, is to reduce salinity levels
for the benefit of Lower Basin water users hundreds of miles downstream
from the sources of salinity in the Upper Basin. EQIP is used to
improve upstream irrigation efficiencies, which in turn reduces
leaching of salts to the Colorado River. The Upper Colorado River Basin
also benefits from the Program as it provides soil and environmental
benefits, improved agricultural production, improved water
efficiencies, lower fertilizer and labor costs, and water distribution
and infrastructure improvements. EQIP also fosters good collaboration
between farmers and ranchers, States, and the Federal Government in
complying with U.S. Environmental Protection Agency mandated water
quality standards. Local producers submit cost-effective applications
under EQIP in Colorado, Utah and Wyoming and offer to cost share in the
acquisition of new irrigation equipment. The mix of funding under EQIP,
cost share from the Basin States and efforts brought forward by local
agricultural producers has created a successful partnership.
This Program is different from small watershed enhancement efforts
common to EQIP. The watershed to be considered stretches more than
1,400 miles from the Colorado River's headwaters in the Rocky Mountains
to the Colorado River's terminus in the Gulf of California in Mexico.
Each year the NRCS State Conservationists for Colorado, Utah and
Wyoming prepare a 3-year funding plan for the salinity efforts under
EQIP.
The State of New Mexico supports this funding plan which recognizes
the need for $12.2 M in EQIP FA allocations in fiscal Year 2024.
Additionally, there is a need for sufficient EQIP Technical Assistance
(TA) dollars to adequately implement the program. State and local cost
sharing is triggered by the Federal appropriation. New Mexico
appreciates the efforts of NRCS leadership and the support of this
subcommittee in implementing the Program.
Damages to water users in the United States and Mexico, caused by
the concentration of salt in the Colorado River, include:
--reduced ability to reclaim and reuse water for beneficial uses,
--reduced yield of salt sensitive crops,
--increased use of imported water and cost of desalination,
--reduced useful life of galvanized water pipe systems and
appliances,
--increased use of bottled water and water softeners,
--increased cost of cooling operations and water softening,
--increased cost of water treatment,
--increased sewer fees,
--decreased lifespan of treatment facilities and pipelines,
--difficulty meeting wastewater discharge requirements to comply with
National Pollutant Discharge Elimination System permit
requirements,
The State of New Mexico is a member of the Colorado River Basin
Salinity Control Forum (Forum) which is composed of gubernatorial
appointees from Arizona, California, Colorado, Nevada, New Mexico,
Utah, and Wyoming. Every third year, the Forum adopts a Plan of
Implementation consistent with efforts to facilitate compliance with
the Clean Water Act. The level of appropriation requested in this
testimony is in keeping with the adopted Plan of Implementation. If
adequate funds are not appropriated, significant damages from higher
salinity concentrations in the water will be more widespread in the
United States and Mexico.
NRCS personnel have developed a productive working relationship
with farmers within the Colorado River Basin. Additionally, technical
assistance is required for planning, design and implementation of
future projects. Continued funding for the monitoring and evaluation of
existing projects is essential to maintaining the salinity reduction
already achieved.
New Mexico stands in support of continuation of EQIP with adequate
funding levels dedicated to the Program.
[This statement was submitted by Mike A. Hamman, P.E., State
Engineer.]
______
Prepared Statement of the Colorado River Basin Salinity Control Forum
Waters from the Colorado River are used by approximately 40 million
people for municipal and industrial purposes and used to irrigate
approximately 5.5 million acres in the United States. Natural and
human-induced salt loading to the Colorado River creates environmental
and economic damages. In 2020 the Bureau of Reclamation (Reclamation)
estimated the quantifiable damages to Lower Basin water users due to
elevated salinity levels at about $354 million per year (unquantifiable
damages add to this amount). Congress authorized the Colorado River
Basin Salinity Control Program (Program) through the Colorado River
Basin Salinity Control Act (Act) (Public Law 93-320) in 1974 to offset
increased damages caused by continued development and use of the waters
of the Colorado River. Modeling by Reclamation indicates that the
quantifiable damages will rise to approximately $671 million annually
by the year 2040 without continuation of the Program. Congress has
directed the Secretary of Agriculture to participate in the
implementation of the Program. The USDA portion of the Program, as
authorized by Congress and funded and administered by the Natural
Resources Conservation Service (NRCS) under the Environmental Quality
Incentives Program (EQIP), is an essential part of the overall effort.
A funding level of $12.2 M in EQIP Financial Assistance (FA) in 2024 is
consistent with the Program's Plan of Implementation and is required to
prevent further degradation of the quality of the Colorado River and
commensurate increases in downstream economic damages to water users.
In enacting the Colorado River Basin Salinity Control Act in 1974,
Congress directed that the Colorado River Basin Salinity Control
Program should be implemented in a cost-effective way. The Program is
currently funded under EQIP through NRCS and under Reclamation's
Basinwide Program. Recognizing that agricultural on-farm improvements
are some of the most cost-effective strategies, Congress authorized the
United States Department of Agriculture (USDA) to establish a
voluntary, cooperative program with irrigators to improve on-farm water
management and reduce watershed erosion through amendment of the act in
1984 (Public Law 98-569). With the enactment of the Federal Agriculture
Improvement and Reform Act of 1996 (FAIRA) (Public Law 104-127),
Congress directed that the Program should continue to be implemented as
part of the then newly created EQIP. Since the enactment of the Farm
Security and Rural Investment Act (FSRIA) in 2002, and more recent EQIP
funding levels, there have been, for the first time in a number of
years, opportunities to adequately fund the Program within EQIP. In
2008, Congress passed the Food, Conservation and Energy Act (FCEA)
(Public Law 110-234). The FCEA amended the act to address the cost
sharing requirement and established the Basin States Program (BSP). The
BSP provides the mechanism for expenditure of 30 percent of the total
amount spent each year by the combined EQIP and BSP effort. With the
passage of the Agricultural Improvement Act of 2018 (Public Law 115-
334), the authority for USDA to implement salinity control activities
in the Colorado River Basin was continued.
The Program, as set forth in the act, is to benefit Lower Basin
water users hundreds of miles downstream from the sources of salinity
in the Upper Basin. The salinity of Colorado River waters increases
from about 50 mg/L at its headwaters to more than 700 mg/L in the Lower
Basin. There are very significant economic damages caused downstream by
high salt levels in the water. EQIP is used to improve upstream
irrigation efficiencies, which in turn reduce leaching of salts to the
Colorado River. There are also local benefits in the Upper Colorado
River Basin from the Program in the form of soil and environmental
benefits, improved agricultural production, improved water
efficiencies, lower fertilizer and labor costs, and water distribution
and infrastructure improvements. Also important is the collaboration
that EQIP fosters between farmers and ranchers, States, and the Federal
Government in complying with U.S. Environmental Protection Agency
mandated water quality standards and the attainment of multi-benefit
economic and sustainability goals. Local producers submit cost-
effective applications under EQIP in Colorado, Utah and Wyoming and
offer to cost share in the acquisition of new irrigation equipment. The
mix of funding under EQIP, cost share from the Basin States and efforts
and cost share brought forward by local agricultural producers has
created a most remarkable and successful partnership.
After longstanding urgings from the States and directives from
Congress, NRCS recognized that this Program is different from small
watershed enhancement efforts common to EQIP. In the case of the
Colorado River salinity control effort, the watershed to be considered
stretches more than 1,400 miles from the Colorado River's headwaters in
the Rocky Mountains to the Colorado River's terminus in the Gulf of
California in Mexico. Each year the NRCS State Conservationists for
Colorado, Utah and Wyoming prepare a 3-year funding plan for the
salinity efforts under EQIP. The Colorado River Basin Salinity Control
Forum (Forum) supports this funding plan which recognizes the need for
$12.2 M in EQIP FA allocations in fiscal Year 2024. Additionally, there
is a need for sufficient EQIP Technical Assistance (TA) dollars to
adequately implement the program. State and local cost sharing is
triggered by the Federal appropriation. The Forum appreciates the
efforts of NRCS leadership and the support of this subcommittee in
implementing the Program.
Damages to water users in the United States and Mexico, caused by
the concentration of salt in the Colorado River, by water usage sector,
include the following:
--a reduction in the ability to reclaim and reuse water for
beneficial uses, including drinking water and irrigation water
supplies, due to high salinities in the water delivered to
water treatment and reclamation facilities,
--a reduction in the yield of salt sensitive crops, increased water
use to meet leaching requirements and additional actions
necessary to comply with the Clean Water Act within the
agricultural sector,
--increased use of imported water and cost of desalination and brine
disposal for recycling water in the municipal sector,
--a reduction in the useful life of galvanized water pipe systems,
water heaters, faucets, garbage disposals, clothes washers and
dishwashers, and increased use of bottled water and water
softeners in the household sector,
--an increase in the cost of cooling operations and the cost of water
softening, and a decrease in equipment service life in the
commercial sector,
--an increase in the use of water and the cost of water treatment,
and a corresponding increase in sewer fees in the industrial
sector,
--a decrease in the lifespan of treatment facilities and pipelines in
the utility sector, and
--difficulty in meeting wastewater discharge requirements to comply
with National Pollutant Discharge Elimination System permit
terms and conditions, and an increase in desalination and brine
disposal costs necessary to minimize accumulation of salts in
groundwater basins.
The Colorado River Basin Salinity Control Forum (Forum) is composed
of gubernatorial appointees from Arizona, California, Colorado, Nevada,
New Mexico, Utah, and Wyoming. The Forum is charged with reviewing the
Colorado River's water quality standards for salinity every 3 years to
facilitate compliance with Section 303(c) of the Clean Water Act
(Public Law 92-500). In so doing, it adopts a Plan of Implementation
consistent with these standards. The level of appropriation requested
in this testimony is in keeping with the adopted Plan of
Implementation. If adequate funds are not appropriated, significant
damages from higher salinity concentrations in the water will be more
widespread in the United States and Mexico.
Over the years, NRCS personnel have developed a productive working
relationship with farmers within the Colorado River Basin. Maintaining
salinity control achieved by implementation of past practices requires
continuing education and technical assistance from NRCS personnel.
Additionally, technical assistance is required for planning, design and
implementation of future projects. Lastly, the continued funding for
the monitoring and evaluation of existing projects is essential to
maintaining the salinity reduction already achieved.
In summary, implementation of salinity control practices through
EQIP has proven to be a very cost-effective method of controlling the
salinity of the Colorado River and is an essential component to the
overall Colorado River Basin Salinity Control Program. Continuation of
EQIP with adequate funding levels dedicated to the Program will prevent
the water quality of the Colorado River from further degradation and
significant increases in economic damages to municipal, industrial and
irrigation users. A modest investment in source control pays huge
dividends in improved water quality for nearly 40 million Americans.
[This statement was submitted by Don A. Barnett, Executive
Director, Colorado River Basin Salinity Control Forum.]
______
Prepared Statement of Entomological Society of America
The Entomological Society of America (ESA) respectfully submits
this statement for the official record in support of funding for
agricultural research at the U.S. Department of Agriculture (USDA). ESA
joins the research community and requests discretionary appropriations
of at least $2.080 billion in fiscal year 2024 for USDA's National
Institute of Food and Agriculture (NIFA), including at least $500
million for the Agriculture and Food Research Initiative (AFRI). The
Society also supports a topline funding level of at least $1.95 billion
for the Agricultural Research Service (ARS) including robust funding
for the ARS Crop Protection budget as well as funding to preserve
valuable pest management research, invasive species programs, and
pollinator health in fiscal Year 2022. Additionally, ESA supports at
least $1.188 billion for Animal and Plant Health Inspection Service
(APHIS) to carry out its mission of safeguarding domestic agriculture
from foreign and invasive threats.
ESA requests at least $2.080 billion in fiscal Year 2024 for USDA's
NIFA. NIFA grants support research that aims to solve national
challenges in agriculture, food, the environment, and communities. One
example of important NIFA grants are those that support integrated pest
management (IPM). IPM is the most sustainable long-term solution to
pest problems, which are a constant threat to the agriculture in the
United States. U.S. farmers lose approximately 10-35 percent of their
crops to pests every year, and they spent $9 billion on pesticides
(including insecticides, fungicides, and herbicides) in 2019 alone. IPM
integrates multiple pest management tactics to protect crops. This
integration of multiple strategies and technologies helps to minimize
overuse of any one strategy, specifically pesticides, which reduces the
risk of resistance development, secondary pest outbreaks, and other
unintended consequences.
NIFA supports several programs that fund IPM research, and IPM is
most directly supported by the Federal Crop Protection and Pest
Management grant program, which was established when several budget
lines were consolidated in 2014. Funding for IPM took dramatic cuts in
the amount of more than $63 million during that consolidation and has
remained static for many years. Continued investment in IPM
Infrastructure is vital for protecting U.S. agricultural production to
safeguard U.S. agricultural industry and food supply.
ESA requests at least $500 million for AFRI in fiscal Year 2024. As
NIFA's premier competitive research program, AFRI funds a wide range of
agricultural research, education, and extension projects at
universities and research institutions nationwide. To maximize its
resources, AFRI supports projects that address key societal challenges
and build foundational knowledge in high-priority areas of the food and
agricultural sciences. For example, with AFRI funding, scientists based
at Iowa State University tested how small strips of prairie grasses
could be integrated into corn and soybean fields in the Midwest to
advance ecosystem services with minimal impacts on crop production.\1\
They found that the integration of prairie grass reduced nutrient
runoff and soil erosion while increasing the abundance and diversity of
bees, without significant loss in agricultural productivity. This work
has been foundational across multiple disciplines, and the technique
was included as a conservation practice supported by the Farm Bill in
2018.
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\1\ https://app.dimensions.ai/details/grant/grant.8819440
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Another critical function of the AFRI program is to fund timely
research on human nutrition. For example, AFRI supported a study at
Virginia Polytechnic Institute focused on determining the protein
content and structure of black soldier fly larvae as a potential
alternative protein source.\2\ Continued funding of work like this can
help clarify the potential role insects can play in food security for
direct human consumption or for livestock feed.
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\2\ https://doi.org/10.3390/insects1112087
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ESA supports at least $1.95 billion for ARS and maintaining strong
funding levels for the Crop Protection and Crop Production accounts. As
USDA's intramural research agency, ARS funds research with a direct
impact on our Nation's agriculture enterprise, including in the areas
of crop and livestock production and protection, human nutrition, food
safety, and environmental stewardship. For example, the Brazilian
peppertree is a highly invasive plant that obstructs restoration
efforts in Everglades National Park.\3\ Recently, ARS scientists
collaborated with the University of Florida and Florida Department of
Food and Consumer Services to test the potential of Brazilian
peppertree thrips, natural predators, as a cost-effective and
environmentally friendly method to control these invasive trees and
found that these insects are a viable solution.\4\
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\3\ https://agris.fao.org/agris-search/
search.do?recordID=US201600024952.
\4\ https://bioone.org/journals/florida-entomologist/volume-105/
issue-3/024.105.0308/Release-and-Persistence-of-the-Brazilian-
Peppertree-Biological-Control-Agent/10.1653/024.105.0308.full.
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ESA supports APHIS's mission to safeguard the Nation's agricultural
enterprise and native ecosystems and requests support for APHIS in
fiscal Year 2024 of at least $1.188 billion in discretionary funding,
in line with the fiscal Year 2024 President's Budget Request. APHIS
plays a critical role in protecting domestic soils from foreign threats
in the form of invasive species. Invasive insect pests are some of the
most costly and troublesome challenges faced by farmers, homeowners,
and others, and APHIS is tasked with preventing their entry into the
country, an increasingly challenging task considering increasing rates
of trade, human movement, and climate change. Only a tiny fraction of
cargo coming in through ports and planes are screened. While data-
driven methods for prioritizing shipment inspections based on
statistical risk are improving the odds of intercepting invasive pests
in international cargo, the capacity for international cooperation on
pre-border, border, and post-border inspection and response must be
expanded and improved. Furthermore, remote sensing could play a
significant role in increasing early detection and rapid response
(EDRR) to invasive pests, but it is virtually absent in insect pest
management. APHIS would benefit from a program dedicated to EDRR for
emerging threats. This would include an additional $25 million on top
of the $75 million authorized in the 2018 Farm Bill for a program
focused on responding to emerging invasive threats via EDRR at a high
level, rather than a threat-specific line item, giving APHIS the
flexibility and discretion to respond as new threats emerge.
In addition to responding to new threats, ESA supports APHIS's
continued research on known and destructive invasive pests including
the khapra beetle, which poses a threat to global food security and
which is not easily controlled with conventional techniques.\5\\6\
APHIS researchers identified a new attractant for use in traps for the
monitoring and surveillance of the beetle, which led to the filing of a
patent and an important public-private partnership to improve trapping
and monitoring of the khapra beetle.\7\
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\5\ https://portals.iucn.org/library/sites/library/files/documents/
2000-126.pdf
\6\ https://fmipa.umri.ac.id/wp-content/uploads/2016/03/
Amalendu_Chakraverty_Arun_S.--Mujumdar_HosahalliBookFi.org--.pdf.
\7\ https://link.springer.com/article/10.1007/s10340-019-01171-z.
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ESA also supports increased funding for research on pollinator
populations. Insects that play a role in pollination are vital to our
Nation's agriculture industry. Honeybees alone pollinate more than 100
crops in the U.S. and are essential to produce an estimated one-third
of all the food we eat or export. To ensure a healthy pollinator
population, more research is needed to examine the diverse factors that
endanger their health. ESA appreciates the establishment of the
Honeybee and Pollinator Research Coordinator position in the 2018 Farm
Bill. To this end, ESA supports USDA's coordination of multi-agency
activities through the Office of the Chief Scientist to further
investigate pollinator health and develop implementation plans to
prevent pollinator population decline.
ESA, headquartered in Annapolis, MD, is the largest organization in
the world serving the professional and scientific needs of
entomologists and individuals in related disciplines. Founded in 1889,
ESA is a non-partisan professional organization with over 7,000 members
affiliated with educational institutions, health agencies, private
industry, and government. Members are researchers, teachers, extension
service personnel, administrators, marketing representatives, research
technicians, consultants, students, pest management professionals, and
hobbyists. Thank you for the opportunity to accept the Entomological
Society of America's support for USDA research programs. For more
information about the Entomological Society of America, please see
http://www.entsoc.org/
[This statement was submitted by Marianne Alleyne, Ph.D.,
President, Entomological Society of America.]
______
Prepared Statement of Environmental and Energy Study Institute
Thank you for the opportunity to submit written testimony for the
record in support of programs under the subcommittee's jurisdiction
that support climate change mitigation and adaptation. Specifically,
our testimony highlights the need for at least $26 million for the
Rural Energy Savings Program (RESP) in Fiscal Year 2024.
The Environmental and Energy Study Institute (EESI) is a non-profit
organization founded in 1984 on a bipartisan basis by members of
Congress to help educate and inform policymakers, their staff,
stakeholders, and the American public about the benefits of a low-
emissions economy that prioritizes energy efficiency, renewable energy,
and new clean energy technologies.\1\ In 1988, EESI declared that
addressing climate change is a moral imperative, and that has since
guided our work. More recently, we have also developed a program to
provide technical assistance to rural utilities interested in on-bill
financing programs for energy efficiency, renewable energy and storage,
and beneficial electrification for their customers.
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\1\ About Us, https://www.eesi.org/about.
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RESP, administered by the U.S. Department of Agriculture (USDA)
Rural Utilities Service (RUS), was first authorized in the 2014 Farm
Bill.\2\ RESP provides zero-interest loans to electric cooperatives,
state financing entities, green banks, and others to establish or
expand residential and small business energy efficiency improvement
programs. These programs offer rural households and small businesses
no- or low-cost financing for cost-effective energy efficiency,
renewable energy, and electrification improvements. These improvements
are made at no upfront cost and repaid over time via a utility bill
line-item.\3\ On average, these improvements cost between $5,000 to
$15,000-an investment otherwise out of reach for many Americans,
particularly in rural areas where families pay on average 40 percent
more of their income for energy compared to their urban counterparts.
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\2\ Rural Energy Savings Program, https://www.rd.usda.gov/programs-
services/electric-programs/rural-energy-savings-program.
\3\ On-Bill Financing Project, https://www.eesi.org/obf/main.
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RESP loans are leveraged, so each dollar of Federal appropriations
facilitates zero-interest loans worth much more. But higher interest
rates mean the credit subsidy mechanism used by RUS results in less
leverage than before. An increase in appropriations in FY2024 is
necessary to keep RESP at a constant level of lending authority, which
also sends a message of certainty and confidence to prospective
borrowers.
The demand for RESP loans remains strong. RUS has awarded almost
$290 million in RESP loans.\4\ USDA plays a key role in efforts to help
drive economic growth and create jobs in rural communities, and robust
funding for RESP in FY2024 is critical to ensure low-income families
can enjoy the benefits of energy efficiency and clean energy
improvements.
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\4\ Rural Investments in Program Areas, https://www.rd.usda.gov/
rural-data-gateway/rural-investments/program-areas.
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The benefits of RESP are wide-ranging. For many families and small
businesses that ultimately receive the funds, they immediately realize
lower energy bills from insulation, air sealing, and new heating and
cooling equipment. Some RESP-funded programs also finance distributed
renewable energy generation, energy storage, electric vehicle supply
equipment, irrigation improvements, and more-provided that improvements
can be shown to be cost-effective to the end user.
These investments all have the added benefits of resource
conservation and, by lowering consumption and replacing fossil fuel
with renewable sources to generate electricity, greenhouse gas
emissions reductions. RESP also helps finance the last stretch of
broadband infrastructure from the main line, which increases the number
of households able to benefit from smart thermostats and other grid-
enabled devices. Many RESP-funded programs are designed so financing
for cost-effective improvements is accessible to all end-users
regardless of income or credit, which helps provide a more equitable
distribution of benefits.
Moreover, when implementing RESP programs, electric cooperatives
and other eligible entities support local jobs implementing these
improvements. The energy efficiency sector by itself accounted for
about 2.2 million jobs in 2021, according to the U.S. Energy and
Employment Report.\5\ Clean energy businesses contribute to local
economic development and provide workers with new training
opportunities, which are often too few in rural communities that
disproportionately suffer from persistent poverty and high energy
burdens.
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\5\ 2022 U.S. Energy and Employment Report Fact Sheet, https://
www.energy.gov/sites/default/files/2022-06/USEER percent202022
percent20Fact percent20Sheet_0.pdf.
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Thank you for your consideration.
[This statement was submitted by Daniel Bresette, President,
Environmental and Energy Study Institute.]
______
Prepared Statement of Food Industry Association
FMI--The Food Industry Association works with and on behalf of the
entire food industry to advance a safer, healthier, and more efficient
consumer food supply chain. FMI brings together a wide range of members
across the value chain--from retailers who sell to consumers, to
producers who supply the food, as well as the wide variety of companies
providing critical services--to amplify the collective work of the
industry. The reach and impact of our industry is extensive, ultimately
touching the lives of over 100 million households in the United States
and representing an $800 billion industry with nearly 6 million
employees.
In one of the final rulemaking actions to implement a relatively
narrow provision of the Food Safety Modernization Act (FSMA) passed by
Congress, the Food and Drug Administration (FDA) issued an incredibly
complex final rule--the Food Traceability Rule--in November 2022, more
than 10 years after FSMA passage (signed into Public Law on January 4,
2011). The legislation contained a much simpler and streamlined
provision targeting a small number of ``high-risk'' foods. However, the
rulemaking is 596 pages in length and the justification for determining
which foods are designated as ``high-risk'' is over 100 pages in
length- certainly challenging for any small business to confront and
attempt to comply with. While the list of foods FDA determined should
be included in this high-risk category, and thus subject to a 2-year
recordkeeping requirement, is not yet defined at the food product
level, the food and ingredient categories determined by an algorithm
include foods like cream cheese that should never be on a high-risk
list.
This action by FDA followed the publication of a proposed rule in
2021 seeking comments from stakeholders. FMI, along with other industry
stakeholders, submitted substantial comments outlining concerns with
the scope and magnitude of the proposed rule, along with the
unrealistic product level tracking provisions and lengthy record
keeping requirements being proposed. FMI also asked FDA to publish a
supplemental rule (as was done with most other FDA rules to implement
provisions of the Food Safety Modernization Act), yet FDA moved forward
with the final rule.
Ultimately, FDA made very few modifications or changes from the
proposed rule to address the concerns raised by FMI and other industry
stakeholders. While the traceability rule was intended to focus on only
``high risk'' foods as authorized by a very narrow provision of the
FSMA law, FDA has morphed this provision into an expansive ``food
traceability list'' that now includes more than two dozen categories of
foods and food ingredients. Thus, the list of food products subject to
this new traceability requirement will number in the tens of thousands,
and even FDA hasn't been able to establish a comprehensive list of
products they expect to be traced.
The original intent of the legislative provision was to target
truly ``high risk'' food products that have experienced challenging
food safety concerns and product recalls. The result of this final rule
is to burden the entire food supply chain with an unworkable product
tracing requirement, where no current technology is in practice to
accomplish this. Furthermore, the rule will produce massive amounts of
records that our industry members will have to maintain for 2 years,
and that FDA likely cannot even effectively utilize in a timely manner.
This rule is entirely reactive rather than focusing on proactive,
preventative food safety measures, which is the focus of the food
industry and should be FDA's focus. This rule will bring significant
costs to the entire U.S. food supply and delivery system and does not
include a single ingredient contained in the infant formula recall that
demanded so many FDA and industry resources and caused so many consumer
challenges this past year.
As a result of these issues and concerns surrounding the final Food
Traceability rule, FMI is requesting the subcommittee's consideration
of bill and report language in the fiscal Year `24 Agriculture
Appropriations bill to require FDA to take additional actions and steps
before implementing or enforcing compliance with the final, 596-page
rule. The proposed language below is needed to require FDA to identify
what technology can feasibly be used by industry to meet the
requirements of the rule, and to develop the complete list of the
thousands of products they intend to be traced. Until FDA can take
these steps, the Agency should not be allowed to implement or enforce
the Food Traceability rule.
The requested bill language and report language are outlined below.
Proposed Bill Language:
No funds appropriated by this act may be used to
implement, administer, or enforce the requirements of
the Final Rule ``Requirements for Additional
Traceability Records for Certain Foods'' (21 CFR Part 1
Subpart S) until the U.S. Food and Drug Administration
provides a comprehensive, electronically downloadable
list of each food product subject to the rule; and
submits a report to this Committee identifying the low-
cost technology available to maintain lot code
information for foods subject to the rule.
Proposed Report Language:
The Committee directs the Food and Drug Administration,
before implementing or enforcing the compliance
requirements of the Final Rule ``Requirements for
Additional Traceability Records for Certain Foods'' (21
CFR Part 1 Subpart S) to: develop a comprehensive,
electronically downloadable list of each food product
subject to the rule; submit a report to this Committee
identifying the low-cost technology solutions currently
available to maintain lot code information for foods
subject to the rule; and publish a protocol detailing
consistent investigation practices the Agency will use
to respond to food borne illness and outbreak
investigations.
On behalf of FMI, we appreciate your consideration of this
important request for our industry members. Please let us know what
additional information we can provide that would be helpful and any
questions we can answer. We look forward to working with you and your
colleagues on this and other important priorities for the U.S. food and
agriculture industry.
Thank you,
Jennifer Hatcher
Chief Public Policy Officer &
Senior Vice President, Government Relations
FMI--The Food Industry Association
______
Prepared Statement of Haleon
Haleon appreciates the opportunity to submit written testimony to
the Senate Committee on Appropriations subcommittee on Agriculture,
Rural Development, Food and Drug Administration, and Related Agencies.
Haleon is a world-leading consumer health company with a clear purpose
to deliver better everyday health with humanity. Haleon is committed to
developing over-the-counter solutions to assist those who seek to
decrease or end their tobacco use. We respectfully request the
subcommittee to support innovation in new tobacco cessation products
through the inclusion of the report language provided below.
Smoking and other forms of tobacco use continue to be major risks
to public health. According to the Centers for Disease Control and
Prevention (CDC), cigarette smoking remains the leading cause of
preventable disease, disability, and death in the United States,
accounting for more than 480,000 deaths every year, or about 1 in 5
deaths. In 2020, nearly 13 of every 100 U.S. adults aged 18 years or
older (12.5 percent) currently smoked cigarettes. This means an
estimated 30.8 million adults in the United States currently smoke
cigarettes. More than 16 million Americans live with a smoking-related
disease. Although cigarette smoking has declined significantly since
1964, disparities in tobacco use remain across race, ethnicity,
educational level, and socioeconomic status. In addition, the most
recent Annual National Youth Tobacco Survey raises significant concerns
that 14.1 percent (2.14 million) of high school students and 3.3
percent (380,000) of middle school students reported current e-
cigarette use.
Given the inherent health risks from smoking and vaping, there is a
need to promote and improve cessation among adults and adolescents.
Fortunately, there are proven tools and methods for decreasing tobacco
use, including nicotine replacement therapy (NRT) and counseling.
Studies have shown that combining these two strategies is the best way
to quit. Haleon is supportive of all efforts to reduce and prevent
tobacco consumption and decrease dependence on nicotine.
Haleon maintains a steadfast commitment to provide safe and
effective over-the-counter (OTC) solutions for consumers looking to
live a healthier life. Millions of Americans rely on safe and effective
NRT products, which can come in forms like lozenges, patches, gum, and
inhalers. We are working to expand access to these products, including
through State quitlines; many of which can provide NRT products for
free.
Haleon recognizes the public health imperative for innovation in
bringing new tobacco cessation products to market; however, we have
concerns that the Food and Drug Administration's approach to OTC NRT
products is hindering, rather than facilitating, their development and
approval. We continue to develop--and are seeking to bring to the U.S.
market--other options.
We respectfully request the subcommittee to include the following
report language for the Food and Drug Administration regarding NRT
products in the FY2024 Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies spending bill:
Ensuring Innovation to combat youth smoking trends.-The Committee
appreciates the Food and Drug Administration (FDA)'s efforts to combat
youth smoking. The Committee, however, is alarmed by the findings from
the most recent Annual National Youth Tobacco Survey, which indicate
that 14.1 percent (2.14 million) of high school students and 3.3
percent (380,000) of middle school students reported current e-
cigarette use. The same study also found that nearly 85 percent of
current users preferred flavored e-cigarettes, with fruit flavors being
the most popular, followed by candy, desserts, or other sweets. Given
these concerning findings, coupled with the ongoing morbidity and
mortality burden caused by tobacco use, the Committee directs the FDA,
no later than March 2024, to report to the Committee on agency efforts
undertaken within the last five calendar years to facilitate the
development of new consumer-oriented smoking cessation products to help
reduce tobacco and e-cigarette use. Further, the FDA is directed to
convene the Nonprescription Drugs Advisory Committee, the
Psychopharmacologic Drugs Advisory Committee, and the Tobacco Products
Scientific Advisory Committee to discuss ways to expand over-the-
counter and prescription options for tobacco cessation.
Haleon believes additional safe and effective over-the-counter NRT
offerings are critical to help millions of Americans quit the harmful
and costly impact of tobacco and nicotine use. We urge Congress and the
FDA to make progress in the Nation's battle against the leading cause
of preventable disease, disability, and death in the United States. We
thank you for the opportunity to submit written testimony for the
record.
[This statement was submitted by Elizabeth Brewer, MS, MPH, Head of
U.S. Government Affairs.]
______
Prepared Statement of the Humane Society Legislative Fund and Humane
Society
fda/reducing animal testing and advancing nonanimal methods
We request no less than the fiscal Year 2023 level of $5 million
for the New Alternative Methods Program and report language: ``The
Committee directs FDA to efficiently and expeditiously utilize existing
funds to reduce animal testing and advance alternative nonanimal
methods in a measurable and impactful way. The agency is further
directed to provide a report to the Committee within 90 days of
enactment that provides details on the status of forming the New
Alternative Methods Program in the Commissioner's office, including but
not limited to a description of program goals and staffing levels by
position classification; FDA's priority areas for reducing animal use
and advancing nonanimal alternatives, including goals, timelines and
funding associated with each of these identified priorities; the
metrics the agency will use to measure impact; and how the agency will
communicate information regarding acceptance of nonanimal alternative
methods to the regulated community. The agency should not use funding
to carry out new animal testing, including to evaluate the predictive
capacity of the nonanimal alternative methods, but instead use human
data or existing animal data. The Committee is also aware that the
regulated community lacks certainty as to when nonanimal methods will
be accepted in lieu of animal testing for safety and efficacy testing,
which serves as a barrier to implementation of such alternative methods
in the industry. To combat this, the Committee directs FDA to clarify
the acceptance of new approach methodologies (NAMs) in its regulations
and related guidance documents where appropriate, communicate up-to-
date information about NAMs acceptance on the agency's website, remove
outdated guidance, and proactively communicate with stakeholders on
NAMs acceptance for regulatory use. Along with these updates, the
Committee directs FDA to prioritize and incentivize the development,
use and regulatory acceptance of NAMs.''
We seek to ensure FDA's judicious and impactful use of funding to
reduce animal testing and advance alternative methods, and request
details related to these efforts. Non-animal approaches include cell
cultures, computer modeling, and other methods that are often faster,
cheaper and more predictive of human health than animal tests. In FY23
Congress directed FDA to report on its progress regarding reliability,
reproducibility and development related to new alternative methods and
the evaluation of the methods with which FDA is involved. FDA
regulations and guidance documents acknowledge that FDA has the
authority and flexibility to accept NAMs for safety and efficacy
testing but in some areas emphasize animal testing that suggests it is
mandatory for all new drug applications. This lack of clarity and
internal consistency serves as a barrier to the adoption and use of
NAMs. The FDA should clarify the acceptance of NAMs in the appropriate
regulations and related guidance documents, communicate up-to-date
information about NAMs acceptance on the agency's website, remove
outdated guidance, and proactively communicate with stakeholders on
NAMs acceptance for regulatory use.
fsis/horse slaughter
We request bill language permanently barring USDA from expenditure
of funds for horse slaughter inspections: ``None of the funds made
available by this or any other act in this or any fiscal year
hereafter, may be used to pay the salaries or expenses of any person or
personnel- (1) to inspect horses under section 3 of the Federal Meat
Inspection Act (21 U.S.C. 603); (2) to inspect horses under section 903
of the Federal Agriculture Improvement and Reform Act of 1996 (7 U.S.C.
1901 note; Public Law 104-127); or (3) to implement or enforce section
352.19 of title 9, Code of Federal Regulations, or any other regulation
concerning the inspection of slaughter horses.''
This provision is vital to prevent renewed horse slaughter activity
in this country and wasting tax dollars on a practice that 83 percent
of the American public opposes as inherently cruel and posing serious
public health risks.
office of the secretary/cage-free and crate-free housing conversion
We request report language: ``The cage-free egg and gestation
crate-free pork market continues to expand due to demand by consumers
and food corporations as well as state laws requiring in-state farmers
to convert to cage-free or gestation crate-free facilities. Producers
may increase their long-term income when they are able to convert to
cage-free and crate-free facilities to better meet these demands. The
Committee directs the Secretary to continue helping egg and pork
farmers address the economic opportunities associated with cage-free
and gestation crate-free housing. In order to meet the needs of this
effort, the Secretary is encouraged to submit a reprogramming of
funding to the Committee.''
Due to an increase in consumer awareness surrounding animal welfare
and food safety concerns in our agricultural systems, more than 200
companies are demanding a 100 percent cage-free egg supply including
McDonald's, Walmart, Kroger, Denny's, and IHOP. Eleven States have
passed laws banning cages for egg laying hens, and eight of those
States require that eggs sold within their state borders are cage-free.
There is also surging demand from major pork buyers like Kroger,
Target, Burger King, Costco, and dozens of others for pork produced
without the use of gestation crates that keep sows in space so tight
they cannot turn around. Ten States have laws banning or restricting
the use of gestation crates. Some producers, however, have been
hesitant to make the switch to cage-free and crate-free systems because
of the initial costs to convert to these systems. USDA data shows that
more than 100 million hens are cage-free (36 percent of the U.S. egg
flock), and according to the National Pork Producers Council, 38
percent of sows are raised in groups at least part of their pregnancy.
Federal support on the upfront conversion costs would help producers
make the shift, bolstering animal welfare and helping the egg and pork
industries take advantage of the expanding cage-free and crate-free
market. In addition to humane concerns, this is a food safety issue
because studies have shown that cage egg operations are significantly
more likely to harbor Salmonella than cage-free facilities. Meanwhile,
leading food safety groups have identified serious concerns about pork
from facilities that confine breeding sows in gestation crates.
aphis/animal welfare act (awa) enforcement
We request bill language: ``The Secretary shall ensure that
appropriate enforcement action in the form of penalties or case
referral to the Office of General Counsel or the Department of Justice
or both is taken when a regulated facility violates the Animal Welfare
Act (7 U.S.C. 2131-2159) as documented on an inspection report, with
due consideration to the appropriateness of the penalty with respect to
the size of the business of the person involved, the gravity of the
violation, the person's good faith, and the history of previous
violations, as provided in 7 U.S.C. Section 2149(b). The Secretary
shall ensure that any interference with or failure to allow access for
an inspection under the Animal Welfare Act, 7 U.S.C. Sections 2131-
2159, is documented on an inspection report. The Secretary shall ensure
that all dealers selling dogs, cats, and other covered animals online
have the necessary license pursuant to Animal Welfare Act, 7 U.S.C.
Sections 2131-2159, as required under 78 Fed. Reg. 57227. The Secretary
of Agriculture shall enter into a memorandum of understanding with the
U.S. Attorney General to encourage greater collaboration on Animal
Welfare Act enforcement and ensure that the Department of Justice has
access to evidence needed to initiate cases.''
Report language: ``Case Referrals for Animal Welfare Act (AWA)
Violations.-The Committee is concerned that USDA is not fully utilizing
its enforcement capabilities, particularly for chronic violators of the
AWA. There has been an overall decline in AWA enforcement since 2010
when USDA initiated 874 cases and 74 stipulated penalties. By 2021,
enforcement dropped to 262 initiated cases of which 18 resulted in
settlements and 17 with administrative orders. The Committee directs
USDA to use its full enforcement capabilities under the AWA including
referring cases to the Office of General Counsel, the Department of
Justice or both, when appropriate according to the factors the agency
must consider under 7 U.S.C. Section 2149(b).''
USDA is responsible for ensuring compliance with AWA standards at
16,853 sites currently, including commercial breeding facilities,
laboratories, zoos, circuses, and airlines. We are concerned with the
agency's inadequate enforcement in recent years. In fiscal Year 2022,
USDA initiated 262 cases against AWA licensees, resulting in 204
warnings, 18 settlements, and 17 administrative orders. Seven licenses
were suspended or revoked. While this was more than the previous 5
years, overall there has been a decline in AWA enforcement since 2010,
when USDA initiated 874 cases, with 74 stipulated penalties. APHIS
should improve enforcement activity, especially by initiating more
significant penalties, and work more with local law enforcement and the
Department of Justice.
aphis/horse protection act (hpa) enforcement
We request no less than $4,096,000 (FY 2023 level) in the bill and
report language: ``The Committee provides $4,096,000 for enforcement of
the Horse Protection Act of 1970, as amended (15 U.S.C. 1831), and
reminds the Secretary that Congress granted the agency primary
responsibility to enforce this law, including the training of all
inspectors. The Committee urges the Secretary to issue the new proposed
HPA rule expeditiously, consistent with the agency's announced
intentions in December 2021, and to finalize and publish the new final
rule by December 31, 2023. The Committee further urges the Secretary to
ensure that the new rule includes at a minimum all the key elements of
the final rule, ``Horse Protection; Licensing of Designated Qualified
Persons and Other Amendments'' [Docket No. APHIS-2011-0009], that was
finalized and displayed in advance public notice in the Federal
Register on January 19, 2017.''
aphis/protecting animals with shelter (paws) implementation
We request $3,000,000 in the bill for PAWS grants and report
language: ``The Committee directs the Secretary of Agriculture to
continue coordinating with the Departments of Justice, Housing and
Urban Development, and Health and Human Services to efficiently
implement the grant program for providing emergency and transitional
shelter options for domestic violence survivors with companion
animals.''
fsis/humane methods of slaughter act (hmsa) enforcement
We request language to strengthen HMSA enforcement. Bill: ``No
fewer than 165 full-time equivalent positions shall be employed during
fiscal year 2024 for purposes dedicated solely to inspections and
enforcement related to the Humane Methods of Slaughter Act. This number
is in addition to the Humane Handling Enforcement Coordinator and
District Veterinary Medical Specialist positions.'' Report: ``FSIS
shall ensure that all inspection personnel conducting humane handling
verification procedures receive robust initial training and periodic
refresher training on the FSIS humane handling and slaughter
regulations and directives. This includes handling of non-ambulatory
disabled animals, as well as proper use of the Humane Activities
Tracking System to ensure humane handling of animals as they arrive and
are offloaded and handled in ante-mortem holding pens, suspect pens,
chutes, stunning areas, and on the processing line. The Committee
directs the agency to continue preparation and online publication of
the Humane Handling Quarterly Reports, to include: (1) the number of
humane handling verification procedures performed, (2) the number of
administrative enforcement actions taken, (3) time spent on Humane
Handling Activities Tracking System activities, and (4) comparisons of
these measurements by plant size and FSIS district. The Committee
recognizes that the humane handling of birds at slaughter according to
Good Commercial Practices (GCPs) reduces the occurrence of adulterated
poultry products in the marketplace and can improve the treatment of
birds at slaughter. The Committee awaits the Department's briefing
requested in the fiscal year 2022 and 2023 reports on documented
instances where establishments lost control of their processes for
handling birds, and consequently were not operating in accordance with
GCPs. Further, the Committee directs the USDA to track the number of
inspector hours spent on GCP verification activities intended to reduce
instances of adulteration using its existing Humane Activities Tracking
System or other appropriate method.''
oig/animal fighting enforcement
We request report language: ``The Committee is concerned about
illegal animal fighting activity that subjects animals to cruel
conditions and has the potential to spread illnesses such as virulent
Newcastle disease and avian flu. The OIG is encouraged to increase its
efforts to pursue animal fighting cases even if related concerns, such
as money laundering and illegal weapons, have not yet been determined
to be at issue before an investigation is opened. OIG is also
encouraged to work with USPS and DOJ to examine the prevalence of the
illegal shipment of game-fowl used in cockfighting. The Committee also
encourages the OIG to audit and investigate USDA enforcement of the
Animal Welfare Act and the Horse Protection Act to help improve
compliance with these important laws. This should include finalizing
the reopening of the audit on the Animal Care Program Oversight of Dog
Breeders to allow completion of in-person visits. Additionally, the
Committee is concerned about the lack of meaningful enforcement of the
AWA and HPA and requests that these audits should also examine what
barriers exist to full enforcement of both Acts, and what if any steps
can be taken within APHIS' Animal Care and Investigative and
Enforcement Services programs to ensure that the regulated community is
held accountable for violations of these Acts.''
nifa/national veterinary medical services act
We request $10,500,000 for the Veterinary Medicine Loan Repayment
Program (Public Law 108-161).
aphis/emergency preparedness and response/animal care
We request $1,450,000 for Animal Care to assist in addressing
animal issues in disasters.
We appreciate the Committee's prior support of animal welfare
issues, and hope you are able to accommodate these requests to better
address the critical issues that impact millions of animals.
[This statement was submitted by Mimi Brody, Director of Federal
Affairs, Humane Society Legislative Fund.]
______
Prepared Statement of Humane Society of the United States
On behalf of the undersigned horse industry, veterinary, and animal
welfare organizations, we submit the following testimony seeking
funding of not less than $4,096,000 and language for the USDA/APHIS
Horse Protection Program, for fiscal Year 2024. We appreciate that
Congress provided $4,096,000 in fiscal Year 2023 for USDA to strengthen
enforcement of the Horse Protection Act. An FY24 appropriation of no
less than that amount is urgently needed as we seek to fulfill the
intent of the Horse Protection Act--to eliminate the cruel practice of
soring--by allowing the USDA to further strengthen its enforcement
capabilities for this law.
We urge you to include the following report language: ``The
Committee provides $4,096,000 for enforcement of the Horse Protection
Act of 1970, as amended (15 U.S.C. 1831), and reminds the Secretary
that Congress granted the agency primary responsibility to enforce this
law, including the training of all inspectors. The Committee urges the
Secretary to issue the new proposed HPA rule expeditiously, consistent
with the agency's announced intentions in December 2021, and to
finalize and publish the new final rule by December 31, 2023. The
Committee further urges the Secretary to ensure that the new rule
includes at a minimum all the key elements of the final rule, ``Horse
Protection; Licensing of Designated Qualified Persons and Other
Amendments'' [Docket No. APHIS-2011-0009], that was finalized and
displayed in advance public notice in the Federal Register on January
19, 2017.''
In January 2017, the USDA announced final regulations to eliminate
industry self-policing and institute other reforms needed to end
soring. These rules (Docket No. APHIS-2011-0009) received over 100,000
public comments in support, including bipartisan letters signed by 182
Representatives and 42 Senators. Unfortunately, the regulations were
withdrawn soon after.
In January 2021, the National Academies of Sciences, Engineering,
and Medicine (NASEM) issued a report that criticized the industry self-
policing system, urging that only veterinarians be allowed to inspect
the horses and making recommendations consistent with the 2017
regulations. The report called for greater use of technologies such as
thermography, prohibited substance testing, and blood testing, as well
as urging that only veterinarians be allowed to inspect the horses.
These recommendations depend on adequate agency resources. With current
funding, Animal Care was only able to attend approximately 18 percent
of the 229 HPA events held in fiscal Year 2022.
In December 2021, the USDA announced plans to propose a new and
improved HPA rule to take into account the NASEM findings. We were
pleased that the agency stated its intention to issue the new rule
expeditiously and identified this as a top regulatory priority.
More than 50 years ago, Congress passed the Horse Protection Act in
1970 to end soring, the intentional infliction of pain on the hooves
and legs of a horse to produce an exaggerated gait in the ``Big Lick''
segment of the Tennessee Walking Horse show industry. Caustic
chemicals--such as mustard oil, diesel fuel, and kerosene--are painted
on the horse's lower front legs. Then the legs are wrapped for days in
plastic wrap and bandages to ``cook'' the chemicals deep into the
flesh, making the horse's legs extremely painful and sensitive. When
ridden, the horse is fitted with chains that slide up and down the sore
legs, forcing the animal to produce an exaggerated, high-stepping gait
in the show ring. Additional tactics include inserting foreign objects
such as hard acrylic between a heavy stacked shoe and the horse's hoof;
pressure shoeing--cutting a horse's hoof down to the sensitive live
tissue to cause extreme pain every time the horse bears weight on the
hoof; and applying painful chemicals such as salicylic acid to slough
off scarred tissue or numbing agents, in an attempt to obscure evidence
of soring.
The Horse Protection Act authorizes the USDA to inspect horses,
including the three specific breeds known to be involved in soring--
Tennessee Walking, Racking, and Spotted Saddle Horses--in transport to
and at shows, exhibits, auctions and sales--for signs of soring, and to
pursue penalties against violators. Unfortunately, since its inception,
enforcement has been plagued by underfunding. As a result, the USDA has
never been able to adequately enforce the act, allowing this extreme
and deliberate cruelty to persist on a widespread basis.
To eliminate soring and meet the goals of the act, USDA officials
must be present at more shows. Years ago, the Agency set up the
industry-run system of certified HIO inspection programs, which are
charged with inspecting horses for signs of soring at the majority of
shows. These groups license examiners known as Designated Qualified
Persons (DQPs) to conduct inspections. Several of these organizations
hire industry insiders who have an obvious stake in preserving the
status quo. Statistics clearly show that when USDA inspectors are in
attendance to oversee shows affiliated with these organizations, the
numbers of noted violations are many times higher than at shows where
industry inspectors alone are conducting the inspections. By all
measures, the overall DQP program as a whole has been a failure--the
only remedy is to abolish the conflicted industry-run inspection
programs charged with self-regulation and have USDA oversee a
legitimate inspection program.
USDA appeared to have attempted to step up its enforcement efforts
some years ago, and had begun to work with the Department of Justice in
prosecuting criminal cases as provided for under the act. In 2011, a
Federal prosecutor sought the first-ever criminal indictments under the
act and as a result, a well-known, winning trainer in the Spotted
Saddle Horse industry served a prison sentence of over 1 year. A former
Walking Horse Trainers' Association Trainer of the Year and winner of
the Tennessee Walking Horse World Grand Championship, Jackie McConnell,
was indicted in 2012 on 52 counts (18 of them felony) of violating the
act and pleaded guilty to felony conspiracy to violate the act. He was
sentenced to 3 years of probation and a $75,000 fine in Federal court.
In 2013, another Tennessee trainer, Larry Wheelon, and three of his
employees were indicted on 19 counts of aggravated animal cruelty
charges under state law in a case flowing from a USDA Office of
Inspector General investigation. While Wheelon's case was dismissed on
a technicality, evidence of soring in his barn was plentiful and
horrifying.
These were significant actions that should have had a deterrent
effect, but there are many other violators who go undetected and many
cases that go unprosecuted due to a lack of resources USDA needs to
carry out its responsibilities under this act as Congress and the
public expect. In years past, Agency inspections were limited to
physical observation and palpation by the inspector. Protocols for the
use of new technologies, such as chemical analysis of prohibited
foreign substances used by violators on the legs of horses (either to
sore them, or to mask underlying soring and evade detection by
inspectors) have been implemented, which can help inspectors identify
violations more effectively. The results of USDA's testing for
prohibited foreign substances are staggering: 46 of the 66 random
samples (70 percent) taken by the USDA (in 2019, the last year for
which the agency has made this data available) at the industry's
pinnacle event--the Tennessee Walking Horse National Celebration--
tested positive for illegal foreign substances including soring,
masking, and numbing agents.
Effective though this inspection protocol may be, due to budget
constraints, USDA has been unable to put enough of this testing into
use in the field, allowing industry players to continually evade
detection. In 2019, USDA collected and tested only 268 samples at only
8 of the largest Big Lick shows; in 2018, 260 samples at only 20 shows;
and in 2017, 316 samples at only 14 shows. With increased funding, the
USDA could purchase more equipment and dispatch more inspectors to use
it, greatly increasing the agency's ability to enforce the HPA.
Currently, when USDA inspectors arrive at shows affiliated with
some industry organizations, many exhibitors leave to avoid being
caught with sored horses. While USDA could stop these trailers, Agency
officials have stated that inspectors are wary of going outside of
their designated inspection area, for fear of harassment and physical
violence from exhibitors. Armed security is frequently utilized in the
designated area to allow such inspections, at additional expense to
this program. That exhibitors feel they can intimidate government
officials without penalty is a testament to the inherent shortcomings
of the current system.
Lack of a consistent presence by USDA officials at events featuring
Tennessee Walking, Racking, and Spotted Saddle Horses has fostered a
cavalier attitude among industry insiders, who have not stopped their
abuse, but have only become more clandestine in their soring methods.
The continued use of soring to gain an advantage in the show ring has
tainted this segment of the horse industry, and creates an unfair
advantage for those who are willing to break the law in pursuit of
victory. Besides the indefensible suffering of the animals themselves,
the continued acceptance of sored horses in the show ring prevents
those with sound horses from competing fairly for prizes, breeding fees
and other financial incentives, while those horse owners whose horses
are sored may unwittingly suffer property damage and be duped into
believing that their now abused, damaged horses are naturally superior.
The egregious cruelty of soring is not only a concern for horse
industry and animal protection organizations, but also for
veterinarians. In 2008, the American Association of Equine
Practitioners (AAEP) condemned soring, calling it ``one of the most
significant welfare issues faced by the equine industry.'' It called
for the abolition of the DQP Program, saying ``the acknowledged
conflicts of interest which involve many of them cannot be reasonably
resolved, and these individuals should be excluded from the regulatory
process.'' The AAEP further stated, ``The failure of the HPA to
eliminate the practice of soring can be traced to the woefully
inadequate annual budget... allocated to the USDA to enforce these
rules and regulations.''
The USDA Office of Inspector General conducted a comprehensive
audit of the Horse Protection Program, and issued its report in
September 2010 documenting serious conflicts of interest and other
significant problems with the industry self-monitoring system of HIOs
on which the APHIS inspection program still relies. The report
recommended the abolition of DQP inspections and an increase in funding
for APHIS enforcement of the Horse Protection Act. The Agency concurred
with the findings and recommendations in the report, pledging to
abolish industry self-policing and agreeing with Recommendation 2:
``Seeking the necessary funding from Congress to adequately oversee the
Horse Protection Program,'' indicating that it would develop a
budgeting and staffing plan to phase in the resources needed to
adequately oversee the Horse Protection Program. Unfortunately, in
recent years, it has been reported that USDA officials have stated
their view that Horse Industry Organizations (HIOs) have primary
responsibility to enforce the HPA, not the Agency.
It is unacceptable that more than half a century after passage of
the Horse Protection Act, the USDA still lacks the resources needed to
end this extreme form of abuse. It is time for Congress to give our
public servants charged with enforcing this act the support and
resources they need to fulfill their duty to protect these horses as
effectively and safely as possible.
We appreciate the opportunity to share our views, and your
consideration of our request.
Sincerely,
Keith Dane, Senior Director, Equine Protection, Humane Society of the
United States
Robert P. Franklin, DVM, DACVIM, President, American Association of
Equine Practitioners
Barry Kipperman, DVM, DACVIM, President, Humane Society Veterinary
Medical Association
Cathy Liss, President, Animal Welfare Institute
Sara Amundson, President, Humane Society Legislative Fund
Nancy Perry, Senior Vice President, Government Relations, American
Society for the Prevention of Cruelty to Animals (ASPCA)
Teresa Bippen, President, Friends of Sound Horses, Inc.
Robin Lohnes, Executive Director, American Horse Protection Association
Neda DeMayo, President, Return to Freedom Wild Horse Conservation In
Our Hands Action Fund
Donna Benefield, Vice President, International Walking Horse
Association
Susan Crotty, President, Plantation Walking Horse Association of
California
Molly Lieberknecht, President, United Pleasure Walking Horse
Association
Gina Vehige, President, Gaitway Walking Horse Association, Inc.
Lucy Rangel, President, Missouri Horse Shows Association
Bonnie Yeager, President, International Pleasure Walking Horse Registry
Penny Austin, President, One Horse At a Time, Inc. Horse Rescue
Fran Cole, President, Northern California Walking Horse Association
Linda Fey, President, New York State Plantation Walking Horse Club, LLC
Libby Kurtz, San Francisco Bay Area Tennessee Walking Horse Club
Nancy O'Dell Plunkett, President, Northwest Gaited Horse Association
Jacquie Cowan, Chesapeake Plantation Walking Horse Club
[This statement was submitted by Keith Dane, Senior Director,
Equine Protection, Humane Society of the United States.]
______
Prepared Statement of Jazz Pharmaceuticals
On behalf of Jazz Pharmaceuticals (Jazz), we respectfully submit
this statement regarding the fiscal Year 2024 budget request for the
Food and Drug Administration (FDA) for inclusion in the Committee's
official record. Jazz appreciates the Committee's support for FDA's
ongoing regulatory oversight of cannabis and cannabis-derived
substances, including encouraging high caliber research, review of
product applications, and robust inspections and enforcement. We
appreciate the Committee's support in the 2023 appropriations cycle and
ask for a continuation of that support so FDA's work may continue.
about our cannabis pharmaceutical development program
Jazz, through GW Pharmaceuticals, is the first and only company to
have brought a cannabis-derived pharmaceutical grade therapy through
the drug review and approval process of the FDA. FDA approved
Epidiolex(r) (cannabidiol) oral solution (Epidiolex) in 2018 for the
treatment of seizures associated with two rare diseases, Lennox-Gastaut
Syndrome (LGS) and Dravet Syndrome (Dravet); in 2020, FDA also approved
Epidiolex for the treatment of seizures associated with tuberous
sclerosis complex (TSC). In addition to continuing explore the
therapeutic potential of Epidiolex for other serious medical
conditions, we have other cannabis-based products in development, in
both the United States and worldwide.
background on cannabis and fda activity
Cannabis is a complex plant containing more than eighty
biologically active chemical compounds called ``cannabinoids.'' The
most commonly known cannabinoids are delta-9-tetrahydrocannabinol
(delta-9 THC) and cannabidiol (CBD).
The 2018 Farm Bill \1\ established that ``hemp'' (i.e., cannabis
plants and plant material with less than 0.3 percent delta-9 THC) and
hemp derivatives were no longer controlled substances. In the 2018 Farm
Bill, Congress also specifically preserved FDA's authority and affirmed
the agency's role in protecting consumers and patients from dangerous
products and unproven therapies.
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\1\ The Agricultural Improvement Act of 2018, H.R. 2; Pub. L. 115-
534.
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CBD is the active ingredient in Epidiolex, an FDA-approved
prescription drug; therefore, it is illegal under the Federal Food,
Drug & Cosmetic Act (FDCA) to add CBD to food or to market it as a
dietary supplement.\2\ Yet, despite its illegality, CBD is widely
available in consumables and personal care products. The global CBD
market size was valued at $5.18 billion in 2021; U.S. sales of CBD
products could climb as high as $11 billion by 2027.\3\
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\2\ See FDA Regulation Of Dietary Supplement & Conventional Food
Products Containing Cannabis And Cannabis-Derived Compounds (accessed
March 9, 2023).
\3\ Cannabinoids/Cannabis 101 (accessed March 9, 2023); CBD Sales
Projected to Hit $11 Billion (accessed March 9, 2023).
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These unlawful, CBD-containing products are often marketed with
claims of medical benefits, without FDA approval, or any scientific
evidence.\4\ FDA has also identified numerous gaps in understanding how
CBD affects human health, and what is known points to real risks to
consuming CBD for any reason, and especially without a physician's
oversight. CBD can cause liver injury, interact with other drugs,
potentially causing serious side effects, and is associated with
reproductive toxicity and damage to fertility. CBD is also associated
with changes in alertness and mood, and gastrointestinal distress.
Additional questions also remain regarding CBD consumption, such as if
it is consumed daily, for sustained periods of time, and CBD's impacts
upon children, pregnant and breastfeeding women, and fetal
development.\5\
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\4\ Cannabidiol (CBD): Implicit, Unsubstantiated Therapeutic Claims
through Academic Joint Ventures in an Unregulated Marketplace Could
Risk Public Health (accessed March 9, 2023); FDA Warning Letters and
Test Results for Cannabidiol-Related Products (accessed March 9, 2023).
\5\ See, e.g., FDA, What You Need to Know (And What We're Working
to Find Out) About Products Containing Cannabis or Cannabis-derived
Compounds, Including CBD (accessed March 9, 2023); Safety of CBD in
Humans--A Literature Review (As of December 12, 2019) (accessed March
9, 2023); January 26, 2023 Statement by Dr. Janet Woodcock, FDA
Concludes that Existing Regulatory Frameworks for Foods and Supplements
are Not Appropriate for Cannabidiol, Will Work with Congress on a New
Way Forward (accessed March 9, 2023) (hereinafter ``Dr. Woodcock
Statement'').
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Based upon these concerns, FDA concluded in January 2023 ``it is
not apparent how CBD products could meet safety standards for dietary
supplements or food additives.'' \6\ The agency has limited tools under
the FDCA ``for managing many of the risks associated with CBD
products.'' As a consequence, the agency announced it would not
initiate rulemaking to permit CBD in dietary supplements and foods. FDA
offered to work with Congress ``to develop a cross-agency strategy for
the regulation of these CBD-containing products to protect the public's
health and safety.'' This new regulatory pathway Congress might
establish could include risk management tools for the agency to manage
CBD risks to consumer health, including ``clear labels, prevention of
contaminants, CBD content limits, and measures, such as minimum
purchase age, to mitigate the risk of ingestion by children.'' \7\ In
the interim, FDA committed to continuing ``to take action against CBD
and other cannabis-derived products to protect the public.''
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\6\ January 26, 2023 Dr. Woodcock Statement.
\7\ January 26, 2023 Dr. Woodcock Statement.
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While Congress and FDA continue to work together to develop an
appropriate framework for CBD, we believe the following continuing
concerns with cannabis-derived products merit inclusion of
appropriations language:
--Cannabis-Derived Products Can Pose Significant Health Consequences.
Cannabis-derived products are not approved by FDA and are often
promoted to vulnerable populations without a prescription or
healthcare professional oversight of dosing, side effects, and
drug interactions. This poses potential dangers to patient and
consumer health because some cannabis derivatives are known to
interact with a variety of commonly used prescription drugs,
cause liver complications, and have other adverse health
effects.\8\ State-legal cannabis products are frequently
contaminated with harmful substances, including mold,
pesticides, heavy metals, and bacteria.\9\
--Dietary Supplements And Foods Containing Cannabis Derivatives Must
Be Differentiated From FDA-Approved Drugs To Preserve Research
And Innovation. FDA-approved drugs are studied for efficacy and
safety in the intended patient population and are manufactured
to exacting standards, all of which ensure American patients
have access to the safest and most advanced drugs in the world.
Dietary supplements and foods containing cannabis-derived
compounds need to be differentiated from FDA-approved drug
products. If there is no distinction made between approved
drugs and unapproved dietary supplements and foods, there is,
similarly, no incentive to undertake costly clinical research
to develop robust data on the therapeutic benefits of cannabis.
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\8\ See, e.g., FDA, What You Need to Know (And What We're Working
to Find Out) About Products Containing Cannabis or Cannabis-derived
Compounds, Including CBD (accessed March 9, 2023); Safety of CBD in
Humans--A Literature Review (As of December 12, 2019) (accessed March
9, 2023); FDA, What You Should Know About Using Cannabis, Including
CBD, When Pregnant or Breastfeeding (accessed March 9, 2023); FDA
summarized the clinical and pre-clinical data (and the absence of such
data) on CBD safety in responses to three Citizen Petitions and two New
Dietary Ingredient Notifications for CBD in full spectrum hemp
extracts. See FDA Issues Response to Three Citizen Petitions Related to
CBD and Dietary Supplements (January 26, 2023) (accessed March 9,
2023); July 23, 2021 Letter from FDA to Mr. Tim Orr, Charlotte's Web
(accessed March 9, 2023); July 23, 2021 Letter from FDA to Irwin
Naturals (accessed March 9, 2023).
\9\ Chicago Sun-Times, ``What's in Illinois' legal weed?'' See also
Poison Alert! Quality Control is Often Lacking for Cannabis Products--
Are your CBD and THC-rich consumables contaminated by heavy metals,
pesticides, and reproductive toxins? N. Seltenrich (Dec. 14, 2022).
State cannabis authorities have issued numerous recalls and advisories
regarding cannabis products contaminated with yeast, mold, pesticides,
heavy metals, and bacteria, including in Vermont, Nevada, Oregon,
Colorado, Oklahoma, and Arizona.
--Many Cannabis-Derived Products Are Marketed Deceptively And
Misleading Claims May Harm Deceived Patients. Since January 1,
2020, FDA has sent over 60 warning letters to marketers of hemp
cannabinoid products that were making unproven and false
medical claims, including treatment claims for COVID-19,
Parkinson's, epilepsy, bi-polar disorder, and autism. The
agency stated these marketing tactics put patients at risk
because the products were not demonstrated to be safe or
effective.\10\ While FDA and the Federal Trade Commission (FTC)
have taken enforcement action against hemp manufacturers
marketing CBD with unsubstantiated therapeutic claims, they
have not taken similar action against medical cannabis
businesses operating in State programs despite those companies
utilizing the same unlawful marketing strategies. Numerous
studies have documented how cannabis manufacturers make health
and disease treatment claims about their products that are not
substantiated by science-based research or rigorous
testing.\11\ Widespread false and misleading marketing spurred
the American Medical Association (AMA) to urge FDA and FTC to
do more to ``protect consumers and combat marketing of
unapproved medical claims for cannabis'' when there is
``currently little available evidence to demonstrate safe and
effective use of these products for these purposes, and in some
cases these claims are completely fabricated and with no
supporting evidence at all.'' \12\ Further, as one study
concluded, ``Regulatory action against unsupported therapeutic
claims by the medical cannabis industry has thus far been
anemic'' with at least one company that received a warning
letter continuing to make unproven and false claims.\13\ As the
AMA stated, permitting medical claims ``outside of those
validated through robust clinical trials has serious impacts
for all patients who may use cannabis and cannabis-based
products.'' These deceptions may keep some patients from
accessing appropriate, recognized therapies to treat serious or
fatal diseases.
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\10\ See FDA Warning Letters and Test Results for Cannabidiol-
Related Products (accessed March 9, 2023).
\11\ Caputi TL, The Use of Academic Research in Medical Cannabis
Marketing: A Qualitative and Quantitative Review of Company Websites. J
Stud Alcohol Drugs, 2022 Jan;83(1):5-17,; Shover CL, et al. Association
of State Policies Allowing Medical Cannabis for Opioid Use Disorder
With Dispensary Marketing for This Indication. JAMA Netw Open.
2020;3(7):e2010001; Cavazos-Rehg PA, et al., Marijuana Promotion
Online: an Investigation of Dispensary Practices. Prev Sci. 2019
Feb;20(2):280-290.
\12\ October 20, 2022 Letter from American Medical Association to
FDA and FTC (accessed March 9, 2023).
\13\ Shover CL, et al.
Based upon the foregoing public health and safety concerns, we ask
for inclusion of the language below to ensure that FDA's work
continues. The proposed language is consistent with fiscal Year 2023
appropriations language.\14\
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\14\ See House Report 117-392 to Agriculture, Rural Development,
Food And Drug Administration, And Related Agencies Appropriations Bill,
2023, H.R. 8239. The Committee's Explanatory Statement adopting House
Report 117-392 is available here. H.R. 8239 became Consolidated
Appropriations Act, 2023, Public Law No: 117-328.
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proposed report language
The Committee is concerned about the proliferation of products
marketed in violation of the Federal Food, Drug & Cosmetic Act (the
``FDCA''), including products containing derivatives of the cannabis
plant. The Committee is aware that non-FDCA-compliant products pose
potential health and safety risks to consumers through misleading,
unsubstantiated, and false claims that cannabis and cannabis
derivatives can treat serious and life-threatening diseases and
conditions, including COVID-19 and cancer. Such products may also be
contaminated with harmful substances.
The Committee recognizes that FDA intends to work with Congress on
creating a regulatory framework that could permit one compound in
cannabis, cannabidiol (``CBD''), in consumer products. FDA indicated
that such a framework could safeguard consumers by providing risk
management tools to the agency to manage CBD risks, including labeling
requirements, prevention of contaminants, content limits, and other
public health protections, such as minimum purchase age, to mitigate
the risk of ingestion by children.
The Committee recognizes FDA's use of its existing authorities to
undertake cannabis-related efforts, including research, requests for
data, consumer education, issuance of guidance and policy around
cannabis-based drug product development, and some enforcement against
wrongdoers.\15\ The Committee expects FDA to continue and to increase
these efforts given the proliferation of non-FDCA-compliant, cannabis-
containing products and the risks they pose to public health. The
Committee also expects FDA to take enforcement action against the
manufacturers of any cannabis products marketed with unlawful
therapeutic claims to preserve the integrity of the drug development
and approval processes, which ensures that products, including
cannabis-containing products, that are marketed as drugs have undergone
a rigorous scientific evaluation to assure that they are safe, pure,
potent, and effective for the diseases and conditions they claim to
treat. It is also imperative that FDA continue to exercise its existing
authorities to preserve incentives to invest in robust clinical study
of cannabis so its therapeutic value can be better understood.
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\15\ See, e.g., Meeting of the Science Board of the U.S. FDA (June
14, 2022) at pages 9-18 (accessed March 9, 2023).
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______
Prepared Statement of the National Association of State Energy
Officials (NASEO)
Chairman Heinrich and Ranking Member Hoeven, I am David Terry,
President of the National Association of State Energy Officials
(NASEO), and I am testifying in support of FY24 funding for the energy
title of the Farm Bill. The mandatory levels of the energy title of the
Farm Bill should be supported (2018 Farm Bill, Public Law 115-334).
Specifically, we support funding of at least $50 million mandatory and
$250 million in additional discretionary spending for the Rural Energy
for America (REAP) program. Fifteen percent of the additional
discretionary funds should be allocated to underutilized renewable
energy technologies through a reserve fund. The REAP program was
created in the 2002 Farm Bill and it has been a huge success. Over
15,000 energy efficiency and renewable energy projects have been
implemented in every State since 2003. Since the 2014 Farm Bill, REAP
has leveraged $7 billion in private investments with the $338 million
in appropriations. We also support $15 million in mandatory funding and
$30 million in discretionary funding; a total of $45 million for the
Rural Energy for America Loans program. ``On-bill'' energy efficiency
financing programs for rural electric cooperatives is an important
activity through USDA. Under the Rural Energy Savings Program (RESP),
$26 million should be provided for FY'24. The models in South Carolina,
Arkansas, and Washington are very exciting. This program should be
dramatically expanded. We also recommend that beneficial
electrification initiatives should be funded with both the REAP and
RESP programs. These recommendations are in addition to funding under
the Inflation Reduction Act and the Infrastructure, Investment, and
Jobs Act.
REAP has specifically benefitted farmers, ranchers and rural small
businesses that are often underserved by other Federal energy efforts.
NASEO's State Energy Office members work directly with eligible
entities, as well as state agricultural agencies and rural interests to
promote this successful program. REAP focuses on facilitating private-
sector led rural economic development.
NASEO represents the energy offices in the 56 States, territories
and the District of Columbia. The REAP program, and the other critical
programs in the energy title of the last multi-year Farm Bill (and
RESP), helps the private sector create jobs, supports increased
agricultural productivity and operational efficiency, reduces energy
costs for farmers, ranchers and rural small businesses, generates home-
grown energy, promotes use of alternative fuels produced by America's
farmers, and further reduces our dependence on imported petroleum. The
cost is very low and the payback is very high.
As noted above, NASEO also supports additional energy title
programs. There are several of note that should be supported at
mandatory funding levels and RESP. These include the Biomass Crop
Assistance Program, Biorefinery Assistance, Renewable Chemical and
Biobased Product Manufacturing Assistance Program, and the Biobased
Markets Program (otherwise referred to as ``Biopreferred''), the
Biomass Research & Development Initiative, the Bioenergy Program for
Advanced Biofuels, the Biodiesel Fuel Education Program, and the Carbon
Utilization and Biogas Education Program.
The RESP zero-interest loans to rural electric cooperatives, state
financing entities and others help on residential and small business
energy efficiency measures. RUS has awarded almost $290 million in RESP
loans.
In FY'24, we urge your support for the REAP program and the Rural
Energy for America Loans program, and additional energy title programs
as noted above. We also support expansion and support for ``on-bill''
financing programs (RESP) through USDA. For all these programs, we
recommend streamlining the applications in order to reduce paperwork
burdens for low-cost grants and loans. The REAP program's small grant
cap should be raised to $75,000.
Contacts: David Terry, NASEO President ([email protected]); and Jeff
Genzer, NASEO Counsel ([email protected]).
[This statement was submitted by David Terry, President, National
Association of State Energy Officials.]
______
Prepared Statement of the National Association of Wheat Growers
The National Association of Wheat Growers (NAWG) appreciates the
opportunity to provide testimony about our priorities for the fiscal
year 2024 Agriculture Appropriations bill. Before outlining our fiscal
Year 2024 requests, we wanted to say ``thank you'' for continuing to
fully fund the U.S. Wheat and Barley Scab Initiative (USWBSI) in fiscal
Year 2023. For fiscal Year 2024, NAWG supports funding the following
U.S. Department of Agriculture's Agriculture Research Service programs:
As our leaders in Congress consider an fiscal Year 2024 Agriculture
Appropriations bill, one of NAWG's main priorities will be to ensure
that no provisions are included that would cut Farm Bill programs,
particularly mandatory programs like crop insurance, farm programs,
conservation programs, or trade promotion programs. As the
Appropriations Committee works to lay out goals for Fiscal Year 2024,
we respectfully urge you to protect crop insurance from harmful cuts.
Even in good years, farmers need access to a strong and secure Federal
crop insurance program, a program that farmers have described time and
again as a critical linchpin of the farm safety net. Given the ongoing
drought throughout winter wheat country and severely wet spring in
spring wheat country, mandatory programs like crop insurance, farm
programs, conservation programs, and trade promotion programs mustn't
be cut or harmed. The 2018 Farm Bill passed through Congress with
strong bipartisan, bicameral support and sent a clear message that
these critical programs should not be harmed.
NAWG also strongly urges Congress to provide at least $255 million
for the Agricultural Trade Promotion and Facilitation Program with at
least $200 million for the Market Access Program (MAP) and $34.5
million for the Foreign Market Development (FMD) program in fiscal Year
2024. We are asking that your subcommittee use discretionary funds to
provide $7 million--less than 3 percent of the program investment--for
USDA administrative and operational costs to help reverse the
diminished real dollar value of MAP and FMD from being funded at the
same level for over 15 years. MAP/FMD funding is critical to help U.S.
farmers, ranchers, and food exporters keep pace and help us make up for
a lost time after two and half years of trade conflict and retaliatory
tariffs.
Wheat is a vital crop and source of economic activity. In the
United States, wheat ranks third in planted acreage, production, and
gross farm receipts, according to the USDA's Economic Research Service
(ERS). According to the USDA, in the 2022/2023 crop year, total U.S.
farmers produced a total of 1.6 billion bushels of wheat from a
harvested area on 35.5 million acres. In any given year, wheat farmers
must deal with a number of disease and pest challenges that can only be
addressed through public and private research efforts. Federal funding
for agriculture research has remained stagnant, threatening the future
viability and competitiveness of U.S. food systems by being out
invested by competitors such as China.
NAWG joins the National Wheat Improvement Committees (NWIC) and
National Barley Improvement Committees in urging the Committee to
maintain full funding for the UWSBSI. Fusarium Head Blight (Scab) is a
plant disease attacking all wheat-producing regions of the U.S. that
impacts not just growers but also millers and bakers because of its
impact on the quality of wheat. The 2018 Farm Bill increased
authorization for the USWBSI from $9.5 million to $15 million to
enhance food safety and supply by reducing the impact of Fusarium Head
Blight (Scab) on wheat and barley. While the President's budget zeroed
out funding for the USWBSI, we appreciate Congress's role in the
appropriations process and for fully funding the initiative for the
past several years. Continued full funding is vital in supporting the
agricultural economy and food system.
Also, NAWG supports the NWIC's request to start funding a Wheat
Resiliency Initiative (WRI) at $1.6 million to address new and emerging
challenges to wheat production. The key challenges are wheat stem
sawfly, Hessian fly, bacterial leaf streak, and the rust diseases.
Changing weather patterns combined with the migration of pest and
disease problems to regions previously unfamiliar with these yield
robbers are resulting in substantial economic losses at the farm gate.
For example, losses caused by wheat stem sawfly are now estimated to
exceed $350 million annually for spring and winter wheat growers in
Montana, Colorado, Nebraska, North and South Dakota, and Kansas. The
Wheat Resiliency Initiative, over time, will require $6.5 million in
new funding--equally split between intramural and extramural funding--
to meet its stated objectives and goals. Fully funded, the initiative
will support multi-disciplinary research and involve scientists in 18
States. However, providing an initial $1.6 million will help this
initiative begin researching wheat stem sawfly and Hessian fly
resistance.
Together, these various pests and pathogens affect every growing
region and market class of wheat grown across the U.S. Wheat is grown,
milled, and delivered as a dietary staple in every State. If funded,
through this initiative, the community of U.S. wheat researchers will
build a new genetic base in all wheat market classes for resiliency to
these challenges posed by wheat rusts, stem sawfly, hessian fly, and
bacterial leaf streak. The strength of local agricultural economies of
every State will be supported through building resiliency in the face
of these challenges to wheat production.
In addition to securing new resources for the WRI, NAWG encourages
the subcommittee to provide an additional $750,000 for strip rust
screening nurseries. Currently, the wheat stripe rust initiative
receives nearly $200,000 annually to support public wheat research into
stripe rust at facilities in Manhattan, KS; Raliegh, NC; Aberdeen, ID;
and Pullman, WA. These additional resources would be used to support
additional stripe rust screening nurseries in all wheat-producing
regions.
NAWG urges the Committee to continue to fully fund the Small Grains
Genomic Initiative (SGGI) at $3.44 million. While the President's
budget cut funding for the SGGI, the program provides critical
resources to four research areas: Next Generation Genotyping, Next
Generation Phenomics, ARS Uniform Small Grains Nurseries, and Doubled
Haploid Research and Production. It is important to retain full funding
for the SGGI in fiscal Year 2024.
Lastly, NAWG supports retaining language that provides $1 million
to support research focused on utilizing crop genetics research at
public-private consortiums. NAWG applauds the funding of the National
Predictive Modeling Tool Initiative (NPMTI) in fiscal Year 2022 at $5
million, and we urge the committee to maintain or increase funding for
the NPMTI as additional resources permit. NAWG continues to support
maintaining at least the current level of funding for the NIFA Hatch
Act, Smith-Lever Formula Grants, and the Agriculture and Food Research
Initiative.
Wheat research at the Federal level is driven by funding to the ARS
division of USDA, land grant universities via Hatch Act and Smith-Lever
Act funds, and Agriculture and Food Research Initiative competitive
grants. State governments support wheat research through funding of
public universities and agriculture experiment stations. Wheat growers
in many States directly support wheat research through checkoffs or
assessments on their crop each year. This collaborative partnership has
made the United States one of the premier countries for wheat research,
with all segments sharing in its cost. The investment has resulted in
wheat varieties with the end-use quality that meets or exceeds the
demands of our customers, both domestic and international.
Agribusiness investment in wheat breeding and wheat improvement in
the United States is minimal compared to other commodities. Private
investment in wheat research has increased in recent years, but
increased Federal investments must be made to provide solutions for
problems affecting wheat productivity in the U.S. Wheat growers and the
wheat industry depend on the USDA-ARS' public research efforts land
grant universities to provide these solutions.
The National Association of Wheat Growers works with our 20 wheat
state associations and industry partners to benefit wheat farmers.
These requests will directly help find new markets to export our wheat,
provide critical investments in research, and facilitate innovative
wheat research to improve quality and protect against disease and pest
challenges. We greatly appreciate your consideration of these requests.
[This statement was submitted by Brent Cheyne, President, National
Association of Wheat Growers.]
______
Prepared Statement of National Coalition for Food and Agricultural
Research (NCFAR)
The undersigned organizations and institutions would first like to
thank you for your collective efforts to complete the fiscal year 2023
appropriations. As Congress moves forward to develop a 2024 spending
package, we encourage you to support increased investments to advance
food and agricultural research at the U.S. Department of Agriculture
(USDA) through the Research, Education, and Economics Mission Area.
Recent data from the U.S. Economic Research Service indicates that
for every $1 in public investment, U.S. food and agriculture R&D has
returned $20 to the American economy. However, the report further notes
that ``U.S. public agricultural R&D spending peaked in 2002, and by
2019 spending had declined to roughly where it was in 1970.''
The food and agriculture enterprise faces unprecedented challenges
from extreme weather exacerbated by climate change, supply chain
disruptions and rising food costs resulting from natural and
geopolitical events, and adverse health outcomes related to nutrition
insecurity and inequality. Fortunately, the key to addressing many of
these challenges lies in strong Federal investments in the broad suite
of research, education, and extension programs within USDA. We urge you
to make the following investments in the final 2024 spending agreement.
Provide $2.080 billion for the National Institute of Food and
Agriculture Research (NIFA) as recommended in the House Agriculture
Appropriations bill.
As USDA's extramural funding arm, NIFA programs integrate research,
education, and Extension to ensure that groundbreaking scientific
discoveries are brought out of the laboratory and into the hands of
those who can put them to work.
Provide increased support for all the capacity programs, which are
fundamental to the extramural research, education, and Cooperative
Extension system.
NIFA's capacity programs provide an innovation network supporting
our Nation's Experiment Stations, research farms, and Cooperative
Extension activities to keep the United States as the global leader of
agricultural research.
--Request $300 million in FY2024 for the Hatch Act account which
supports 1862 land-grant university federal-state partnerships
that employ science experts across each State at Experiment
Stations respond to critical issues that affect production,
profitability, invasive plant/animal species, biosecurity, land
and water use, climate resilience, economic analysis, and farm
safety. The multistate component of Hatch ensures coordination
on key projects that advance agricultural production and
processing, profitability, and sustainability.
--Requests $108 million in FY2024 for the Evans-Allen account to
provide capacity funding for food and agricultural research at
the 1890 Historically Black land-grant universities and
Tuskegee University. The Evans-Allen Program enables research
for small farmer challenges, food security and nutrition, rural
prosperity and economic sustainability, natural resources and
the environment and workforce development. Most Black students
majoring in agriculture graduate from 1890s universities.
--Request $17.5 million for the Tribal College Research program for
research funding that helps to protect reservation forests,
woodlands, grasslands, and crops, and monitoring of the quality
of soil, water, and other environmental factors.
--Requests $46 million to support the McIntire-Stennis Cooperative
Forestry research which investigates carbon sequestration,
development of biobased products, prevention of forest fires,
identification of biobased-energy sources, and training of
forest and natural resource scientists.
--Requests $420 million in Smith-Lever3(b) and 3(c) funds to support
the Cooperative Extension System (CES), a unique network of on-
farm researchers, specialists, agents, and educators who
deliver vital, practical information to agricultural producers,
small business owners, communities, youth, and families.
--Requests $88 million for the Extension Services of 1890s land-grant
universities. This program supports adoption of new farm
production and management approaches through informal education
via on-site demonstrations.
--Requests $17.5 million in Fy2024 for Tribal Colleges Extension,
which supports community-based learning on topics such as
farmer education, youth development, diet and nutrition, and
rural entrepreneurship.
Provide $500 million in funding for the Agriculture and Food
Research Initiative (AFRI) as recommended in the House Agriculture
Appropriations bill.
AFRI is USDA's premier competitive research program, supporting
fundamental and applied research to address key problems of local,
regional, national, and global importance in conventional, organic, and
urban agricultural systems. This funding level for the program is
needed to invest in crucial areas aimed at addressing our Nation's most
urgent and pressing food, agriculture, and public health challenges.
AFRI-funded research supports COVID-19 recovery, climate change
adaptation and mitigation, equity across the food system, food safety
and traceability, supply chain resiliency, bioenergy, nutrition and
wellness, agricultural technology, rural economic prosperity, and a
diverse research workforce. At its current funding level, AFRI can
support fewer than a third of the projects recommended for funding.
AFRI research programs support the development of new technologies and
a workforce that will advance our National security, agricultural
productivity, and the health of Americans.
Provide $500 million in funding for the Research Facilities Act
(RFA) as recommended in the House Appropriations Minibus bill.
Agricultural and food research solves global issues including
preventing the next pandemic, addressing energy sustainability,
limiting forest fires, and feeding global populations. Yet, the U.S. is
at a hazardous crossroads and is rapidly losing ground as the global
leader in agricultural science. 70 percent of the research facilities
at U.S. public colleges of agriculture are at the end of their useful
life. RFA funding will allow land-grant universities and non-land-grant
colleges of agriculture to construct and modernize their research
infrastructure to meet the needs of 21st century agricultural
challenges.
A 2021 report determined 70 percent of research facilities at U.S.
public colleges of agriculture are at the end of their useful life with
$11.5 billion in deferred maintenance. RFA allows for construction of
modern facilities at colleges of agriculture that support agricultural
research, that will increase pest and disease preparedness and use of
advanced technologies, nation-wide.
Provide $1.95 billion for the Agricultural Research Service (ARS)
as recommended in the Senate Agriculture Appropriations bill.
As USDA's principal in-house research agency, ARS advances
scientific knowledge through its four national program areas:
nutrition, food safety and quality; animal production and protection;
natural resources and sustainable agricultural systems; and crop
production and protection. As one of the only funding sources available
for long-term agricultural research, the ARS labs and research sites
foster synergistic research collaborations across scientific
disciplines and geographic locations. This funding would also help to
address ARS infrastructure improvements critical to carrying out its
research responsibilities.
Provide at least $50 million in funding for the Agriculture
Advanced Research and Development Authority (AgARDA) as recommended in
the House Agriculture Appropriations bill.
The power of an advanced research program lies in its unique
selection process to identify innovative ideas and technologies,
allowing significant achievements to occur more rapidly than in a
conventional research setting. By fully funding AgARDA, Congress can
respond to our most pressing challenges: threats from plant and animal
pests and diseases, rising costs and limited availability of inputs,
inefficiencies in planting, harvesting and processing, and
vulnerabilities to increasingly extreme weather.
Our food and agricultural system is vast, complex, and
interconnected. Shocks from natural disasters, geopolitical
instability, and labor and supply chain disruptions have shown us that
now, more than ever, we need a radically different approach to
achieving solutions. AgARDA can reach across the boundaries of
traditional scientific disciplines and draw from industries of the
future--nanotechnology, quantum computing, and machine learning--to
sustainably increase the quantity and quality of our food supply.
The U.S. food and agricultural enterprise is at a crossroad:
continue to underinvest in research and innovation or support a robust,
diverse public agricultural research portfolio that will transform our
agricultural system and maintain U.S. global leadership. AgARDA can be
a key component of that future, but we can't wait, the time to invest
is now.
Provide $98 million for the Economic Research Service (ERS) as
recommended in the FY2024 President's Budget U.S. agriculture benefits
greatly from ERS and NASS data and modeling. This information not only
helps the industry and academia but also guides sound policymaking.
Some of these datasets need to be developed from scratch and may
lead to a better understanding of adaptation strategies to climatic
change or improve our knowledge of mitigation strategies (e.g., the
value of cover crops and why it is not widely adopted). These datasets
can also help us better understand how to deal with disasters and
reduce the cost of natural disasters. Data that can help understand the
importance of capacity building in rural America. Finally, the datasets
can also better inform us of the energy transition effect on
underserved communities and the impact of climatic disasters on these
communities.
Provide $241 million for the National Agricultural Statistics
Service (NASS) as recommended in the FY2024 President's Budget The
investments in USDA research, education, and extension programs made
today will be responsible for developing the scientific outcomes and
workforce urgently needed to meet identified and as-yet unknown
challenges in the future. We urge you to do all you can to support a
robust, diverse research, education, and extension portfolio within
USDA.
We thank you for your continued support and look forward to working
with you on this important effort.
Sincerely,
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
President, NCFAR
______
Prepared Statement of National Commodity Supplemental Food Program
Association (NCSFPA)
Mister Chairman and subcommittee members, thank you for this
opportunity to present information regarding the USDA/FNS Commodity
Supplemental Food Program (CSFP). The National Commodity Supplemental
Food Program Association (NCSFPA) requests that the Senate Agriculture
Appropriations subcommittee fund CSFP for fiscal Year 2024 at
$390,000,000 subject to cost revisions to be submitted by the U. S.
Department of Agriculture. NCSFPA would also like to thank the
subcommittee for providing sufficient funding to support CSFP service
in all 50 States, and sustained caseload as we continue to support the
program to statewide levels in all 50 States.
CSFP is a unique program which brings together Federal and State
agencies, along with public and private entities. CSFP currently
provides services through over 150 non-profit community and faith-based
organizations at 1,800 sites located in 50 States, the District of
Columbia, Puerto Rico, and eight Indian Tribal Organizations (Red Lake,
Minnesota, Oglala Sioux, South Dakota, the Seminole Nation in Oklahoma,
the Spirit Lake Sioux Tribe in North Dakota, the Shingle Springs Band
of Miwok Indians in California, Wichita and Affiliated Tribes), and
most recently, the Mississippi Band of Choctaw Indians, and Winnebago
Tribe of Nebraska. Each month up to 760,547 low-income seniors are
authorized to receive a nutritionally balanced food box. The program
has moved to serve exclusively elderly participants, as required by the
Agricultural Act of 2014. Our Association thanks the subcommittee for
funding that enables us to continue serving our vulnerable population.
The CSFP Local Agencies are committed grassroots operators with
dedicated volunteers fulfilling a mission to provide quality nutrition
assistance economically, efficiently, and responsibly. In cooperation
with USDA, NCSFPA seeks to meet the current and emerging needs of CSFP
participants. NCSFPA wishes to commend the Food Distribution Division
of the Food and Nutrition Service (FNS) of the Department of
Agriculture for their continued support of CSFP through the pandemic
through efforts to address product shortages through substitute
products and distribution flexibilities which we would like to
continue, until production limitations subsided. At this time, CSFP
agencies have been advised to return to distributing complete monthly
boxes that will include all pre-pandemic items. Additional CSFP funding
will continue to sustain national inventories and address the increased
food costs.
As the Food and Nutrition Service notes in its Budget Explanatory
Notes:
"According to the Census Bureau, the elderly population
in the United States has been growing over the past
several years and will continue to grow by an
additional 27 percent by 2050. SNAP data shows that, of
the proportion of the elderly population who are
eligible, only about 41 percent currently receive SNAP
benefits; meaning that many low-income, elderly persons
rely on other sources of food assistance through food
banks and food pantries, and programs such as CSFP.''
``CSFP requests a total appropriation of $390 million
in 2024 to continue to serve the full caseload of
764,000. This increase is due to current and projected
prices for commodities as well as the assumption that,
as the pandemic wanes, participation will return to
higher levels. Currently, the program is experiencing
lower-than-normal participation levels during the
pandemic, which is a reversal of the increased
participation trend seen in 2019 and early 2020.
However, by 2024, FNS expects that participation will
return to the robust levels seen pre-pandemic. CSFP is
currently able to support caseload due to an infusion
of resources from supplemental spending bills in 2021.
Those additional resources will be depleted during
2023.''
Equally encouraging are the comments from the Presidential
Proclamation honoring May 2022 as Older Americans Month:
"Older adults have always been a vital source of
strength and resilience in America. During the
pandemic, many seniors came out of retirement to serve
their communities in health care and education roles,
filling job vacancies in critical shortage areas.
Moving forward, we must ensure that older Americans
have the appropriate resources to maintain their
independence and stay connected to their communities.''
The President went on to say ``My Administration is
committed to keeping older Americans safe and healthy
as they age. The American Rescue Plan allocated $1.4
billion to providing older adults with services for
nutrition, health promotion, disease prevention,
caregiver support, and long-term care.''
As a senior-based program, CSFP has a long-standing presence in
providing healthy food to some of our most vulnerable citizens.
Commitment to supporting CSFP in fiscal Year 2024 will build on that
foundation at a time when our senior population continues to grow, and
new distributions remain needed to reach unserved populations in States
across the US.
CSFP continues to be a testimony to the power of community
partnerships with faith-based organizations, farmers, private industry,
and government agencies. The CSFP offers a unique combination of
advantages unparalleled by any other food assistance program:
--The CSFP specifically targets one of our Nation's most
nutritionally vulnerable populations: low-income seniors.
--The CSFP provides a monthly selection of food packages tailored to
specific nutritional needs.
--The CSFP involves the entire community. Tens of thousands of
volunteers and private companies donate money, equipment, and
most importantly time and effort to deliver food to needy and
homebound seniors. These volunteers not only bring food but
companionship and other assistance to seniors who might have
limited support systems.
--The COVID-19 pandemic provided some powerful examples of the
protective benefits of CSFP. While stores continued to see
limitations for some food items, CSFP participants still had
access to nutritious foods, provided through safe and socially
distant practices implemented during the pandemic. No-contact
distributions, including home deliveries, electronic intake
practices, and drive-up food pick-ups streamlined efforts to
protect staff, volunteers, and participants.
--With the aging of the Baby Boomers and the coming 'Silver Tsunami',
CSFP is uniquely positioned to meet the nutritional needs of
our Nation's growing population of vulnerable seniors.
Replenishing national food inventories and increasing caseload
are vital as we work to keep up with this growing population.
NCSFPA senior participants across the country value their CSFP
benefits for both the balanced meals that CSFP provides each month and
the interaction between seniors and program staff. CSFP is a program
that promotes healthy lifestyles and reduces any discomfort associated
with participation in food support programs. The program allows seniors
to live more stable, self- sufficient lives, whether homebound, living
with limited income, or lacking access to other food and support
options. It allows participant income to be put toward other costs of
living, such as rent/mortgage, utilities, medical care.
America is aging and CSFP is an integral part of senior nutrition
programming that is a cost effective and nutritionally sound way to
ensure that today's seniors remain productive, healthy, and independent
to maintain a good quality of life. It is of note that many seniors are
now continuing to work at least part-time beyond retirement age to
ensure that they can afford basic necessities. As such, CSFP is an
important tool for them to remain healthy so that they may continue to
be an active part of the work force.
The Agriculture Appropriations subcommittee has consistently
supported CSFP, acknowledging it as a cost-effective way of providing
nutritious supplemental foods. We urge the subcommittee to provide
$390,000,000 subject to cost revisions submitted by the U. S.
Department of Agriculture for the Commodity Supplemental Food Program
in order to allow us to provide needed services to a minimum of 760,547
vulnerable seniors each month.
Again, thank you for your continuing support. We look forward to
working with you on behalf of CSFP participants.
[This statement was submitted by Christina Peretti, President,
[email protected], National Commodity Supplemental Food Program
Association.]
______
Prepared Statement of the National Environmental Health Association
(NEHA)
The National Environmental Health Association (NEHA) represents
almost 7,000 environmental health professionals throughout the U.S. and
around the world. NEHA is the profession's strongest advocate for
excellence in the practice of environmental health. Our mission is the
advancement of the environmental health professional and we serve to
provide quality training, continuing education, and credentialing to
our members and environmental health professionals.
As the committee reviews the fiscal year 2024 (FY 2024) budget, we
would like to emphasize the following:
------------------------------------------------------------------------
Program Name FY 2023 FY 2024 Request
------------------------------------------------------------------------
Food and Drug Administration $1,519 million $1,730 million
Food Safety Program..........
Federal and State Initiative.. $120 million $150 million
New Era of Smarter Food Safety $3.5 million $40.5 million
Integrated Food Safety System. $115.6 million $128 million
------------------------------------------------------------------------
the u.s. food safety system
The U.S. has one of the safest, if not the safest, retail and
manufactured food systems in the world. The rate of foodborne disease
in our Nation, however, remains too high. The U.S. food industry is
worth approximately $1.5 trillion, accounting for one-fifth of the U.S.
economy. FDA oversees 78 percent of the U.S. human food supply.
The programs highlighted above support efforts of the Food and Drug
Administration (FDA) to provide resources to State, local, Tribal, and
territorial (SLTT) food safety programs that protect this nation's food
safety system through inspection, education, and enforcement.
Foodborne illness outbreaks can originate from any stage in the
food production line. Restaurants are the most reported location of
food preparation associated with outbreaks, accounting for 64 percent
of the outbreaks for which a single location of preparation was
reported; most of such outbreaks (48 percent) occur in sit-down
establishments.
NEHA would like to highlight three points regarding this nation's
food safety system:
Food Safety Is Performed by State, Local, Tribal, and Territorial
Agencies.
The numerous Federal agencies regulating foods (primarily FDA) rely
on their SLTT counterparts to implement their food safety programs.
There are 70 State agencies alone that apply the FDA Food Code-mainly
through their departments of agriculture, health, or environment-to
protect the public from adverse food incidents. There are over 3,500
local health departments with food safety authorities, several Tribal
jurisdictions with delegated authority from their States and the
Federal Government, and U.S. territories that have food safety
responsibilities.
SLTT programs implement the requirements of FDA food safety
programs. The vast majority of food safety inspections, both retail and
manufacturing, are performed by SLTT inspectors. The majority of
enforcement actions occur by SLTT agencies, under SLTT authorities.
FDA's Retail Flexible Funding Model (RFFM) provides the resources
that SLTT food agencies need to meet the requirements of the Retail
Food Standards and the Food Code, and has been very beneficial to the
jurisdictions that have accepted the funding.
Food safety will only succeed if SLTT agencies are well-funded
through programs like the RFFM and provided with resources necessary to
implement and administer food safety measures.
The FDA Uniform Food Safety System promotes public health.
National uniform adherence with FDA retail food regulation best
practices-such as the FDA Food Code and Voluntary National Retail Food
Regulatory Program Standards (Retail Program Standards)-decrease the
occurrence of foodborne illness outbreaks. The FDA Federal and State
Initiative and Integrated Food Safety System promote a uniform food
safety system.
The Retail Program Standards provide a clear set of evidence-based
guidelines for self-assessment and continuous improvement of regulatory
agency programs and processes. SLTT enrollment with the Retail Program
Standards aids in the reduction of foodborne illness incidence by
providing standardized training, program evaluation, and technical
support for SLTT jurisdictions.
Adoption of the FDA Food Code prevents foodborne illness. The FDA
Food Code advances known practices for preventing foodborne illness.
The code promotes the best advice from FDA to address the safety and
protection of food offered at retail food and food service industries.
FDA's purpose in maintaining an updated Food Code is to assist SLTT
jurisdictions by providing them with a scientifically sound, technical,
and legal basis for regulating the retail segment of the food industry.
The Retail Food Safety Association Collaborative, a cooperative
agreement funded by FDA, promotes the adoption of the Food Code.
There are more than 3,500 SLTT government agencies that have the
primary responsibility of regulating retail food and food service
industries in the U.S., all of which follow some version of the Food
Code. These agencies regulate food service operations in restaurants,
retail food stores, food vendors, schools, hospitals, assisted-living
facilities, nursing homes, and childcare centers.
Conformance with the Food Code and Retail Program Standards
encourages STLL jurisdictions to follow a standardized set of
guidelines for food safety that are known to lower the incidence of
foodborne outbreaks.
A strong, qualified environmental health workforce is necessary to
meet the public health mandate around food and human food needs.
Trained and credentialed personnel within SLTT food safety programs
prevent adverse foodborne health outcomes through ensuring human food
remains healthy and nutritious. This workforce is vital in FDA meeting
its human food objectives.
Credentialed personnel within SLTT food safety programs improve the
health and quality of life of people living in their communities. Their
services prevent adverse health outcomes. FDA needs to improve its
ability to recruit, hire and retain personnel with the skills necessary
to meet its objectives, both at the Federal and STLL levels.
According to the Reagan-Udall report on human foods, FDA should
move to a stronger, more cooperative relationship with States and other
local authorities. Approximately half of the human food inspections are
done by States through contracts and cooperative agreements, accounting
for over 13,190 human food inspections in FY22. Funding for a strong,
qualified SLTT workforce through FDA's Federal and State Initiative,
the Integrated Food Safety System, and the Retail Flexible Funding
Model is imperative in meeting FDA's goal of meeting public health
mandate around food safety.
Food safety is a critical public health issue that affects
individuals and communities across the U.S. and around the world.
We look forward to working with Congress and FDA in funding a
system that improves the Nation's food safety system.
In health,
D. Gary Brown, DrPH, CIH, RS, DAAS
2022-2023 President
National Environmental Health Association
[email protected]
David T. Dyjack, DrPH, CIH
Executive Director and Chief Executive Officer
National Environmental Health Association
[email protected]
[This statement was submitted by Doug Farquhar, JD, Director,
Government Affairs, National Environmental Health Association.]
______
Prepared Statement of National Farmers Union
I write on behalf of National Farmers Union's (NFU) more than
220,000 family farmer, rancher, and rural members. Farmers and ranchers
have faced many challenges over the past year, including high input
costs and lingering supply chain disruptions caused by trade disputes,
the COVID-19 pandemic, and Russia's war on Ukraine. Natural disasters
and extreme weather events exacerbated by climate change continue to
make the business of farming more difficult. Additionally, underlying
market concentration across food and agricultural supply chains
continues to squeeze family farmers and ranchers.
These challenges result in significant stress for farmers and their
communities.
As you draft and advance appropriations legislation, I urge you to
provide funding for programs that alleviate the challenges facing rural
and agricultural communities and that improve the resiliency of our
food system.
fair, competitive, and resilient markets
Most sectors in American agriculture are dominated by a small
handful of multinational corporations. Multiple waves of unfettered
mergers and acquisitions over several decades have resulted in
agriculture and food supply chains that are uncompetitive and that
underpay farmers while overcharging consumers. This extreme
concentration leaves food and agriculture supply chains less resilient
and more vulnerable to shocks.
Concentration in the livestock and poultry industries has been on
the rise for decades. Just four companies controlled 85 percent of beef
slaughter and processing in 2019, and concentration is high in pork and
poultry as well. Concentrated market structures increase opportunities
for anticompetitive behavior. Thus, it is essential that the Packers
and Stockyards Act (P&S Act) is enforced. The P&S Act is a law meant to
protect farmers from discriminatory and monopolistic practices in the
livestock, meat, and poultry industries.
NFU appreciates the committee's recognition of these issues in the
FY23 funding bill by including our requested report language and by
securing funding for enforcement of the Packers & Stockyards Act. NFU
requests the continued inclusion of the following report language to
address these issues:
The Committee recognizes that consolidation in agribusiness can be
detrimental to farmers, consumers, workers, and the environment. The
Committee considers enforcement of the Packers and Stockyards Act a top
priority and directs the Department to continue enforcing the act to
the fullest extent of the law. Further, the Committee urges the USDA
Agricultural Marketing Service (AMS) and other agencies and mission
areas to fully incorporate fair and competitive markets priorities
across relevant programs and operations.
We also request that the Committee provide USDA AMS with additional
funding for Packers and Stockyards Act enforcement at the $35 million
level in FY24.
Additionally, NFU supports the USDA Agricultural Marketing Service
(AMS), Packers and Stockyards Division, being permitted to complete the
P&S Act rulemakings the agency is currently promulgating. NFU opposes
any efforts to interfere with USDA's rulemaking authority and the
ongoing P&S Act rulemakings.
Furthermore, NFU supports strong funding for USDA's Food Safety and
Inspection Service (FSIS) to help ensure the safety of the Nation's
commercial supply of meat, poultry, and eggs, and to support building
fairer and more competitive markets for producers. NFU supports FSIS
continuing to fund the reduction in overtime and holiday inspection
fees for small and very small establishments. NFU also strongly
supports USDA FSIS's comprehensive review and ongoing rulemaking
regarding the ``Product of USA'' voluntary labeling claim.
climate change and conservation
America's family farmers and ranchers have been and will continue
to help address climate change. But they need the support of voluntary,
incentive-based conservation programs to implement effective practices
on their land. On-the-ground capacity at the Natural Resources
Conservation Service (NRCS) continues to be a limitation for farmers
seeking to implement conservation practices. Funding for Conservation
Technical Assistance (CTA) is needed for NRCS to hire more staff and
partner with organizations to do conservation planning on farms and
assist with conservation program implementation.
We ask that you provide no less than $1.2 billion in funding for
Conservation Operations, including CTA, in FY24. The request for this
funding should be in addition to any Congressionally Directed Spending
used for Conservation Operations and CTA.
Improved pasture and grazing management can play a substantial role
in carbon sequestration and improving soil health. NFU appreciates the
committee's provision of $14 million for the Grazing Lands Conservation
Initiative (GLCI) in FY22 and FY23.
We ask the committee to build on these investments by providing at
least $30 million in FY24 for GLCI, administered by NRCS. The
initiative should provide competitive grants or cooperative agreements
for locally led efforts to provide technical assistance to help
maintain and improve the management, productivity, and health of our
Nation's grazing lands.
farm and ranch stress assistance network (frsan)
Farming can be a stressful and isolating occupation. There are
multiple causes of stress among farmers and their families, including
volatility in the farm economy, the financial risk involved in
agriculture, weather unpredictability, and a changing climate. FRSAN
funds regional service provider networks that connect individuals and
their families engaged in farming, ranching, and other agriculture-
related occupations to stress assistance programs. These regional
networks help State and local governments, nonprofits, and other
institutions share best practices, fill service gaps, and avoid
duplicating efforts. FRSAN has also helped existing service providers
reach more individuals and families in need.
We urge the committee to increase funding for FRSAN, administered
by the National Institute of Food and Agriculture (NIFA), from $10
million in FY23 to $12 million in FY24 to address the urgent need to
address farm stress and save lives.
rural cooperative development grant (rcdg) program
The objective of the RCDG program, administered by USDA's Rural
Business-Cooperative Service, is to improve the economic condition of
rural areas by assisting individuals or entities in the startup,
expansion, or operational improvement of rural cooperatives through
Cooperative Development Centers. The RCDG program has received stagnant
funding at $5.8 million since FY12. Congress should increase the
funding available for Cooperative Development Centers to ensure
technical assistance is available in more communities to help spur
economic growth and job creation.
NFU requests at least $15 million for grants through RCDG for
Cooperative Development Centers for FY24.
broadband and high-speed internet
Rural Americans are 10 times more likely than urban residents to
lack access to quality broadband. Robust Federal investment in
broadband internet connectivity is essential for advancing telehealth
and distance learning in rural areas, and to ensure family farms and
ranches can thrive. NFU supports the ReConnect Loan and Grant Program,
which helps fund the construction, improvement, or acquisition of
facilities and equipment needed to provide broadband service in
eligible rural areas.
NFU urges the committee to provide full funding in FY24 to continue
the ReConnect Loan and Grant Program, administered by USDA's Rural
Development (RD) Rural Utilities Service (RUS).
food safety education, outreach and technical assistance
The Food Safety Outreach Program (FSOP) provides outreach,
education, and technical assistance to small- and mid-sized, beginning,
and socially disadvantaged farmers and processors to help them comply
with Food Safety Modernization Act (FSMA) regulations. FSMA regulations
are complex, and it is essential that producers have access to
assistance to help them understand how to comply with the law.
To help ensure a safe food supply for American families, and to
help small- and mid-sized, beginning, and socially disadvantaged
farmers comply with food safety regulations, we urge you to provide $10
million for FSOP, administered by the National Institute of Food and
Agriculture (NIFA), in FY24.
We also request robust funding for Food and Drug Administration
(FDA) FSMA implementation that will allow FDA to continue their current
outreach, education, and technical assistance efforts. We request the
following report language:
The agreement directs the Food and Drug Administration (FDA) to
provide outreach, training, and technical assistance to farmers for
compliance with the Food Safety Modernization Act (FSMA) and directs
FDA to provide funding at no less than the fiscal year 2023 level. The
agreement also directs the FDA to continue working with small farms to
clarify requirements for compliance with FSMA and directs FDA to
provide funding at no less than the fiscal year 2023 level.
conclusion
Thank you for your attention to these matters. If you have any
questions or would like to further discuss NFU's requests, please
contact Aaron Shier, NFU Government Relations Director, at
[email protected].
[This statement was submitted by Rob Larew, President, National
Farmers Union.]
______
Prepared Statement of National Center for Appropriate Technology
Appropriations Bill: Agriculture
Specific Agency: Rural Business--Cooperative Service
Appropriations Account: Rural Cooperative Development Grants
Program: Appropriate Technology Transfer for Rural Areas
Amount requested for fiscal Year 2024: Appropriations: $3.5 million
Amount Provided in fiscal Year 2023: $3.5 million
summary
ATTRA (Appropriate Technology Transfer for Rural Areas) provides
trusted, practical, research-based information to tens of thousands of
farmers, ranchers, extension agents, conservation professionals, on-
farm energy specialists, and urban agriculture practitioners. ATTRA is
a long-standing Farm Bill program with a current authorization for
appropriations of $5 million annually. ATTRA is a one-stop shop for
sustainable agriculture information for farmers and ranchers, managed
by the National Center for Appropriate Technology under a Cooperative
Agreement with USDA Rural Development's Rural Business--Cooperative
Service.
The program offers free technical assistance on sustainable
agriculture production and farm energy issues via a toll-free hotline
that is answered in English and Spanish for nine hours per day and
through our websites www.ncat.attra.org and www.ncat.attra.org/espanol.
Assistance is also available through email, texting, social media, and
online chat. NCAT's agricultural specialists include 30+ highly
qualified experts from diverse agricultural disciplines including
horticulture, agronomy, animal science, economics, soil science,
business planning, and marketing. Most staff also have experience in
farming, ranching, Extension, and education. The In addition to
answering specific producer questions, the ATTRA staff also produce
workshops, webinars, and multi-media materials and meet with producers
at conferences and during farm visits and field days.
In addition to technical assistance and educational materials,
ATTRA also helps train military veterans with its Armed to Farm program
and is accelerating the adoption of regenerative agriculture practices
through NCAT's Soil for Water program, which combines peer-to-peer
learning networks with rangeland monitoring, workshops, and direct
producer technical support.
We appreciate the current year appropriation of $3.5 million and
for fiscal Year 2024, we again request $3.5 million, level funding with
fiscal Year 23, as we continue to expand ATTRA services for technical
assistance to respond to the myriad farming needs of our clients,
including improving soil health and water retention, increasing farm
resilience, expanding market opportunities, adopting on-farm renewable
energy programs including agrisolar, and expand training for beginning,
socially disadvantaged, limited resource, and veteran farmers.
NCAT has also signed on in support of other appropriations requests
when those requests are linked closely to ATTRA's mission and where
ATTRA can provide resources and expertise to support other programs,
including support for farm sustainability, climate resilience, soil and
water conservation and quality, value-added marketing, on-farm
renewable energy production, and farming opportunities for beginning
socially disadvantaged, limited resource, and veteran farmers. These
linkages are highlighted at the end of this testimony.
attra highlights and initiatives
Educational Materials and Outreach: ATTRA offers over 1,200
educational resources in print publications, webinars, databases,
podcasts, videos, blogs, and tutorials directly related to sustainable
agriculture, soil health, regenerative land management, climate
solutions, business planning, and marketing. In its 2022 program year,
ATTRA's digital resources were accessed over 2.5 million times. Fifty
new podcast episodes were provided, along with 169 new videos and
webinars. For example, ATTRA specialists presented a webinar to over
250 NRCS staff on tools and equipment for small and urban farms, and to
115 participants from various USDA agencies as part of the Southwest
Drought Network on soil health and water resources.
Technical Assistance: ATTRA provides one-on-one assistance, small-
group assistance, and peer-to- peer learning networks through
workshops, conference presentations, farmer listening sessions, farm
tours, and social media. In its 2022 program year, ATTRA provided TA to
nearly 30,000 clients, including over 2,000 cases that required in-
depth research. Topics included grazing management, soil health
training, cover crops, land access, bio-solarization, financing for
producer cooperatives, and crop insurance education, among many others.
Training: ATTRA has a strong reputation for providing practical
training for farmers and ranchers, with a particular emphasis on
beginning, socially disadvantaged, historically underserved, and
military veteran farmers. More than 200 trainings are offered,
virtually and in-person, each year.
Armed to Farm is a sustainable agriculture training program for
military veterans. During the 2022 project year, more than 1,000
veterans have been trained, in-person and virtually, in week-long
sessions through farm visits, hands-on activities, and classroom
sessions on business planning, marketing, recordkeeping, access to USDA
programs, and various production topics. In-person trainings in 2022
took place in MD, GA, NM, and CA. To date 80 percent of participants
are farming or in the process of starting a farm; 94 percent say that
the training improved their ability to farm; and 35 percent added new
enterprises to their farm since attending the training. NCAT hosts a
website, newsletter, listserv, and an Armed to Farm Facebook page to
connect veterans to resources and to facilitate peer-to-peer learning.
Soil for Water is accelerating the adoption of regenerative
agricultural practices that catch and hold more water in soils. Peer-
to-peer learning networks are combined with, workshops, and support for
producers who are trying new ways to improve health of their land and
soils. ATTRA resources have been leveraged to expand these networks
with support from NRCS, SARE, and private foundations. Soil for Water
is a free, voluntary network available to all commercial agriculture
producers in the U.S. Soil for Water has launched a new website, online
forum, and the Regenerator's Atlas of America to strengthen peer-to-
peer learning and networking opportunities.
The AgriSolar Clearinghouse is connecting businesses, land
managers, and researchers with trusted resources to support the growth
of co-located solar and sustainable agriculture. The AgriSolar
Clearinghouse boasts more than 400 peer-reviewed articles and practical
resources for farmers, land managers, and solar developers to maximize
land and farm revenue. The hub includes a peer-to-peer forum, a bi-
monthly newsletter, and one-on-one technical assistance from the NCAT
energy and agriculture teams. ATTRA resources supporting farm energy
solutions have been leveraged through the U.S. Department of Energy to
develop the AgriSolar Clearinghouse.
To learn more about ATTRA's activities, please see our 2021-
2022Report to RBCS as well as the ATTRA website.
attra regional offices
Work carried out under ATTRA is accomplished among NCAT's 10 field
offices, located in Butte, Montana (headquarters), Arkansas,
California, Colorado, Idaho, Kentucky, Mississippi, New Hampshire,
Pennsylvania, and Texas. Six of those offices provide support across an
entire region of the U.S.: Montana covers the northern plains, Arkansas
covers the southeast, California covers the west, Texas covers the
southwest, New Hampshire covers the northeast, and Mississippi covers
the Gulf States region
attra and ncat contributions to other programs in the annual
appropriations bill
In addition to running a first-class education, training, and
technical assistance program via a cooperative agreement with USDA with
funds provided by this subcommittee, we also have a closely linked
interest and make contributions to and help promote many other USDA
programs and thus also have an interest in their annual funding level.
We support of robust appropriations for the following:
--NIFA's Sustainable Agriculture Research and Education (SARE)--$60
million
--RBCS' Rural Energy for American Program (REAP)--$30 million
--RBCS's Value-Added Producer Grants (VAPG)--$15 million
--NRCS' Grazing Lands Conservation Initiative (GLCI)--$30 million
from within the NRCS CTA account
--Farm and Ranch Stress Assistance Network (FRSAN)--$10 million
NCAT is proud to be a long-term partner with USDA in support of
sustainable agriculture, value-added production and marketing, local
food systems, and training and technical assistance for beginning,
socially disadvantaged, limited resource, and veteran farmers. We
appreciate the subcommittee's ongoing support for ATTRA as the Nation's
premier source of information on sustainable agriculture and for the
range of other programs that help farmers thrive by producing healthy,
fresh food to the American people while conserving natural resources
and supporting rural communities.
[This statement was submitted by Ferd Hoefner, Consultant to NCAT.]
______
Prepared Statement of National Institute of Food and Agriculture
Founded in 1912, FASEB is a nonprofit which provides a forum for
educational meetings, develops publications, and disseminates results
of biological research. Now the Nation's largest biomedical coalition,
it represents 27 scientific societies and more than 115,000 researchers
worldwide. Our mission is to advance health and well-being by promoting
research and education in biological and biomedical sciences through
collaborative advocacy and service to our member societies and their
members.
FASEB's fiscal Year 2024 Recommendation for the Agriculture and
Food Research Initiative is $700 million to fulfill its mission as the
leading competitive grants program for agricultural sciences.
Federal investments in fundamental research have led to remarkable
progress in the biological and biomedical sciences-an increasingly
multidisciplinary team-based effort. These collaborative research
efforts have enabled investigators to respond to pressing scientific
challenges. Basic research was the groundwork for the speed-months
instead of years-that led to the development of COVID-19 vaccines and
also supports pre-clinical research involving the use of animal studies
to achieve medical progress.
A major contributing factor to the success of team science is the
mobilization of core facilities and shared research resources (SRRs),
including the scientific technology and expertise infrastructure within
research organizations. SRRs and cores work across different scientific
disciplines and deliver unbiased research data in support of scientific
rigor and transparency. They are essential training grounds for the
next generation of skills-based scientists from diverse backgrounds.
Despite Congress' bipartisan support for investing in science,
Federal funding for research has not kept pace with scientific
opportunity, posing a threat to our Nation's competitiveness. We face a
real threat of losing our edge in industries such as biotechnology if
we do not continue to prioritize increasing investments in science,
shared resource facilities, including core facilities, and building a
diverse workforce.\1\ The U.S. spends less on research and development
(R&D) than many countries. If the U.S. is to be prepared to respond to
future threats, our scientific leadership must progress. According to
Science Is Us, more than 67 million workers in the U.S. are
professionals in science, technology, engineering, and math (STEM)
fields. STEM economic activity accounted for 40.5 percent of U.S. gross
domestic product in 2021.\2\
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\1\ The State of U.S. Science and Engineering 2020--NSF--National
Science Foundation
\2\ People-of-Science-Economic-Impact-Analysis-FINAL--March--
2023.pdf (scienceisus.org)
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Our agricultural system faces unprecedented challenges, including
global food and fuel demand, water availability, and training a diverse
agricultural workforce. The U.S. Department of Agriculture's National
Institute of Food and Agriculture (NIFA) is the lead Federal agency
providing extramural funding for food and agricultural sciences. NIFA
funds an interdisciplinary research portfolio that brings pioneering
science to address complex problems through the Agriculture and Food
Research Initiative (AFRI), our Nation's leading competitive grants
program for agriculture that supports education, research, extension,
and integrated projects. AFRI funds agricultural and food sciences
research at colleges, universities, and other institutions nationwide.
Established by the Farm Bill in 2008, AFRI funding, while not keeping
pace with the cost of doing research, has resulted in numerous
advances, including new wheat cultivars and novel ways to combat
invasive species.\3 4\
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\3\ The Agriculture and Food Research Initiative (AFRI), National
Institute of Food and Agriculture (usda.gov)
\4\ AFRI Project Types (usda.gov)
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AFRI funds agricultural and food sciences research at colleges,
universities, and other institutions nationwide. Established by the
Farm Bill in 2008, AFRI funding, while not keeping pace with the cost
of doing research, has resulted in numerous advancements, including new
wheat cultivars and novel ways to combat invasive species.
Despite AFRI's progress-and the need for scientifically informed
solutions-the program is appropriated at about 65 percent of its
authorization, leaving hundreds of innovative proposals unfunded.
According to the latest AFRI 2020 annual report, of the total 2,783
competitive grant applications for fiscal Year 2020, awards totaling
$377,748,316 were made to 715 high-ranked applications across AFRI with
a success rate of 24 percent. There were an additional 895 proposals
that were highly ranked (Outstanding, High Priority, or Medium
Priority) which were unsupported due to a lack of Federal funding.
AFRI should be funded at its full $700 million authorization, which
is $245 million above fiscal Year 2023 enacted (53 percent increase),
to fulfill its mission as the leading competitive grants program for
agricultural sciences.
[This statement was submitted by National Institute of Food and
Agriculture.]
______
Prepared Statement of National Institute of Food and Agriculture
Thank you for your continued support of the U.S. Department of
Agriculture's (USDA) extramural research, Cooperative Extension, and
education programs funded through the National Institute of Food and
Agriculture (NIFA). The APLU Board on Agriculture Assembly (BAA)
requests bold Federal investment in our Nation's colleges of
agriculture and forestry by advancing funding increases for core
accounts that underpin the strength of our Nation's public research,
Extension, and education system serving U.S. food and agriculture.
The return on investment of U.S. agriculture research and
Cooperative Extension is $20 for every public $1 invested. Yet Federal
support for NIFA agricultural research, education, and Extension has
been flat in real dollars, resulting in destabilization of the very
system the U.S. relies on to cultivate agricultural leaders, reinforce
domestic preparedness against pests and diseases, and ensure the U.S.
leadership in global food security and technology. We request
investment that rebuilds U.S. preeminence across public university
research, Cooperative Extension System, education programs, and
research facilities.
research
We respectfully request robust funding for the following programs
that provide capacity and competitive funds to support faculty,
students, and technicians solving climate, production, nutrition, and
agricultural resilience challenges:
--Hatch Act-$300 million: Agricultural Experiment Stations located in
every State provide research capacity for critical issues and
innovations that affect agricultural production, profitability,
and sustainability, such as climate resilience strategies,
conservation, economic analysis, food safety, invasive species,
biosecurity, and precision agriculture. Geographically relevant
research occurs across national, regional, State, and local
contexts.
--Evans-Allen-$108 million: Agricultural research at 1890s colleges
of agriculture takes place due to Evans-Allen capacity funds
that enable research for small farmer challenges, food security
and nutrition, and workforce development. Most Black students
majoring in agriculture graduate from 1890s institutions.
--1994 Institution Research Program-$17.5 million: The Tribal College
Research Program supports research that protect reservation
forests, woodlands, grasslands, and crops, as well monitor soil
and water quality.
--McIntire-Stennis-$46 million: Forestry research capacity addresses
development of biobased products, prevention of forest fires,
identification of new energy sources, expansion of outdoor
recreational activity, and mitigation techniques for invasive
species. It is a direct source of funds for resource science
graduates.
--Agriculture and Food Research Initiative (AFRI)-$500 million: The
flagship competitive grants program for Federal priorities that
improves rural economies, increases food production, stimulates
the bioeconomy, mitigates the impacts of climate variability,
addresses water availability issues, ensures food safety,
enhances human nutrition, and trains the next generation of
agricultural professionals.
cooperative extension
We respectfully request increased investments for the following
programs that support the Cooperative Extension System (CES):
--Smith-Lever Section 3(b) and (c)-$425 million: Capacity for 1862
Extension that supports a network of land-grant-university-
connected state, Tribal, and local educators who deliver vital,
timely, practical information to agricultural producers, small
business owners, communities, youth, and families.
--Extension services at 1890 institutions-$88 million: Capacity that
assists 1890s in working with diverse communities with
research-based, non-formal education about market development,
acquisition of capital and technology, eState planning, and
profitability. Stakeholders include small to medium size
farmers or other underserved populations.
--Extension services at 1994 institutions-$17.5 million: Enables 1994
institutions to deliver science-based, culturally relevant
extension education programs to address biobased energy,
production, and food safety needs, improving quality of life on
reservations.
--Smith Lever 3(d) Programs-$95 million: Includes the following
important programs-Expanded Food and Nutrition Education
Program (EFNEP); Farm Safety and Youth Farm Safety Education;
New Technologies for Agricultural Extension; Children, Youth,
and Families at Risk; and Federally Recognized Tribes Extension
Programs.
education
The agricultural sector will face severe workforce shortages in the
near future. Robust funding in the following NIFA education programs
for food, agriculture, and natural resources are critical to address
the Nation's diverse talent needs:
--Women and Minorities in STEM (WAMS)-$10 million: Increases student
success for rural women and minorities in agricultural
research, education, and Extension.
--1994 Institutions Equity Payment-$17.5 million: Focuses on Tribal
college undergraduate and graduate studies in the food and
agricultural sciences by supporting curricula design, faculty
development, experiential learning, equipment, and student
retention.
infrastructure
Our country is facing unprecedented challenges, from extreme
droughts and floods to invasive species and new plant and animal
diseases. What's more, a 2022 Economic Research Service (ERS) report,
found that U.S. public agricultural R&D spending in 2019 was 1/3 of
that in 2002 (constant dollars) and the U.S. is falling behind
international trade partners including China and the European Union.\1\
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\1\ https://www.ers.usda.gov/amber-waves/2022/june/investment-in-u-
s-public-agricultural-research-and-development-has-fallen-by-a-third-
over-past-two-decades-lags-major-trade-competitors/
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However, our agricultural research infrastructure dates to the
1950s and 1960s and cannot meaningfully address 21st century
challenges. A 2021 report estimated that nearly 70 percent of these
buildings are at the end of their useful lives, and the cost of
upgrading deferred maintenance is $11.5 billion.\2\ With outdated and
dilapidated facilities, scientists cannot be expected to keep pace with
international competitors.
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\2\ https://www.aplu.org/library/a-national-study-of-capital-
infrastructure-at-colleges-and-schools-of-agriculture-an-update/file
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To address this urgent need we request $500 million for
agricultural research facilities at public colleges of agriculture, as
authorized through the Research Facilities Act (RFA) in Section 7503 of
the Agricultural Improvement Act of 2018 (P.L 115-334). RFA will
support competitive grants to land-grant universities and non-land-
grant colleges of agriculture for facility construction, alteration,
acquisition, modernization, renovation, or remodeling.
global agriculture research and extension partnerships
Support critical international grants that foster international
collaborations:
--International Capacity and Competitive Grants-$15 million:
Partnerships to Build Capacity in International Agricultural
Research, Extension, and Teaching program strengthens
international collaboration and the exchange of research
results that promote teaching and Extension. Competitive Grants
for International Agricultural Science and Education program
strengthens U.S. economic competitiveness and promotes
international market development.
The challenges our agricultural sector faces are significant and
have broad, nationwide impacts. Our Cooperative Extension specialists
are being asked to do more with less and our research facilities are
falling down-not only hindering innovation, but our ability to recruit
the best and brightest to the agricultural sciences, repercussions that
will ripple throughout the ag sector for years to come. However, with
bold investments across NIFA's extramural programs, there is an
opportunity to transform the face of modern agriculture and ensure the
United States remains a leader in agricultural innovation. We hope you
will support us in these efforts.
[This statement was submitted by Douglas Steele, Ph.D., Vice
President, Food, Agriculture, & Natural Resources (FANR).]
______
Prepared Statement of National Multiple Sclerosis Society
Chairman Heinrich, Ranking Member Hoeven and Members of the
Committee, thank you for this opportunity to provide testimony on
behalf of the National Multiple Sclerosis Society (Society) regarding
fiscal year 2023 (FY23) appropriations for the Food and Drug
Administration (FDA). The Society urges the Committee to fund the FDA's
budget authority at the Administration's request of $372 million
increase in BA (taxpayer) funding, including $3 million to fund the
Neurology Drug Program.
MS is an unpredictable disease of the central nervous system.
Currently, there is no cure. Symptoms vary from person to person and
may include disabling fatigue, mobility challenges, cognitive changes,
and vision issues. An estimated 1 million people live with MS in the
United States. Early diagnosis and treatment are critical to minimize
disability. Significant progress is being made to achieve a world free
of MS. The Society, founded in 1946, is the global leader of a growing
movement dedicated to creating a world free of MS. To fulfill this
mission, we fund cutting-edge research, drive change through advocacy,
facilitate professional education, collaborate with MS organizations
around the world, and provide services designed to help people affected
by MS move their lives forward.
The Society sees itself as a partner to Federal agencies under the
Committee's jurisdiction and partner with many of the programs that
provide services across the country, particularly the FDA. While we
advocate for the government's involvement in accelerating the
discovery, development, and delivery of new treatments, we do it as an
organization whose research investment exceeds $1 billion to date.
the role of the fda
The FDA is the Nation's pre-eminent public health agency,
responsible for oversight of more than $2.6 trillion in medical
products, food, and other consumer goods. It oversees the entirety of
new drugs and therapies, vaccines, medical devices, and personal care
products and 70 percent of our Nation's food supply. Altogether, the
products and industries regulated by FDA account for about 20 percent
of all consumer spending in the United States, approximately $2.4
trillion per year.
No Federal agency's mission and responsibilities are more affected
by changes in science, technology, innovation, and social trends than
the FDA. People with MS not only rely on the FDA to approve safe and
effective therapies to help manage their disease, but also to ensure a
safe food supply, regulate tobacco (smoking may increase the risk of
developing in MS and can worsen MS symptoms), help expedite the
approval generic medications are approved to help address prescription
drug affordability. Further, MS healthcare providers rely on the
accurate, science-based information from the agency to utilize in
conversations with people with MS, their families, and care partners
around health care and treatment decisions.
FDA's core mission should receive robust and sustained funding to
meet the challenges of advances in science and technology that make
regulatory decisions more complex and require greater sophistication
and expertise to complete. The agency should have additional resources,
more scientific and technical staff, and better analytical tools that
support scientific-based decision-making and keep up with innovation in
both food and medical products and we believe the Administration's
request allows for FDA to invest in these key areas.
the neurology drug program
The FDA has been instrumental in approving and regulating MS
disease modifying therapies (DMTs), as well as other treatments that
aid with symptom management. In 1992, there were no FDA approved
therapies for MS. Today, we have more than 20 disease-modifying
therapies approved by the FDA: however, . more work remains to help
people with MS access needed DMTs, novel therapies, medications to aid
in symptom management and ultimately to find a cure for MS. MS presents
and progresses differently in every individual, and there are multiple
variables that go into decision-making for the use of DMTs. DMTs are
generally not interchangeable and do not work in every person with MS.
The Society is grateful that Congress provided funding for the
establishment of a Neurology Drug Program in FY23. We have long been
concerned that the Agency does not have the personnel and expertise
needed to develop policy and guidance that keep pace with emerging
research in brain disease and neuroscience, as well as ensure that the
Agency has a comprehensive approach to patient engagement as a core
component of the regulatory process.
Stakeholders report uncertainty and inconsistency in which types of
data will be acceptable to individual review divisions regarding
patient experience-informed endpoints. We believe that the initial
investment in the Neurology Drug Program will allow FDA to gain the
expertise to develop policies and guidance that keep pace with emerging
brain science. We look forward to working with FDA personnel to ensure
this investment results in advances that encompass all areas of brain
health including neurodevelopmental, neurodegenerative, psychiatric,
brain injuries and more.
We believe that people with MS and patients in all disease States
would be best served if the agency had consistent processes for
engagement with all stakeholders and that these processes should be a
core part of the agency's mission. The Society urges the subcommittee
to ensure that these efforts are appropriately funded and prioritized
within the agency's base funding, as this is an area of regulatory
science that requires training and specific staffing throughout the
agency and within review divisions.
conclusion
In conclusion, we hope that the Committee continues to invest in
the Agency and fund the FDA's budget authority at the Administration's
request of $372 billion for FY24.
[This statement was submitted by Leslie Ritter, Associate Vice
President, Federal Government Affairs.]
______
Prepared Statement of the National Organic Coalition
I am submitting this testimony on behalf of the National Organic
Coalition (NOC) to detail our fiscal year 2024 funding requests for
USDA programs of importance to the organic sector.
usda/agricultural marketing service (ams)
National Organic Program
Request: $26.4 million
Organic agriculture is one of the fastest growing sectors of
agriculture, fueled by strong consumer demand. The organic sector now
exceeds $66 billion in annual sales with over 27,000 certified organic
family farmers and other businesses represented.
The National Organic Program (NOP) is the agency charged with
regulating and enforcing the USDA organic label. NOP was funded at $18
million for FY 2021, $20 million for FY2022, and $22 million for
FY2023. We are requesting $26.4 million for the NOP for FY 2024 in
recognition of the need for enhanced oversight, enforcement, and
rulemaking for the rapidly growing sector.
In addition, we are requesting the following report language to
encourage NOP to increase enforcement efforts regarding the soil health
requirements of existing organic standards:
USDA organic standards require organic farmers to use
farming practices that improve soil health, such as
crop rotations, cover cropping, and pasture-based
livestock practices. By improving soil health, these
farming practices also increase the carbon
sequestration potential of the soil and improve the
farm's resilience to extreme weather events and
patterns. To maximize the climate benefits of organic
agriculture, the Committee urges the National Organic
Program to continue to increase enforcement efforts to
ensure full compliance with the soil health and pasture
requirements of USDA organic standards.
usda (ams, nass, ers)
Organic Data Initiative
Request: $1 million for organic data collection and analysis
Authorized by Section 7407 of the 2002 Farm Bill, the Organic
Production and Marketing Data Initiative states that the ``Secretary
shall ensure that segregated data on the production and marketing of
organic agricultural products is included in the ongoing baseline of
data collection regarding agricultural production and marketing.'' In
addition to mandatory funding, Section 10103 of the 2018 Farm Bill
authorizes $5 million annually in discretionary funding.
As the organic industry matures and grows at a rapid rate, the lack
of data for the production, pricing, and marketing of organic products
has impeded further development of the industry and limited the
functioning of USDA organic programs. Organic data collection and
analysis at USDA has made significant strides in recent years but
remains in its infancy.
We request $1 million for FY 2024 for organic data collection at
AMS, NASS, and ERS.
usda/national institute of food and agriculture (nifa)
Organic Transitions Program
Request: $10 million
The Organic Transitions Program, authorized by Section 406 of the
Agricultural Research, Education and Extension Reform Act (AREERA) for
Integrated Research Programs, is a research grant program to help
farmers address challenges of organic production and marketing. As the
organic industry grows, the demand for research on organic agriculture
is experiencing significant growth as well. This research has broad
applications to all sectors of agriculture, even beyond the organic
sector.
Many organic research needs go unmet because of lack of adequate
funding. As demand for organic products continues to grow at a fast
rate, domestic production of organic food has not kept pace, requiring
a greater percentage of organic product to be imported to meet the
consumer demand. Funding for organic research has not kept pace with
the growth in the industry either.
The Organic Transition Program was funded at $7 million for FY
2021, and $7.5 million for FY 2022 and FY 2023. We are seeking $10
million for FY 2024, with report language to specify that the increase
in funding should be used for fund research regarding climate change
and organic agriculture.
Agriculture and Food Research Initiative (AFRI)
Request: Report language on public cultivar development
In recent decades, public resources for the development of improved
plant varieties and cultivars have dwindled, while resources have
shifted toward genomics and biotechnology, with a focus on a limited
set of major crops and regions.
In Section 7406 of the Food, Conservation, and Energy Act of 2008,
the National Research Initiative was merged with the Initiative for
Future Agriculture and Food Systems to become the Agriculture and Food
Research Initiative (AFRI). Congress included language within AFRI to
make ``conventional'' plant and animal breeding a priority for AFRI
grants, consistent with concerns expressed by the Appropriations
Committee in past appropriations cycles.
In the last several years, USDA has made regionally adapted
cultivar development using conventional breeding techniques a higher
priority within the plant breeding funding area.
In response to direction from the Senate Agriculture Appropriations
Subcommittee report language, a ``Conventional Plant Breeding for
Cultivar Development'' program area was created within the Plant Health
and Production and Plant Products (PHPPP) priority area with the
Foundational and Applied Science RFA of AFRI. While this development
represents progress, there are several areas where further improvement
is needed: 1) the amount of funding overall remains extremely low
relative to the need; 2) the AFRI practice of awarding three-to-five-
year grants conflicts with the longer-term breeding cycles required for
public cultivar development projects 3) the ``Conventional Plant
Breeding for Cultivar Development'' RFA does not specify that the
cultivars developed with these grants should remain publicly available
for farmers and for plant breeders for future breeding efforts; and 4)
the maximum grant in this new program area priority is $500,000,
whereas the grant limit within the other PHPPP program area priorities
range from $650,000 for standard grants up to $800,000 for
partnerships.
Therefore, we request the following AFRI report language to address
these concerns:
Section 7406 of the Food, Conservation, and Energy Act
of 2008 specifies priority areas within the Agriculture
and Food Research Initiative [AFRI], including an
emphasis on conventional (classical) plant and animal
breeding. The Committee strongly concurs with the
intent of this section and appreciates the agency's
progress in creating a distinct Conventional Plant
Breeding for Cultivar Development program area priority
within the AFRI program for development of locally and
regionally adapted cultivars, as the Committee
previously directed. While noting this progress, the
Committee expects the agency to significantly increase
funding for this AFRI priority area, to increase the
timeframe for grants made in this area to be more in
keeping with classical plant breeding timeframes, to
increase grant funding limits to be parallel with the
other AFRI Plant Health and Production and Plant Health
program areas, and to require that cultivars developed
using these grants be publicly available for farmers
and for plant breeders for future breeding efforts. In
addition, the agency should take steps to improve its
tracking of public cultivar development projects within
AFRI. The Committee further directs the agency to
report its progress in meeting these requirements.
Sustainable Agriculture Research and Education (SARE)
Request: $60 million
The SARE program has successfully funded on-farm research on
environmentally sound and profitable practices and systems, including
organic production. The reliable information developed and distributed
through SARE grants is very helpful to organic farmers. SARE was funded
at $40 million in FY2021, $45 million in FY2022, and $50 million in
FY2023. The President's FY2024 Budget requests $60 million for SARE. We
are also requesting $60 million for SARE for FY 2024.
usda/national agricultural statistics service (nass)
Tenure, Ownership, and Transition of Agricultural Land (TOTAL) Survey
Request: $15 million
Land access is a major challenge facing beginning, socially
disadvantaged, and young farmers, including organic farmers. Sec. 12607
of the 2018 Farm Bill tasked the National Agricultural Statistics
Service with completing an updated TOTAL Survey to provide data on
farmland ownership, tenure, transition, and entry of beginning and
socially disadvantaged farmers. NOC is requesting $15 million for the
TOTAL survey for FY2024.
usda/agricultural research service (ars)
Organic Research within the Agricultural Research Service (ARS)
Request: $35 million
Organic farmers across the country lack research on basic agronomic
challenges. ARS organic funding has declined from over $15 million in
FY2007 to just $12 million in FY2020. This is less than 1 percent of
the ARS research budget. If ARS were to invest 6 percent of its total
research budget on organic, commensurate with organic's market share,
that would equate to over $120 million. To start addressing this
inequity, we are requesting FY2024 report language to require not less
than $35 million for ARS organic research.
Thank you for your consideration of these requests.
[This statement was submitted by Steven Etka, Policy Director,
National Organic Coalition.]
______
Prepared Statement of the National Treasury Employees Union
food & drug administration
NTEU is grateful to have this opportunity to submit this statement
of our views on Fiscal Year 2024 appropriations for the Food & Drug
Administration (FDA) where our union represents the bargaining unit
employees.
The Administration has requested a 10 percent increase ($372
million above the FY23 enacted level) for the Food & Drug
Administration (FDA). The total FDA budget request is for $7.2 billion
of which $3.93 billion would come from funds appropriated by Congress,
$2.5 billion from medical products user fees, and $700 million from
tobacco user fees. NTEU strongly endorses the Administration's request
and urges Congress to fully fund the requested amounts.
The FDA workload is constantly growing and must grow as private
sector growth continues in medical, pharmaceutical, veterinary and food
production marketing. To hold back FDA would mean to hold back the
innovations of the private sector in these critical and necessary
products. That would not be in the interests of the health and safety
of the American public.
FDA is a staff-intensive organization, with more than 80 percent of
its budget devoted to personnel costs. FDA employees are among the most
highly skilled and dedicated employees that will be found anywhere in
the public or private sector. The agency needs to be able to recruit
and retain skilled scientists, inspectors, chemists and other
professionals. FDA certainly does not match the superior pay offered by
the private sector, where these skills are very much in demand, but it
does have a workforce committed to public service and public health.
However, FDA has a turnover rate two times the government wide
average and 70 percent of the staff are retirement eligible. According
to a recent Government Accountability Office (GAO) report, the crafts
with the greatest pay and benefits differential from the private sector
are scientists, physicians and regulatory attorneys. More broadly,
there are hiring and retention problems with the professional and
technical staff as well as those who work in medical product review.
And of constantly growing importance is FDA's foreign inspection
program. As we have told the Members of this Committee before, FDA has
a hiring and retention crisis. Failure to overcome this crisis will
mean a failure in the mission of FDA.
NTEU applaudes the steps FDA has been taking to address this
crisis. In listening to the employees at FDA, we find that the most
effective initiatives are improved student loan repayment benefits, an
expanded child care subsidy and telework. These initiatives can help
retain skilled professionals while attracting new employees to service
at FDA. Assuming robust implementation, these initiatiives will achieve
great strides in addressing the staffing crisis. We believe that the
President's budget submission includes the resources needed to fully
implement these initiatives and that the funding allocated in the
request should be directed there. In addition, each of these
initiatives also create cost savings that help to mitigate their costs,
particularly in decreasing new employee training.
Telework and remote work provide the greatest opportunity for
recruiting and retaining the best employees. While not all positions at
FDA lend themselves to telework--chemists need to be in their
laboratories and inpectors have always worked remotely as they move
from facility to facility for their inspections--there are at FDA those
who analyze text rather than substances or perform administrative or
grants management tasks that are well suited for telework. In the
coming years, FDA should re-evalute the amount of space it leases at
taxpayer expense and significantly reduce its footprint, savings tens
of millions of dollars. Further savings are likely to be achieved when
full time remote workers re-locate away from the FDA offices which are
often in urban areas with high Federal locality pay to rural and small
town areas where the employee accepts a lower locality pay while at the
same time bringing jobs and their paycheck to rural and small town
America.
However, there are three issues where FDA needs attention:
Among the least desirable tasks of FDA Consumer Safety Officers
(CSO) is carrying out overseas inspections. It has been very difficult
to fully staff these positions even though it is essential that
overseas pharmetcuticial, medical and food producers be held to the
same high standards that domestic firms are held to. To hold importers
to a more leinient standard than American producers not only harms the
heath and food safety of American consumers, it is also unfair to
American businesses.
Let me be clear. These inspection trips are not a vacation. They
are typically three week trips overseas visiting multiple facilities in
remote industrial zones in countries like China. All Grade 12 or above
CSOs are required to be available for these inspections. It is hard
work, where inspectors spend this time away from their families in a
foreign country where both the facility and the government may be less
than welcoming and not committed to the transparency the inspector
seeks. Employees also have concerns about their personal safety. FDA
needs additional funding to make these jobs more desirable. NTEU
supports new funding for bonuses for inspectors and reduction of trips
from three weeks to two weeks. Congress should also fund positions at
FDA to serve as translators for the inspectors. Currently the
translators are provided by the facility or maybe even the Chinese
government. While this has been a much criticized arrangement, to date,
Congress has not provided the needed funding for FDA to hire its own
translators.
Recruiting and retaining the best and most highly skilled employees
is not just a matter of compensation and worklife issues and FDA
management needs to better recruit from parts of our society that have
not been well included in the FDA staff. In our call for improved
diversity, equity and inclusion at FDA, this year, I would like to
particularly highlight the missed potential of many high skilled
military veterans. The Department of Health & Human Services, which FDA
is part, has one of the lowest percentage of military veterans on staff
of any Federal agency. HHS is at 8 percent while 30 percent of Federal
civilian employees overall are veterans. NTEU believes that while FDA
suffers significant staffing shortages, there are significant numbers
of qualified veterans who would make superior employees at FDA. More
robust affirmative steps should be taken to notify veterans of
employment opportunities at FDA, recruit them and retain them.
Lastly, FDA is currently undergoing a reorganization of its food
safety function. It would be useful for management to meaningfully
consult with the union as it implements this re-organization.
Thank you for your consideration. NTEU appreciates the opportunity
to present this statement.
[This statement was submitted by Anthony M. Reardon, National
President.]
______
Prepared Statement of Organic Farmers Association
The Organic Farmers Association is a nonprofit membership
organization that represents U.S. certified organic farmers. We
appreciate the opportunity to share these requests related to fiscal
Year 2024 appropriations for agencies within the U.S. Department of
Agriculture.
national organic program
Account: Agricultural Marketing Service
OFA fiscal Year 2024 request: $26.4 million
The integrity of the organic label is organic farmers' top
priority. If the National Organic Program is not able to enforce the
organic standards, consumers will lose trust in the integrity of the
label, putting the economic viability of organic farmers at risk. The
NOP has oversight of the standards that define the USDA certified
organic label as well as the accredited certifying agencies that
inspect organic farms and food companies. The NOP must be able to grow
to provide proper oversight of certifiers and enforcement in an
industry that is rapidly expanding to create complex new supply chains
that present numerous opportunities for fraud. Enforcement priorities
for OFA include compliance with the Pasture Rule, finishing the
Strengthening Organic Enforcement rulemaking, clarifying standards and
certification interpretation of hydroponic and container operations,
and reducing opportunities for fraud in the organic supply chain.
Despite the explosive growth of the organic industry into a global
industry and repeated instances of failures by USDA to keep up with
oversight and enforcement, the NOP was level funded at $9 million from
fiscal years 2014 to 2017. The NOP was funded at $16 million in 2020,
$18 million in 2021, $20 million in 2022, and $22 million for FY23. We
request $26.4 million for the NOP for fiscal Year 2024, and report
language continuing to urge NOP to increase enforcement of soil health
requirements critical to organic's role in addressing climate change,
including use of cover crops, crop rotation and enforcement of pasture
standards.
organic data initiative
Account: Agriculture Marketing Service, National Agricultural
Statistics Service, and Economic Research Service
OFA fiscal Year 2023 request: $1 million (authorized level)
As the organic industry has grown, we have struggled to represent
that growth to policy makers and regulators, in part because USDA has
been slow to develop systems to track the growth of organic. Increasing
USDA's capacity to conduct the Certified Organic Production Survey and
other organic data collection will not only help us show the public and
policy makers that organic is a growth industry for U.S. farmers,
having accurate data on the amount of organic acreage around the world
will also help the National Organic Program and organic certifiers to
better enforce organic standards. Accurate information about the amount
of organic production that is happening can help provide a way to
identify potential fraud in the supply chain.
As the organic industry grows, the lack of good organic data has
been an impediment. We request $1 million for the Organic Data
Initiative for AMS, NASS, and ERS to expand organic data collection and
analysis efforts.
organic transitions program
Account: National Institute of Food and Agriculture
OFA fiscal Year 2024 request: $10 million
Many of the challenges facing the organic sector can be addressed
with increased research. Organic research often investigates practices
and challenges that are also relevant to farmers who are not certified
organic or who farm conventionally. An increased focus on soil health,
alternatives to chemical pest management and cover crops across all
sectors of agriculture show that this kind of research can serve an
audience that is wider than certified organic. The Organic Transitions
Program focuses on these types of topics and addresses the historic
backlog of research needs in this sector.
The growth in demand for organic products means that there is
potential for more organic farms and operations in the U.S., but
obstacles such as research to address and promote organic farming
solutions to production problems has lagged historically. Many of the
debates about specific materials that can or cannot be used in organic
production boil down to a lack of research on organic materials or
practices that can be used as an alternative to the conventional
approach of using a synthetic material. The backlog of research needs
for organic farmers can begin to be addressed if the Organic
Transitions Program continues to grow.
OFA is requesting $10 million for fiscal Year 2024, with a focus on
using the increase to fund climate change research related to organic
agriculture.
sustainable agriculture research and education program
Account: National Institute of Food and Agriculture
OFA fiscal Year 2023 Request: $60 million
Another critical research program for organic farmers is the SARE
program. SARE has been a leader in addressing key sustainability
challenges facing agriculture for over 30 years and remains USDA's only
farmer-driven research program. It has helped create more innovative
organic and conservation farm practices that are adopted by farmers on
the ground than any other competitive agricultural research program.
Yet despite SARE's long-standing record of helping farmers and ranchers
develop and adopt innovative practices and systems, the program has yet
to reach its full authorized amount of $60 million. Without increased
investments, farmers will not be able to meet future productivity
challenges and remain competitive, and they will lack the easily
accessible and regionally appropriate research that they need to
develop sustainable and climate resilient farming systems. In light of
this, we support full funding for SARE at its authorized level of $60
million for fiscal Year 2024.
organic research within the agricultural research service (ars)--$35
million
Organic farmers across the country lack research on basic agronomic
challenges. ARS organic funding has declined from over $15 million in
FY07 to just $12 million in FY20. This is less than 1 percent of the
ARS research budget, versus organic's market share of 6 percent. If ARS
were to invest 6 percent of its total research budget on organic, it
would equate to over $120 million. To start addressing this inequity,
we are requesting $35 million for ARS organic research in FY24.
usda response to pfas contamination of farms
OFA urges the Committee to instruct USDA to assist state
agriculture departments in a robust response to the emerging issue of
per- and polyfluoroalkyl substances (PFAS) contamination of farms and
livestock. The widespread use of PFAS chemicals in a variety of
industries makes it likely that the PFAS-contamination of farmland and
livestock being discovered in some States is likely to be repeated
around the country. The USDA could assist States in responding to this
emerging crisis for farms in several ways:
1) creating an indemnity or disaster response program for farms
(other than dairy farms) with PFAS contamination;
2) conducting and disseminating research on the fate and transport of
PFAS in soils to various types of crops and foods;
3) conducting and disseminating research on methods for remediating
PFAS contaminated farm soils or livestock;
4) providing grants, equipment and technical assistance to States to
increase capacity for testing farm soils and water supplies.
funding for regionally adapted, public cultivar development programs--
afri report language
Farmers need access to seeds and animal breeds adapted to their
farming systems, soils and climates. USDA recently responded to the
request by the Senate Appropriations Committee for a separate AFRI
funding stream for regionally adapted cultivars, by establishing an
AFRI ``cultivar development'' program priority area. The FY2024
appropriations bill should call for increased funding for this AFRI
priority area.
Thank you for the opportunity to present this testimony on fiscal
Year 24 funding levels for programs that serve organic farmers.
[This statement was submitted by Lily Hawkins, Policy Director,
Organic Farmers Association.]
______
Prepared Statement of Organic Farming Research Foundation
I am submitting this testimony on behalf of the Organic Farming
Research Foundation (OFRF) to detail our fiscal year 2024 funding
requests for USDA-REE agency programs important to the maintenance and
growth of the organic sector.
usda--agricultural research service
Research into organic agriculture topics at ARS facilities
Request: $35 million and report language
Organic farming is a bright spot in the agriculture economy, yet
organic producers across the country remain disadvantaged by the lack
of research on basic agronomic and economic challenges. Funding from
the USDA ARS for organic farming research is not commensurate with the
continued rapid growth of the organic market. In fact, according to ARS
data, current organic farming research funding within the agency
represents less than one percent, or about $15 million, of the total
ARS research budget. Meanwhile, the organic sector's market share is
six percent, which should reflect over $120 million in ARS research
funding. This funding gap must be closed to provide equity and address
barriers to wider adoption of organic production practices. Investments
in organic agriculture research will advance the substantial
contributions of the organic sector's efforts to address pressing
environmental, climate, and human health concerns. The ARS research
facility located in Salinas, California conducts the sole organic
focused research project in the country, and continues to produce high
quality, action-oriented research products but continues to face budget
constraints and is at risk.
The ARS recently released its Organic Research Priorities and
roadmap for organic research to the Appropriations Committees. These
priorities highlight the need for continued and expanded investments
into researching organic crop and livestock production necessary to
provide organic farmers cutting edge, usable research and technologies.
Putting this plan into action is critical to meet the needs of organic
and transitioning to organic and transitioning to organic producers.
ARS works at the forefront to find solutions to agricultural
problems. The long-term research carried out at the agency is and will
continue to be critical in preparing farmers and ranchers, organic and
non-organic, to adapt to and mitigate the climate crisis. ARS National
Programs and LTAR sites support long-term basic and applied research
vital to the understanding of phenomena such as soil carbon
sequestration, nutrient cycling, plant-soil-microbe interactions, and
climate resilience in different farming systems. We believe that
increasing funding for organic research, building on the just-released
ARS strategic plan for organic research, will help the agency address
the historical lack of investment in organic agriculture research and
help organic and non-organic producers alike overcome challenges to
realize their potential to mitigate and adapt to the impacts of the
climate crisis.
In conjunction with that agency plan, we believe that appropriators
should act to ensure organic agriculture receives its share of the ARS
research budget to reverse the chronic underinvestment in organic
research at the agency. A $20 million increase in Fiscal Year 2024
would put the ARS research budget on a path toward an equitable
distribution of research funding for organic agriculture over the
course of the next several fiscal years. ARS looks to the
Appropriations Committee for their direction, and providing clear
support for expanding organic agriculture research is necessary for ARS
to act.
Therefore, we request the following ARS report language:
The Agricultural Research Service (ARS) currently
invests $15 million, or less than one percent of their
budget, into organic farming research. Meanwhile, the
organic sector's market share is six percent and
growing. Organic's fair share of the total budget
should reflect over $120 million in ARS research
funding; this $35 million request in FY24 is a down
payment toward meeting the need. This funding gap must
be closed to provide equity and address barriers to
wider adoption of organic production practices.
Investments in organic agriculture research will
advance the substantial contributions of the organic
sector's efforts to address pressing environmental,
climate, and human health concerns.
Previous report language:
FY 23 House report https://www.congress.gov/117/crpt/hrpt392/CRPT-
117hrpt392.pdf--page 19
Organic Research.--The Committee looks forward to receiving the 5
year plan requested in House Report 117-82.
FY 22 House report https://www.congress.gov/117/crpt/hrpt82/CRPT-
117hrpt82.pdf--page 23
Organic Research.--The Committee directs ARS to develop a 5-year
plan for organic food and agriculture research encompassing all
relevant crop, animal, nutrition, and natural resource national
programs.
usda--national institute of food and agriculture
Organic Transitions Program
Request: $10 million
This is a key competitive grants program that supports organic
agriculture research at universities around the country, including many
research programs that benefit farmers and consumers across the United
States. The overall goal of the Organic Transition Research Program
(ORG) is to support the development and implementation of research,
extension and higher education programs to improve the competitiveness
of organic livestock and crop producers, as well as those who are
adopting organic practices and transitioning to organic certification.
Investing in organic systems research is an effective way to invest in
developing tools to support both climate mitigation and adaptation
through land management. Practices and systems addressed by ORG include
those associated with organic crops, organic animal production, and
organic systems integrating plant and animal production. ORG
consistently receives more funding requests than can be accommodated as
consumer demand for organic products outpaces domestic production. For
example, in 2020 there were 34 applications and only 12 awards
distributed. Without continued funding of ORG as an organic-specific
research grant program, this gap will only increase.
The program should be funded at $10 million in FY2024, to ensure
that U.S. farmers and ranchers have the information and technology
necessary to meet the high demand for organic products in the
marketplace.
Sustainable Agriculture Research and Education Program
Request: $60 million
The Sustainable Agriculture Research and Education (SARE) program
has a clear and consistent focus on sustainability and farmer-driven
research. For over 30 years, SARE has been at the forefront of research
and extension activities for farming systems based on profitable and
environmentally sound practices developed with farmer and business
input. Despite SARE's popularity and demonstrated administrative
efficiency, after more than 30 years of proven on-the-ground results,
the program has yet to reach its full authorized amount of $60 million.
As a result, USDA can only fund roughly 10 percent out of all eligible
research and education pre-proposals submitted to the program each
year. We urge Congress to provide full funding at $60 million for SARE
in fiscal Year 2024.
usda--economic research service, agricultural marketing service, and
national agricultural statistics service
Organic Data Initiative
Request: $1 million
The Organic Data Initiative (ODI) collects and disseminates data
regarding organic agriculture through the Agricultural Marketing
Service (AMS), Economic Research Service (ERS), and National
Agricultural Statistics Service (NASS). This program has been
successful in providing valuable information to Congress, government
agencies, and the organic sector. Funding specifically designated to
the Organic Data Initiative is used for economic analysis, organic risk
assessments, survey and statistical analysis, and market data
collection and analysis. We urge strong funding for this small but
valuable program, this increase in funds would allow for stronger
intra-agency cooperation and be used to modernize systems and provide
high-value, accurate organic price reporting and organic data
collection.
Organic farms, both certified and non-certified, throughout the
United States, representing an over $52 billion industry, will benefit
from an increase in organic farming data tools and functions.
Thank you for the consideration of these requests, and I look
forward to discussing them with you.
[This statement was submitted by Gordon N. Merrick, Policy &
Programs Manager, Organic Farming Research Foundation.]
______
Prepared Statement of the Organic Trade Association (OTA)
On behalf of the Organic Trade Association (OTA) and membership, I
respectfully request appropriate and adequate funding levels and
oversight for programs whose mandate is to support the growth of the
organic industry. OTA is the membership-based business association for
organic agriculture and products in North America. OTA is the leading
voice for organic in the United States, representing over 10,000
organic farms and businesses across all 50 States through direct
membership and our farmer's advisory council. Our members include
growers, shippers, processors, certifiers, farmers' associations,
distributors, importers, exporters, brands, consultants, retailers, and
others. OTA believes increasing appropriations for U.S. Department of
Agriculture (USDA) programs and initiatives which regulate current
operations or benefit new farmers entering organic is important as the
industry continues to experience growth on a year-to-year basis.
Despite the many challenges facing the food and agriculture sector,
U.S. organic soared to new highs in 2022, growing to $66 billion in
annual sales. As one of the fastest-growing food and farming sectors in
the U.S. and global marketplace, organic is an increasingly essential
part of American agriculture. Organic provides economic opportunities
for farmers, creating jobs, and lifting rural economies, while also
utilizing sustainable farming practices which benefit the environment.
Organic provides a safe, healthy choice to consumers, who are
increasingly seeking out the trusted USDA Organic seal on the food and
products they purchase for their families.
Therefore, in order to continue this growth, we request the
Committee consider the following appropriations requests for USDA
programs most impactful on organic production in the United States:
--USDA (AMS) National Organic Program (NOP)--$26.4 million;
--USDA (FSA) Organic Certification Cost-Share Program (OCCSP)--$5
million;
--USDA (NIFA) Organic Agriculture Research and Extension Initiative
(OREI)--$10 million;
--USDA (AMS) Organic Data Initiative--$1 million; and,
--USDA (NIFA) Organic Transition Research Program--$10 million.
national organic program (nop)
The National Organic Program (NOP) is the regulatory program within
the USDA Agricultural Marketing Service responsible for developing and
enforcing national standards for certified organic agricultural
products. These standards assure consumers that products with the USDA
organic seal meet consistent, uniform standards. The NOP is vital to
meeting growing consumer demand for organic products. Recognizing the
continued growth of the industry, we ask for $26.4 million, the full
amount of the last authorization plus an additional 10 percent to
accommodate growth. Moreover, this would give NOP the resources it
needs to enforce the organic regulations globally, to continue to
develop international equivalency agreements to expand the market for
American organic products worldwide, and to develop new organic
standards for emerging sectors. Increased funding will allow NOP to
update existing standards to address developing new developments in
best practices, scientific evidence, and consumer demands. Therefore,
OTA requests $26.4M for continued operations of the NOP.
Additionally, non-foods represent 10 percent of the organic
marketplace. OTA requests the subcommittee consider the inclusion of
report language addressing the ability of NOP to enforce standards
``The committee requests that the National Organic Program apply its
authority to the maximum extent possible and exercise oversight and
enforcement of organic claims made on agricultural products which are
non-food, including but not limited to textiles (processed fiber
products), dietary supplements, pet food, personal care products
(including cosmetics), household items (e.g. cleaners, detergents), and
flowers, and assist any other agencies that might have some authority
over these final products with a definition of organic production and
handling and rules for the use of organic label claims. Additionally,
the Committee requests the National Organic Program to take steps to
ensure any certifying agents acting on the behalf of the USDA are
applying the organic standards for non-foods in a uniform and
consistent manner.''
organic certification cost-share program (occsp)
The Organic Certification Cost Share program is important to
attracting new, young farmers to organic. Farms can receive up to $750
each year (75 percent of the certification fee) through the Farm Bill
to help defray the annual costs of organic certification. However,
despite the commitment of Congress to assist organic farmers, the last
2 years USDA announced reimbursement rates for certification costs
would be cut to 50 percent of the certified organic operation's
eligible expenses, up to a maximum of $500 per scope due to funding
shortfalls. We urge the inclusion of this additional funding to ensure
that organic farms and businesses can continue to count on this long-
standing program to help offset their certification requirements as the
producers continue to experience increasing costs. In order to
accommodate the growing need and actions of the USDA in previous fiscal
years, OTA requests $5M for the program.
organic agriculture research and extension initiative (orei)
OREI is the flagship research program for organic agriculture
within USDA. Research is necessary to measure and optimize the outcomes
of organic agriculture systems and develop new ecological technology--
which benefits both organic and conventional producers, as conventional
producers often adopt ecological agricultural practices developed from
this research. Organic makes up six percent of U.S. food sales and
should be equally represented in Federal research funding. OREI
receives mandatory funds through the Commodity Credit Corporation, but
OTA requests an additional $10 million of discretionary funding to
ensure the benefits of organic research reach farmers in the field
through increased extension and outreach activities.
organic [tc1][pm2]data initiative (odi)
The organic industry has grown at a tremendous rate over the past
several years, and accurate data for the production, pricing and
marketing of organic products is essential to maintaining stable
markets, identifying fraud, creating risk management tools, tracking
production trends, and increasing exports. ODI collects and
disseminates data regarding organic agriculture through the
Agricultural Marketing Service (AMS), the National Agricultural
Statistics Service (NASS) and the Economic Research Service (ERS). This
program has been successful in providing valuable information to
Congress, government agencies, and the organic industry at a low cost.
The necessity of this data is evidenced by the difficulty in obtaining
the data to properly roll out the Organic Dairy Marketing Assistance
Program, which would deliver needed relief to organic dairy farmers as
a result from rising costs due to the war in Ukraine and supply chain
issues. OTA asks for $1 million in discretionary funding for the
agencies tasked with data collection and analysis to continue
collecting organic pricing information and conducting surveys and
expand collections to levels comparable to conventional agriculture.
Increased data collection will empower Congress and USDA to better
modify existing programs so organic farmers can fully participate.
organic transition research program (org)
The overall goal of the Organic Transition Research Program (ORG)
is to support the development and implementation of research,
extension, and higher education programs to improve the competitiveness
of organic livestock and crop producers, as well as those who are
adopting organic practices and transitioning to organic certification.
Practices and systems addressed include those associated with organic
crops, organic animal production, and organic systems integrating plant
and animal production. ORG consistently receives more funding requests
than can be accommodated as consumer demand for organic products
outpaces domestic production. Without continued funding of ORG as an
organic-specific research grant program, this gap will only increase.
OTA requests Committee fund the program at $10 million, to facilitate
growth of this important research.
In conclusion, organic food and farming are built on a commitment
to shape our collective future for the better. The organic industry is
creating jobs, stimulating our rural economy, creating domestic
capacity, and delivering quality products in high demand to consumers.
OTA requests the subcommittee continue to work towards providing the
necessary support to achieve even greater success.
I thank the members of this subcommittee for their consideration
and look forward to working with you to advance the organic industry.
Sincerely,
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
CEO
Organic Trade Association
______
Prepared Statement of the Oregon Water Resources Congress
The Oregon Water Resources Congress (OWRC) strongly supports
increased funding for the U.S. Department of Agriculture's (USDA)
Natural Resources Conservation Service (NRCS) programs for fiscal Year
2024. A minimum of $4 billion is needed to support watershed protection
and irrigation modernization efforts across the Nation, split between
the PL-566 programs, the Regional Conservation Partnership Program
(RCPP), and the Environmental Quality Incentives Program (EQIP). Within
the PL-566 programs, a minimum of $1 billion is needed to support
ongoing irrigation modernization efforts under the Watershed Protection
and Flood Prevention Operations (WFPO) Program and $500 million is
needed for coordinated Federal agency watershed planning and assistance
with dam rehabilitation under the Small Watershed Rehabilitation
Program (SWRP).
OWRC was established in 1912 as a trade association to support the
protection and use of water rights and promote the wise stewardship of
water resources in Oregon. Our members are local governmental entities,
including irrigation districts, water control districts, drainage
districts, water improvement districts, and other agricultural water
suppliers that deliver water to one-third of all irrigated land in
Oregon. These water stewards operate complex water management systems,
including water supply reservoirs, canals, pipelines, fish screens, and
hydropower facilities.
pl-566 program needs & benefits
Our members in Oregon face many challenges related to irrigation
water supply reliability, including recurring drought, aging
infrastructure, climate change, and issues related to the Endangered
Species Act (ESA) and the Clean Water Act (CWA). While there are common
concerns and interests throughout irrigated agriculture, each basin is
unique, and necessitates local communities' work collaboratively to
identify needs and develop tailored solutions. NRCS's programs support
multi-benefit projects that help improve water quality, restore
habitat, and more efficiently deliver water to users, without placing
the entire burden on the backs of the agricultural economy that
produces food and fiber for our Nation.
These programs also leverage scarce State and local resources and
incentivize phased-in strategic approaches to meet the myriad of
watershed needs, allowing for irrigation districts and other partners
to plan and implement projects incrementally. NRCS-funded irrigation
modernization projects go through a robust public outreach and scoping
process which leads to the development of a Draft Watershed Plan and
Environmental Assessment. Once the watershed plan is completed and
approved by NRCS, the project is eligible for implementation funding
through the PL-566 WFPO program. While the 2021 Bipartisan
Infrastructure Law provided $500 million for WFPO, this amount is still
woefully insufficient in comparison to the multitude of funding needs
in Oregon and across the Nation. Given the high interest in planning or
implementing projects using NRCS PL-566 funding, we anticipate a
sustained demand for additional funding to support projects like the
examples below.
examples of wfpo projects in oregon
The irrigation modernization projects below are in various stages
of developing and implementing Watershed Plans through the WFPO
program. More projects like these could be developed and implemented in
Oregon and throughout the Nation with additional Federal support.
Arnold Irrigation District, Deschutes County--The District recently
received approval for its NRCS Watershed Plan and is moving forward
with its first phase of project implementation in Fall of 2023. The
overall project will convert 11.9 miles of open canals into pipe and
install two SCADA systems to improve operational efficiency over the
course of 6 years. Additionally, 88 turnouts will be upgraded to
pressurized delivery systems. The project will save 32.5 cfs of water,
conserve 80.8K kWh/year in energy, improve water quality, and improve
52 miles of the Deschutes River. The District is seeking funding for
the subsequent phases of its Watershed Plan.
Hermiston Irrigation District, Umatilla County--The District is
proposing to modernize aging infrastructure to conserve water, improve
operational efficiencies, improve water quality, enhance fish and
wildlife habitat in the Umatilla River, reduce public safety risks, and
increase recreation opportunities. By converting open-ditch irrigation
canals into underground, closed-pipe systems or lining the District's
remaining open canals, the proposed Hermiston Irrigation District
Modernization Project could reduce conveyance and operational losses
over the entire irrigation season and improve the District's ability to
efficiently provide water to its patrons.
Klamath Drainage District, Klamath County--The District is process
of developing a Watershed Plan to modernize district irrigation
infrastructure and improve watershed protection. Proposed projects
include install fish screens at the district's diversions on the
Klamath River, extend and re-engineer sections of canals to increase
flows to the Lower Klamath National Wildlife Refuge (LKNWR), and
improve the district's use and control over water throughout the
district. The proposed project would enable the district to improve
water management within the district's conveyance system and benefit
fish populations by preventing fish from getting trapped in the
district's canals. By reducing water use inefficiencies, the proposed
project would improve water quality. The project would also allow the
district to supply additional water to the LKNWR, which would increase
critically needed habitat for wildlife.
North Unit Irrigation District, Jefferson County--The District is
moving forward with implementing initial projects from its Watershed
Plan, which will install 27.5 miles of gravity-pressurized, buried
pipe; upgrade 153 turnouts; and construct four 1,000 cubic-yard
retention ponds, each approximately 0.5 acres in size. The project will
improve water conservation on District-operated laterals; improve water
delivery reliability and drought resilience to NUID irrigators; reduce
NUID's operation and maintenance costs; reduce operational spills into
natural waterbodies; and improve streamflow, water quality, and habitat
in the Deschutes River. Following project completion, 4,567 acre-feet
of the water saved annually by the project would augment water supplies
for NUID's existing patrons, helping to fulfill existing water rights,
and alleviate water supply shortages across the District. The remaining
1,522 acre-feet of water saved annually would be allocated for instream
purposes and released into the upper Deschutes River during the non-
irrigation season.
Tumalo Irrigation District, Deschutes County--The District was
among the first in the Nation to receive funding for an Irrigation
Modernization Project through WFPO and has been implementing identified
projects in phases over the past 5 years. The project includes
modernizing up to 1.9 miles of the District's canals and 66.9 miles of
laterals to improve water conservation, water delivery reliability, and
public safety. The project will occur in phases over 11 years. By
converting open irrigation ditches into a closed piped system, the
project will reduce water loss from canals by up to 48 cubic feet per
second (cfs). Water saved from the project will be protected in the
Deschutes River and Tumalo Creek, benefiting fish and wildlife habitat.
The project also will deliver water to irrigators in a safer, more
efficient manner and reduce energy consumption from pumping. The
District is reaching the final phases of funding eligibility based on
current program caps but still has several project phases to implement.
Owyhee Irrigation District, Malheur County--In recent years, the
District has faced droughts that limit water supply to irrigators and
the design and age of the District's conveyance system no longer meets
its obligations. To address these concerns, funds will be used to
implement ag-water management and conservation practices and
rehabilitate the conveyance system to improve water delivery
reliability and water conservation throughout the District. Modernizing
the conveyance infrastructure will enable opportunities to benefit the
local agricultural community by improving drought resilience and
reducing inefficiencies associated with the current system.
small watershed rehabilitation program needs
OWRC also strongly supports funding for projects under the Small
Watershed Rehabilitation Program. Two of our members, Sutherlin Water
Control District (SWCD) and Middle Fork Irrigation District (MFID) have
dams that were built under the original PL-566. SWCD and MFID have
received funds to begin the long and expensive process of updating
their 50-year-old dams to today's standards for safety, however; both
districts will need continued funding from the Watershed Rehabilitation
Program and other NRCS funding programs to fully update their
infrastructure.
SWCD operates two dams built under PL-566, Plat I and Cooper Creek,
located in the Umpqua River watershed in Douglas County. While they
were built to seismic standards 55 years ago, they do not meet today's
standards for earthquakes. SWCD's dams serve as multi-purpose storage
for the community: providing flood control, irrigation water for
farmland, municipal water for the city of Sutherlin, and recreation. To
date, SWCD has been authorized to receive funding for planning, design,
and construction of one of their dams and planning and design for the
other. However, SWCD will still need considerable funding dollars to
complete necessary work on both dams. Current estimates for Cooper
Creek are 2.4 million for construction and a minimum of $7 million for
Plat I, primarily for dredging, sediment removal.
MFID is responsible for the management and maintenance of Clear
Branch Dam, a PL-566 dam within the Hood River watershed, which
provides a clean, dependable water supply and distribution system for
the irrigation of pears, apples, cherries, and other high value crops.
Rehabilitation of the dam is needed to protect the public from
flooding, for access to a clean and dependable water supply, and to
maintain agricultural productivity. In the past year, MFID has
continued the dam rehabilitation planning process with its Federal
partners (NRCS as the lead Federal agency and USDA Forest Service as a
cooperating agency), which has included analysis of elements to include
in an updated watershed workplan and EIS document. Planned
rehabilitation project elements that support dam stability include
seismic upgrade, seepage mitigation, fish passage and water quality
improvements that support ESA listed species while maintaining the
project purpose and the need to support irrigated agriculture with a
clean and dependable water supply. Considering the high costs to fix
just three of the PL-566 dams in Oregon, and the immense price tag of
modernizing infrastructure to increase water conservation, preserve
wildlife habitat, and increase water reliability for farmers and
ranchers, a minimum of $500 million is needed to fund this important
program in fiscal Year 2024.
rcpp & eqip benefits & needs
OWRC strongly supports robust funding for RCPP and EQIP, which are
critical tools for districts and other agricultural water suppliers in
developing and implementing water and energy conservation projects in
Oregon. RCPP currently has over 2,000 partners engaged in locally led
conservation efforts that help implement collaborative basin-level
solutions and reduce detrimental legal action, resulting in better
outcomes for all. Since 2014, RCPP has invested over $1 billion in over
375 projects across all fifty States and Puerto Rico. That $1 billion
investment has leveraged an additional $2 billion from State and local
partners for a total of $3 billion invested in RCPP related water
conservation projects. Federal support of water conservation activities
funded through NRCS programs, including the RCPP, is essential to the
conservation of our natural resources and critical to protecting our
food, energy, and water supply. Irrigation districts in Oregon are the
model of successful RCPP projects that ``innovate, leverage additional
contributions, offer impactful solutions and engage more
participants.''
Ongoing RCPP Projects in Oregon--East Fork Irrigation District,
Hood River County--This project brings together a diverse set of
partners in the Hood River watershed to focus on a top-priority water
conservation and fish habitat project. The project will construct Phase
1 of a pipeline project, assist agricultural producers with
approximately 400 acres of on-farm water conservation practices,
educate producers and farm workers on the latest irrigation water
management techniques, and restore one mile of spawning and rearing
habitat for threatened fish species. NRCS programs that will support
these efforts include EQIP, CSP, and PL566. Together, these projects
will increase irrigation water reliability for high value food crops,
improve resilience to drought, and restore instream habitat for ESA-
listed species.
Additional funding for PL-566, RCPP, and EQIP programs will ensure
NRCS can continue to provide critical technical and financial
assistance to project partners and build upon momentum from successful
projects to accelerate innovative solutions to some of our most vexing
water management challenges. Increasing the budget for NRCS programs is
a strategic investment that will pay both environmental and economic
dividends for current and future generations in Oregon and nationally.
Thank you for the opportunity to provide testimony on fiscal Year
2024 Budget for the U.S. Department of Agriculture's (USDA) Natural
Resources Conservation Service (NRCS) programs.
Sincerely,
April Snell, Executive Director
Address: 795 Winter St. NE, Salem, OR 97301
[This statement was submitted by April Snell, Executive Director,
Oregon Water Resources Congress.]
______
Prepared Statement of the Personalized Medicine Coalition (PMC)
Chairman Heinrich, Ranking Member Hoeven and distinguished members
of the subcommittee, the Personalized Medicine Coalition (PMC)
appreciates the opportunity to submit testimony on the U.S. Food and
Drug Administration (FDA)'s fiscal year 2024 appropriations. PMC is a
nonprofit education and advocacy organization comprised of more than
220 member institutions across the health care spectrum who are working
together to advance personalized medicine in ways that benefit patients
and health systems. We appreciate that the subcommittee provided an
increased budget for FDA in fiscal Year 2023 to allow the agency to
continue carrying out its public health mission. However, the agency's
responsibilities increase in complexity each year. For this reason, the
agency requires a budget that grows each year. Thus, as the
subcommittee begins work on the fiscal Year 2024 Agriculture, Rural
Development, FDA, & Related Agencies Appropriations bill, we
respectfully ask that you continue to invest in FDA by appropriating
$3.914 billion to FDA's budget authority as requested by the
Administration. Such an increase will position FDA to provide access to
safe and effective medical products, including advances in technologies
that are the foundation for the future personalized medicine.
Personalized medicine, also called precision or individualized
medicine, is an evolving field in which physicians use diagnostic tests
to determine which medical treatments will work best for each patient
or use medical interventions to alter molecular mechanisms that impact
health. By combining data from diagnostic tests with an individual's
medical history, circumstances, and values, health care providers can
develop targeted treatment and prevention plans with their patients.
Personalized medicine promises to help us detect the onset of disease,
pre-empt its progression, and improve the quality, accessibility, and
affordability of health care.\1\
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\1\ http://www.personalizedmedicinecoalition.org.pdf
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Budget authority provides FDA with the broadest and most flexible
means of meeting all its responsibilities.\2\ Previous increases in
budget authority enabled the agency to implement multiple programs
facilitating the development of personalized medicine products, which
require greater sophistication and expertise to review. Additional
increases in fiscal Year 2024 budget authority would allow FDA to
expand these initiatives and launch new ones with a highly skilled and
technically empowered workforce equipped with modernized analytical
tools that support science-based decision-making. By increasing Federal
investment in FDA activities fostering the development of innovative
medical products, real-world evidence (RWE), and digital health,
Congress can help usher in a new era of personalized medicine at a
pivotal moment, promising a brighter future for health systems and
patients with unmet medical needs.
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\2\ https://acrobat.adobe.com/link/
track?uri=urn:aaid:scds:US:fbda0765-44c4-47d2-aa11-
71a4721a4d3f#pageNum=2
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the role of fda in personalized medicine
Thanks in part to a responsive regulatory agency, personalized
medicine is progressing steadily. As of 2022, more than 300
personalized treatments are available for patients. That number has
continued to grow, with personalized medicines accounting for more than
a quarter of all new drugs approved by FDA for each of the past 8
years, including 34 percent of the new drugs approved by FDA last
year.\3\ These new approvals are helping to transform care for
molecularly selected subsets of patients with cancer, where 53 percent
of newly approved personalized medicines are indicated, as well as
rare, common, and infectious diseases, which account for the rest. In
2022, FDA also approved five gene and cell-based therapies and new
diagnostic indications for 12 testing platforms.
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\3\ https://www.personalizedmedicinecoalition.org/Userfiles/PMC-
Corporate/file/report.pdf
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FDA is the gateway for many personalized medicine breakthroughs
entering the market. FDA's Center for Devices and Radiological Health
(CDRH), Center for Drug Evaluation and Research (CDER), and Center for
Biologics Evaluation and Research (CBER) each have responsibilities for
evaluating the safety and efficacy of breakthrough medical products. As
personalized approaches to treatment and prevention have grown, new
types of drugs, tools, and technologies leveraging complex and
sophisticated data, like RWE, have challenged existing regulatory
frameworks and processes.
facilitating the development of personalized medicine products
FDA is taking a number of steps to modernize its regulatory
processes, such as streamlining its technical and data infrastructure
to shorten review times, improving clinical trials to address unmet
medical needs, integrating RWE into medical product reviews, and
building partnerships to foster digital health and artificial
intelligence (AI) technologies. In future years, robust funding from
Congress will help FDA continue to build upon this work and bring
personalized medicine products to patients as efficiently as possible.
expediting product development
As a byproduct of scientific breakthroughs, the amount and variety
of data that FDA generates, needs and uses is rapidly increasing. Even
though FDA has taken action across the agency in recent years to make
more rapid decisions and improve communications with medical product
developers, the agency's technical infrastructure remains fragmented.
In 2021, FDA announced a new Office of Digital Transformation to
advance the agency's information technology transformation, which began
in 2019. The $10 million included in the Administration's proposed
budget for fiscal Year 2024 would allow further investments in
enterprise data and IT modernization to streamline data practices
across centers and help translate FDA's wealth of information into
knowledge supporting progress in personalized medicine.
The agency must also bolster its workforce to build in
flexibilities across each of its centers and to keep pace with the
growing pipeline of cell and gene therapies. Cell and gene therapy
holds considerable potential for the treatment of hereditary genetic
disorders, including rare, neurodegenerative, and infectious diseases.
The number of cell and gene therapy submissions FDA receives is rising
sharply. More than 200 new gene therapy Investigational New Drug
applications are coming to FDA's CBER annually, up sharply from just
over 100 in fiscal Year 2017.\4\ CBER provides extensive scientific and
regulatory advice to product manufacturers throughout the medical
product lifecycle. The center also develops policy and guidance on
novel clinical, scientific, and manufacturing challenges for these
products. An increase in FDA's budget authority would allow the agency
to continue working with stakeholders to facilitate end-to-end
solutions addressing key issues limiting the development and
application of gene therapies, like manufacturing challenges, that make
these therapies cost-prohibitive and in some cases not commercially
viable.
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\4\ https://www.fda.gov/media/166182/download
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modernizing clinical trials
More rare diseases and cancers are being defined by biological
markers, creating smaller groups of patients who are more likely to
respond to targeted treatments and are candidates for participation in
trials. Trials that rely on identification of patients by biological
markers, such as enriched trials, trials with master protocols, and in
silico trials using computer modeling, present opportunities to
streamline clinical research, especially in cases where a scarcity of
patients makes a randomized control infeasible and where important
personalized medicines may be delayed or discarded because FDA cannot
afford to run the trials needed to validate them.
For many rare diseases, treatments are now within reach. Incentives
and regulatory pathways, however, must be maintained for all rare
diseases to make development financially viable. FDA's Orphan Products
Grant Program supports the development of products to treat orphan or
rare diseases including programs to support clinical trials, natural
history studies, and new authority to fund grants addressing regulatory
science challenges.\5\ Advances in the understanding of rare diseases
and novel technology platforms have transformed many disease pipelines.
By providing $30 million for the Orphan Products Grant Program, this
subcommittee can respond to the documented economic burden rare
diseases present to families and the country.\6\
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\5\ https://www.fda.gov/industry/medical-products-rare-diseases-
and-conditions/orphan-products-grants-program
\6\ https://everylifefoundation.org/wp-content/uploads/2022/04/
Orphanet_Journal_of_Rare_Diseases.pdf
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To help expand the development of new scientific approaches and
tools available for advancing effective medical products that can
prevent, diagnose, mitigate, and treat rare neurodegenerative diseases,
Congress passed the act for ALS Act. This bill authorized $2.5 million
in funding for staffing to support implementation.\7\ To allow FDA to
facilitate access to therapies for neurodegenerative diseases such as
amyotrophic lateral sclerosis (ALS) while continuing to focus on
innovation and scientific advancement of new medical products to
address other critical and rare diseases, the subcommittee should
provide the agency with the full authorized funding level.
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\7\ http://docs.house.gov/meetings/AP/AP01/20230329/115588/HHRG-
118-AP01-Wstate-CaliffR-20230329.pdf
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The Administration's fiscal Year 2024 budget proposal also calls
for $50 million for FDA to advance the President's Cancer Moonshot
goals. These funds would enhance agency-wide efforts to improve
evidence generation for underrepresented subgroups in oncology clinical
trials. They would also support pragmatic, decentralized trials and the
development of sources of evidence that incorporate patient-generated
data and RWE.\8\ If appropriated, these resources will assist in the
expansion of FDA's efforts to facilitate the approvals of innovative
new cancer treatments by international regulatory authorities at the
time of FDA approval, thus fostering collaboration on cancer treatments
with other countries with standards comparable to those prevailing in
the U.S.
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\8\ https://www.whitehouse.gov/ostp/news-updates/2023/03/09/fact-
sheet-cancer-fy24/
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advancing the use of real-world evidence (rwe)
Traditional post-market studies require years to design and
complete and cost millions of dollars. The use of data collected
outside of a clinical trial plays a vital role in answering key
questions about therapeutics, diagnostics, and other healthcare
interventions. The proliferation and widespread adoption of electronic
health records, as well as other emerging digital health solutions,
have made real-world data (RWD) an attractive source of data for
clinical and translational research. FDA has a long history of using
RWD and RWE to monitor and evaluate the post-market safety of approved
medical products. Advances in the availability and analysis of RWD have
increased the potential for generating robust RWE to support FDA
regulatory decisions.\9\ FDA continues to work to expand the use of
fit-for-purpose RWD to generate RWE in regulatory decision-making
regarding medical product effectiveness. RWE has even supported some
approvals of applications meeting evidentiary standards. FDA has also
published a series of foundational draft guidances regarding the use of
RWD, including assessing whether RWD, such as registries, are fit for
use. These foundational guidances will be followed by further guidance
on clinical trial and other study designs using RWD. For this type of
information to be useful in achieving the goal of generating and using
RWE and RWD for personalized medicine, the data must be of high
quality. Increased budget authority for FDA would create a more
reliable source of funding for FDA's activities that strengthen
programs focused on improving the quality of RWE and RWD.
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\9\ https://www.fda.gov/science-research/science-and-research-
special-topics/real-world-evidence
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fostering digital health technologies and artificial intelligence (ai)
CDRH launched the Digital Health Center of Excellence (DHCoE) to
help both FDA staff and external stakeholders advance the development
and FDA review of digital health technologies.\10\ The DHCoE is focused
in multiple areas including AI and machine learning (ML). AI/ML
technologies have the potential to transform health care by deriving
new and important insights from the vast amount of data generated
during the delivery of health care every day.\11\ Digital health and AI
are becoming increasingly important for personalized medicine as
patients assume a larger role in managing their own health care and are
more informed by their ability to access data about their unique
biology. Additional appropriated resources would enable FDA to continue
developing training programs to clarify regulatory pathways for
internal FDA and external digital health stakeholders through the
DHCoE. They would also strengthen the agency's partnerships focused on
AI/ML and wearable technology, software, and patient-generated health
data. Activities in these areas will help patients achieve their goals
of getting high quality digital health technologies to patients.
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\10\ https://www.fda.gov/medical-devices/digital-health-center-
excellence/digital-health-center-excellence-services
\11\ https://www.fda.gov/media/166182/download
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conclusion
PMC appreciates the opportunity to highlight FDA's importance to
the continued success of personalized medicine. A budget authority
appropriation for FDA in fiscal Year 2024 of $3.914 billion will help
the agency chart an efficient path for advancing innovative medical
product development and bring us closer to a future in which every
patient benefits from a personalized approach to health care.
[This statement was submitted by Cynthia A. Bens, Senior Vice
President, Public Policy, Personalized Medicine Coalition.]
______
Prepared Statement of Pet and Women Safety Act (PAWS)
The Pet and Women Safety Act (PAWS) Coalition, a group of
organizations working together in support of domestic violence
survivors and their pets, strongly supports continued appropriations
for the Emergency and Transitional Pet Shelter and Housing Assistance
Grant Program. Together, we call on Congress to fund the program at the
fully authorized amount of $3,000,000.
PAWS Act legislation was included in the 2018 Farm Bill (Section
12502), establishing this important grant program to support domestic
violence shelters as they help survivors and their pets safely seek
shelter when leaving an abuser. These grants provide emergency and
transitional shelter and housing assistance or short-term shelter and
housing assistance. Grants awarded may also be used for programs that
enable a survivor to locate and secure safe housing with their pet,
safe boarding for their pet, or related services such as transportation
and other assistance. In 2023, funding will provide training and
technical assistance to existing grantees from fiscal Year 2020-2022.
The U.S. Department of Justice (DOJ) Office of Victims of Crime (OVC)
is now in its third year of administering this program, and demand for
this funding is high.
The $3.3 million appropriated for 2023 follows the success of the
fiscal Year 2020, fiscal Year 2021, and fiscal Year 2022 Emergency
Transitional Pet Shelter Housing and Assistance Grant Programs, which
awarded approximately $2 million to six organizations in six States
across the Nation in 2020, a total of $2.42 million to five
organizations in 2021, and a total of $2.7 million to 12 organizations
in 2022. Grants have enabled shelters to expand housing and supportive
service resources for domestic violence survivors, provide assistance
including rent, pet deposits, and pet supplies to those seeking
transitional housing with their pet, and more. Each year, the PAWS Act
Coalition has worked to raise awareness among the domestic violence
shelter community of the availability of this important funding.
PAWS Act Coalition members are also contributing funds and
volunteer hours to the cause of making more domestic violence shelters
pet-friendly. For example, in 2022 alone, Purina and RedRover awarded
nine additional Purple Leash Project grants to domestic violence
shelters across the country in need. These grants provide funding and
resources to transform domestic violence emergency shelters into safe
spaces for survivors and their pets. Shelters can use the grant money
to complete renovations and upgrades to their survivor services
offerings that will allow people and pets to escape abuse and heal
together. The success of this program demonstrates that smaller-size
grants can still have a big impact. Purple Leash Project grants
typically range between $20,000 and $50,000 each. Since founding the
Purple Leash Project, Purina and RedRover have provided 34 grants
totaling more than $700,000 in funding to domestic violence shelters
across the United States. Since 2012, RedRover has awarded 185 Safe
Housing grants to domestic violence shelters in 46 States to help them
become pet-friendly, and the majority of these grants are less than
$20,000. Purina and RedRover are working towards the goal of helping 25
percent of U.S. domestic violence shelters to become pet-friendly by
the end of 2025. While these public-private partnerships are hugely
important, fully funding the PAWS Act grant program will help to
address the widespread need for funding to support similar programs
across the country.
The PAWS Act Coalition is grateful to have had the opportunity to
meet with the DOJ OVC and the U.S. Department of Agriculture (USDA) to
discuss the grant program and offer constructive feedback.
Specifically, the Coalition encouraged the USDA and the DOJ to consider
providing a greater number of grants at lesser dollar amounts in 2021,
with the intention of filling a gap in funding resources and helping
more shelters become pet-friendly, especially those that are smaller
and more rural. In response, the fiscal Year 2022 and fiscal Year 2023
Grant Programs include small awards designed for shelters and other
transitional housing services for DV survivors and their pets that may
only be seeking funding for smaller purchases such as kennels, crates,
pet supplies, beds and other items that may be necessary to housing
survivors and pets together.
Funding the Emergency and Transitional Pet Shelter and Housing
Assistance Grant Program at $3 million is essential to saving the lives
of people and pets. According to the Centers for Disease Control, about
1 in 3 women and 1 in 4 men have experienced physical violence by an
intimate partner within their lifetime and over 61 million women and 53
million men have experienced psychological aggression by an intimate
partner in their lifetime.\1\ More than 10 million U.S. adults
experience domestic violence annually. On a typical day, there are more
than 19,000 phone calls placed to domestic violence hotlines
nationwide.\2\
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\1\ Centers for Disease Control (2022). IPV Factsheet. Retrieved
from https://www.cdc.gov/violenceprevention/pdf/ipv/IPV-
factsheet_2022.pdf
\2\ National Coalition Against Domestic Violence (2020). Domestic
violence. Retrieved from https://assets.speakcdn.com/assets/2497/
domestic_violence-2020080709350855.pdf?1596811079991.
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There remains a critical need for shelter options that accommodate
pets. According to a recent nationwide survey of 2,500 domestic
violence survivors commissioned by the Urban Resource Institute (URI)
and the National Domestic Violence Hotline, 50 percent of respondents
reported that they would not consider shelter for themselves if they
could not take their pets with them. Ninety-seven percent of
respondents said that keeping their pets with them is an important
factor in deciding whether or not to seek shelter. Ninety-one percent
of respondents indicated that their pets' emotional support and
physical protection are significant in their ability to survive and
heal. Further, 48 percent reported the threat of harm to pets was a
worry and 37 percent reported their abuser had threatened to harm or
kill a pet.\3\
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\3\ Urban Resource Institute (URI) and The National Domestic
Violence Hotline (2019). National Survey on Domestic Violence and Pets:
Breaking Barriers to Safety and Healing. Retrieved from https://
urinyc.org/wp-content/uploads/2021/05/PALS-Report-Exec-Summary.pdf
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A growing body of science has demonstrated a link between domestic
violence and animal cruelty\4\. An outlet of emotional support for
survivors, the family pet often becomes a target for physical abuse.\5\
In studies that have explored the role of companion animals in an
abusive relationship, companion animals are used by abusers to control,
hurt, and intimidate their partners.\6\
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\4\ Faver, Catherine A., and Elizabeth B. Strand. ``Domestic
violence and animal cruelty: Untangling the web of abuse.'' Journal of
Social Work Education 39.2 (2003): 237-253.
\5\ Matthews, Kevin, and Kelly McConkey. ``Examining the nexus
between domestic violence and animal abuse in a national sample of
service providers.'' Violence and victims 27.2 (2012): 280.
\6\ Flynn, Clifton P. ``Battered women and their animal companions:
Symbolic interaction between human and nonhuman animals.'' Society &
Animals 8.2 (2000): 99-127.
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Research demonstrates the link between pets and improvements in
mental health, particularly for those who have experienced trauma.
Companion animals often serve as a much needed and effective outlet for
overcoming abuse, and have also been shown to improve mental health
conditions such as depression, stress and anxiety, all of which can
manifest from intimate partner violence.\7\ The pervasiveness of
domestic violence during the COVID-19 pandemic and the incidence of
violence towards pets in the United States shows the urgency of
providing safe shelter for survivors and their pets.
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\7\ World Health Organization. Global and regional estimates of
violence against women: prevalence and health effects of intimate
partner violence and non-partner sexual violence. World Health
Organization, 2013.
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The need for additional pet-friendly options for domestic violence
survivors remains an under-addressed, critical issue facing our
country. The continuation of the Emergency and Transitional Pet Shelter
Housing and Assistance Grant Program funding is an important step to
meet this need. Please support Federal funding in fiscal Year 2024 for
the PAWS Act grant program to the fully authorized amount of $3 million
so that no survivor of domestic violence will have to choose between
their own safety or the safety of their pets.
The PAWS Act Coalition is counting on your strong support for the
Emergency and Transitional Pet Shelter Housing and Assistance Grant
Program. Together, we can protect survivors of domestic violence by
protecting the animals they rely on for comfort and healing.
Respectfully submitted,
Steven Feldman
Human Animal Bond Research Institute (HABRI)
On behalf of the Pet and Women Safety Act Coalition Members:
Nestle Purina Petcare
Human Animal Bond Research Institute
Pet Partners
RedRover
Urban Resource Institute
[This statement was submitted by Steven Feldman, Human Animal Bond
Research Institute (HABRI).]
______
Prepared Statement of Research!America
On behalf of Research!America, thank you for this opportunity to
submit testimony on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies appropriations for Fiscal Year
2024 (FY24). Research!America is a non-profit, non-partisan advocacy
alliance. Our more than 300 organizational members work to elevate the
priority assigned to speeding the pace of medical and public health
progress.
The FDA plays a critical role in ensuring public health and safety
through oversight of drugs, biologics, medical devices, food, and
cosmetics. In the interest of the continued protection and advancement
of our Nation's health, we request that the Committee allocate $3.963
billion for the FDA in FY24, an increase of $420 million over FY23.
the food and drug administration
The FDA is the oldest consumer protection agency in the U.S. and
has overseen an extensive catalog of consumer products for over a
century. An estimated $2.7 trillion in food, medical, and tobacco
products are currently regulated under the purview of the FDA,
constituting nearly 20 percent of every dollar spent by U.S. consumers.
The FDA oversees more than $360 billion in imports and $245 billion in
exports annually, and monitors more than 270,000 facilities producing
drugs, food, biologics, and devices. Furthermore, the FDA regulates
nearly 80 percent of the U.S. food supply.
Robust funding for the FDA is critical to ensuring the agency can
perform its critical responsibilities with rigor and efficiency. In
FY21, over $3 billion of the FDA's $6.1 billion budget was spent in
programs evaluating the safety and effectiveness of human drugs,
biologics, medical devices, and radiological technology. An additional
$1.1 billion was spent in programs that regulate foods. Considering the
expansive scope of FDA oversight, it is not a reach to say that every
household in the U.S. contains food, medical, and/or cosmetic products
that were evaluated for safety and efficacy by the agency.
The need for increased funding reflects both the growing demands on
the agency and the growing complexity of those demands. We are in a
period of unimagined medical progress, epitomized by gene therapy,
immunology, the expanding use of digital technologies, and artificial
intelligence applications. FDA clearly needs additional funding to
fulfill its key role in assuring these developments translate into safe
and effective advances benefiting the American people, while assuring
ongoing rigor and effectiveness across its other responsibilities.
Given the pivotal role the FDA plays in our public health system
and economy, and the increasing scope and complexity of its oversight
responsibilities, we believe it is vastly in the Nation's best
interests to increase its budget by at least $420 million in FY24.
Thank you for considering our testimony, and for your efforts, and
those of your respective staff members, on behalf of us all.
[This statement was submitted by Ellie Dehoney, Senior Vice
President of Policy and Advocacy, Research!America.]
______
Prepared Statement of the Sustainable Agriculture Research and
Education
Thank you for the opportunity to present our fiscal year 2024
funding requests. We appreciate your work on the Consolidated
Appropriations Act, 2023, which addressed many of our priorities for
FY23. On behalf of our member organizations from around the country, we
submit the following requests for the Department of Agriculture. These
requests are listed in the order they typically appear in the
appropriations bill.
national institute of food and agriculture
sustainable agriculture research and education program
For over 30 years, the Sustainable Agriculture Research and
Education (SARE) program has been a leader in addressing key
sustainability and profitability challenges facing agriculture. As
USDA's only farmer-driven research program, SARE has helped create more
innovative farm practices that are actually adopted by farmers on the
ground than any other competitive research program. SARE is also
expanding outreach to historically underserved farmers and ranchers by
providing funds to support education and training. Investing in
agriculture research is a win for taxpayers too: every dollar invested
in public research generates $20 in economic activity.
Since the program launched, SARE has awarded over $377 million to
over 8,300 initiatives focused on farmer-driven research and education
efforts in every State across the country. Despite SARE's long-standing
record of helping farmers and ranchers develop and adopt innovative
practices and systems, the program has not reached its full authorized
amount of $60 million. As a result, USDA can only fund a fraction of
eligible proposals submitted each year. To meet future challenges,
farmers need research that is accessible and relevant to their farms.
We therefore urge Congress to provide full funding for SARE at its
authorized level of $60 million, mirroring the President's Budget
Request for FY24. This funding will allow SARE to continue supporting
research at land grant universities, accessible and practical
information for farmers, resources tailored to underserved farmers,
farm-based resilience to climate change, and thriving rural
communities.
organic transitions initiative (org)
The Organic Transitions Research, Education, and Extension program
(ORG) helps farmers fill knowledge gaps and overcome barriers in
successfully transitioning to organic farming. For nearly 20 years, ORG
has invested $44 million in over 90 projects to develop and implement
research and education programs to improve the competitiveness of
organic and transitioning-to-organic livestock and crop producers. By
providing critical funding to colleges and universities conducting
organic farming research, ORG also helps farmers better understand the
economic and environmental benefits of organic farming.
Since the 1990s, the organic market has grown into a multi-billion-
dollar industry. Despite this growth, total USDA investment in organic
research remains below 2 percent of its annual research budget, far
short of the 6 percent market share of organic products in the US.
Given the growth of the organic sector and the continued demand for
support to organic farmers, investment in the ORG program must increase
to keep pace with this need. We therefore urge Congress to provide $10
million in discretionary funding in FY24 for the Organic Transitions
Program.
agricultural marketing service and rural business--cooperative service
local agriculture market program
The Local Agriculture Market Program (LAMP) serves as an umbrella
program for the Farmers Market and Local Food Promotion Program
(FMLFPP) and the Value-Added Producers Grant Program (VAPG). Through
these programs, USDA has invested in the physical infrastructure,
training, and relationship development necessary to expand local and
regional supply chains. These investments provided significant return
when the pandemic and other recent supply chain disruptions upended our
food system. LAMP helped ensure that infrastructure and relationships
were in place to enable local and regional food distribution networks
to fill critical supply chain gaps and provide for the most vulnerable
in our communities.
VAPG offers grants to farmers and ranchers who are developing farm
and food businesses to manage risk and boost income, create jobs, and
support regional supply chains in rural America. A recent Economic
Research Service report shows that businesses that received VAPGs were
89 percent less likely to fail 2 years after the grant compared to
similar businesses that did not receive support through the program.
FMLFPP is a competitive grants program that funds direct-to-
consumer marketing and local businesses that act as intermediaries
between producers and consumers by aggregating, storing, processing,
and distributing local or regional food. Since 2006, FMLFPP and its
predecessor program have invested over $250 million in strengthening
local and regional food systems in every State in the country. Despite
a long and successful track record and interest in local and regional
markets and value-added products, funding for both of these programs is
only a fraction of what is needed to meet demand. Therefore, we support
the President's Budget Request of $16 million in discretionary funding
for VAPG and $7.5 million in discretionary funding for FMLFPP for FY24.
natural resources conservation service (nrcs)
conservation technical assistance and the grazing lands conservation
initiative
Conservation Technical Assistance (CTA), a subset of Conservation
Operations, is the backbone of USDA's conservation programs. Through
CTA, NRCS field staff work with farmers to develop and implement
conservation plans to steward resources, assess conservation practices
on farms, fulfill conservation compliance requirements, and collect and
disseminate data on the Nation's natural resources. This funding is
critical to help producers develop site-specific plans to conserve
water, prepare for extreme weather, and address natural resource
concerns on their land. CTA funding can also support NRCS efforts to
provide technical assistance to farmers and ranchers interested in
improving their grazing operations.
Grazing-based farm and ranch operations improve profitability for
producers across the Nation. Grass-based agriculture is an important
strategy for introducing new farmers and ranchers into livestock
management because they can be low upfront-capital operations that
nonetheless generate good income. Well managed grazing of livestock can
help new and established farmers and ranchers alike thrive and stay in
their rural communities. Effectively managed grasslands also protect
water quality, improve soil health, and provide a good habitat for
pollinators and wildlife.
Whether it is one-to-one technical assistance focused on grazing or
the development of conservation plans for an individual farm, on-the-
ground capacity at NRCS continues to be a limiting factor for
conservation implementation, and an increased investment in CTA
(including GLCI) will give NRCS the ability to truly build local
capacity, leading to improved conservation and resource management. To
ensure that CTA has the resources needed to help producers implement
the conservation practices that are essential to mitigating climate
change, we urge Congress to provide $1.1 billion for CTA, with $30
million of that specifically dedicated to GLCI.
office of urban agriculture and innovative production
The 2018 Farm Bill authorized the creation of the Office of Urban
Agriculture and Innovative Production (the Office), whose mission is to
encourage and promote urban, indoor, and other innovative agricultural
practices. While the name implies a restriction to urban areas, urban
agriculture broadly covers a variety of growing techniques that lend
themselves to urban environments but have been adopted in both suburban
and rural areas. The Office promotes a wide variety of practices
including community gardens, outdoor vertical production, greenhouses,
indoor farms, and hydroponic facilities.
The Office received funding for the first time in FY20 to implement
its authorities. Since FY20, funding has been utilized to pilot an
advisory committee for the Office and USDA, a competitive grants
program, a Community Compost and Food Waste Reduction cooperative
agreement program, and 17 urban and suburban Farm Service Agency (FSA)
County Committees. Both the competitive grants and food waste reduction
cooperative agreements have garnered interest far beyond available
funding. In fiscal year 2021 alone, the Office awarded $6.6 million in
grants and cooperative agreements, $4.75 million for 10 Planning
Projects and 11 Implementation Projects, and $1.92 million in 24
compost cooperative agreements.
Due to overwhelming interest, especially from farmers of color
frequently operating in urban areas, we urge Congress to fully fund the
Office of Urban Agriculture at the authorized level of $25 million in
FY24 so that it has sufficient resources to meet the demand of a
growing farming sector and expand beyond initial pilot States.
office of partnerships and public engagement and national institute of
food and agriculture
farming opportunities training and outreach program
The 2018 Farm Bill created the Farming Opportunities Training and
Outreach (FOTO) program to strengthen USDA's efforts to train and
assist beginning, veteran, Tribal and other underserved farmers. FOTO
combines two of USDA's flagship training and technical assistance
programs: the Beginning Farmer and Rancher Development Program (BFRDP)
and the Outreach and Assistance to Socially Disadvantaged and Veteran
Farmers and Ranchers Program (aka ``Section 2501'').
Since 1990, the 2501 Program has been the only program investing
millions of dollars to reverse disadvantages and disparities that have
faced our Nation's military veterans and minority farmers by providing
tools they need to thrive in today's agricultural economy. For over a
decade, BFRDP has been the only Federal program exclusively dedicated
to training new farmers and ranchers and has invested over $176 million
in grants to ensure they have the skills to start successful farms.
Both programs have funded academic institutions, extension services,
and community organizations to support and train farmers and ranchers.
Ensuring the success of minority farmers, veteran farmers, and new and
beginning farmers through technical assistance and other resources is
critical to the continued success of a new generation of American
agriculture. Therefore, we urge Congress to provide $10 million in
discretionary funding in FY24 for the Farming Opportunities Training
and Outreach Program, split equally between BFRDP and 2501.
general provisions
packers and stockyards act rulemaking riders
The Packers and Stockyards Act (PSA) was passed a century ago to
combat anticompetitive practices in the livestock and poultry
industries as corporate meatpackers and processors consolidated and
amassed power over producers. From authority given in the 2008 Farm
Bill, USDA published a set of proposed regulations to strengthen PSA
enforcement and received over 61,000 comments largely in support of the
rules. However, livestock and poultry companies lobbied Congress to use
the annual appropriations process to block USDA from finalizing the
rules, known as ``GIPSA'' rules. As a result, the annual agriculture
appropriations bill for FY2012-2015 included ``GIPSA riders'' to block
USDA from implementing the rules and, in some cases, to require USDA to
rescind rules that had been finalized.
Since June 2022, USDA has released two rules to strengthen PSA: the
Transparency in Poultry Growing Contracts and Tournaments rule, and the
Inclusive Competition and Market Integrity rule--while a third rule is
still anticipated. It is critical that USDA is allowed to implement
these pro-competition rules to protect producers and consumers alike
from unfair and anticompetitive practices in agricultural markets These
reforms cannot happen if appropriations riders block them. As such, we
urge appropriators to not include any general provision blocking the
USDA from finalizing the PSA fair competition rules.
[This statement was submitted by Mike Lavender, Policy Director:
[email protected]]
______
Prepared Statement of Spark Climate Solutions
In this testimony, Spark Climate Solutions, a nonprofit
organization, urges the Senate to invest in research and development to
increase livestock productivity and significantly reduce livestock
enteric methane emissions. We must also modernize regulatory processes
to evaluate, and where appropriate, approve, new solutions that will
keep American producers globally competitive while working towards
climate goals. Near-term action is needed to achieve this goal by
funding research and development of new solutions, producer education,
regulatory innovation, and targeted incentives.
In 2023 the USDA's Agriculture Food & Research Institute is funding
$5,000,000 in competitive grants for livestock enteric methane
emissions research. We recommend increasing USDA-AFRI's funding in 2024
to expand this program. We also recommend that Hatch funding, NIFA
Animal Health and Disease, USDA Equipment Grants, USDA-ARS and other
competitive and capacity funding be appropriated towards achieving this
goal.
Agriculture emits 36 percent of United States methane emissions,
more than that leaked from U.S. fossil fuel infrastructure.\1\ While a
significant amount of these emissions come from manure, 70 percent of
agriculture methane comes from cattle as methane exhaled from cattle
from a process called ``enteric fermentation.'' \2\ Remediating
livestock enteric methane emissions represents an opportunity to reduce
the US greenhouse gas footprint by 3 percent. Because the enteric
methane comes from the calories in the feed being used inefficiently,
this could simultaneously potentially improve cattle productivity by up
to 6 percent. Currently available solutions can address, at most, about
10 percent of US enteric emissions, and not all of those solutions are
yet approved to be used by American producers, while they have been
approved for major livestock competitors in Brazil, Australia, Europe
and other agricultural export nations.\3\ And we need to find new
solutions for the remaining majority of emissions. As methane is an
unproductive byproduct of ruminant digestion, research and development
should prioritize enhanced productivity that simultaneously reduces
emissions. Yet over the last 5 years, the US Federal Government has
spent less than estimated $5,000,000 per year on research and
development in this area, very low in light of the high potential
climate and productivity impact, compared to other agricultural
research areas.\4\
---------------------------------------------------------------------------
\1\ https://cfpub.epa.gov/ghgdata/inventoryexplorer/#allsectors/
allsectors/allgas/gas/all
\2\ https://www.epa.gov/system/files/documents/2022-04/us-ghg-
inventory-2022-chapter-5-agriculture.pdf
\3\ https://globalresearchalliance.org/wp-content/uploads/2021/12/
An-evaluation-of-evidence-for-efficacy-and-applicability-of-methane-
inhibiting-feed-additives-for-livestock-FINAL.pdf
\4\ https://thebreakthrough.org/issues/food-agriculture-
environment/from-lab-to-farm
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Lowering enteric methane emissions would help bolster U.S.
agricultural leadership and export competitiveness. To that end, we
recommend investing in building regulatory pathways that are ready to
make informed decisions about new solutions coming on the market and
authorizing and appropriating $82,000,000 per year to a US Department
of Agriculture enteric emissions research and innovation program which
would advance solutions that could easily drop into existing farm
practices and convert avoided methane into increased milk and meat
production. We set out the justification for this amount below, which
can be addressed by a combination of authorizations and appropriations.
challenge & opportunity
Cattle and other ruminants digest their food via anaerobic (oxygen-
free) fermentation. This allows them to digest roughage such as grasses
and other forage and transform it into meat and milk. But it also
generates methane. Cattle release on average 6 percent of the calories
they eat as methane, a substantial loss in their potential meat and
milk productivity. This methane is in addition to the methane emitted
by their manure.
An invisible and odorless gas, methane is a powerful greenhouse gas
that is responsible for 0.5C of the 1C of modern global warming
(based on the 2010-2019 average).\5\ One-third of U.S. anthropogenic
methane emissions come from cattle and other ruminants. Solutions may
be able to be developed that both disrupt enteric methane production
while also increasing cattle productivity. That would help reduce
global temperatures and provide benefits for both producers and
consumers. Currently, there are a few tested and marketable solutions
that use chemicals to disrupt methane-creating microbes in the cattle's
first stomach (the rumen). These are important solutions that need to
be evaluated for regulatory approval. However, additional research and
development must also be done, to help address the majority of
emissions that don't yet have available solutions, particularly from
cattle grazing in pastures. Additional work is also needed to continue
developing solutions that consistently lead to a productivity benefit.
Focused scientific research could deepen our understanding of cattle
metabolism, and advance new solutions for reducing enteric methane
further.
---------------------------------------------------------------------------
\5\ https://www.ipcc.ch/report/ar6/wg1/figures/summary-for-
policymakers/figure-spm-2
---------------------------------------------------------------------------
Progress on this front also requires improved research tools to
measure how much methane cattle breathe out burp and relate these
methane emissions to their productivity and intake of feed and forage.
Access to such research tools enables researchers and innovators to
develop and evaluate new solutions. We know that methane emissions
rates vary widely between cattle on the same farm of the same breed, as
well as across breeds. Currently these tools are expensive and not
widely available, for example the primary tool available measures
thirty cattle per day, costs $100,000, and can be found at only a
handful of research institutions. That presents a practical problem of
access not only for producers but also for non-specialist scientific
innovators. Making those tools more accessible, for example via fee-
for-service centers at leading US Land Grant institutes, would make
them more affordable for producers and researchers. That would help
unlock the creativity of US innovators, and provide evidence that their
solutions really work for producers, and are having positive climate
impact.
Even when new solutions are found and proven, innovators still face
a 10-year FDA approval process. This is uncompetitive and restrictive
compared to other countries. Since much faster approval is possible in
Australia, Brazil, and Europe, innovators have an incentive to launch
their products and build their businesses there rather than in the USA.
And as climate-aware export markets develop, slow FDA approval will
cost US producers market share and market opportunity. We therefore
recommend that the FDA be given authority and direction to evaluate new
methane-reducing products for safety on an accelerated timeline, while
maintaining critical human and animal safety standards. This would help
the US position itself as a global leader in a potential multi-billion
dollar market while upholding its climate commitments.
To achieve these goals, we propose the following steps:
fund basic & applied livestock enteric methane research
Developing science-based, effective livestock enteric methane
solution depends on a detailed understanding of cattle microbiology as
well as practical understanding of what makes solutions easy to adopt.
Increasing funding for basic and applied research could accelerate
development of new methods, and rapidly build a portfolio of scalable
potential solutions. We recommend that within USDA-NIFA, that AFRI,
Hatch, Animal Health and Disease, and other competitive and capacity
funding be appropriated to:
--Basic research in livestock methane microbiology, to create a
knowledge base that will support development of new win-win
solutions.
--Applied livestock methane solutions research, simultaneously
prioritizing productivity and methane reduction solutions, that
could be administered in a long-duration (e.g. once per year)
product formulation compatible with grazing cattle. Such
technology already exists for cattle nutrition and disease
prevention\6\.
---------------------------------------------------------------------------
\6\ https://www.natual-techna.com/en/bolus-bovine-ovine-goat
--Surveys and other social science research to understand barriers
and opportunities for implementation, with the goal of finding
simple, inexpensive ways American producers and ranchers can
---------------------------------------------------------------------------
implement new solutions.
Funds Needed: $50,000,000 per year
Congress should also include report language urging USDA to
increase funding for enteric methane within the Division of Animal
Systems, for example:
Enteric Methane Innovation.-The Committee recognizes the
innovations that increased public research on enteric methane could
make possible. The Committee encourages AFRI to make the advancement of
enteric fermentation solutions, such as cattle feed additives, methane-
inhibiting vaccines, and breeding for low-methane cattle, a distinct
research priority.
create public fee-for-service testing facilities for livestock methane
Access to methane test facilities, from the laboratory to the dairy
barn, is a bottleneck. It limits how many innovative ideas for
solutions can be tested. Only a small number of institutions worldwide
have the tools needed to test methane, and outside access to those
tools is limited. We recommend funding be appropriated for innovation-
enabling research infrastructure to USDA-ARS and USDA-NIFA, through
USDA Equipment Grants and USDA-AFRI. This funding would:
--Establish a nationwide network of fee-for-access livestock methane
research facilities, equipped with research measurement
equipment and technical staff. US Land Grant universities
already possess the necessary research cattle management
expertise. Joint investment with them and partial support from
research users would quickly resolve access issues and help
make the US an international leader in livestock methane
research.
--Develop a USDA-ARS national center for pre-livestock testing and
screening of potential products, which would serve as a user
facility, accessible to scientists in many fields. Specialized
cattle researchers shouldn't be the only ones who can test new
ideas for reducing livestock enteric methane. Accessible
facilities could unlock innovation from the leading U.S.
biology researchers.
US Department of Energy national labs have successful user
facilities which could serve as a model. For example, the National
Renewable Energy Lab leads standard-setting and validation for high-
efficiency solar energy technology. New Zealand's AgResearch is another
model. It has a grant-accessible anti-methane rapid testing facility
and it recently developed a breed of sheep with 10 percent reduced
methane emissions and higher productivity.
Funds Needed: $15,000,000 per year
fund development of low-cost cattle methane measurement technology
What can be measured can guide innovation and management, and what
we measure easily and consistently, we improve. Producers measure milk
production on every cow every day and we've seen this lead to a 300
percent productivity increase since 1950. But producers and most
researchers do not measure livestock methane production. Livestock
methane measurement equipment currently costs about $100,000 for a
system that measures 30-40 cattle a day. We recommend that within USDA-
NIFA, that AFRI, Hatch, Animal Health and Disease, and other
competitive and capacity funding be appropriated to:
--Develop lower-cost measurement systems, so every research barn can
afford to measure livestock methane. US Land Grant universities
have over 10,000 research cattle. Equipped with measurement
systems, they could all provide livestock methane research
data.
--Develop farm-integrable measurement systems that make methane
emissions visible to US producers, enabling them to experiment
and innovate. Methane is a loss for livestock production. If
producers can see it, they'll work to decrease methane and
improve their bottom line.
A $15 million annual budget for technological development might
lead to rapid improvements in measuring equipment systems. A portion of
this could fund interdisciplinary projects that bring engineers from
across industry and livestock experts together. Another portion could
be framed as a grand challenge to achieve cost and performance targets
connected to a government procurement market-shaping program.
Funds Needed: $15,000,000 per year
direct the fda to create a new regulatory category and team for
climate-positive livestock products
Current anti-methane feed additives are regulated as drugs,
requiring a ten-year approval process. As European export markets
increasingly regulate emissions, this may lead to a lack of
competitiveness for US products. To address this, Congress should
create a special FDA category with a dedicated team for climate-
positive livestock products, with appropriate funding to resource the
team and infrastructure necessary to achieve the goals of robustly
evaluating new anti-methane solutions for safety and efficacy, and
making new solutions available to US farmers if safe and effective.
[This statement was submitted by Spark Climate Solutions,
Sparkclimate.org.]
______
Prepared Statement of Spark Climate Solutions
In this testimony, which I am submitting on behalf of Spark Climate
Solutions, a non-profit organization, I urge the Senate to invest in
research, development and best management practice adoption to
modernize soil management and fertilizer usage, leading to improved
crop productivity, further climate resilience, and increased resilience
to global fertilizer shortages.
Building and maintaining soil organic matter is widely viewed as
beneficial for multiple reasons, including provisioning of nutrients
for crop productivity, improving soil aeration and water holding
capacity, maintaining habitat for beneficial soil microorganisms,
sequestering carbon, and retaining nitrogen and phosphorus. Proper soil
management that retains nutrients not only improves crop productivity,
but also reduces harmful soil erosion and nutrient runoff and reduces
emissions of the potent greenhouse gas, nitrous oxide (N2O). Here we
present recommendations to address the multiple goals of improving soil
quality for crop production, sequestering carbon, retaining nitrogen,
and reducing N2O emissions.
Spark would recommend the following guidelines for investments in
advancing these objectives regarding carbon gains and avoiding nitrogen
losses, including nitrous oxide (N2O), whether applied to spending
authorization of activities indicated in the IRA and other existing
programs, or new authorizations under the 2023 Farm Bill:
1. Both carbon sequestration and nitrogen retention (resulting in
lower nitrogen losses and lower N2O emissions) should be promoted with
incentives for farmers to adopt best management practices (BMPs).
Increased funding for programs such as USDA's Environmental Quality
Incentives Program (EQIP) and Conservation Innovation Grants (CIG)
would promote adoption of BMPs including:
--Developing and updating nutrient management plans
--Planting cover crops for the non-growing season
--Spring rather than fall application of fertilizers
--Split application of smaller doses of fertilizers during the
growing season
--Conservation tillage practices that are appropriate for each
region's crops, soils, and climate
--Using enhanced efficiency fertilizers and inhibitors of urease and
nitrification
--Experimenting with multi-cropping
--Experimenting with re-integrating livestock and crop production
systems
2. Incentive programs should focus on adoption of these BMPs rather
than verification of the specific effects at the farm scale. BMP
adoption is relatively easy to verify with a combination of satellite
imagery, drone overflights, brief on-site visits, and farmer self-
reporting. While verifying the benefits of these BMPs for carbon
sequestration, reduced nitrate runoff, and reduced N2O emissions may
not be feasible or affordable at the individual farm scale, in the
aggregate, widespread BMP adoption will yield these benefits at larger
scales. Unless and until monitoring, reporting, and validation (MRV) of
soil carbon credits at the farm scale can meet more rigorous standards,
incentives and outreach to encourage BMP adoption will be a more
effective policy approach to increasing soil carbon sequestration and
reducing nitrogen losses and N2O emissions. Additional research should
be funded to quantify average environmental benefits of BMPs by soil
type, climate, and crop. The Long-Term Agricultural Research (LTAR)
network within USDA-ARS would be well suited to conduct this research.
It should be authorized and its annual funding increased to $42m. This
research will enable BMP impacts on environmental outcomes to be
evaluated at the regional scale.
3. USDA should be tasked and funded to harmonize and coordinate MRV
requirements for the rapidly emerging markets for carbon credits in
agricultural soils. These markets already have considerable momentum
but lack rigor and consistency-guidance that USDA could help provide.
Regional Climate Hubs should be authorized and the budget increased to
$30M annually to develop and share resources related to MRV
requirements and tools.
4. Funding should be increased for social science studies to better
understand why farmers choose to accept or decline incentive programs
to adopt BMPs or to participate in soil carbon credit programs. Farmer
decision making is not confined only to the influences of agronomic
advice and economic benefits, but is also influenced by numerous social
factors, such as education, tradition, trusted sources of information
from family or crop advisors, risk aversion, etc. These factors are
poorly understood due to insufficient funding of social science
research in agronomy. It's urgent to close this research gap. The
Economic Research Service (ERS) currently hosts most of USDA's economic
research, but we believe that basic social science research should be
added to the remit of the National Institute of Food and Agriculture
(NIFA), with funding of $10M per year for basic socio-economic research
on farmer decision making regarding adoption of BMPs. Funding for R&D,
including agronomic, economic, or social science research, should
emphasize farmer participation and follow emerging principles of
stakeholder engagement in convergent science. Farmers have knowledge
and experience that can help inform the design, implementation, and
analysis of research. Their participation in all stages of research
also improves the probability they will buy into the resulting
recommendations.
5. Additional R&D funding is needed for medium-to-long-term efforts
toward decoupling food production from intensive use of nitrogen
amendments. This will require significant advanced research and
transformative innovation of our food production system, which is the
objective of the Agriculture Advanced Research and Development
Authority (AgARDA; a ``DARPA-style'' approach to transformative
technological innovation). The current suite of BMPs promoting the
``4Rs'' of nutrient stewardship (the right form, right time, right
amount, and right place of fertilizers applications) are helpful and
worthy of continued support. But their incremental improvements in
nitrogen use efficiency have been insufficient to reduce total nitrogen
pollution as agricultural productivity increases in response to growing
food demand. Therefore, longer-term, innovative and transformative
solutions should be promoted through funding appropriation to AGARDA at
the currently authorized level of $50M/yr, with increases in both
authorization and appropriations to at least $200M/yr, to pursue
innovations in the topics listed below, among many other important
agricultural innovation priorities. In addition, USDA should establish
new centers of excellence for research on each of these topics:
--Developing decentralized green ammonia production (using renewable
energy to produce the hydrogen used for ammonia synthesis).
This would provide farmers with reliable, year-round access to
fertilizers so that applications could be more closely matched
and optimized with crop growth.
--Expanding direct feeding of livestock with synthetic nitrogen,
including urea, nitrate, and synthetic amino acids, so that
less cropland and less fertilizer are needed to nourish
livestock (e.g., less soybean and alfalfa and lower nitrogen
concentrations in grains like corn)
--New efforts in crop breeding to enable crops to grow further into
cold seasons (thus remaining sinks for soil nitrogen for a
longer period), internal recycling of nitrogen within crop
plants, nitrogen concentrations of grain that are optimized for
specific markets, production of natural nitrification
inhibitors, and perennialization of grain crops.
[This statement was submitted by Eric A. Davidson, Ph.D., Spark
Climate Solutions Sparkclimate.org.]
______
Prepared Statement of Squaxin Island Tribe
On behalf of the Tribal Leadership and citizens of the Squaxin
Island Tribe, I am honored to submit written testimony on our annual
budget priorities for the fiscal Year 2024 Appropriations for the
Department of Agriculture funding for Tribal Programs in Rural
Development and the Food and Nutrition Service. The Squaxin Island
Tribe requests that all Tribal program funding throughout the Federal
Government be exempt from future sequestrations, rescissions, and
disproportionate cuts.
TRIBAL SPECIAL REQUEST
1. Food Distribution Program on Indian Reservations (FDPIR)
Demonstration Project--Increase funding to expand the number of Tribes
participating--Squaxin Island Tribe requests to participate--Food
Nutrition Service
NATIONAL AND REGIONAL REQUESTS
1. Permanent authority for the 638 FDPIR Demonstration Project
2. Support efforts to Fulfill U.S. Trust Responsibility to Indian
Tribes in the Stewardship of Federal Lands and Waters
3. $2.0 Million--Rural Development Technical Assistance Program
4. Support the requests of the National Congress of American Indians
(NCAI) and the Affiliated Tribes of Northwest Indians (ATNI)
squaxin island tribe background
We are native people of South Puget Sound and descendants of the
maritime people who lived and prospered along these shores for untold
centuries. We are known as the People of the Water because of our
strong cultural connection to the natural beauty and bounty of Puget
Sound going back hundreds of years. The Squaxin Island Indian
Reservation is in southeastern Mason County, Washington and the Tribe
is a signatory to the 1854 Medicine Creek Treaty. Our treaty-designated
reservation, Squaxin Island, is approximately 2.2 square miles of
uninhabited forested land, surrounded by the bays and inlets of
southern Puget Sound. Because the Island lacks fresh water, the Tribe
has built its community on roughly 26 acres at Kamilche, Washington
purchased and placed into trust. The Tribe also owns 6 acres across
Pickering Passage from Squaxin Island and a plot of 36 acres on
Harstine Island, across Peale Passage. The total land area including
off-reservation trust lands is 1,715.46 acres. In addition, the Tribe
manages roughly 500 acres of Puget Sound tidelands.
Our Tribal governance combines our sovereign powers as well as U.S.
Congressional acts related to treaties, statutes, and public law.
Squaxin Island Tribe, like all Tribal Nations, continue to work through
the impacts of the pandemic. Prior to COVID-19, the Tribal government
and our economic enterprises constituted the largest employer in Mason
County with over 1,250 employees. The Tribe has a current enrollment of
1,040 and an on-reservation population of 426 living in 141 homes.
Squaxin has an estimated service area population of 2,747; a growth
rate of about 10 percent, and an unemployment rate of about 30 percent
(according to the BIA Labor Force Report). We continue to need the
assistance of Congressional relief funds to mitigate the ongoing
challenges to recovery. We are grateful for the support we have
received so far.
squaxin island tribe specific request/justification:
the farm bill reauthorization
The 2018 Farm Bill was a major bipartisan achievement that included
an impressive Tribal agenda. It has been a catalyst for Tribal rural
communities to advance food sovereignty and security, economic and
workforce development initiatives, public health priorities, and rural
broadband internet deployment just to name a few. The Squaxin Island
Tribe is a self-determining, self-governing sovereign nation and for
more than 35 years, we have administered programs, functions, services
and activities that were previously assumed to be performed for our
benefit by the Federal Government. We enjoy our autonomy but are
limited by Self-Governance authority only in the Department of the
Interior, Department of Health and Human Services and Department of
Transportation. While the 2018 Farm Bill provided Tribes with
unprecedented opportunities, the next version should build on the
progress made to date and advance a Federal agricultural policy that
incorporates our priorities and expands Self-Governance authority.
food distribution program on indian reservations (fdpir) demonstration
project--increase funding to expand the number of tribes participating
and allow additional tribal goods on products list
The Squaxin Island Tribe has been successfully operating programs,
services, functions and activities previously performed by both the
Department of Interior's Bureau of Indian Affairs and the Department of
Health and Human Services' Indian Health Service under 638 contracts
and Self-Governance compacts for more than thirty-five years. We will
be exploring options in the Department of Transportation under Self-
Governance soon.
The USDA Indigenous Food Sovereignty Initiative has been operating
since 2021. The ``Food Distribution Program on Indian Reservations
(FDPIR)'' demonstration project, is an initiative that allows Tribes to
promote Traditional foods, agriculture markets and indigenous healthy
foods tailored to American Indian and Alaska Native dietary needs.
Tribes also market Tribal foods, support seed saving centers along with
other traditional food practices. We are excited to see the FDPIR
demonstration project in USDA and are anxious to explore how to expand
the FDPIR products and get more seafood on the products list. Squaxin
Island has many other seafood products, such as clams, oysters, salmon
and geoducks, and we would like to have an opportunity to offer these
additional products to the FDPIR products list.
We ask this subcommittee to continue to invest in this
initiative and increase the funding that will allow
additional Tribes to participate in the 639 FDPIR
demonstration project and allow for other Tribal
practices to be showcased and support self-
determination and self-government.
NATIONAL AND REGIONAL REQUESTS:
1. Permanent authority for the 638 FDPIR Demonstration
Project--For nearly 35 years Tribes have operated programs
under the Self-Governance authority in the Indian Self-
Determination and Education Assistance Act (ISDEAA), that were
previously performed by Federal personnel. Tribes have improved
program administration, management and operations efficiently
and effectively for better delivery of services to our Tribal
citizens and within our communities. We ask that the Committee
continues to provide funding for the expansion of the
demonstration. With documented success, permanent authority
should be imminent in the 2023 Farm Bill Reauthorization.
2. Support efforts to Fulfill U.S. Trust Responsibility to
Indian Tribes in the Stewardship of Federal Lands and Waters--
The Secretaries of Agriculture and Interior issued a Joint
Secretarial Order 3403 to ensure that their departments and
component bureaus and offices are fulfilling the Trust
Responsibility in the stewardship of Federal lands and waters.
Even though there have been more than 20 new co-stewardship
agreements with Tribes to further stewardship goals, in the
past, Tribes have been made many promises and as we move into
another chapter of American Indian and Alaska Native history
with the United States, we ask that such fulfillment of the
U.S. Trust Responsibility be codified to protect the progress
made under this Joint Secretarial Order.
3. Include $2 Million for USDA Rural Development Tribal
Technical Assistance Program--The 2018 Farm Bill mandated the
establishment of a Tribal Technical Assistance Program within
USDA-Rural Development (RD) designed to address the unique
challenges Indian Country faces when seeking infrastructure,
cooperative development, housing, and other development
opportunities funded by USDA-RD. Funding for this newly
established area is especially critical due to the unique
circumstances surrounding lending and infrastructure deployment
in Tribal communities, which often leads to either
misinformation provided to Tribal nations or misinterpretation
of Tribal applications. Appropriating $2 million to this
program will help to eliminate these unnecessary barriers to
development in Indian Country.
4. Support the fiscal Year 2024 Budgets Requests of the
National Congress of American Indians (NCAI) and the Affiliated
Tribes of Northwest Indians (ATNI)
Thank you for this opportunity to present written testimony and
considering these requests.
[This statement was submitted by Hon. Kristopher Peters, Chairman.]
______
Prepared Statement of the Transfarmation Project
Thank you for the opportunity to present The Transfarmation
Project's fiscal Year 2024 funding requests. The Transfarmation Project
works with farmers, local technical consultants, and research
universities across the country to model agricultural systems that
demonstrate the feasibility of transitioning contract poultry and
livestock operations to more lucrative and resilient farming methods
that center farmer autonomy and more sustainable production practices.
We match enrolled farmers with local technical consultants and industry
experts to design individualized farm transition plans, document those
transitions, and create public-facing resources and economic models to
serve as guides for other farmers to easily replicate. The
Transfarmation Project aims to facilitate alternative business
opportunities to farmers who would like to feed our Nation outside of
the industrialized model. These alternatives offer farmers autonomy to
make decisions for their business needs and promote competition by
supporting local food systems.
On behalf of the farmers, technical consultants, and supporters we
serve, we submit the following requests for the Department of
Agriculture:
general provisions
Create a Climate-Smart Transition Initiative. USDA's conservation
programs provide significant cost-share dollars for farmers
implementing practices that protect water, soil, and wildlife; preserve
ecosystems; and help farmers impacted by natural disasters. Federal
programs like the Environmental Quality Incentives Program, should be
leveraged to more actively support climate-smart farm transitions that
restore value to stranded farm assets and support beginning and
socially disadvantaged farmers, in a larger effort to increase the
resiliency of our entire agricultural system.
Utilizing existing funding authorized under the Inflation Reduction
Act (Section 21001(a)(1) of Public Law 117-169) to create a Federal
climate-smart transition initiative would create a more just,
equitable, and sustainable food system by transitioning high-emission
animal confinement operations, such as contract poultry and hog farmers
and dairy farmers, to growing lower-emission crops in a more resilient
manner. These transitions level the playing field between foreign
competition, and create a more secure domestic food system, by
increasing year-round specialty crop production. This initiative will
give farmers the freedom to respond to market changes, be competitive
in emerging markets, create new jobs in rural communities, and leverage
funding for the dual purpose of protecting environmental resources and
increasing farm values.
Proposed Bill Language. Climate-Smart Transition
Initiative.-Of the funds authorized under Section
21001(a)(1) of Public Law 117-169, the Secretary shall
provide grants and cooperative agreements that will
facilitate the adoption of more resilient and climate-
smart agricultural practices by livestock and poultry
producers through infrastructure improvements related
to (1) providing animals with access to the outdoors or
pasture, and (2) converting to specialty and organic
crop production.
Proposed Accompany Report language: Section 21001(a)(1)
of Public Law 117-169 appropriates $1.75 billion for
Fiscal Year 2024 to support conservation activities
under the environmental quality incentives program that
directly improve soil carbon, reduce nitrogen losses,
or reduce, capture, avoid, or sequester carbon dioxide,
methane, or nitrous oxide emissions, associated with
agricultural production. The committee directs the USDA
to include in these efforts, support for farmers who
wish to transition from high-emission animal production
systems to lower-emission farming methods that utilize
specialty crops and organic production methods.
Further, the committee directs the USDA to monitor
these climate-smart transition efforts, including but
not limited to: the costs associated with transitions
including any necessary upgrades, debt-relief, the
viability and the profitability of plant-focused
farming using existing infrastructure from animal
agriculture operations. The Committee directs the
Secretary to report back to this Committee with his
findings no later than 180 days after the enactment of
this legislation.
Additional Background:
The uncertainty faced by our Nation's farmers due to the unbalanced
influence of large agribusiness companies is an overlooked social and
economic danger in the United States. The widely utilized contractor
model that is especially prevalent in animal agriculture, combined with
extreme weather events and the increasing unpredictability of market
forces, have resulted in the bankruptcy and foreclosure of thousands of
small American farmers, or the abandonment of farming altogether.
To evaluate the economic viability of converting contract poultry
and livestock facilities to specialty crop production, we worked with
Virginia Tech to create proposed infrastructure conversion
recommendations and with an agricultural economics firm to study the
potential return on investment of these recommendations. We analyzed
four crops to assess their potential to service the debt of these
recommended infrastructure conversion. This data will help farmers
interested in exiting the contract poultry or swine industry to select
transition crops.
The four crops we analyzed were cucumbers, tomatoes, microgreens,
and strawberries. For each analysis, we created a projected enterprise
budget that assumed an infrastructure conversion cost of $87,520 to
$148,730 (depending on the crop analyzed); used a labor rate of $17.58
per hour; and included a sensitivity analysis for factors such as price
received, yield, and labor rate, as well as packaging, natural gas use,
soil, and other relevant variable costs. The conversion costs in these
analyses were based on the recommendations we received from Virginia
Tech and independent greenhouse consultants for converting a 16,000-
square-foot space.
The table below summarizes crop-specific gross returns, operating
income, debt obligations, and debt-service coverage ratios for both 10-
year and 20-year financing. A debt-service coverage ratio (DSCR) is a
measurement of an operation's available cash flow to pay current debt
obligations, calculated as net income divided by debt obligations
(principal and interest payments). A DSCR of less than 1.0 poses
potential solvency problems, while a ratio of at least 2.0 is generally
considered very strong.
----------------------------------------------------------------------------------------------------------------
Tomatoes Cucumbers Microgreens Strawberries
----------------------------------------------------------------------------------------------------------------
Estimated cost to convert....... $147,820 $148,730 $87,520 $87,520
Gross returns................... $228,000 $180,000 $611,604 $140,000
Operating income................ $55,294 $26,046 $284,578 $52,944
10-year debt obligation......... $18,506 $18,620 $45,072 $18,888
10-year (6.5 percent interest) 2.99 1.39 6.31 2.80
DSCR...........................
20-year debt obligation......... $11,599 $11,670 $28,250 $11,838
20-year (6 percent interest) 4.77 2.23 10.07 4.47
DSCR...........................
----------------------------------------------------------------------------------------------------------------
As you can see from the table above, each crop analyzed has the
potential to service the debt necessary to convert contract poultry and
livestock operations, and provide substantial income to farmers. As
this is a new use of these facilities and a new market for farmers who
choose to enter this field, support from the Federal Government in the
forms of grants and cooperative agreements would dramatically reduce
the barriers to entry for farmers wanting to diversify their farming
operations. In addition to reducing their environmental footprint,
these transitioned operations will support the growth of rural jobs by
diversifying their local economy.
In the face of many complex challenges, such as food security,
increased droughts, inflation, collapsing supply chains and global
pandemics, investments are needed in American farmers, who stand at the
very core of rural America, in a way that allows them to restore
profitability and ensure their legacy of farming lives on for future
generations. As small business owners who are integral to local
economies and rural communities, farmers are stewards who remain driven
by financial and production-oriented concerns. The costly and time-
consuming work of repurposing farmers' unused, stranded assets into
active, resilient, and diversified farming operations has the potential
to revitalize rural economies but only if producers have the ability to
shift their production to readily respond to market conditions and
capitalize on growing trends. Without action by policymakers, the
current trends of dwindling farmers will further intensify and increase
rural flight.
[This statement was submitted by Frances Chrzan, The Transfarmation
Project, [email protected]]
______
Prepared Statement of the Western Governors' Association (WGA)
Chair Heinrich, Ranking Member Hoeven, and Members of the
subcommittee, the Western Governors' Association (WGA) appreciates the
opportunity to provide written testimony on the appropriations and
activities of the U.S. Department of Agriculture (USDA). WGA is an
independent organization representing the Governors of the 22
westernmost States and territories. The Association is an instrument of
the Governors for bipartisan policy development, information sharing
and collective action on issues of critical importance to the western
United States.
USDA programs have a significant effect on the American West and
the economic viability of its rural communities. Western Governors
recognize the importance of a close and productive working relationship
between States and the Federal Government and understand that more
effective cooperation depends on Federal recognition of States as co-
sovereigns and partners. The promotion of greater partnership between
States and the Federal Government is central to the mission of WGA and
is reflected in the Governors' Policy Resolution 2021-01, Strengthening
the State-Federal Relationship. WGA also commends your attention to
other Western Governors' resolutions that articulate policy positions
relevant to the subcommittee's work. These include Policy Resolutions
2020-06, Western Agriculture; 2021-03, National Forest and Rangeland
Management; 2022-11; Biosecurity and Invasive Species Management; 2021-
08, Water Resource Management in the West; 2021-04, Species
Conservation and the Endangered Species Act; 2020-07, Rural
Development; and 2020-08, Broadband Connectivity
Agriculture in western States faces a variety of challenges,
including extreme variations in soil, climate, terrain, commodity and
specialty crops, production practices, and water availability. Amid
these difficult conditions, the western agricultural sector provides a
vast array of high-demand, high-quality food products for American and
foreign markets. Western agricultural lands also serve as primary
sources of crucial ecosystem services, including open space, wildlife
habitat, and water supplies, and support a diverse suite of rural
economic opportunities in the recreation, food, fiber, energy, and bio-
based product industries.
USDA conservation programs promote responsible land management in
western States and are of crucial importance to the agricultural
sector, including livestock producers dependent on using Federal
allotments through permits and fees to sustain their operations.
Western Governors support targeted, voluntary, and collaborative
conservation to address locally identified natural resource issues
affecting farms, rangelands, and forests on private and public lands.
These issues include soil health, air and water quality, drought and
wildfire resilience, wildlife habitat conservation, and invasive
species. WGA supports the role of conservation title programs under the
Agriculture Improvement Act of 2018 (Pub. L. 115-334) in promoting
voluntary solutions to the challenges of threatened and endangered
species, water quality impairments, and groundwater recharge. Western
Governors encourage the subcommittee to support appropriate funding
levels for programs addressing these critical concerns.
The work of the Natural Resources Conservation Service (NRCS) is
especially important to western States, and WGA encourages the
subcommittee to provide adequate funding for conservation programs
administered by the agency. NRCS empowers private landowners to work
with States and the Federal Government on large-scale management
priorities across landscapes with different land ownerships. NRCS
programs provide multiple benefits to western communities:
--Stimulating economic activity and creating jobs in local
communities;
--Conserving habitat for the greater sage-grouse, lesser prairie
chicken, and other species;
--Mitigating wildland fire potential in western States;
--Improving water quality;
--Reducing the threat of invasive species on western lands; and
--Responding to imminent hazards caused by floods, wildfire,
windstorms, and other natural disasters through the Emergency
Watershed Protection Program.
Western Governors also support adequate funding of NRCS' Snow
Survey and Water Supply Forecasting (SSWSF) program. Sufficient funding
is required to ensure the long-term viability of the program's
continued and uninterrupted collection of snowpack and water data, the
full operation and maintenance of all snow survey sites, the hiring of
needed program staff, and technological and software upgrades. The
SSWSF program provides integral information for water supply management
decisions in agricultural production, hydroelectric power generation,
reservoir operations, industry, recreation and economic development,
and international treaties. The program's predictive capabilities are
critically useful throughout the arid West, where snowpack accounts for
the vast majority of the region's annual water supply.
Western Governors support adequate funding for the National
Institute of Food and Agriculture (NIFA). Western Governors recognize
the valuable role NIFA plays in research on biosecurity and invasive
species and support further research to understand the potential spread
of invasive species and to develop geographically appropriate control
measures.
The West's network of land grant universities and colleges,
including Cooperative Extension Service programs and Agricultural
Experiment Stations, provides national leadership in research to
develop more resilient seeds and crops, manage soil health, advance
technology deployment in the bio-based economy, and conduct on-farm
research experiments that help farmers and ranchers be more effective
and efficient. Western Governors support efforts to expand research
funding to address drought, a changing climate, and extreme weather
risks facing western producers. WGA also encourages the effective use
of Extension to deliver practical tools, technologies, and information
to farmers, ranchers and forest landowners and to respond to the
changing needs of rural communities.
Healthy, vibrant, and prosperous rural communities are critical to
western States. Rural communities, however, face a variety of
challenges with respect to economic development, infrastructure, and
quality of life. Western Governors support USDA's Rural Development
programs, which address those challenges, and request an increased
emphasis on rural capacity-building efforts. Building local capacity
through training, technical assistance, and consistent support for
institutions that serve rural communities is fundamental to economic
and community development and maximizes the effect of State and Federal
resources. It will be especially important to maximize the benefits of
the Infrastructure Investment and Jobs Act (Pub. L. 117-58) for rural
communities. At the same time, Western Governors urge USDA to evaluate
rural development programs, identify barriers for rural applicants, and
revise onerous requirements in a manner that recognizes the limited
resources and capacity of rural applicants.
Western Governors support rural development programs aimed at
fostering small businesses, entrepreneurs, and cooperative business
models, and appreciate the increase in funding for the Rural Business-
Cooperative Service in fiscal Year 2023. Western agricultural
cooperatives perform many important functions for their members and
rural communities. These include provision of seed, feed, and
fertilizer to growers; product storage, processing, and transportation;
trade and market promotion; supply chain solutions; and education and
technical assistance. Cooperative business models can also help meet
rural community needs for childcare, homecare, main street businesses,
and more. Western Governors recognize the need for substantial
technical assistance and education in developing new cooperative
businesses and support funding to promote these efforts, including USDA
Rural Cooperative Development Grants and Value-Added Producer Grants,
and programs administered by USDA's Agricultural Marketing Service and
NIFA.
Western Governors also remain committed to creating new
opportunities for rural job seekers and for young people to pursue
careers in their rural communities. WGA supports solutions that
leverage public universities, community colleges, and the business
community to provide the appropriate training and skills for the jobs
that are available in rural communities.
Western Governors support funding for the Market Access and Foreign
Market Development Programs to promote opportunities for western
producers to increase export revenues and encourage trade agreements
that maximize benefits for the West's farmers, ranchers, and forest
landowners. WGA also supports adequate funding for the Specialty Crop
Block Grant Program, which provides critical research, education, and
promotion tools to fruit and vegetable producers.
Western Governors support the continued efforts of the Rural
Utilities Service to provide financial assistance for drinking water
and wastewater facilities, renewable energy projects on agricultural
lands, and broadband connectivity in rural and remote areas,
particularly in communities that have minimal or no such
infrastructure. Western Governors support dedicated funding to develop
innovative solutions for communities and Tribes that cannot be served
by traditional drinking water and wastewater systems. Governors also
remain concerned by the Nationwide shortage of certified water system
operators. Ongoing and coordinated efforts to develop these skilled
workers are necessary to ensure that existing water access in rural
communities can be maintained.
Expanding broadband access to rural America empowers citizens to
compete in a global market and access electronic information and
telecommunications technologies to support and promote telehealth and
distance learning. Western Governors note the significance of programs
such as the Distance Learning and Telemedicine Program and the
ReConnect Program, which support broadband deployment to underserved or
wholly unserved rural communities, and appreciate the subcommittee's
continued commitment to the ReConnect Program and rural broadband.
Consistent funding for these programs is critical to closing the
digital divide. In addition, Western Governors are pleased that the
minimum speed for ReConnect eligibility remains at 100/20 Mbps, as 25/3
Mbps does not correspond with the requisite download and upload speeds
necessary to support modern internet needs.
Given the numerous Federal agency programs, policies, and
regulations directly affecting the collective States, agency
coordination with States and the integration of state data into Federal
programs for policymaking is paramount to their success. Western
Governors support full and consistent Federal funding for agencies to
carry out the requirements of the Foundations for Evidence-Based
Policymaking Act of 2018 (Pub. L. 115-435) and encourage the
subcommittee to direct Federal agencies to improve their internal
processes and coordinate with States on Federal data policies and
procedures, as required in the act.
Western Governors recognize that nutrition assistance programs can
help meet the needs of children and the most vulnerable, while creating
economic opportunity across the agriculture supply chain from the store
where food is purchased all the way back to the farm. Nutrition
assistance programs should continue to provide flexibility for States
to respond to unique economic conditions, serve all eligible
participants without drastically reducing benefits, and pursue
transparency and accountability in program administration.
Western States and Federal agencies deal with a complex web of
interrelated agriculture, conservation, and economic development
priorities. It is an enormous challenge to judiciously balance
competing needs in this environment, and Western Governors appreciate
the difficulty of the decisions the subcommittee must make. The
foregoing recommendations are offered in a spirit of cooperation and
respect, and WGA is prepared to assist you in discharging these
critical and challenging responsibilities.
[This statement was submitted by Jack Waldorf, Executive Director,
Western Governors' Association.]
______
Prepared Statement of the Wildlife Society
The Wildlife Society (TWS; wildlife.org) inspires, empowers, and
enables wildlife professionals to sustain wildlife populations and
their habitat through science-based management and conservation.
Founded in 1937, TWS and our network of affiliated chapters and
sections represents more than 15,000 professional wildlife biologists,
managers, and educators dedicated to excellence in wildlife
stewardship. As leaders in wildlife science, management, and
conservation, TWS promotes the use of science in all aspects of policy
and decision-making and is also committed to the identification and
removal of barriers to recruitment, effective mentoring, and retention
of a diverse workforce.
The Wildlife Society appreciates the opportunity to submit
testimony concerning the Fiscal Year 2024 budgets for the Animal and
Plant Health Inspection Service (APHIS), National Institute of Food and
Agriculture (NIFA), and the Natural Resources Conservation Service
(NRCS). We respectfully request the following programmatic funding in
fiscal Year 2024. Thank you in advance for considering the views of The
Wildlife Society.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Fiscal year 2023 FY2024 TWS
Agency Program Enacted Recommendation
--------------------------------------------------------------------------------------------------------------------------------------------------------
APHIS/Wildlife Services.......................................... Wildlife Damage Management $122 M $123 M
--------------------------------------------------------------------------------------
Methods Development $26.2 M $27 M
--------------------------------------------------------------------------------------------------------------------------------------------------------
NIFA/Formula Grants.............................................. RREA $4 M $10 M
--------------------------------------------------------------------------------------
McIntire-Stennis $38 M $43 M
--------------------------------------------------------------------------------------------------------------------------------------------------------
NIFA/Minority-Serving Institution programs....................... Hispanic Serving Institutions $16 M $20 M
Education Partnerships Grants
Program
--------------------------------------------------------------------------------------
Alaska Native Serving and Native $5 M $6 M
Hawaiian-Serving Institutions
Education Grants
--------------------------------------------------------------------------------------
1890 Institutions Centers of $10 M $11 M
Excellence
--------------------------------------------------------------------------------------------------------------------------------------------------------
NRCS............................................................. Private Lands Conservation $827 M $904 M
Operations
--------------------------------------------------------------------------------------------------------------------------------------------------------
animal and plant health inspection service
APHIS Wildlife Services resolves human-wildlife conflicts and
protects wildlife, agriculture, and human health and safety from
wildlife damage and wildlife-borne diseases. The Wildlife Damage
Management program provides frontline assistance to cooperators to
protect natural and human-made resources. We appreciate the increase
for this program in fiscal Year 2023 and encourage Congress to provide
another small increase in funding in fiscal Year 2024 to $123 million
as requested by the Administration. Maintaining inflation-adjusted
funding levels will allow Wildlife Services to carry out programs
identified by Congress as key focus areas, including the National
Rabies Management Program, which distributes oral rabies vaccines to
wildlife within targeted areas with the goal of disease elimination,
and the feral swine management program, which works with cooperators to
protect natural and human-made resources against this highly
destructive non-native species.
Methods Development, also within Wildlife Services, funds the
vitally important National Wildlife Research Center (NWRC), which
provides tools that the Damage Management program, as well as federal,
State, and local partners need to deter human-wildlife conflict in the
field setting. TWS thanks Congress for increased funding in fiscal Year
2023 and requests another small increase in fiscal Year 2024 to allow
the NWRC to continue to deliver new research critical to state wildlife
agencies, Federal agencies, and municipalities, including novel
deterrents to prevent predator conflict with livestock, the development
of new humane toxicants against feral swine, and research into the
efficacy of fertility control applications in free-roaming horses.
national institute of food and agriculture
The Renewable Resources Extension Act (RREA) provides resources to
state extension programs that share with landowners and managers the
latest management tools applicable to forest and rangeland resources,
including wildlife management. RREA funds private landowner outreach
and effectively leverages cooperative partnerships at an average ratio
of four to one. These extension programs improve management practices
on over 43 million acres. Authorized at $30 million, RREA has seen flat
funding at only $4 million annually for over a decade. TWS requests an
increase in RREA funding to at least $10 million in fiscal Year 2024.
The McIntire-Stennis Cooperative Forestry Program also has a long
history of effectively leveraging outside dollars that benefit private
land management practices. This program requires a 1:1 non-federal
match for research projects related to producing, using, and protecting
natural resources based on identified private landowner needs. The
funds are targeted at public and land grant university research, which
in turn fosters the next generation of natural resources professionals.
Private landowners own approximately 300 million acres (over 35
percent) of the Nation's forests and woodlands. Funding of $43 million
in fiscal Year 2024 will allow NIFA to make continued investments in
conservation and management techniques on the Nation's private lands.
The USDA's budget request includes $370 million for Minority-
Serving Institution programs, which support capacity-building
initiatives, education, and pathways to employment at minority-serving
institutions. TWS strongly support policies, programs, and practices
that advance efforts to recruit, mentor, and retain professionals from
a broad spectrum of identities, including individuals from historically
underrepresented backgrounds.
The Hispanic Serving Institutions Education Partnerships Grants
Program expands and strengthens academic programs in the agricultural
sciences, natural resources, forestry, and other disciplines tied to
the food and agriculture production and delivery systems at Hispanic-
serving colleges and universities. TWS supports the administration's
request for a $4 million increase for this program and encourages
funding at $20 million in fiscal Year 2024.
The Alaska Native Serving and Native Hawaiian-Serving Institutions
Education Grants are aimed at recruiting, supporting and educating
minority scientists and professionals, and advancing the educational
capacity of Native-serving institutions. TWS appreciates the recent
increases in funding for this program and encourages funding at $6
million in fiscal Year 2024.
The 1890 Institutions Centers of Excellence are designed to supply
the country with a globally diverse workforce and support critical
global development needs, thereby addressing trans-boundary research
and education challenges including climate change, biodiversity
conservation and development. We encourage Congress to provide a small
increase for this important program in fiscal Year 2024, bringing
funding to $11 million.
We also encourage Congress to support other USDA Minority-Serving
Institution programs administered by NIFA, such as the National
Scholars Program, which is intended to increase the number of minority
students enrolling in agriculture, food, natural resource sciences, and
other related programs in pursuit of a bachelor's degree at Land Grant
Universities, and the Tribal Scholars Program, which seeks to increase
the number of American Indian and Alaska Native students studying
agriculture, food, natural resources, and related disciplines.
natural resources conservation service
The Natural Resources Conservation Service (NRCS) is the primary
Federal agency working with private land and farm owners to help them
conserve, maintain, and improve natural resources on their lands,
including soil, water, air, plants, fish, and wildlife. In fiscal Year
2024, TWS requests that Congress provide full funding to the
conservation programs authorized by the 2018 Farm Bill, which work with
landowners to provide measurable benefits for fish and wildlife.
TWS also urges Congress to provide critical discretionary funding
for Private Lands Conservation Operations administered by NRCS,
including Conservation Technical Assistance (CTA). The CTA program
provides landowners with site-specific solutions needed to implement
conservation programs, while also providing for public accountability
to ensure funds are spent as intended. As Congress turns its attention
to constructing and modifying private lands programs in the 2023 Farm
Bill, demand for technical assistance will continue to grow. TWS
requests Congress fund this vital program at the Administration-
requested $904 million in fiscal Year 2024.
Thank you for considering the views of wildlife professionals.
Please reach out to Caroline Murphy, AWB(r), TWS government relations
manager ([email protected]), with any questions regarding these
recommendations.
[This statement was submitted by Don Yasuda, CWB(r), President, The
Wildlife Society.]
______
Prepared Statement of National Center for Appropriate Technology
Request: An increase of $2.5 million fiscal Year 2024 appropriation
for biochar research by the USDA Agricultural Research Service (ARS)
for new research at the Sidney, Montana Northern Plains Agricultural
Research Laboratory, the Prosser, Washington ARS site, and the ARS
National Laboratory for Agriculture and the Environment at Ames, Iowa
to be undertaken in conjunction with ongoing ARS biochar research at
other sites. This request is for ongoing appropriations for permanent
positions to conduct long-term research.
Background: The proposed research would test a common set of
biochar types across multiple sites to advance understanding of the
impact of diverse types of biochar in varying soils and circumstances
on soil health, productivity, and carbon sequestration. This multisite
research will inform farmers and ranchers on which types of biochar
have positive impacts in their soils and circumstances.
Findings would be used to develop and refine decision-support tools
for use by producers and provide the basis for expanding applied
research on integration of biochar in local production systems. The
research would also provide the knowledge to design and certify
different types and treatments of biochar for use in different soils
and circumstances.
Rationale: Research suggests that appropriately designed biochar
can increase soil health, plant available water, soil fertility and
plant growth and yields, thereby enhancing agricultural productivity
and resilience as well as food security. Research results are
inconsistent, however, because different types of biochar are being
tested in varying soils and circumstances.
Biochar is highly effective in addressing the challenge of building
and maintaining soil carbon/organic matter. Planting cover crops can
add carbon to soil and no-till farming can in some instances slow
breakdown of crop residue. But under either practice, organic matter is
largely decomposed in a few years and released back to the atmosphere
as CO2.
The unique promise of biochar is that it provides ``recalcitrant''
soil carbon that lasts for hundreds to thousands of years. In addition,
appropriately designed biochar can slow the breakdown of other soil
carbon. Thus, biochar integrated with other soil building practices may
add more to soil carbon and organic matter than the sum of each alone.
But to realize biochar's full potential, we need coordinated
research to determine which types of biochar are beneficial in varying
soils and circumstances. This request meets that need and reflects the
recommendations of leading biochar researchers and the 2022 Convening
on Biochar Research and Commercialization which included agency and
industry stakeholders. The cross-site research that would be supported
by this research is far more efficient way to close critical knowledge
gaps on biochar than funding uncoordinated individual research
projects.
The Biochar Policy Project has discussed this proposal with, and
received favorable responses from, the relevant ARS National Program
Leaders and with staff at the three proposed locations.
[This statement was submitted by Chuck Hassebrook, Director of the
Biochar Policy Project of the National Center for Appropriate
Technology.]
LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS
----------
Page
Alliance for a Stronger FDA, Prepared Statement of the........... 87
American:
Brain Coalition, Prepared Statement of...................... 90
Commodity Distribution Association, Prepared Statement of.... 92
Farm Bureau Federation, Prepared Statement of................ 94
Society:
for:
Microbiology, Prepared Statement of.................. 96
Nutrition, Prepared Statement of..................... 98
The Prevention of Cruelty to Animals (ASPCA),
Prepared Statement of the.......................... 99
Animal:
Health Institute, Prepared Statement of...................... 103
Welfare Institute, Prepared Statement of
Baldwin, Senator Tammy, U.S. Senator From Wisconsin, Questions
Submitted by
Califf, Hon. Dr. Robert, M.D., Commissioner, Food and Drug
Administration:
Prepared Statement of........................................ 54
Statement of................................................. 51
Summary Statement of......................................... 53
Campaign for Contract Agriculture Reform, Prepared Statement of.113
Central Arizona Water Conservation District, Prepared Statement
of............................................................. 116
Center for Invasive Species Prevention, Prepared Statement of the 117
Collins, Senator Susan M., U.S. Senator From Maine, Questions
Submitted by
Colorado:
River:
Basin Salinity Control Program, Prepared Statement of the
Board of California (Board), Prepared Statement of the... 120
Entomological Society of America, Prepared Statement of.......... 125
Environmental and Energy Study Institute, Prepared Statement of.. 126
Feinstein, Senator Dianne, U.S. Senator From California,
Questions Submitted by......................................... 38
Fischer, Senator Deb, U.S. Senator From Nebraska, Questions
Submitted by
Food Industry Association, Prepared Statement of................. 127
Haleon, Prepared Statement of.................................... 129
Heinrich, Senator Martin, U.S. Senator From Mexico:
Opening Statement of
Questions Submitted by....................................... 73
Hoeven, Senator John, U.S. Senator From North Dakota:
Questions Submitted by....................................... 80
Statement of
Humane:
Society:
Legislative:
Fund and Humane Society, Prepared Statement of the... 130
United States, Prepared Statement of the....................133
Hyde-Smith, Senator Cindy, U.S. Senator From Mississppi,
Questions Submitted by......................................... 83
Jazz Pharmaceuticals, Prepared Statement of...................... 136
Manchin, Senator Joe, U.S. Senator From West Virginia, Questions
Submitted by
Moran, Senator Jerry, U.S. Senator From Kansas, Questions
Submitted by................................................... 43
National:
Association:
State Energy Officials (NASEO), Prepared Statement of the 139
Wheat Growers, Prepared Statement of the................. 140
Center for Appropriate Technology, Prepared Statement of..... 150, 190
Coalition for Food and Agricultural Research (NCFAR),
Prepared Statement of...................................... 142
Commodity Supplemental Food Program Association (NCSFPA),
Prepared Statement of...................................... 144
Environmental Health Association (NEHA), Prepared Statement
of the..................................................... 145
Farmers Union, Prepared Statement of......................... 148
Institute of Food and Agriculture, Prepared Statement of
Multiple Sclerosis Society, Prepared Statement of............ 155
Organic Coalition, Prepared Statement of the................. 156
Treasury Employees Union, Prepared Statement of the.......... 158
Oregon Water Resources Congress, Prepared Statement of the....... 166
rganic:
Farmers Association, Prepared Statement of...................
160........................................................
Farming Research Foundation, Prepared Statement of...........
162........................................................
Trade Association (OTA), Prepared Statement of the...........
164........................................................
Personalized Medicine Coalition (PMC), Prepared Statement of the.
169............................................................
Pet and Women Safety Act (PAWS), Prepared Statement of...........
172............................................................
Rapp, Mr. John, Director, Office of Budget and Program Analysis,
Accompanied By.................................................
1..............................................................
Research!America, Prepared Statement of..........................
174............................................................
Spark Climate Solutions, Prepared Statement of
Squaxin Island Tribe, Prepared Statement of...................... 182............................................................
Sustainable Agriculture Research and Education, Prepared
Statement of the...............................................
175............................................................
Transformation Project, Prepared Statement of the................
184............................................................
Vilsack, Hon. Thomas J., Secretary, Department of Agriculture:
Prepared Statement of........................................
5..........................................................
Statement of.................................................
1..........................................................
Summary Statement of.........................................
3..........................................................
Western Governors' Association (WGA), Prepared Statement of the..
186............................................................
Wildlife Society, Prepared Statement of the......................
188............................................................
SUBJECT INDEX
----------
DEPARTMENT OF AGRICULTURE
Page
Additional Committee Questions...................................
38.............................................................
Brazilian Beef...................................................
31.............................................................
Broadband Coordination...........................................
42.............................................................
Business and Industry Program....................................
42.............................................................
Captive Marine Mammal Care.......................................
40.............................................................
Cattle Identification Tags.......................................
19.............................................................
Chronic Wasting Disease
Climate-Smart Commodity Partnership Initiative...................
37.............................................................
Collaboration with University Partners...........................
46.............................................................
Concentration of Slaughter Industry..............................
18.............................................................
Conservation:
Stewardship Program..........................................
41.........................................................
Technical Assistance.........................................
41.........................................................
Creating More and Better Markets.................................
8..............................................................
Crop:
Insurance for Specialty Growers..............................
40.........................................................
Loss From Natural Disasters..................................
39.........................................................
Cuts to:
Conservation Programs........................................
18.........................................................
Federal Food Assistance......................................
17.........................................................
Dairy Business Innovation Initiative.............................
36.............................................................
Definition of Rural..............................................
20.............................................................
Deferred Maintenance for Research Facilities.....................
38.............................................................
Difficult Terrain and Access to Urban Area Project...............
42.............................................................
Disaster Assistance
Drought in the West..............................................
24.............................................................
Extreme Drought..................................................
49.............................................................
Farm:
Service:
Agency:
Loan Officers........................................
45.................................................
Staffing.............................................
30.................................................
Genetically Modified Organism Corn...............................
27.............................................................
Grazing Lands Conervation Initiative.............................
36.............................................................
Highly Pathogenic Avian Influenza................................
23.............................................................
International Market Access......................................
43.............................................................
IRA Conservation Funding.........................................
28.............................................................
Labor Costs......................................................
38.............................................................
National Bio Agro-Science Facility...............................
26.............................................................
Pollinators......................................................
33.............................................................
Pork Processing Capacity.........................................
50.............................................................
Polyflouorinated Substances......................................
15.............................................................
Precision Agriculture
Preservation of Multi-Family Housing.............................
13.............................................................
Processing Opportunities for Bison...............................
32.............................................................
Rebuilding:
Rural America................................................
8..........................................................
USDA through Diversity, Equity, and Inclusion................
10.........................................................
Reconnect
Deployment...................................................
44.........................................................
Regional Conservation Partnership Program........................
41.............................................................
Remote Work and Upgrades to USDA Headquarters....................
43.............................................................
Research:
And Innovation...............................................
6..........................................................
Investments in Food Supply...................................
16.........................................................
Select Agent Registration........................................
45.............................................................
Single-Family Housing Recapture..................................
32.............................................................
School Meals Proposed Rule.......................................
13.............................................................
Supporting Nutrition for the Nation..............................
9..............................................................
Tackling the Climate Crisis......................................
7..............................................................
Transitioning Next Generation Farmers............................
35.............................................................
Unobligated Covid Funding........................................
47.............................................................
USDA Staffing Needs..............................................
42.............................................................
Water Quality and Quantity.......................................
47.............................................................
__________
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Additional Committee Questions................................... 73
advancing Medical Product Safety................................. 56
Enhancing Food Safety, Nutrition, and Cosmetics Oversight........ 55
Investing in Core Operations..................................... 57
Modernizing Infrastructure, Buildings & Facilities............... 57
Pandemic Preparedness............................................ 58
Tobacco Regulation............................................... 57
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