[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

                                 ------                                

     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

                              ----------                              

                                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

                              ----------                              


                        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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \4\ https://www.pfizer.com/news/press-release/press-release-detail/
pfizer-and-biontech-provide-update-rolling-submission
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \5\ https://www.fda.gov/news-events/press-announcements/
coronavirus-covid-19-update-fda-postpones-advisory-committee-meeting-
discuss-request-authorization
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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=
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \9\ Food and Drug Administration Summary of Safety and 
Effectiveness Premarket Approval submission number P130001
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \10\ 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,\11\ and the 
Critical Path (C-Path) Institute \12\ to explore avenues to advance 
research and policy regarding existing therapeutics.
---------------------------------------------------------------------------
    \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/
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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]