[Senate Hearing 117-629]
[From the U.S. Government Publishing Office]
S. Hrg. 117-629
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND
DRUG ADMINISTRATION, AND RELATED AGEN-
CIES APPROPRIATIONS FOR FISCAL YEAR 2023
.=======================================================================
HEARINGS
BEFORE A
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
SECOND SESSION
ON
H.R. 8239
AN ACT MAKING APPROPRIATIONS FOR AGRICULTURE, RURAL DEVELOPMENT, FOOD
AND DRUG ADMINISTRATION, AND RELATED AGENCIES FOR THE FISCAL YEAR
ENDING SEPTEMBER 30, 2023, AND FOR OTHER PURPOSES
__________
Department of Health and Human Services: Food and Drug Administration
Department of Agriculture
__________
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
46-644 PDF WASHINGTON : 2023
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COMMITTEE ON APPROPRIATIONS
PATRICK J. LEAHY, Vermont, Chairman
PATTY MURRAY, Washington RICHARD C. SHELBY, Alabama, Vice
DIANNE FEINSTEIN, California Chairman
RICHARD J. DURBIN, Illinois MITCH McCONNELL, Kentucky
JACK REED, Rhode Island SUSAN M. COLLINS, Maine
JON TESTER, Montana LISA MURKOWSKI, Alaska
JEANNE SHAHEEN, New Hampshire LINDSEY GRAHAM, South Carolina
JEFF MERKLEY, Oregon ROY BLUNT, Missouri
CHRISTOPHER A. COONS, Delaware JERRY MORAN, Kansas
BRIAN SCHATZ, Hawaii JOHN HOEVEN, North Dakota
TAMMY BALDWIN, Wisconsin JOHN BOOZMAN, Arkansas
CHRISTOPHER MURPHY, Connecticut SHELLEY MOORE CAPITO, West
JOE MANCHIN, West Virginia Virginia
CHRIS VAN HOLLEN, Maryland JOHN KENNEDY, Louisiana
MARTIN HEINRICH, New Mexico CINDY HYDE-SMITH, Mississippi
MIKE BRAUN, Indiana
BILL HAGERTY, Tennessee
MARCO RUBIO, Florida
Charles E. Kieffer, Staff Director
Bill Duhnke, Minority Staff Director
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Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies
TAMMY BALDWIN, Wisconsin, Chairman
JEFF MERKLEY, Oregon JOHN HOEVEN, North Dakota, Ranking
DIANNE FEINSTEIN, California MITCH McCONNELL, Kentucky
JON TESTER, Montana SUSAN M. COLLINS, Maine
PATRICK J. LEAHY, Vermont, (ex ROY BLUNT, Missouri
officio) JERRY MORAN, Kansas
BRIAN SCHATZ, Hawaii CINDY HYDE-SMITH, Mississippi
MARTIN HEINRICH, New Mexico MIKE BRAUN, Indiana
Professional Staff
Dianne Nellor
Rachel Erlebacher
Hannah Chauvin
Angela Caalim
Morgan Ulmer (Minority)
Patrick Carroll (Minority)
Elizabeth Dent (Minority)
Administrative Support
Ann Tait Hall
C O N T E N T S
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hearings
Thursday, April 28, 2022
Page
Department of Health and Human Services: Food and Drug
Administration................................................. 1
Tuesday, May 10, 2022
Department of Agriculture........................................ 55
back matter
List of Witnesses, Communications, and Prepared Statements....... 103
Subject Index:
Department of Health and Human Services: Food and Drug
Administration............................................. 105
Department of Agriculture.................................... 105
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2023
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THURSDAY, APRIL 28, 2022
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:04 a.m. in Room SD-124, Dirksen
Senate Office Building, Hon. Tammy Baldwin (chairwoman)
presiding.
Present: Senators Baldwin, Tester, Hoeven, Hyde-Smith, and
Braun.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
STATEMENT OF HON. ROBERT CALIFF, M.D., COMMISSIONER
opening statement of senator tammy baldwin
Senator Baldwin. I want to welcome everybody to our first
budget hearing for this subcommittee of fiscal year 2023. And
Dr. Califf, welcome back to the subcommittee. We appreciate
your being here this morning to discuss the Food and Drug
Administration's fiscal year 2023 budget request. In fiscal
year 2022, this subcommittee provided historic funding for a
wide variety of activities at the agency, and I want to
continue that upward trajectory of the FDA, so it remains the
world's gold standard for protecting public health.
That starts with the budget before us, which includes
increases for important initiatives, including a focus on food
safety, addressing maternal and infant health, and continuing
to address the COVID-19 pandemic.
The fiscal year 2023 budget request for the FDA is
ambitious and reflects the vast responsibilities of the agency.
We need to ensure FDA has the resources they need to continue
their mission. We must invest in safer drugs, safer medical
devices, and a safer food supply. Dr. Califf, I am looking
forward to hearing your vision for the FDA and how this budget
will advance that vision and support these important
investments. And I am particularly interested in learning about
your proposed increases for FDA's core safety programs.
The budget request includes significant increases for food
and drug safety, device shortages, and focuses on the
infrastructure needs of the agency. The FDA has the ability,
and frankly the duty, to serve the public in a range of ways
that matter deeply to people's health.
We ask a lot of the FDA, from rigorous reviews of
medications and medical devices, to addressing a rapidly
changing food system. The work the FDA does impacts the lives
of every American. Recent reports have raised serious concerns
about the FDA's food mission and have identified many areas
where the agency has both chronically and acutely fallen short
of its mission to the public.
Americans rely on the FDA to ensure that the food they are
eating is safe and that they have the information they need to
make informed decisions about what to feed their families. In
many cases, it seems that the FDA has put food safety issues on
the back burner. The FDA has to do better, and I look forward
to hearing your response to that reporting here this morning.
Additionally, I know from my constituents, there has been
much frustration regarding standards of identity and FDA's lack
of urgency when dealing with this issue. The FDA did issue a
rule on standards of identity for yogurt, but many provisions
were objected to by the dairy industry, and a stay was
eventually put in place. It should not take the agency 40 years
to update a rule.
These are major challenges, and as chair of the
subcommittee, I want to make sure the FDA has the resources
they need so that Americans aren't left waiting and can trust
the food they are eating.
Again, I look forward to your testimony and appreciate your
being here today. And with that, I will turn it over to Ranking
Member Hoeven for any opening remarks he may have.
statement of senator john hoeven
Senator Hoeven. Thanks, Madam Chairman. Appreciate it.
Thanks, Dr. Califf, for being here. Appreciate you being here
to discuss FDA's funding priorities for 2023. Also appreciate
visiting with you yesterday ahead of time so we could go
through some things. We want to congratulate you on your return
to the Commissioner's Office, and also thank you for your many
years of public service.
And I was pulling for Duke, too, as I said, mainly because
I wanted to see Krzyzewski win it on his last year coaching. He
has just such a remarkable, incredible record. I met Dr. Wooden
and of course thought he was the finest basketball coach of all
time. But I would have to say Krzyzewski is right up there with
him.
He is just a class act, too. Obviously, FDA plays a
critical role in advancing the safety and prosperity of our
Nation. You regulate more than $2.5 trillion worth of products
on a daily basis. And so, you know, obviously, you are and have
to be really the gold standard for food and drug safety. It is
what the public requires.
And really the rest of the world looks to you in terms of
setting that standard for that safety for our citizens, and not
just citizens of America, but obviously there is consumers
across the world that are affected by the products that you
oversee in your duty for safety. So in the past decade, we have
had seven FDA Commissioners, you know, which is a lot of
turnover in the agency, obviously. And so really, the challenge
is of course, at the same time, pandemic, COVID-19.
We have also had to deal with Zika, Ebola, and other, you
know, public health issues. Opioid epidemic. So all these
things are incredibly important and are real issues of
obviously life and death. And so, you know, creating some
longevity in terms of, you know, planning and long term
planning and, you know, stability for the agency is important.
Over the decade, we have provided almost $850 million in
additional baseline funding. That is about an almost 35 percent
increase over the 10 year period.
More than $1 billion in emergency funding for public health
emergencies. $500 million to implement 21st Century Cares Act.
And then there is also a $1.1 billion in increased user fee
assessments. So there is an increasing resource pool. I know
resources are always a challenge, but we have got to deploy and
utilize these resources wisely and as well as we can.
You know, so I think that investment certainly represents
our commitment of this subcommittee, and really the whole
Appropriations committee, you know, to the safety of our food
and drug supply. With that said, we have got to continue to
make strategic investments, something you and I have talked
about. We have got to modernize.
The technology is incredibly important. It is going to play
a huge role going forward as it is in almost every other aspect
of what we do. But clearly, you have a challenge to get your
technological capabilities up to where they need to be.
And as we talked about, that is a process. I don't know
that you ever get there, right? Because as soon as you get
there with one part, then you have got to upgrade some other
part. The technology develops so fast, but it is obviously
incredibly important that we upgrade your technology..
So again, I think that all comes as part of you trying to
instill this, you know, longer term view, not only for your
term as Commissioner, but for future Commissioners, getting a
strategic plan that really you can work to deliver, and your
successors can continue. They may modify it, you know, because
everybody has their own ideas about things, particularly round
here. And so but, you know, they will make changes, of course,
but still, nailing down this plan, I think, can be a real
legacy issue for you, particularly with your background and
experience.
So I think that is incredibly important. I guess those are
the main thoughts that I have for you. And again, thanks for
being here today and for testifying and taking our questions.
Appreciate it.
Senator Baldwin. Thank you. We will now hear from Dr.
Califf, Commissioner of the Food and Drug Administration.
summary statement of dr. robert califf
Mr. Califf. Chair Baldwin and Ranking Member Hoeven and
members of the subcommittee, thanks for the opportunity to
appear before you today to discuss the 2023 budget request.
Also, thanks for your kind comments and the delineation of the
challenge, which I think is very real.
As a loyal Duke fan, I am not sure Chairwoman Baldwin is
totally on board with that wearing her Wisconsin red, but,
well, it is good to have something like sports which comes and
goes, and it is perfectly okay. So let me thank the
subcommittee for your continued support, which you have just
enumerated, particularly over the last 2 years as the agency
has worked tirelessly to respond to the COVID-19 pandemic.
I also want to thank the entire FDA staff. I am happy to be
back with them and to join the effort to end this pandemic and
ensure that we are prepared for the future. To realize our
potential as we move forward, we need to look carefully and
critically at the past 2 years. One of the most important
lessons learned was the need to modernize the technology and
scientific infrastructure that enables FDA's experts to do
their work.
It is also important to consider the best technology will
be to no avail if we don't attract and retain our first rate
workforce. The same forces that are driving the amazing
bioscience and digital revolutions are also causing intense
competition for the limited cadre of well-trained experts. The
budget I present to you today will build the foundation for FDA
to continue this good work and ultimately allow the agency to
meet the growing needs and mandates upon which the public
depends.
While there are many critical priorities in our budget
proposal, I would like to focus on three specific funding needs
that do not get enough public attention, although you both
mentioned them in your introductory remarks. The first is data
and technology modernization. The second is people.
And the third is infrastructure. I know what most people
are thinking, with 5 minutes to present, you want to talk to us
about data, people, and buildings? The answer is yes. Data is
used to support every decision the FDA makes, and modern
computation holds the key to the efficiency and effectiveness
that I know you want. There is a reason for the saying, in God
we trust, all others must bring data.
The FDA houses more data than the Library of Congress and
houses and protects trillions of dollars' worth of commercial
and intellectual property, as well as clinical trial data that
encompasses the health information of tens of millions of
patients across the country and the world. But the technology
and data systems are not of the quality we need for us to fully
facilitate innovation in the rapidly moving industries that we
regulate, nor to protect the public from the well-meaning, or
from either well-meaning or intentionally harmful products.
We must modernize to be able to keep up with burgeoning
industries and support innovation as underscored by the
messenger RNA vaccine effort that was so essential to our
pandemic response. Our budget requests approximately $68
million for data modernization to help bring the agency into
the 21st century. Many of you have been concerned about the
efficiency of the agency.
Much of FDA's work involves inspections and review of
applications and data from companies developing and refining
products through integration of increasingly complex biology
and digital technology. A modernized technology and data
infrastructure at FDA will have direct benefits on these core
functions. At the same time, we are inundated with claims from
the real world of the post-market environment, where we often
find major safety issues, some of those in the press as we
speak, as these products are used by our diverse population in
different environments.
It would be unwise for the FDA to be hobbled by inferior
technology to deal with food outbreaks and importation, complex
medical products, or understanding the consequences of toxins
in our food. FDA inspectors, even during the pandemic, traveled
to a variety of places or used virtual technology to record
data about the quality of products and the quality of the
systems and processes that make the products high quality and
safe, whether the product is a food, a complex device, or a
sophisticated drug or vaccine.
These inspectors currently must spend significant time
entering data into systems that are outmoded and cannot
integrate the information in a way that modern technology can
support. FDA reviewers are also increasingly dealing with
complex datasets that are generated through deep biological
computations that involve integration of disparate sources of
data from embedded biosensors and digital technology.
Each Center at FDA has invested in its own technology,
remnants of a time when interoperability was not a
consideration and artificial intelligence seemed like science
fiction. This balkanization wastes time, drains resources, and
creates safety vulnerabilities. In short, we need to be able to
do more inspections, do better and more reviews, and much more
efficiently detect signal from noise and post-market safety.
By embracing the full array of data science, advanced
statistics, machine learning, and artificial intelligence, we
can enable our inspectors and reviewers to focus their effort
on areas where they can make a difference. This will not only
enable our workforce to be more efficient, but also will make
their jobs more interesting, and this is a win-win.
Our physical infrastructure is also in desperate need of
modernization. The agency has a $300 million backlog of
building maintenance and repairs, which increases every year.
Our Nation depends on these facilities to test, review, and
evaluate the safety of the food we eat and the medical products
we use. The budget asked for approximately $40 million to
support these physical upgrades.
I invite the subcommittee to visit our facilities across
the Nation and see our work in action. I know you will agree
our work is worth the investment. I know infrastructure doesn't
have the same gluts as some topics, but unless we make these
investments now, much of our ability to regulate and support
the innovation that makes us competitive will go to waste.
Throughout this session, I am prepared to provide specific
examples of how data and technology modernization, support of
our workforce, and upkeep of our facilities will lead to
improved health and competitive advantage in global
competition. And before I close, I want to flag an issue I know
is a keen interest to the subcommittee.
I am pleased to announce that this morning FDA will issue
to propose tobacco standards, one prohibiting menthol as a
characterizing flavor in cigarettes, and another prohibiting
characterizing flavors other than tobacco and cigars. Through
careful consideration of the scientific evidence and our
authorities under the Tobacco Control Act, we have determined
that these actions are appropriate for protection of the public
health.
The proposed product standards would, among other things,
improve the health and reduce the mortality risk of current
smokers of menthol cigarettes or flavored cigars by
substantially decreasing their consumption and increasing the
likelihood of cessation. This is another important move forward
in the agency's efforts to combat youth tobacco use and promote
health equity.
And we look forward to working with Congress and the public
as we seek feedback on our proposed standards. Thank you for
inviting me, and I look forward to answering your questions.
[The statement follows:]
Prepared Statement of Dr. Robert M. Califf, M.D.
Chair Baldwin, 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 2023 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 appreciates the funding increases
provided by the subcommittee in the fiscal Year 2022 Omnibus and your
ongoing partnership is much appreciated as we execute our mission to
protect and promote the public health, including our ongoing response
work related to the COVID-19 pandemic. As we collectively work together
as a nation to try and turn the corner of the COVID-19 pandemic, the
Agency is using the lessons learned over the past 2 years and
optimistically looking forward. FDA's talented and dedicated workforce
has worked night and day for the past two-plus years to respond to the
pandemic and this work has been deeply consequential for strengthening
our Nation's response and protecting public health. At the same time,
one of the biggest lessons learned from our COVID-19 response was the
overwhelming need identified by FDA leadership to modernize the Agency,
including through improved data processes, IT infrastructure, and
facilities, to name just a few priorities. As a private citizen who was
involved in the pandemic response alongside many in industry and
academia, I can attest to the fact that this sentiment was also
observed by many outside the Agency as well. This effort will require
significant additional funding and we look forward to providing you
with the rationale for our plans to meet these needs, delineating the
benefits to the public health that will accrue, and working with you to
make sure the FDA remains the gold standard around the world.
FDA's fiscal year 2023 Budget Request builds upon our fiscal year
2022 request while also acknowledging additional future needs and
challenges. Our program level request totals $8.4 billion, which
represents an overall increase of approximately $2.1 billion above the
FY 2022 Enacted level. Of this total, $3.0 billion is for user fees,
which is an increase of approximately $153 million above the fiscal
Year 2022 Enacted level. Further, the Budget requests a total of $3.7
billion in discretionary budget authority, which is an increase of
approximately $356 million above the fiscal year 2022 Enacted level,
and $1.63 billion in mandatory funding to support the Administration's
plan to transform U.S. capabilities to prepare for and respond rapidly
and effectively to future pandemics and other high consequence
biological threats. These increases are organized into six critical
areas that advance the Agency's critical activities in support of
protecting and promoting the public health: (1) enhancing food safety
and nutrition; (2) advancing medical product safety; (3) investing in
core operations; (4) modernizing infrastructure, buildings and
facilities; (5) tobacco user fees; (6) supporting Cancer Moonshot
goals; and (7) pandemic preparedness.
enhancing food safety and nutrition
FDA's Budget requests an increase of approximately $76 million
above the fiscal year 2022 Enacted level, to support our continuing
efforts to enhance human and animal food safety and human nutrition.
Every American deserves access to safe and nutritious food, and our
foods program staff at FDA work countless hours in partnership with
federal, State, local, Tribal, and territorial partners to ensure that
our Nation's food supply is safe. To deliver on this promise, the
Budget requests funding to address health equity issues related to
access to healthy and safe food. The Budget also seeks to address the
rapid changes occurring in the way foods are produced, delivered, and
handled. We must have modern tools and technologies to ensure the
Agency's capabilities do not lag behind these sweeping changes. As a
regulatory agency, if FDA cannot keep up with industry, our oversight
will struggle to be effective. Modernization of our systems will enable
us to prevent significant harm to the public from unsafe food.
new era of smarter food safety
The Budget requests approximately $59 million, an increase of $43
million above the fiscal year 2022 Enacted level, for our New Era of
Smarter Food Safety initiatives. The goal of these initiatives is to
bend the curve of foodborne illness in this country by reducing the
number of illnesses attributed to FDA-regulated human and animal foods
and to protect consumers from other unsafe foods. This approach builds
on the modernized food safety regulatory framework created by the Food
Safety Modernization Act (FSMA), including investments in animal food
safety oversight. The requested funding would support the use of new
technologies and data analytics to strengthen prevention activities,
including the use of artificial intelligence, improve the ability of
the Agency to rapidly trace food contamination back to the source and
address the cause, and improve the efficiency and effectiveness of
FDA's oversight activities.
healthy and safe food for all
As a nation, we continue to need to improve not only the
healthfulness of food that we put into our bodies, but also the safety
of this food, including steps to reduce the presence of toxic metals
and chemicals, especially in the food consumed by our most vulnerable
and underserved citizens.
As a cardiologist, I have seen the effect of poor nutrition on the
human body, often beginning in childhood. Additionally, I am acutely
concerned with the safety and availability of infant formula as a sole
source of nutrition for many infants in our country today. To make
progress on these issues, the Budget requests an additional $33 million
above the fiscal year 2022 Enacted level across several initiatives
that would seek to improve health equity through nutrition; to
research, detect, and reduce exposure to harmful chemicals and toxins
in food; and to complete additional nutrition work specific to infants,
toddlers, and pregnant and lactating people.
advancing medical product safety
The increasing sophistication, complexity, and digitization of
medical products will benefit the public greatly, but these trends also
require more sophisticated regulation to facilitate innovation and
prevent unintended harm. In addition to our important work on food
safety and nutrition, FDA also continues to face record levels of
submissions for new medical products.
Despite the pandemic, in the last few years, the Agency has
continued to approve a record number of safe, reliable, effective, and
innovative products that will improve the length and quality of life of
patients and their families. In order to maintain this essential work
and uphold the high standards upon which Americans rely when reviewing
these products, the Budget requests an increase of approximately $95
million above the fiscal year 2022 Enacted level. These additional
funds will help address some of the Agency's highest priorities,
including post-market monitoring for the continued performance, safety,
and effectiveness of approved products and addressing public health
issues such as the opioid epidemic. The U.S. faces significant
challenges, including diseases and conditions, both rare and common,
for which there are few or no therapies, current and future medical
product shortages, and ongoing efforts to enhance patient safety.
Investments in FDA medical product programs will assist on these fronts
and ensure that FDA can continue to be an able, dynamic, and trusted
partner to patients, physicians, and other health care professionals.
cancer moonshot
FDA is committed to supporting efforts to deliver safe and
effective new therapies to patients, including through working to
advance critical disease research, including on cancer. The Budget
requests $20 million for the Oncology Center of Excellence to support
the Administration's goal of reducing cancer-based death and illness as
part of the Cancer Moonshot initiative. These elements of FDA's
contributions to the Cancer Moonshot would include the advancement of
research, external collaborations, educational outreach programs, and
programs that expedite the development of oncology and malignant
hematology products using an integrated clinical evaluation approach.
Among other activities, resources will also enable FDA to expand
efforts that facilitate approval of important cancer treatments by
international regulatory authorities at the time of FDA approval and
will foster harmonization of cancer treatments in other countries with
the U.S. standard of care.
supply chain
By the time a public health emergency is declared, it is often too
late to effectively prevent or mitigate shortages, and our goal as an
Agency and as a nation should be to proactively intervene to assure
patients and our health care providers on the front lines maintain
access to the devices they need. That is why I strongly support efforts
to fully fund the Budget's approximately $17 million request in
additional resources for the Resilient Supply Chain and Shortages
Prevention Program. Funding will complement foundational work supported
with our COVID-19 supplemental dollars and will continue to build
capabilities for a permanent program for U.S. supply chain resilience
for medical devices. This program will help ensure that U.S. patients
and the clinicians who care for them have access to the critical
devices they need and help reduce U.S. dependence on devices from other
nations, including masks, gowns, and other forms of PPE. The program
will enhance FDA's capacity to rapidly intervene to prevent and
mitigate device supply chain interruptions by developing and applying
data analytics for predictive modeling, improving early signal
detection and monitoring, and investing in preventive measures to avert
shortages. This funding will ultimately promote enhanced resiliency in
the medical device supply chain, and in addition to helping FDA be
prepared for the next pandemic, it will also allow the U.S. to be
better prepared for future events that don't rise to the level of a
public health emergency, such as during hurricanes and other natural
disasters, as well as during steady state operations.
Complimentary to our initiative on devices, FDA is also seeking
over $6 million across both the human and animal drug product areas in
order to enhance supply chain surveillance in these industries as well.
Investing in these key product areas at FDA will allow us to build both
more technologically advanced supply chain surveillance systems beyond
just devices and promote a regulatory environment that is more
responsive to notifications from stakeholders and health care
professionals, allowing for a nimbler and more responsive FDA.
cybersecurity
Further, the Budget requests approximately $5 million above the
fiscal year 2022 Enacted level to address medical device cybersecurity,
along with a request for new related authorities, as we continue to see
cybersecurity threats to medical devices increase. Cybersecurity
exploits are one of the most substantial threats faced by this nation,
and the impact could be particularly harmful for our health care
system, where vulnerabilities could compromise entire hospital systems
or disrupt manufacturing of countless devices. Funds for our device
cybersecurity initiative will be used to help address risks associated
with legacy devices, such as automated insulin pumps and implantable
cardiac pacemakers, and rapidly address new medical device
vulnerabilities.
opioids
I remain deeply concerned about the devastating impact of the
opioid crisis on families across our country. FDA's Budget includes a
requested increase of $30 million above the fiscal year 2022 Enacted
level to support the Administration's Advancing the Goal of Ending the
Opioid Crisis. FDA is taking steps to address four priority areas of
this epidemic: (1) decreasing exposure and preventing new addiction;
(2) supporting the treatment of those with opioid use disorder; (3)
fostering the development of novel pain treatment therapies; and (4)
improving enforcement and assessing benefit-risk. Among other planned
activities, these funds will address these priorities by supporting
development of opioid overdose reversal treatments and treatments for
opioid use disorder, assessing feasibility to integrate opioid Risk
Evaluation and Mitigation Strategies (REMS) education into IT health
systems/Electronic Health Records, expand current initiatives to
interdict shipments of opioids, unapproved foreign drugs, counterfeit
pharmaceuticals, and fraudulent products, and advance the development,
evaluation, and marketing authorization of digital health medical
devices that help address opioid use disorder.
investing in core operations
The Budget requests an additional $158 million above the fiscal
year 2022 Enacted level to support Agency-wide crosscutting initiatives
that support both food safety and medical product safety and are
complimentary to funding initiatives described earlier in this
testimony. While the Agency has a number of critical needs in this
area, including the ongoing need to support lab safety, address
employee pay costs, and reduce animal testing using alternative
methods, I would like to draw your attention to two especially critical
topics- data and technology modernization and inspectional activities.
data modernization and enhanced technologies
To fulfill our ongoing and evolving public health mission, FDA
requires the ability to continuously access, aggregate, visualize, and
analyze multiple sources of information. Improving FDA's data processes
and infrastructure is not only a good investment, but a necessary one
in order to keep up with today's modern regulatory landscape. These
investments are also important not just for FDA, but for our partners.
FDA shares data both internally and externally and requires the ability
to quickly and reliably extrapolate information to inform emergency
response, as well as for standard oversight activities. FDA is
requesting approximately $42 million above the fiscal year 2022 Enacted
level for Agency-wide investments in centralized data modernization.
Without additional funds to modernize our data systems, FDA will be
forced to continue to use outmoded, legacy systems that do not
integrate with more current systems, test reviewers will not be able to
reliably keep up with expected growth in product submissions over the
upcoming years, and Agency-wide efforts to leverage new data-rich
capabilities like machine learning and artificial intelligence will be
delayed. This translates into a slower and less effective FDA. We must
make these investments now to ensure the Agency remains the gold
standard for product standards and reviews.
optimizing inspectorial activities
The Budget also includes a request for an increase of $24 million
to optimize our inspections work Agency-wide. As you know, our ability
to execute our inspections was disrupted due to the evolving COVID-19
pandemic. The requested funding will help to bring our program back on
track and to improve its operational readiness. As we do this, the
requested funding would support capacity building to improve data
analysis, increase efficiency and productivity, and ultimately
streamline and optimize end-to-end inspections across both foods and
medical product areas. I am aware of this subcommittee's interest in
our inspectional work and our Budget request will help to ensure the
Agency can modernize and execute our inspectional programs effectively.
modernizing infrastructure, buildings & facilities
FDA's fiscal year 2023 Budget also requests approximately $40
million above the fiscal year 2022 Enacted level, for a total of $353
million, to ensure that FDA's offices and labs across the country are
optimally functioning to enable FDA to carry out its mission. This
funding is critically needed to complete projects that will improve the
condition of FDA's owned buildings and site infrastructure. Of the
total $40 million request, $31 million is specifically for Buildings
and Facilities, an increase of $18 million above the fiscal Year 2022
Enacted level, to improve the condition of FDA's mission-critical,
owned site infrastructure and buildings. Currently, the poor overall
condition of FDA's owned buildings and facilities, especially its labs,
directly affects FDA's ability to foster the scientific innovation
necessary to improve health care, expand access to medical products,
and advance public health goals.
tobacco user-fees
Additionally, the Budget request includes $812 million in user fees
to support FDA tobacco's program. Included within this total is an
additional $100 million in tobacco user fees and updated authorities to
include manufacturers and importers of all deemed products (i.e., to
include those not already subject to user fees such as e-cigarettes)
among the tobacco product classes for which FDA assesses user fees. FDA
is also requesting an inflation adjustment for all tobacco user fees to
ensure that the resources can keep up with the Agency's public health
mandate and with the evolving marketplace of tobacco products. Without
additional user fees, FDA will be forced to continue to spread out the
flat budget available for tobacco regulation, which has remained
stagnant for the past 3 years, limiting our ability to protect the over
2 million young people who reported using e-cigarettes and other
tobacco products in the last year.
I must also note that in addition to presenting a heavy resource
challenge, a lack of new tobacco user fees also represents a
fundamental parity issue across tobacco-related industry.
Prior to the court-ordered deadline of September 9, 2020, FDA
received timely premarket tobacco product applications for
approximately 6.7 million products. Thanks to the tireless efforts of
the over 1,100 staffers at FDA's Center for Tobacco Products, together
with the support of over 200 employees from across other parts of the
Agency, we have met this challenge and have acted on over 99 percent of
these applications thus far, and the remaining product reviews will be
completed expeditiously. However, I must emphasize that this tremendous
effort was undertaken with no additional resources--without e-cigarette
manufacturers having to pay a single cent despite their products taking
up a significant amount of our tobacco workload. I would strongly urge
this subcommittee to work with authorizers in this fiscal year to
provide the requested authority and new resources so that we may more
expeditiously and comprehensively take the actions necessary to prevent
new youth initiation of tobacco products, and to support those of all
ages who are seeking to reduce smoking of tobacco products and quit
these products.
pandemic preparedness
Finally, the Budget includes a request for $1.63 billion in new
mandatory resources over a 5-year period to implement the HHS Pandemic
Preparedness Plan. Of this total figure, the request includes $1.1
billion to expand and modernize FDA's regulatory capacity, IT, and
laboratory infrastructure in order to facilitate development and
expedite evaluation of vaccines and therapeutics that target high-
profile viral families. The request also includes $355 million to speed
development of diagnostics, as well as $175 million to strengthen
foreign inspections, harmonize premarket product reviews, and reduce
zoonotic pathogen spillover.
The funds would support biodefense preparedness, expediting overall
vaccine design, testing, and authorization capacity by bolstering FDA's
cadre of reviewers, increasing resources for inspections, and investing
in electronic information exchange among stakeholders. It would
increase the Agency's readiness to facilitate the development of new
vaccines, including those based increasingly on mRNA technology and
other rapidly modifiable or novel platforms, and enhance FDA's active
and passive vaccine safety and effectiveness surveillance programs.
This request would also support the development of a training center
for inspection of advanced medical products.
Along with these initiatives, the pandemic preparedness request
would also be used to establish a cross-agency One Health Center of
Excellence, allowing FDA to strengthen its interdisciplinary approach
to solving multifaceted health challenges, like COVID-19, where the
health of humans, animals, and their shared environment are
intrinsically linked. This effort will also build internal capacity to
address ongoing public health challenges that are exacerbated during
pandemics like the COVID-19 public health emergency, such as human and
animal food contamination, diabetes, heart disease, and cancer. The
resources requested for vaccine activities, One Health, and other
integral parts of the broader HHS Pandemic Preparedness Plan, are
critical to ensure the United States is properly prepared for the next
pandemic and to increasing our chances of preventing future pandemics.
As a nation, we cannot afford to play catch up with the next threat to
our National wellness and readiness.
conclusion
I would like to close by thanking the subcommittee again for your
continued support of the Agency, and again thank you for inviting me to
testify today. I look forward to working with you and I am happy to
answer your questions.
Senator Baldwin. Thank you, Dr. Califf. As I mentioned in
my opening statement, there was a recent Politico article that
highlighted what seems to be significant dysfunction and lack
of urgency in the food safety mission of FDA.
Dr. Califf, I would like to give you an opportunity to
respond to that article. And as Commissioner, I would like to
ask you what fundamental changes are needed in order to make
food safety more of a priority within the agency?
Mr. Califf. Well, I do appreciate the opportunity to
respond. And I want to assure you that any criticism like this
is to be taken seriously, particularly since it did involve
some former people that have worked at the FDA.
And so I have been looking at the criticism carefully, but
also was aware of concerns before coming back. The first order
of business is to assure you and the public that our food is as
safe as it has ever been. And we know much more about nutrition
now than we did 5 years ago when I was here, thanks to the good
work of the people who are at the FDA and at other Federal
agencies, not to mention the States and people involved.
And I have spent some time going to sources to verify that
this is the case. And the people who keep the data are assuring
me that this is the case. But that doesn't mean we can't do
better. And in fact, a lot of what I tried to lay out in the
opening comments was that it really is a combination of the
people involved, with their skills and talents and the
technology that will make a difference going forward.
We have a plan which is on record already before I came
back about the smarter era of food safety, which is based on
the concept that, you know, we have a rapidly growing industry
that has many, many facets, and the only way to really keep
track of it and assure safety is going to be increasingly to
use digital technologies so that we can make the best of the
human talent that we have.
And this is very much baked into our plan, but it is also
very dependent on the funding that we have asked for. In
addition to those measures, of course, we are looking at our
internal operations and it is absolutely essential that the
industries know who they--is accountable, who they are talking
with. I will have more to say about that over the next few
months, but we are intensively looking at the issue of how we
are organized.
Senator Hoeven already mentioned, there have been a large
number of Commissioners in this chair, and that is very
destabilizing for any place that you work if the bosses are
changing at such a high frequency.
So I don't want to rush into something and immediately
react to suggestions that have been made. I want to do
something that has a lasting effect so the next person in this
chair will not be feeling like they need to start from scratch.
Senator Baldwin. Dr. Califf, rebuilding public trust in the
functions of the food mission area is going to take time. This
is important for consumers and public health, but it is also
critical for industry. Farmers, food processors, and retailers
build their businesses to meet the process and ingredient
claims that FDA regulates.
These businesses need certainty so that they can focus on
their important work of providing food that consumers can
trust. A key way FDA has fallen short is the way it has handled
the use of dairy terms.
You and I have talked about this extensively before.
Despite providing clear requirements for what products must do
in order to use a dairy term on their label, FDA has failed to
enforce these labels and has stood by while a wide range of
dairy alternatives have emerged and market themselves using
dairy terms, dairy labels.
When we met prior to your confirmation, I appreciated the
commitments you made to look into this and find a resolution.
Could you share an update on where we are at?
Mr. Califf. Glad to share an update. I mean, first, just a
background, which you know well is that there are approximately
280 standards of identity. The process to deal with these is
quite cumbersome, involving rulemaking, as you know. And when
objections are raised, then a lot of additional time goes by.
But that doesn't mean that I am happy or anyone at FDA is happy
with how long it has taken to get things done.
So we do appreciate the money that has been allocated in
this year's budget and also we have asked for more going
forward to optimize this. Specifically, as you know, the milk
related issues are under consideration as we speak. So I can't
give details of exactly what is being said, but I will just
mention two.
One key principle and one finding, which is publicly known
from the public meetings that we have held, I think all of us
believe that people who buy a product should be able to
understand what is in the product and also what the value of
the product is, particularly when it comes to food in terms of
nutritional value.
And in that score, so far in the public meetings, the tenor
has been that people generally do know the difference between
plant and animal milk. They can tell that difference, but they
are not very equipped to deal with what is the nutritional
value.
And so those are just considerations from the meeting. We
are moving along quickly, and it is a priority to get this
done, so I can assure you we will get done. And I know that you
will be calling me to account for every day that it is not
done.
Senator Baldwin. Thank you. Senator Hoeven.
Senator Hoeven. Thank you, Madam Chair. Going back to
something that I mentioned in the outset and that you mentioned
as well, and that is the turnover we have had, 7 Commissioners
in 10 years. I want to acknowledge Dr. Woodcock for her work at
the Center for Drugs and also for acting as Acting Commissioner
for the past year. So I want to do that. And then, but then I
also want to follow up with you on it, Commissioner, you know,
with regard to your plans to modernize the agency.
Talk a little bit about your multi-year build out plan, and
specifically metrics and goals that you plan to use to guide
that effort, to track results, you know, set goals and
benchmarks for your team, also, again, with the idea that kind
of setting it up for the next Commissioner as well, so it is
something that continues.
Mr. Califf. Yes, I really appreciate the question. I also
want to publicly acknowledge Dr. Woodcock who graciously has
agreed to stay on. And I think this is really a critical part
of what I hope to accomplish. Neither she nor I are youngsters.
I am 70 years old. She was actually overseeing my clinical
trials when I was a young cardiologist.
Senator Hoeven. Didn't you tell me you have a student at
Duke, though? So you are a young 70 if you still got kids in
school, man?
Mr. Califf. No, no. My student at Duke graduated years ago.
Got his time on ESPN for having attended the----
Senator Hoeven. Oh, okay.
Mr. Califf [continuing]. but he is almost 40 years old now.
But I do have two 18 year old grandkids, so that--who are going
to college next year. And neither at Duke, you know, I must
say, but quite proud of them and where they are headed. Dr.
Woodcock is going to be a great asset because she knows the FDA
really well and she is going to be focused on the operations of
the FDA and the kinds of improvements that I will talk about.
I tried to get across in my opening comments, I think I
have learned a lot both in my academic, medical, clinical
practice and having worked at Alphabet. I have learned a lot
about how computers can improve the efficiency of human work,
but also make it more fun. And when we think about a job at the
FDA, you know, it is hard work, and you get criticized every
day and that is understood as part of it. And for us to attract
the best people, we have got to have really first rate
technology on that front.
But from the point of view of our ultimate customer, the
American public, given the expansiveness of the industries that
we are regulating, I mean, they are really succeeding. America
is a leader in biotechnology. We are feeding large parts of the
world and we have the capability of doing more of it if we
employ the technology that is in front of us.
So how are we going to regulate this if the FDA doesn't
have the right technology? How would you even know if it had an
algorithm in a software that is in a tractor on a farm has a
problem or not if you don't have people at the FDA with the
technology that they need in order to oversee it. And the same
would hold for the vast importation of seafood, for example,
which has been of great interest to Congress.
A majority of our seafood is imported, coming from faraway
places. We can't inspect every batch of seafood, but we have a
pilot project which we are going to expand. We are using the
same technology that Amazon or Google would use, using
algorithms and artificial intelligence. We can send the
inspectors to where the highest probability of a problem is. So
that is the kind of thing that I am talking about.
I am talking about people at FDA that have a better job
where they are aided by technology and can do a better job for
the public. And one of the great things about this is that this
will not reduce the number of people that we need because the
industries are expanding so rapidly. It is just going to mean
that they will be able to do a better job. It is not a loss of
jobs. It is really making the jobs better.
On another day, I hope we will engage in discussions about
the job of the FDA Commissioner. There is a reason that there
is a turnover that is so great. And, you know, I think it
deserves careful thought by everyone involved about how to make
this a job which maybe someone younger than age 70 would want
to take.
That is sort of one way of saying it. But I think it does
deserve some consideration the conditions of this particular
job. None of our jobs are easy. This is a particularly tough
one. I was glad to come back because I have been through it
already and I see the chance to do something for the next
generations.
But for someone in mid-career who you might want in this
job, it is really hard to take it right now the way it is.
Senator Hoeven. Well, I think that does merit discussion.
And I think that is an important point you bring up and
something we should discuss.
Mr. Califf. I mean, it is a matter of public record that
all of the living former FDA Commissioners have written about
this. And, you know, we come from a variety of political
backgrounds, having all been political appointees, but there is
a pretty common view of it among every single living FDA
Commissioner, and that is a fairly large number now.
Senator Hoeven. Right. I guess one more question, we may
have to pick it up in the next round, but advanced
manufacturing and manufacturing here. What can we do? You know,
we provide significant funding.
I think it is around almost $40 million to promote domestic
manufacturing. So there is a real concern about that now. So
maybe start with--I am already over my time. I will save that
one for the next round.
Mr. Califf. Yes, I look forward to answer on the next
round. I think is really important.
Senator Hoeven. Yes.
Senator Hyde-Smith. Thank you, Chairwoman Baldwin and
Ranking Member Hoeven for having this hearing today. And I
would also like to thank Commissioner Califf for being here to
discuss this budget with us and appreciate your efforts and
willingness to step up.
Earlier this week, we had a very good conversation together
and I really enjoyed learning about your experience in rural
Quitman County in Mississippi and helping the folks there that
are medically underserved, and that really hits home, since
Mississippi is a very rural State, that you do have that
interest.
But I look forward to finding ways to advance rural health
and to work on this issue together in your new role. One of the
other issues we spoke about on our call was the FDA's decision
to remove the in-person dispensing requirement of the chemical
abortion drug mifepristone, and how this change would expand
the distribution of products like this that can be delivered
directly to someone's mailbox, effectively permitting mail
order abortion in this country.
And in February of this year, I sent you a bicameral letter
requesting that you immediately rescind the removal of in-
person dispensing requirements for this drug. And your
response, which I did get last week, said that you had
conducted a comprehensive review of the REMS program and that
you concluded that even without the in-person dispensing
requirement, this drug would be safe and effective.
And I and many others disagree with that. There is plenty
of evidence showing this chemical abortion pill, there are
dangers to women who take them and can be extremely dangerous
in certain situations. It is the job of the FDA and your job as
Commissioner to protect patients by ensuring the safety of
drugs.
And the stronger REMS that had been in place since 2019
included safeguards to protect patients from unnecessary risks
posed by this drug. And given your belief that your review was
fully comprehensive, I will request full information on all
literature reviewed by FDA during this process and other
information related to that specific review. And I will be
following up with both the letter and questions for the record
for this hearing about the review.
So I am just asking, can you provide full and complete
information on this review to me in a timely manner?
Mr. Califf. Well, Senator, first of all, thanks for noting
the places where we will work together. And on this matter, of
course, we will be responsive to your concerns and in a timely
manner. I have great confidence in the FDA staff who did this
review, and it involved a variety of materials.
And as we also discussed, there are still a requirement for
reporting adverse events related to this, and they will
continue to look with due diligence.
Senator Hyde-Smith. And do you commit to answer all the
questions that we send you?
Mr. Califf. I will commit to being responsive to your
requests.
Senator Hyde-Smith. And additionally, you said on our call
that data showed chemical abortion numbers were going down and
you were certainly glad about that and in favor of that. But
however, data analyzed by the Charlotte Lozier Institute shows
the opposite. And chemical abortions now make up more than half
of all abortions in the United States, in this country. I did
not realize that.
And in 2019, chemical abortions jumped 11 percent in
Mississippi. And this is obviously a very serious concern of
mine from talking to OBGYN friends. And as you said, you want
to see the number of abortions going down. What are you doing
to reverse this trend of increasing chemical abortions and
actually helping to lower those numbers?
Mr. Califf. Well, just to be clear, I hope I didn't
misspeak on our phone conversation. The total number of
abortions is going down. The proportion of that total that are
chemical abortions is going up, you are correct. And I think we
all would like to see as few abortions as possible in our
future as a general goal. So I hope you didn't take it to mean
that I was saying that the chemical abortions were going down
because I didn't intend to say that. It is the total number of
abortions.
Senator Hyde-Smith. Okay. But you--obviously you are
correcting that of what we thought that it was going down and
you are stating that chemical abortions are going up.
Mr. Califf. The proportion--actually, I would have to go
back to the record to see about the total number because of the
total numbers coming down and the proportion that are chemical
are going up, I actually don't have the number in front of me
about the absolute number. I hope that makes sense to you.
Senator Hyde-Smith. Oh, yes.
Mr. Califf. Okay.
Senator Hyde-Smith. Thank you very much.
Senator Baldwin. Senator Tester.
Senator Tester. Thank you, Madam Chair and Ranking Member.
Appreciate you doing this hearing. It is good to see you in
front of the committee, Doctor. I am glad that you got
confirmed and I am glad you are here, okay.
Mr. Califf. Thank you.
Senator Tester. I just want to talk a little bit about FDA
and its role in food. I could get you some statistics on what
has been spent on medicine versus what we spend on food 30, 40,
50 years ago. You are saying to yourself, where the hell is he
going with this? And I can tell you right now we are spending a
lot more money on medicine than we ever did 50 years ago. And
quite frankly, food is a lot cheaper, which is not a bad thing.
But in the end, I ask myself things like being a farmer,
raising wheat, and having wheat being--so many people allergic
to wheat, okay. Is the staff for life really the staff for life
today? And the question is for you is not anything more than
what does FDA, what role does FDA play, if any, in our just our
general food supply and making determinations whether things
like grains reduce inflammation, and whether what we are really
eating is medicine, is going to really nourish is moving
forward.
Just curious, and I know this is from outer space coming in
at you, but I am just curious to know where your vision is for
the FDA on that, and if they want to play in that, or if they
do play in that, or if they----
Mr. Califf. Thanks for that question. And I want to relate
it to a couple of things. First, Senator Hyde-Smith brought up
rural health. And, you know, I am a cardiologist. I had a very
busy intensive care unit practice in North Carolina for many
years, and I have seen the consequences of having the wrong
diet.
My time in Quitman County, Mississippi, was dealing with
obesity and diabetes as a problem, trying to figure out how to
get electronic health records to interdigitate to do a better
job of caring for it. And I would just say we are in the midst
of it all the time. To point out one other particular thing, we
talk a lot about vaccines and drugs and PPE for the pandemic.
We have sort of forgotten about the food supply, which was
a major crisis, as you remember. And the FDA had a major role
in helping deal with the supply chain as it related to foods,
just as one example.
But on the science basis, and this is really critical to
some of the discussion going on right now, Senator Baldwin
referred to the Politico article, there is a thing at the
National Academy of Sciences, it is called a convergence, which
means because more of our knowledge is becoming digital, when
we talk about chemistry, biology, physics, agriculture, and
nutrition, it is all becoming the same underlying structure of
knowledge.
And so there is a real advantage to FDA dealing with the
kind of things that you mentioned about what is safe and
unsafe, what are the safe levels? Because across the FDA, we
have a tremendous amount of scientific expertise. And as you
know, we do have the responsibility for food labels.
That is a huge part of what affects the way Americans eat.
And then finally, you know, and a lot of this is shared with
the Department of Agriculture, as you well know. But I think we
are going to be looking, you know, regardless of what you think
is causing climate change, just look at the--you know, I lived
in San Francisco until coming back to Washington here.
Look at what the drought is look like in California right
now. We are going to have tremendous capability to feed the
world if we take advantage of the technology that is before us.
And I think the FDA is almost uniquely equipped to deal with
that because we deal with it across human health, whether it is
a drug or device, biologic or food.
Senator Tester. So, we happen to have some bills, and the
Administration has done some things on the supply chain for
food. Senator Hyde-Smith spoke eloquently two days ago on a
couple of bills that we have that deals with supply chain
issues in food. And look, in my real life, I am a farmer and I
do believe that we raise some of the safest food in the world.
The thought does cross my mind that who is kind of watching
to make sure what we are doing, because we tend to manipulate
food all the time, because we know more than we have ever known
in the history of man, that the manipulation is actually not
making a sick, that is making us healthy?
Mr. Califf. Well, Senator Baldwin referred to the metrics.
I think compared to what I saw in the industry I just worked in
Silicon Valley, the metrics and readiness of the metrics that
we have right now related to health are just not where they
need to be. And I was on a call yesterday with a Dr. Walensky
at CDC, which keeps a lot of the metrics.
We have a shared responsibility to upgrade the system
because there is no reason with our data capabilities now that
we shouldn't be able to sort of like the weather, you are used
to, you know, turning on the TV and the weather report is
saying, here is what is going to happen tomorrow, here is what
is going to happen a month from now, or here is the next 3
months.
The further out you get, the less precise you are. But we
should have that for our health, too. And in fact, I am 100
percent sure we are capable of doing it. We just have to work
with you to get the right funding and the right technology.
And last thing I would mention about that, we have to work
with the American people to build confidence that the data that
comes up is going to be used for good purpose. And I don't want
to make light of that other responsibility.
Senator Tester. Well, look, I appreciate your history and
where you have been and your knowledge, and like I said in the
beginning, I think it is great you are in this position. I
think you are the right person for this position. And I look
forward to your guidance that you can help give Congress to
make sure that we are meeting the needs of the agency, but
ultimately the people. So, thank you. Thank you.
Mr. Califf. Thank you.
Senator Baldwin. Thank you. We are going to undertake a
second round of questioning. Dr. Califf, even before the COVID-
19 pandemic, FDA did face backlogs and delays with regard to
inspections. Last year, a Baltimore facility that was
manufacturing the J&J vaccine was found to have contaminated
material in their vaccines. And a recent report cited problems
at an infant formula manufacturing site that left babies sick.
What you are doing now to ensure more rigorous inspections
are occurring? What are your plans for ramping those things up
in the future? And the budget is requesting an additional $23.8
million for increased site inspections. How will this funding
support decreasing the backlogs that we have right now?
Mr. Califf. Thanks for bringing up the chance to talk about
this. And, you know, I think it is obvious to everybody in the
midst of a pandemic, it is going to be hard to physically get
to locations. And we even have cases, as in the infant formula
case, which is in the press now, where a COVID outbreak in the
facility makes it so the inspectors sometimes can't go in.
But we are recovering now in terms of the numbers. We will
be able to provide you with exact numbers after the meeting if
you want to have them. But we are recovering. But we do need
additional funding to get more inspectors out there because
there is a backlog that is very real. What I also wanted to get
across in my opening comments and repetitively today that we
are dealing with an expanding industry, and a global industry,
and Americans like homegrown food and products, but they are
buying a lot of things that come from overseas.
So we have got to put money into technology that allow our
workforce to get more done, more intelligently using
computational and artificial intelligence so that they are
inspecting the right things at the right time.
Senator Baldwin. Yes. On that topic, you know, aside from
the physical plant inspections, tell me about the current
availability of the technology and tools that you are
describing, and how quickly those could be implemented to
supplement the physical inspections.
Mr. Califf. Well, I think the best way to say it is there
is a synergy here between the plans for the people and the way
the technology works. So just think about yourself, for better
or worse, the way you buy things now by looking at on the
Internet, there is three dimensional viewing you can do. You
can test that all out and it is all done without having to
travel and physically go to the store.
Now, some of us will wish we more often physically went to
stores nearby, but you can do that because of technology. So
then imagine an FDA inspector at a mail facility and I would
urge you to go look at this. Americans are buying all sorts of
stuff, much of which is dangerous.
And an inspector has to record tremendous amounts of data
when something is picked up because every importer has a
recourse to go to court to contest seizures and findings.
Imagine that you are having to use the technology like you were
buying stuff 15 years ago and then apply it to an inspector on
the job today. A lot of things that the inspectors would
otherwise stop are getting through because there is just not
time to do it.
And I think if we modernize the technology, they will be
much more efficient. I think Dr. Hoeven got it right. You know,
if we are synergistic, it is not linear it is more than that.
But it is an ongoing, at least a five year effort.
And if I might say so, the Federal Government in general is
not ideally suited for the kind of technology outfit that is
needed. And I think we are all going to have to work together
at HHS on this issue. I know CDC has talked on the Hill
extensively about the needs there.
Senator Baldwin. Thank you. Senator Braun, have I given you
enough time to ask your questions? Okay. Go right ahead, you
are recognized.
Senator Braun. It would seem like it, but I am prepared.
Senator Baldwin. Excellent.
Senator Braun. Thank you, Madam Chair. Good to see you
again. I think it has probably been covered somewhat, but I
know that your leadership at the FDA in 2016 and we have
discussed it before to kind of weaken the risk evaluation and
mitigation strategy protocol on the drugs used in chemical
abortions. And studies have shown that the rate of abortion
related emergency room visits after chemical abortions have
risen by about almost 500 percent.
And when we last spoke, you testified that the FDA had
filed a court document about the evaluation of the data on the
chemical abortion drug and that the reevaluation is imminent.
My question is, why has the FDA allowed these weakened
protocols for chemical abortion drugs, and are they undergoing
FDA and court review for safety and efficacy?
And a follow up would be, should REMS be strengthened to
protect women from dangerous effects from chemical abortion
drugs as well? So if you could answer those two questions, I
would appreciate it.
Mr. Califf. Yes. Senator Braun, we did cover this a little
bit earlier, but I know that you are very interested in this
and see this topic as very important. As we discussed before,
the Commissioner doesn't make decisions about individual
products.
There is a team within FDA that does that. But of course,
Commissioner gets to see the work. I have great confidence in
the team. They have thoroughly done the job and they are going
to continue to monitor as required by law.
There is a requirement to submit adverse events to the FDA
and they will continue to look. And if there is a need for a
change, I have every confidence they will do so.
Senator Braun. Well, I think as we transition to where that
looks like the modality preference, I think it needs to be paid
attention to. And it will be interesting to see if the same
standards are adhered to with that as maybe what has been done
in the past. Let's move to another subject on opioids.
The National Academies report on combating the opioid
epidemic suggested the FDA develop a new process for reviewing
the safety of all approved opioids. I understand that you were
confirmed not too long ago, obviously, but this information has
been out there since 2017. Since your confirmation, have you
reviewed the recommendations from the National Academies
report?
Mr. Califf. Yes. In fact, I am a member of the National
Academies, and I asked for that report during my tenure in
2016. So I followed it pretty carefully since I thought it was
an important component of changing the paradigm that the FDA
was working under.
And there is now a draft guidance that takes into account
one of the most important parts of that report, which is
normally the way a decision about risk and benefit for a drug
works is, is the risk and benefit to the individual to whom the
product is prescribed, but that is not adequate for opioids.
Senator Braun. So you have done a formal review of it in
addition to reading it.
Mr. Califf. Yes. And there is a--well, when you say formal
review, yes. I mean I have read it and I have thought about it,
and we have a whole team working on implementing a number of
changes.
Senator Braun. So then I guess to cut to the chase, when it
comes to any rulemaking that might change vis a vis that
report, do you anticipate that happening and when?
Mr. Califf. I think you will see over the course of the
next year or starting imminently, and you are probably familiar
with the opioid summit that happens in Atlanta that Congressman
Rogers started over a decade ago. I attended that and gave a
very detailed speech about our plans. And it is a matter of
public record, and we will make sure your staff gets it and you
can look at it.
There are a whole number of things, some of which are in
process now and some of what you will see in the next month,
and there are--I must say, there are a couple of areas where we
are probably going to come back to you if there's concurrence
within HHS and say that we need some new legal authority. Just
to give an example of one that I am particularly concerned
about that we have talked about a lot.
Right now, the FDA doesn't have legal authority when it
comes to a new drug application to require that it provide
superiority to drugs that are already on the market. The
comparator legal comparator standard is compared to placebo or
nothing.
And I think for opioids don't work like other drugs. And I
think that is something that I would like to see happen that
may require something from Congress to institute that. That is
one example.
Senator Braun. I think at the level of where the crisis
still is relative to opioids, that additional authority and
then subsequent rulemaking that tries to do more there, most of
us would expect that to happen and would be warranted.
Mr. Califf. Well, thank you. And I just want to remind you,
as we discussed, that between my two sons, we started a not for
profit in Dayton, Ohio, that dealt with everything from detox
for people that were trying to withdraw from opiates all the
way up to finding jobs and dealing with the legal system.
So I have a pretty comprehensive list. And I know Dr. Gupta
from West Virginia, who is now at Office of National Drug
Control Policy (ONDCP), just released the plan from the
Government. And we are totally in support of that, and we will
work as hard as we possibly can. And I have seen this in real
life in Ohio, and it is something we have got to deal with.
Senator Braun. So on both issues, we will be watching. It
sounds like you are willing to engage on it. And thank you for
the time today.
Mr. Califf. Thank you.
Senator Baldwin. Senator Hoeven.
Senator Hoeven. Thank you, Madam Chair. So back to the
advanced manufacturing and drugs, biological products, and
devices. You know, how do we do more to produce and manufacture
those things here at home? So, clearly something we need to do,
and people are well aware of it.
Mr. Califf. It is so essential. And I was serving on the
National Academies Supply Chain Committee until I was
nominated, and I had to drop off. Their report is now out so I
can talk about it. And I think it is useful to divide this into
several categories. And there are other reports that you have
in hand from various agencies.
Resilience of the supply chain is a critical issue. And I
think given the internationals strife right now, things that we
didn't think were possible, we now have to also potentially
anticipate. So we have got to have a resilient manufacturing
base that Americans have access to. That doesn't mean that
everything needs to be made in America because there is value
in international trade, I think, as everyone knows.
But if we get ourselves in a situation where another
country could either due to a natural disaster, or intention,
or the way markets would cut off our supply. That is a real
problem. So FDA has been working hard on this, as you know, and
we appreciate the funding that we have gotten. And a lot of
energy is being spent on upgrading our own capabilities. The
reason the FDA needs to be so involved, I see it as twofold.
You might say, why does an industry just do this? Well, the
markets don't necessarily work that way. And so there are areas
where we think we can help industry quite a bit by creating
prototypes and public, private partnerships. And the advanced
manufacturing for our messenger RNA is one example that is
pretty far along that you will see come to fruition fairly
soon.
But the other part is, as we get to the more advanced part
of advanced manufacturing, where you can, for example, make
drugs locally in a small little shop, which is, you know, going
to become possible sometime in the near term, the future of
regulating that means that we have got to be sure that we can
tell the difference when a good job is being done and not a
good job.
And so the funding is much appreciated. We got more
requests but the purpose is for exactly what you said. We think
Americans should be secure, that the essential products that
they need, whether it is food or drugs or devices, will be in
hand when the time comes using all of our capabilities and
technology.
Senator Hoeven. I think so. And I think that is an area
where, you know, we do have to put an emphasis and a focus on,
because I think the public very much wants just given what is
going on and has gone on nowadays with COVID and everything
else. Along those lines, investment in gene therapy.
You know, clearly we need to do more there. Talk about
that. I didn't see a significant request in the budget for
investment, you know, to expedite reviews for gene and cell
therapies. Clearly, though, that is an area with incredible
promise. So would you please address that?
Mr. Califf. This is something that personally, as an
intensive care unit doctor, I am very interested in and have
spent a lot of time in the rare disease communities. In my time
at Duke, colleagues developed the treatment for Pompe disease,
which used to almost uniformly lead to death of young children
and now gives some life.
So I very much want to make this work. We did get some
funding in this past year's budget due to some overlap issues.
You know, people said, well, what more do you want? And we do
appreciate the funding we have gone. But I also want to report
that in the user fee agreements, the industry recognizes that
this is an area where FDA needs more resources.
So we have, I think, reached a good agreement and the user
fees to increase the support for this area. That doesn't mean
we are not going to come back to you later or whether areas
where the user fees aren't going to cover.
And again, I think a general principle, as I work with you
all this time around, I am much more aware now of the role of
FDA and Government in places where there is not an incentive
for industry to develop things that society needs.
And I think what happened with a vaccine is like the super
example where the investment that we made early in getting all
members, Government and private, to the table made a big
difference. There are other areas, I might point to antibiotics
is another area, and some areas of gene therapy and
regenerative medicine where there is not a ready market, or no
one is sure how it is going to be paid for.
So we will be back in touch about that for sure.
Senator Hoeven. Yes. And I think it really does also
correlate into being ready to prevent the next kind of
pandemic, so we don't have what happened with COVID-19.
Mr. Califf. We will do everything in our power on that. And
I do want to call your attention there to One Health, which is
something I think this committee ought to have a particular
interest in. I have a daughter-in-law who is a veterinarian, so
I have heard a little bit about this personally also. But even
going back 15 years, Duke started a medical school in
Singapore.
And I saw firsthand what was happening with transmission of
viruses and bacteria from animals all over the world to humans
and back and forth. It is due to the fact that we all travel
these days and the international commerce. So essentially, then
my first stint at FDA, I saw the technology evolving. Now, of
course, we have whole genome sequencing so we can actually
track.
But the informatics of this and the technology involved is
far advanced over what we currently have on hand. But so we
have got an ask in about One Health to start something in the
center for Veterinary Medicine. I want to put in my pitch here.
You all are all from rural areas. So I think CBM is the most
underappreciated part of the FDA.
And typically, people only think about it when, you know,
when we had the dog food problem, a lot of people wrote in and
probably the biggest response until COVID times. But we do have
a One Health request in which is mostly oriented to how do we
create a data systems that allow us to track what is happening
around the world so that we can intervene early and prevent the
next pandemic.
Senator Baldwin. Thank you. Senator Hyde-Smith.
Mr. Califf. Thank you very much, Madam Chairwoman. I am
just going to change to another issue right now on medical
gases. More than a million patients use medical gases every day
with like oxygen playing a critical role when we were
responding to COVID-19.
And the Food and Drug Administration Safety and Innovation
Act of 2012 did an APA to issue regulations for medical gases
by July of 2016. However, no regulations had been issued to
date despite the requirement in place by law. And there is a
plant in Walnut, Mississippi--I think the population of Walnut,
Mississippi is a little over 700 people, but they produce
medical gases.
And the lack of regulations surrounding medical gases make
it very difficult for my constituents in Mississippi to produce
these lifesaving products and they have approached us with this
issue. But where does the significantly overdue rulemaking on
medical gases currently stand? And I know you are probably
going to have to get back with me on this since you wouldn't
know that immediately, I wouldn't think.
And just asking for your commitment that the FDA will
publish this rule--there is a deadline of May of 2022, right,
this right now, which was set in the fall of 2021 on the
unified agenda. And I would just like to see if you had any
responses to that and how they should be regulated rather than
continuing to be regulated as drug products.
Mr. Califf. You know. Well, thank you for the question. And
I am getting a little worried now because maybe I am so old
that I can say I have been involved in just about everything.
But in my younger days, I founded a company dealing with nitric
oxide, which is in that category.
And so I am very familiar with the issues and also an
intensive care practice we use a lot of medical gases. And we
will have to get back with you, but just about one thing, my
understanding is there was a regulation. It didn't quite go
over that well. There were other issues brought up, and we are
taking those into account now.
And my understanding is that we are on track. And it is
part of the unified agenda, so it is definitely a priority, not
just at FDA, but across the Administration. So we will get back
with you on the details. But I think I have a pretty good
understanding of the issues that are involved, and we will make
sure they are taken care of.
Senator Hyde-Smith. Great. Thank you. I appreciate that.
Senator Baldwin. We are going to do a speed third round of
questions. Okay. I think I have a couple more and ranking
member does too. So we spoke earlier about the proliferation of
synthetic nicotine products. And in the 2022 omnibus, that
loophole was closed.
We made it clear that FDA had the authority to go after bad
actors in this space to protect public health. I would love a
report on progress in this space. Dr. Califf, can you provide
an update on the FDA's efforts to address synthetic nicotine
products? How many companies have filed applications seeking
authorization? And are there additional resources that need to
be applied to this part of the mission?
Mr. Califf. Well, thanks for bringing this up. And it gives
me a chance to thank Congress for rapidly passing a law,
because just for those not familiar with the issue was, we are
regulating nicotine, but the law said tobacco and products
derived from tobacco. And of course, if you are making nicotine
in a synthetic laboratory, you can claim that it doesn't fall
under the regulation.
So that loophole was closed in a very rapid timeline, in
about a month for people to absorb it, then a month or two to
get applications in for those who wanted to go through regular
pathways that are available. And we will have to get back with
you on the exact numbers.
But by mid-May, we should pretty well have this cleared up
with those who shouldn't be on the market off of it, and or at
least getting warning letters, and those who are applying,
having their applications reviewed. I will take this moment to
point out that all of our work at the Center for Tobacco
Products has been done without user fees from the vaping
industry. So, and you are aware of, you know, 6.7 million
products.
Actually I sort of heard the number, but when I came into
the chair and they said, what we are trying to deal with 6.7
million products that is a tall order. And a lot of work has
been done, basically borrowing people's time from other funded
areas. So we have got a request in for $100 million in user
fees from the vaping industry because we still got a lot of
work to do. Two million, at least two million teenagers are
currently vaping.
Knowing what we know about nicotine addiction, and it is
safe to assume the majority of those are already seriously
addicted to nicotine. And I got to say, talking to my two 18
year old teenage grandkids, I am a little bit worried that
there is underreporting going on among the teenage population,
which would be understandable.
I think this is a big problem that we want to work on and
help with, but we have no resources dedicated to it now.
Senator Baldwin. Not to mention, my understanding is that
there is not an approved treatment for adolescents and youth as
there are for adults in this space.
Mr. Califf. Perhaps another time I would love to visit with
you. And I think a general comment I would make is that if you
look at people currently using tobacco products or addicted to
nicotine with vaping, we need a care package to help them quit.
People don't realize that the addictiveness of nicotine ranks
right up there with opioids.
Now, you know, nicotine doesn't make you stop breathing. So
there is not an acute overdose issue in general. But this is
not an easy thing to quit. And we actually, I think, could do a
better job of putting together products, including digital
technologies now that could help people trying to get off of
this addiction.
Senator Baldwin. Thank you. Senator Hoeven.
Senator Hoeven. Thanks, Madam Chair. The public health
emergency declaration in 2020 allows the FDA to issue emergency
use authorizations. But when that public health emergency
declaration expires, that doesn't mean your emergency use
authorizations necessarily expire. So how do you plan to phase
those out?
Mr. Califf. Yes. So that is a great question and one that
is sort of pressing now with the funding issue that is going
on. We need to have these products transitioned at some point.
The question of when is important. So on the drug side, this
has pretty much been, I don't want to call it straightforward,
but the same studies that were used for a EUA, as continued
with modifications, are producing the data that you would need
for a standard approval.
So I think we feel on the drug side that we are in pretty
good shape over time to phase out the EUAs and phase on the
standard approval that a company could use. On the device,
there is a definite plan in place that would involve
notification and transition. We are sort of waiting on that
time to come.
The device side, I think, you know, has many more products
because it includes, you know, all sorts of tests and things
that don't usually have the same level of study that would be
needed even for an Emergency Use Authorization (EUA), for a
drug. And so there is work to do there, but there is definitely
a plan, and we would be glad to get back to you with the
details of that plan.
Senator Hoeven. Going back to actually the question that
the chairman started with, some of the articles that have been
critical of the FDA recently in the food area as probably even
more so than on the drug side with reference to the structure
at FDA.
So as you are doing your planning here, and as we talk
about not only updating your technology, but the other things
you want to do in terms of a strategic plan, goals, metrics,
benchmarks, all those kind of things, you know, creating not
only that stability, but strengthening the agency, whether it
is the technology or anything else, both during your tenure,
but for the future, are there restructuring or structural
aspects to that that you are, you know, kind of considering in
that strategic plan, you know, that we should be aware of,
talking about, looking at?
Do you think that is going to be part of what you want to
do as you embark on this long term planning?
Mr. Califf. Again, at my age, I have worked in every
industry. I have been in, you know, health care, academic
medicine, computer industry, biotech, Government. I think there
are always are opportunities to improve structures, so I would
say everything is on the table, but I don't think the problems
that I have discussed today, that the primary problem is one of
structure.
There is some elements of structure at FDA that would be
really hard to change, like, you know, the drug device,
biologic food centers, and animal centers. They each have
constituencies and industries that they interact with and
ecosystems. And yet if you look across centers, as I have said
before, there is a common base of science and technology that
we need.
That is where I think we need to work. And I don't know if
you have looked at the latest Federal regulations on changing
structures and Government agencies, but if you have like a good
night when you want to take a, you know, go to sleep, you
should try reading it. It is a challenge though.
I don't want to wait on those structural changes to do the
things because I think in most businesses and systems I have
been in, having the right functions, having the right people
doing the right functions makes the biggest difference.
You can spend a lot of time changing a structure, and if
you don't really figure out how to get the functionality right,
you change your structure and you can write about it and talk
about it but doesn't solve the problem. But the short answer
would be everything is on the table. I don't think structural
change is a primary issue that we need to deal with.
Senator Hoeven. Okay. The reason I ask is because of your
experience, your broad experience in the medical industry, both
in the public and private sector, but also the fact that you
had a stint at FDA before.
So you are coming in, you are looking at these things,
gives you some perspective, and so I am just curious as to your
analysis of what, you know, what is going to make this agency
as effective as it can possibly be?
Mr. Califf. Yes, Senator. I mean, you are right to point
out the FDA has been criticized. In fact, you are not FDA
Commissioner if you are not waking up at 5:00 a.m. every day to
a whole list of criticisms. That was true in 2016. It is true
today.
But one of the things that made me want to come back and
that gave me great solace when I got here, is if you look at
the center directors at the FDA, they have been there a while.
They are very dedicated to their work. They keep coming to work
every day despite all the criticism.
And I know what their capabilities are. So I think there is
continuity. It is important. And I think you pointed out a
major issue we need to deal with, which is as the Commissioner
is changing every year, priorities change, and every new person
has some new things, and they don't necessarily want to be held
to the old person's way of thinking. So more continuity there,
I think, would make a big difference.
Senator Hoeven. Thank you.
ADDITIONAL COMMITTEE QUESTIONS
Senator Baldwin. Thank you. Dr. Califf, thank you so much
for being here today. I think we had a good interaction and
discussion, and I look forward to working with the FDA and
members of the committee as we start the 2023 appropriations
process this year. Questions for the record are due by next
Thursday, May 5th. And we would certainly appreciate the FDA's
responses within 30 days. And with that, this hearing is
adjourned.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Dianne Feinstein
Question. Thank you for your past leadership at FDA and continuing
to prioritize efforts on ensuring the safety of personal care products.
We spoke last week about the FDA still being woefully underequipped to
ensure the safety of personal care products that we use on a daily
basis, such as shampoo and deodorant.
What authorities and resources does the FDA need in order to
adequately protect Americans from harmful cosmetics?
Answer. FDA's regulatory authority for cosmetics, which dates to
the 1938 Food, Drug & Cosmetic (FD&C) Act, gives FDA very limited post-
market authority over cosmetic safety. In order to adequately protect
Americans from harmful cosmetics, FDA would need explicit authority to:
(1) require domestic and foreign cosmetic firms to register their
establishments and list their products with FDA; (2) require domestic
and foreign cosmetic firms to report serious and frequently occurring
adverse events to FDA; (3) promulgate and require compliance with Good
Manufacturing Practices regulations; (4) require domestic and foreign
cosmetic firms to allow FDA access to records (including consumer
complaints and safety data) during a routine or for-cause inspection;
(5) require recalls for cosmetics that pose serious risk to the public
health; and (6) require listing of known cosmetic allergens in the
ingredient list on the product label for all cosmetic products.
Additionally, FDA would need adequate funding for the increased
resources needed to modernize FDA's Cosmetic Safety Program. Such new
authority and additional funding would enable FDA to significantly
strengthen its post-market surveillance systems and better protect the
public health by helping to ensure the safety of cosmetic products and
ingredients that are in use in the United States. A legislative
proposal to this effect was offered in the fiscal Year2023 FDA
Congressional Justification.
Question. What concerns to public health has FDA documented as a
result of lacking these authorities and resources?
Answer. As part of FDA's work to protect consumers from unsafe
cosmetic products on the market, the FDA routinely monitors the market
for products and ingredients that may pose a public health risk. Over
the past 17 years there have been numerous public health issues related
to cosmetic safety that highlight FDA's limitations under current law
in regulating these products, for example:
--Asbestos Contamination of Talc-Containing Cosmetics: FDA is
continuing its efforts to have additional talc-containing
cosmetics tested for asbestos. However, the 1938 FD&C Act does
not require cosmetics establishments or manufacturers to
register their facilities or file cosmetic product ingredient
statements with FDA. Thus, the major source of information
available to FDA about cosmetics marketed in the U.S., and
their ingredients, is the Voluntary Cosmetic Registration
Program (VCRP). Because the VCRP is voluntary, it provides FDA
with only a limited picture of cosmetics that are being sold to
consumers. Furthermore, the lack of information makes it
difficult for the agency to efficiently target its limited
inspectional resources.
--Hair products (shampoo and conditioners): During an inspection FDA
became aware of more than 21,000 consumer complaints of hair
loss, including alopecia associated with one company's hair
products. Because companies are not required to show their
consumer complaint records to FDA, the company has not provided
all of these consumer complaints to FDA.
--Microbiological contamination of cosmetic products: A number of no-
rinse cleansers, wipes, washes and mouth rinses have been
recalled from the market due to potential microbiological
contamination. For example: in early 2018, a no-rinse cleansing
foam contaminated with Burkholderia cepacia caused outbreaks in
several health care facilities in six States. In 2020, a baby
wash was recalled because of potential Pseudomonas aeruginosa
contamination. These outbreaks emphasize the importance of
following appropriate good manufacturing practices to reduce
the risk of microbial contamination of cosmetic products during
processing.
--Lip products: FDA received 126 reports between August 6, 2014 and
June 12, 2017, of consumers developing rashes around the mouth
as well as blistering and cracking of the lips following the
use of certain lip products. FDA was not able to determine the
cause of the reactions because of inadequate information
provided by the company. The law does not require cosmetic
companies to list known cosmetic allergens found in fragrances
or flavors in the ingredient list on the product label or share
their safety data, or consumer complaints with FDA. In
addition, the complaints that came to FDA mostly from consumers
did not provide enough information to determine why some
consumers experienced reactions when they used these products.
These examples are just a few that highlight the challenges FDA
faces when working to protect the safety of cosmetic products in the
marketplace. With the growth and innovation in the cosmetics industry,
many new cosmetics products are being marketed to consumers in the U.S.
It will be challenging to ensure the safety of these products without
updated authorities and new resources. For example, cosmetics products
marketed as containing probiotics (i.e., live microorganisms) are found
increasingly in the cosmetic marketplace, with potential implications
for skin integrity and health, and product safety, and preservation.
Yet, there is no requirement for manufacturers to provide safety data
to FDA for such ingredients. In light of both the pace of innovation
and the growth of the industry, FDA has inadequate, incomplete, and
often outdated baseline data on marketed cosmetic products and
ingredients. FDA also has limited data on serious or frequent adverse
events associated with cosmetic products, due to the lack of mandatory
notification of adverse event reports. FDA appreciates your ongoing
support for modern cosmetic authorities and adequate resources for the
FDA Cosmetic Safety Program.
Question. In your previous tenure at FDA, you oversaw
implementation of many food safety regulations stemming from the ``Food
Safety Modernization Act.'' I certainly appreciate the strides that the
agency has made, but outbreaks of Listeria, Salmonella, and E. coli
continue to happen regularly. What steps are you taking to implement
all the authorities provided to FDA in the ``Food Safety Modernization
Act,'' including for agricultural water?
Answer. The FDA Food Safety Modernization Act (FSMA) is
revolutionizing how we regulate our food supply. Since the law's
passage in 2011, with the support of Congress we have been working
diligently to implement the landmark law and modernize our food safety
capabilities. We have published eight foundational final rules and more
than 50 draft and final guidances to help transform our Nation's food
safety system into a prevention-oriented framework. Currently, we have
teams continuing the work needed to fully implement FSMA through
additional rulemakings (such as for food traceability recordkeeping
requirements), guidance development, training, inspections, and other
implementation activities. As with any complex, scientific issue, FSMA
rulemakings have involved research, analysis of data, and, in certain
cases, engagement with the scientific community to inform decision-
making and adjustments when new science emerges. Stakeholder input also
is essential to ensure that requirements we put into place are feasible
to implement once enacted.
This is true for FDA's agricultural water requirements. FDA
originally promulgated requirements for pre-harvest, harvest, and post-
harvest agricultural water in 2015 as part of the Produce Safety Rule.
When it became apparent that some provisions were too complex and
difficult to implement, and as new science emerged as part of our
investigations of produce-related outbreaks, the Agency pursued a
rigorous and thorough process for engaging with stakeholders as FDA
considered the practical implementation of the agricultural water
requirements and how to best achieve related public health protections
for covered produce other than sprouts. FDA experts participated in
hundreds of farm visits to better understand the diversity of uses of
agriculture water, as well as listening sessions and meetings with
industry, consumer groups, academia, and regulatory partners. The
Agency believes this was time well-spent to ensure that the proposed
approach would be deeply rooted in the most current science and
protective of public health. In late 2021, these efforts culminated in
proposed new requirements for pre-harvest water for covered produce
other than sprouts that we believe would be both feasible and
effective, if finalized.
Looking ahead, FDA is committed to building on the work of FSMA
while taking a new approach to food safety that leverages technology
and other tools and approaches to create a safer and more digital,
traceable food system. This approach, which we're calling the New Era
of Smarter Food Safety, aims to bend the curve of foodborne illness in
this country by reducing the number of illnesses attributed to FDA-
regulated foods.
Question. As we have discussed previously, the creation of
appropriate regulations for the use of antibiotics in livestock must be
a priority for the FDA. For many years, I introduced the ``Preventing
Antibiotic Resistance Act,'' which would have required a medical need
before administering antibiotics to food-producing animals. I
appreciate the steps FDA has taken since 2017 to implement regulations
in line with the provisions in my bill, but I am concerned about the
potential for continued overuse of antibiotics in animals under the
carve-out for preventive use. In broiler chickens, for example, the
window FDA has allowed for administering preventive antibiotics is
longer than the chicken's lifespan. What steps are you taking to ensure
that antibiotics administered to food-producing animals have a
medically-relevant need and appropriate duration?
Answer. Establishing appropriately targeted durations of use for
medically important antimicrobials used in the feed of food-producing
animals is a priority and a component of FDA's overall effort to
support antimicrobial stewardship in animals and combat antibiotic
resistant bacteria. FDA has already initiated public comment on this
issue and is gathering the data necessary to address the issue in a
science-based manner, including through funding several ongoing
studies. Our primary objective is to get product dosage regimens
updated to better target when and for how long a medically important
antimicrobial drug may be used in the feed of food-producing animals to
provide effective therapy while minimizing drug exposure and resistance
selection pressure.
Question. Research has identified phthalates as neurotoxic
chemicals that can do lasting harm to child brain development and
increase children's risks for learning, attention, and behavioral
disorders. Phthalates have also been long known to harm reproductive
tract development in males and there is growing evidence that
reproductive problems also occur in females. In addition, recent
analysis of fast food restaurants found phthalates were detected in the
vast majority of sampled foods, demonstrating that phthalates leach
from processing equipment and packaging into food. In 2016, health and
environmental organizations petitioned FDA to ban harmful chemicals
called phthalates in food packaging and processing materials.
What actions has FDA taken since then in response to this petition?
Answer. On May 19, 2022, FDA issued a rule to amend its food
additive regulations to no longer provide for most previously-
authorized phthalates to be used as food additives because these uses
have been abandoned by industry. FDA revoked authorizations for the
food contact use of 23 phthalates and two other substances used as
plasticizers, adhesives, defoaming agents, lubricants, resins, and
slimicides. The Agency also issued a request for information about the
current specific food contact uses, use levels, dietary exposure, and
safety data for the remaining phthalates still authorized as
plasticizers for use in food contact applications.
In addition, over the last few years, FDA has analyzed numerous
samples of PVC and non-PVC fast food packaging and food contact
articles (for example, gaskets, tubing, and conveyer belts) available
on the U.S. market for the presence of phthalates. Data from these
studies were published in 2018, 2021, and 2022, and suggest that
manufacturers have been replacing phthalates as their primary
plasticizer with alternative compounds. For example, no phthalates were
detected in eight representative samples of food contact tubing that
FDA obtained and analyzed in 2021. That evidence suggests that at this
time the use of phthalates in food contact applications is limited and
consumer exposures to phthalates from food contact uses is decreasing.
Question. Does FDA have any plans to address the issue of harmful
phthalates in food packaging and other food contact materials this
year?
Answer. As mentioned above, FDA issued a request for information
about the current specific food contact uses, use levels, dietary
exposure, and safety data for the remaining phthalates still authorized
as plasticizers for use in food contact applications. The Agency may
use this information to update the dietary exposure estimates and
safety assessments for the permitted food contact uses of phthalates.
FDA also intends to continue work investigating possible sources of
phthalates in food contact applications. The Agency has recently
evaluated the effectiveness of portable devices that industry and FDA
could use to identify plasticizers, including phthalates, in PVC tubing
as part of our continued efforts to identify phthalates in food
packaging and processing materials.
______
Questions Submitted by Senator Patrick J. Leahy
Question. The COVID-19 pandemic has had a devastating effect on
opioid usage across the Nation. The Vermont Department of Health
recently reported that nearly 210 Vermonters died from opioid overdoses
in 2021, the highest number of fatal opioid overdoses the State has
ever recorded. A large contributor to the increase in overdose cases
has been the presence of fentanyl in counterfeit opioid products. The
FDA's budget includes a requested increase of $30 million above FY22 to
support the Administration's goal of ending the opioid epidemic. How
will this funding be used to combat the explosion of counterfeit
pharmaceuticals and fraudulent products?
Answer. The Agency is actively targeting illegal online sales of
unapproved and misbranded opioids, including fentanyl, through
surveillance and compliance activities. Our collaboration with the
Department of Justice has led to successful prosecution of numerous
defendants for illegal conduct involving the online sale of
prescription opioids. Unfortunately, this exemplifies the availability
of counterfeit and unapproved opioids for sale on the internet. We
continue to send warning letters to operators of websites marketing
potentially dangerous, unapproved and misbranded opioids, as well as
other controlled substances such as benzodiazepines and Schedule II
stimulants. In June 2020, FDA partnered with the National
Telecommunications and Information Administration to launch a 120-day
pilot with participating domain name registries to help reduce the
availability of unapproved opioids illegally offered for sale online.
As a result of the pilot, nearly 30 websites illegally offering opioids
for sale became inaccessible to the public. Since 2018, FDA has hosted
three Online Opioid Summits to look for innovative solutions to prevent
the illegal sale of opioids through internet platforms and services,
with the most recent held virtually in September 2021. In April 2022,
FDA and DEA issued joint warning letters to operators of two websites
illegally selling Schedule II stimulants, including amphetamine drugs
products marketed as Adderall. FDA has also recently approved research
funding for the development and deployment of new survey modules to
collect self-reported data on awareness, experiences, etc. with
falsified/counterfeit drugs.
The decision to buy opioids on the internet and through other
channels where counterfeit medications are more likely to be
encountered reflects the significant misuse and use of opioids. Some of
this use may be spurred by exposure to opioids for pain management.
Inappropriate opioid prescribing and lack of proper disposal of opioid
pain medications might contribute to the exposure. It may also reflect
undertreatment of opioid use disorder (OUD). The tragic deaths that
result from use of opioids and other drugs contaminated with fentanyl
or fentanyl analogs, might be prevented by better access to opioid
overdose reversal agents.
In addition to continued focus on counterfeit opioid products, the
$30 million increase in funding will go to address these underlying
issues, by increases in staff and targeted funding into research and
policy development in the following areas:
--Additional research to address appropriate pain management as well
as opioid and polysubstance misuse, use, and overdose. These
activities include dynamic system modeling and analysis of
real-world evidence (e.g., surveys of persons using opioids
alone and in combination with other substances).
--Supporting the development of novel treatments for opioid overdose
reversal and for OUD. These activities include modeling to
examine the role of naloxone administration paradigm on ability
to revive a person experiencing drug overdose when opioid use
is suspected (single substance and polysubstance use).
--FDA's implementation of SUPPORT Act Section 3041. These activities
include studies on opioid packaging and disposal.
--Expanding and promoting prescriber education to improve pain
management, reduce inappropriate prescribing of opioids,
advance development of evidence-based clinical practice
guidelines for acute pain, and broaden patient access to OUD
treatment.
In addition, some of the funding will be invested in our Opioid
Data Warehouse to enable FDA to use the best data and analytics in
implementing policy and identifying emerging issues that need to be
addressed.
Question. I have championed legislation to increase competition
between generic and brand name prescription drugs and to target
anticompetitive behaviors of pharmaceutical companies. Generic
alternatives saved the U.S. health care system $338 billion in 2020
alone. Despite this, many generic drug makers still report challenges
in bringing these more affordable drugs to market. This includes slow
application turnarounds from the FDA and continuing anticompetitive
actions from brand name drug companies. What does the FDA need to bring
more generic drugs to market and bolster anticompetitive enforcement?
Answer. FDA is committed to increasing competition for prescription
drug and biological products to help facilitate the entry of lower-cost
alternatives and improve patient access to affordable medicine. FDA is
working to advance the Administration's initiatives outlined in the
President's Executive Order on Competition in the American Economy to
increase competition and reduce gaming of the system, including through
FDA's Drug Competition Action Plan and Biosimilars Action Plan, and
will continue these and other efforts this year.
The President's fiscal year 2023 budget proposal also included a
legislative proposal titled ``Amend the 180-Day Exclusivity Provisions
to Encourage Timely Marketing of First Generics''. FDA is proposing to
amend sections 505(j)(5)(B)(iv) and (D)(i)-(iii) of the FD&C Act, more
commonly known as ``Hatch-Waxman'', that govern the 180-day patent
challenge exclusivity provisions to specify that FDA can approve
subsequent applications unless and until a first applicant begins
commercial marketing of the drug, at which point approval of subsequent
applications would be blocked for 180 days, ensuring that the
exclusivity period actually lasts 180 days (i.e., from the date of
first commercial marketing by a first applicant until 180 days later)
rather than multiple years as can occur under current law. In practice,
patent challenge exclusivity is not operating as expected to encourage
early generic entry, because this exclusivity is often ``parked'' by
first applicants who either receive approval but do not begin marketing
for extended periods of time following approval, or by first applicants
who delay in seeking final approval of their ANDAs for extended periods
of time. FDA believes this proposal would substantially increase the
likelihood that generic versions of patent-protected drugs will come
into the market in a timely fashion, and that multiple versions of
generic products will be approved quickly (leading to significant cost
savings).
Question. As the sale of CBD and other hemp-derived foods,
supplements and animal feeds continues to grow in the marketplace,
there is increasing concern and confusion about the safety of such
products in light of the continuing absence of FDA regulation. I
understand one of the barriers may be the FDA's earlier approval of a
drug made with CBD, even though the CBD in that product may not even be
derived from hemp. The FY23 Omnibus Bill directed FDA to establish a
policy of enforcement discretion so it could properly address these
issues?
Can such enforcement discretion be used to enable FDA to regulate
the introduction of hemp into food, dietary supplements and animal
feed, such as by distinguishing the broad range of hemp CBD products
currently in the market from the specific FDA-approved drug?
Answer. FDA understands the significant interest in this space and
is committed to addressing this issue, including ongoing work to
evaluate enforcement policy options. While the Agency encourages the
development of safe and effective therapeutics, many consumers and
stakeholders want access to more readily available products. With
respect to potentially relevant pathways outside of the drug approval
context, it should be noted that even if there were no restriction on
marketing certain drug ingredients in dietary supplements or food,
cannabidiol (CBD) and cannabis-derived products would still be subject
to the same safety requirements as apply to any other ingredient in the
products FDA regulates. The Agency knows that CBD is not a risk-free
substance, as is the case with many other compounds found in cannabis
and must carefully consider those risks. As an additional matter, we
note that any policies FDA adopts would only directly impact products
subject to our jurisdiction. There may be CBD or other cannabis-derived
products not subject to the Agency's jurisdiction.
Question. What other approaches to enforcement discretion can
enable FDA to address these issues, and by when can we expect such a
policy to be instituted?
Answer. As noted in the previous response, CBD is not a risk-free
substance and even if FDA exercised enforcement discretion for the
restrictions on using certain drug ingredients in food and dietary
supplements, the CBD products would still be subject to the same safety
standards that apply to any other ingredient in the products FDA
regulates. FDA is prioritizing the evaluation of potential options and
looks forward to discussing this further with Congress when there is
additional information to share.
Question. What additional resources, if any, does your Agency need
in order to implement a policy of enforcement discretion to effectively
address these issues?
Answer. As noted in the previous responses, CBD is not a risk-free
substance and, outside of the drug approval context, even if FDA
exercised an enforcement discretion policy for certain cases, the CBD
and cannabis-derived products would still be subject to the safety
requirements that apply to any other ingredient in the products FDA
regulates.
However, should CBD or other cannabinoids be legally permitted in
additional products, FDA would require additional resources to
effectively regulate those markets.
______
Questions Submitted by Senator Brian Schatz
Question. At-home over-the-counter antigen tests are an important
public health tool to mitigate the spread of COVID-19. These tests can
be manufactured cheaply and at-scale and should be broadly available to
all U.S. residents and visitors. While the Biden Administration has
invested billions of dollars to increase the production and
accessibility of these tests, only 18 at-home, over-the-counter antigen
tests are authorized for emergency use by the FDA, and only 5 have been
authorized so far in 2022.
What is the scientific rationale for FDA's performance requirement
for over-the-counter at-home antigen tests of a minimum sensitivity of
80 percent when it is broadly understood that there are limits to the
technology's ability to perform at lower viral loads?
Answer. On July 29, 2020, FDA posted a template for at-home
diagnostic tests, including at-home antigen tests, which include
recommendations for validating such tests, including FDA's expectation
of 80 percent sensitivity. This is much lower than the expectation of
95 percent sensitivity for lab-based molecular tests, most of which
perform at over 98 percent. FDA recognized that antigen test technology
is generally not as sensitive as PCR technology, but has several
advantages, including lack of reliance on large lab-based instruments,
rapid turnaround time, and potentially less expensive manufacturing
which can facilitate greater access to testing and faster results. We
knew that available, at-home, over the counter (OTC) tests would
supplement laboratory testing by increasing the overall amount of
testing performed and as a result identify more infections and help
mitigate the spread of the virus, bolstering our pandemic response.
Therefore, FDA accepted lower sensitivity for antigen tests to help
increase availability of tests and provide a feasible pathway for
authorization. 80 percent sensitivity is feasible as evidenced by the
19 authorized OTC at-home tests to date. We recognize, however, that a
lower bar, could result in tests missing more people, particularly
those in early stages of infection or who are about to become
infectious, and could lead to spread of disease from this false sense
of security.
FDA has also monitored evolving circumstances and growing
scientific knowledge and made adjustments when appropriate to help
streamline and expedite the path to market for these and other tests as
much as possible while assuring they are supported by sound science. In
March 2021, FDA obtained results from an NIH-sponsored study that
supported further streamlining of FDA's at-home test recommendations.
Based on these data, on March 16, 2021, FDA provided a supplemental EUA
template for test developers who are interested in a streamlined path
to authorize tests with at least 80 percent sensitivity in symptomatic
individuals, with sensitivity falling in a range as low as 70 percent
in certain circumstances, for developers to offer their test for OTC
serial screening without additional data collection. Multiple tests
were authorized under this approach within weeks.
Question. As variants and subvariants emerge, how does FDA plan to
use clinical data to ensure that the 18 approved at-home antigen tests
do not become obsolete if future variants no longer have the gene that
the test detects?
Answer. FDA uses multiple techniques to monitor the performance of
at-home tests with current and future viral mutations. First, all
Emergency Use Authorization (EUA) holders, including those for at-home
tests, are required by their letter of authorization to evaluate the
impact of SARS-CoV-2 viral mutations on their test's performance. These
evaluations must occur on an ongoing basis and must include any
additional data analysis that is requested by FDA in response to any
performance concerns the EUA holder or FDA identify during routine
evaluation. If the EUA holder's evaluation identifies viral mutations
that affect the stated expected performance of their device, they must
notify FDA immediately. As the FDA's or the developer's analysis
identifies tests whose performance could be impacted by SARS-CoV-2
viral mutations, these tests are added to FDA's SARS-CoV-2 Viral
Mutations: Impact on COVID-19 Tests \1\ webpage. This includes posting
the latest information on variants and testing implications as they
become available.
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\1\ https://www.fda.gov/medical-devices/coronavirus-covid-19-and-
medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests
---------------------------------------------------------------------------
FDA is collaborating with NIH's Variant Task Force \2\ (VTF)
program to identify and prioritize over the counter (OTC) tests for
additional testing of clinical samples on currently circulating
variants. VTF's activities ``currently comprise in silico genomic
bioanalytical testing, sample collection, and clinical in vitro lab
testing of technologies supported by the RADx program to ensure their
detection efficacy with variants entering the population matches that
of the original strain.'' \3\ FDA uses this clinical and analytical
data to determine whether and how a test's performance is impacted by
emerging variants. As part of this collaboration, the VTF and FDA use
antibody epitope mapping, a way to identify the part of the virus that
is recognized by the test, to predict reactivity of existing tests with
future variants.
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\2\ RADx Variant Task Force Program for Assessing the Impact of
Variants on SARS-CoV-2 Molecular and Antigen Tests--PMC (nih.gov)
\3\ Id.
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In addition to these pandemic specific activities, FDA leverages
its robust medical device postmarket surveillance and signal management
program. Monitoring adverse event reports and other safety signals has
enabled FDA to identify problems with tests on the market and work with
developers to correct the issue or conduct recalls as appropriate.
Question. Although COVID-19 poses less risk to children than older
Americans, infants and young children are vulnerable to
hospitalization, ICU admission, and long-term health effects of COVID-
19. The CDC found these serious consequences were exacerbated when the
Omicron variant predominated in December 2021 through February 2022.
U.S. families are concerned about their young children's health,
particularly as precautions, such as mask wearing requirements, are
easing in their communities. Parents are anxiously awaiting an approved
vaccine and there have been a series of delays to FDA's emergency use
authorization for the Pfizer-BioNTech and Moderna vaccines for children
under 6 years old. In December 2021, Pfizer-BioNTech announced data
indicating a two dose 3 mg series of its vaccine generated similar
immunogenicity for children ages 6 months to 2 years as 16- to 25-year-
olds.
Did FDA have a role in the postponement of the Pfizer-BioNTech
vaccine EUA amendment in December 2021? If so, what was behind that
decision-making?
Answer. On February 1, 2022, Pfizer announced that it had initiated
a ``rolling'' submission for an emergency use authorization (EUA) of
their COVID-19 vaccine in children 6 months through 4 years of age. In
a February 11, 2022 press release, Pfizer and BioNTech announced their
plans to extend their rolling EUA submission to FDA and to wait for
data for the three-dose series that may provide a higher level of
protection in this age group.\4\ Pfizer stated that their independent
Data Monitoring Committee (DMC) for the study supported the
continuation of the trial.
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\4\ https://www.pfizer.com/news/press-release/press-release-detail/
pfizer-and-biontech-provide-update-rolling-submission
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On February 11, FDA announced in a press release that it was
notified by Pfizer of their plans to extend their rolling EUA
submission because of the new data that had emerged in children 6
months through 4 years of age.\5\ Based on the Agency's preliminary
assessment of the totality of data from the ongoing trial that had been
provided by Pfizer at that time, we believed that additional
information regarding the ongoing evaluation of a third dose should be
considered as part of our decision-making for potential authorization.
As a result, FDA postponed the Vaccines and Related Biological Products
Advisory Committee (VRBPAC) meeting originally scheduled for February
15, 2022.
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\5\ https://www.fda.gov/news-events/press-announcements/
coronavirus-covid-19-update-fda-postpones-advisory-committee-meeting-
discuss-request-authorization
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On April 29, 2022, FDA announced that it anticipates convening its
VRBPAC to discuss the pediatric data for the Pfizer-BioNTech COVID-19
Vaccine and Moderna COVID-19 Vaccine and the requests for emergency use
authorization by the companies for pediatric populations. Since then,
FDA has publicly confirmed that on June 14, 2022, the VRBPAC will meet
in open session to discuss amending the EUA of the Moderna COVID-19
Vaccine to include the administration of the primary series to children
and adolescents 6 years through 17 years of age. On June 15, 2022, the
VRBPAC will meet in open session to discuss amending the Moderna COVID-
19 Vaccine EUA to include the administration of the primary series to
individuals 6 months through 5 years of age, and also to discuss
amending the Pfizer-BioNTech COVID-19 Vaccine EUA to include the
administration of the primary series to individuals 6 months through 4
years of age.
Having safe and effective COVID-19 vaccines available for children
is a priority for FDA. The Agency understands the urgency to authorize
a vaccine for age groups who are not currently eligible for vaccination
and is working diligently to complete our evaluation of the data.
Following a transparent public dialogue with our VRBPAC, the Agency
will only authorize COVID-19 vaccines for children that meet our
scientific and regulatory standards and for which the known and
potential benefits outweigh the known and potential risks.
Question. Why did FDA postpone its February 2022 Vaccines and
Related Biological Products Advisory Committee meeting instead of using
this forum to review data on Pfizer-BioNTech's two dose vaccine series
for children ages 6 months to 2 years?
Answer. See response above.
Question. I am very concerned about youth use of e-cigarettes.
According to the most recent State-level data (2019), 30 percent of
high school students in Hawaii use e-cigarettes. Despite a court order
setting a timeframe for FDA to complete required premarket reviews of
e-cigarettes, an alarming variety of youth-appealing flavored e-
cigarette products are still available online and in stores. FDA should
fully use its regulatory authority to prevent manufacturers from making
and selling tobacco products that are enormously appealing to kids.
When does the FDA anticipate completing its required premarket
review process and will it use this process to remove from the market
all e-cigarettes that are likely to attract young people, such as
flavored e-cigarettes?
Answer. FDA received premarket tobacco product application (PMTA)
submissions for about 6.7 million products by the court-ordered
September 9, 2020, deadline and we have taken action on over 99 percent
of those total applications. There are three major phases of PMTA
review--acceptance review, filing review, and then scientific review.
If an application fails to satisfy regulatory and/or statutory
requirements at any of these stages, FDA issues a negative action, such
as a Refuse to Accept Letter, a Refuse to File Letter, or a Marketing
Denial Order (MDO). If an application provides scientific data that
demonstrates permitting the marketing of a product is appropriate for
the protection of the public health, FDA issues a Marketing Granted
Order (MGO).
To date, FDA has made significant progress and has taken action on
over 99 percent of the applications submitted by September 9, 2020. FDA
has:
--Refused to accept applications for over 200,000 products
--Refused to file applications for over 5 million products
--Issued MDOs for more than 1 million flavored electronic nicotine
delivery systems (ENDS)
--Issued MGOs for 23 ENDS products (for devices and tobacco-flavored
products)
Reviewing this volume of applications is unprecedented for the
Agency, and we remain focused on completing our review of the remaining
product applications. FDA allocated significant resources to review
applications from the five companies whose brands represented over 95
percent of the e-cigarette market because FDA believes these products
would have the greatest chance, either positively or negatively, of
impacting public health due to their market share- Fontem (myblu),
JUUL, Logic, NJOY, and R.J. Reynolds (Vuse). FDA has issued decisions
on many of these products, including:
--JUUL Labs Inc. (JUUL device and JUULpods) on June 23, 2022
--NJOY LLC (NJOY Daily) on June 10, 2022
--R.J. Reynolds Vapor Company (Vuse Ciro and Vuse Vibe) on May 12,
2022
--NJOY LLC (NJOY Ace) on April 26, 2022
--Fontem, US, LLC (myblu) on April 8, 2022
--Logic Technology Development, LLC (Logic Vapeleaf, Logic Pro, and
Logic Power) on March 24, 2022
--R.J. Reynolds Vapor Company (Vuse Solo) on October 12, 2021
Question. How many e-cigarettes remain on the market despite having
failed to file a premarket application or having received a marketing
order denial?
Answer. Products for which no application is pending, including,
for example, those for which no application was submitted, are among
our highest enforcement priorities. From January 2021 through April
2022, FDA issued warning letters to 240 firms that collectively have
more than 17 million unauthorized electronic nicotine delivery system
(ENDS) products listed with the FDA and that had not submitted
premarket applications for these products by the September 9, 2020
deadline.
Additionally, any products subject to a negative decision may not
be introduced or delivered for introduction into interstate commerce.
Any products receiving a negative decision that are already on the
market must be removed from the market or risk enforcement. To date,
FDA has issued warning letters to more than 115 firms for continuing to
unlawfully market ENDS products that are the subject of marketing
denial orders (MDOs), Refuse to File (RTF) letters, or Refuse to Accept
(RTA) letters.
Many firms comply after receiving a warning letter. FDA typically
confirms the firm's corrective action by subsequent inspection and
surveillance. If a firm continues to violate the law, investigators
collect evidence and depending on the facts in the case, enforcement
action, such as an injunction or seizure, may be pursued.
Question. Given the risk of flavored e-cigarettes to youth, why
does the FDA allow manufacturers to continue to sell their products
while the agency is reviewing their applications?
Answer. All new tobacco products on the market without the
statutorily required premarket authorization are marketed unlawfully
and are subject to enforcement by FDA. FDA will continue to make
enforcement decisions on a case-by-case basis according to our
enforcement priorities and the individual circumstances.
The Agency works closely with the Department of Justice (DOJ),
without whose support neither injunctive actions nor seizures can be
taken. FDA consults the DOJ regularly with respect to potential
enforcement actions, including in relation to unauthorized tobacco
products that are the subject of pending applications.
Question. Is FDA evaluating menthol flavored e-cigarettes under the
same criteria used in evaluating other flavors of e-cigarettes?
Answer. Under Section 910(c)(4) of the Federal Food, Drug, and
Cosmetic Act, FDA reviews all premarket tobacco product applications to
determine if the marketing of the new product would be appropriate for
the protection of the public health (APPH). In doing so, the statute
requires FDA to consider the risks and benefits to the population as a
whole, including both tobacco users and nonusers, taking into account
the increased or decreased likelihood that existing users of tobacco
products will stop using such products and the increased or decreased
likelihood that those who do not use tobacco products will start using
such products. In making the APPH assessment for an electronic nicotine
delivery system (ENDS) product, FDA weighs, among other things, the
negative public health impact stemming from youth initiation and use of
the product against the potential positive public health impact
stemming from adult cigarette smokers transitioning away from
combustible cigarettes to the ENDS product. ENDS product flavors are an
important consideration in ascertaining the health risks of these
products because of a flavor's potential impact on appeal to youth and
young adults, consumer perceptions, and product toxicity.
Question. Menthol cigarettes and flavored cigars mask the harshness
and soothe irritation caused by tobacco smoke, which makes it easier
for beginners, particularly youth, to experiment and become addicted to
these products. Menthol cigarettes are the only flavored cigarette left
on the market and remain popular, particularly among Black communities
targeted by the tobacco industry. I applaud the FDA's recent
rulemakings prohibiting menthol cigarettes and flavored cigars. Is it
still FDA's view that enforcement of the menthol cigarette and flavored
cigar prohibitions would ``only address manufacturers, distributors,
wholesalers, importers, and retailers'' not individual consumers who
possess or use these products?
Answer. Yes. If these proposed rules are finalized and implemented,
FDA enforcement will address only manufacturers, distributors,
wholesalers, importers, and retailers who manufacture, distribute, or
sell such products within the U.S. that are not in compliance with
applicable requirements. This regulation does not include a prohibition
on individual consumer possession or use, and FDA cannot and will not
enforce against individual consumers for possession or use of menthol
cigarettes or flavored cigars. FDA notes that State and local law
enforcement agencies do not independently enforce the Federal Food,
Drug and Cosmetic Act. These entities do not and cannot enforce against
any violation of the act or this regulation on FDA's behalf.
Question. In recent years, interest in research on psychedelics has
increased rapidly, including in the development of new medicines.
What is the current status of FDA's efforts to work collaboratively
with NIH to identify research needs that would serve all medicine
developers in the field of psychedelic research for therapeutic
purposes?
Answer. The Agency has long worked with NIH and supports its
efforts to investigate the use of psychedelic drugs to treat mental
health conditions. Most recently, in January 2022, we worked with NIH
to conduct a joint 2-day workshop focusing on psychedelics and
entactogens as therapeutics for serious mental illness and substance
use, with participation from NIH, FDA, NIDA, and NIAAA. There were
roughly 4,500 participants from all continents (except Antarctica) and
presenters from academia, government, and industry. The workshop was
divided in three parts: the first part of the workshop focused on basic
and translational research, the second part on the results of recent
clinical trials and lessons learned, and the third part focused on
overcoming challenges and considering the consequences of real-world
use.
We also note that in fiscal year 2022, FDA designated psychedelics
as a research area of interest through our Broad Agency Announcement
mechanism. Specifically, the Agency stated in the announcement that we
intend to ``Improve scientific understanding of psychedelics: Develop
methods and carry out studies to better understand the trajectory of
psychedelics use and associated public health consequences.'' \6\
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\6\ Food and Drug Administration Broad Agency Announcement for the
Advanced Research and Develop//ment of Regulatory Science (Page19)
https://sam.gov/api/prod/opps/v3/opportunities/resources/files/
47c7fd2ac6374a70acf8579beb81cbdf/download?&token=
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Question. Please provide a list of Investigational New Drug
applications for psychedelics on which FDA is currently engaged with
medicine developers.
Answer. Consistent with Federal statutes and FDA's implementing
regulations concerning the confidentiality of commercial information,
and to protect the integrity of the review process, FDA generally
cannot disclose information about an unapproved application or an
investigational new drug application, including the status of the
Agency's review of a particular drug product \7\. Therefore, the Agency
is unable to provide updates about specific pending applications,
including whether a specific application has been filed. We suggest
reaching out to the company directly for information about a specific
development program because they can choose to disclose information
about their product development, including any interactions with the
FDA. Another possible source of information would be the website
www.ClinicalTrials.gov.
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\7\ Relevant law includes the Trade Secrets Act (18 U.S.C. 1905),
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 33l(j)), (21 U.S.C.
360bbb-3(h)), and FDA regulations (21 CFR 20.61(c); 21 CFR 312.130(b);
21 CFR 314.430(c) and (d)(l)).
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Questions Submitted by Senator Martin Heinrich
Question. Colorectal cancer is the third leading cause of cancer-
related deaths in men and women in the United States. According to the
American Cancer Society, it was expected to cause roughly 53,000 deaths
in 2021. That's why I introduced the Colorectal Cancer Detection Act,
which would increase access to blood-based screening tests. Can you
share the importance of the FDA evaluating and approving blood based
screening tests, for early cancer and disease detection especially for
rural and Tribal communities, and even when there are other albeit more
invasive methods of detection?
Answer. FDA believes that marketing authorization of a well-
validated, blood-based screening test for early cancer detection will
benefit these communities, as it will increase accessibility and
compliance to screening, due to the less invasive nature of this type
of testing. However, the test should be well-validated, and have
acceptable performance characteristics, so as to minimize the number of
individuals receiving false negative or false positive results, which
can lead to failure to provide appropriate treatment or unnecessary
follow-up testing, with its own attendant risks, due to the need to
confirm the presence or absence of cancer with invasive procedures. FDA
review and authorization of an analytically and clinically validated
test with favorable benefit/risk assessments and transparent
performance is very important for public health and to ensure that
patients and their physicians are informed of the strengths and
weaknesses of different testing options.
An advantage of blood-based testing is the opportunity to expand
the number of individuals who undergo colon cancer screening because
stool-based testing procedures have limited adherence. Approximately 20
percent of eligible individuals aged 50 to 75 years have never been
screened for colon cancer, and half are inadequately screened.\8\
Blood-based cancer screening has the potential to offer a convenient
testing option, which is expected to improve compliance with early
detection, when treatment may be curative.
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\8\ Richardson, Lisa et al 2022. Adults who have never been
screened for colorectal cancer, behavioral risk factor surveillance
System, 2012 and 2020. https://www.cdc.gov/pcd/issues/2022/22_0001.htm
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In 2016, FDA approved the first blood-based screening test for
colon cancer.\9\ The test (Epi proColon) relies on qualitative
detection of DNA in the blood stream from colorectal cancer (CRC) cells
and represents an advancement in cancer screening technologies. The
indications for use for Epi proColon places this test as second line
(ordered only after other CRC screening tests recommended by the U.S.
Preventive Services Task Force (USPSTF) have been offered and rejected
by the patient). This is because the sensitivity and specificity of the
test is lower than stool-based methods. The benefit of the test was
that patients may be more compliant with blood-based CRC screening
methods compared to stool-based methods. At this time, blood-based
testing is not recommended by the USPSTF, due to the limited evidence
supporting its use.
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\9\ Food and Drug Administration Summary of Safety and
Effectiveness Premarket Approval submission number P130001
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Question. Over 30 years, the FDA's accelerated approval pathway has
had important successes, particularly with oncology treatments, which
have approval around 3.4 years earlier than with the traditional FDA
approval. Many patients suffering from neurological conditions and
serious rare diseases are wondering if this success can extend to their
own, or their loved one's condition. Can the accelerated approval
pathway be optimized for treatments to neurological disorders and rare
diseases?
Answer. FDA has several programs intended to facilitate and
expedite the development, review, and approval of products intended to
address unmet medical need in the treatment of serious conditions,
including: Fast Track, Breakthrough Therapy Designation, Regenerative
Medicine Advanced Therapy Designation, Accelerated Approval, and
Priority Review. Drugs granted accelerated approval or developed under
any of the expedited programs must meet the same statutory standards
for safety and effectiveness as those granted traditional approval.
While traditional approval is based on a showing of a drug's clinical
benefit to patients, accelerated approval is based on a different study
endpoint: most commonly, the drug's effect on a surrogate endpoint that
is reasonably likely to predict a clinical benefit to patients.
Consequently, drugs approved under accelerated approval are required to
conduct a post-approval trial to verify that the drug provides the
expected clinical benefit.
Accelerated approval and other expedited programs for the
development, review, and approval of drugs and biologics are a critical
part of addressing unmet medical needs related to neurological
disorders and rare diseases. Through these approaches, FDA can speed
the availability of drugs that treat serious diseases benefits patients
and their families, while ensuring that rigorous standards for safety
and effectiveness are met. This is especially true when the drugs are
the first available treatment which is often the case for rare
diseases. We are committed to ensuring the continued availability,
transparency, and advancement of these programs to deliver drugs and
biologics that meet FDA's gold standard to patients with rare diseases.
Question. Over the last 2+ years, we have seen that vaccines are
the best way to protect ourselves from COVID-19. That is why I led a
letter to Acting Commissioner Woodcock advocating for the FDA to work
as quickly as science allowed to authorize safe and effective COVID-19
vaccines for children 5-11. I know the FDA is working diligently to
evaluate vaccines for children under 5, but my constituents in New
Mexico are eager to vaccinate their kids as soon as possible. Can you
share an update on the FDA's timeline to evaluate and approve vaccines
for kids under 5? Can also you share any insight about how the roll out
of vaccines for children under 5 may differ from the rollout for ages 5
to 11 and 12 to 17?
Answer. Having safe and effective COVID-19 vaccines available for
children is a priority for FDA. The Agency ensures that the data
support a vaccine's safety and effectiveness, and a favorable benefit-
risk balance, in any pediatric population before authorizing for
emergency use or approving a COVID-19 vaccine for use in that
population. As with other regulatory and scientific decisions about
COVID-19 vaccines that we have made during this pandemic, we will
thoroughly evaluate the data on the use of COVID-19 vaccines in
pediatric populations. Our multi-disciplinary teams of doctors,
scientists, statisticians, and other experts will thoroughly assess the
data when making any determination about the use of COVID-19 vaccines
in pediatric populations.
FDA has been working closely with vaccine manufacturers to provide
advice as data accrue about safety and effectiveness of the vaccines.
FDA is convening its Vaccines and Related Biological Products Advisory
Committee (VRBPAC) meetings to discuss amending the Moderna and Pfizer-
BioNTech emergency use authorizations (EUAs) for their COVID-19
vaccines to include younger populations. Specifically, on June 14,
2022, the VRBPAC will meet in open session to discuss amending the EUA
of the Moderna COVID-19 Vaccine to include the administration of the
primary series to children and adolescents 6 years through 17 years of
age. On June 15, 2022, the VRBPAC will meet in open session to discuss
amending the Moderna COVID-19 Vaccine EUA to include the administration
of the primary series to individuals 6 months through 5 years of age,
and also to discuss amending the Pfizer-BioNTech COVID-19 Vaccine EUA
to include the administration of the primary series to individuals 6
months through 4 years of age.
The agency understands the urgency to authorize a safe and
effective vaccine for age groups who are not currently eligible for
vaccination and is working diligently to complete our evaluation of the
data. Following a transparent public dialogue with our VRBPAC, the
agency will only authorize COVID-19 vaccines for children if the Agency
finds that the evidence shows the vaccines meet our scientific and
regulatory standards and the Agency finds that the known and potential
benefits outweigh the known and potential risks. After a vaccine
receives authorization, vaccine distribution and prioritization is
coordinated by HHS and CDC.
______
Questions Submitted by Senator John Hoeven
Question. Breakthrough and expedited approval pathways allow FDA
efficient development opportunities for treatments of diseases and
conditions that have few or no therapeutic options. Drug repurposing
could be a viable option to meet unmet medical needs, if approval
pathway qualifying criteria specifically included drug repurposing use
cases. An example of this could be allowing preliminary clinical
evidence from real-world data sources such as off-label use in clinical
settings. Another could be creating pathways for accelerated or
priority review of labeling supplements of previously approved FDA
products that have demonstrated a clinical benefit for rare/infectious
disease populations. Does FDA plan to use existing funding under your
current operating budget or the requested funding for FY 23 to specify,
update, or create expedited or accelerate approval pathway(s) such as
drug repurposing to maximize the value of FDA regulated products for
all populations, especially those with rare conditions or special
populations?
Answer. The Agency agrees that data on how approved drugs are being
repurposed may inform the development of new clinical uses for these
drugs as potential treatments for diseases and conditions that have few
or no therapeutic options. FDA has and will continue to consider fit-
for-purpose real-world data in regulatory decisions relating to the use
of repurposed drugs, including utilizing such data when appropriate
under our expedited programs for drugs and biologics to treat serious
conditions. These programs have been and will continue to be utilized
to advance consideration of repurposed drugs.
The agency has also devoted significant resources to exploring the
use of repurposed drugs for diseases or conditions with unmet medical
needs. In December 2019 the agency launched the CURE ID repository (a
website and mobile application) globally, and rapidly expanded it in
June of 2020 to respond to the COVID-19 pandemic.\10\ The repository
captures clinical outcomes from the clinical community when drugs are
used for new conditions, in new populations, in new doses or in new
combinations. Health care professionals generally may choose to
prescribe or use a legally marketed human drug or medical device for an
unapproved or uncleared use when they judge that the unapproved use is
medically appropriate for an individual patient. The systematic
collection of real-world experience in the CURE ID platform can help
identify drug candidates for additional study, encourage further drug
development and serve as a resource for physicians to share information
where no FDA-approved product proven to be safe and effective exists
for the new use. Repurposing approved drugs for new clinical uses can
potentially offer an efficient drug-development pathway for treatments
of diseases and conditions that have few or no therapeutic options.
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\10\ https://www.fda.gov/drugs/science-and-research-drugs/cure-id-
app-lets-clinicians-report-novel-uses-existing-drugs
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In June of 2020, the agency also announced the creation of a
public-private partnership (PPP), convened by the Critical Path
Institute, called the CURE Drug Repurposing Collaboratory (CDRC) and
provided funding to initiate this effort. The Agency plans to continue
our work with the CDRC, which has since received additional support
from HHS. Additionally, the Agency has continued to work with National
Institutes of Health (NIH), the Reagan Udall Foundation,\11\ and the
Critical Path (C-Path) Institute \12\ to explore avenues to advance
research and policy regarding existing therapeutics.
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\11\ https://www.fda.gov/drugs/news-events-human-drugs/repurposing-
patent-drugs-research-regulatory-challenges-12052019-12062019
\12\ https://c-path.org/programs/cdrc/
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The agency believes that the existing expedited programs for drug
development and the agency's ability to leverage these programs when
approved drugs show promise with rare diseases are sufficiently
flexible and robust to address public health needs, including with
respect to repurposing, or expanding the approved uses of, approved
drugs. The agency is committed to utilizing these programs when
appropriate to expedite development of repurposed drugs, including
drugs repurposed for rare diseases. The Agency will also continue
working with sponsors pursuing repurposing opportunities for areas of
unmet medical need. The FDA instituted its Accelerated Approval Program
to allow for earlier approval of drugs that treat serious conditions,
and that fill an unmet medical need, based on a surrogate endpoint
reasonably likely to predict benefit. Validated surrogate endpoints can
be used for traditional approvals. A surrogate endpoint is a marker,
such as a laboratory measurement, radiographic image, physical sign or
other measure that is thought to predict clinical benefit, but is not
itself a measure of clinical benefit. The use of a surrogate endpoint
can considerably shorten the time required prior to receiving FDA
approval.
While the agency believes the current accelerated approval pathway,
enhanced by the agency's other expedited programs, provide an
appropriate means for expanding the approved uses of approved drugs,
the President's budget includes a legislative proposal titled
``Ensuring Feasibility and Timeliness of Confirmatory Studies and
Enhancing Withdrawal Procedures for Prescription Drugs Approved through
Accelerated Approval''. This proposal seeks to amend the accelerated
approval provisions of the FD&C Act to (1) revise section 506(c)(2)(A)
of the FD&C Act such that FDA may require, as a condition of a drug
product application's acceptance for filing, or as a condition of a
drug product's receipt of accelerated approval, that a drug sponsor
must first demonstrate that a proposed post-approval (i.e.,
confirmatory) study is adequately designed to verify and describe
clinical benefit and can be completed in a timely manner; (2) revise
section 506(c)(3) so that FDA can follow its dispute resolution
procedures for drug applications when withdrawing a drug product's
accelerated approval; and (3) revise the withdrawal standard at FD&C
Act 506(c)(3)(C) so that it mirrors the analogous withdrawal standard
set forth in section 505(e) for drugs with traditional approvals. The
FD&C Act does not provide FDA with easily implementable legal
authorities to help target the problem of studies that progress too
slowly. FDA believes that such a provision would help provide greater
assurance at the time of a drug product's accelerated approval that the
confirmatory study can progress in a timely manner, and reap high-
quality, interpretable results. Enhancing the timeliness and quality of
confirmatory studies will help support FDA's regulatory decision-making
for drugs approved through the accelerated approval pathway and
minimize the time that a product is marketed based on accelerated
approval before its clinical benefit can be confirmed.
Question. It is important to ensure that those who require
compounded hormone therapies are able to access them in a safe manner.
As FDA reviews recommendations from the National Academies of Sciences,
Engineering, and Medicine's report on the Clinical Utility of
Compounded Hormones, will you commit to work with, and be responsive
to, all relevant stakeholders as part of FDA's review of the report and
its recommendations?
Answer. This is an issue the Agency takes seriously. As you know,
to help inform the public and FDA's policies regarding compounded
bioidentical hormone replacement therapy (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
---------------------------------------------------------------------------
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. When developing Agency policies, FDA intends
to consider the information in the NASEM report, along with information
and comments received from members of the public, while taking into
account patient access concerns.
Question. We understand that FDA expects to issue revised long-term
sodium reduction targets in the next few years. How will FDA ensure
these targets are scientifically-based and achievable, while at the
same time taking into account the need to preserve consumer choice?
Answer. FDA is committed to voluntary sodium reduction efforts, and
providing consumers with the education and resources needed to choose
lower-sodium foods will be important to reducing risk for negative
health outcomes like hypertension and cardiovascular disease. Reducing
sodium intake has the potential to prevent hundreds of thousands of
premature deaths and illnesses in the coming years. FDA is focusing its
work with industry on meeting the short-term goals. Any longer-term
voluntary sodium reduction targets would be science-based and
achievable, and would provide an opportunity for public input and
stakeholder engagement, in keeping with the Agency's mission and
established procedures.
Question. At the urging of Congress, FDA published final guidance
on mitigation of bacteria in blood platelets, which took effect in
October of 2021. This guidance suggested multiple options to address
the problem of bacterial contamination in platelets, which due to their
nature must be stored at room temperature. In December, FDA issued a
notice stating that one bacterial mitigation method in particular has
been implicated in recent cases of sepsis and two patient deaths. The
FDA also said it is investigating more cases. Can you provide me with a
status update of the investigation?
Answer. FDA shares the goal of enhancing the safety of the blood
supply through controlling the risk of bacterial contamination of
platelets. With respect to the cases of septic transfusion reactions,
as explained in our April 2019 and December 2021 safety communications,
FDA continues to investigate cases of septic reactions and bacterial
contamination where additional genetic testing indicated a potential
common source, and which involved various bacterial risk mitigation
approaches. To facilitate further investigation, FDA encourages blood
establishments and transfusion services to contact FDA when they
identify suspected contamination of platelets with the implicated
organisms, or suspected septic transfusion reactions involving
pathogen-reduced platelet components.
Regarding cases of septic transfusion reactions which involved
certain bacterial species, further genetic testing by CDC indicates a
high probability that the organisms are related. Although genetic
testing conducted by the CDC indicated these organisms may have a
common source, no such source has been identified to date. As part of
our ongoing investigation, CDC and FDA maintain regular communication
and coordination. This also includes interactions with blood collectors
and device manufacturers. We continue to monitor and investigate any
reports where the implicated organisms are identified either by
bacterial testing or during investigation of clinical reactions.
Question. Is FDA seeing instances of health care systems limiting
consumer choice by providing patients with only one bacterial
mitigation methodology? If so, do you believe this is concerning?
Answer. Hospitals generally make the decisions on what blood
components they would prefer to use for their patients, and these
decisions may depend on what their blood collector can provide. FDA has
been contacted by a few health care providers regarding the bacterial
mitigation strategies implemented by their blood suppliers. However,
patients are not usually offered choices of different types of blood
components, and we are not aware that recipients of platelets have
expressed concern. FDA is aware of the unique operational and inventory
challenges in various hospital settings; consequently, our
recommendations present blood collection establishments and transfusion
services multiple options for complying with FDA's regulations that
require blood establishments to reduce the risk of bacterial
contamination of platelets.
FDA works with blood establishments and transfusion services
equally to implement FDA's requirements, based on the options they
choose. While we recognize that blood suppliers make business decisions
that may affect their hospital customers, such negotiations or
contractual relationships fall outside the statutory provisions and
regulations that we enforce.
Question. The FDA determines whether drugs are safe and effective,
and is the gold standard in science-based, rigorous drug review. Are
you familiar with a National Coverage Determination (NCD) recently
finalized by the Centers for Medicare and Medicaid Services related to
an Alzheimer's disease drug approved by FDA under the accelerated
approval process? Are you concerned that this NCD appears to establish
new requirements for FDA-approved drugs, and if so, could this
undermine FDA's gold standard? Do you believe this could cause
companies who are seeking accelerated approval to reconsider moving
forward with their applications?
Answer. The agency is committed to using expedited programs to
bring medicines to underserved populations with serious conditions and
unmet medical need when the science supports the decision within the
statutory authorities given to FDA by Congress. Our decision regarding
Aduhelm exemplifies that commitment. It is important to distinguish
between FDA's and CMS' role. The standard for Medicare coverage is not
the same as the standards for FDA approval of a drug. Our role is to
determine if drug is safe and effective for its intended use. The
agency cannot speak for CMS. We continue to see sponsors pursue
accelerated approval.
______
Questions Submitted by Senator Mitch McConnell
Question. In 2021, FDA stated to my office that FDA was continuing
to accept ingredients listed in the Office Publication (OP) of the
Association of American Feed Control Officials (AAFCO) for use in
animal food, as long as no safety issue arises. FDA stated that ``at
this time no approved animal food additive petitions, or ingredients
definitions listed in the AAFCO OP, for any substances derived from
hemp, and FDA is unaware of any generally recognized as safe (GRAS)
conclusions regarding the use of any substances derived from hemp in
animal food.'' FDA stated the Agency is continuing to encourage
stakeholders to develop the necessary data and submit GRAS notices,
food additive petitions, or AAFCO ingredient definitions for hemp-
derived animal food ingredients that do not contain CBD. FDA stated the
Agency has no plans to issue guidance on this topic at the time (2021),
but that FDA has been actively engaged with the industry and researches
on the data needed to access the correct safety measures for hemp-
derived animal feed. As FDA continues to study the safety measures,
what is the timeline for issuing guidance the FDA may offer about using
hemp grain as an additive for livestock feed?
Answer. At this time, FDA does not have plans to issue guidance
about hemp grain in particular, but has referred interested parties to
other available guidance on the animal food review process (GFI 221:
Recommendations for Preparation and Submission of Animal Food Additive
Petitions and GFI 262: Pre-Submission Consultation Process for Animal
Food Additive Petitions or Generally Recognized as Safe (GRAS)
Notices). FDA continues to actively engage with the hemp industry
regarding data needed to demonstrate the safety of these ingredients
for animal food. As announced publicly by the submitter, the Agency is
currently reviewing the first submission for hemp-derived ingredients
for use in animal food.
Question. In 2020 and 2021, Congress provided FDA with increases
totaling $7 million for additional research and work on CBD. FDA's
March 2020 report to Congress on potential regulatory pathways included
a number of key questions FDA wanted to address including the effects
of daily use, comparing different methods of exposure, effects on
children and others.
Despite this Congressional priority, there is no further clarity
for the CBD market today than there was in 2018. It has been more than
3 years since passage of the Farm Bill that legalized hemp. President
Biden's 2023 FDA budget notes that the agency is continuing to research
CBD, but provides no details on movement and no additional funding is
requested.
How has FDA allocated the appropriations funding from Congress, and
how have these steps advanced FDA's plans to regulate CBD?
Answer. FDA appreciates the funding Congress has provided since
fiscal Year2020 to support the Agency's efforts on cannabis and
cannabis derivatives. Of the $7 million appropriated for these efforts,
FDA has allocated funding to the Center for Food Safety and Applied
Nutrition ($3 million), the Office of Regulatory Affairs ($2 million),
the Center for Veterinary Medicine ($1 million), and FDA headquarters
($1 million). These resources are being used for a variety of purposes,
including to support additional FTE in several programs to support the
work in this quickly expanding area.
Funds have also supported efforts including:
--Several ongoing toxicology studies with CBD, including an in vitro
evaluation of male reproductive toxicity of CBD and its main
metabolites, developmental neurotoxicity of CBD in rats, immune
modulating effects of perinatal exposure to CBD in rats, and
multiple studies on CBD pharmacokinetics
--A large-scale product sampling and testing study targeting
approximately 1400 samples to test for toxic elements,
pesticides, residual solvents, microbes, and 11 cannabinoids
--Monitoring and analyzing adverse event data from multiple sources
--Partnering with external groups to obtain market, consumer, and
safety data
--Ongoing monitoring of scientific literature
--Issuance of warning letters to firms marketing products that pose
particular public health concerns, including products with
unsubstantiated claims for treating serious diseases, including
cancer, ALS, and COVID-19; products marketed towards children;
products marketed for use in food producing animals; and
products with concerning routes of administration (e.g.
ophthalmic).
Question. FDA's March 2020 report to Congress identified six
additional next steps FDA would undertake while evaluating potential
pathways to market CBD. These included establishing Enforcement policy,
gathering additional safety information, further engagement with
Federal, State, Local, Territorial, Tribal, and International Partners,
further evaluation of ``Full Spectrum'' and ``Broad Spectrum'' hemp
extracts, additional research, and product sampling. What actions has
FDA taken to implement these six steps? What does FDA plan to continue
doing in each of these six areas?
Answer. FDA has undertaken a number of actions to implement the
steps outlined in the report issued in response to the Further
Consolidated Appropriations Act of 2020. Specifically, the Agency has
initiated the following:
--Gathering additional research and safety information, including the
evaluation of ``Full Spectrum'' and ``Broad Spectrum'' hemp
extracts and product sampling: FDA participated in a Health
Canada study to establish a consistent, validated, analytical
method for the quantitation of hemp and cannabinoids broadly in
a variety of products. Additionally, the Agency has four
ongoing method development and chemical profiling projects and
seven in vitro testing projects, all working with hemp extracts
provided by the FDA Center of Excellence, National Center for
Natural Product Research. FDA is also finalizing the results of
a long-term sampling study, which collected and tested nearly
1,400 products (including tinctures/oils, capsules, gummies,
drinks, food, pet products, and cosmetics) from both internet
purchases and brick and mortar locations. FDA anticipates this
report being finalized in Fall 2022. A second year of the study
is being initiated and will focus on further sampling of pet
products and an additional evaluation of variability within and
between products.
--Engagement with Federal, State, Local, Territorial, Tribal, and
International Partners: According to the National Conference of
State Legislatures, as of February 3, 2022, 37 States, four
territories and the District of Columbia allow the medical use
of cannabis products; and as of May 27, 2022, 19 States, two
territories and the District of Columbia have enacted measures
to regulate cannabis for adult non-medical use. It is estimated
that nearly 1 in 3 Americans now lives in a State where adult-
use is legal. However, each State legislates, regulates, and
operates its cannabis programs differently. FDA has fielded
inquiries from nearly every State and territory, and from a
number of Tribal governments. In addition, we engage with these
important stakeholders in many ways, including:
--speaking with several States' cannabis regulatory agencies and
departments of health to learn more about their regulatory
cannabis programs and adverse event reporting systems;
--encouraging States to submit adverse event reports to FDA through
the MedWatch Program;
--holding discussions and panels with state cannabis regulators and
state associations;
--encouraging stakeholder feedback to our draft guidances regarding
drug products containing cannabis or cannabis-derived
compounds;
--talking with States and encouraging them to share information so
FDA can learn more about their approaches and requirements,
as well as any challenges they may be facing, related to
quality considerations for cannabis and cannabis-derived
compounds within their systems; and
--interacting with States' Attorneys General.
--Enforcement Policy: The Agency understands the significant interest
in this space and is prioritizing the evaluation of potential
enforcement policy options. FDA looks forward to discussing
this further when there is additional information to share.
Question. Can you provide an update on the activities laid out in
the FDA Fall 2021 Data Acceleration Plan?
Answer. FDA has undertaken a number of activities to meet the goals
laid out in the Data Acceleration Plan. Some safety vigilance
activities include performing comprehensive evaluations of existing FDA
safety surveillance and epidemiologic databases, such as the FDA
Adverse Event Reporting System and the American Association of Poison
Control Centers National Poison Data System; funding a pilot project to
explore the utility of media reports and social media (i.e., Reddit)
for the identification of new safety signals with cannabis-derived
products (CDPs); developing custom based surveys to obtain data related
to CDP utilization and associated adverse events; and exploring the
capabilities of different electronic health record (EHR) data sources
to capture exposure information and for safety signal detection. As a
result of data obtained through some of these activities, FDA has taken
a number of actions related to safety of CDPs, such as issuing a
consumer update for delta-8 THC \14\ and issuing a safety alert for
edible products containing THC and the potential for accidental
pediatric exposures.\15\
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\14\ https://www.fda.gov/consumers/consumer-updates/5-things-know-
about-delta-8-tetrahydrocannabinol-delta-8-thc
\15\ https://www.fda.gov/food/alerts-advisories-safety-information/
fda-warns-consumers-about-accidental-ingestion-children-food-products-
containing-thc
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Question. Please provide a review of what information has been
collected by FDA to determine the parameters for safety.
Answer. During review of the marketing application for the CBD-
based drug Epidiolex, FDA identified certain safety risks, including
the potential for liver injury and for adverse reactions caused by the
interaction between Epidiolex and other medications. FDA has reviewed
published literature to assess the safety of the use of CBD in human
food. FDA identified potential for liver injury from CBD and
potentially harmful interactions with certain drugs, and studies in
animals have shown that CBD can interfere with the development and
function of testes and sperm, decrease testosterone levels, and impair
sexual behavior in males.
In order to better understand potential effects of CBD, as stated
above, FDA is investigating potential CBD interference with
testosterone production and underlying mechanisms of toxicity. The
results of this study align with other studies indicating that CBD
might have negative effects on the male reproductive system. The first
results from this study have been published. Other ongoing FDA studies
include investigation of developmental neurotoxicity of CBD in rats, a
study of immune modulating effects of perinatal exposure to CBD in
rats, and multiple studies on CBD pharmacokinetics.
Other data collection efforts are ongoing including a large-scale
product sampling and testing study targeting approximately 1400 samples
to test for toxic elements, pesticides, residual solvents, microbes,
and 11 cannabinoids, monitoring and analyzing adverse event data from
multiple sources, and partnering with external groups to obtain market,
consumer, and safety data.
Question. Does FDA ever expect to issue a proposed rule? If not,
why not and what barriers continue to exist?
Answer. Over the past several years, the Agency has worked to
collect data about the effects of CBD in animals and humans, including
potential adverse effects. Based on the information FDA currently has
obtained, the appropriate regulatory pathway is still uncertain. FDA is
prioritizing the evaluation of potential options and looks forward to
discussing this further with Congress when there is additional
information to share.
______
Questions Submitted by Senator Roy Blunt
Question. The accelerated approval pathway has been successful in
ensuring patient access to new medications, and has been especially
effective for patients with cancer. Previously, you have recognized the
benefits of the pathway, while also looking for additional ways to
confirm clinical benefit for the drugs approved under accelerated
approval. As part your approval process, you noted that you would
reform the agency's accelerated approval pathway? What reforms do you
see implementing? Are you committed to continuing the accelerated
approval pathway?
Answer. The President's budget includes a legislative proposal
titled ``Ensuring Feasibility and Timeliness of Confirmatory Studies
and Enhancing Withdrawal Procedures for Prescription Drugs Approved
through Accelerated Approval''. This proposal seeks to amend the
accelerated approval provisions of the FD&C Act to (1) revise section
506(c)(2)(A) of the FD&C Act such that FDA may require, as a condition
of a drug product application's acceptance for filing, or as a
condition of a drug product's receipt of accelerated approval, that a
drug sponsor must first demonstrate that a proposed post-approval
(i.e., confirmatory) study is adequately designed to verify and
describe clinical benefit and can be completed in a timely manner; (2)
revise section 506(c)(3) so that FDA can follow its dispute resolution
procedures for drug applications when withdrawing a drug product's
accelerated approval; and (3) revise the withdrawal standard at FD&C
Act 506(c)(3)(C) so that it mirrors the analogous withdrawal standard
set forth in section 505(e) for drugs with traditional approvals. The
FD&C Act does not provide FDA with easily implementable legal
authorities to help target the problem of studies that progress too
slowly. FDA believes that such a provision would help provide greater
assurance at the time of a drug product's accelerated approval that the
confirmatory study can progress in a timely manner, and reap high-
quality, interpretable results. Enhancing the timeliness and quality of
confirmatory studies will help support FDA's regulatory decision-making
for drugs approved through the accelerated approval pathway and
minimize the time that a product is marketed based on accelerated
approval before its clinical benefit can be confirmed.
Question. Dr. Califf, there has been concern from several different
companies about FDA review, and how long the process to get clearance
from the agency. We have heard from constituent companies, including
Avadel Therapeutics, with concern how long the timeline has stretched.
Can you share how the agency is prioritizing review of drugs?
Answer. Earlier this year the Agency released our PDUFA \16\, BsUFA
\17\ and GDUFA \18\ annual performance reports. In these reports the
agency delineates the previous year's performance on various user fee
goals, including review timelines, within the three programs. Despite
an increased workload, FDA has maintained a high level of performance
in meeting PDUFA, BsUFA, and GDUFA goals and initiatives.
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\16\ https://www.fda.gov/media/156077/download
\17\ https://www.fda.gov/media/155870/download
\18\ https://www.fda.gov/media/155760/download
---------------------------------------------------------------------------
In PDUFA, FDA agreed to specific goals for improving the drug
review time and created a two-tiered system of review times--Standard
Review and Priority Review. A Priority Review designation means FDA's
goal is to take action on an application within 6 months (compared to
10 months under standard review).
A Priority Review designation will direct overall attention and
resources to the evaluation of applications for drugs that, if
approved, would be significant improvements in the safety or
effectiveness of the treatment, diagnosis, or prevention of serious
conditions when compared to standard applications.
Significant improvement may be demonstrated by the following
examples:
--evidence of increased effectiveness in treatment, prevention, or
diagnosis of condition;
--elimination or substantial reduction of a treatment-limiting drug
reaction;
--documented enhancement of patient compliance that is expected to
lead to an improvement in serious outcomes; or
--evidence of safety and effectiveness in a new subpopulation.
While the agency cannot speak to any specific product due to
commercially confidential information, we encourage the company to
reach out to the relevant review division for more information on their
specific product.
Question. How has COVID-19 contributed to this issue, and would you
agree that there is a backlog of drugs that have not been reviewed?
Answer. The continuing COVID-19 epidemic has certainly made for
unique circumstances in the agency. For PDUFA in fiscal Year 2021,
despite the sustained high workload, the increased use of expedited
programs, and the development and review of new therapeutics and
vaccines to address the public health emergency, FDA rose to the
challenge and maintained its high level of performance in meeting PDUFA
goals and initiatives. As noted in the PDUFA Performance Report for
fiscal Year 2021, FDA completed 2,055 actions as of September 30, 2021.
FDA is currently meeting or exceeding 9 of the 12 review performance
goals for fiscal Year2021. With 1,466 submissions under review and
still within the PDUFA goal date, FDA has the potential to meet or
exceed 10 of the 12 review performance goals for fiscal Year 2021.
Question. Does this issue extend to other product reviews, such as
devices?
Answer. Review times for tests and other device Emergency Use
Authorization (EUA) requests have increased over time as the number of
EUA and Pre-EUA submissions quickly surged to unprecedented levels
during the COVID-19 pandemic. Since January 2020, FDA has received over
8,000 EUA requests and Pre-EUA submissions for devices (including over
1,000 so far in Fiscal Year 2022). The Agency continues to receive
nearly 120 device EUA requests and pre-EUA submissions each month, the
majority for tests, and has begun receiving conventional submissions
from firms intending to transition their products beyond emergency use.
In order to address high submission levels of device EUA requests,
FDA has implemented important measures to reduce review times. These
steps include:
--Temporarily reassigning staff to increase review capacity;
--Leveraging contractors from outside organizations to provide
technical expertise to supplement our review staff (personnel
authorized to work alongside full-time employees, integrated
into our internal review teams);
--Using supplemental funds from Congress to hire 30 new, temporary
staff to support review of EUAs;
--Implementing a triage process for new EUA requests; and
--Working to efficiently use resources for low-impact and poor-
quality submissions, including expanding the use of holds when
important data is missing, and instituting a process to
prioritize submissions where our resources should be focused
(namely, on those submissions that would have the greatest
impact on public health).
Additionally, as a result of the unprecedented number of EUA
requests and pre-EUA submissions that FDA received for COVID-19 tests
and collection kits, we have not been able to review some non-COVID in
vitro diagnostic (IVD) pre-submissions. To address this issue, FDA's
IVD office has focused on increasing staffing to address the increased
volume of work, allowing us to provide more resources to our
conventional premarket workload. We are pleased to announce that, as of
June 1, 2022, FDA plans to accept all non-COVID IVD pre-submissions.
Due to the continued elevated workload related to COVID-19, it is
likely that these IVD pre-submissions will initially be reviewed under
an extended timeline.
FDA looks forward to our continued interactions with device
submission sponsors and appreciates their patience and understanding as
we work to return to normal operations while continuing to respond to
the public health emergency. The commitment that FDA and the medical
device industry share to prioritize innovation and increase patient
access is central to our mission to protect and promote the public
health. This commitment is exemplified by the recommendations for the
reauthorization of Medical Device User Fee Amendments for Fiscal Years
2023-2027 (MDUFA V) in the commitment letter, which has been submitted
to Congress. The recommendations in the MDUFA V commitment letter are
intended to increase efficiency of regulatory processes and reduce the
time it takes to bring safe and effective medical devices to the U.S.
market.
______
Questions Submitted by Senator Jerry Moran
Question. The Drug Quality and Security Act of 2013 (DQSA) includes
strong protections intended to promote patient safety and to strengthen
the integrity of the FDA drug approval process. The Agency has said it
will clarify its position on DQSA's prohibition on compounding drugs
that are ``essentially a copy of an approved drug'' when using FDA-
approved drugs as the starting material. When will the Agency provide
this clarity? Does the Agency intend to ensure that the use of FDA-
approved drugs as a starting point, and that a change in a container
closure system (eg, a transition from vial to a syringe), would not
fall within the meaning of the essentially a copy prohibition? This
lack of regulatory clarity has led to numerous, very costly lawsuits
that are driving up the price of compounded medications and resulting
in a shortage of ready-to-administer drugs. As a result, patients are
encountering increased barriers inhibiting their access to essential
medications.
Answer. Since the enactment of the Drug Quality and Security Act,
FDA has made significant progress on clarifying the Agency's policies
on compounding drugs that are ``essentially a copy of an approved
drug,'' taking into consideration real world implications as well as
comments and concerns expressed by the public. The questions and
comments regarding compounding raise complex issues requiring extensive
review by Agency officials, and efforts have been made to provide the
Agency's thinking. Most recently, on January 1, 2018, FDA issued a
final guidance for industry, ``Compounded Drug Products That Are
Essentially Copies of Approved Drug Products Under Section 503B of the
Federal Food, Drug, and Cosmetic Act,'' that aimed to provide further
clarity on the Agency's policies. The Agency has since received further
questions and comments related to its policies for applying the
``essentially a copy'' provision, including questions regarding when
outsourcing facilities compound drugs starting with an approved drug
rather than a bulk drug substance. While we cannot provide a specific
timeline, FDA understands that these questions are important to
stakeholders and is currently working diligently to address them,
including addressing these issues in an updated guidance.
Question. The Agency announced earlier this year that it will
undertake notice-and-comment rulemaking related to the Memorandum of
Understanding (MOU) between the FDA and States that regulates the
number of compounded therapies distributed across state lines. As the
Agency drafts this proposal, it's important to ensure that patients
have unfettered access to the compounded medications they need to live.
A recent version of the MOU issued by the FDA included dispensed
(patient specific prescriptions) within the definition of distribution
which would limit the distribution of compounded preparations shipped
across state lines to 50 percent of all prescriptions each month for
States signing the MOU. Although many compounding pharmacies do not
exceed this threshold, low-volume pharmacies located near state borders
who will be disproportionately and adversely impacted. This means
patients who receive their compounded therapies from out of state may
have to find a new pharmacy to provide their medicines at the end of
each month. This is unacceptable. One way to fix this patient access
problem is to exclude the number of drugs dispensed to specific
patients, pursuant to a prescription, from the total number of drugs
pharmacies distribute across state lines. Will the revised MOU proposal
do this?
Answer. As you noted, in February 2022, the Agency publicly stated
that FDA intends to undertake notice-and-comment rulemaking related to
statutory provisions regarding certain distributions of compounded
human drug products and a standard memorandum of understanding (MOU)
between FDA and States. The standard MOU is an agreement that is
intended to address interstate distribution of inordinate amounts of
compounded drugs and complaint investigation by a State regulator
relating to compounded drugs distributed outside the state. Federal law
limits distribution of compounded drugs outside the state by a
pharmacist, pharmacy, or physician located in a State that has not
entered into the MOU to 5 percent of total prescription orders
dispensed or distributed. An essential element of FDA's rulemaking
process is a public comment period, which provides an important
opportunity for stakeholder engagement. We wish to also note that under
the most recently published MOU (which is now suspended) States signing
the MOU would have agreed to report, among other things, information
about compounders who have distributed interstate more than the 50
percent threshold described. We would like to emphasize that this
reporting threshold would not have placed any limit on the distribution
of compounded drugs interstate by a pharmacy located in a State that
entered into the MOU.
Question. I have been outspoken about shortages in our Nation's
blood supply, which is of great concern to patients and hospitals in
Kansas. I recently became aware of some actions by blood centers which
may restrict hospital choice when it comes to blood platelets intended
for transfusion and further exacerbate shortages of this particular
blood product. I am specifically referring to FDA's guidance addressing
the mitigation of bacterial contamination in blood platelets, which
became effective in October of 2021. This guidance to industry suggests
up to three clinically equivalent mitigation strategies for blood
platelets. Yet some major blood centers are forcing hospitals to
purchase blood platelets prepared with only one of the options which I
understand is not only the most expensive option, but is also
associated with a shorter product shelf-life than the other options
resulting in more wastage. Importantly, this option has been linked to
multiple cases of sepsis and fatalities per an FDA bulletin in December
of 2021. FDA stated in this bulletin that it is investigating even more
cases. This is of concern to me, from a hospital choice, cost, and
patient safety perspective--what steps will FDA take to ensure that
hospital choice is preserved and blood shortages are minimized?
Answer. FDA guidance addressing the mitigation of bacterial
contamination in platelets presents blood collection establishments and
transfusion services multiple options for complying with FDA's
regulations to reduce the risk of bacterial contamination of platelets.
FDA will continue to monitor the safety and availability of the blood
supply and the effectiveness of the strategies recommended for
controlling the risk of bacterial contamination of platelets, included
in the December 2020 guidance. While we recognize that blood suppliers
make business decisions that may affect their hospital customers, such
negotiations or contractual relationships fall outside the statutory
provisions and regulations that we enforce.
With respect to the cases of septic transfusion reactions, as
explained in April 2019 and December 2021 safety communications, FDA
continues to investigate cases of septic reactions and bacterial
contamination where additional genetic testing indicated a potential
common source, and which involved various bacterial risk mitigation
approaches. To facilitate further investigation, FDA encourages blood
establishments and transfusion services to contact FDA when they
identify suspected contamination of platelets with the implicated
organisms, or suspected septic transfusion reactions involving
pathogen-reduced platelet components.
Question. As you know, the law Congress approved is clear that OTC
hearing devices are intended only for those over the age of 18 with
``perceived mild-to-moderate hearing loss.'' However, the proposed rule
allows OTC devices to be amplified up to 120 decibels (dB) without
imposing any hearing gain limit. This threshold allows those with
hearing loss greater than the intended mild-to-moderate level to access
OTC hearing devices. This hurts consumers and patients in two ways.
First, it means individuals suffering from greater levels of hearing
loss could put off a needed visit with a licensed hearing professional.
Doing so could lead to worsening their existing symptoms, delaying an
accurate diagnosis and treatment, and even creating irreparable damage
to their hearing. Secondly, it means those with perceived mild-to-
moderate hearing loss would be exposed to harmful levels of noise that
could result in further damage to their long-term hearing. In order to
avoid these concerns, FDA should impose a gain limit of 25 dB and an
overall output limit of 110 dB.
Ninety-one stakeholders ranging from patient advocacy organizations
to trusted hearing providers submitted formal comments to the FDA
expressing concern that the proposed 120 dB maximum output limit and
omission of a gain requirement will put patient safety at risk. These
stakeholders include University of Kansas Medical Center, the American
Academy of Otolaryngology--Head and Neck Surgery, American Society on
Aging, the American Speech-Language-Hearing Association, the American
Academy of Audiology, and more.
The Kansas Board of Hearing Aid Examiners expressed the following
concerns with the proposed rule:
``We concede that a lower output limit of 110 dB SPL may be
suboptimal for enjoyment of some live music, but we feel that
this is a worthy trade-off to mitigate the risk of noise-
induced auditory damage from the hearing aid. The FDA proposed
rule suggests that consumers can remove a hearing aid within 30
to 60 seconds following onset of loud acoustic events. This may
be true for many but we are concerned that vulnerable
populations, such as those with cognitive and/or physical
limitations, may be unable to remove the hearing aids quickly
enough to avoid acoustic trauma.''
Dr. Califf, I think you would agree it is important to protect
consumers. Can you tell me what is being done to ensure OTC hearing
aids will not cause greater hearing loss for individuals?
Answer. FDA appreciates the feedback you have provided with respect
to the proposed rule, Medical Devices; Ear, Nose, and Throat Devices;
Establishing Over-the-Counter Hearing Aids, and for sharing your
concerns about the output limits proposed for over-the-counter hearing
aids, as well as the views of stakeholders who express similar concerns
based upon their professional judgment. As you know, section 709(b)(2)
of the FDA Reauthorization Act of 2017 (Public Law 115-52) directs FDA
to establish or adopt output limits appropriate for over-the-counter
hearing aids as well as other requirements that provide reasonable
assurance of the safety and effectiveness of the devices.
FDA is currently reviewing and considering the comments submitted
to the docket. Many of them cited quantitative methods to develop an
output limit they believe is appropriate to over-the-counter hearing
aids. Further, as you noted, many such comments suggested that FDA
establish a limit on gain, separate from and additional to the
appropriate output limit. Conversely, several current hearing aid users
provided comments describing the benefits they personally receive at
specific (quantified) amplification levels. People with expertise in
electronics and sound amplification similarly added to our knowledge of
real-world performance. In sum, while many professionals back a lower
output limit, many other professionals-some of them hearing aid users
themselves-voiced support for FDA's proposed output limit.
All of these perspectives addressed a nexus of complex medical and
scientific issues, the real-world effects for hearing aid users, and
protecting and promoting the public health. To determine appropriate
output and, potentially, a gain limit, FDA continues to engage with the
comments addressing the scientific literature, patient perspectives,
institutional knowledge (e.g., adverse event reports), and expertise of
other agencies, including the National Institutes of Health. Our
scientific deliberations are ongoing.
As we finalize the requirements, we are keeping in mind concerns
about users who might delay a productive visit with a hearing health
care provider and users who might be exposed to harmful amplification
levels from over-the-counter hearing aids. These concerns are some of
the most important considerations for the safety and effectiveness of
over-the-counter hearing aids and carry over into additional
requirements (e.g., labeling, electroacoustic performance, design
features, and conditions for sale).
FDA remains committed to establishing a science-based regulatory
category for over-the-counter hearing aids that provides reasonable
assurance of safety and effectiveness while promoting access to devices
that will help address a significant public health need.
Question. New innovations in plant breeding techniques, such as
genome editing, will be crucial to sustainably increase agricultural
production and enhance food and nutritional security. Clear FDA policy
for food derived from genome editing improved varieties is critical if
we are to expand the diversity and availability of food.
FDA's biotechnology consultative process for food derived from
biotech plant variety is over 25 years old. In the last several years,
there has been observable decline in the predictability and timeliness
of the process. The ability of our farmers to remain competitive
globally depends on timely access to the newest and best varieties.
How do you plan to expediate modernization of the FDA process so it
doesn't become an unnecessary hurdle to innovation, especially from
small and medium sized public and private enterprises?
Answer. FDA agrees that innovation in plant breeding techniques is
important for the future of agriculture and that the voluntary
consultation process can take longer than it has in the past. Some of
this is due to the complexity of products entering FDA's program. For
example, the Agency recently completed voluntary consultations on two
separate products that contained 8 and 13 new genes. There are also
many new, smaller companies engaging with the Agency, and it requires
greater staff time to walk them through the voluntary consultation
process.
FDA is taking steps to help address the timeliness concern. For
example, the Agency is beginning to strengthen the Center for Food
Safety and Applied Nutrition's Biotechnology Team to help address the
new, complex and innovative products coming through the door, and has
improved the process work-flow for the consultation process. FDA also
intends to update its guidance on voluntary consultation procedures,
last updated in 1997, to reflect what it has learned over the past 25
years.
FDA is also in the process of developing draft guidance for
industry regarding foods from genome edited plant varieties. Issuing
this draft guidance is a priority. FDA has already taken several steps
to help inform our drafting process, including issuing a request for
information in January 2017. The Agency has reviewed the comments and
has been following (and participating in) the international
conversation around these techniques while developing the draft
guidance. While this draft guidance is under development, FDA is
actively working with developers of genome edited plants. Many of these
firms are small and medium sized entities that benefit from FDA's
iterative voluntary consultation process to help them understand their
legal responsibilities as they bring safe and innovative products to
market.
Question. FDA, CVM holds the regulatory authority for gene-edited
(GE) farm animals and is currently exercising their regulatory
authority using the proposed GFI #187 that seeks to treat the genetic
application like a new animal drug. Does FDA intend to publish their
finalized version of GFI #187 within the next year to give increased
clarity to their future regulatory process for GE animals and is the
agency considering how their final guidance could support the MOU
signed with USDA, APHIS in January 2021 for shared regulatory authority
for GE farm animals?
Answer. FDA's regulation of intentional genomic alterations (IGAs)
in animals is focused on ensuring that the IGAs are safe to animals,
safe to consumers, and accomplish what their developer claims they will
accomplish. FDA regulates them under the Federal Food, Drug, and
Cosmetic Act and FDA's existing regulations. GFI #187, as with all FDA
guidance documents, represented the FDA's current thinking on a
particular subject. While guidance documents are not binding on the
public or FDA, they are an important way to communicate FDA's
recommendations to developers of FDA-regulated products.
FDA first issued GFI #187 in 2009 and issued a draft revised
version in 2017. In response to stakeholder concerns, FDA has now
significantly revised GFI #187 including splitting it into two parts.
The resulting guidances are currently under OMB review. The need to
publish GFI #187 to provide greater clarity to stakeholders and the
public is independent of the HHS-signed MOU, which is currently not in
effect.
FDA is making continuous improvements to its regulatory oversight
to ensure a transparent, flexible and science-based approach to
efficiently get safe products to market. One such improvement is FDA's
implementation of additional risk-based flexibilities as demonstrated
by FDA's recent low risk determination for the marketing of food and
other products from genome edited SLICK cattle.
FDA supports both FDA and USDA utilization of their respective
expertise under existing authorities to help provide regulatory
certainty to the animal biotechnology industry. It is critical to
continue progress in this field so that developers of innovative
biotechnology products have the information they need to bring
beneficial products to market without further delay.
Question. FDA, CVM has recently engaged in stakeholder meetings,
facilitated by the Reagan-Udall Foundation, to discuss public-private
partnerships for antimicrobial use data collection for food-producing
animals. Will the agency pursue any antimicrobial use data collection
process purely on a voluntary basis or are there plans by the agency
for mandatory antimicrobial use data collection and reporting for food-
producing animals in the near future?
Answer. Section 105 of the Animal Drug User Fee Amendments of 2008
(ADUFA) amended section 512 of the Federal Food, Drug, and Cosmetic Act
(FFDCA) to require antimicrobial drug sponsors to annually report to
FDA the amount of antimicrobial active ingredient in their drugs that
have been sold or distributed for use in food-producing animals. There
is no parallel statutory requirement for producer and veterinary
practitioner reporting of antimicrobial use data. Although sales and
distribution data are useful, antimicrobial use data would better
inform FDA and other interested stakeholders about how antimicrobial
drugs are being used, enhance understanding about the drivers of
antimicrobial resistance, and help to identify use practices
opportunities that reflect good stewardship of antimicrobials.
Given the importance of this information, FDA has pursued
strategies for collecting antimicrobial use data, including funding
several cooperative agreements with researchers to develop pilot data
collection methodologies. The initial findings from these pilot
projects were published in a series of papers in Zoonoses and Public
Health \19\ in November 2020. The agency hopes to gain additional
insight into the feasibility of establishing a voluntary data
collection system from a report drafted by the Reagan-Udall Foundation
(the Foundation) for the Food and Drug Administration. The report,
entitled Exploring the Potential for a Public-Private Partnership to
Support the Tracking and Monitoring of Antimicrobial Use in Food-
Producing Animals \20\, summarizes key findings from a series of
targeted conversations with stakeholders from animal agriculture,
veterinary, and public health organizations, along with other key
representatives. The objective is to determine the feasibility of
establishing a voluntary public-private partnership to collect and
analyze data on antimicrobial use in food-producing animals. FDA has
opened a docket through August 21, 2022 to receive public comment on
the report and the Foundation plans to host a public meeting on June
14, 2022, to share insights from the report and to allow for questions
from the public.
---------------------------------------------------------------------------
\19\ https://onlinelibrary.wiley.com/toc/18632378/2020/67/S1
\20\ https://reaganudall.org/sites/default/files/2022-05/
Tracking%20and %20Monitoring%20of%20Antimicrobial%20Use%20in%20Food-
Producing%20Animals%20Preliminary%20Summary%20Report.pdf
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Question. What steps does FDA intend to take to improve the
standards of identity review process going forward?
Answer. FDA recognizes the importance of updating standards of
identity in an efficient and transparent manner and appreciates the
$1.5 million in new funding for standards of identity (SOIs) work in
fiscal Year 2022. FDA is working to support innovation, especially when
it can increase the availability of healthier foods in the food
marketplace, by continuing its work to modernize food SOIs. This is
part of our daily work and we are taking several steps to facilitate
the process, including:
--Developing principles to more transparently communicate what we
consider when we establish, revise, or eliminate a food
standard. FDA started this process in 2005 when it published a
joint proposed rule with USDA to provide each agency a set of
general principles. After re-opening the comment period on the
2005 proposed rule, FDA is working with USDA to re-issue a
proposed rule for stakeholders to provide input on.
--Prioritizing SOI work that supports FDA's nutrition initiatives.
--Using new strategies to more efficiently work on SOIs, such as
making amendments across multiple SOIs--allowing FDA to update
more than one in a single rulemaking when applicable.
--Updating individual standards of identity that focus on (1)
improving public health and (2) to allow the use of modern
technologies. Many standards are outdated and, as a matter of
good government, need to be updated to better serve our
stakeholders.
--Continuing to review citizen petitions that request FDA to
establish, revise, or eliminate a standard of identity. Citizen
petitions for standards of identity that do not promote honesty
and fair dealing in the interest in consumers or do not contain
sufficient data will be denied.
--Continuing to transparently communicate about FDA's recent actions
and current activities on the Agency's recently developed SOIs
webpage (see https://www.fda.gov/food/food-labeling-nutrition/
standards-identity-food).
--In November 2021, FDA published guidance for industry to clarify
aspects of the temporary marketing permit (TMP) process and to
describe changes that streamline and simplify the TMP
application process. TMPs allow a company to test the market
acceptance of products that deviate from an SOI, in order to
obtain data necessary for reasonable grounds in support of
their citizen petition to amend an SOI and ensure the interests
of consumers are adequately safeguarded.
Modernizing SOIs will enhance industry's ability to innovate and
produce healthier food while maintaining the basic nature, essential
characteristics, and nutritional integrity of the food.
Question. Will FDA commit to establishing a transparent standards
review process that includes reasonable deadlines for agency action and
greater accountability to consumers, industry and Congress in the
future?
Answer. Yes, FDA is committed to establishing a transparent
standards review process and, as part of this commitment, launched an
SOI webpage in April 2022 that includes a general overview of what an
SOI is and its purpose, priorities for updating SOIs, a list of current
SOIs that are being reviewed, and updates and current statuses (https:/
/www.fda.gov/food/food-labeling-nutrition/standards-identity-food).
Question. What actions is FDA taking to address stakeholders'
objections and requests for hearings regarding the recently updated
standard of identity for yogurt?
Answer. On March 22, 2022, FDA published a notice to clarify that
the effectiveness of certain provisions of the yogurt standard of
identity have been stayed. Dairy standards of identity are subject to
formal rulemaking procedures, which provide a 30-day period for any
person adversely affected to file an objection and request a hearing.
If objections are properly filed, then the provisions to which
objections were made do not go into effect (i.e., they are ``stayed'').
FDA received properly filed objections to certain provisions of the
final rule within this timeframe; those provisions are stayed pending
final FDA action on the objections. FDA is actively evaluating the
objections. Publishing a response to the objections received is a CFSAN
priority.
______
Questions Submitted by Senator Cindy Hyde-Smith
Question. Dr. Califf, as you know medical oxygen is an essential
and indispensable front line treatment for COVID-19 that has been
saving lives across America. We have seen tragic news from India about
what can happen when there is a shortage of medical oxygen. In 2012,
Congress enacted historic and bipartisan reforms for medical gases--
which include medical oxygen--included in the Food and Drug
Administration Safety and Innovation Act (FDASIA Section 1112) that
required the Food and Drug Administration (FDA) to promulgate new
regulations for medical gases by July 9, 2016. When FDA failed to meet
the FDASIA statutory deadline, in a further effort to get FDA to
comply, language was enacted in the Fiscal Year 2017 Consolidated
Appropriations Act which required FDA to publish final medical gas
regulations by July 15, 2017. Separate regulations for medical gases
will ensure that these products are regulated in a way that takes into
account the unique safety considerations of medical gases and will
ensure they are available to the health systems that need them,
especially as the Nation continues to treat individuals for COVID-19.
I am concerned that the FDA has failed to follow through on its
statutory obligations from 2012 and 2017 to establish separate
regulations for medical gases especially in light of their significant
use in treating COVID-19. Where does this significantly overdue
rulemaking on medical gases currently stand and will you commit to me
that the FDA will publish this rule by this month (May 2022)'s deadline
set in the Fall 2021 Unified Agenda?
Answer. On May 20th, FDA announced a notice of proposed rulemaking
\21\,\22\ that proposes to establish regulations regarding
certification of designated medical gases and that proposes to amend
the current good manufacturing practice (CGMP), postmarketing safety
reporting, and labeling regulations that apply to certain medical
gases.
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\21\ https://www.federalregister.gov/public-inspection/2022-10458/
current-good-manufacturing-practice-certification-postmarketing-safety-
reporting-and-labeling
\22\ https://public-inspection.federalregister.gov/2022-10458.pdf
---------------------------------------------------------------------------
FDA has engaged with stakeholders and Congress for several years to
gather input and evaluate the need for changes to regulatory
requirements for medical gases. If finalized, this proposed rule would
clarify the regulatory obligations of entities that manufacture,
process, pack, label, or distribute medical gases.
Examples of proposed key provisions include:
--Proposed labeling requirements to clarify the statement of
ingredients and quantity of contents for designated medical
gases, revise warning statements for certain designated medical
gases, and establish more limited labeling requirements for
bulk or transport containers.
--Proposed CGMP requirements that recognize important differences in
how medical gases are manufactured, processed, packed, and held
compared to other types of drugs, including the reuse of
containers and labeling; mixing and commingling of gases; that
gases are generally manufactured in a closed, pressurized
system; and that many medical gases are generally not expected
to expire or degrade.
--Proposed regulations to codify the certification process for
designated medical gases, including provisions regarding
supplements to granted certifications, annual reporting, and
withdrawal or revocation of approval of an application.
--Proposed safety reporting requirements under which certain events
related to designated medical gases would not need to be
reported to the Agency.
Question. Dr. Califf, I received your April 21, 2022, letter
responding to a bicameral letter I sent you on February 18, 2022. Our
letter had requested that you immediately rescind the removal of in-
person dispensing requirements for the chemical abortion drug
mifepristone (Mifeprex). Your recent response said that you had
conducted ``a comprehensive review of the Mifepristone REMS Program,''
and that you concluded that without the in-person dispensing
requirement, the drug would remain ``safe and effective.'' However, as
I noted at the hearing, I disagree, as do many others.
I have reviewed quite a lot of evidence showing that this drug is
actually quite dangerous to the women and girls who take them. Given
your unequivocal statement that your review was comprehensive, then, I
have a list of questions for you. Thank you for your commitment at the
hearing to be responsive to all of my questions about this.
Did your ``comprehensive'' review include the following relevant
studies? If so, please indicate how FDA considered them, referencing
all correspondence, analysis or conclusions FDA reached related to
them. If not, please explain why you excluded them from the review and
how your review can be considered ``comprehensive'' without them.
--https://doi.org/10.1177 percent2F23333928211053965 James Studnicki,
et al., A Longitudinal Cohort Study of Emergency Room
Utilization Following Mifepristone Chemical and Surgical
Abortions, 1999-2015, Health Services Research and Managerial
Epidemiology. Vol. 8 1-11 (2021).
--https://doi.org/10.1093/humrep/der016 Mentula MJ, Niinimaki M,
Suhonen S, et al., Immediate Adverse Events After Second
Trimester Medical Termination of Pregnancy: Results of a
nationwide registry study, Human Reproduction. 2011;26(4):927-
932;
--https://doi.org/10.1097/aog.0000000000000897 Chen MJ, Creinin MD,
Mifepristone with Buccal Misoprostol for Medical Abortion,
Obstet. Gynecol 126 (1) July 2015 12-21
--https://doi.org/10.1186/s12905-018-0645-6 Carlsson I, Breding K,
Larsson PG, 2018, Complications Related to Induced Abortion: A
Combined Retrospective and Longitudinal Follow-up Study, BMC
Women's Health 18:158.
Answer. With the exception of the Studnicki study, which was
published in November 2021, after the completion of our literature
review, the Agency considered these studies, as well as other studies,
as part of its review of the Mifepristone REMS Program. A discussion of
these studies can be found in the citizen petition response we
reference in the April 15, 2022 letter.
Question. In reviewing the data to determine safety, the FDA would
necessarily have had to make calculations to determine rate of
complications or incidents. What was the rate of complications as
determined by the FDA? Please describe the calculations, including the
numerator and denominators used and how those numbers were determined
adequate for statistical purposes. What rate did FDA determine would
exceed safety and therefore require the REMS for mifepristone to have
remained unchanged?
Answer. FDA's determination as to whether a REMS is necessary to
ensure that the benefits of a drug outweigh its risks is a complex,
drug-specific inquiry, reflecting an analysis of multiple, interrelated
factors (such as the seriousness of any known or potential adverse
events that may be related to the drug and the background incidence of
such events in the population likely to use the drug; and the expected
or actual duration of treatment with the drug) and of how those factors
apply in a particular case. In conducting this analysis, FDA considers
(based on premarketing or postmarketing risk assessments) whether there
is a particular risk or risks associated with the use of the drug that,
on balance, outweigh its benefits and whether additional interventions
beyond FDA-approved labeling are necessary to ensure that the drug's
benefits outweigh its risks.
Question. In the course of this review, did FDA consult with non-
government employees during this process, and if so, whom? Please
provide names, titles and organizations for all outside individuals
consulted in the review.
Answer. The Agency did not consult with any non-government
employees during the course of its review of the Mifepristone REMS
Program.
______
Questions Submitted by Senator Mike Braun
Question. Since Congress legalized hemp in 2018, the FDA has failed
to provide a pathway for the industry to bring their products to
market. Congress has provided funding increases to support research on
CBD products. This data is to help FDA provide regulatory clarity. In
2020, FDA put out two reports requested by this Committee on CBD,
including one on mislabeled or adulterated CBD products and the other
on potential regulatory pathways and data gathering efforts on CBD.
What steps has FDA taken with this funding to evaluate a potential
pathway to market CBD that preserves the spirit of free market
competition and transparency?
Answer. FDA appreciates the funding Congress has provided since
fiscal Year 2020 to support the Agency's efforts on cannabis and
cannabis derivatives. Unfortunately, prior to passage of the
Agriculture Improvement Act of 2018, there was very little research
into this area, so this funding has been critical in helping the Agency
begin to fill knowledge gaps.
These resources are being used for a variety of purposes, in
particular to study and collect data on cannabidiol (CBD) and other
cannabinoids to better understand their effect on humans and animals.
In addition, FDA is using funds to better understand the marketplace
for cannabis-derived products (CDPs), for policy development, and to
hire additional FTE in several of our programs to support the work in
this quickly expanding area. These are necessary steps as FDA
prioritizes the evaluation of potential regulatory options. The Agency
looks forward to discussing this further with Congress when there is
additional information to share.
Question. In recent years, the animal nutrition industry has made
significant strides with respect to developing technologies that can
help reduce on-farm emissions. Yet FDA's regulatory process
administered by the Agency's Center for Veterinary Medicine (CVM) does
not facilitate the deployment of these innovations.
For environmental claims and performance claims for animal feed
additives, the CVM still reviews these claims as if they were animal
drug claims. In my view, these regulations are overdue for an update.
For example, the CVM Program Policy and Procedures Manual Guide
1240.3605 was last updated on September 18, 1998.
Can you detail for the committee what steps you intend to take and
are currently taking to ensure the FDA regulatory review of these
claims is updated expeditiously to reflect the important environmental
benefits of modern animal nutrition technologies?
Answer. CVM has established a workgroup and is currently evaluating
the possibility of environmental and performance claims for foods under
existing authorities. We are looking at all the options under our
current authority to address this issue and exploring ways in which our
historic approach could change to reflect the evolving scientific
knowledge while still maintaining safety standards and consistency with
current laws. This evaluation will inform CVM's plans to update
policies in the Program Policy and Procedures Manual Guide 1240.3605.
If new animal food additive review policies are developed, additional
resources would be needed to support review of the anticipated increase
in submissions and to ensure timely safety review of any new claims on
currently marketed products.
Question. I'm concerned that over the past few years, while FDAs
Center for Drug Evaluation and Research (CDER) has announced a draft
guidance titled ``Innovative Approaches for Nonprescription Drug
Products,'' no further action has been taken to date. Potential changes
were first described in 2012 and while some progress has been made, we
are, years later, still waiting for a rule. The pandemic has
illustrated the importance of consumers having ready access to a range
of over-the-counter (OTC) self-care products. This lengthy delay is
standing in the way of a potential pathway that could allow for more
complex switches of OTC products, increasing access, affordability,
equity, and convenience for consumers.
Without this rule, consumers will further be denied the cost
savings from prescription to OTC switches and the convenience of the
availability of these medicines over-the-counter. I am concerned that
while we have heard this administration discuss the importance of OTC
medicines, we've seen little action on this rule. What can you tell me
about the FDAs delayed action on prescription-to-OTC Switch?
Answer. Currently, nonprescription drug products are limited to
drugs that, among other things, can be labeled with sufficient
information for consumers to appropriately self-select and use the drug
product without the supervision of a health care practitioner. For
certain drug products, limitations of labeling present challenges for
adequate communication of such information needed for consumers.
On June 27, 2022, FDA announced the issuance of a proposed rule
which, if finalized, would establish requirements for certain
nonprescription drug products that would need an additional condition
that an applicant must implement to ensure appropriate self-selection
and/or appropriate actual use, by consumers without the supervision of
a health care practitioner.\23\ The proposed rule is be intended to
address situations when labeling alone is not sufficient to ensure that
the consumer can appropriately self-select or use a drug product
correctly in a nonprescription setting, and would allow an applicant to
submit an application proposing an additional condition that a consumer
must successfully fulfill before accessing the drug product. The
proposed rule is intended to increase the availability of safe and
effective nonprescription drug products.
---------------------------------------------------------------------------
\23\ https://www.fda.gov/news-events/press-announcements/fda-
introduces-innovative-proposal-advance-consumeraccess-nonprescription-
drugs
---------------------------------------------------------------------------
Question. Breakthrough and expedited approval pathways allow FDA an
expanded universe of flexibility to unlock efficient development
pathways for treatments of diseases and conditions that have few or no
therapeutic options. Drug repurposing could be a viable option to close
unmet medical needs if approval pathway qualifying criteria
specifically included drug repurposing use cases.
Does FDA envision using a portion of existing funding under their
current operating budget or the requested funding for FY23 to specify,
update, or create expedited or accelerate approval pathways to maximize
the value of FDA regulated products for all populations, especially
those with rare conditions?
Answer. The Agency agrees that data on how approved drugs are being
repurposed may inform the development of new clinical uses for these
drugs as potential treatments for diseases and conditions that have few
or no therapeutic options. FDA has and will continue to consider fit-
for-purpose real-world data in regulatory decisions relating to the use
of repurposed drugs, including utilizing such data when appropriate to
support the criteria for our expedited programs for drugs and biologics
to treat serious conditions. These programs have been and will continue
to be utilized to advance consideration of repurposed drugs.
The agency has also devoted significant resources to exploring the
use of repurposed drugs for diseases or conditions with unmet medical
needs. In December 2019 the agency launched the CURE ID repository (a
website and mobile application) globally, and rapidly expanded it in
June of 2020 to respond to the COVID-19 pandemic.\24\ The repository
captures clinical outcomes from the clinical community when drugs are
used for new conditions, in new populations, in new doses or in new
combinations. Health care professionals generally may choose to
prescribe or use a legally marketed human drug or medical device for an
unapproved or uncleared use when they judge that the unapproved use is
medically appropriate for an individual patient. The systematic
collection of real-world experience in the CURE ID platform can help
identify drug candidates for additional study, encourage further drug
development and serve as a resource for physicians to share information
where no FDA-approved product proven to be safe and effective exists
for the new use. Repurposing approved drugs for new clinical uses can
potentially offer an efficient drug-development pathway for treatments
of diseases and conditions that have few or no therapeutic options.
---------------------------------------------------------------------------
\24\ https://www.fda.gov/drugs/science-and-research-drugs/cure-id-
app-lets-clinicians-report-novel-uses-existing-drugs
---------------------------------------------------------------------------
In June of 2020, the agency also announced the creation of a
public-private partnership (PPP), convened by the Critical Path
Institute, called the CURE Drug Repurposing Collaboratory (CDRC) and
provided funding to initiate this effort. The Agency plans to continue
our work with the CDRC, which has since received additional support
from HHS. Additionally, the Agency has continued to work with National
Institutes of Health (NIH), the Reagan Udall Foundation,\25\ and the
Critical Path (C-Path) Institute \26\ to explore avenues to advance
research and policy regarding existing therapeutics.
---------------------------------------------------------------------------
\25\ https://www.fda.gov/drugs/news-events-human-drugs/repurposing-
patent-drugs-research-regulatory-challenges-12052019-12062019
\26\ https://c-path.org/programs/cdrc/
---------------------------------------------------------------------------
The agency believes that the existing expedited programs for drug
development and the agency's ability to leverage these programs when
approved drugs show promise with rare diseases are sufficiently
flexible and robust to address public health needs, including with
respect to repurposing, or expanding the approved uses of, approved
drugs. The agency is committed to utilizing these programs when
appropriate to expedite development of repurposed drugs, including
repurposed drugs for rare diseases. The Agency will also continue
working with sponsors pursuing repurposing opportunities for areas of
unmet medical need. The FDA instituted its Accelerated Approval Program
to allow for earlier approval of drugs that treat serious conditions,
and that fill an unmet medical need, based on a surrogate endpoint
reasonably likely to predict clinical benefit. Validated surrogate
endpoints can be used for traditional approvals. A surrogate endpoint
is a marker, such as a laboratory measurement, radiographic image,
physical sign or other measure that is thought to predict clinical
benefit, but is not itself a measure of clinical benefit. The use of a
surrogate endpoint can considerably shorten the time required prior to
receiving FDA approval.
While the agency believes the current expedited approval pathway,
enhanced by the agency's other expedited programs, provides an
appropriate pathway for expanding the approved uses of approved drugs,
the President's budget includes a legislative proposal titled
``Ensuring Feasibility and Timeliness of Confirmatory Studies and
Enhancing Withdrawal Procedures for Prescription Drugs Approved through
Accelerated Approval''. This proposal seeks to amend the accelerated
approval provisions of the FD&C Act to (1) revise section 506(c)(2)(A)
of the FD&C Act such that FDA may require, as a condition of a drug
product application's acceptance for filing, or as a condition of a
drug product's receipt of accelerated approval, that a drug sponsor
must first demonstrate that a proposed post-approval (i.e.,
confirmatory) study is adequately designed to verify and describe
clinical benefit and can be completed in a timely manner; (2) revise
section 506(c)(3) so that FDA can follow its dispute resolution
procedures for drug applications when withdrawing a drug product's
accelerated approval; and (3) revise the withdrawal standard at FD&C
Act 506(c)(3)(C) so that it mirrors the analogous withdrawal standard
set forth in section 505(e) for drugs with traditional approvals. The
FD&C Act does not provide FDA with easily implementable legal
authorities to help target the problem of studies that progress too
slowly. FDA believes that such a provision would help provide greater
assurance at the time of a drug product's accelerated approval that the
confirmatory study can progress in a timely manner, and reap high-
quality, interpretable results. Enhancing the timeliness and quality of
confirmatory studies will help support FDA's regulatory decision-making
for drugs approved through the accelerated approval pathway and
minimize the time that a product is marketed based on accelerated
approval before its clinical benefit can be confirmed.
SUBCOMMITTEE RECESS
Senator Baldwin. The hearing was adjourned.
[Whereupon, at 11:21 a.m., Thursday April 28, the
subommittee 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 2023
----------
TUESDAY, MAY 10, 2022
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 10:00 a.m. in Room SD-124, Dirksen
Senate Office Building, Hon. Tammy Baldwin (chairwoman)
presiding.
Present: Senators Baldwin, Feinstein, Tester, Leahy,
Heinrich, Hoeven, Collins, Blunt, Moran, Hyde-Smith, and Braun.
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 TAMMY BALDWIN
Senator Baldwin. I am going to call the Subcommittee on
Agriculture, Rural Development, FDA, and Related Agencies to
order.
Good morning, and welcome to the second budget hearing for
this subcommittee for fiscal year 2023.
Secretary Vilsack, welcome back, and thank you for joining
us. And Mr. Rapp, we welcome you here too. We are glad to have
both of you here today.
The Department of Agriculture's vast mission includes
ensuring the health and care of our Nation's land, plants, and
animals, as well as improving the quality of life and economies
in rural America. The Department serves Americans at the
county, state, and national level with even more locations
overseas. We are grateful for the work of the USDA employees
that support our farmers and ranchers at home and abroad.
The fiscal year 2023 Budget Request for USDA is ambitious,
and I am pleased that this request continues investments in
climate resilience, as well as support for our rural economies.
It also includes funds to ensure that socially and
geographically disadvantaged farmers and ranchers are able to
access the services and opportunities that are essential to
their success.
I look forward to discussing these initiatives, among the
many others included in your budget request. I am also pleased
the budget continues to invest in programs that support our
rural communities, the backbone of this country.
Rural development includes significant increases from
broadband, to housing, to water, and wastewater infrastructure.
As inflation drives up home ownership opportunities and rental
prices it is essential that we ensure rural Americans have
access to affordable housing. I am pleased to see a number of
proposed increases for rural housing programs.
One issue that I know is important to both of us, Mr.
Secretary, is ensuring USDA employees have the resources they
need to get the job done. We spoke last week about some of the
staffing challenges you face, and I hope we can have a good
discussion this morning about solving this problem, and how
this subcommittee can be helpful.
This subcommittee has a long tradition of bipartisanship,
and I look forward to working with our Ranking Member as we
begin the process of drafting the fiscal year 2023 Bill.
Again, thank you for being here this morning. I look
forward to your testimony.
And as he has not yet arrived, I think we will recognize
Ranking Member Hoeven as soon as he does appear. But why don't
we begin right now with your testimony and at the conclusion of
that we can recognize the Ranking Member.
SUMMARY STATEMENT OF HON. THOMAS J. VILSACK
Secretary Vilsack. Well, thank you, Madam Chair, and I
certainly appreciate the opportunity to be here this morning,
and appreciate the attention of the committee members as well.
Let me start with a very important, and I think significant
statistic about the AG appropriations process. Non-defense
discretionary spending over the last eight or 9 years has grown
by 27.4 percent across all departments, while the USDA's
discretionary budget has grown about 14.3 percent, roughly
half.
And essentially what this has done is it has created some
challenges with reference to the Department, and I appreciate
the Chair's commenting on two of the three that I am going to
discuss today.
You mentioned the issue of staffing. Madam Chair, I will
tell you, this is a serious issue for us, and when you look at
our nutrition programs we have seen a doubling of the amount of
resources that goes through those programs, but we have seen
the workforce at FNS be cut by 25 percent.
When we talk about rural development, the department that
basically is in the mission areas that is in charge of 3,142
rural counties across the United States, 15 percent of
America's population, roughly 75 percent of America's land
mass, deals with 30- to $40 billion in loans and grants each
and every year, oversees a significant portion of the $230
billion loan portfolio that we have at USDA, but it is short
about 500 workers.
And when we take a look at the backroom operations of USDA,
the departmental administration, we have seen a nearly doubling
of procurement responsibilities in that department, but the
workforce has been cut by 43 percent. So I think it is
essential and necessary for us to talk about the staffing
levels at USDA. I think it is also necessary for us to talk
about research. While health care research has, understandably,
grown significantly by as much as 400 percent over the last
decade, research in the AG area has flatlined after you take
inflation into consideration.
At one point in time it represented 4.3 percent of the
overall non-defense research allocations and appropriations for
the Federal Government, today it is 2.3 percent. So it has been
literally cut in half. This, despite the fact that for every
dollar we invest in agricultural research there is a return of
investment of $17. And I would say that--most would say that is
a pretty good return on investment.
So our hope would be that as we talk about the budget that
we focus on the important role of agricultural research.
And you mentioned rural housing. That is also a challenge.
We appreciate the additional support and help that this
committee has provided in this space, but the reality is that
we continue to struggle to maintain adequate housing. And we
are going to see, over time, a significant reduction in the
number of units as loans are paid off.
Essentially what happens is those units convert from being
subsidized to being available at market rates. So we are
encouraging this committee to take a look at ways in which we
could decouple the mortgage--the interest rates, and the
mortgage and the loan from the subsidization, so that we would
continue to be able to provide additional units, and also
investing in their rehab of existing units so that the housing
is not only available, but also decent.
And in the time that I have remaining, Madam Chair, let me
talk about something that is really of concern to me, that is a
bit outside the purview of this particular Department but it
is--of this budget committee, but it is something I think we
all ought to be concerned about.
There are 61,670 farm families in America today that are on
the brink, 61,670 farm families that are either delinquent in
their loans to USDA, are bankrupt, or are pending foreclosure.
This is a serious issue that--and I am pretty confident that
every single member of this committee probably has a number of
those 61,000 farmers living in their states.
It is important and necessary for us to put a spotlight on
the challenges. Now, these are people who have borrowed from
USDA, or who have had a guaranteed loan from USDA, which means
that they haven't been able, on their own, to go to a
commercial bank and be able to secure financing. So these are
folks who need help, they need assistance.
I have represented farmers during the 1980s as a small town
lawyer, I can tell you the pain, I can tell you the stress, I
can tell you that the decisions that folks make under these
circumstances. I can tell you of very tragic decisions that
they make under these circumstances. So I would hope that as we
talk about the future of agriculture in this country, that we
don't lose sight of those 61,670 farm families.
They deserve our attention, they deserve some creative
thought about how we might be able to assist them during this
pandemic-stricken time, and I sincerely hope that we can work,
collaboratively, together in a bipartisan way to make sure that
they have a hopeful future, as opposed to one that is currently
stress-filled today.
I see the Ranking Member is here, and so I am going to stop
talking.
[The statement follows:]
Prepared Statement of Hon. Thomas J. Vilsack
Thank you, Chair Baldwin, Ranking Member Hoeven, and members of
this subcommittee, for inviting me here today to discuss the
Administration's priorities for the Department of Agriculture (USDA)
and to provide you an overview of the President's fiscal year 2023
budget for USDA.
Under the President's leadership, America is building back better.
We have begun to turn the tide on the pandemic and our country has made
historic progress in the face of unprecedented challenges. With Putin's
price hike affecting American families at the pump and at the grocery
store, we are pulling out all stops to tackle inflation. At the same
time, economic indicators are overwhelmingly positive. We created more
than 6.5 million jobs in 2021, the most our country has ever recorded
in a single year. Our economy grew at 5.7 percent, the strongest growth
in nearly 40 years. The unemployment rate has fallen to 3.8 percent,
the fastest decline in recorded history. This progress was not an
accident. It is a direct result of President Biden's strategy to combat
the pandemic and grow our economy from the bottom up and the middle
out.
The fiscal year 2023 Budget details the President's vision to
expand on this Administration's progress and commitments to the
American people and recognizes the historic investments that Congress
has made through the American Rescue Plan and the Infrastructure
Investment and Jobs Act. This Budget begins to reinvest in USDA's long
overlooked workforce through investments in staff and technology, as
well as the foundations of our country's strength: education, research,
food security, safe and affordable housing, and productive lands. These
are all areas that for far too long their funding has been stagnant or
nearly level. The work proposed by this budget will spur new job
creation and opportunities in rural America; help build resilience in
the food supply chain and restore America's advantage in agriculture;
leverage all of USDA's expertise to address climate change; and support
a stronger nutrition safety net.
The President's Budget for 2023 for USDA programs within this
subcommittee is $189 billion, of which approximately $165 billion is
mandatory funding and $24 billion is net discretionary funding. It
gives USDA a new set of tools and builds on our existing capabilities
to address the urgent challenges of our time-responding to the
nutrition insecurity crisis, investing in research, rebuilding the
rural economy, strengthening and building markets for farmers and
producers, and addressing the impacts of climate change. This Budget is
not a wish list, it is a to do list. The challenges of our time and our
ability to address those, require serious investments in USDA agencies
and operations, non-action or continued underinvestment has significant
and immediate implications for the United States of America.
rebuilding rural america
It is no surprise when I say the United States' prosperity and
well-being are intrinsically tied to rural America's ability to thrive
in the new global economy. The President's Budget proposal enables USDA
to work closely with rural America and empower communities to take the
reins as they rebuild their economies, workforces, and infrastructure
to create more opportunities for a circular economy where wealth is
created and stays in rural areas.
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 increased access to broadband service, affordable housing
in underserved communities, or resilient wastewater infrastructure.
Beyond improvements to the quality of life, these investments attract
new businesses, create a greater sense of pride in the community, and
allow rural America to prosper.
To bring these outcomes to reality, the Budget proposal increases
funding for Rural Development by $935 million, including critical
increases for combatting climate change. Funding includes $1.773
billion for USDA multifamily housing programs, an increase of $256
million over the 2022 enacted level. This significant investment would
start to reverse chronic defunding of these programs and help address
housing insecurity and rent burdens in rural communities. This funding
will be prioritized for projects that improve energy or water
efficiency or facilitate climate resilience. Additionally, the Budget
proposes $1.5 billion in loan level for low-income single family
housing loans, an increase of $250 million, and proposes a critical
increase of $204 million for Rural Development to revitalize its
staffing and technological capacity. The Budget also increases USDA's
investment in expanding rural broadband service to put rural America on
a long-term path to economic success. The Budget includes $600 million
for ReConnect, an increase of $200 million in new competitive funding
over the 2022 enacted level, to provide flexible loans and grants to
deploy broadband to unserved areas. This investment also builds on the
$2 billion of funding provided by Congress in the Infrastructure
Investment and Jobs Act.
The President's Budget proposes $727 million in budget authority
and $1.5 billion in loan level for USDA's Water and Wastewater Grant
and Loan Program. This includes a new $100 million in set aside funding
for lead pipe replacement in rural households, and $140 million in loan
level for the most economically distressed communities with borrower
interest rates offered at one and zero percent. This is an increase of
$73 million over the 2022 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 and are essential to rural residents.
The proposed increase would create good-paying jobs and help thousands
of communities across rural America gain much needed access to clean
drinking water.
supporting nutrition for the nation
USDA's core nutrition programs are the most far-reaching, powerful
tools available to ensure that all Americans, regardless of race,
ethnicity, or background, have access to healthy, affordable food.
Building on these programs, the Budget makes strategic investments to
ensure that those in need can access nutrition programs that are run
efficiently and effectively; to advance nutrition security through
education and evidence-based interventions; and to support the purchase
of nutritious and local foods. I want to highlight just a few
priorities.
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 to address
disparities in maternal and child health outcomes. Continuing the
bipartisan commitment to full funding, the Budget requests $6 billion
for WIC to serve an estimated 6.25 million moms, infants, and young
children per month in FY23. It also proposes to continue the enhanced
Cash Value Benefits (CVB) through 2023 to provide participants with
increased benefits to buy fresh fruits and vegetables. This ensures
that all participating women and children have access to the
scientific-based recommended level of fruits and vegetables.
SNAP is the primary source of nutrition assistance for many low-
income people and research has shown that participation in SNAP reduces
food insecurity and allows families to have healthier diets. Healthier
diets are known to lead to better health outcomes and, in the long-
run, lower health care costs. In 2023, participation is estimated to
increase to an average level of 43.5 million participants per month
from 42.3 million in 2022. While participation is expected to increase,
the overall cost of the program is actually expected to decrease by
more than $29 billion. The decrease is primarily due to the expected
expiration of emergency allotment (EA) payments that have been provided
during fiscal years 2020 through 2022. Those EA payments and other
program waivers are anticipated to continue for the length of the
Public Health Emergency, likely through the majority of fiscal year
2022.
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. When students participate in school meals
programs, their behavior, comprehension, and attendance improve. The
meals children receive prepare them for learning and shape their food
choices and health outcomes as adults. Providing healthy, nutritious,
and appropriate food choices can decrease obesity rates, and will
reduce food insecurity and result in better health outcomes. To better
support this work this Budget funds the Child Nutrition Programs,
through new appropriations and prior year balances, at a level that
will allow for the anticipated increases in participation and food cost
inflation. The Budget projects serving 5.6 billion lunches and snacks
(an increase of about 350 million over the current estimate for 2022)
and 2.7 billion breakfasts in schools, 2.2 billion meals in child and
adult care programs, and 145 million meals through the Summer Food
Service Program.
Mounting evidence supports the effectiveness of USDA nutrition
education and promotion efforts to improve knowledge and catalyze
healthier behaviors. Still, USDA faces multiple challenges in our
efforts to deliver effective and cohesive nutrition education across
programs. The Budget seeks funding for a new initiative to build and
broaden Food and Nutrition Service' (FNS) capacity to deliver effective
nutrition education and promotion to all Americans within existing
program structures by supporting research and evaluation of effective
strategies; leveraging partnerships with States, local, and
nongovernmental organizations; targeting underserved communities with
culturally appropriate resources and interventions; and improving
public access to USDA's nutrition education resources.
The Budget also invests in the vital functions of FNS to deliver on
this ambitious agenda.
While Federal funds managed by FNS have increased dramatically, as
much as 70 percent in recent years, the staffing levels have decreased.
The Budget proposes significant investments in FNS to ensure the agency
can provide the appropriate level of oversight and stewardship, pursue
its crucial mission to address food and nutrition security, and
innovate and modernize to best serve those in need.
supporting research
USDA research influences every program that we implement, and it is
incredibly important to deepen our support for the organizations that
conduct and synthesize USDA studies and information. The share of total
food and agriculture research conducted by the U.S. government was
relatively stable at around 50 percent from 1970 to 2008. But, by 2013,
that share had fallen to under 30 percent. That's a significant
difference since private R&D tends to focus on commercial applications
(and only a few major crops and livestock markets) while the public
sector is still responsible for much of the fundamental research that
creates the building blocks for major agricultural innovations.
Fundamental work conducted by public R&D, in areas like food safety,
animal health, specialty crops, water quality and human health, benefit
society more broadly but may offer potentially lower monetary returns
or nonmarket benefits.
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 is why this Budget proposes an increase of over $355 million
for a total of $4.05 billion for USDA's research, education, and
economics programs. This investment is critical to addressing the
mounting hunger and nutrition insecurity crises, strengthening and
building markets for farmers and producers, and addressing the impacts
of climate change. This Budget includes increasing the National
Institute of Food and Agriculture's (NIFA) Agriculture Food Research
Initiative (AFRI) to $564 million, an increase of $119 million over
2022 enacted to include broad emphasis on rural circular economies
through clean energy technologies and climate-smart agriculture and
forestry. These investments complement proposed increases for the
Agricultural Research Service (ARS) to expand research to fully
understand the myriad aspects of climate change drivers and impacts,
and to strategically develop approaches that can help mediate climate
change and its impacts on agriculture, our rural economy, ecosystem
services, and the quality of our natural resources.
Finally, the Budget proposes investments in USDA's research
agencies to rebuild both capacity and credibility after years of staff
losses. In fiscal Year2021, the Research, Education, and Economics
Mission Area was successful in hiring above their fiscal Year2020
staffing levels, but they are still significantly understaffed to
address the current and emerging challenges noted above.
combating climate change
Climate change presents real threats to U.S. agricultural
production, forest resources, and rural economies. Producers and land
managers across the country are experiencing climate impacts on their
operations through shifting weather patterns and increasingly frequent
and severe storms, floods, drought, and wildfire. This Budget
underscores the Biden-Harris Administration's commitment to address the
impacts of climate change with a comprehensive approach that's
inclusive of science and on-the-ground investments to support our
producers and land managers across the country.
Farmers, ranchers, and foresters can lead the way with tackling the
climate crisis through the adoption of voluntary and farmer friendly
incentive-based climate-smart agricultural and forestry practices. That
is why this Budget proposes $1 billion for Conservation Operations to
support producers and landowners in undertaking voluntary conservation
and climate-smart practices on agricultural lands that will improve the
profitability and resilience of producers and reduce emissions.
The Budget 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.
The Budget proposes to enhance the 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.
This will allow for important outreach and promotion of inclusive
outcomes in a collaborative approach. Another critical investment in
the Budget is $21 million to support and expand NRCS's greenhouse gas
measure, monitor, report, and verify efforts as well as efforts to
increase internal capacity related to climate change science. The
budget also includes additional funds for the Natural Resources
Conservation Service (NRCS), to increase the delivery of science-based
conservation planning and technical assistance that supports the needs
of producers seeking to implement voluntary conservation practices that
can have technical, climate, financial, and economic benefits for their
farms.
The Budget also provides $300 million in new funding to support de-
carbonization of the electric grid to meet the Administration's goal of
zero carbon electricity by 2035. Specifically, grants and loan
modifications will be used to encourage rural carbon pollution free
electricity, with the greatest benefit going to the optimal combination
of carbon reductions and need.
Increasing annual funding for the Rural Energy for America grant
program will assist agricultural producers and rural small businesses
to purchase or install renewable energy systems or make energy
efficiency improvements, as well as funding to State, Tribal, or local
governments, institutions of higher education, rural electric
cooperatives, and public power entities or councils for energy audits
or renewable energy development assistance to rural small businesses or
agricultural producers.
In addition to combatting climate change, this Budget also helps us
react to the implications of a changing climate as we respond to the
prevalence and spread of chronic wasting disease (CWD) as well as the
spread of invasive plants, pests, and other diseases which are moving
at an unprecedented speed. The Budget calls for an investment of $6
million for the Civilian Climate Corps within our Animal Plant Health
Inspection Service (APHIS) to address issues related to invasive
species control and climate change and an increase of $3 million to
research the implications of climate change on the pervasiveness of
CWD.
focus on diversity, equity, and inclusion
Building a better America means bringing people of all backgrounds
and lived experiences to be a part of a healthy, safe and inclusive
workplace--from ensuring we are recruiting the best and the brightest
across our great country to investing in our employees through
recognition, wellness programs, and support to our employees, including
LGBTQ+, veterans, employees with disabilities and employees from
historically underserved communities, ensuring they have the equipment
they need, and access to promotions, learning and development and
retirement with a great sense of achievement. And building a better
America is about ensuring all people 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 fiscal
Year2023 Budget focuses on building a USDA that is a model employer and
a 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.
One long-standing barrier preventing farmers from benefitting from
USDA programs is heirs' property, which refers to when family land is
inherited without a will or legal documentation of ownership. Heirs'
property has historically been challenging to heirs because of their
belief that they cannot get a farm number without proof of ownership or
control of land. Though those affected are in all geographic and
cultural areas, many Black farmers and other groups who have
experienced historic discrimination, have heir's property. This Budget
requests $62 million for the Heirs Property Relending Program to assist
heirs in resolving ownership and succession issues on farmland with
multiple owners. Examining barriers to heirs' property owners is a part
of a broad USDA effort to revising policies to be more equitable.
To better use the research and development capacity at Minority
Serving Institutions (MSIs), this Budget proposes nearly $315 million
with almost $227 million going toward Historically Black Colleges and
Universities, which includes the 1890 Land Grant Institutions. The
Budget also supports preparing more Hispanic Americans for careers in
agricultural science and agribusiness through important investments in
the Hispanic Serving Institutions Education Partnerships Grants
Program. The Budget includes a 120 percent increase above 2022 enacted
levels for Federally Recognized Tribes Extension Program, to allow the
program to serve the demand from 1994 Land-grant Institutions more
fully and effectively.
Ensuring that all rural communities are made aware of and
encouraged to participate in USDA programs, this Budget proposes $39
million to sustain and expand the Rural Partners Network (previously
known as StrikeForce) authority. The Rural Partners Network will
provide targeted training, technical assistance, and outreach to
distressed communities including energy communities in rural America
through an all-of-government approach and support more strategic
community engagement, facilitate 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.
making usda a strong, modern organization and a best place to work
Nearly 100,000 strong and with a budget of more than 200 billion,
you would expect- and hope-that USDA has a robust operational core: An
operational core that has top notch human capital and administrative
staff and offices that can support and provide critical guidance given
the anticipated retirements, need to hire and hire in a vastly
competitive climate, and focus on having cultures and workplaces that
demonstrate a commitment to the employees. I have made it a priority to
make USDA a Best Place to Work. We have prioritized creating a diverse,
inclusive, equitable and accessible workplace; engaging and supporting
our employees in meaningful ways; recruiting the next generation of
USDA staff and leaders. However, we are challenged because more often
than not USDA's 'staff offices' operate on shoe-string budgets and with
staffing levels that dwarf the responsibility USDA offices bear.
An analysis of staffing levels since 2008 indicates that the
communications shop, for example, has been whittled down from 85 to
fewer than 50 people today--and the work as well as the importance to
message to the American people about services, benefits and programs as
well as to rebuild trust in our Federal institutions is more important
than ever. Our Office of Contracting and Procurement is a fraction of
the size it needs to be to oversee the contracting offices throughout
the Department. USDA obligates $10 billion on contracts annually, and
this Budget requests funds to ensure a larger staff and sound
succession plan are in place to provide strong leadership over
contracting and procurement throughout USDA. You might expect an agency
of the size and scale of USDA to have a robust training division--a
team focused on workplace wellness, employee engagement and recruiting
the next generation of USDA staff and leaders in rural America. But
you'd be wrong. Our Budget proposes to increase USDA's Office of Human
Resource Management by 31, compared to the current staff of just 87
staff. These increases will help us leverage the HR work that we do
with the Mission Areas and build a best- in-class operation for our
nearly 30 agencies and offices that employ about 100,000 people.
Year after year, USDA staff have taken on more and more work to
meet our complex mission and new directives from Congress. But without
commensurate increases in staff support, it positions us for greater
risk and creates a culture of siloes where we must find ways internally
to fund these necessary functions. While our mission areas, agencies,
and specific programs have often drawn greater interest and funding
increases from Congress, the FY23 budget proposes an initial set of
steps to build back a robust operational core within USDA. Doing this
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.
The fiscal year 2023 Budget lays out a plan for USDA to build on
the early progress and commitments of this Administration, build back
our workforce, and implement the historic legislation passed in the
past year while tackling critical issues within the food supply chain,
the impacts of climate change, and the pressures on our public and
private lands. As I stated at the beginning of my testimony, the Budget
is not a wish list, it is a to do list and USDA needs the support of
this subcommittee and of Congress to make the much-needed investments
called for in the President's fiscal Year2023 Budget. I look forward to
working with this subcommittee and to answering any questions you may
have about our Budget proposals.
Senator Baldwin. Senator Hoeven.
STATEMENT OF SENATOR JOHN HOEVEN
Senator Hoeven. Thank you, Madam Chair. And thank you,
Secretary, for joining us today. Good to see you. Appreciate
our conversation earlier; and of course your testimony today.
Welcome back in front of the committee.
I have heard you say before that the Department of AG
touches the lives of all Americans every day, and in every way
and that is certainly true. Probably more true now than ever.
Really current events highlight the importance of our food
supply, and the importance of what our farmers and ranchers do
for our country every single day. Food security is national
security, and our farmers provide the lowest cost, highest
quality food supply in the world.
Right now of course we are struggling with inflation. We
see it obviously for our farmers and ranchers, we see it for
consumers across the board, we see it in the prices that people
pay at the grocery store, we see it at the pump, today gasoline
hit a record price average across the country of about $4.40 a
gallon, right in that range.
And so we have got to find ways to produce more energy in
this country, to find ways to address the supply chain issues,
and the other challenges that are creating inflation. And our
farmers are a big part of that. They are seeing it in the price
that they pay, not only for fuel for their tractor, and other
equipment that they have to run every year to plant a crop, and
harvest a crop, but also, obviously, in fertilizer, and their
other inputs.
And so it is very important that we do everything we can in
terms of the Department of Agriculture, and as well as in the
energy patch to address these issues. And I know that you are
working hard on it, we need to continue to do that. And of
course we are making significant investments here in this AG
Appropriations Committee to make sure that you are able to do
that on behalf of our farmers.
Just in recent years, in Fiscal 2022, USDA programs
actually received an increase of 6.2 percent over the fiscal
year 2021 levels, and that included a funding increase of 6.5
percent for research, which has been amazing in terms of what
it has done for our farmers and ranchers, and their ability to
raise crops and animals across this Nation. I have seen it in
my own state. I know you have seen it in yours. It is truly,
truly remarkable.
Also the resources for the FSA are incredibly important too
to help get our farmers through drought, through floods,
through tough weather, tough prices, and in some cases trade
agreements that aren't fair, FSA has a major role to play in
keeping our farmers going.
I want to be sure that our commitment to support rural
America is as strong as ever. I know you share that. I know you
have got some ideas on how to do that, we do too, we will talk
about those this morning. Also, I want to make sure that the
funding that we have put in place for things like the Livestock
Emergency Relief Program, WHIP+ for our farmers, that those
funds get out to our farmers.
You and I have talked about that. We will talk about it
some more today. And I know you are coming up with some ideas
to expedite that, I appreciate that, and look forward to
working with you on it.
Thanks again for being here today. I appreciate it very
much.
Thank you, Madam Chair.
Senator Baldwin. Thank you. We are going to now begin
rounds of five-minute questions. And I will begin.
Mr. Secretary, rural America has historically lagged behind
urban regions in educational attainment, poverty levels, and
overall well-being, and data shows that rural America has
recovered from the great recession at a slower pace than urban
America, which has major implications for rural America's
ability to adapt to the current economic and inflationary
trends. So I was excited to see USDA formally launch the Rural
Partners Network, which we provided initial funding for in the
fiscal year 2022 Appropriations Act.
Secretary, can you provide an update on how the Rural
Partners Network is being implemented, and how it will target
funding to distressed communities? Additionally, talk about the
fiscal year 2023 budget proposal of 39 million for this
initiative, and what additional resources will these funds
provide?
And lastly, which agencies at USDA and other departments
play a role in implementation of this initiative?
Secretary Vilsack. Madam Chair, this is I think a pretty
significant question you have asked. The Rural Partnership
Network is really designed to provide intensive care, and
direction, and focus on communities that have been persistently
poor, communities that have had a poverty rate in excess of 20
percent for more than 20 or 30 years.
They require folks on the ground, living, working raising
their own families in these communities, and then helping
community leaders and community building organizations access
the variety of programs that are available. We have started
this in five states, Georgia, Kentucky, Mississippi, New
Mexico, and Arizona. We have targeted communities within each
of those five states. We are in the process of hiring staff
today who will actually live in communities within those states
that we have selected through a process, a data process, data-
driven process.
Those individuals will begin to identify programs, and
challenges, and projects, that folks are interested in
pursuing, and then they will work collaboratively with 13
Federal agencies, and three commissions who will have what are
called ``rural desk officers'' in each of those agencies; so
this is Transportation, HHS, Education, et cetera.
Those rural desk officers will be responsible for working
collaboratively with the folks on the ground in those five
states, in those communities, to identify the programs, and to
short-circuit, if you will, the process for applying for,
successfully, resources.
Our belief is, that by providing this intensive care, and
by providing an all-of-government approach, we will be in a
position to provide a meaningful progress, that folks will be
able to see, and that they will actually learn, if you will,
how to participate in Federal programs, and they will see a
Federal government that is working collaboratively with state
and local governments to make life better.
Our goal and hope is that we are able to expand this
program significantly, which is why we have asked for an
additional $39 million. This is going to, essentially, pay for
individuals who will be living in those communities, and
working in those communities, as well as state directors
overseeing those operations. It will also provide additional
training. We know that there is a significant amount of
training that is required for community leaders to understand
the processes that they have to go through in applying for
various grants.
So these resources will allow us to expand the program, we
have designated an additional five states, hopefully, to be
able to select by the end of this year, this fiscal year, and
with this additional resources we would be able to
significantly expand this effort across the United States in
places where we just have had poverty that just hasn't gone
away.
Senator Baldwin. Thank you. Have you identified these five
additional states? Or are you still in the process of that data
collection effort?
Secretary Vilsack. We have identified those five additional
states. And I am sorry, I know a few of them but I don't know--
I can't tell.
Senator Baldwin. You can follow up with that.
Secretary Vilsack. Actually I think Wisconsin happens to be
one of them.
Senator Baldwin. Okay.
Secretary Vilsack. North Carolina happens to be one of
them, and I can't--I am sorry I can't remember the others.
Senator Baldwin. Please just follow up afterwards, that is
totally fine.
Next, I am going to recognize Senator Hoeven for your
questions, first round of questions.
Senator Hoeven. Thank you Madam Chairwoman.
Mr. Secretary, at the end of September we authorized
funding both for WHIP+, and for the livestock assistance. That
was about $10 billion, 750 million for what, you know, is
referred to as the Emergency Livestock Relief Program, and then
$10.23--excuse me--$9.23 billion that is actually available for
WHIP+. We have talked about both, not only with you, but with
Zach Ducheneaux.
We appreciate the working relationship. The emergency
livestock relief assistance is out there for the livestock
producers, about 560 million of it. The remaining part I know
you are working on, we will work with you on that, we
appreciate that; that is underway.
But I want to ask you about WHIP+. Where are we with WHIP+
and in getting it out to our farmers?
Secretary Vilsack. I appreciate the support from Congress.
Senator, we are in the process of finalizing the work that will
allow us to pre-fill the application that will be required for
farmers to benefit from the WHIP+ Program. In the past there
were roughly 250 questions that would be asked of a farmer to
be answered, to be able to apply for WHIP funding.
We are going to pre-fill that application, so at the end of
the day it will be just a handful of boxes that have to be
checked, and signed. Our hope and belief is that within the
next couple of weeks, we announce the structure and the
framework for how you go about applying for these resources so
that payments can, potentially, start in June.
Senator Hoeven. Yeah. And what you have explained to me,
and I appreciate, is that it has taken longer on the frontend
to get it set, but that once you announce it, it will be
quicker to get it out, correct?
Secretary Vilsack. Correct. And we are going to do this in
two tranches. You mentioned the livestock situation, $560
million has been provided, the additional resources will be
provided in a second tranche, for those that the folks that
aren't--that weren't covered by Livestock Forage Program, or
they had shallow losses, or they had a loss that wasn't quite
covered by some of those programs.
Senator Hoeven. Right.
Secretary Vilsack. What we have done is we have taken the
information and data from those programs, like Crop Insurance,
like the NAP Program, and we pre-fill these applications for
the grain folks. There may be people who will be left out in
that process as well, so there will be a smaller second round
of funding after the June payments.
Senator Hoeven. And once it is out, we would like you to
have somebody get out there with us, and talk to the livestock
groups, or in this case the commodity groups, the farm groups,
so we can explain it, if that would--if that is something that
you would work with us to do.
Secretary Vilsack. Absolutely. And our state folks will
continue to do this at a state level, our state directors that
is part of their responsibility to make sure people understand
about this.
Senator Hoeven. Yeah. And we want to join with them in
doing that so we can explain it to producers. Livestock
Indemnity Program, again, we appreciate that, we have had
blizzards, we have had some calf mortality, not only in our
state but other places. So the Livestock Indemnity Program,
very important this year.
One of things we talked about, and that is for calves under
250 pounds, which is typically where you have a lot of the
mortality in these spring blizzards, that payment rate for 2022
really is not reflective of the cost of those animals. And I
have asked if you would work on adjustment there. And then also
making sure that for animals that get sick because of that
weather, they may not die right away, but they get anthrax,
pneumonia, or something else, and then they die later, that
that they are--you know, that the Livestock Indemnity Program
applies to those animals. So would you address those two things
under that program?
Secretary Vilsack. Sure. Actually we are focusing on those
two, plus the issue of timeliness, so those are three issues
that we are taking a look at. The payment rate is obviously a
challenging one, because it is essentially, we have tried to
marry the livestock program to--what kind of what we do on the
crop side, where essentially we take a look at a less than
market weight, as being almost like a freshly sewn crop, and
comparing it, and contrasting it to that.
We are in the process of taking a look at this, because you
have raised the issue about what has happened in North Dakota,
and we are taking a look at this. We are also taking a look at
the cause of loss, recognizing, as you point out, that it could
be delayed. There may be a problem that occurs initially during
a blizzard, whatever, but it doesn't surface until many, many
months later.
And we recognize and appreciate that may have an impact on
value, so both of those issues are being looked at by the team.
And we are also trying to figure out ways in which we could,
potentially, provide for more annual production information as
we do with crops, which might make it easier for us to have a
better understanding of how to value livestock at various times
depending upon the disaster, and depending upon weight.
As it is now we have to basically collect the stat on a
disaster-by-disaster basis, and that is problematic.
Senator Hoeven. Yeah I appreciate that. But it is
particularly that one category. So we are not saying cross off
categories, we are saying in that category 250 pounds and less,
so that is what we want you to take a look at, and I know you
understand that. Thank you.
Thank you, Madam Chair.
Senator Baldwin. Thank you, Senator Hoeven.
I understand there is a special birthday today. Happy
Birthday, Senator Hyde-Smith.
Senator Hoeven. Is this where we sing, or not?
Senator Leahy. No. I think that would ruin her birthday.
Senator Baldwin. Open to suggestions. It doesn't move you
up in the queue though. Sorry about that.
Senator Leahy.
Senator Leahy. Thank you Chair. I wished the Senator a
happy birthday earlier, and I said, I am glad to see these
young people here, in so far as everybody is in the Senate.
Secretary, it is great to see you. I appreciate all the
times we have been able to chat and good to see you.
And Secretary, I want to discuss a new initiative. I have
worked with Senators Baldwin, Hoeven, and Shelby to put in the
fiscal year 2022 Spending Bill for the Department, a new
investment for the Department which helped establish Institutes
of Rural Partnerships. Whether it was when Tropical Storm Irene
tore through Vermont, devastating and isolating so many
communities, or challenges brought out around the country with
COVID-19, Vermont is trying to find new ways to collaboratively
tackle these problems.
The Institutes for Rural Partnerships through the USDA can
help rural America plan for future challenges. That is a
priority of this committee, and they can forge connections
between public and private entities across every level of
government. And I think they are extremely important.
You, probably more than any, Mr. Secretary, understand
rural America. When do you anticipate the Department is going
to move forward with this initiative? How will USDA partner
with these institutes to promulgate best practices that can be
used in rural areas?
Secretary Vilsack. Senator, our National Institute of Food
and Agriculture is our lead agency on this. They are in the
process of working with staff to make sure that we are
structuring this program in a way that is consistent with
congressional intent, and the feedback that we have recently
received about how these institutes should be set up. I foresee
that they will work closely and collaboratively with
missionaries like the Economic Research Service, ERS, to
collect data and information. I am sure that they work closely
with Rural Development to make sure that we know what kind of
programs.
As I have shared with the Chair, we have the Rural
Partnership Network, and I would imagine the institutes will be
quite interested in studying the impact and effect of those
partnerships. They will obviously continue to work with the
research aspect of USDA, so I think there is great
possibilities, and potential.
The challenge I think for us is to make sure we know
exactly what it is you want us to do because it could be an
incredibly broad array of things we could do, but that is the
reason why we are spending a little time listening but we are--
I would anticipate and expect that we are going to get this
thing going before the end of the fiscal year.
Senator Leahy. And one thing I am sure you are hearing from
everybody because of COVID, the food insecurity in our country.
I know our food banks in Vermont are feeling this. I think that
can probably be said about every state. Schools are now facing
the expiration of USDA child nutrition waivers that allowed
them to expand especially during the summer months.
I am pleased to see the administration propose increased
funding for the Emergency Food Assistance Program (TEFAP), a
vital source of funding for food banks, which I support. There
is another area, I know again--without being too parochial,
Vermont has been a leader in growing local and organic food,
but it is very difficult to get that included in Federal
nutrition programs such as TEFAP. Can we find ways to get
Federal dollars more involved in this?
Secretary Vilsack. Senator, we established a local and
regional food aspect of TEFAP this year, in which we are asking
the state agencies to work with us to provide, and we are
providing roughly $600 million as an initial effort, so that
food banks would be able to access locally grown and raised
foods, that could include organic.
So the State of Vermont, for example, could encourage that,
for both the food banks as well as for the school meal program.
And what we want to be able to do is create a stronger, local,
and regional food system that complement our commodity
production agriculture so that we have a more resilient food
system. So that is in the works.
Senator Leahy. Good. And we will work with you any way we
can. I just want to thank you, Mr. Secretary. I know the final
spending package for fiscal year 2022 saw a responsible, and I
believe very transparent, return to congressionally directed
spending. I want to applaud this subcommittee for the way they
worked, and worked across the aisle. I know you are working
with us on that, and I think you will find broad bipartisan
support to get it done. So I thank you. And I thank you, Chair.
Senator Baldwin. Senator Collins.
Senator Collins. Thank you. Welcome, Mr. Secretary. Prior
to your confirmation we had an in-depth conversation that led
to my decision to vote for your confirmation. We discussed two
issues in particular, and I am going to follow up on those two
issues today, and express my disappointment.
The first is the issue of PFAS, those forever chemicals,
Maine is in the forefront of efforts to address contamination
on our farms from PFAS. I told you that in 2016 a dairy farmer
in Arundel, Maine, had discovered that the milk that was being
produced by his cattle contains some of the highest levels ever
reported from a PFAS contaminant.
Since that time these forever chemicals have been found in
feed, in soil, and water, in crops, in livestock, on farms all
across Maine. So this is obviously devastating for these
farmers, and their livelihoods, and their families, they are
facing extreme financial hardship, and we have learned that the
USDA's Dairy Indemnity Payment Program only covers fluid milk,
so it does not begin to cover all of the problems for these
dairy farmers, in particular.
In October last year I sent you a letter and asked you to
provide me with an update on what USDA could do to assist these
farmers. I received no response. Then in March, I again sent
you a letter that was signed by all the members of Maine's
delegation, requesting that USDA use all of its existing
authorities and programs to provide assistance.
Mr. Secretary, we received a response to that letter at
1:24 a.m. this morning. We never received a response to my
October letter, and the letter to you that we sent in March, we
got the response literally at 1:24 a.m. this morning.
Putting that aside. Will you work with us, and I mean
really work with us to identify programs that you either have
now, or that we could ask to be modified so that we can assist
these affected farmers?
Secretary Vilsack. Senator, I am surprised by your
question. And the reason I am is because I am under the
impression that we, in fact, are providing indemnity for
livestock as opposed to fluid milk. Recognize, we started this
process with just basically paying for the milk that was
damaged, and realized that that was not adequate, and so we are
in the process--I think we have done this, begin paying farmers
for the loss of livestock.
So I think we want to check on that but--so we have taken
action. Certainly apologize for not answering letters. I can
tell you the young lady behind me can attest to the fact that I
have put a concerted effort to try to get a response to
congressional inquiries. I am embarrassed by this, and I
apologize for it. We are going to try to do better on the
correspondence side, which is why you got the response at 1:48
this morning, better late than never, but certainly not
responsible as it should be.
The PFAS issue. Let me explain to you what I think we need
to do. We are working with EPA to try to establish a national
standard on what is an acceptable level, or not, of PFAS, and
the reason for this is so that we can, basically, help to
define the level of assistance and help that is required.
You are absolutely right. This is pervasive. It is not just
in Maine, it is everywhere, because basically sludge was used
to fertilize farm fields for many, many, many years without an
understanding and appreciation of the challenge.
So I would say two things, one, happy to work with you,
happy to work with the EPA to set a national standard, happy to
work with this committee, or whatever committee to establish an
amount of resources that would help deal with this issue. It is
going to be a large amount. And then I would certainly say, we
need to make sure we continue to fund research, because I think
we are going to continue to find some challenges with reference
to things that we have done for years, and years, and years
that are now cropping up as being problems.
Senator Collins. Thank you. I look forward to our second
round.
Senator Baldwin. Senator Heinrich.
Senator Heinrich. Thank you, Madam Chair.
Secretary, last week President Biden announced a major
disaster declaration in New Mexico as a result of multiple,
severe wildfires, including one that was initiated by a U.S.
Forest Service prescribed fire that simply escaped control.
I want to make sure that the USDA is fully prepared to
assist affected communities, and mitigate potential flood
damages before this year's upcoming monsoon season which
starts, typically, in early July. The Emergency Watershed
Protection Program is going to be really essential in that
recovery.
The village of Ruidoso, which was subject to a wildfire
that caused several fatalities, destroyed over 200 homes, they
have already requested EWP assistance, and I am expecting that
a number of communities in northern New Mexico may do so soon.
My concern is really that the NRCS office in New Mexico has
just never had to deal with this quantity of EWP assistance
before, and may need additional personnel, or other resources
to be able to conduct those assessments and implement some
recovery on the ground before we get hit by those big
thunderstorms.
So just given the severity of the fire's destruction and
the upcoming monsoon season, I want to ask that you would work
with NRCS to make sure that they can meet that urgent need.
Secretary Vilsack. Happy to do it. And we are adding
additional personnel, Senator, across NRCS, to try to beef up
significantly capacities at the state level.
Senator Heinrich. That is great news. One of the other
areas that I think is going to be important, from the same sort
of perspective, is like EWP, other disaster programs within
Farm Service Agency, for example the Livestock Indemnity
Program, is going to be another one of those places where it is
just not set up for the scale of--you know, the demand that we
are going to see in the immediate after-effects of these fires.
And so I would also just ask that you look closely at FSA,
and make sure that they are able to get on the ground, and
really meet people in these communities, and get them to
understand what they need to do to access those sorts of
programs.
Secretary Vilsack. We will certainly do that. And if it
turns out that the staffing is not adequate, there are surge
teams that we can put in place. We, unfortunately, and
tragically have had far too much experience with this issue,
not just in New Mexico but in many other western states. So we
understand and appreciate what we have to do.
Senator Heinrich. No, I appreciate that. One of the related
issues I want to raise for you, and it actually goes back to
when you were talking about the Rural Partners Network, many of
the communities affected by these particular wildfires are
really under resourced, persistently poor, as I believe you
described it.
And because of the significant need for assistance in those
communities, the New Mexico delegation actually requested that
President Biden waive the Federal cost share for FEMA
assistance. I would like to be able to work with you to look at
the appropriate cost share for USDA disaster programs simply
because these are the exact same communities that--on the New
Mexico list that you referenced before that were barely getting
by before, they were just devastated by these fires. So would
like to be able to work with you to develop some guidelines for
what might be an appropriate cost share in this case.
Secretary Vilsack. That is an appropriate request, and to
the extent that we have the capacity through our regulations
and statutes to do so, we will be happy to work with you.
Senator Heinrich. Great. To shift gears for a second; on
last year's Agriculture Appropriations Bill, this subcommittee
encouraged USDA to conduct demonstration programs on dual-use
renewable energy systems, these are otherwise known as
agrivoltaics.
I wanted to ask, does USDA have enough funding for the
renewable energy infrastructure, and the research expertise to
really conduct some of these demonstration programs that we
have looked at through this committee?
Secretary Vilsack. Well I think it has the expertise, I
don't know that we necessarily have the resources. It is just
why part of what would be involved here would be NIFA, our
National Institute of Food and Agriculture, as well as our ARS
facilities, and I am frank to say we think that we need more
resources in those areas, across the board, not just in this
area, but in terms of staffing, in terms of facilities, and in
terms of the capacity to do more work with land-grant
universities.
Senator Heinrich. Madam Chair, I hope the committee will
look at this, as we have had a number of places around the
country where there has been a direct conflict between taking
land out of production to do renewable projects, and we have
seen great success in a few places where they have actually
been able to effectively produce energy and farm on the same
footprint, and increase the income for the farmer as a result.
And I think it has a lot of promise.
Senator Baldwin. Next, Senator Hyde-Smith.
Senator Hyde-Smith. Thank you, Chairwoman Baldwin.
And thank you, Secretary Vilsack, and Mr. Rapp for being
here today, and your willingness to serve and participate.
Mr. Secretary, as you know, the USDA, Natural Resources
Conservation Service, the NRCS, assists state and local bodies
with flood mitigation, and water quality improvements, erosion
control, and several things related to that through the
watershed, and Flood Prevention Operations Program, which is
really important to a state like Mississippi.
Like many rural communities and landowners across the
country, Mississippi and its people have been hit particularly
hard in recent years by excessive rainfall, flooding and other
problems caused by natural disasters. The Watershed and Flood
Prevention Operations Program has been invaluable in allowing
small towns to recover from these events and, importantly, to
prepare for the next one, because we know the next one will be
coming as well.
In early June 2021, many parts of Mississippi experienced
just unprecedented rainfall, some receiving more than 12 inches
of rain in less than 12 hours. My office was getting phone
calls all day, and videos, during that time. And, as you might
expect, it caused severe flooding, and the roads and bridges,
and failures of dams, and levees, and everything that such an
event as that would cause, and thousands of Mississippians were
affected, and millions in damages occurred.
Fortunately, we have programs like Watershed and Flood
Prevention Operations administered by NRCS, but because of the
problems and similar problems I have mentioned, I requested 8.4
million in watershed operations funds in the fiscal year 2022
Agriculture Appropriations Bill for NRCS Mississippi, to help
address some of our challenges.
Funds were used to support nearly ten or more projects
across nine Mississippi counties. That provision became law
with the enactment of the Consolidated Appropriations Act 2022.
And I thank Chair Baldwin and Ranking Member Hoeven for
supporting my request throughout that conference process. But
all along with my staff and many constituents, we have a great
respect, and don't know what we would do without the NRCS, and
we appreciate the many services that they provide.
But Mr. Secretary, what is the status of the Watershed and
Flood Prevention Operations Funding provided in that fiscal
year 2022 Omnibus? And I am looking for some feel-good news
that it is, you know, being put to very good use. But please
share any updates that you may have as to how the funds
provided by NRCS and Mississippi are, or will soon be utilized
to help rural communities and landowners addressing flood water
and these issues that I have just articulated?
Secretary Vilsack. With specifically, the $8.4 million, the
NRCS folks are working with the local sponsors of the projects
that were identified to basically work through the
implementation plan, so that process is in place. In addition,
the State of Mississippi was the recipient of $47.8 million of
additional resources under the Bipartisan Infrastructure Law of
the 500 million that was allocated under that law for watershed
and flood prevention operations, Mississippi receiving $47.8
million of additional resources.
So NRCS is working on a variety of projects in Mississippi.
My staff will be able to give you the list of the projects that
were identified in that 47.8 million. You know, we are working
on, for example, a big project with Madison County on a stream
bank erosion issue. We know that a lot of the sediment issues
in Mississippi are not a result of your losing your topsoil, it
is a result of the banks, basically, eroding and over time
creating some challenges.
And so I think you are going to see significant activity in
this space in the Mississippi because of the money and
resources that have been provided through the appropriations
process, and through the infrastructure law.
Senator Hyde-Smith. Wonderful. I appreciate that answer.
And I have got a few seconds left. Rural communities across
U.S., we will always be faced with these weather-related
challenges, and I was pleased that the fiscal year 2023 budget
request for USDA included the WFPO funding in it as well.
Should Congress provide funding to address project, or
watershed specific challenges through the WFPO in fiscal year
2023? How confident are you that the NRCS can put those funds
to good use?
Secretary Vilsack. Well, I am confident they can as long as
we continue to increase the staffing levels. I think the key
here is not just increasing the resources, but making sure that
you have got the staff on the ground that can implement these
resources in a proper way.
Senator Hyde-Smith. Great. Thank you, Madam Chairman.
Senator Baldwin. Thank you. Senator Feinstein.
Senator Feinstein. Thanks very much Madam Chairman.
I just want to say you have a very tough job, to start
with. My understanding is that the west has become a real
problem for fire. Since 2017 wildfire has burned 10 million
acres in my state, California, killed nearly 200 people, and
destroyed more than 32,000 homes. Even as we speak I understand
that large wildfires are burning in New Mexico and Arizona.
So what do we do? The agencies have been chronically
understaffed, many Federal wildland firefighters are moving to
state jobs, particularly in my state because the pay is better.
So Mr. Secretary, I want to know what you think would help
most? Is it that rise in pay? What is it? Because we have got
to hire enough people to handle what is going to happen with
global warming? And that particularly goes for my state. And I
am very concerned.
Secretary Vilsack. Senator, thanks for the question. I
think it is important for us to do two things--actually three
things. One, transition some of our part-time people to full-
time status, which would provide them additional pay and
benefits, and we are doing that we are literally transitioning
hundreds of firefighters.
Two, a new classification system for wildland firefighting,
we are in the process, as directed by Congress and the
President, we are in the process of working with the Department
of Interior and the Office of Personnel Management to develop a
new classification that will create a more competitive salary
scale for wildfire fighters.
And then three, we are going to continue to implement the
additional resources that were provided under the
Infrastructure Law to provide additional pay this year that
will allow us to be able to do a better job of recruiting and
retaining our workforce. So those three things are in the
process of being done, and I think you are going to see more
firefighters on the ground which is going to be absolutely
necessary, because we are not going to see an abatement of
these wildfires for some time.
Senator Feinstein. Well, in your recently released ten-year
strategy to address this crisis, you indicated your focus would
be on communities most at risk, and this is especially
important for more rural communities in California at the
Wildland Urban Interface. It is my understanding that your
fireshed map identified that many at-risk communities in
California are not near Federal lands, which means they won't
be eligible for most Forest Service funding for wildfire
mitigation.
How is the Department going to help rural communities,
especially those not adjacent to Federal land; to reduce their
risk and become more resilient?
Secretary Vilsack. Well, your support and the support of
others in the Senate for the passage of the Bipartisan
Infrastructure Law is a response to that question, because $1.5
billion of the resources that you allocated for the Forest
Service will be provided to state and local communities for
that very purpose, giving them the resources to be able to work
collaboratively with us.
It is collaboration, Senator. The fact that it may not be
on a particular map doesn't mean that we won't work with those
local communities, provide the technical assistance, direction,
and assistance. We do that all the time. But now we have the
resources, and we can give those local and state--states
resources to be able to provide more community preparedness,
more training, more support for their volunteer fire
departments, et cetera. So that $1.5 billion is incredibly
important.
Senator Feinstein. Well, you certainly have my support. And
I want to say, I think, you know, for the largest state in the
union my concern about fire in the last 10 years has just gone
straight up. I see these fires and I see what can happen, and I
really don't know what we can do to give you the resources to
put up those--the ability to stop big massive fire in our
state.
Secretary Vilsack. Well, the ten-year fire mitigation
strategy is designed to do that, and certainly the Bipartisan
Infrastructure Law was a start in terms of the financial
resources necessary.
But committees are going to have to continue to provide
that support over the next decade for us to see a significant
reduction in the risk, because we have hundreds of millions of
acres of dead trees as a result of pine bark beetle, and
climate. We have got a substantial amount of hazardous fuel
buildup that has to be addressed. It is going to require
resources. We have got them for the next couple of years. The
key will be to continue that effort over a ten-year period.
Senator Feinstein. Well, let me ask this. I would be most
interested in helping with a plan if you have one, to see that
we can provide what we need to provide. I am really very
worried because California is extraordinarily dry, and fire is
a real enemy.
Secretary Vilsack. We will absolutely work with you,
Senator.
Senator Feinstein. Thank you. I appreciate that.
Thanks, Madam Chairwoman.
Senator Baldwin. Thank you. Senator Blunt, you are next.
Senator Blunt. Thank you, Chairman.
Secretary, great to see you; and I think every appearance
may be some kind of record, because of your long service in
this job. And I am grateful that you have done that and
continue to be willing to do it.
You and I have talked about this before. I was a supporter
of relocating the headquarters of ERS and NIFA to another
location, that turned out to be in Kansas City, and of course I
was even more pleased with that. There was a report issued by
GAO that stated that the previous administration's decision to
relocate those agencies was not fully consistent with an
evidence-based approach.
You then pointed out, or the Department pointed out that
the GAO used metrics established after the relocation, and that
that was not exactly a fair analysis of what they would have
been looking at at the time. I have I have been to that
location recently, they are about to really come alive,
frankly, for the first time. A great space but highly
underutilized, because people have been working from home.
I am wondering, based on your previous role, and the
perspective you would have, if you have seen yet a way that
this move alters operations or applications. I think that
location with three-hour car drive from eight different land-
grant universities, which we thought was one of the principal
advantages you might have in the future. But are you seeing any
difference yet in operations there? Or what have you seen in
terms of filling job vacancies in that location?
Secretary Vilsack. Senator, we have a goal of about 750
people between the ERS facility and the NIFA Mission area. We
are about 650. We have seen about 450 folks who have been hired
in those two mission areas, so the hiring has been, I think,
robust. I think people are anxious and interested in working in
that environment.
You know, we have got some great people who work over
there, and they turn out the work, regardless of pandemics,
regardless of whatever the challenges may be. We had a morale
issue which we are dealing with, and I think as we hire more
folks, that issue, it becomes less, less of an issue.
The work is getting done, and it is getting done on time.
You know, the reality is that those agencies have great working
relationships with land-grant universities and minority serving
institutions all across America.
You know, I think I would say that as we look at this
concept the challenge I think is to do it in a way that
provides less disruption than the way it was handled before,
and I think there are ways to do that, and I think this is, you
know, I think we are going to see a lot of good work coming out
of that facility. I have no doubt about that.
Senator Blunt. Well, I appreciate that. And I think for
lots of reasons, cost of living, and other things, there are
reasons to look at other locations now as we think about
expanding here, or moving somewhere else. And I appreciate your
sense that what the impact on the current workforce, and how
you maybe transition is important there.
You know, those agencies, among others, really looking
carefully at world food need right now, and what happens as a
result of what is happening in Ukraine. What concerns do you
have, and what should the Department do? Should we make more
American acreage available for--in some foreseeable window that
might not be available otherwise? Or should we step back from
taking more acres offline as we try to figure out what happens
with this great food producing part of the world being so
impacted, in Africa, and other places that have benefited from
that raw, unprocessed food stuff being impacted?
Secretary Vilsack. Senator, I am traveling to Germany
tomorrow, and then to Poland in order to get a first-hand look
at the situation in Ukraine. We have a twin challenge here. We
have got an immediate global food security challenge by virtue
of the disruption that the invasion has caused, and the impact
it is going to have on unstable, potentially, unstable
conditions in the Middle East and North Africa because of food
shortages.
So we need to address that. And that is one of the reasons
why we tapped the Bill Emerson Trust, part of the challenge
there isn't just tapping the Trust but making sure that it is
replenished, which I think is important, and the supplemental
appropriations bill that you are considering would begin that
process.
The other challenge with that Trust is the transportation
cost. It is amazing to me that it costs more than the value of
the product we are transporting to get that food to Ethiopia,
and some of the North African countries. So I think there is an
opportunity for us to look at ways in which that could
potentially be addressed.
I would say with the second challenge we have is the issue
of climate, because that is going to impact our long-term
capacity to meet global food needs, and I am really, really
excited about the reaction to the Climate-Smart and Forestry
Product Partnership Initiative. We got 450 applications from
350 organizations and groups; commodity groups non-profits, for
profit organizations, all 50 states, probably three to four
times the billion dollars that we put on the table. So there is
tremendous interest in doing that as well.
So I think what we have to do is figure out ways in which
we could do both. And one thing we could do is look for ways,
creative ways to help double-cropping opportunities, expand the
number of counties that are insured, figure out the other
administrative ways to make it easier for farmers reducing the
risk of double cropping.
Senator Blunt. Thank you. Thank you, Chairman. I have,
there may be other questions either for the record, or for a
second round, if there is one.
Senator Baldwin. Well, we are starting it right now. And I
will recognize myself for five minutes of questions in the
second round.
Mr. Secretary, I want to talk a little bit about climate-
smart agriculture. Our farmers, ranchers, and producers
experience firsthand the impacts of climate change. I
appreciate this administration's whole-of-government approach
to combating the climate crisis, including the U.S. Department
of Agriculture's efforts to conserve and protect our Nation's
natural resources, while enhancing economic growth and creating
new streams of income for our producers.
Can you give the committee an update on the climate-smart
agriculture activities of the Department? And also what is the
Department doing to ensure that farmers, ranchers, and
producers of all backgrounds are able to access the resources
needed to strengthen their climate-smart agricultural
practices?
Secretary Vilsack. There are three ways I would like to
respond to that question. First, there has been a significant
effort on the part of NRCS to catalog, and to characterize
climate-smart practices, and to provide information on
different activities that farmers and producers can take to be
climate smart. Whether it is reducing greenhouse gas emissions,
or whether it is sequestering more carbon, and we are going to
continue to do a better job of providing that information.
NRCS has worked with a grant program with 118 different
organizations that are connected to minority producers, and
socially disadvantaged producers, historically underserved
producers, in an effort to try to make sure that those
individuals who may, in the past, have had a hard time
accessing that kind of information, get that information, and
that program is going to continue. That is something we feel
very strongly about.
That is in addition to the additional technical
assistance--efforts underway under the American Rescue Plan
under Section 1006, you provided resources to be able to
expand. We currently have 20 larger community building
organizations that are connected to minority producers that are
also working to make sure that they have the full array of FSA
and NRCS programs.
Secondly, as I just mentioned to Senator Blunt, we are
really excited about the response to the billion dollars that
was put on the table, to ask producers to put together pilot
projects and demonstration projects.
The fact that we got 450 applications from 350 different
organizations and entities across all 50 states, even at the
minimum, we are talking about $2.2 billion. I know some of
those applications were for $50 million or more. So I am pretty
sure we are probably 3X or 4X to what we put on the table. So
there is obviously tremendous interest there.
And then finally, I think there is, again, a research
component to this in which we are working with NIFA, and
working with ARS to provide the tools, and the technologies,
and the capacity for farmers to have a better understanding of
what climate smart actually means, and be able to measure, and
quantify, and verify it.
Senator Baldwin. Thank you. I know we are on our second
round of questions, but I am going to interrupt the back and
forth of Democrat and Republican, to allow Senator Tester to
ask his first round of questions.
Senator Tester. Goodness, if I only knew what I was going
to ask. I want to, first of all, thank you for being here,
Secretary Vilsack. It is always good to see you, doing the
Lord's work, making sure that family, farmers, and ranchers
have a shot out there. And we all know that rural America has
been declining, and is going to continue to decline unless we
do some things a little differently.
And you know where I am going with this. A few weeks back
the Senate Agricultural Committee, and I am sure you were
watching it, held a hearing on two bills that deal with
consolidation in the marketplace when it comes to the cattle
industry.
You know, the statistics for companies control over 80
percent of the marketplace, capitalism doesn't work in
situations like that. And we want capitalism to work. We want
there to be competition in the marketplace, so that both the
cow-calf operators and consumers can reap the benefits of a
good competitive system.
The President's budget asks for $35 million for packers and
stockyards, given the issues that I just said, and I just
brought up beef, pork, poultry, and others are in a very
similar situation. Do you think that level of funding is
adequate, the 35 million for packers and stockyards?
Secretary Vilsack. It would represent a very significant
increase, Senator. And I think it would be adequate for us as
we strengthen packers and stockyards, this year you will see
probably three rules coming out from the Department in an
effort to try to strengthen the enforcement capacity of the
Department. And those resources would be very important to
being able to do that.
Senator Tester. That is good because it is going to be--I
mean you are the key to unlocking this, you or your Department,
and you. And so making sure you have the resources to deal with
the situation a fair way is really critically important. As I
told you before, I am not for putting anybody out of business,
what I am for is add more competition to the marketplace. And
the Packers and Stockyards Act, was originally set up to do
that, and we just haven't had the enforcement capabilities.
I don't need to tell you about the, historically, bad
drought west of the Mississippi. Last year was the worst year I
ever had, this is 44 years on the farm, grandfathered homestead
at 110, and I think with the exception of 1919 and 1920 when
they had to move back the Red River Valley after the historic
homesteading because of drought, this may be the worst year
since then.
And by the way, where I happen to live in North Central
Montana, I have been seeding the last weekend in dry dirt. If
we don't get rain it is going to be worse than last year.
We passed billion in disaster relief last fall, including
750 million bucks for livestock producers. This is critically
life-and-death money, I mean truthfully, it is nobody wants to
get a check from the Federal government, but the bottom line is
the drought has caused hay prices to go through the roof, there
has been no grass resource because there has been no water,
there has been no crops raised because there has been no water.
And so can the USDA, can you share any update on the
progress of getting that $10 billion in disaster relief out the
door?
Secretary Vilsack. Livestock producers have received checks
in the amount of $560 million last month and this month. So
there will be a second round of funding for the livestock
producers who weren't necessarily covered by the Livestock
Forage Program, or the Livestock Indemnity Program. We took
information from that, from those programs and basically pre-
filled the application so that we could move the money out more
quickly than in the past.
In terms of on the crop side, we anticipate and expect
announcing this month the structure for how the crop
reimbursements will take place, that will also involve pre-
filled applications, there are roughly 250 questions that are
asked of a producer in order to be able to access WHIP+, most
of those questions will be pre-filled from crop insurance and
NAP data, and we expect and anticipate the checks will come out
in June.
Senator Tester. So doing some quick math in my head so
there is about 190 million on the livestock side that is yet to
be allocated?
Secretary Vilsack. It is because we want to make sure we
cover those producers that didn't necessarily have, they may
have had a shallow loss, they may have had a loss that didn't
qualify for one of those programs, so therefore there wouldn't
have been the data, or the information available to the
Department. So we will go through a process of having them
apply for the resources.
Senator Tester. And thank you for that. And one really,
really quick; I was talking to, sitting in the airport last
Thursday, and I was talking to a guy that said that he had
received some money on cattle shipping to be able to move his
cattle. Is that number one--I certainly don't have a problem
with that, with the price of fuel, and lack of trucks. Are you
aware of that program, because it is not one I was aware of?
Secretary Vilsack. Well, we are providing it. We have
expanded the Livestock Indemnity Program, or I believe that is
the Livestock Indemnity or the Forage Program, to include
additional assistance for transportation.
Senator Tester. Okay, good.
Secretary Vilsack. I am not sure whether it is the cattle,
or whether I think it is transporting the cattle to where there
may be feed or grain.
Senator Tester. That is correct.
Secretary Vilsack. Yeah.
Senator Tester. That is exactly it.
Secretary Vilsack. We have expanded the program to include
reimbursement for that transportation expense.
Senator Tester. I don't know whose idea that was, but great
idea. Thank you.
Thank you, Madam Chair.
Senator Baldwin. Thank you. Next, Senator Moran.
Senator Moran. Thank you, Chairwoman.
Mr. Secretary, hello. Seems like every conversation with
the Secretary of Agriculture, for as long as I have been in the
Congress, includes conversations about disaster, and I want to
highlight a problem we have with the Emergency Livestock Relief
Program, we have had drought and wildfires across our state,
but most recently, in December of 2021, 160,000 acres across 13
counties in Kansas burned, grassland, forage sorghum, and other
feed sources that producers rely on to get through the winter.
Since those fires occurred outside the quote, ``normal grazing
period'' these producers are not eligible for LFP, and
therefore are not being helped by disaster assistance.
USDA described in the announcement, on March 1st, as Phase
One, will Phase Two of the Disaster Assistance provide support
to livestock producers who lost forage and grazing lands to
wildfires outside normal grazing periods?
Secretary Vilsack. Senator, we are in the process of
developing a list of those non-covered disasters, as the one
you have just mentioned, to make sure we have a comprehensive
list, and then from that list we are going to make a
determination of how best to spend and invest the second
tranche of resources.
Certainly understand what you have outlined, and I will
tell you that the concerns that you have expressed are on the
list, they have been placed on the list. You know, I want to
make sure that I check with our folks to make sure that I am
right when I say, we are going to consider this seriously. I
don't know that we have necessarily made a decision yet about
exactly who gets what, but I know that is on the list.
Senator Moran. If you would give me the chance to make the
case, it should be high on the list, I would appreciate that.
Secretary Vilsack. Certainly.
Senator Moran. Does USDA expect to need additional funding
for Ad Hoc Disaster Assistance?
Secretary Vilsack. Well, I am never going to ask or
question where, do you need additional resources? Here is the
problem, Senator, and you have addressed it. Our disaster
assistance programs are sort of a one-size-fits-all, and the
reality is we are now learning that there are multiple types of
disasters in multiple different areas, involving multiple
commodities, and in multiple different ways.
And it is going to be important and necessary for us, I
think, to have enough flexibility and resources to be able to
try to tailor the disaster assistance to the actual disaster,
as opposed to having a one-size-fits-all, and sometimes your
folks don't fit in it, and that is unfortunate.
You know, more resources, but I would say in addition to
more resources let us make sure it is flexible enough to be
able to use it for multiple disasters.
Senator Moran. I always like that flexibility until it
doesn't cover something that I think needs to be covered. And I
appreciate the conversation, and perhaps you are leveraging me
to suggest we need more disaster assistance, or more dollars.
Input costs, fertilizer prices, I have asked the
subcommittee that I am the lead Republican on, has jurisdiction
over the Department of Commerce. We are trying to do something
about countervailing duties on phosphates from Morocco, and to
stop the implementation of duties on nitrogen fertilizer from
Trinidad and Tobago. Can you help? Can you be an ally in any of
this?
Secretary Vilsack. Well, we have certainly indicated a
necessity of looking at those countervailing duties. In
addition, as you know, we have announced an effort to try to
put resources on the table to see what we could do here in the
United States to produce more fertilizer. We are also working
with producers on crop choice, and conservation practices that
could potentially reduce fertilizer use.
We are also focusing on a split nitrogen policy for crop
insurance that will basically cover crop losses if you decide
to half your nitrogen application. I mean there are a series of
things we are doing. And we are also working with state
attorney generals to take a look at whether or not the
fertilizer costs that are currently being paid by farmers are
legitimate.
It is an interesting, a very interesting graft, if you take
a look at the history, of fertilizer and crop prices as crop
prices go up so do fertilizer costs. And may just--no reason
for that, but.
Senator Moran. Mr. Secretary, thank you. I don't understand
the love affair with the countervailing duties on components of
fertilizer. And I will continue my efforts, and I appreciate
any help you can give.
The supplemental--the double cropping issue, planting
soybeans after winter wheat just announced a week or so ago, I
would remind you that sorghum is a major food crop for many
African nations, and it is a crop that can be planted behind
wheat in many parts of Kansas. Additionally, much of the
world's sunflower oil comes from Ukraine, another crop that
could be utilized in that fashion.
Why does the administration's supplemental request only
propose to incentivize soybean and not include other food
crops, like sorghum and sunflowers?
Secretary Vilsack. It was conservation starter, and you are
absolutely right, and there is no reason why we couldn't
include those, and should.
Senator Moran. And would that include the $10 per acre
incentive for----
Secretary Vilsack. To the extent that there are incentives
that we are looking at, or flexibilities that we are looking
at, we are going to try to be as comprehensive as we can be.
Senator Moran. Right. Thank you, Mr. Secretary. I
appreciate your answers.
Senator Baldwin. Thank you. Next, I am going to go a little
bit out of order. I know Senator Collins has a time schedule
issue. So I am going to call on you for your second round; then
Senator Braun for your first round.
Senator Collins. Thank you very much, Madam Chair. And
thank you, Senator Braun.
Secretary Vilsack, you won't be surprised that the second
issue that I am going to bring up with you today concerns
potatoes. Potatoes are an extremely nutritious vegetable. They
contain more potassium than bananas, they are a good source of
fiber, vitamin B6, vitamin C, and very important today to
families that are struggling to buy groceries. They are
affordable.
During the Obama administration, and I won't relive this,
but we went back and forth on whether potatoes should be
restricted in the school lunch, and school breakfast programs,
and the WIC programs, and they were not.
When you appeared before the subcommittee last year, I
questioned USDA's proposed elimination of funding for the
highly successful Potato Breeding Research Program. Congress,
on a bipartisan basis, not only rejected the elimination of
that program, but rather than zeroing it out, actually
increased it somewhat to $3 million a year.
Given the strong congressional support, I was very
surprised to see that your budget is again proposing to zero
out this program, especially when the administration is seeking
an overall increase of more than $2 billion in discretionary
spending for USDA.
The University of Maine is the leader in the research in
this program, and has worked with growers to develop a new
variety named the Caribou Russet, that is producing high
yields, and is much more disease resistant. And one needs to
look no further than the recent outbreak of the potato wart in
Prince Edward Island in Canada to understand the importance of
continuing to invest in research that produces hardier crops,
and protects our domestic markets.
So my question for you: Given Congress' action last year,
given what a small amount this is in the context of your entire
budget; why are you again seeking to completely eliminate
funding for the Potato Breeding Research Program which has been
proven successful in helping our growers prevent agricultural
and economic losses?
Secretary Vilsack. Senator, I rely on the professionals at
ARS to give me a list of their priorities and, you know, I
think it goes back to my earlier comments about the importance
of investing more money in research, and investing more money
in ARS. I mean the reality is that these have been flatlined
for an extended period of time, and when they are flatlined,
you establish priorities. And obviously if Congress, basically,
directs us to maintain that program we obviously will, but I
would hope that it does so in the context of significantly
increased resources for ARS, including resources to improve the
facilities.
Part of the challenges that we are now facing, we have 118
facility projects roughly 30 of them are either fully or
partially funded, that leaves quite a few that aren't. And so
it is a matter of resources. But if we have more resources, we
can do more work.
Senator Collins. Well, I am going to give you the chart
that I always hand out on potatoes. And which you have received
from me previously, but it doesn't make sense you end up
spending more money if you have to provide disaster assistance,
or other kinds of assistance, than if you invest upfront in the
research that produces a more disease-resistant crop.
Secretary Vilsack. Well, Senator that would be true if that
was the only crop that we had to be concerned about, and the
only research project, but it is not, that is the problem. We
have, as we have already discussed here today, a multitude of
disasters and challenges, and that is the issue. If we have
more resources, then we can obviously cover more research
projects.
Senator Collins. But potatoes do not receive crop support
money, they do not receive price support.
Secretary Vilsack. They don't receive that support.
Senator Collins. They don't.
Secretary Vilsack. But there is 9.9 billion pounds of food
that we purchase through our commodity purchasing programs,
which includes potatoes. So in a sense there is also that kind
of support. Sometimes there is a tendency to forget that the
other ways in which we provide assistance for specialty crops
that is one way, not the only way.
Senator Collins. I just, you know, when I look at your
previous efforts to eliminate the University of Maine's
Agricultural Lab altogether during the Obama administration,
and restrict the use of potatoes, despite the Institute of
Medicine's study, that there was no basis for doing so.
Secretary Vilsack. That that wasn't the reason for the WIC
decision, as we have explained before. It was a situation where
we were trying to encourage folks to purchase those items that
they would not otherwise purchase with their own resources. It
wasn't that we didn't think potatoes were nutritious,
obviously, and we have just most recently expanded
opportunities for potato exports in Mexico. So it is, you know,
I have nothing against potatoes.
Senator Collins. Well, it feels like it. I can tell you.
Thank you, Madam Chair.
Senator Baldwin. Senator Braun.
Senator Braun. Thank you, Madam Chair. You know,
agriculture has gotten so complicated. I mean, didn't grow up
on a farm but have lived on one ever since I moved back to my
hometown. Fell in love with the forestry side of agriculture.
In Indiana we were probably 90 percent forested at one time,
and got through subsistence farming, cut down to like 5
percent.
It is kind of reforested to the tune of about maybe 30- 35
percent, and value-added it is equal to, if not exceeds, the
value-add that you get from row crops. I think that is
something that most people don't understand. They see the vast
fields of corn, and soybeans. So I think it is important to
keep that in mind, to keep our forest owners healthy, and to
make sure that is as important part of the equation as the row
crop side is.
Since that is simple, the trees just grow and get larger,
don't involve any inputs, you know, and it is kind of a
generational crop. What I hear most about currently is two
things. It would be the concentration of AG when it comes to
industries across the input spectrum that used to have so many
local options, fewer and fewer companies.
I think that is something that we got to be aware of. The
individual farmer has had to go from small acres to many acres
to keep economic--economy of scale in place, frustrated each
year that they have maybe got fewer options.
I would like your comment on, is that side of farming in
peril because markets aren't as broad and available as they
used to be? We recently discussed it in the AG Committee on the
meatpacking industry. Would you want to weigh in on that?
Secretary Vilsack. Well, Senator, I think there are two
issues here. One, you have identified, which is the
concentration, and that is absolutely true. You know, we are
dealing with fertilizer issues right now. That is a very
concentrated industry at this point, the processing industry,
and we are trying to address that with some of the work that we
are doing at USDA.
I think the second issue, and you also alluded to it, is
the fact that there is a limited number of ways in which
farmers today profit. They grow crops and sell them, or they
grow crops and feed to the livestock, and sell the products of
livestock. What we need to do is be able to create additional
ways in which profit centers and income sources can come from
the farm.
That is why your work, and Senator Stabenow's work, and
others on the Climate-Smart Agriculture effort was important,
because it basically creates the platform, and the structure
for that possibility, that climate and climate-related
activities could create a revenue stream, an opportunity.
The conversion of agricultural waste to chemicals,
materials, fabrics, and fibers also creates another new revenue
stream that we are in the process of trying to support. So I
think the key here is for us to address the concentration issue
but also to address creating multiple income streams on the
farm.
Senator Braun. I think that is very important. Any business
that prospers over time, I can tell you, I ran one for 37
years, whatever you are knocking it out of the park with
currently, is sure to be different five to 10 years down the
road. And agriculture is a monoculture in terms of really what
you have been used to doing; it has got to reflect what you are
talking about.
The other real concern I hear, which is palpable was what
farmers are going to do in 2023. Let us put the cost aside.
That was a big challenge this year. Most ended up getting the
inputs they needed to get a crop out. With the current dynamic
in place, with our dependency on certain inputs that look like
they are in places of peril, do you think farmers will be able
to get the inputs for 2023, setting the cost aside? I hear real
concern about, they just limp through 2022, what are we going
to do for 2023?
Secretary Vilsack. Well, one of the things we were looking
at is, whether or not there is a possibility of taking a look
at our storage programs, because there may very well be the
capacity to purchase and store, which farmers could potentially
utilize to get them through a potentially tough 2023 crop year.
Then secondly, obviously, we work on strategies to try to
reduce the amount of these inputs. That takes us into precision
agriculture. I will just share with you, there is sensor
technology that is being developed at Iowa State University
that suggests that 30 percent of the corn acres in America
today, in the Midwest, do not require fertilizer. So if we can
accelerate that kind of research, and accelerate the capacity
of farmers to have that kind of precise information about their
farms, we may be able to get them through a process maybe not
2023, but in the future where they are not as reliant as they
have been on those inputs.
Senator Braun. Leveraging technology and finding new
markets would be the hallmark of any successful sector of our
economy; and never more applicable than in agriculture today.
Thank you.
Senator Baldwin. Senator Hoeven, you are now recognized for
a second round.
Senator Hoeven. Thank you, Madam Chair. Did you already do
your second round? I don't want to jump in.
Senator Baldwin. Yes, I did.
Senator Hoeven. Okay. Good to know, all right.
Secretary, I am concerned about the increase in the TRQ for
sugar, it has been raised twice now, 170,000 tons and then more
recently. I guess in April it was 220,000 tons, and then more
recently another 170,000 tons. That is about a 400,000-ton
increase.
I know that some of this came from production shortfall in
Michigan, but that certainly wouldn't be anything near 400,000
tons. So can you address that?
Secretary Vilsack. Senator, I want to be able to check our
numbers with your numbers, because we are under the assumption
it is a little bit less than what you have outlined. But having
said that, the key here, from our perspective, is to maintain a
proper balance; and the stocks to ratio has historically been
somewhere between 13.5 to 15.5, we got it down to 12.5.
And what we have been able to do with this additional
purchase is to put us within that 13.5 to 15.5 range. And that
is where we are comfortable, where we think the program works
particularly well balancing the equities that are involved.
Senator Hoeven. Okay. Well, we are concerned it is going to
take you above that range, and so again we want to make sure
that that--you know, that those increases do keep it in that
range, and we are not getting above it.
Rural broadband, obviously you have got significant funds
in terms of rural broadband, and obviously it is a priority,
and I think a bipartisan priority so, you know, what is--where
are you at with getting those dollars out, and what is your
plan to do it?
Secretary Vilsack. We made a--so there are two pots of
money, the first pot came from American Rescue Plan, the
Pandemic Assistance Programs, and so forth, that pot has gone
through several rounds. We most recently completed a round. We
received 305 applications for roughly $1.15 billion. Those
applications I think were in the neighborhood of two to three
times that amount. So obviously, great interest.
We also received the bipartisan infrastructure resources of
1.9 billion. We are now taking a look and analyzing the
applications of 305 applications, Senator, to determine whether
or not there is a possibility of accelerating and utilizing
some of the BIL money, in that third round, because essentially
they would potentially qualify for the same requirements. That
would allow us to put several billion dollars into awards to
get action this year.
And then the balance of whatever is left from the
Infrastructure Law, we would announce availability sometime
later this year, for awards, probably, early part of 2023.
Senator Hoeven. Being around four, or would that be----
Secretary Vilsack. It would three and----
Senator Hoeven. You would just keep going?
Secretary Vilsack. Right.
Senator Hoeven. In other words, you are going to continue
on?
Secretary Vilsack. Yes.
Senator Hoeven. Okay. And so when do you anticipate funding
announcements then for round three?
Secretary Vilsack. This summer.
Senator Hoeven. This summer.
Secretary Vilsack. We are going to complete the--we would
be able to make these announcements sooner, but we want to see
whether or not there is a way of accelerating the BIL money
into this round. And that requires us to analyze where these
applications are, you know, how many of them would, in fact,
qualify.
And it just--it is going to take some time. But we think by
the latter part of this month we will have a better
understanding of how much of that BIL money could actually be
incorporated in this round.
Senator Hoeven. Okay.
Secretary Vilsack. And then that will be the set of
announcements this summer.
Senator Hoeven. All right. On the child nutrition waivers,
what steps are you taking as we get back to the traditional
program to be ready for next year, what are you doing?
Secretary Vilsack. Let me tell you something, Senator, this
is going to be chaotic. Just make no mistake about it, the
failure to have these waivers is going to create a lot of chaos
in schools across the United States. There is, very limited
things that we can do, we don't have the flexibility to provide
waivers to the extent that we have provided them, very, very
limited.
We can't increase the reimbursement rate, we can't expand
universal free school meals, so we will focus on community
eligibility, we will focus on the limited waivers that we have,
we will take a look at any additional capacity we have with
resources in terms of commodity purchases, but schools are
going to have a very difficult time. Make no mistake about it.
Senator Hoeven. So Madam Chair, I have a couple questions
left that I do want to ask--but I am happy to defer if you want
to. But then, I would like another shot at it.
Senator Baldwin. We can give you a special third round.
Senator Hoeven. Fantastic.
Senator Baldwin. Senator Hyde-Smith.
Senator Hyde-Smith. Mr. Secretary, in recent years this
subcommittee has made just historic investments in developing
methods to better understand, and detect, and respond to
chronic wasting disease. And, you know, an incurable, always
fatal disease affecting the white-tailed deer, and other
members of the deer family. Historically, there have been many
questions and unknowns about the disease, but thanks to the new
CWD research being conducted by USDA, and its university
partners, along with the better surveillance and response
efforts carried out by the states' wildlife agencies; we are
starting to make great strides in CWD.
And hunting and outdoor recreation contributes billions to
the American economy, more than 2.7 billion in annual economic
output in Mississippi alone. Would you agree that our
investments in CWD are paying off, that we are seeing a
positive return on our investments? And would you agree that we
need to continue investing in activities related to chronic
waste disease in fiscal year 2023, and beyond that?
Secretary Vilsack. I think I would answer that yes, yes,
and yes. I think you asked three questions. Yes. We have got 35
herds, there is no vaccine or cure yet, it is in 25 states,
there is a need for more and additional resources, those
resources will allow us to do more surveillance, more testing,
more management, and hopefully more responsive activities. So
clearly we need additional resources.
Senator Hyde-Smith. Thank you very much.
Thank you, Madam Chairwoman.
Senator Baldwin. Senator Hoeven.
Senator Hoeven. I want to commend Senator Hyde-Smith, just
in general, but here specifically for setting up my question.
Which is, we have legislation to do more with chronic wasting
disease, it is bipartisan. Martin Heinrich's lead on the
Majority side, but we have got others on both sides of the
aisle.
So clearly you would, based on your last comment, support
that legislation which would provide more funding for research,
relative to chronic wasting disease, because it affects both
domestic and wild animals.
Secretary Vilsack. Yes.
Senator Hoeven. Okay, great. FCIS--excise me--FSIS
overtime, we have got food safety, and inspection challenges I
mean we have workforce challenges everywhere, right, but with
our inspectors in FSIS we have some challenges, and so we
included some provisions that give you more flexibility so
where are we at with implementing that?
Secretary Vilsack. It is implemented, Senator, the problem
is, it is a 1 year--you have got to do it every year.
Senator Hoeven. Right.
Secretary Vilsack. But it does give us a tremendous amount
of flexibility, and it makes it a little bit easier, reduces
the stress, workers still have the option of working those
overtime hours, but if for whatever reason they are just spent,
this gives us the ability to continue to keep the plan open but
have the flexibility to have the inspectors on staff, who want
to be there.
Senator Hoeven. Which is something you need right now.
Secretary Vilsack. Absolutely.
Senator Hoeven. Yeah. Okay. And then, my last question
relates to the--is also a workforce question, and that is
getting the H-2A-eligible people through the process, and on
the job. And there two aspects to it, one, as for some of the
Ukrainians that are coming, you know, Ukraine is so similar to
us in terms of their AG base, as a matter of fact some of their
livestock, and so forth, come from my state where we have
actually--some of our producers have flown breeding stock over
on 747s, if you can believe that, and you maybe have seen some
of that. It is unbelievable.
Secretary Vilsack. Well, Iowa started that a long time ago.
Senator Hoeven. Yeah. I figured you probably have been
involved with it too. It is really impressive.
Secretary Vilsack. We did it in Japan in the--when they had
a typhoon back in the 1960s.
Senator Hoeven. Yeah. But you would think they would go by
boat, but they actually put them on these huge aircrafts. It is
amazing.
Secretary Vilsack. Yeah.
Senator Hoeven. Yeah. You mean when pigs fly, right, how
crazy is that?
Secretary Vilsack. Yeah, they did, they really did.
Senator Hoeven. You have probably said that a few times as
governor. But you didn't mean it literally, necessarily. But it
is both processing these H-2A applications which we need to get
these folks, who are eligible, through the system, and in a lot
of cases are folks that have come before. And you know the need
out there for workers in the AG area.
So utilizing some of these Ukrainians that are coming here,
expediting their ability to get those work permits would be
good for them, good for us. That is one aspect of the question.
Then the other is, in terms of some flexibility in the work, in
that they can be out there and do fieldwork, and that kind of
stuff, or on farm work, but then we also need folks in the
processing plants, and their visa doesn't necessarily allow
them to do both, but it is really very--you know, it is just a
continuation of pretty much the same thing.
And it has some of the seasonality to it. So in is there a
way we can, maybe, do both of these things to kind of help with
the labor issue?
Secretary Vilsack. You know, I will make you a deal,
Senator.
Senator Hoeven. Sure--well, maybe.
Secretary Vilsack. I will help you with this problem if you
can get your colleagues to vote on the AG Workforce
Modernization Act, and actually get these things solved in a
permanent way. This is nuts. This is just crazy what is going
on here with the workforce.
We are sort of nickleing-and-dime it, we are putting a
Band-Aid on it, we are constantly talking about H-2A, when we
all know that, fundamentally, we have got to fix the
immigration system, and the AG community and the labor
community has come and said: Here is the fix that we would like
to see in our part of the industry, and it passes the House in
a bipartisan way. I just don't understand why it can't pass
this body.
Senator Hoeven. Well, it gets pulled into everything else,
you know that. But in the meantime though----
Secretary Vilsack. But why? Why does it get pulled into
everything else?
Senator Hoeven. Well, you know how that--you know how that
process works here, but in the meantime are these some things
we can do?
Secretary Vilsack. In the meantime we will work--in the
meantime we will continue to look for ways in which we can try
to alleviate the stress, but it is a temporary fix; it is not
going to solve the problem, it is not going to relieve the
underlying lack of confidence that farmers now feel. They just
don't know if they are ever going to have the workforce. And
they are they are scared about this. They are really concerned
about it.
Senator Hoeven. Well, and that is where the merit-based
aspect comes in that is very important. But again, our guys are
concerned about getting these folks through the system people
who are eligible now, and so we need your help on it.
Secretary Vilsack. I am happy to help.
Senator Hoeven. Good.
Secretary Vilsack. And I would hope that you will help me
get 59 other Senators to vote for the AG Worker Modernization
Act.
Senator Hoeven. Thanks for your work on all these things,
Secretary. We have had opportunity to work together as
governors, 8 years during the Obama administration, and so I do
appreciate your help on these things, thanks; and thank you for
being here today. And to your crew, to people like Zach
Ducheneaux, you have a lot of folks out there working really
hard for our farmers, and ranchers. And so I want to express my
appreciation for that.
Secretary Vilsack. Thank you, Senator.
Senator Baldwin. And Mr. Secretary, I want to add my words
of thank you, to both you and Mr. Rapp for being here today. I
think we had a good discussion, and I look forward to
continuing to work with you as we begin the appropriations
process for fiscal year 2023.
ADDITIONAL COMMITTEE QUESTIONS
Questions for the record are due by next Tuesday, May 17th,
and we would appreciate responses from the USDA within 30 days.
Secretary Vilsack. Madam Chair.
Senator Baldwin. Yes, you may.
Secretary Vilsack. Can I say just one thing? Because
Senator Hoeven was not here, I don't think, when I gave my
opening comments, and maybe he got in at the tail end.
Senator, I just want to leave with you the same statistic
that I left with the rest of the committee members. 61,670 farm
families are currently on the brink, these are people that have
borrowed money from USDA that are either delinquent, bankrupt,
or pending foreclosure. And it is an issue that we have got to
address.
Thank you, Madam Chair.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Dianne Feinstein
supply chain disruptions
Question. Supply chain disruptions over the past year have resulted
in massive losses for the agricultural industry, particularly in
California. A study out of UC Davis indicated that the California
agriculture sector lost $2.1 billion from May through September of last
year alone because of their inability to export products. These losses
are compounded by rising input costs, including more expensive gasoline
and fertilizer.
Secretary Vilsack, what is your Department doing to support the
agricultural sector during this unprecedented disruption to our export
capabilities, particularly the many California farmers who grow
perishable crops and have lost more than $2 billion as a result?
Answer. USDA is acutely aware that fewer shipping containers have
been made available for U.S. agricultural commodities as ocean carriers
have circumvented traditional marketing channels. To this end, earlier
this year, I announced plans to increase capacity at the Port of
Oakland in Oakland, California, and improve service for shippers of
U.S. grown agricultural commodities. Part of this effort included
helping establish the Howard Terminal ``pop-up'' site at the Port of
Oakland, which is providing space to prepare empty containers.
Specifically, USDA's Agricultural Marketing Service (AMS) covered 60
percent of the start-up costs for the pop-up terminal. Through the use
of Howard Terminal, agricultural companies and cooperatives have easier
access to containers, which they can fill with commodities; this
additional capacity will help relieve congestion and restore shipping
services.
On May 25, 2022, USDA shared that it would also begin accepting
applications for the new Commodity Container Assistance Program (CCAP),
which includes partnerships with both the Port of Oakland and the
Northwest Seaport Alliance, a marine cargo operating partnership in
Washington State. Under CCAP, USDA's Farm Service Agency (FSA) is
providing a $125 per container payment to partially assist agricultural
commodity owners for the additional logistical expenses associated with
picking up empty shipping containers to be filled with agricultural
commodities and products at the Port of Oakland. FSA is also providing
payments of $200 per dry container and $400 per refrigerated, or
reefer, container to help cover additional logistical costs associated
with moving a shipping container twice, first to the preposition site
and then to the terminal loading the vessel, along with cost of
temporary storage. FSA will make monthly direct payments to
agricultural companies and cooperatives on a per-container basis, based
on the location of the port and the type of shipping container.
Additional information about CCAP can be found at farmers.gov/pandemic-
assistance/CCAP.
Ongoing market disruptions have created logistical challenges
associated with the availability and flow of shipping containers to
transport agricultural commodities, which has prevented or delayed
American-grown agricultural commodities from reaching their markets.
USDA continues to work with industry partners throughout the supply
chain to relieve the disruption created by the COVID-19 pandemic. The
following are examples of additional USDA activities to support
solutions to best address specific challenges agricultural producers
are facing along the supply chain:
--USDA formed partnerships with several west coast ports as part of
the Administration's Supply Chain Task Force efforts with State
and local governments and builds on earlier efforts including a
US Department of Transportation partnership with the Port of
Savannah in Georgia. The benefits of relieving congestion and
addressing capacity issues at ports through partnerships go
well beyond the local region, as commodities and agricultural
products grown and processed from thousands of miles away flow
through these ports.
--Beyond the CCAP program described above, USDA continues to seek
opportunities to partner with additional ports or other
intermodal container facilities to help American farmers and
agricultural producers move their product to market and manage
the short-term challenges while pressing the ocean carriers to
restore better levels of service.
--USDA will also continue to partner with other Federal agencies and
State and local governments to address port operation
challenges resulting from the ongoing pandemic.
--As Secretary, I've pressed executives of five major ocean carriers
to address concerns about service and availability raised by
agricultural exporters, and encouraged greater cooperation with
agricultural export efforts, including committing to providing
needed empty containers.
--USDA will announce its Food System Transformation framework on June
1, 2022, targeted at strengthening critical domestic supply
chains and addressing structural challenges that benefit
consumers, producers, and rural communities, including
California farmers. USDA is limited in its domestic use of
market development funds to address supply chain issues.
Programs such as the Market Access Program (MAP), Emerging
Markets Program (EMP), and Technical Assistance for Specialty
Crops (TASC) assist California farmers who grow perishable
crops with increasing their export capabilities.
--The Farm Bill authorized Market Access Program, administered by the
Foreign Agricultural Service, provides Commodity Credit
Corporation (CCC) funding to U.S. commodity and trade
associations to aid in developing, expanding, and maintaining
foreign markets for U.S. agricultural commodities and products.
For fiscal year 2022, USDA awarded $28.4 million of this $200
million program to 16 non-profit California trade organizations
and cooperatives to promote U.S. agriculture products. Despite
supply chain issues causing a dent in their export numbers,
recipients continue to conduct export marketing efforts and
build demand for U.S. agriculture and affirm the U.S. is a
consistent supplier of high-quality agricultural goods.
--The Farm Bill authorized Emerging Markets Program, which provides
funding for technical assistance activities intended to
develop, maintain, or expand markets for U.S. agricultural
exports in emerging market countries. The program underwrites
assessments of the food and rural business system needs of
emerging markets and can also fund knowledge transfer
activities aimed at developing the food and rural business
systems in eligible markets. For fiscal Year2022, USDA awarded
$368,560 to support California entities in emerging markets
throughout India, Southeast Asia, Mexico, and South America.
--The Foreign Agricultural Service-administered Technical Assistance
for the Specialty Crops program is designed to assist public
and private U.S. organizations by providing funding for
projects that seek to remove, resolve, or mitigate existing or
potential sanitary, phytosanitary, or technical barriers that
prohibit or threaten the export of U.S. specialty crops. For
fiscal year 2022, USDA awarded $1.2 million to non-profit
California organizations promoting blueberries, avocadoes, and
wine to address technical trade barriers and counterfeiting.
Question. Many school districts across California-and the country-
are already dealing with many challenges because of the pandemic and
disruptions to U.S. supply chains. I appreciate your efforts to
mitigate the impact to children and families of ending nationwide child
nutrition waivers on June 30, 2022.
Secretary Vilsack, can you discuss the impact that the loss of the
waivers will have on children, families, and schools this summer and
during the 2022-2023 school year, and do you think that there is still
a need for the Senate to extend your nationwide child nutrition waiver
authority?
Answer. In March 2020, Congress first provided USDA with the
authority to waive the statute and regulations for Child Nutrition
Programs through the Families First Coronavirus Response Act of 2020
(the FFCRA), and later through the Continuing Appropriations Act, 2021
and Other Extensions Act. These Acts allowed USDA to address the urgent
need for nutrition assistance during the COVID-19 pandemic by granting
USDA broader waiver authority than provided through Section 12(l) of
the National School Lunch Act, including the ability to grant waivers
nationwide and allow waivers that increased program costs. These
waivers allowed us to equip schools and other program operators with
resources and operational flexibilities that are still desperately
needed as our schools still grapple with the ongoing challenges
resulting from the pandemic. However, this authority expires June 30,
2022, and Congress has not been able to reach a deal to extend those
vital waivers yet. This means USDA can no longer offer the full range
of waivers that are currently available.
We know that Child Nutrition Program operators, including schools,
childcare providers, and community organizations, are still facing
tremendous challenges, and USDA has worked as quickly as possible to
identify everything we can do within our permanent statutory authority
to support them in this transition. Unfortunately, without the broader
nationwide waiver authority, our toolbox is limited.
Going forward, USDA won't be able to offer the full range of
waivers that have been available to schools, child and adult care
providers, and summer meal providers. Without the waiver to provide all
students meals that are reimbursed at the free rate and the waiver
providing the higher reimbursement rates for schools, we estimate that
the average school will see a 40 percent decrease in the reimbursements
they receive next school year. In addition, we expect average
reimbursement rates for CACFP family day care homes to drop starting
July 1, 2022, due to the lapse in waiver authority that allowed some
providers to receive higher reimbursements, many summer meals and at-
risk afterschool sites will no longer be able to operate as they are
located in areas that are not eligible for participation without the
waivers.
USDA is able to issue waivers on a State-by-state basis under the
permanent Child Nutrition waiver authority found in Section 12(l) of
the National School Lunch Act when certain conditions are met,
including that the waiver cannot increase the cost to the Federal
Government. Therefore, USDA has offered, on a State-by-state basis,
some ``no cost'' flexibilities that were previously available
nationwide. We are hearing from our stakeholders that the flexibilities
USDA is able to offer this summer and next school year simply don't
address all the challenges schools and other operators are facing and
will face in the fall. USDA would need additional waiver authority,
similar to the authority provided in FFCRA, to address ongoing critical
needs and meet our program operators where they are.
We are deeply concerned that without additional support, school
meal programs will struggle to manage the serious challenges they are
facing. The school meals marketplace has some specific features which
make it particularly vulnerable to current market disruptions. We have
engaged extensively with stakeholders, including school nutrition
professionals, industry representatives and others, who report numerous
concerns. School districts are putting out bids for next school year
and getting no responses, and many items, both food and supplies, are
very difficult to obtain. School nutrition staff report turning to
local retail outlets or other sources at the last minute to obtain
items needed to maintain meal service. School districts have unique
transportation, storage and distribution needs, and those networks are
extremely strained. Finally, school meals programs consistently report
major challenges with staff vacancies.
As a result, we are very concerned about program operators' ability
to maintain the high standards of quality, customer service, and
nutrition support which our students need and deserve. Schools will
likely be forced to reduce menu offerings and will likely have to
repeat service of available items very frequently. Popular items may be
unavailable, and schools will be forced to make substitutions of less
favored products, often on the day of service, frustrating students and
parents by not providing what is expected. Nutrition quality may suffer
if schools are unable to obtain the range of products needed to provide
healthy meals and instead must rely on whatever is available to them,
but waivers would help mitigate this concern. In this environment,
schools may struggle to maintain participation levels, further
exacerbating their financial challenges caused by the expiration of the
waivers.
While we do not necessarily expect large-scale exit from school
lunch and breakfast programs, we are concerned that more will consider
scaling back on other critical nutrition programs, such as after-school
snack and supper programs. We are also concerned that the return to
application-based programs will likely result in a rise in unpaid meal
charges, as eligible families who have not had to apply for free or
reduced-price meals for 2 years may be slow to do so. This would
further strain school meals programs financial status, as well as
increase the potential for ``lunch shaming'' whereby students without
funds to pay for a meal are denied service or otherwise singled out.
______
Question Submitted by Senator Patrick J. Leahy
partnership for climate smart commodities
Question. On February 7, 2022, the USDA announced the Partnerships
for Climate-Smart Commodities program, which will finance partnerships
to support the production and marketing of climate-smart commodities.
The pilot projects, which will last between one and 5 years, will
provide technical and financial assistance to producers, and pilot
innovative and cost-effective methods for quantification, monitoring,
reporting, and verification of greenhouse gas benefits.
The effects of climate change will vary geographically. We know
that agriculture is one of the most vulnerable sectors to climate
change in New England and in Vermont, specifically. Rising temperatures
and changes in water availability hit hard for a region that is home to
so many dairies, maple syrup, and small and diversified farming
operations. These farms may not, individually, fall within the typical
definition of ``commodity scale'' production. Would you agree that the
challenges related to climate change are regionally distinct, and that
as a result of being so, can you promise that Partnerships for Climate-
Smart Commodities will consider pilot projects in a variety of
geographic areas, including New England and the Northern Forest?
Answer. As you can see through the funding opportunity, there are a
variety of goals and objectives of the Partnerships for Climate Smart
Commodities. USDA intends to fund a diverse set of projects and will
not discriminate based on size of the project. Diversity of
applications, including geographic diversity and size and scale of
projects, will be considered when making award decisions. USDA will
select a variety of projects so that this emerging marketplace starts
out with robust competition and options for producers.
______
Questions Submitted by Senator Brian Schatz
illegal logging
Question. Illegal logging and associated trade has been ranked as
the third-largest global transnational crime after counterfeiting and
drug trafficking, generating between $52-157 billion per year. In many
tropical countries, over half of deforestation is illegal. Left
unaddressed, persistent illegality and impunity undermine all
conservation and climate efforts, including the recent pledge by the
United States and 140 countries to halt and reverse forest loss by
2030.
In 2008, the United States, the world's largest consumer of forest
products, became the first country to ban trafficking of products
containing illegally sourced wood. The Lacey Act Amendments of 2008
were adopted with bipartisan support and have demonstrated their
potential for impact. Yet unacceptable delays in full implementation
and sporadic enforcement continue to limit their effectiveness.
In 2009, the Department provided a schedule where major product
categories would be phased in by September 30, 2010.\1\ However, the
current Lacey Act declaration requirements, which are managed by USDA
APHIS, still only apply to approximately 42 percent of the value of
wood products imported into the United States. This leaves $45 billion
of annual imports subject to the prohibition in the Lacey Act, in
practice, uncovered by the declaration requirement. This includes
nearly all imports of wooden furniture, pulp and paper, particleboard,
and fiberboard. It is long past due that APHIS fully implement the
Lacey Act Amendments of 2008--and there a growing chorus from industry,
civil society, and lawmakers to complete this phase in by the end of
2022.
---------------------------------------------------------------------------
\1\ https://www.federalregister.gov/documents/2009/02/03/E9-2232/
implementation-of-revised-lacey-act-provisions
---------------------------------------------------------------------------
What is your plan to phase in all outstanding plant and wood
product categories--including wood furniture, pulp and paper,
particleboard, and fiberboard?
Answer. I agree that illegal logging and the resulting
deforestation are enormous problems. The scope of the material covered
by the Lacey Act is also significant-APHIS currently receives
approximately 1 million declarations each year (1.1 million in fiscal
year 2021) but estimates that when the declaration requirement is fully
implemented, the number could be as high as 12 million per year. Prior
to fiscal Year2022, APHIS' annual appropriation for the Lacey Act was
$1.9 million. APHIS implemented the program and rolled out the
declaration requirement in six phases, starting with raw wood and
working towards more processed products. APHIS also worked to implement
an electronic filing system for the Lacey Act and to connect it to the
Department of Homeland Security's (DHS) Customs and Border Protection's
(CBP) Automatic Commercial Environment (ACE) system to allow for more
efficient processing of declarations.
The program's annual appropriation supported the development and
maintenance of the electronic filing system and staff. Additionally,
APHIS works cooperatively with industry groups to effectively implement
the declaration requirements, including reaching out to industry ahead
of time to learn about the details of their supply chains, storage, and
manufacturing processes. The most recent implementation phase; Phase 6
covering wooden pallets and essential oils among other products, was
originally to be effective October 1, 2020, but it took an additional
12 months due to issues raised by the pallet industry and the
government of Canada. Our lessons learned from Phase 6 show that adding
more products to the implementation schedule will require significant
outreach to launch effectively, a minimum of 12 months. Accordingly,
APHIS will not be able to incorporate additional products by the end of
fiscal year 2022.
Question. If your plan is not to complete the full phase in by the
end of 2022, please explain why this deadline is not attainable?
Answer. The Agency has a plan to add remaining products in two
large phases and appreciates the additional funding provided for the
Lacey Act in the fiscal year 2022 appropriation, which will allow the
program to expand capacity to handle additional declarations. Phase 7
will include as many non-composite products as possible, including
furniture, remaining essential oils, baskets, cribs, and cabinets,
among other products. Phase 8 would then include the remaining
products, those made with composite materials that include mechanically
or chemically broken-down materials such as pulp and paper,
particleboard, and fiberboard, among others. Many composite plant
materials are currently manufactured in a manner that makes
identification of the genus, species, and country of harvest of the
plant content extremely difficult and costly. APHIS is continuing to
evaluate and address the issues associated with composite products.
______
Questions Submitted by Senator John Hoeven
national accuracy clearinghouse for food and nutrition progams
Question. As you know, the 2018 Farm Bill established the National
Accuracy Clearinghouse (NAC) in order to prevent duplicate receipts of
the Supplemental Nutrition Assistance Program (SNAP) in more than one
state. I remain concerned about the implementation delay for the NAC.
Can you explain the reasons for the delay and how the Department
intends to implement the statute before Congress writes the next Farm
Bill?
Answer. Food and Nutrition Service (FNS) is committed to ensuring
the NAC is built and deployed with maximum effectiveness for long term
program integrity. We take seriously our responsibility to do this in a
way that minimizes burdens on participants and delays in benefit
determination and leverages optimal security arrangements using the
latest and best technology to protect the personally identifiable
information (PII) of SNAP participants.
In its original design, the NAC would have stored the names, social
security numbers, and dates of birth of all SNAP participants
nationwide. While all appropriate security protocols were included in
the design, the Department decided to pause development in June of
2021, to explore options to enhance the protections for applicants and
participants by revising the technical requirements of the system to a
solution that does not store PII. On July 2, 2021, FNS briefed staff
for the House and Senate Agriculture and Appropriations Committees on
the Department's decision.
The updated NAC system design provides a method for States to de-
identify the name, social security number, and date of birth of
individuals before sharing this information to the NAC through a
privacy-preserving record linkage (PPRL) process. The PPRL process
accurately matches individuals, while preventing the collection and
storage of PII in the NAC system.
The first four States expected to implement the NAC (Iowa,
Louisiana, Massachusetts, and Montana) are already working closely with
the NAC project design and development team. These initial adopters of
the Nationwide NAC have committed to making the necessary technical and
programmatic changes to implement the NAC matching processes as part of
the initial system launch planned for December 2022.
Question. Has the Food and Nutrition Service (FNS) considered
allowing States to use the NAC data for other programs such as TANF,
Medicaid, and CHIP?
Answer. The 2018 Farm Bill provision that required the
establishment of the NAC (Sec. 4011) specified that NAC data shall be
used only ``to prevent multiple issuances of supplemental nutrition
assistance program benefits to an individual by more than 1 State
agency simultaneously.'' Nevertheless, we are mindful that if
successful, other programs may want to consider building upon the NAC
framework.
dietary guidelines for america
Question. The Consolidated Appropriations Act of 2021 required,
within 1 year of enactment, the National Academy of Sciences,
Engineering, and Medicine (NASEM) to complete a detailed review of the
development of the 2020 edition of the Dietary Guidelines for Americans
(DGAs), and to provide a report to the Secretary of Agriculture, the
Secretary of Health and Human Services and Congress. However, this
report is now months overdue.
Regardless, the Departments of Agriculture and Health and Human
Services have moved forward in initiating the next 2025 DGA process by
proposing scientific questions and calling for public comment without
having the benefit of NASEM's review of the 2020 process.
When can Congress expect the full NASEM report, and will Congress
receive notice and briefings on it?
Answer. It is my understanding that NASEM will provide Congress
with the study's midcourse report on May 18, 2022. NASEM requested an
extension to complete the study, and the committee now expects to
submit its final report to Congress by the end of this calendar year.
NASEM has told us it is their standard practice to offer Congress a
briefing on its study Committee's work. USDA is also happy to brief
Congress on the midcourse report that will be released publicly on May
19, 2022, and on the final report once we receive it ourselves.
Question. Given the Departments, relevant Congressional committees,
the scientific community, and general public have not first had the
benefit of learning from the NASEM report on the 2020 guidelines, do
you believe it may be premature to move forward with the 2025 DGA
process?
Answer. While the DGA is published every 5 years, the work to
develop each new edition is a multiyear process. In order to ensure we
release the next edition of the DGA on time, as mandated by Congress,
we had to begin work when we did, particularly to ensure we have enough
time to give the public ample opportunities to weigh in and participate
throughout.
The purpose of the NASEM study currently underway is to assess the
process for developing the 2020-2025 Guidelines in light of the 2017
NASEM study recommendations. While the current NASEM study will not
include recommendations on the process to develop the Dietary
Guidelines for Americans, continuous quality advancement is critical to
our work, and we'll continue to work towards integrating the
recommendations from the 2017 NASEM study into our process as we move
forward.
We appreciate the ongoing work by NASEM on this analysis, described
in the midcourse report, and look forward to the final report once it
is published. This is one of many tools we will use to help support our
continuous process improvement and promote science-based decision
making across all that we do.
rural partners and strikeforce
Question. Rural Partners/Strike Force, the Fiscal Year 2022
Appropriations bill provided Rural Development up to $5 million for the
Rural Partners/Strike Force program.
Please provide a detailed budget breakout for the fiscal year 2022
funding, as well as a breakout of the fiscal year 2023 budget request.
The information should include a breakdown of FTE costs associated with
the proposal (including Salaries/FERS expenses) both at Headquarters
and in the field, information technology needs, funding provided to
other Federal Agencies/Departments, and funding provided to outside
groups.
Answer. The Rural Partners Network is a first-of-its-kind
collaboration between Federal agencies and local leaders and residents.
This Network is focused on improving social and economic well-being
bolstered by existing local partnerships and assets. The Network will
launch in selected communities in Georgia, Kentucky, Mississippi, New
Mexico as well as certain Tribes within Arizona. Community networks
within these States will receive individualized support with the
expertise to navigate Federal programs, build relationships and
identify additional resources to promote community-driven solutions.
The table below displays how the funding will be used to support
this effort:
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
______
Questions Submitted by Senator Mitch McConnell
grain storage after tornados
Question. Following the devastating tornadoes that hit Kentucky in
December 2021, the FY22 Appropriations bill included report language
that instructed USDA to identify funds to build temporary grain storage
facilities at public and private inland waterway ports for the 2022
harvest season.
Please provide an update on identification of funds for the FY22
directive for a grain storage facility in Kentucky.
Answer. USDA acknowledges the report language in the 2022 Enacted
appropriations; however, we have limited authorities when it comes to
providing funding for temporary grain storage facilities. Grain storage
facilities are commercial in nature, therefore programs such as Rural
Development Community Facilities (CF) programs do not have statutory
authority to support such a project since the CF authorities are
targeted at essential public services and facilities. Within the
Guaranteed Business and Industry Loan program regulation requires
projects to meet credit standards, collateral must be adequate, and the
term of the loan cannot exceed the useful time of the temporary
facility. A short-term project such as a temporary grain storage
facility is unlikely to meet those requirements.
I understand that our staff continue to discuss the need on the
ground and what the best option could be to support the challenges your
producers are facing, given our statutory limitations.
Question. On March 15, 2022, the FY22 Appropriations package, which
began in the Democrat controlled House and was supported by all 50
Democrat Senators, became law. At no point did the Biden Administration
request the extension of COVID-related USDA nutrition waivers. While
legislation to extend these COVID-related waivers carried a cost of $11
billion, several of these waivers can be extended under existing law
with no cost.
Does USDA have authority to issue a State-by-state extension of
these no-cost nutrition waivers?
Answer. USDA is able to issue waivers on a State-by-state basis
under the permanent Child Nutrition waiver authority found in Section
12(l) of the National School Lunch Act when certain conditions are met,
including that the waiver cannot increase the cost to the Federal
Government. Therefore, USDA has offered, on a State-by-state basis,
some ``no cost'' flexibilities that were previously available
nationwide through COVID-related nationwide waiver authority. In
addition, Section 12(l) explicitly prohibits waivers that pertain to
nutrition standards, Federal reimbursement rates, and free/reduced
price meal eligibility. Given these constraints, Section 12(l), cannot
be used to grant a number of waivers that have supported program
operators during the pandemic, including:
--Waivers of area eligibility requirements, which allowed summer and
afterschool feeding programs to operate anywhere, as well as
allow all Child and Adult Care Food Program (CACFP) family day
care homes to receive the higher tier 1 rate;
--Operating the Seamless Summer Option during the school year, which
allowed schools to be reimbursed at the free rate for all meals
served, without having to collect and process applications;
--Offering the higher Summer Food Service Program reimbursement rate
for school meals served during the school year; and
--Waivers of meal pattern requirements.
Although USDA has worked hard to expeditiously approve state
requests for individual waivers that meet 12(l) requirements, USDA is
hearing from our stakeholders that the available flexibilities simply
do not address all of the challenges schools and other operators are
facing this summer and will face in the fall. For example, without the
ability to offer all students meals that are reimbursed at the free
rate or the higher reimbursement rates for schools, we estimate that
the average school will see a 40 percent decrease in the reimbursements
they receive next school year.
In addition, we expect average reimbursement rates for CACFP family
day care homes to drop starting July 1, 2022, due to the lapse in
waiver authority that allowed some providers to receive higher
reimbursements, and many summer meals and at-risk afterschool sites
will no longer be able to operate as they are located in areas that are
not eligible for participation without the waivers. USDA would need
additional waiver authority, similar to the authority provided in
Families First Coronavirus Response Act (FFCRA), to address these and
other ongoing critical needs.
covid state waivers
Question. Which waivers, and for which States, has USDA approved a
no-cost extension in advance of the expected end of the universal COVID
waivers?
Answer. As of May 31, 2022, USDA has approved 884 individual State
waivers related to COVID-19 using the waiver authority in Section 12(l)
of the National School Lunch Act. These approvals reflect the requests
submitted by each individual State; therefore, the specific waivers
approved vary by State. Waivers approved using 12(l) authority may not
increase costs to the Federal Government.
For the Summer of fiscal Year 2022 and School Year 2022-23, waivers
include:
Summer Food Service Program/Seamless Summer Option:
--Non-Congregate feeding
--Parent/Guardian Pickup
School Lunch and Breakfast:
--Non-Congregate feeding
--/Guardian Pickup
--Meal Service Times
--Offer Vs. Serve
School Meals Administration:
--Local School Wellness Policy Triennial Assessment
--Food Service Management Company Contract Duration
--Administrative Review Onsite Requirements
Reporting Requirements:
--Second (Independent) Review
--Administrative Review Data
Special Milk Program:
--Non-congregate Milk Service
--Parent/Guardian Milk Pickup
Fresh Fruit and Vegetable Program:
--Parent/guardian Fresh Fruit and Vegetable Program Pickup
--Alternate Site
--Unanticipated School Closures (USC):
--Non-congregate Meal Service during USCs
--Parent/Guardian Pickup during USCs
--Meal Service Time during USCs
Child and Adult Care Food Program:
--Non-congregate Meal Service
--Parent/Guardian Pickup
--Meal Service Times
--State Agency On-Site Monitoring
--Sponsoring Organization Monitoring On-Site
Additional Flexibilities:
--Paid Lunch Equity
--Carryover Eligibility
States requesting Child Nutrition operations waivers include those
displayed on the following table:
State Agencies Requesting Child Nutrition Operating Waivers for Summer
2022 and School Year 2022-23 as of May, 2022
------------------------------------------------------------------------
Total
number of
State Agency waivers
requested
------------------------------------------------------------------------
Alaska Department of Education and Early Development; 20
(DEED)....................................................
California Department of Education; (CDE).................. 19
California Department of Social Services; (CDSS)........... 5
Colorado Department of Education; (CDE).................... 19
Colorado Department of Education; (CDE).................... 21
Colorado Department of Public Health and Environment; 5
(CDPHE)...................................................
Connecticut State Department of Education; (CSDE).......... 24
DC Office of the State Superintendent of Education; (OSSE). 26
Delaware Department of Education; (DDOE)................... 24
Georgia Department of Early Care and Learning; (DECAL)..... 10
Georgia State Department of Education; (GaDOE)............. 17
Georgia State Department of Education; (GaDOE)............. 2
Hawaii State Department of Education; (HSDOE).............. 20
Idaho Department of Education; (IDE)....................... 3
Idaho Department of Education; (IDE)....................... 3
Idaho Department of Education; (IDE)....................... 2
Illinois State Board of Education; (ISBE).................. 24
Illinois State Board of Education; (ISBE).................. 2
Indiana Department of Education; (IDOE).................... 24
Kansas State Board of Education; (KSDE).................... 21
Kansas State Board of Education; (KSDE).................... 2
Kentucky Department of Education; (KDE).................... 15
Louisiana Department of Education; (LA DOE)................ 24
Maine Department of Education; (Maine DOE)................. 24
Maine Department of Education; (Maine DOE)................. 2
Maryland Department of Education; (MSDE)................... 23
Massachusetts Department of Elementary and Secondary 24
Education; (MA DESE)......................................
Massachusetts Department of Elementary and Secondary 2
Education; (MA DESE)......................................
Michigan Department of Education; (MDE).................... 22
Nevada Department of Agriculture; (NDE).................... 24
Nevada Department of Agriculture; (NDE).................... 2
New Hampshire Department of Education; (NHDOE)............. 15
New Hampshire Department of Education; (NHDOE)............. 2
New Jersey Department of Agriculture; (NJDA)............... 24
New Jersey Department of Agriculture; (NJDA)............... 2
New York State Department of Health; (NYDOH)............... 5
New York State Education Department; (SED)................. 19
New York State Education Department; (SED)................. 2
Ohio Department of Education; (ODE)........................ 24
Ohio Department of Education; (ODE)........................ 26
Oregon Department of Education; (ODE)...................... 24
Oregon Department of Education; (ODE)...................... 26
Pennsylvania Department of Education; (PDE)................ 24
Pennsylvania Department of Education; (PDE)................ 2
Puerto Rico Department of Education; (AESAN)............... 6
Rhode Island Department of Elementary and Secondary 23
Education; (RIDE).........................................
Rhode Island Department of Elementary and Secondary 2
Education; (RIDE).........................................
South Carolina Department of Education; (SCDE)............. 19
Tennessee Department of Education; (TDOESNP)............... 19
Tennessee Department of Human Services; (DHS).............. 11
Texas Department of Agriculture; (TDA)..................... 22
Texas Department of Agriculture; (TDA)..................... 24
Vermont Department of Education; (VTAOE)................... 24
Virginia Department of Education; (VDOE)................... 15
Virginia Department of Education; (VDOE)................... 1
West Virginia Department of Education; (WVDE).............. 22
Wisconsin Department of Public Instruction; (WDPI)......... 22
Wisconsin Department of Public Instruction; (WDPI)......... 24
Total--All Waivers Requested for Summer 2022 and SY 884
2022-23...............................................
------------------------------------------------------------------------
mexico ban on glyphosate
Question. At the end of 2020, Mexico adopted a decree that
progressively bans the use, distribution, and importation of glyphosate
by 2024. This decree adopted by Mexico violated Mexico's obligations
under USMCA. The Mexican government's justification for eliminating
glyphosate creates a dangerous precedent and it is vital our trade
partners uphold their commitments in trade agreements. Being that
Mexico is the second largest market for U.S. agriculture exports
totaling $18.4 billion annually,
What has USDA done so far to investigate and help mitigate this
violation of the USMCA trade agreement?
Answer. USDA is carefully monitoring Mexico's implementation of the
decree and related developments. We have frequently communicated our
concerns to Mexican officials. In fact, during my recent visit to
Mexico, I personally raised these concerns at the highest level of the
Mexican government, and USDA has been working diligently to explore all
possible avenues toward a satisfactory resolution.
Question. Is USDA currently working with any other agency to ensure
Mexico and other countries uphold their trade agreements?
Answer. USDA continues to work closely with the Office of the U.S.
Trade Representative on these issues in Mexico to ensure compliance
with USMCA trade agreement commitments.
Question. Last year, USDA announced that $500 million in funds
would be set aside to expand meat and poultry processing capacity
across the U.S, with $150 million for existing small and very small
processing facilities. Kentucky is the largest cattle producer east of
the Mississippi River and the eighth most nationally but remains
underserved in slaughter capacity.
How will the distribution of these funds ensure that facilities in
States with an imbalance of capacity are prioritized?
Answer. USDA recognizes that strengthening the meat and poultry
supply chain requires geographic diversity. The scoring process for the
Meat and Poultry Processing Expansion Program allows for Discretionary
Points which are to be used, as noted in the Request for Applications
(RFA), ``...for projects to maximize diversity among awards on the
basis of geography (including those located in underserved
communities), operation size, species, ownership, and business model.''
Similarly, discretionary points may be awarded under the new Meat and
Poultry Intermediary Lending Program, ``to facilitate geographic,
species, or project diversity that increases capacity of the supply
chain or makes it more diverse, secure, or resilient.''
______
Questions Submitted by Senator Susan M. Collins
pfas impacts to producers
Question. Secretary Vilsack, in response to my question about
relief to producers impacted by PFAS, you stated that ``you were under
the impression you are providing indemnity for livestock in addition to
fluid milk.'' You also stated you ``think you have done this'' and are
``paying farmers for the loss of livestock.'' Unfortunately, this is
not the case in Maine. The Maine Executive Director of Farm Service
Agency in Maine confirmed to me that ``no DIPP payments [have been
made] for livestock depopulated due to PFAS.''
While USDA may be willing to provide indemnity for depopulated
livestock and has made the regulatory changes that allows the
Department to do so, the reality in Maine is that no payments have been
made thus far. It is important that the record be corrected on this
issue. When will DIPP payments be made to Maine farmers for
contaminated livestock?
Answer. I appreciate your continued focus on this important issue
for both impacted Maine producers, and those across the country. When I
was asked about this at the hearing, it was my understanding that the
Farm Service Agency's (FSA's) County and State Offices had received and
reviewed a DIPP cow indemnity application, along with supporting
documentation, from a producer in Maine, as well as other applications
from a producer in another state, which is the first step in this
process to begin paying farmers in the Dairy Indemnity Payment Program
(DIPP) for the loss of the livestock, or more specifically for a dairy
cow contaminated with PFAS. What I was not aware of at the time of the
hearing was that the State and County offices determined that the
documentation provided by the Maine producer did not substantiate the
number of cows for which compensation was requested. The State Office
has contacted the producer and provided appeal rights. I am sorry for
the confusion I may have caused at the hearing when I stated that we
are in the process to begin paying farmers for the loss of livestock.
Specific to the timeline you asked about for making the DIPP payments
to Maine farmers for contaminated dairy cattle, in this particular case
that is dependent on that appeal process and our receiving the
appropriate documentation to substantiate the requested compensation
level.
Question. Vegetable farmers across Maine are now finding PFAS in
their soil and have no program at USDA to turn to for relief. What
relief can you provide to these vegetable farmers today? How to you
plan to expand the scope of existing USDA programs to serve the needs
of all affected farmers, not just dairy farmers?
Answer. The Farm Production and Conservation (FPAC) agencies; Farm
Service Agency (FSA), Natural Resources Conservation Service (NRCS) and
Risk Management Agency (RMA) are evaluating existing safety net and
conservation programs for their applicability to provide immediate or
longer-term support to our customers that are directly impacted by
PFAS.
Currently, there is no FPAC program that is statutorily designed to
address PFAS contamination for agricultural producers. Several key
programs that could possibly be utilized include the Conservation
Reserve Program (CRP), Farm Loan Programs, Environmental Quality
Incentives Program (EQIP), and RMA Multi-Peril Crop Insurance, among
others. NRCS is actively developing a new Conservation Evaluation and
Monitoring Activity (CEMA) to support PFAS testing in water and soil at
agricultural farms that may be contaminated with PFAS, which could be
utilized in EQIP and other programs. FSA is actively looking at options
and requirements for the establishment of a Conservation Reserve
Enhancement Program (CREP) agreement that could be applicable to
agricultural producers, which includes vegetable farmers, impacted by
PFAS and is also soliciting proposals for research related to PFAS and
plant uptake. For crop insurance, by law, PFAS is not currently an
insurable cause of loss. However, RMA is reviewing options for
providing some relief if PFAS contamination is confirmed.
Finally, because the Environmental Protection Agency (EPA) is
leading regulatory actions on PFAS, USDA is working with EPA and other
Federal partners to develop solutions and a coordinated strategy for
moving forward.
______
Questions Submitted by Senator Roy Blunt
covid relief progam implementation
Question. The COVID-19 pandemic had a dramatic impact on farmers of
all commodities and of all sizes. When constructing and implementing
relief programs, I respect your goal of making sure they reach the
producers who require the most assistance and your use of guardrails to
prevent abuse. However, at times, these guardrails can be a roadblock
to producers who are in dire need of assistance.
I have heard from several pork producers in Missouri that this
problem has occurred with the Spot Market Hog Pandemic Program's
exclusion of hogs that were sold on a formula agreement based on spot
prices. Were Congress to make funding available, would USDA be able to
use a framework similar to SMHPP to make these formula/LMR Code 3
producers whole?
Answer. As part of USDA's Pandemic Assistance for Producers
initiative, which has been focused on addressing gaps in previous
assistance, USDA created the Spot Market Hog Pandemic Program (SMHPP)
to assist producers who sold hogs through a spot market sale from April
16, 2020, through September 1, 2020. If Congress were to provide
additional funding to provide relief to a different subset of the hog
industry impacted by the pandemic, USDA would ensure it is ready to
expeditiously distribute that funding to eligible producers.
reconnect program
Question. In November 2021, I joined my colleagues in sending a
letter to you expressing concern regarding a new policy in USDA's
ReConnect Program that would favor broadband grant applicants that
commit to net neutrality principles. In my view, this represents a
backdoor way to impose heavy-handed net neutrality rules on the
industry. USDA should instead be focusing on rural broadband, not
politicizing the ReConnect Program and dragging the net neutrality
fight into it.
Moreover, the ReConnect program has been criticized for unduly
favoring grants for local governments, to the detriment of private
broadband investment, and for inadequately coordinating with other
government programs, such as the FCC's Universal Service Fund.
Secretary Vilsack, will you commit to focusing squarely on unserved
households in distributing the current round of ReConnect funding? To
that end, will USDA stop using ReConnect funding to advance partisan
priorities like net neutrality, broadband rate regulation, and
government-owned networks?
Answer. The third funding round of the ReConnect Program closed on
March 9, 2022, and the Rural Utilities Service is currently reviewing
the applications submitted. USDA is committed to working to close the
digital divide in rural communities and we know this effort is an all-
hands-on-deck effort. Acknowledging that, the third round revised the
scoring points structure that sought to encourage more partners to join
this effort and prioritize the communities with the most need. Seventy
out of the total 175 voluntary points possible, 40 percent of those
points, were offered for applications that prioritized the most
unserved rural communities: 25 points for applications that would serve
the least dense rural areas, 25 points for applications that would
connect areas without access to 25 Mbps downstream and 3 Mbps upstream
speeds, and 20 points for applications that would serve areas with a
high economic need. In addition, 15 points, which is only 8.5 percent
of the total available, were offered to encourage municipalities and
cooperatives to join this all-hands-on-deck effort. To get those 15
points, it is also important to note that a private corporation could
collaborate with a municipality or a cooperative to receive those
points. Even with this voluntary points structure, the majority of
applicants continued to be for profit and private entities.
USDA also offered 10 additional points for applicants that
volunteered to practice the principles of no blocking lawful content,
no degrading lawful traffic, and no engaging in paid prioritization of
content. USDA did not impose these principles, but instead presented an
opportunity for applicants to choose these additional points if they so
desired.
These basic ``net neutrality'' principles have been publicly
embraced by many large and small Internet Service Providers (ISPs) as a
way to ensure that consumers and businesses get the quality service
they pay for: full access to the Internet, unhampered by blocking,
impairment or degrading of lawful Internet content. The principles also
protect competition and innovation by ensuring that an ISP's
subscribers are not trapped in a service that favors its own or paid
content or services over content or services offered by others. These
principals are not partisan priorities, but rather a way to help equip
rural America to have the kind of broadband access that is meaningful
and that actually can make a difference to these rural communities that
are currently unserved and underserved. Adherence to these principles
has proven beneficial to broadband customers, particularly in areas
without multiple ISPs, where switching between providers is not an
option.
USDA is not involved in broadband rate regulation--that is the
realm of the Federal Communications Commission as the Federal authority
with the power to regulate the telecommunications industry.
______
Questions Submitted by Senator Jerry Moran
bill emerson humanitarian trust
Question. Does USDA have recommendations for policy changes that
Congress should consider to improve the functionality of the Bill
Emerson Humanitarian Trust and make it more accessible in the future?
Answer. Under the current law the Bill Emerson Humanitarian Trust
(BEHT) is not triggered until USAID has fully allocated the Food for
Peace program funds. USAID makes the commodity selections and also
identifies the recipients for the commodities purchased under the fund.
The proposal is then sent to USDA for concurrence. Under current law,
there is no USDA role in the process relative to the identification of
commodities. USAID makes the commodity selections to align with
countries that are both in need and where the product would be
culturally appropriate, and does not factor in U.S. prices or supply.
In addition, as we have seen with the current food security crisis,
there are countries that need food assistance, but do not meet the
threshold of USAID's emergency assistance programming.
When the BEHT is fully tapped, as it was earlier this year, the
current replenishment rate of $20 million per year, may preclude the
BEHT purchase of U.S. commodities to meet future global food security
needs. As Congress considers reauthorization of the Farm Bill next
year, USDA looks forward to engaging in the process to ensure that all
USDA programs, including international food assistance efforts are
maximized to benefit U.S. farmers producing high quality and nutritious
commodities and combat global food insecurity.
cost effective malnutrition interventions
Question. Secretary Vilsack, with over 44 million children on the
brink of starvation in the Horn of Africa alone, there is a strong need
for proven and cost-effective malnutrition interventions such as ready-
to-use therapeutic food (RUTF). I understand that two countries (South
Sudan and Ethiopia) have already requested RUTF through the Bill
Emerson Humanitarian Trust. Do you support including funding for RUTF
via the Bill Emerson Humanitarian Trust, the emergency supplemental
package, or annual appropriations process to ensure that this
lifesaving product gets into the hands of those who need it most?
Answer. USAID in consultation with USDA has selected Ready to Use
Supplemental Food (RUSF) through the BEHT to targeted beneficiaries in
Ethiopia and South Sudan. RUSF is designed to treat children ages 6
months to 5 years who have been diagnosed with moderate acute
malnutrition (MAM). While RUTF is meant as a meal replacement, RUSF is
typically a supplement to other feeding. RUSF treats the low-grade
malnutrition that leads to stunting and a multitude of other health
problems. It lowers the cost of intervention as a child only needs one
packet per day--not three. The BEHT commodity choices are meant to
supplement existing food interventions where we have current
shortfalls.
______
Questions Submitted by Senator Cindy Hyde-Smith
guaranteed loan program
Question. USDA's Business and Guaranteed Loan Program (B&I program)
has successfully grown rural businesses, created new jobs, and expanded
rural economies for many years by increasing access to capital through
loan guarantees. Because of the COVID pandemic and current inflation,
more small banks in rural areas are timid to make large financial
loans. This, along with the growth in popularity of the program, has
rapidly increased the demand for guaranteed loans. Currently, the B&I
Program will soon run out of funding, well before the end of the fiscal
year, leaving many rural businesses eager to grow with no access to
capital. How do you plan to use your authority to ensure the B&I
Program is funded through the fiscal year? Are there funds within USDA
that can be transferred to fully support the B&I Program? If so, will
you ensure that the B&I Program, which has successfully grown rural
economies and local food systems, will be funded by USDA through the
fiscal year?
Answer. The budget authority (BA) provided by Congress for the B&I
Guaranteed Loan Program, along with carryover BA, will support the
authorized lending level for fiscal year 2022 of $1.4 billion. As in
any fiscal year, the discretionary appropriation provides a specific
funding level for loans and grants. These levels are meant to provide a
specific amount of assistance for the program. These are not mandatory
programs, and, as such, not funded to meet the annual demand. There are
many programs across government where the annual demand is greater than
the funding amount available, and the government does not routinely
increase these programs mid-year when demand is higher than expected.
We consider the program delivery to be successful in carrying out the
will of Congress if we are funding the full loan level provided by
Congress in the annual appropriation bill. However, we recognize that
the COVID pandemic and current inflation rates have put an
unanticipated demand on the B&I loan guarantees.
Consequently, USDA is investigating options that will allow
additional loan level within fiscal year 2022 to address this. We are
hopeful that our efforts prove successful but caution that there is no
guarantee that the additional funding will be sufficient to meet the
demand for the year, since it is not possible to know what that amount
is with any precision.
SUBCOMMITTEE RECESS
Senator Baldwin. Thank you Mr. Secretary.
And with that, the subcommittee is adjourned.
[Whereupon, at 11:40 a.m., Tuesday, May 10, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]
LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS
----------
Page
Baldwin, Senator Tammy, U.S. Senator from Wisconsin:
Opening Statement of
Braun, Senator Mike, U.S. from Indiana, Questions Submitted by...
51.............................................................
Blunt, Senator Roy, U.S. Senator from Missouri, Questions
Submitted by
Califf, Hon. Dr. Robert, M.D., Commissioner, Food and Drug
Administration:
Prepared Statement of........................................
6..........................................................
Statement of.................................................
1..........................................................
Summary Statement of.........................................
3..........................................................
Collins, Senator Susan M., U.S. Senator from Maine, Questions
Submitted by...................................................
99.............................................................
Feinstein, Senator Dianne, U.S. Senator from California,
Questions Submitted by
Heinrich, Senator Martin, U.S. Senator from New Mexico, Questions
Submitted by...................................................
36.............................................................
Hoeven, Senator John, U.S. Senator from North Dakota:
Questions Submitted by
Statement of
Hyde-Smith, Senator Cindy, U.S. Senator from Mississippi,
Questions Submitted by
Leahy, Senator Patrick J., U.S. Senator from Vermont, Questions
Submitted by
McConnell, Senator Mitch, U.S. Senator from Kentucky, Questions
Submitted by
Moran, Senator Jerry, U.S. Senator from Kansas, Questions
Submitted by
Rapp, Mr. John, Director, Office of Budget and Program Analysis,
Accompanied By.................................................
55.............................................................
Schatz, Senator Brian, U.S. Senator from Hawaii, Questions
Submitted by
Vilsack, Hon. Thomas J., Secretary, Department of Agriculture:
Prepared Statement of........................................
58.........................................................
Statement of.................................................
55.........................................................
Summary Statement of.........................................
56.........................................................
SUBJECT INDEX
----------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
Page
Additional Committee Questions...................................
26.............................................................
Advancing Medical Product Safety.................................
7..............................................................
Cancer Moonshot..................................................
7..............................................................
Cybersecurity....................................................
8..............................................................
Data Modernization and Enhanced Technologies.....................
9..............................................................
Enhancing Food Safety and Nutrition..............................
6..............................................................
Healthy and Safe Food for All....................................
7..............................................................
Investing in Core Operations.....................................
9..............................................................
Modernizing Infrastructure, Buildings & Facilities...............
9..............................................................
New Era of Smarter Food Safety...................................
7..............................................................
Opioids..........................................................
8..............................................................
Optimizing Inspectorial Activities...............................
9..............................................................
Pandemic Preparedness............................................
10.............................................................
Supply Chain.....................................................
8..............................................................
Tobacco User-Fees................................................
9..............................................................
__________
DEPARTMENT OF AGRICULTURE
Additional Committee Questions...................................
89.............................................................
Bill Emerson Humanitarian Trust..................................
101............................................................
Combating Climate Change.........................................
60.............................................................
Cost Effective Malnutrition Interventions........................
101............................................................
Covid:
Relief Progam Implementation.................................
100........................................................
State Waivers................................................
96.........................................................
Dietary Guidelines for America...................................
94.............................................................
Focus on Diversity, Equity, and Inclusion........................
61.............................................................
Grain Storage After Tornados.....................................
95.............................................................
Guaranteed Loan Program..........................................
101............................................................
Illegal Logging..................................................
92.............................................................
Making USDA a Strong, Modern Organization and a Best Place to
Work...........................................................
62.............................................................
Mexico Ban on Glyphosate.........................................
98.............................................................
National Accuracy Clearinghouse for Food and Nutrition Progams...
93.............................................................
Partnership for Climate Smart Commodities........................
92.............................................................
PFAS Impacts to Producers........................................
99.............................................................
Rebuilding Rural America.........................................
58.............................................................
Reconnect Program................................................
100............................................................
Rural Partners and Strikeforce...................................
94.............................................................
Supply Chain Disruptions.........................................
89.............................................................
Supporting:
Nutrition for the Nation.....................................
59.........................................................
Research.....................................................
60.........................................................
[all]