[Senate Hearing 117-630]
[From the U.S. Government Publishing Office]








                                                        S. Hrg. 117-630

            FOOD SAFETY AND THE FOOD AND DRUG ADMINISTRATION

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

                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             SECOND SESSION

                               __________

                            SPECIAL HEARING

                     JULY 20, 2022--WASHINGTON, DC

                               __________

         Printed for the use of the Committee on Appropriations



[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]





       Available via the World Wide Web: https://www.govinfo.gov 
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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

                              ----------                              

                                PANEL I

                                                                   Page

Statement of Dr. Robert Califf M.D., Commissioner................     1 
    Accompanied By: 
        Mr. Frank Yiannas, M.P.H., Deputy Commissioner, Food 
          Policy and Response....................................     1
        Susan, T. Mayne, PH. D, Director, Center for Food Safety 
          and Applied Nutrition..................................     1 
        Michael C. Rogers, M.S., Assistant Commissioner, for 
          Human and Animal Food Operations.......................     1 
Opening Statement of Senator Tammy Baldwin.......................     1 
Summary Statement of Dr. Robert Califf...........................     2 
    Prepared Statement of Dr. Robert M. Califf, M.D..............     4
        FSMA.....................................................     5 
        New Era of Smarter Food Safety...........................     5 
        Challenges...............................................     6 
        Conclusion...............................................     8 
Statement of Senator John Hoeven.................................    12 
 
                              ----------                              

                                PANEL II

Statement of Ms. Sarah Gallo, Vice President, Product Policy 
  Consumer Brands Association....................................    30 
    Prepared Statement of Ms. Sarah Gallo........................    32 
        Unifying FDA's Food Program Under a Deputy Commissioner 
          for Foods..............................................    32 
        Modernizing the Agency...................................    33 
        Applying Lessons Learned from the COVID-19 Crisis........    33 
        Conclusion...............................................    34 
Statement of Mr. Brian Ronholm, Director, Food Policy Consumer 
  Reports........................................................    34 
    Prepared Statement of Mr. Brian Ronholm......................    36 
        FDA Governance and Performance...........................    36 
        Fragmented Structure and Poor Governance.................    36
        FDA Resource Management and Food Program Funding 
          Transparency...........................................    37 
        Recommendations..........................................    38 
Additional Committee Questions...................................    41 
Questions Submitted to Dr. Robert Califf.........................    41 
Questions Submitted by Senator Dianne Feinstein..................    41 

 
            FOOD SAFETY AND THE FOOD AND DRUG ADMINISTRATION

                              ----------                              


                        WEDNESDAY, JULY 20, 2022

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10:01 a.m. in Room SD-124, Dirksen 
Senate Office Building, Hon. Tammy Baldwin (chairwoman) 
presiding.
    Present: Senators Baldwin, Tester, Heinrich, Hoeven, Moran, 
Hyde-Smith, and Braun.



                                PANEL I

                      Food and Drug Administration

STATEMENT OF DR. ROBERT CALIFF M.D., COMMISSIONER
ACCOMPANIED BY:
        MR. FRANK YIANNAS, M.P.H., DEPUTY COMMISSIONER, FOOD POLICY AND 
            RESPONSE
        SUSAN, T. MAYNE, PH. D, DIRECTOR, CENTER FOR FOOD SAFETY AND 
            APPLIED NUTRITION
        MICHAEL C. ROGERS, M.S., ASSISTANT COMMISSIONER, FOR HUMAN AND 
            ANIMAL FOOD OPERATIONS


               opening statement of senator tammy baldwin


    Senator Baldwin. Good morning, everybody. I want to welcome 
everyone to our hearing today. We have a distinguished panel of 
witnesses here to discuss the important food safety mission at 
the Food and Drug Administration.
    For our first panel I would like to welcome Dr. Robert 
Califf, FDA Commissioner. He is joined by Dr. Susan Mayne, and 
Mr. Frank Yiannas, and Mr. Michael Rogers. Thank you all for 
being here this morning.
    The FDA is charged with the critical mission of protecting 
America's food supply, yet recent reports have highlighted a 
lack of leadership, poor communication, and slow governance at 
the agency that have had a detrimental impact on the safety of 
the food that every American relies upon.
    This hearing will highlight not only FDA's decisionmaking 
with regards to food safety, but also the impact those 
decisions have on industry and the overall food supply.
    The question we need to ask today is: Is food safety a 
priority of the FDA? America has the safest food in all the 
world, but serious concerns remain about the priority that FDA 
gives to food safety and the missteps that have led to 
outbreaks, or critical shortages, and individuals getting sick. 
An easy explanation is that FDA does not have the resources or 
personnel to oversee such a massive industry.
    There may be some truth to that, but there is more to the 
story. Since the passage of the Food Safety and Modernization 
Act, or FSMA, this committee has provided the FDA with hundreds 
of millions of dollars in increases for food safety, yet 
inspections continue to decline and outbreak breaks remain.
    Additional resources are not the only answer, and that is 
why this hearing is so important. The FDA needs to do better. 
Lack of communication, outdated ways of thinking, and overall 
lack of leadership have negatively impacted the agency, and we 
have seen that with the recent infant formula crisis.
    Since 2002, the FDA has had seven different commissioners. 
Over the last 20 years FDA has gone without a Senate-confirmed 
commissioner for almost 6 years of that time. That is not 
acceptable, and there is no way an agency as large as the FDA 
can be leaderless and not have serious issues.
    I commend the career employees at the FDA. They have forged 
ahead even when acting commissioners were in charge. The role 
of this committee is to provide the agencies we oversee with 
support and resources that they need. FDA has had so many 
different and complex responsibilities.
    I want to assure you, Dr. Califf, that as chair of this 
subcommittee I am committed to providing FDA with what it needs 
to get the job done.
    With that, I will reserve the time for the Ranking Member 
to give his opening statement when he arrives.
    Senator Moran, would you like to make an opening statement?
    Senator Moran. I sure thank you for asking. But no, it is 
not necessary.
    Senator Baldwin. Okay.
    Senator Moran. I will just reserve for questions.
    Senator Baldwin. Very good. Let us start, and let us start 
with Dr. Califf.


                 summary statement of dr. robert califf


    Dr. Califf. Thank you, Chair Baldwin, and I want to assure 
you that the safety of our nation's food supply is one of my 
absolute top priorities. Although foodborne outbreaks continue 
to occur, all experts with whom I have consulted agree that 
America's food supply has never been safer than it is today.
    But as the industry, the environment, and the international 
landscape change we must prepare for future challenges. As 
envisioned in the New Era of Smarter Food Safety, a report put 
together before my arrival, the combination of tech-enabled 
traceability, smarter tools for prevention and response, new 
business models, and retail modernization, and a collaborative 
food safety culture where industry is implementing the 
preventive framework envisioned by FSMA, paint an exciting 
picture for the future.
    The recent acceleration of digital technologies enabling 
traceability and predictive capabilities, innovation and 
genomics facilitating outbreak response, and advances in 
agricultural biotechnology that allow food production to resist 
the effects of climate change, and feed the growing global 
population to bring that vision even closer within reach.
    Further, food is the foundation of health, smarter food 
safety, better nutrition and ongoing efforts to reduce 
environmental contaminants and toxins in our food supply are 
critical for improved health of the whole U.S. population. I 
anticipate a future in which people have more reliably safe 
food, more access to variety and certainty about availability, 
and the agricultural ecosystem thrives, enabling it to feed the 
U.S. and the rest of the world.
    To realize this future we must reexamine and reinvent the 
ways we approach our food safety and nutrition work. During my 
confirmation I was contacted by multiple experts and concerned 
groups about the perception that the FDA's Foods Program is not 
adequately organized or supported.
    In my first 5 months back in the job, I have met with 
stakeholders and experts to discuss FDA's Foods Program and 
food policy priorities for the next decade.
    My assessment is that the Foods Program is staffed by 
highly dedicated people, I can't stress enough how hard they 
work and the depth of their knowledge, but they are working in 
a sub-optimal environment that needs to be reformed. 
Accordingly, we have initiated a full review of the Foods 
Program, including its structure, function, leadership, 
authorities, and funding. I want to assure you that I intend to 
communicate about and implement any organizational and 
strategic changes that will further improve the performance of 
the Agency's Foods Program.
    Several key issues must be addressed and will not wait for 
the results of the full assessment to get started. Hiring and 
retaining Foods Program staff has long been a concern. I am 
grateful that the User Fee Reauthorization Bills in both 
chambers recognize the great need to get the right staff on 
board quickly.
    Failures of the supply chain throughout the pandemic, and 
particularly the recent infant formula crisis have shown the 
importance of new authorities FDA seeks to anticipate and 
respond to supply shortages. As the world moves to digitize 
this information, the Foods Program must upgrade its technology 
and modernize its work processes to enable its workforce to be 
maximally productive using machine learning and virtual methods 
to keep up with the vast and rapidly expanding foods ecosystem.
    Food contamination and recall events will always capture 
the headlines, but we must balance a food safety plan with work 
on nutritional science and labeling that enables consumers to 
make informed dietary choices, and facilitates industry 
reformulation.
    When FDA added trans-fat to the nutrition facts label, 
intake decreased by 80 percent. The results of FDA's nutrition 
work go largely unseen, only becoming evident through 
generations of health data. Yet turning the tide on diet-
related chronic disease is a critical priority for me and for 
this administration because of the potential to impact the 
health of every American, dramatically reduce health care 
costs, and close our life expectancy gap.
    Currently we live 5 years shorter in the United States than 
the average of other high-income countries. As we work together 
to implement needed changes, and identify critical gaps in 
authorities or resources, I will continue to engage with 
Congress as we all share the same goal of having a safer food 
supply.
    In conclusion our food has never been safer, yet challenges 
remain and we must do better. One food outbreak is one too 
many. I appreciate your attention to this and look forward to 
continuing to work with you to ensure the Foods Program at FDA 
has the right structure, people, budget, and authorities to 
keep our food supply safe.
    [The statement follows:]
            Prepared Statement of Dr. Robert M. Califf, M.D.
    Before the subcommittee on Agriculture, Rural Development, Food and 
Drug Administration, and Related Agencies Committee on Appropriations, 
U.S. Senate Chair Baldwin, Ranking Member Hoeven, and Members of the 
subcommittee, thank you for the opportunity to appear before you today 
to discuss FDA's Foods Program.
    The ongoing situation with infant formula has brought needed 
attention to the critical nature of our food safety and nutrition work. 
I look forward to discussing the long-term efforts the Agency is making 
within the program to try to keep pace with the massive transformations 
that have occurred over the last two decades in the industries that 
this program regulates, and the even more dramatic changes we foresee 
happening across the food industry in the years ahead.
    FDA's Foods Program regulates approximately 80 percent of foods 
consumed by Americans, including those bought in grocery stores, 
restaurants, and cafeterias, as well food consumed in other venues, 
such as on airlines. While much of our discussion today will focus on 
food safety work, which includes mitigating the risk of potential 
exposure to a wide variety of hazards such as microbial, certain 
chemicals, toxic elements, and allergens, the program also drives 
public health policy and education work to improve the nutrition of all 
Americans and reduce the burden of diet-related chronic disease. With 
the exception of products regulated by the U.S. Department of 
Agriculture, such as meat, poultry, and pork, FDA's Foods Program 
regulates nearly all of the Nation's food supply, including all of the 
ingredients used in foods and all of the substances that come in 
contact with those foods throughout the production cycle, from the 
farmers' fields through harvest, processing, manufacture, distribution, 
packaging, and delivery to the consumer. Additionally, the program 
regulates animal foods for all species of animals including animals 
kept in zoos and exhibits, the pets that are part of most American 
families, and the animals that make or will become human food and other 
products like leather and fiber.
    Further, the Foods Program regulates cosmetics, dietary 
supplements, and, as we are all acutely aware, infant formula and 
medical foods industries.
    Regulating this volume and diversity of products and facilities, as 
well as addressing the diversity of hazards that can enter the food 
supply, is an immense undertaking with serious consequences for 
American consumers when the regulated entities fail to control the 
hazards that could impact the safety of their products.
    In a perfect world, consumers would not need to know how the safety 
of these industries is secured--they would correctly assume that the 
products they purchase will not harm them or their loved ones. Millions 
of products are purchased and safely consumed every day, evidence of 
the robustness of our food safety system, which includes an industry 
shift to a prevention- oriented framework and the dedication and 
diligence of the public servants tirelessly working in FDA's Foods 
Program from our entry level employees on up through the leaders who 
accompany me today.
    While food contamination and recall events capture the headlines, a 
far greater threat to public health is the morbidity resulting from 
American dietary and nutritional trends. Our Center for Food Safety and 
Applied Nutrition (CFSAN) takes a leading role in Federal efforts to 
drive reformulation of foods to cut back on sodium and trans-fat, 
promote transparency in labeling, and allow consumers to make informed 
dietary choices. The results of this work go largely unseen, only 
becoming evident through health data over generations, yet this is one 
of the most critical and resource intensive public health efforts 
across government because of the potential to impact every American.
    The Foods Program is not without challenges. Some, like the rapid 
pace of change and the breadth of the work, are inherent in our 
mission. Others, like hiring and retention, organizational structure, 
and the lack of authority to access some essential information, can be 
more readily tackled. I appreciate your partnership in identifying and 
implementing lasting solutions.
                                  fsma
    Today's global food system depends on an increasingly complex and 
fluid supply chain, which cannot be adequately regulated by a 
surveillance and response framework alone. To address this, the FDA 
Food Safety Modernization Act (FSMA) of 2011 transformed FDA's food 
safety program and, in turn, the Nation's food safety system. FSMA 
instituted a preventive model for protecting food safety to replace the 
responsive model that previously prevailed.
    With the support of Congress, FDA has made significant progress in 
implementing the landmark law and modernizing our food safety 
capabilities by promulgating and largely implementing eight 
``foundational rules,'' including preventive controls for human and 
animal food, produce safety, foreign supplier verification for 
importers, intentional adulteration, and sanitary transportation. To 
facilitate the food industry's shift to a prevention-oriented safety 
and compliance paradigm, FDA has also published more than 50 draft and 
final guidances. As the food industry continues to change, implementing 
FSMA will be an ongoing process. As such, we have staff continuing the 
work needed to further implement FSMA through additional rulemakings 
(such as for food traceability recordkeeping requirements), guidance 
development, training, inspections, and other activities.
    As with any complex, scientific undertaking, FSMA rulemakings 
require 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 promulgate are feasible.
    For example, in late 2021, FDA proposed new requirements for pre-
harvest agricultural water for covered produce other than sprouts. The 
new proposal takes a comprehensive, systems- based approach to 
identifying and addressing hazards in pre-harvest agricultural water 
that we believe, when implemented, will be a game-changer for public 
health protection. FDA issued this proposal after stakeholder concerns 
were raised about the complexity and practical implementation of the 
pre-harvest agricultural water testing requirements in the 2015 Produce 
Safety Rule. These concerns led the Agency to pursue a rigorous and 
thorough process for engaging with stakeholders. FDA experts 
participated in hundreds of farm visits, listening sessions and 
meetings with industry, consumer groups, academia, and regulatory 
partners to better understand the diversity of uses of agricultural 
water. The Agency believes this was time well spent to ensure that the 
proposed approach is feasible while also being protective of public 
health, deeply rooted in the most current science, and adaptable to 
future advancements in agricultural water quality science.
    Among the highest FSMA-related priorities is finalizing a rule on 
food traceability, including the food traceability list, which outlines 
foods for which additional recordkeeping requirements will apply, to 
help FDA rapidly and effectively identify recipients of foods to 
prevent or mitigate foodborne illness outbreaks.
    Additionally, FDA is continuing to implement the Laboratory 
Accreditation for Analysis of Foods Rule. The portal for Accreditation 
Bodies to apply to participate in the program opened in February 2022, 
and 6 entities have been approved to date. Implementation of the 
Preventive Controls for Animal Food rule is also continuing. This rule 
has faced challenges because in some cases the animal food industry and 
our State, local, and Tribal regulatory partners lack the 
infrastructure and expertise needed to meet and monitor compliance with 
FSMA requirements, and the resources dedicated to this sector lag 
behind those for human food.
                     new era of smarter food safety
    FDA is committed to building on the work of FSMA while taking a 
modernized approach to food safety that leverages technology and other 
tools to create a safer and more digital, traceable food system. This 
approach, which we call 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.
    We are in the midst of a food revolution-including how foods are 
produced, delivered, and handled. Many of the changes which were 
already underway have been accelerated by the pandemic as we acclimate 
to a new normal in all aspects of life. Through the New Era initiative, 
we are identifying technologies, data streams, and approaches that will 
greatly reduce the time it takes to trace the origin of a contaminated 
human or animal food.
    In July 2020, we published the New Era for Smarter Food Safety 
blueprint, which identified four Core Elements that we see as critical 
to this work. These include:

  --Tech-Enabled Traceability: technologies, data streams, and 
        approaches that will greatly reduce the time it takes to trace 
        the origin of a human or animal food of public health concern.

  --Smarter Tools and Approaches for Prevention and Outbreak Response: 
        adapting and incorporating new data, information, and 
        approaches to respond to outbreaks and prevent them from 
        happening again.

  --New Business Models and Retail Modernization: advancing the safety 
        of food produced and sold by both new and traditional business 
        models for retail food safety.

  --Food Safety Culture: strengthening FDA's approach to recognizing 
        the critical importance of food safety culture and behavioral 
        change in the Agency's work processes, promoting food safety 
        culture throughout the food system, and developing smarter food 
        safety consumer education.

    Together, these Core Elements will enable the change necessary for 
FDA and the entire food industry to adapt to the future. We have had a 
number of recent accomplishments in this area, including publishing a 
Foodborne Outbreak Response Improvement Plan, working toward 
finalization of the proposed Food Traceability Rule, completing the 
second phase of an artificial intelligence/machine learning pilot to 
enhance the Agency's ability to quickly and efficiently identify 
imported seafood products that may pose a threat to public health, 
signing five domestic mutual reliance agreements with California, 
Florida, Utah, Wisconsin, and Minnesota which enhance FDA's use of 
State agencies to strengthen oversight of the food supply, and holding 
a three-day e-commerce summit to help the Agency improve its 
understanding of how human and animal foods are sold through business-
to-consumer e-commerce models across the U.S. and globally.
    I thank the Committee for its commitment to food safety by 
providing us funds in recent years to support our New Era of Smarter 
Food Safety initiative. In fiscal Year2023, we plan to take our efforts 
modernizing America's food safety regulatory framework to another level 
and are requesting a total of $43 million across the Foods Program. In 
a rapidly changing world, this funding will allow the Agency to 
continue to leverage new and emerging technologies, enhance 
implementation of traceability, and adapt oversight to new production 
and business models. This is work that will have an immediate impact on 
food safety in this country while also preparing the Agency to be more 
adaptable to changes across the food system in the future.
                               challenges
    As I have explained, the food system has been growing ever more 
complex and is undergoing rapid change unlike anything seen in a 
century. This growth has created new challenges in both keeping up with 
and attempting to get ahead of industry innovation.
    Unfortunately, we have found that there are barriers which make it 
difficult to keep pace.
    For example, on-site food facility inspections remain an important 
oversight tool for FDA. However, given the very large number of foreign 
and domestic food facilities to be inspected, and the level of existing 
FDA resources for this work, fully meeting the FSMA requirement to 
inspect all domestic facilities at least once every 5 years-every 3 
years for high-risk facilities-has sometimes been unattainable since 
the requirement went into effect in 2011. As a result, we are exploring 
the use of other tools to enhance our oversight. This includes use of 
new data streams, technologies, and tools to better prioritize 
oversight activities and respond nimbly to newly identified or changing 
risks. While in-person inspections will remain the foundation of our 
oversight of these facilities, authorities around remote regulatory 
assessments as requested by the Administration would also greatly 
assist in our ability to more efficiently evaluate food facilities.
    Hiring and retaining Foods Program staff has long been a challenge. 
Many State and local health and agriculture departments across the 
Nation express concern about the food safety system's decades-long 
shortage of qualified personnel. In FDA's Office of Regulatory Affairs, 
direct-hire authority proved very helpful in making strides towards 
closing the hiring gap in its investigative and compliance staff, but 
this authority expired in October 2021 and ORA, along with other 
offices within the Agency including CFSAN, the Office of Food Policy 
and Response, and the foods-related portions of the Center for 
Veterinary Medicine continue to have great difficulty recruiting and 
hiring critical experts with the agility and speed needed to rival the 
private sector without similar authorities granted to the medical 
products centers under the 21st Century Cures Act. Our Foods Program's 
need for mission-critical skill sets and keeping up with the pace of 
industry innovation is no less critical than the Medical Products 
Program, which has hiring authorities under the 21st Century Cures Act. 
We believe the hiring flexibilities provided in the user fee 
reauthorization bill will give FDA agile and competitive hiring tools 
in the foods program to get the right staff we need and to get them 
quickly.
    Failures of the supply chain throughout the pandemic, and 
particularly the recent crisis, have shown the importance of new 
additional authorities to anticipate and respond to supply shortages, 
particularly for infant formula and medical foods. No law requires 
manufacturers of these products to notify FDA when they become aware of 
a circumstance that could lead to a shortage of these products. Without 
this information, the Agency may have little or no insight as to when a 
major shortage may occur, preventing us from taking potential 
mitigation efforts until a crisis becomes apparent. This is why early 
in the pandemic (March 2020) we began work on a legislative proposal 
seeking authority to require firms producing infant formula and medical 
foods to notify FDA of anticipated significant interruptions in the 
supply. The proposal has appeared in the fiscal Year 22 and fiscal Year 
23 budgets and would ensure that FDA routinely receives timely and 
accurate information about likely or confirmed shortages and can take 
steps to promote the continued availability of these essential foods. 
The proposal also provides for infant formula and medical food 
manufacturers to develop and make available to FDA supply redundancy/
risk management plans. In addition, we are seeking authority to require 
firms to provide shortage notification for other FDA-designated 
categories of food during a declared public health emergency. In future 
situations where supply chain disruptions are likely, this would help 
address some of the shortage issues like those we witnessed early in 
the pandemic and are currently witnessing in the wake of the Abbott 
Nutrition recall.
    Although we greatly appreciate the Committee's work to fund our 
foods safety work, it is important to understand that our resources in 
this area have not kept up with inflation and the growing and ever-
changing foods industry. Prior to passage of the first Prescription 
Drug User Fee Act in 1992, our Center for Drug Evaluation and Research 
(CDER) and CFSAN were comparably sized. Now, CDER is approximately five 
times the size of CFSAN, which receives 97 percent of its funding 
through budget authority. This amounts to only about six percent of the 
Agency's total budget and has prevented the center from performing the 
food safety and nutrition work that Americans expect. This is a long-
term challenge and our budget request this year is intended to begin 
the process of closing the capability gap.
    As products, manufacturing processes, and supply chains have become 
increasingly complex, the potential for hazards to impact the safety of 
these products has multiplied. FDA is continually examining the 
industry and our existing policies and practices to anticipate and 
adapt to the changing landscape and still strike the right balance 
between regulatory oversight and affordable, available products.
    FDA has been seeking to make gains in balancing the ongoing efforts 
of providing safe food with a renewed emphasis on encouraging the 
increased availability in the marketplace of healthy food options. To 
meet this goal, FDA needs better data, tools, and greater capacity to 
generate and analyze real-time information on the food supply's 
evolving composition.
    Leveraging foundational data and building these tools and capacity 
would enable FDA to better understand and address population exposure 
to various food components-both those that are helping consumers reduce 
their risk to diet-related chronic disease and also those that may be 
leading to exposures that have chronic health risks. In that regard, 
reducing people's exposure to chemicals known to be harmful in foods to 
the greatest extent possible is essential to protecting long-term human 
health and ensuring consumer confidence in the safety of the foods they 
eat.
    We recognize that our pre-market programs are challenged to keep 
pace with increasing innovation by industry and advances in science, 
and our post-market oversight and our capacity to mitigate risk due to 
chemical hazards across our products have been especially under- 
resourced and falling behind in their ability to keep pace with 
increasing numbers of signals of possible concerns about chemical 
hazards in foods. We are working to modernize and streamline our 
regulatory frameworks, including by acquiring new tools that leverage 
new and evolving toxicity data sources to support pre-market safety 
evaluations and to prioritize our post- market efforts in a scientific 
and risk-based way.
    Finally, the Office of the Commissioner is actively evaluating 
changes to ensure the foods program is best organized, resourced, and 
has the right authorities and modern data systems to be effective for 
the next decade of challenges in food policy, systems, and regulation. 
An optimal foods program organization must take into account that FDA's 
product areas and centers are not silos, but a matrix of interdependent 
information and operations encompassing product and regulatory 
organizations and enterprise-wide support organizations. I look forward 
to continuing the conversation beyond today as my evaluation wraps up.
                               conclusion
    We are in an unprecedented time; our food has never been safer, yet 
the challenges remain significant, and we strive to do better. We must 
remain vigilant and adaptable. We look forward to working with you to 
continue to ensure Americans' access to safe, nutritious food.

    Senator Baldwin. Next, I will call on Mr. Frank Yiannas.
    Next, I will turn to member questions. I understand that 
you have provided the opening statement on behalf of all of the 
witnesses, so.
    Dr. Califf. I am trying to speak for the group here.
    Senator Baldwin. Excellent. So Dr. Califf, if we had a 
discussion on food safety when you were here to testify on the 
fiscal year 2023 Budget Request, and I wanted to follow up with 
you. As the Commissioner of FDA what do you see as the biggest 
challenges facing the agency with regard to your food safety 
mission? And every agency, as I mentioned, can use additional 
resources that can't be the only solution to the problem. So 
what changes do you believe need to occur to make food safety a 
higher priority?
    Dr. Califf. Let me start by just thanking you for bringing 
up the fact that we have an agency that has had multiple 
commissioners with very short tenures. I am getting ready to 
turn 71, I don't plan to be here forever, but I hope I am here 
long enough to get a situation in place that is sustained 
regardless of who is the commissioner. And that is the number 
one goal.
    So when you ask what is most important, you know, I look at 
the overall situation and just see a rapidly expanding group of 
industries that are producing food. I don't need to tell anyone 
today about climate change with the heat that we are seeing, 
and the impact that is going to have, not to mention the war in 
Ukraine having enormous impact on nutrition in the world.
    So we have this increasingly complex, critical set of 
industries that we need to regulate. And I think we have to 
look at the whole picture, it is a structure, it is a function, 
it is a leadership. You have mentioned that resources are not 
the only issue, I completely agree with that, but I do believe 
that when we finish our complete top to bottom evaluation, you 
know, we will be coming to you with specific requests for 
places where additional resources can make a difference.
    And I know it has already been discussed in some of the 
budget plans, and that is much appreciated. So you know, I 
think it is very hard to pick out one or two things. It is a 
multi-dimensional industry where so much good can be done and 
if we get good nutrition to people in plentiful supply, at a 
time when it is going to be very stressed in the future.
    Senator Baldwin. The previous administration undertook some 
structural changes with the goal of raising the profile of food 
safety. Dr. Califf, do you believe that these changes were 
effective, or worked?
    Dr. Califf. Well, first of all, let me say I don't question 
the motives of the previous administration in this regard. I 
think the right things were said, and efforts were made. But, 
you know, I heard a resounding chorus from the outside world 
and you know, I must say from inside the Foods Program, that it 
hasn't gotten the priority that it deserved.
    I think over the last couple of years I would just point 
out that the pandemic has had an enormous effect on the whole 
FDA, and what has gone largely unnoticed is the amazing work 
that the Foods Program has done, just to--you remember the 
early days of the pandemic when you couldn't find anything on 
the grocery shelves and, you know, we definitely have a problem 
with infant formula. But by and large, these people have put in 
a huge amount of work to be adaptable with regard to 
regulations and rules to ensure that people had food to eat at 
a time when there was a question as to whether that would 
occur.
    So the short answer is, it is not, I think there is 
consensus in the food world that whatever was done in the past 
has not been successful in getting the Foods Program to the 
priority that it deserves.
    Senator Baldwin. I am sure you are all familiar with a 
political article that was published in April, it quoted 
several people who agreed that the agency is simply not working 
in order to advance food safety. Some of the quotes included: 
broken, byzantine, ridiculous, a joke.
    I would ask both Dr. Mayne and Dr. Califf; how you 
responded to such very strong criticism? And how you responded 
to the article itself?
    Dr. Califf. If I may, could I go first? And then I would 
like to definitely get Dr. Mayne on the floor.
    I just want to vigorously rebut the way those comments were 
made.
    Senator Baldwin. Mm-hmm.
    Dr. Califf. We have the safest food in the world, and every 
expert I have talked with, the CDC monitors this carefully, our 
food is as safe as it has ever been, so to say it is not 
working is, in my view, just incorrect. That doesn't mean it 
can't be a lot better and that there aren't major problems. So, 
you know, that is why we are doing this top-down review, and 
plan to make significant changes.
    But some of the people quoted in that have been in 
leadership within the FDA. I could say they had a chance to fix 
it. It is not so easy to fix. So we all need to work together 
on this collaboratively, but also there is accountability, so 
we are going to need to make changes.
    Senator Baldwin. Yes.
    Dr. Califf. Dr. Mayne.
    Dr. Mayne. And thank you for the question, Senator Baldwin. 
And what I will say is food safety is not a joke at CFSAN, it 
is our mission within CFSAN, and as Center Director I can tell 
you, it is one of my absolute top priorities.
    That being said, we do take all criticisms seriously, and 
are always looking forward to ways that we can continually 
modernize and improve our work within the Center. So that is a 
priority for us.
    I will say, reflecting back on the last 10 years, we have 
accomplished a tremendous amount in the Foods Program. For 
example, with food safety, the establishment of whole genome 
sequencing, which is game changing globally in food safety. 
That was work that came out of CFSAN.
    Also our work with regard to FSMA implementation, the 
foundational rules that have come out of 50 guidances to help 
move industry to the prevention-oriented framework that you all 
envisioned with FSMA, that is really important and notable 
progress forward.
    Also, with regard to nutrition, Dr. Califf highlighted our 
work on trans-fat, but there is much more. Empowering consumers 
with information, really important things, like menu labeling, 
so consumers have information to make the decisions they need 
with regard to their personal health.
    But we know more can be done. Resources are certainly 
something that was identified in that particular article. I 
will point out that we are 97 percent funded by budget 
authority, and not by user fees. So as more work comes in we 
absorb that work because we don't have a user fee base to 
increase our staff along the way as the work increases. So that 
is relevant and we look forward to working with you on that.
    Dr. Califf also mentioned authorities. There are areas that 
we are seeking new authorities that would make our work more 
efficient. And so this is the type of work we look forward to 
working with you on, on resources, and authorities, as well as 
the outcome of the review that Dr. Califf mentioned, to make it 
the strongest possible Foods Program.
    Senator Baldwin. Thank you. I have exceeded my time 
already. I am going to reserve time for a second round.
    But next, I would call on Senator Moran.
    Senator Moran. Chairwoman, thank you very much. Thank you 
all for joining us this morning.
    You mentioned efficiencies at work just in your concluding 
sentences. It is my understanding that many of the staff at FDA 
continue to work from home, and I would be--I think it is a 
reasonable expectation to have our employees back to work in 
the office, in the laboratories, and across the agency.
    Is my understanding about the volume of employees that are 
still absent from the workplace accurate? And what is the plan 
to return them to the workplace soon?
    Dr. Califf. Thanks for the question, Senator. There we go. 
Thanks for the question, and I think what you said is partially 
accurate, but I want to be very explicit here about what I 
think the facts are. People that have worked in our 
laboratories have always gone to work throughout the pandemic. 
You know, if your job required that you be at work that has 
happened.
    Our ORA inspectors, as Mr. Rogers will talk about, you 
know, there were cutbacks because of the peril of travel, and 
also difficulty often even getting into a facility when there 
were outbreaks.
    But our inspectors have put themselves at risk routinely 
going there. The place where people have had the option of 
virtual or hybrid work, has been those who are dealing with 
data or administrative functions that really don't require that 
you are there in person to be most efficient. And I think our 
productivity is exemplified by the fact that we carried on all 
the usual activities, plus the pandemic activities.
    And I think if you talked to most of the industries that we 
regulate, they are pretty happy with the performance of the 
FDA. Now, we are in a pilot program now to look at the hybrid 
environment. In my previous job at Google I spent a lot of time 
on this where we had tremendous resources to do the analysis, 
and I think all of this is best handled by looking at the 
particular job, the particular function.
    And the question is: What is going to lead to the most 
productive employee who is most satisfied with the work.
    Senator Moran. So what percentage of the workforce no 
longer comes to the workplace?
    Dr. Califf. No longer comes? I would say maybe about half--
well, I wouldn't say ``no longer comes'', that is a difficult 
thing to answer in many respects.
    Senator Moran. No longer comes on a regular weekly or let 
me--a regular, daily basis.
    Dr. Califf. I would say the majority are not in the 
physical location on a regular, daily basis, but remember we 
have a very large part of the workforce that is out in the 
field traveling.
    Senator Moran. Well, I don't want to at all disparage, in 
fact, I want to compliment those who worked through the 
pandemic, and the risks they took to make certain that their 
jobs, their responsibilities were fulfilled. I don't believe 
that you can have and we will see what your study indicates, 
but I think it is very difficult to have a team effort in the 
absence of half of your employees on an ongoing basis.
    I understand the need to do this for the crisis of COVID, 
but I am discouraged by your suggestion that this will be an 
ongoing method by which the FDA employees work. And it doesn't 
sound like at the moment there is a timeline or a plan to 
return them to the office, we are awaiting this analysis?
    Dr. Califf. Well, I would say more and more people are 
returning to work, and as we work out the hybrids into the work 
environment they have been in, and as we work on the hybrid 
data, we are going to make decisions as we go as to what is 
most efficient and----
    Senator Moran. Any thought about having people come back to 
work, and then work on the hybrid plan, go back to where you 
were before?
    Dr. Califf. I mean, we will certainly discuss that, but 
right now it doesn't seem like the most efficient approach 
especially right now when we are in the midst of the BA.5 
surge.
    Senator Moran. You stated in previous testimony, I will 
change a bit of the topic to Congress, and testimony to 
Congress that the FDA intends to pay special attention to 
formula distribution in rural areas. Would you detail for me 
FDA's plans to prioritize formula distribution to rural 
communities?
    Dr. Califf. Well, first of all let me just say that the 
formula distribution is a function not just of FDA, but of the 
entire government because it involves, as you know, the 
Department of Agriculture, HHS, and the Executive Branch. But 
the basic plan, you know, the first thing was to get production 
up in the U.S. then to use the enforcement discretion, I know 
we will probably talk about this later with Dr. Mayne and Mr. 
Yiannas, to bring in the international sources.
    The distribution initially was through the larger chains, 
and now there is an intense focus on getting to the smaller 
stores as quickly as possible. And that is a matter of hooking 
up particularly the foreign firms that have not distributed in 
the U.S., before to these smaller areas. That is one of the two 
areas of our major focus at this point.
    Senator Moran. Thank you. My time, too, has expired.
    Senator Baldwin. I would like to welcome Ranking Member 
Hoeven. And would you be prepared to give an opening statement 
at this juncture?
    Senator Hoeven. I certainly can, Madam Chair. Thank you.
    Senator Baldwin. All right.

                    STATEMENT OF SENATOR JOHN HOEVEN

    Senator Hoeven. Welcome to our guests. I apologize for 
being tardy. But thank you very much for being here. Madam 
Chair, thanks for convening the hearing. And given the ongoing 
infant formula shortages, appreciate the opportunity to have a 
dialogue with Commissioner Califf, and the rest of the 
panelists this morning on that issue, as well as the FDA's 
overall approach to food safety.
    Now, you have got an extraordinary mandate. You are 
responsible for making sure that our nation's food and drugs 
are safe and effective. As you may recall during our earlier 
budget hearing, and the expressed concern the FDA has had seven 
commissioners this past decade. During that same period we have 
increased funding for FDA by 35 percent for the food programs, 
and the bulk of that is targeted to food safety and inspection 
improvements.
    Unlike other public safety agencies, such as Centers for 
Disease Control and Prevention, this committee has provided FDA 
with a lot of budget flexibility as well, to ensure that the 
highest priority needs get addressed.
    Additionally, it has been more than a decade since Congress 
enacted the Food Safety Modernization Act, FSMA, to update 
regulations regarding food production, and provide FDA with 
additional authorities to oversee and enforce the safety of our 
food supply.
    Yet, the CDC estimates that more than 128,000 people in the 
United States are hospitalized, and 3,000 people die from food-
borne illnesses each year. And it is my understanding that 
figure is the same as pre-FSMA implementation rates. So we need 
to talk about that, you need to talk about what you are doing, 
and how we can continue to work to improve it.
    Dr. Califf, you stated that one of your responses to the 
ongoing infant formula shortage is to undertake a top-to-bottom 
review of the food safety program, which you and I have talked 
about, and institute changes necessary to ensure a crisis like 
that doesn't happen in the future. As a parent and a 
grandparent, I can't overstate my concern about what happened 
in that regard and we have to make sure that, you know, we 
don't have something like that happen again.
    Going forward, I think that FDA should treat essential 
foods, such as infant formula in the same manner the agency 
treats essential medicines.
    So with that, again, I apologize that I was late this 
morning. But I want to thank you, Madam Chair, for calling this 
hearing. And I will turn it back to our witnesses.
    Senator Baldwin. Okay. Sure. I am going to now recognize 
Senator Heinrich for his questions.
    Senator Heinrich. Thank you, Chair Baldwin.
    Commissioner Califf, outside of acutely contaminated 
drinking water sources, people who are most exposed to PFAS 
chemicals through the food that they eat, food can become 
contaminated when it is grown, or what we have seen in New 
Mexico where animals drink PFAS-laden water, as well as through 
food packaging, and in several parts of the country PFAS 
contamination has manifested in agriculture, posing a food 
safety risk.
    What is the FDA doing to regulate PFAS chemicals in our 
agricultural products? And does your agency have the resources 
it needs to successfully pursue that work?
    Dr. Califf. Thank you, I am so used to the microphones that 
come on automatically. Thank you for raising this issue. And to 
me it exemplifies a whole host of similar issues that we have 
with contaminants that are there to some level. The 
epidemiology of this is very complicated, and it takes a lot of 
science to figure out where to draw the line, and where to 
intervene in these industries that are so critical to all of 
our welfare.
    So I will ask Dr. Mayne to give some of the details of what 
we are doing on this.
    Dr. Mayne. Thank you, Senator. So PFAS is a very important 
priority for us, and not just at the FDA, but across the 
interagency, and we are working in partnership with all the 
different key interagency partners, including EPA.
    In terms of our role, and we have multiple roles with 
regard to PFAS, but the first one is just understanding what 
the dietary exposure is. We need to understand, what is the 
hazard, and what is the exposure. So we have been conducting 
analyses of the U.S. food supply through what is called our 
Total Diet Study. In that testing, we have tested over 500 
different samples, we found 10 that had detectable levels of 
PFAS in the general food supply, so very reassuring information 
with regard to the general food supply.
    However, of those ten samples, eight of them that were 
detectable were seafood samples, and that has led us to be 
doing additional analyses on PFAS and potential contamination 
in seafood, we released some data very recently on that. So 
that is a key part of our work.
    The second part of it is when there are instances of local 
environmental contamination, as has occurred in your state, we 
work very closely with our state partners. And so we provide 
technical assistance, we have done analyses of samples for 
state partners because our analytical labs are capable of doing 
that. We have done that for New Mexico, and then we provide 
advice on what to do. This is a challenging problem, we are 
working with USDA, especially in the case of PFAS exposures, 
and EPA, so it an important priority.
    The last piece is the food contact use. There are certain 
authorized food contact uses of PFAS. If we have a concern 
about safety we take the step----
    Senator Heinrich. Are you largely talking about packaging 
in this case?
    Dr. Mayne. Yes.
    Senator Heinrich. Yeah.
    Dr. Mayne. Yes. I am talking about food packaging. Thank 
you. And so there are certain authorized uses for food contact. 
If we have a concern about safety we would withdraw those 
authorizations. And that has happened previously. We have had a 
market withdrawal recently for some short-chain PFAS that we 
had some lack of confidence in the safety of those compounds.
    So those are the roles we are taking in PFAS. With regard 
to your question about resources, we have absorbed this work in 
our base budget, but we have requested new resources in the 
fiscal year 2023 budget, and we would be very grateful for 
support to increase our work in PFAS.
    Senator Heinrich. You mentioned the prevalence of seafood 
within the samples that did test positive. Do you understand 
the mechanism or the vector there?
    Dr. Mayne. Yeah, we are just early in the days of getting 
information about seafood contamination with PFAS. What we did 
was a targeted sampling assignment of 81 different seafood 
samples. We looked at the most commonly consumed seafood in the 
U.S., things like tilapia, and shrimp, and salmon, clams, for 
example.
    Our results were released, we would be happy to share them 
with you. What we did see were some very concerning levels in 
one particular commodity, and that was canned clams coming in 
from China. So that is new data that we have.
    Your question about mechanism of action, we suspect this is 
due to environmental contamination where those clams are coming 
from.
    Senator Heinrich. Gotcha.
    Dr. Mayne. But we are working with the companies to try to 
understand that better and prevent those types of exposures.
    Senator Heinrich. Dr. Califf, before my time is expired. 
Obviously it is super hyper-critical that families can trust 
infant formula to be safe, and I know you have put a lot of 
effort into bringing offshore formula products up to our 
standards, but here in the U.S., I have heard complaints of 
long wait times for review, for responses for small domestic 
manufacturers.
    So what is the FDA doing to make sure its scarce resources 
prioritize those domestic American manufacturers and producers?
    Dr. Califf. I mean, as you know, we are working 24 by 7 on 
this to make sure that we have adequate supply, and there is 
priority given to large quantity suppliers while we are in 
shortage. But we are not going to slight U.S. producers. I 
might ask Dr. Mayne to also comment since she is running the 
diligent work of review.
    Dr. Mayne. With regard to the immediate action to try to 
get more formula on shelves, one of our criteria for moving 
forward with enforcement discretion was available product, and 
quantity of available product, because our goal as directed by 
the Administration is get formula on shelves as quickly as 
possible.
    At the same time, one of the things what we really want to 
do is make sure that we have a diverse infant formula 
manufacturing base going forward in time. There is a really 
important role here for U.S. manufacturers to play. So we want 
to encourage U.S. domestic manufacturers, we have some under 
review right now for enforcement discretion, but at the same 
time we are also looking beyond the current shortage, and we 
would like to support them in terms of providing more diversity 
to infant formula manufacturing in this country for a more 
resilient supply.
    Dr. Califf. Madam Chair, can I make one more quick comment 
on this?
    Senator Baldwin. Please, Dr. Califf, go ahead.
    Dr. Califf. It is just, I heard your admonition about it is 
not all about money and resources, but I mean this is an area 
where we know we have nine people working on this. You 
graciously added funding for four additional people last year. 
Given the need, it is an area where we just need to have enough 
people to do the work. You know, we have moved a lot of people 
over from other things to help make this happen now, but we 
can't sustain that without specific funding.
    Senator Baldwin. Thank you. Senator Hoeven.
    Senator Hoeven. Thanks, Madam Chair. I guess my first 
question would be in regard to the infant formula situation.
    Now, Chairman Baldwin and I did send, Dr. Califf, a letter. 
We got that I think the day before yesterday, so kind of short 
for our staff. And they work hard, and got a lot of things they 
have to get ready for these hearings. So if you could get 
responses sooner it would certainly be considerate of them in 
their timeline, because they try to get stuff ready.
    Dr. Califf. I apologize for that. I wish it had gotten to 
you sooner. I did read the entire thing. It is a number of 
pages, single spaced.
    Senator Hoeven. Pretty long, yeah.
    Dr. Califf. And a lot of work went into it. But I know you 
can--you know, I have the same concern myself. If people do a 
perfect job and it gets to me before I have a chance to read 
it, when I have to do something, it is not very helpful.
    Senator Hoeven. Yeah.
    Dr. Califf. We will double down on it.
    Senator Hoeven. Yeah, that speech you get as you are 
walking on stage to give it, a little hard to review, you know. 
So I know you get it, and I know you care about all the 
hardworking folks around here, they are trying to do good jobs, 
that that timeline would be helpful.
    But obviously that has been a real concern. I mean, you 
know, we can all imagine moms and dads, most of us having been 
moms and dads, in my case grandparents, you as well I think, 
you know, sweating out trying to get that infant formula. And, 
you know, the kind of the whole sequence of events, from 
inspectors not inspecting that plant, then getting out and 
inspecting the plant, and then the amount of time between 
inspection of the plant, determination of the problem, and then 
leadership at FDA being made aware of it.
    Those are real concerns. I know in going through with our 
committee staff they talked about, when the saving bag--when 
they had the issues in Puerto Rico with some facilities down 
there, and there was an instantaneous effort to get after some 
of those medical equipment, and needs, and that kind of thing.
    I get that that is on the drug side but, you know, 
something like baby formula, you are in that mode of, you know, 
having to have it, and in some ways almost like you would on 
the drug side. So how do we make certain, on the food side, 
that we have covered this that we don't have it happen again? 
And then there are still shortages in the stores. Where are we 
there? How soon are we going to have it squared away so that, 
you know, we don't have the empty shelf problem?
    Dr. Califf. Let us see. There was a lot included in your 
question.
    Senator Hoeven. Yeah. Well, I warned you last night on the 
phone that I was good with questions, so it is not that you 
weren't thinking about it anyway.
    Dr. Califf. Yeah, this is something we take so seriously 
for all the reasons that you gave, and I feel like I have been 
living with the folks you see here at the table, pretty much, 
since day one, since the recall occurred on the day I was 
confirmed. And you know, I stepped right into it. They have 
been working night and day.
    First of all, you raised the question of: What are we doing 
to correct errors that may have been made? It is well--known 
that Dr. Steve Solomon, who runs our Center for Veterinary 
Medicine, has a long history of knowledge of inspections, and 
other parts of FDA that is doing an after-action review. That 
is moving along. The interviews have been completed so I am 
expecting a report soon on that.
    We are also doing the top-to-bottom review that we 
announced yesterday, and Dr. Solomon's review will be available 
as part of that.
    And I will go through item by item, all the timeline, and 
all the things that happen, and corrective action for many of 
these things, like the escalation issue that you raise we 
already have instituted policies. As a health care person, this 
is a very common issue in health care provision nurses for 
example, if they see something wrong, escalating the issue. So 
I think we have already fixed that problem for the future.
    In terms of where we are, things are getting better. I 
think that is pretty well known. The numbers are looking 
better. It is not going to be a sudden fix, but we have each of 
the manufacturers, both the incumbent manufacturers, and also 
those that have now entered the market with enforcement 
discretion. We have their production estimates, and I would say 
it is a very diversified, robust pipeline coming in. But there 
was a deficit that is going to take a while to fix.
    And there is one other issue which I think is important for 
people to understand which is that, and when there is--in any 
commodity when there is a shortage, as I have learned, I was 
not an expert in supply chain management, you know, in industry 
when there is a shortage people change what they make to make 
it so that they are, for example, may be larger containers to 
optimize bringing forward the product for purchasing.
    So, some of the things that people are used to seeing on 
the shelf, may not be there even if the total amount of formula 
is the same, or higher than it was.
    The really good news I think is that production is 
exceeding buying by a significant amount now, and we expect 
that to continue. You may remember that there was a spike in 
purchasing when people became concerned, understandably, 
families went out and stocked their pantry in case there was a 
problem.
    But we have seen that now return to a normal level, even a 
little bit below normal level of purchasing. So that difference 
between what we are producing and what is being bought should 
be sustained now over the next few months. So I would just 
expect, like a plane taking off, I would expect to see a 
gradual improvement in the shelves.
    Senator Hoeven. Okay. Thank you. I guess I will defer my 
additional questions now to the next round.
    Senator Baldwin. So next, Senator Hyde-Smith.
    Senator Hyde-Smith. Thank you, Chairwoman Baldwin; and 
Ranking Member. And I certainly appreciate our panel being here 
today. Sorry that I had to leave another meeting and come in, 
so I am glad that I have had the opportunity to be with you.
    Commissioner Califf, I want to talk about the shrimp 
industry. You know, Mississippi, we are a big shrimping state, 
and it is very important to Mississippi. And our shrimpers 
harvest as much as 10 million pounds of shrimp each year, and 
then we have a lot of small family-owned processors that they 
meet very high health and safety standards to deliver our 
delicious Gulf shrimp that we like to advertise so well on the 
tourism commercials, and to American consumers across the 
country.
    But unfortunately, our shrimp industry is forced to compete 
with a lot of ever-growing volumes of the imported shrimp. So 
much of which is dumped on our market and subsidized by foreign 
governments, and more than 90 percent of the shrimp we consume 
in the U.S. is imported, you know, that is just the fact. And 
in many cases from countries where the food safety standards 
that are inferior to ours, even more concerning is the FDA's 
ability or inability to adequately inspect imported shrimp to 
ensure these imports meet our own health and safety standards.
    It is no secret that drugs not approved for use in the 
United States are often used in foreign aquaculture operations, 
and that the residues of these drugs may lead to some cancer 
allergic reactions when consumed by humans because of the 
carcinogenics that are found there.
    I am very pleased that imported shrimp was selected for 
FDA's recently launched Regulatory Partnership Pilot Program, 
and I hope these regulatory partnerships with exporting nations 
will lead to better safety compliance and oversight.
    But my question is: Can you give us an update on the status 
of this pilot program, and any specific improvements you have 
seen with respect to the regulations of imported shrimp?
    Dr. Califf. Thank you, Senator, for bringing that up. I 
think you may be the only Senator in this group that 
appreciates my love for shrimp and grits. I am from a 
Charleston family, as evidenced by the seersucker. It is a 
great day to wear seersucker in the 90-plus degree weather.
    I think we are making great progress here. And I would 
actually like Dr. Mayne and Mr. Yiannas to both comment about 
the specifics of what is going on. I think we are making great 
progress here.
    Senator Hyde-Smith. Thank you.
    Dr. Mayne. Thank you. And I will say we are grateful for 
the resources that we have received, $6 million to help advance 
this work on imported shrimp, and the safety of imported 
shrimp, and is directed in both fiscal year 2021 and 2022.
    In terms of how we have used those resources, you mentioned 
our regulatory partnerships. So one of the things we have done, 
is we focused in on the countries that import the most shrimp 
into the United States. That includes India, Indonesia, and 
Ecuador, and we have been establishing regulatory partnerships 
with the government authorities in all three of those 
countries.
    A key part of these regulatory partnerships is also data 
sharing agreements, confidentiality commitments, so that we can 
share information that they can have about their growers, their 
producers. That is important data that we can use for analytics 
as we look to improve our predictions about imports, and what 
we want to screen at imports. So that is one part of this, the 
regulatory partnership piece of it.
    But there is more, as well. And in terms of what we are 
doing with these countries, we have also been doing training. 
We have actually sent some of our seafood safety experts to 
these countries to improve the training around seafood safety 
with regard to shrimp, so we have been doing that as well as 
the partnership agreements.
    The last thing I will mention is, we are using these new 
technologies at the border, and to try to identify the highest 
rate of violative products using data and analytics.
    I will turn it over to Deputy Commissioner Yiannas to 
discuss a little bit more about our predictive analytics using 
technology.
    Senator Hyde-Smith. Thank you.
    Mr. Yiannas. Yeah. Well, thank you for that question. And 
we understand that American consumers want their food and 
shrimp to be safe regardless of where it comes from. And so we 
are working on that, and the pilot has been very successful.
    Let me emphasize just a couple of things. On the regulatory 
partnerships data sharing is going to be key. Can we get data 
from these regulatory partners and the entities that they are 
regulating to inform our risk prioritization efforts? So we are 
making progress on that.
    One other point that I will make before we get to our 
analytical approaches is, we have invested some of those funds 
on analytical equipment. Some of these products, as you know, 
are aquaculture, and so there are drugs and residues that might 
be added, and I want to make sure that we can detect it.
    But I think the big thing that I am very excited about is 
the use of data. Every single line of shrimp import that comes 
into the United States gets screened by FDA through something 
that we call the PREDICT system. And we are trying to leverage 
in this pilot, work that we started earlier on a Seafood AI 
Pilot. We are using the power of artificial intelligence and 
machine learning to strengthen our predictive capability of 
finding those violative products.
    And so we have embedded shrimp in the Seafood AI Pilot, and 
early results are very promising. We are on a third round of 
piloting, and the results suggest that we might dramatically 
increase our ability to find which seafood shipment, shrimp 
shipments are violative.
    Senator Hyde-Smith. Thank you so very much for that work. 
And my time is up.
    Dr. Califf. I want to comment on whether South Carolina 
shrimp is better than Mississippi shrimp. But I do have an 
opinion about it.
    Senator Baldwin. Following the subcommittee, that would be 
great lunch.
    [Laughter.]
    Senator Baldwin. Senator Braun.
    Senator Braun. Thank you, Madam Chair.
    Dr. Califf, last August your agency entered into a 
memorandum of understanding with the USDA's Food Safety and 
Inspection Service to facilitate information exchange between 
the two entities. So there has to be, I think, ideally a 
communication when there is a kind of dual agency 
responsibility.
    In that MOU it requires the FDA and FSIS to inform one 
another in the case of outbreaks, adverse cases of 
adulteration, or mislabeling, infestations, et cetera. Now, 11 
months into this MOU, is the FDA planning to conduct a public 
critical review for its actual implementation?
    Dr. Califf. Senator Braun, I am sure that will be part of 
the top-to-bottom review that we announced yesterday. I know 
this is within Mr. Yiannas' portfolio, the relationships with 
the other agencies, so I might ask him to comment.
    Mr. Yiannas. The answer is yes. We work almost on a daily 
basis with USDA on this shared issue, and so there is regular 
conversation. And so the answer is yes. We are closely 
evaluating how we are going to work through these processes 
together, and we are making progress.
    Senator Braun. And do you think the FDA has done its part 
in being a co-equal partner, and trying to pursue, and discuss 
these issues?
    Mr. Yiannas. Absolutely, yeah. We have signed an MOU with 
the identification of roles and responsibilities, and I can 
tell you we have done our part. And my sense is that USDA will 
tell you that they are very happy with the role we play.
    Senator Braun. Very good. This is on a different topic, and 
Dr. Califf, last year we suffered a record high of 100,000 
opioid overdose deaths. As a result Senator Manchin and I sent 
a letter to you in April urging that you implement 
recommendations from the National Academies to improve the 
FDA's policies for addressing this epidemic.
    A report that I think you requested during your first stint 
at the FDA. I know that was a critical part of the questioning 
when you went through the process of heading the FDA. Have we 
taken meaningful steps to do something about it?
    I know that yesterday Manchin and I co-sponsored changing 
the culture of the FDA Act, to kind of prod into something that 
looks like it is being taken more seriously, and would love to 
hear your comments on where we are at there, because it doesn't 
look like it is getting any better.
    Dr. Califf. I would say in terms of mortality rate from 
overdose is not getting better. And in fact CDC yesterday 
reported that it has gotten worse. And so this is something 
from day one, when I came in, we have been working on it, and 
my personal energy I will say got diverted a bit to infant 
formula. But in a very short period of time during the summer 
we are going to come out with a statement about the things that 
we are doing in this regard.
    There is a lot underway of the parts of it that are in our 
bailiwick, and our control, including the promised review of 
the past.
    And I don't think you solve future problems just by looking 
at the past, but you can learn things from the past that you 
need to take into account. You may have noticed yesterday Dr. 
Sokolowski was promoted into a joint role between the Drug part 
of the FDA and the Commissioner's Office, to head up this part 
of the effort. So we have a whole team working on it.
    One of the things that is really difficult and frustrating 
about this, is that in our list of things to do almost every 
one of them involves interaction with some other entity that 
has some say or control over it. And, you know, I will just 
point to over-the-counter naloxone is an example of something 
that is very complicated, because the cost may actually go up 
when you go over the counter, in that situation, to the person 
that needs it. But we have approaches to that that we are going 
to put forward.
    I also just want to call attention to the big new thing 
that is happening that we would better all pay attention to, is 
the essentially mail-order high-dose, chemically synthesized 
fentanyl and methamphetamine coming in by the mail, direct 
delivery to people, that is killing some of our most promising 
students who think they are getting Adderall or something to 
help them study.
    This is different. The things that we have worked on in the 
past are not going to solve this part of that too.
    Senator Braun. So we are out of time here. And you said 
during the summer, this is the summer. So when can we expect 
that to be out there for us and the public to see?
    Dr. Califf. Yeah, I can't give you an exact date, other 
than to say it is within the summer. And I know you are all 
over it----
    Senator Braun. I will take that by September 21st then?
    Dr. Califf. Oh, no.
    Senator Braun. But we need it, yeah.
    Dr. Califf. No. I think of that as and I don't know--the 
way I grew up, I think of the summer not officially, but more 
like September, 1st of September.
    Senator Braun. Labor Day, okay. Well, that is even better. 
Look forward to seeing it. Thank you.
    Senator Baldwin. I am going to begin a second round of 
questions. And I want to make sure I ultimately involve all the 
panelists in questions.
    So Mr. Yiannas, you have prior experience working outside 
of the FDA with major food corporations. Can you discuss, and I 
know this top-to-bottom review is ongoing, or is just 
commencing. But can you discuss what changes you view need to 
occur to make food safety more of a priority at the agency? And 
do you think that the agency is too slow to respond to 
outbreaks of food-borne illnesses?
    Mr. Yiannas. Well, thank you for those questions. Let me 
take the first one at the top. Yes, I am very fortunate to have 
worked for 30 years in two organizations that are world class, 
I would say, large global footprints, and I have learned a lot 
in this experience. But I did come to FDA a few years ago to 
try to make a difference in the public sector, serving the 
American people who, ultimately, I think we all agree, are our 
bosses, the American public, and so.
    But a couple of the best practices that I have learned 
working for these world-class organizations, I think are 
appropriate at FDA. Let me give you three real quickly.
    Number one is that food safety is a priority at FDA, but I 
think we have to go beyond making it a priority, and making it 
part of the culture. It really has to be an unwavering 
commitment that we are going to do everything that we can to 
ensure that Americans have safe food.
    And the organizations that I work for, the reason they were 
great, really it was their cultures. And I know sometimes 
people think that is the soft stuff, but it is the hard stuff. 
It has got to be part of the organization's DNA.
    Number two, the organizations that I work for were just, I 
would say, ruthlessly committed to continuous improvement 
modernization and reinvention. You know, one went from being 
non-existent to the world's largest company, Fortune 1 in 50 
years. How did they do that? Because they constantly reinvented 
what they do, and at FDA we are trying to do that under the 
auspices of something we have launched during my tenure, called 
the New Era of Smarter Food Safety.
    It is this idea that we are living in modern times, and we 
are going to need more modern approaches to how we regulate 
food. And so that is the second thing that I think good 
companies do well, those companies that go from good to great, 
and at FDA we are committed to continued modernization. And I 
would love to tell you more about New Era.
    But the last thing I would say is those organizations do a 
really good job of setting very high performance expectations, 
having high expectation standards of themselves, just like this 
conversation we are having here, we appreciate that you have 
high expectations of us, we have high expectations too, to do a 
brilliant job of clarifying roles and responsibilities so that 
when you work as a team there is no duplication of effort, and 
you get more done.
    And I would say the other thing the private sector does 
really well, is the use of performance measures or metrics. 
They measure everything, leading indicating, plotting 
indicators. And I know it is something that Dr. Califf really 
wants to do, is really leverage data and measurements. We are 
doing all of these things, but clearly there is more that we 
can do.
    In terms of the question, and it is a good question: Do I 
think we are too slow responding to outbreaks? I certainly 
think there is more we can do. Responding to foodborne 
outbreaks fast and thoroughly is critical. The faster you 
respond the quicker you can pull contaminated products off of 
the market and protect others from getting ill, and we have to 
do a better job of understanding the root cause. Why did the 
outbreak happen in the first place, so you could prevent it 
from happening again?
    We have publicly stated we think we can do more, and we can 
go faster. But let me give you just two quick examples of 
areas, and where we have improved. When I first arrived at FDA 
3 years ago, there was quite a bit of criticism that we are too 
slow arriving to let us say a field, a farm, or a site after an 
outbreak; I can tell you that now we generally show up quickly, 
and as fast as 24 hours or shortly thereafter.
    When I arrived there was criticism that when these 
outbreaks happen the outbreak reports were too slow, if they 
ever came, so that the industry could learn from them. I can 
tell you we have doubled, nearly tripled the number of outbreak 
investigation reports that we now publish, so industry knows 
what happened. And we have issued some as quickly as six weeks, 
six weeks after the CDC has declared the outbreak over. Now, 
that is fast.
    Having stated that, there is more that we can do, and in 
December, under the auspices of our New Era of Smarter Food 
Safety, we published a report that we are calling The Foodborne 
Outbreak Response and Improvement Plan. We contracted with the 
University Of Minnesota School Of Public Health, they worked 
with other Federal partners, and did a review of our outbreak 
investigation procedures, and we published a plan on how we 
further intend to improve how quickly and thoroughly we 
respond. So thank you for that question.
    Senator Baldwin. Thank you. We know that the Office of 
Regulatory Affairs at FDA has vast responsibility for 
overseeing inspections and enforcement of FDA regulations. One 
criticism that we have heard is that FDA is too slow, that the 
agency is stuck with outdated ways of thinking, and is not 
nimble to keep up with modern trends.
    So Mr. Rogers, how do you respond to those sorts of 
criticisms?
    Mr. Rogers. Yeah, thank you for the question. You know, I 
think we have demonstrated the ability to be nimble, especially 
in response to foodborne outbreaks, and emergencies. As Deputy 
Commissioner Yiannas mentioned, we have on many occasions, in 
response to an emergency, been able to get boots on the ground 
within 24 hours, on the farm, and in the facility.
    I can say that we are an organization that is committed to 
continuous improvement. We certainly welcome any feedback that 
would help us better achieve our public health mission and we 
certainly will react to the recommendations that are part of 
the ongoing internal review.
    Senator Baldwin. I am going to suspend the second round so 
we can give Senator Tester his first round of questions.
    Senator Tester. Thank you, Madam Chair. Anytime I can cut 
in front of Moran that is a good day. I will tell you, that is 
how much I know.
    Well, first of all welcome to you all. Dr. Califf, it is 
good to have you in front of the committee, it is good to see 
you got confirmed. I like all that, okay.
    You are a cardiologist, which means you are a doctor, which 
means you should know medicine, and you know probably better 
than anybody that the cost of medicine as part of the family's 
budget, has increased significantly over the last few decades. 
That is the bad news for the budget.
    The good news for the budget is the price of food has 
decreased as far as the overall amount put out for this. It is 
due to a lot of good science, quite honestly, developing hybrid 
plants that people like me, as a farmer, depend upon.
    But the truth is, is I don't know that we are doing enough 
to find out if the food we eat is still medicine, which food is 
medicine. And I think you would agree on that. You eat good 
food you usually have better health outcomes. There is a lot of 
information out there about people's allergies to wheat, and 
their ability to not eat it, which by the way is the staff of 
life.
    The question is, if the FDA, or is there anybody doing 
research on the work that man has done to modify plants, to 
make them so they produce higher protein, and bigger yields to 
be able to feed the world, which are all noble causes, but they 
are not so noble if they don't reduce inflammation, if they 
don't if they are not good for you.
    And one of your predecessors, I think I told you this when 
I brought them in and asked them this question. They said, 
wheat, we don't need to do any research on wheat because wheat 
is wheat, regardless whether it has been genetically modified, 
or hybridized, or anything.
    I am not arguing against any of that, because quite 
frankly, I have profited from that good science. But the bottom 
line is, is anybody doing any research to make sure what people 
are eating actually is making them healthier in the area of--
that the plants have been hybridized.
    Dr. Califf. Senator Tester, I really appreciate you 
bringing this up. I mean this gets into the area of precision 
nutrition in my view, which is a great topic. Dr. Mayne is the 
world's authority in this area.
    Let me just say, in my opening statement I made the point, 
we now, as Americans, live 5 years shorter than the average of 
other high-income countries. And the foundation of good health 
is a good diet, and not using tobacco products. So that 
combination.
    Senator Tester. That cuts me out on both by the way. Go 
ahead.
    Dr. Califf. So then the question is: What is good diet? And 
what is a good diet for an individual? And what are the 
constituents of the diet that make a difference? And with our 
change to a digital world of data, there is so much more that 
we can do.
    So Dr. Mayne, you may want to address that?
    Dr. Mayne. So thank you, Senator Tester. So a couple 
comments; first of all from an FDA perspective with regard to 
genetically engineered crops or gene-edited crops. We do play 
an important role through our Biotech Notification Program.
    So we look at the types of changes that are being 
intentionally made to these crops for very important 
characteristics. For example, drought resistance, resistance to 
viruses, improved nutrient levels, those are the types of 
innovations that we are seeing so our job is to make sure that 
those crops, when they are introduced into the market are safe 
and that they are appropriately labeled.
    Senator Tester. So how do you do that? And I am not only 
talking about GMOs, I am actually even talking about 
hybridized. It has been around my lifetime, my entire lifetime.
    Dr. Mayne. Yes.
    Senator Tester. So how do you actually test to see--for 
example, Turkey Red, which is a wheat that my grandfather 
raised when he homesteaded the farm, actually reduces 
inflammation, or at least I have been told that, okay, by 
people who are smart.
    And I have been told, by the way, that some of the wheats 
that we raise that are very, very common now, don't do that. 
That seems to me to add to costs, and people eat wheat because 
they think it is good for you, and I am one of those people 
that think it is good for me, because I eat a lot of it. Is 
there anybody that does any research to say yeah, you know 
what, 27431, developed by whatever university you want to say, 
really doesn't have those inflammation reduction qualities.
    Dr. Mayne. Yes. I guess how I would respond is, with regard 
to traditionally bred, hybrid types of crops?
    Senator Tester. Yes.
    Dr. Mayne. That type of research would be done primarily 
out of USDA working with the Federal agencies. So when it comes 
to basic science research, client research, USDA and NIH, are 
critical partners.
    Senator Tester. So is that done because Congress wants USDA 
to do it, because USDA ain't going to--that dog ain't going to 
hunt in USDA. I am just telling you. There is no way. They have 
got other stuff that they are doing. Why isn't FDA doing it? I 
mean you guys, it is Food Administration, and we will leave 
Drugs out, Food Administration.
    Dr. Mayne. Yes. How I would respond is, we do not have a 
significant budget to support things like extramural research, 
and----
    Senator Tester. So you need more money?
    Dr. Mayne. If we were to take on a mission like that, we 
are not resourced to do that at this time.
    Senator Tester. And if I might, Madam Chair, and then I 
will shut up? Might I ask if you had the money to do it, do you 
think that the science community would try to stop you from 
doing that research?
    Dr. Mayne. We always follow the science on anything that we 
do and----
    Senator Tester. Okay. But remember the science is disease 
resistant, drought resistant, bug resistant, all good things by 
the way, all stuff that I applaud as a farmer when I put it in 
the ground, but on the other side, if it doesn't produce the 
kind of food effects that you want, and nobody is testing it 
don't you think people get a little bit nervous if you started 
testing for this, for the food nutrition, the qualities?
    Dr. Mayne. When it comes to, again, the genetically 
engineered, gene-edited ones we--if they are improving nutrient 
content, we require evidence of that when we are looking at 
those types of submissions. But we don't review the regular 
crops.
    Dr. Califf. Could I make one comment?
    Senator Tester. And I don't want to beat this dog to death, 
but nutrient costs, is one thing, health care benefits aren't--
I think another?
    Dr. Califf. You showed a lot--in my opinion, you showed a 
lot of wisdom there, Senator. You sounded like a researcher.
    If I can make one quick comment about this, and I think Dr. 
Mayne agrees with me on this. Nutritional research needs to be 
an all-of-government effort. I mean, to leave out the NIH would 
be a big mistake, to not involve USDA would be a big mistake. I 
think FDA should have a bigger role, we have got a lot of 
expertise, and we understand health effects.
    I mean, the point you made about measuring just 
inflammation not that the overall health effect is a really 
important one. And we couldn't even address this until 
recently, because we didn't have the big data capabilities that 
we now have to study populations.
    I called your attention to a White House Conference coming 
up in September where all the players are going to be at the 
table, I would urge you to get your say in, because I think you 
are saying the right thing.
    Senator Tester. You are very kind. Thank you all for being 
here. Thank you, Madam Chair.
    Senator Baldwin. Do you have a second round of questions, 
Senator Moran.
    Senator Moran. Yes, and I hate follow Senator Tester. Thank 
you, Chairwoman Baldwin.
    Senator Baldwin. You are welcome.
    Senator Moran. Dr. Califf, it currently takes three to 5 
years for a new animal feed ingredient to be approved. In 
fiscal year '20 I worked to secure an additional $5 million for 
FDA to hire additional personnel to review feed ingredient 
approvals.
    In fiscal year 2022 Congress provided another million to 
improve, or attempt to improve this process. Since receiving 
those additional resources what steps have FDA taken to improve 
timeliness of reviewing and approving animal ingredients? And 
then when you answer that question, then I want to flag a 
policy concern I have in that process.
    Dr. Califf. Well, you know, the additional funding has been 
appreciated. I know that Dr. Solomon and CVM have worked really 
hard to speed up the process, and do the evaluations that are 
needed, and I think the Center for Veterinary Medicine is the 
most underappreciated part of the FDA. I mean, oversight is 
good, support is good, and I have to go back and talk with Dr. 
Solomon to get a more detailed answer but I do appreciate the 
question.
    Senator Moran. If you would ask him to contact me or my 
staff that would be wonderful.
    Dr. Califf. We will do it.
    Senator Moran. The follow up to that is a policy concern 
with the approval process. The livestock industry is looking to 
offer solutions to meet the challenges related to climate; 
however, the current FDA policy interpretations regulate 
certain feed ingredients which could reduce greenhouse gas 
emissions as animal drugs instead of as a feed ingredient.
    It is my understanding that the FDA Center for Veterinary 
Medicine Policy Manual dictating these decisions has not been 
updated since 1998. Would you commit to reviewing those 
policies related to categorizing feed ingredients as animal 
drugs, and working with me to improve the approval process so 
our livestock producers can get these climate solutions 
available in a more timely fashion?
    Dr. Califf. I know there are several issues in that 
category, so I am definitely committed to reviewing it. The 
impact on emissions has got to be an important consideration in 
that overall picture. So the short answer is, yes.
    Senator Moran. Thank you, Doctor.
    Senator Baldwin. All right, Senator Hoeven.
    Senator Hoeven. Thanks, Madam Chair.
    Dr. Califf, you mentioned the top-to-bottom review, when do 
you expect it to begin? And then I trust you will be sharing it 
with Congress as well, correct?
    Dr. Califf. I think a lot of people are going to be 
watching this and, you know, in an interview I did yesterday I 
pointed out that we have a lot of bosses, and Mr. Yiannas said 
the public, I agree with that. You guys are our bosses. We 
can't make the kind of changes we are going to need without 
your agreement. So I don't see it as, just informing you, I 
think we are going to have to iterate about what we are finding 
and what you believe. And we are also part of the Executive 
Branch, so we got a lot of masters there that we have to 
satisfy.
    We are going to start as soon as we get the contracting 
done. You know, the people that do the work are going to put a 
lot of time and effort into it. So we are working on that right 
now through the Reagan-Udall Foundation, and we are committed 
to having a report within 60 business days of the time that the 
work begins.
    Senator Hoeven. Okay. Thank you. Budget transparency, also 
I brought up the Food Safety Modernization Act, and both 
performance before and after, can you incorporate into your 
budgeting process or reporting process, how you are trying to 
implement that flexibility, and improve your processes? Will 
that be part of this review as well?
    Dr. Califf. The short answer is yes. I will say I have 
worked in just about every kind of organization. The Federal 
Agency budgets, I would say, are among the more difficult to 
decipher because of the mixed mission, and sort of all these 
things come into play.
    And I think on the food side, you know, one thing about the 
user fees on the medical product side, is it brings a 
discipline to the budget that is very clear, which has some 
value. We don't have that on the food side. But we are 
committed to making the budget much more transparent and 
understandable.
    Senator Hoeven. So Mr. Yiannas, and I know, I talked to Dr. 
Califf about this as well. I know you are trying to use 
technology to create a safer food supply, a more traceable food 
supply, and all that kind of thing. You have worked with large 
companies, I certainly understand how they can implement the IT 
to do that kind of thing, but there is a lot of small companies 
out there, how are they going to be part of this effort? I 
mean, and it seems like a very worthy effort, but how are they 
going to have the resource base to do this?
    Mr. Yiannas. Well, thank you for that question, and you are 
right, we have to be very cognitive of this. You have 
acknowledged we want to use technology such as machine learning 
to strengthen our predictive capabilities. We have an interest 
in leveraging technology such as distributive ledger to see if 
we can track and trace foods faster, but we have to be 
cognitive and very careful of what we ask or require of the 
industries that we regulate. And so we are taking that into 
consideration.
    Let me give you one quick example of how we are doing that. 
I think many of you know, we have a proposed food traceability 
rule. When we issued that proposed food traceability rule, it 
was just for certain foods that are most likely to be involved 
in foodborne outbreaks, number one.
    Number two, when we proposed the rule we said that the 
records can be kept for each node in the system, not for the 
entire continuum, but for each node, and it can be kept on 
paper. So we are not requiring that it be kept digitally. We 
have carved out exemptions for small food producers, and for 
small retailers, and so we are being cognitive.
    We do know that some in the food industry, as the food 
industry becomes increasingly digitized, because it is 
happening, it hasn't happened real quickly as it has happened 
in other industries, because of the margins on food, but it is 
going to happen because it drives efficiencies.
    As that happens we have to be careful that we don't create 
what I call a digital divide. And so one of the things we did 
just last year, we did something that was a little bit less 
traditional. We didn't write rules, we didn't write guidance, 
but we held what we call the Food Traceability Challenge, and 
we called it a low- to no-cost food traceability challenge.
    Let me emphasize, it was low- to no- cost. We know that 
data can be digitized, we have been digitizing data for 
decades, but we went out to food traceability solution 
providers, and we said, can you create solutions that are low 
to no cost, so they can scale for food producers at all sizes? 
And our call to action was answered in a big way. We had over 
90 submissions representing 12 countries around the world, we 
have selected winners.
    And a lot of the solutions are low to no cost. If you think 
about social media platforms, many of us are in them, how much 
do you pay to participate? Most of us none, because they have 
created economic models that allow those solutions to scale, 
and so rest assured that we are very careful of this, and we 
won't require something on food producers that is not doable. 
And we will make sure that our food safety policies and rules 
are sustainable, and that they can be executed by food 
producers of all sizes.
    Senator Hoeven. Thank you. I appreciate that answer, 
clearly something you have been thinking about necessary.
    Mr. Yiannas. Yes.
    Senator Hoeven. Dr. Califf, this relates a little bit to 
what you were talking to Tester about, but there are 21 Federal 
agencies that all have different programs, standards, 
requirements, recommendations, suggestions, I mean you name it, 
but they all want to kind of tell you how you ought to improve 
your diet to make you more healthy, okay?
    Well, that can create a lot of challenges out there for a 
lot of folks. Like school nutritionists, for example, who I 
think know quite a bit about nutrition and what those school 
children should eat, will eat, won't eat. And sometimes all 
these, you know, mandates from on high where somebody just 
knows how all 300-plus million folks ought to eat every day, 
you know, create some real challenges out there.
    As lead agency on food safety, how do you--how do you kind 
of weigh in on that, and kind of rationalize the thing in a way 
that works for consumers and for the folks, the professionals 
out there that are trying to do it, but you still got to give 
people choice, and discretion. And, you know, I mean, they 
might want to eat Mississippi shrimp, or they might want to eat 
South Carolina shrimp, and so they should be informed, but they 
should also have their choice.
    Dr. Califf. I am going to turn to Dr. Mayne, but let me 
just say, she and I, I remember going back to 2015, have 
arguments about this on the scientific basis of how you derive 
the conclusions that you need to derive, because you could 
write a book about, just about any diet now and sell it to a 
lot of people. It might not be good for any of them. But Dr. 
Mayne is in charge of this food labeling effort. It is just an 
amazing----
    I just think of in my lectures between my stints at FDA, I 
said, you have got a space about this big to inform 320 million 
people who speak different languages, and have different levels 
of education, it is a big task.
    Dr. Mayne. So I would say we are very committed to doing 
what you just said, which is empowering consumers with 
information, we want consumers to have the information they 
need to make those types of choices. And labeling is a key 
tool. And you mentioned 21 Federal agencies, but only a few of 
them are regulatory, like FDA. And so we do have some unique 
levers to really help empower consumers with information. So 
that is a key part of what we do.
    In terms of consumer choice, we agree with consumer choice, 
we are trying to support innovation throughout the food supply, 
but to make sure those products are safe, and then they are 
properly labeled so consumers do have those choices.
    In terms of the foundation of dietary recommendations, that 
is the dietary guidelines process; that is a joint process that 
is done every 5 years. It is a partnership between the U.S. 
Department of Agriculture and Health and Human Services, we do 
play a role in that as part of HHS, but all the Federal dietary 
guidance derives from the dietary guidelines process that 
occurs every 5 years.
    Senator Hoeven. How about standards of identity? In one 
case there is one that dates back to 1988. How are we making 
sure that these standards of identity are being--those 
decisions are being made, they are being made well, and they 
are being made timelier?
    Dr. Mayne. Thank you for that. Should I take that one?
    Dr. Califf. Please.
    Dr. Mayne. Yes, thank you for that question.
    Senator Hoeven. My next one is going to be Mississippi and 
South Carolina shrimp. So it is going to get tougher after this 
one too.
    Dr. Mayne. Yeah. There are a large number of standards of 
identity, some of them definitely need to be updated, and we 
have some petitions that we have been working our way through, 
and we are very committed to updating, modernizing standards of 
identity, and where appropriate creating new standards of 
identity. We have some requests to create new standards of 
identity, for example.
    But one of the challenges with regard to standards of 
identity, it is not designed to be an agile process, this 
process to update a standard of identity involves rulemaking, 
and rulemaking always takes time.
    And with certain standards of identity it involves formal 
rulemaking which is, in some ways, an even more complicated 
process. So it is not a quick process. The other piece is, as 
we work to update a standard of identity it is really critical 
that we have extensive stakeholder engagement to understand the 
practices that are used by the folks who are making those 
standardized foods, so that the modernized standard of identity 
really reflects what is in there.
    So we are very committed to doing that, we are making 
progress on that, we appreciate new resources that we have 
received from you all.
    Senator Hoeven. Which were provided, yeah.
    Dr. Mayne. Yes. This has been a very under-resourced area, 
and CFSAN is one of the most under-resourced in the past, and 
that created a backlog, like the 1988 one that you mentioned. 
But with the new resources, we have been able to hire 13 new 
people. We have five new recruits that we are working to get 
through the process. I will mention that the Foods Program does 
not have the Cures hiring authority that is as agile as the 
medical products, so it takes us longer to get those new hires 
on board.
    So we know we have had conversations with many of you about 
hiring authorities that the medical product centers have, if 
the Foods Program had those same hiring authorities your 
resources would translate into bodies on board more quickly in 
the Foods Program.
    Senator Hoeven. I appreciate that. That is a good 
recommendation, and I am glad you brought up the additional 
funding. I was going to do it, you did, good for you. The 
Flexibility Hiring Authority is something that we should look 
into. I appreciate that recommendation.
    This is a challenging area. I am sure that the Chairman can 
tell you. You know, for example milk products, you know, so but 
a very important area. So thank you for your response.
    Senator Baldwin. Thank you. I want to share my gratitude 
with all the witnesses from FDA. I think we had a good 
discussion, and I want to assure you that the committee is here 
to support you in the important work you do.
    I am now going to dismiss this panel, and invite the second 
panel to come forward. And I will be introducing them as that 
transition is taking place.
    So you are excused. And thank you again for appearing.



                                PANEL II

    Senator Baldwin. I want to welcome our second panel. Mr. 
Brian Ronholm is the Director of Food Policy at Consumer 
Reports. Brian leads consumer reports advocacy efforts with 
regard to food safety. He was previously a deputy 
undersecretary for food safety at USDA, and also served as an 
agriculture appropriations associate for Representative Rosa 
DeLauro.
    Ms. Sarah Gallo is the Vice President of Product Policy at 
Consumer Brands Association. In her role she oversees the 
Consumer Brand's regulation issues, from advocacy through 
education. She has also served as Vice President of Agriculture 
and Environment for the Biotechnology Innovation Organization, 
otherwise known as BIO.
    These witnesses bring years of experience, and expertise, 
and we are looking forward to hearing from both of you today. 
So if I have given you enough time to get settled. I will start 
with Ms. Gallo.
STATEMENT OF MS. SARAH GALLO, VICE PRESIDENT, PRODUCT 
            POLICY CONSUMER BRANDS ASSOCIATION
    Ms. Gallo. Plenty of time to get settled. Thank you 
Senator.
    Chairwoman Baldwin, Ranking Member Hoeven, and other 
members of the subcommittee, thank you for the invitation to 
testify today. As you noted my name is Sarah Gallo, and I serve 
as Vice President of Product Policy for the Consumer Brands 
Association.
    Consumer Brands champions the industry whose products 
Americans depend on every day, representing more than 2,000 
iconic brands. From cleaning and personal care, to food and 
beverage products, the consumer packaged goods industry plays a 
vital role in powering the U.S. economy, contributing $2 
trillion to U.S. GDP and supporting more than 20 million 
American jobs. The CPG industry depends on the FDA to perform 
its regulatory role effectively, efficiently, and 
transparently.
    As we look to the future of our industry, modernizing and 
reforming FDA is top of mind, for food, beverage, and personal 
care companies we represent, and their experiences provide 
real-world evidence of why a modernized FDA is warranted.
    Consumer Brands is calling on FDA to unify its food program 
under a deputy commissioner for foods, with accountability to 
the Commissioner and direct line authority over CFSAN, CVM, and 
the food-related components and operations of ORA.
    The lack of a single full-time fully empowered expert 
leader affects all aspects of the FDA's food program. 
Inefficient decisionmaking has slowed reviews, hindering 
progress, and even rendering innovation obsolete. Inexperienced 
and under-trained inspectors are being sent into the field, a 
split and siloed food program undercuts communication and 
collaboration.
    There is an urgent need for this change to be made and the 
appointees should have relevant and appropriate food 
credentials to quickly implement modifications that will 
benefit consumers and our industry.
    A unified structure and a full-time senior leader 
translates into results we all care about, focused leadership, 
accountability, and effective dialogue with myriad 
stakeholders, and FDA can make this change now.
    The creation of a deputy commissioner for foods does not 
require an act of Congress or rulemaking. In fact, the position 
existed under the Obama administration, and worked to ensure 
programs and oversight worked at optimal levels.
    We know that FDA's food program may require increased 
funding to fulfill this mission. We also appreciate that 
Congress has provided considerable funding going back to fiscal 
year 2015. A strategic review, and realignment around 
priorities could help FDA and its stakeholders make the case 
for additional funding if needed.
    Organizing under a deputy commissioner for food is step 
one, but it is not the only step. Consumer Brands set a goal to 
define a series of high-value, product related policies that 
reframe FDA's food operations.
    A decade ago, we would have thought about modernizing FDA 
to move at the speed of business, but years later it is 
essential that FDA is reformed to move at the speed of the 
consumer, meeting their rapidly changing preferences and 
demands. We are in the progress of articulating these policies 
with our member companies, and look forward to sharing our plan 
with you in the coming months.
    Modernizing the agency also should be business critical for 
the agency, reforms stand to position FDA as the leader and a 
subject matter expert in facilitating innovation, assisting 
industry to meet state mandates and enabling data to drive 
decisionmaking.
    Consumer Brands calls on FDA to convene an independent 
outside panel of experts to address modernization of food 
program policy and operations,
    Finally, I would note that the COVID-19 pandemic 
demonstrates that regulators like FDA and industry can work 
together to improve the regulatory environment. I will note a 
few policies that worked during the pandemic, and that continue 
to work in today's operating environment.
    First, incorporating remote regulatory assessments in 
modernized inspection approaches has the potential to save 
hours or even days' worth of time for companies, as well as for 
government agencies and departments.
    Second, a process for quickly creating just-in-time 
industry best practice documents, clearing them, and 
subsequently sharing them with appropriate Federal and state 
government agencies, and then posting to a website, should be 
the new normal, and the Federal government should partner with 
industry to achieve this goal.
    Labeling flexibility is provided by the FDA during the 
pandemic to address those persistent supply chain challenges 
were critical to the CPG industry's ability to deliver 
essentials to consumers, particularly when they were homebound. 
These flexibilities make supply chains more nimble, allowing us 
to better navigate shortages while ensuring consumer safety.
    Working at the speed of the consumer requires a strong, 
modernized FDA, one that is structured, governed, and funded 
for success. That might not be the case today, but it also 
doesn't need to be the fate of tomorrow if FDA chooses to make 
smart, needed changes.
    We look forward to working with the committee to achieve 
this goal. And I look forward to your questions, and appreciate 
the opportunity to present our perspective. Thank you.
    [The statement follows:]
                 Prepared Statement of Ms. Sarah Gallo
    Chairwoman Baldwin, Ranking Member Hoeven and members of the 
subcommittee, thank you for the invitation to testify at today's 
hearing. My name is Sarah Gallo, and I serve as vice president of 
product policy for the Consumer Brands Association.
    Consumer Brands champions the industry whose products Americans 
depend on every day, representing more than 2,000 iconic brands. From 
cleaning and personal care to food and beverage products, the consumer 
packaged goods (CPG) industry plays a vital role in powering the U.S. 
economy, contributing $2 trillion to U.S. GDP and supporting more than 
20 million American jobs.
    There is a considerable range of issues currently affecting CPG 
products. Consumer Brands has been laser focused on supply chain and 
packaging sustainability for several years, as both issues impact the 
entirety of the CPG industry and require continued attention. As we 
look to the future of our industry, modernizing and reforming FDA is 
top of mind for the food, beverage and personal care companies we 
represent.
    To meet consumers where they are today, FDA rightly should be 
modernized to keep pace with consumer demand and preference. Our 
members' experiences across the CPG industry provide real world 
evidence of why a modernized FDA is warranted. Companies are halting 
innovation in food packaging and novel foods because of delays in FDA's 
review of industry submissions. We hear concerns about an inability to 
innovate, grow and thrive because FDA lacks streamlined decision making 
for the range of products within its jurisdiction.
    Addressing structural and governance issues at the agency, 
particularly with respect to FDA's food and nutrition program, is 
foundational to modernizing FDA in this space. The aggressive 
modernization of FDA's medical products programs that took place 
several years ago should serve as model and imperative for FDA's food 
program to keep pace with industry innovation and consumer demands.
    We are hopeful that today's hearing can begin a process to elevate 
and strengthen FDA's role in supporting the CPG industry in meeting 
consumer demands and expectations and innovating for enhanced safety 
and environmental quality in the decades ahead.
   unifying fda's food program under a deputy commissioner for foods
    The CPG industry depends on FDA to perform its regulatory role 
effectively, efficiently and transparently. We appreciate FDA's past 
collaboration with our industry, consumer groups and the States in 
implementing the Food Safety Modernization Act (FSMA) and executing on 
its New Era of Smarter Food Safety initiative. Unfortunately, problems 
in the food program's organizational structure, governance and 
performance are impacting the effectiveness of that relationship. 
Specifically, the lack of a single, full-time, fully empowered, expert 
leader affects all aspects of the FDA's food program. Inefficient 
decision making has slowed reviews, hindering progress and even 
rendering innovation obsolete. Inexperienced and undertrained 
inspectors are being sent into the field. A split and siloed food 
program undercuts communication and collaboration at the expense of 
efficiency and responsiveness. Each of FDA's major food program units, 
the Center for Food Safety and Applied Nutrition (CFSAN), Center for 
Veterinary Medicine (CVM) and the Office of Regulatory Affairs (ORA), 
stands to benefit from a common strategic direction, clear priorities, 
sound resource management and internal accountability that could result 
from unifying the program under an expert leader who is accountable and 
responsible for the program.
    Consumer Brands is calling on FDA to unify its food program under a 
deputy commissioner for foods, with accountability to the commissioner 
and direct line authority over CFSAN, CVM and the food-related 
components and operations of ORA. There is an urgent need for this 
change to be made, and the appointee should have relevant and 
appropriate food credentials to quickly implement modifications that 
will benefit consumers and our industry. A unified structure and a 
full-time senior leader translate into results we all care about--
focused leadership, accountability and effective dialogue with myriad 
stakeholders. We believe that the ultimate success of FSMA, as well as 
execution of the New Era of Smarter Food Safety blueprint, requires 
transparency and robust engagement with industry, consumer groups, 
state associations and other stakeholders. This is lacking under the 
current structure and governance model.
    FDA can make this change now. The creation of a deputy commissioner 
for foods does not require an act of Congress or rulemaking. In fact, 
the position existed during the Obama administration and worked to 
ensure programs and oversight work at optimal levels.
    I have made several references to accountability and want to note 
that Consumer Brands acknowledges that FDA's food program may require 
increased funding to fulfill its mission. We also appreciate that 
Congress has provided considerable funding for the FDA food program 
going back to Fiscal Year 2015. A strategic review and realignment 
around these enhanced priorities could help FDA and its stakeholders 
make the case for bolstering funding if needed. We will continue 
working with the FDA and this committee to ensure FDA's funding needs 
are transparent, understood, requested and appropriated.
                         modernizing the agency
    Organizing under a deputy commissioner for food is step one, not 
the only step. Consumer Brands set a goal to define a series of high 
value, product-related policies that embrace technological advancements 
and reframe FDA's food program operations. A decade ago, we would have 
thought about modernizing FDA to move at the speed of business. Years 
later, it is essential that FDA is reformed to move at the speed of the 
consumer, meeting their rapidly changing preferences and demands.
    We are in the process of articulating these policies with our 
member companies and look forward to sharing our plan with you in the 
coming months. Certainly, policies related to modernizing inspections, 
labeling and recall processes, new policy formulation to address e- 
commerce and the use of technology and new models for FDA-industry 
collaboration will be included.
    Modernizing the agency is business-critical for our industry. FDA 
must develop and implement a structured, prioritized regulatory agenda 
for its food program, utilizing a transparent process that allows for 
stakeholder input and includes a public process for rulemaking and 
issuance of guidance.
    But modernizing the agency also should be business-critical for the 
agency. Reforms stand to position FDA as a leader and subject matter 
expert in facilitating innovation, assisting industry in meeting state 
mandates on issues related to packaging materials and enabling data to 
drive decision making. We are encouraged that Commissioner Califf noted 
in testimony before House Oversight and Investigations subcommittee 
that he will be looking at the overall food program from the 
perspective of reforming it. Consumer Brands calls on FDA to convene an 
independent, outside panel of experts to address modernization of food 
program policy and procedures.
           applying lessons learned from the covid-19 crisis
    The COVID-19 pandemic created unprecedented challenges for the CPG 
industry, demanding new approaches to manufacturing processes and 
temporary changes to government policies and regulations. Many of these 
crisis-driven actions have proven as safe and more efficient at 
achieving the goals of pre-crisis public policy and should be made 
permanent. The experience of the pandemic demonstrates that regulators 
like FDA and industry can work together to improve the regulatory 
environment.
    Here are a few policies that worked during the pandemic and that 
continue to work in today's changed operating environment, producing 
better results for consumers and businesses alike:

    1. Develop and Implement Modernized Routine Inspection and Third-
Party Audit Models That Include Remote Regulatory Assessments

        COVID-19 illustrated it is possible to facilitate efficient 
        regulatory oversight by inspectors--and verification of 
        suppliers by auditors--through alternative approaches that 
        replace certain in-person practices. Incorporating remote 
        regulatory assessments in modernized inspection approaches has 
        the potential to save hours of time for individual facilities 
        and days for companies with multiple facilities, as well as for 
        government agencies and departments.

    2. Expand Government Capabilities to Provide ``Speed of Business'' 
Regulatory Responses to Stakeholder Inquiries and Emerging Issues

        During the COVID-19 crisis, regulators provided timely and 
        complete responses and solutions to stakeholder questions and 
        problems. Most regulatory agencies and departments have 
        mechanisms in place for this type of stakeholder engagement, 
        but typically the speed of the response and the provision of 
        practical solutions take weeks. The process deployed during the 
        pandemic for addressing industry's questions and solving 
        problems in real time should be the new normal post-pandemic.

    3. Expedite Creation of Just-In-Time Best Practice Documents

        During the COVID-19 crisis, multiple just-in-time industry best 
        practice documents were created by trade associations, 
        including Consumer Brands, that were ``blessed'' by agencies--
        CDC and FDA in particular. A process for expeditiously creating 
        these documents, clearing them, subsequently sharing with 
        appropriate Federal and State government agencies for their 
        concurrence (as opposed to clearance) and then posting on the 
        web was established and implemented. These documents were fit 
        for use, timely, ensured consumer safety and served to help 
        numerous individual facilities and establishments. This process 
        and expectation should be the new normal and the Federal 
        Government should partner with industry to achieve this goal.

    4. Maintain Food Labeling Flexibility

        Labeling flexibilities provided by the FDA during the pandemic 
        to address persistent supply chain challenges were critical to 
        the CPG industry's ability to deliver essentials to consumers, 
        particularly when they were homebound. From allowing minor 
        ingredient substitutions without corresponding label changes to 
        permitting the diversion of product labeled for one use (i.e. 
        restaurants) to be redirected to an area of greater need (i.e. 
        grocery store shelves), these flexibilities make supply chains 
        more nimble, allowing us to better navigate shortages and 
        ensure consumer access and safety.

                               conclusion
    The CPG industry is accountable to and responsible for the 
consumers it serves. Working at the speed of the consumer requires a 
strong, modernized FDA--one that is structured, governed and funded for 
success. That may not be the case today, but it is also not the fate of 
tomorrow if FDA chooses to make smart, needed changes.
    Our industry stands ready to respond to and partner with the FDA to 
meet the essential, daily needs of American families. We believe there 
is ample opportunity for industry, Congress and the administration to 
work together and deliver a modernized FDA food program. We look 
forward to working with the committee to achieve this goal.
    I look forward to your questions and appreciate the opportunity to 
present our perspective.

    Senator Baldwin. Thank you, Ms. Gallo. Next, we will hear 
from Mr. Ronholm.
STATEMENT OF MR. BRIAN RONHOLM, DIRECTOR, FOOD POLICY 
            CONSUMER REPORTS
    Mr. Ronholm. Thank you Madam Chair, and Ranking Member 
Hoeven. I know my written testimony is in the record, but I 
will just take a moment to make some brief comments. And I know 
during his testimony today, Dr. Califf made a couple mentions 
of the top and bottom reviews that will be conducted as part of 
their process.
    And I would just point that the critical points to these 
top-to-bottom reviews are, as Sarah alluded to, independent and 
transparent.
    And yesterday's announcement about the Reagan-Udall 
Foundation conducting the evaluation is an interesting 
development that will deserve monitoring. Given that the 
purpose of the Foundation is to support the FDA's mission we 
certainly are eager to learn more details about how the 
Foundation will ensure that that process is independent.
    And we are also eager to learn more about how the 
Foundation will ensure the transparency of their process, and 
how they intend to engage with internal stakeholders within 
FDA, particularly CFSAN, CVM, ORA, those offices, and also how 
they intend to engage with external stakeholders, consumer 
groups, industry, state and local regulators.
    I think having as much input as possible throughout this 
process will be critical to their process in conducting a true, 
comprehensive, top-to-bottom review. And I know a coalition of 
groups including Consumer Brands and Consumer Reports are 
certainly looking forward to working with the Foundation 
throughout that process to resolve the concerns.
    And it is those concerns that link to my testimony which 
focuses on how the structure, governance, and performance of 
the food program impacts recalls and food policy decisions, 
between inadequate responses to recalls a failure to implement 
a culture of illness prevention, and a failure to move quickly 
on proposed rules and initiatives, there are a number of 
questions about whether the FDA is performing its regulatory 
role effectively.
    It is struggling in its role to protect consumers, and it 
is preventing the food industry from operating effectively.
    The recent infant formula crisis was merely one symptom 
that exposed a greater organizational structure and culture 
problem, and it is clear that the confidence in the food 
program is eroding. A big reason for the lower confidence is 
that the food program has second-class status within FDA, and 
it has resulted in serious problems.
    The FDA also lacks a single full-time, fully empowered, 
expert leader to provide strategic leadership and management 
accountability to a set of offices that are responsible for 
approximately 80 percent of the food supply. It is a fragmented 
structure in the food program that led an unprecedented 
coalition of consumer groups, industry trade associations, and 
state local regulators to join together to call on FDA to unify 
the food program under a deputy commissioner for foods. And 
this is what Sarah alluded to in her testimony.
    This position would have accountability to the 
Commissioner, and direct oversight authority over CFSAN, CVM, 
and the food-related operations of ORA, that would bring 
focused leadership and accountability to the food program at 
the agency.
    The current framework often results in an overall lack of 
urgency in making compliance decisions including recalls, and 
an aggressive lack of ambition on policy initiatives. Another 
area where there are serious questions and certainly 
appropriate to this subcommittee, is how funding is allocated 
within the food program.
    ORA, which is responsible for inspections and compliance 
receives approximately 70 percent of all FDA food program 
funding, and despite the funding increases that the FDA has 
received post-FSMA, we have seen inspections decline in the 
years following the enactment of FSMA, and even before the 
pandemic shutdown. So while there is general agreement among 
stakeholder groups for the need for increased funding for the 
food program at the agency it should come with more 
accountability and more transparency.
    Unlike those other programs at FDA, FDA co-regulates food 
safety with state local programs. These programs have had 
funding capped in recent years. ORA also significantly reduced 
FDA-funded state inspections which can be conducted at a lower 
cost. Meanwhile, ORA is seeking to count state inspections 
conducted without Federal funding towards its FSMA mandate.
    The success of the food program, overall, requires a full-
time, empowered expert leader who could lead culture change, 
and ensure accountability for resource management. We are 
fortunate to have a person with immense expertise and 
abilities, like Dr. Califf, serving as FDA Commissioner. His 
assertions about investing in technology to leverage oversight 
activities, certainly makes sense; however, investing in 
technologies and implementing structural changes for improved 
governance are not, mutually, exclusive opportunities.
    We are not going to algorithm our way out of the existing 
problems in the food program. We also need structural and 
governance changes, stronger leadership, and a higher priority 
that puts food and nutrition policy at the same level at the 
agency with drugs, devices biologics, and tobacco.
    Thank you for the opportunity to testify today, and I look 
forward to your questions.
    [The statement follows:]
                Prepared Statement of Mr. Brian Ronholm
    Chairwoman Baldwin, Ranking Member Hoeven, and subcommittee 
members, thank you for the opportunity to appear before you today to 
discuss the FDA food program.
    Founded in 1936, Consumer Reports is an independent, non-profit and 
non-partisan organization that works with consumers to create a fair 
and just marketplace. Known for its rigorous testing and ratings of 
products, Consumer Reports advocates for laws and company practices 
that put consumers first. We are dedicated to amplifying the voices of 
consumers to promote safety, digital rights, financial fairness, and 
sustainability. The organization surveys millions of Americans every 
year, reports extensively on the challenges and opportunities for 
today's consumers, and provides ad-free content and tools to 6 million 
members across the U.S.
                     fda governance and performance
    I would like to focus my testimony on how the organizational 
structure, governance, and performance of the FDA food program impacts 
food recalls and food policy decisions. Between inadequate responses to 
recalls, a failure to implement a culture of illness prevention, and a 
failure to move quickly on proposed rules and initiatives, there are a 
number of questions about whether the FDA is performing its regulatory 
role effectively. The FDA food program appears to be struggling in its 
role to protect consumers and is preventing the food industry from 
operating effectively.
    There are many stakeholder groups in the food policy community who 
believe that the recent infant formula crisis exposed a greater 
organizational structure and culture problem that has long existed at 
FDA. It has become increasingly clear that confidence in the FDA food 
program is eroding among consumers, industry, States and other 
stakeholder groups.
                fragmented structure and poor governance
    A significant reason for the diminished confidence is that the FDA 
food program has second class status within the agency and it has 
resulted in serious problems relating to its structure, governance and 
performance. Another primary reason is the FDA lacks a single, full-
time, fully empowered expert leader of all aspects of the food program.
    As you know, in recent decades, most FDA commissioners have been 
medical specialists who naturally focus on the programs impacting 
medical products. This leadership focus is certainly warranted 
considering the significant impact these programs have on public 
health, and the pandemic provides an example of this.
    However, this usually results in intense competition for the 
commissioner's time and support, and focus on the food program is 
typically what has suffered under this dynamic. It has become virtually 
impossible for an FDA commissioner to possess the bandwidth to provide 
strategic leadership and management accountability to a large set of 
offices that regulate approximately 80 percent of our food supply.
    The lack of a single full-time leader affects all aspects of FDA's 
food program. The most significant is the effect of these issues on the 
implementation of the Food Safety Modernization Act (FSMA).
    The success of FSMA depends on all major food program units--Center 
for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary 
Medicine (CVM), and the Office of Regulatory Affairs (ORA)--working 
together with state partners and with a common strategic direction, 
clear priorities, sound resource management, and internal 
accountability.
    Success also requires transparency and robust engagement with 
consumers, industry, States, and other stakeholders. This is an element 
that is currently lacking with the FDA food program.
    It is this fragmented structure and dynamic in the FDA food program 
that led an unprecedented coalition of consumer groups, industry trade 
associations and State and local regulators to join together recently 
to call on FDA to unify the food program under a deputy commissioner 
for foods. This position would have accountability to the commissioner 
and direct line authority over CFSAN, CVM, and the food-related 
components and operations of ORA. The coalition letter urged 
Commissioner Califf to immediately appoint someone with relevant and 
appropriate food credentials.
    In addition to bringing focused leadership and accountability to 
the FDA's food program internally, a unified structure and a full-time 
senior expert leader would strengthen the program's standing externally 
and its ability to be in effective dialogue with its many stakeholders.
    While typically many of the organizations that sent the letter may 
not agree on a number of issues, we do agree that there are serious 
problems within FDA's food program as it relates to organizational 
structure, governance and performance. We are aligned on the importance 
of the food program for protecting consumers and the ability of the 
food industry to operate effectively.
    The fragmented structure and framework of the food program results 
in delays in making compliance decisions, including recalls. The 
duplicative multiple compliance and recall groups within each part of 
the food program and the lack of unifying leadership often result in 
these delays and an overall lack of urgency.
     fda resource management and food program funding transparency
    Another area of broad general agreement among stakeholder groups is 
the need for increased funding for the FDA food program to fulfill its 
mission. But, this increased funding should come with more 
accountability and transparency. This subcommittee, and Congress in 
general, has provided considerable funding for the food program, 
especially for the implementation of the Food Safety Modernization Act 
(FSMA).
    However, the current fragmentation of the food program and the lack 
of a single, empowered full-time expert leader has caused delays in the 
implementation of FSMA and questions about how funding is allocated 
within the FDA food program.
    The essence of FSMA was calling for a shift in FDA's culture from 
one that reacted to food safety situations to one that focused on 
prevention. This is most critically needed in ORA, which is responsible 
for inspection and compliance, and receives approximately 70 percent of 
all FDA food program funding.
    ORA is viewed historically as an insular organization that resists 
change, does not transparently share food resource and program data 
with food policy leaders in CFSAN and CVM. Under the current governance 
structure, ORA makes unilateral, unaccountable resource allocation 
decisions that have resulted in a large overhead structure. Only about 
a third of its resources are allocated to its food safety and 
compliance activity.
    Despite the funding increases Congress has provided, ORA's domestic 
food inspections declined significantly in the years following the 
enactment of FSMA and before the pandemic shutdown in March 2020. 
Unlike other programs, FDA co-regulates food safety with State and 
local programs. These programs have found funding capped in recent 
years, and the agency at times reducing its commitment to States. ORA 
also significantly reduced FDA-funded state inspections, which can be 
conducted at a lower cost. Meanwhile, ORA is seeking to count these 
state inspections that are conducted without Federal funding towards 
its FSMA mandates.
    It has become evident that ORA is taking a dismissive approach to 
the inspection mandates under FSMA, viewing them as the maximum number 
of domestic inspections and has used the mandates as an excuse to 
reduce inspection work by the States. An FDA inspection task force 
issued a report last year recommending that Congress consider repealing 
the FSMA inspection mandates. In the absence of a transparent approach 
to assessing facility risk and clear identification of how ``risk-
based'' inspections would occur, this would be a significant step 
backward.
    The questions this subcommittee needs to be asking about ORA are: 
How does ORA allocate food program funding? and Is ORA making the best 
use of these resources?
    The success of FSMA, and the FDA food program overall, requires a 
full-time, empowered, expert leader who can lead culture change and 
ensure accountability for resource management across ORA, CFSAN, and 
CVM.
    We are fortunate to have a person with immense expertise and 
abilities like Dr. Califf serving as FDA Commissioner. His assertions 
about investing in technology to leverage oversight activities 
certainly makes sense. However, investing in technologies, and 
implementing structural changes for improved governance are not 
mutually exclusive opportunities. We are not going to be able to 
algorithm our way out of the existing problems in the FDA food program. 
We also need structural and governance changes, stronger leadership and 
a higher priority that puts food at the same level with drugs, devices, 
biologics, and tobacco at FDA.
                            recommendations
    Below are recommended actions that the subcommittee can take to 
address the systemic problems at FDA that exacerbated the infant 
formula recall situation.

  --Urge Dr. Califf to unify the food program under a deputy 
        commissioner for foods that would have accountability to the 
        commissioner and direct line authority over CFSAN, CVM, and the 
        food-related operations of ORA. This unified structure and a 
        full-time senior expert leader with relevant and appropriate 
        food credentials would strengthen the program's standing 
        externally.

  --Seek detailed answers from FDA on how ORA allocates food program 
        funding to determine whether ORA is making the best use of 
        these resources.

    Thank you for the opportunity to testify today. I look forward to 
any questions.

    Senator Baldwin. Thank you for your testimony. I would like 
to start by asking Ms. Gallo about how your member companies 
interact with the FDA? And how you believe those interactions 
can be improved? And then I want to get more specific about 
how, during this top-to-bottom review, you would like to see 
that input take place.
    Ms. Gallo. Thank you, Senator. Also used to microphones, 
like the Commissioner.
    I would say, to start off, it is absolutely critical that 
industry and FDA have a predictable and functional working 
relationship. We want and need the regulatory to be--the 
regulatory system to be successful in order to provide a safe 
food supply. And certainly our industry's interest is making a 
more productive agency that serves consumers.
    And a key component of that is a food program that speaks 
with one voice. We appreciate when the agency reaches out 
proactively, but that really does need to become the new norm. 
And I think you heard many of the FDA officials note 
stakeholder engagement, and the importance of stakeholder 
engagement, and we entirely concur with that.
    We would like to see an agency that is less siloed and less 
fragmented, industry needs that unified Foods Program to 
provide a strategic and proactive regulatory agenda, and again 
improving stakeholder engagement. In addition to rulemaking, 
there are certainly other ways that the industry can 
meaningfully engage with FDA, like industry roundtables, or 
even other discussions that I think could inform FDA's actions 
in real time.
    As it relates to the top-to-bottom-down review, certainly 
we welcomed that announcement from FDA yesterday, and are 
encouraged that they are aligned in our thinking that there 
needs to be a holistic evaluation of what is going on there, 
and how modernization could occur. And like Brian referenced, I 
think we will be watching very closely the scope of that.
    There were aspects of the food program that were not 
specifically named, CVM being one of them, is what is on the 
radar to look at from that top to bottom, so we will be 
watching that, and look forward to informing or sharing that 
information however we can.
    Senator Baldwin. I would ask pretty much the same question 
to Mr. Ronholm. You said in your testimony how important it 
would be for this review to be truly independent, certainly add 
in accountability and transparency. How would you characterize 
an adequate amount of input, and how would you like to see that 
take place? And if you want to amplify anything about your 
concern about the foundation maintaining its independence, 
please do.
    Mr. Ronholm. Sure. Thank you for the question, Madam Chair. 
Absolutely, I mean, I think in terms of how this process plays 
out, it is absolutely critical to have that internal engagement 
at the agency to ensure that all aspects of the food program 
are being considered as part of this discussion.
    So that entails, obviously, ORA, you have CFSAN, CVM as 
Sarah mentioned and, you know, he Office of Food Policy and 
Response, which is Frank Yiannas' shop. I think incorporating 
those key officials in all of those offices as part of those 
internal engagement, as part of that process, I think ensures 
transparency, it ensures the independence, it ensures that all 
aspects of this issue get considered and discussed.
    From the external standpoint, you know, certainly as Dr. 
Califf alluded to, there is a lot of noise, a lot of groups 
involved in this issue, from a wide variety of consumer groups, 
industry trade associations, estate and local regulators, we 
all want FDA to succeed, we all want the food program to 
succeed, and we all have a key seat at the table.
    So to be able to incorporate those critical external 
stakeholders as part of that discussion I think really enhances 
the recommendations that come out of it.
    Senator Baldwin. Very good. Senator Hoeven.
    Senator Hoeven. Thank you, Madam Chair. I would like to 
thank both witnesses for being here, and note that you both 
included in your comments, recommendations that the deputy 
commissioner for foods be restored in terms of the management 
at FDA. And I guess what I would like to get your thoughts on 
from both of you, is the need for additional hiring authorities 
that FDA has requested in their budget submission. And so if 
you could each kind of address that, I would appreciate it.
    Ms. Gallo. I would be happy to start, Senator, thank you. I 
would say we certainly agree that there is a need to fill 
vacancies with qualified people more quickly, and I think the 
examples that were given around the inspection force are 
certainly--are certainly ringing true for our members as well.
    So we would support efforts to permit FDA to do that. I 
would also just mention while you are asking, because this 
generally gets to some budget questions, and both Brian and I 
have referenced that. In order for us to feel more comfortable 
going in and advocating, we do think that there needs to be 
more transparency around the way that FDA has used the funds 
that you all have appropriated to the agency.
    I think that level of transparency will give us a lot of 
confidence in looking at priorities, and seeing how they want 
to move forward. But as far as FDA's ability, and helping them 
with the ability to get more qualified individuals out into the 
field, that is something that we would support.
    Senator Hoeven. Thank you.
    Mr. Ronholm. Yeah. I don't think I can add much to that. We 
certainly support looking at, you know, flexible hiring 
authorities. I know Dr. Mayne had mentioned, and Dr. Califf as 
well, that they have trouble with, you know, maintaining 
qualified expert staff on board, so certainly looking at giving 
them more flexibility to hire these experts.
    You know, especially inspectors from the ORA standpoint, I 
think certainly would be helpful in consumer protection and 
outbreak response. And to Sarah's point, when you link that 
with additional transparency I think it makes for a better 
system for sure.
    Senator Hoeven. Okay. Thank you very much. No further 
questions, Madam Chair.
    Senator Baldwin. All right. I can wrap up with an 
additional question. Both of you pointed to the need for a 
deputy commissioner. I would like to hear a little bit more 
amplification and detail on how you believe a Deputy 
Commissioner for Foods would improve food safety overall, but 
also improve accountability. So start with Ms. Gallo.
    Ms. Gallo. Thank you, Senator. So I am glad you asked, 
because I think one thing that we haven't said today, and it 
seems rather obvious, but I think it is a good point, is that 
not having a single entity overseeing all of those makes it 
really hard to connect the dots at what is happening at FDA.
    You know, at this time we are certainly, as was in our 
testimony, calling on FDA to appoint that deputy commissioner, 
one, because they have the authority to do so right now. So 
that is not something that we have to wait on a very laborious 
process to do. So having the ability to do that, and get the 
modernization, or just that general transparency, and better 
collaboration started is something that we are strongly 
encouraging the agency to think about.
    We certainly know that having a single person that can look 
and make sure that the subject matter experts are in line with 
the inspection force in connecting those dots, I think just 
really helps the agency speak with one voice. It helps them 
externally present that unified agenda that makes businesses 
able to operate more efficiently and to better meet the needs 
of consumers.
    And I think it helps with consumer communication and 
consumer expectation, if consumers can see that there is a 
person overseeing all aspects of a food program, I think that 
inherently gives a lot of confidence in the ability to know 
what is in the food supply, feel safe about the food supply, 
and also that we can bring innovative products to markets to 
meet the consumer demand.
    Mr. Ronholm. And I would just add to that, that a big piece 
of this in having an empowered deputy commissioner position, is 
it would bring that focused leadership and accountability that 
the food program desperately needs.
    As you all know the FDA commissioners throughout the past 
few decades have specialized in--are medical professionals, and 
so naturally their focus is on pharmaceutical products, medical 
products, and certainly that has a big impact on public health, 
and the pandemic is a good example of that, of that needed 
focus.
    But inevitably what ends up happening, is there is this 
intense competition for the time of the commissioner as it 
relates to food. And so what ends up happening is that food 
gets pushed to the back burner, a lot of the times and obtains 
that kind of second-class status.
    So when you have that kind of fragmented structure like you 
saw today, in that there are various people that report 
directly to the Commissioner. Mr. Yiannas reporting directly to 
the Commissioner, Dr. Mayne, Mr. Rogers, they all report 
directly to the Commissioner, and they all have some say in 
food programs.
    So when you kind of have those fragmented voices all 
having--you know, they are not strategically aligned with an 
agenda, and that is how you end up with a situation where it is 
fragmented that impacts response, outbreaks, you know, it 
impacts policy development as well.
    Senator Baldwin. I want to thank both of you for being here 
today, and a very good complement to the first panel, so I 
appreciate that. And I look forward to working with you in the 
future as we tackle these complex issues.

                     ADDITIONAL COMMITTEE QUESTIONS

    For the benefit of subcommittee members, questions for the 
record are due within one week. And for all of our witnesses, 
panel one and panel two, we would appreciate responses to 
questions for the record within four weeks.
                Questions Submitted to Dr. Robert Califf
            Questions Submitted by Senator Dianne Feinstein
    Question. Many recent reports have highlighted the slow pace at the 
FDA's food division, and many stakeholders indicate that they are not 
included in key discussions.
    For example, the FDA has been working to develop a durable 
``Standard of Identity'' for yogurt since 1981. That's more than 40 
years, just to define yogurt. The most recent iteration of this rule 
was paused to evaluate a 0.1 percent shift in the acid content and to 
ensure that a common ingredient in high-protein yogurts did not 
invalidate a product. These are small changes that could have been 
included from the beginning if more stakeholders were involved in the 
process.
    Farmers and food producers are trying to innovate with new products 
and formulations to respond to new technology and ever-evolving 
consumer demand.
    Commissioner Califf, what steps are you taking to provide direction 
to the food division at FDA, and how will you work to increase the 
speed of the regulatory process?
    Answer. The foods that Americans consume have never been safer, in 
part because of the great work of our employees. Over the past decade, 
our Foods Program has achieved a great deal, including the adoption of 
Whole Genome Sequencing of pathogens, enabling faster outbreak 
identification and response; the implementation of the FDA Food Safety 
Modernization Act (FSMA), publishing over fifty FSMA-related guidances; 
the launch of our New Era of Smarter Food Safety initiative, which 
builds on the work of FSMA while taking a modernized approach to food 
safety that leverages technology and other tools; and making 
significant progress on the nutritional quality of the foods we eat, 
including empowering consumers through major changes to product and 
menu labeling, and the reduction of trans fats and sodium-each of which 
are estimated to save thousands of lives. That said, we can always find 
ways to do our jobs better, including how we can make our regulatory 
process more efficient.
    In February, I rejoined FDA as Commissioner of Food and Drugs, 
having served in the role 5 years earlier. During my confirmation I 
heard many concerns about the status of the Foods Program. Since my 
return, the Agency has continued to take many significant actions that 
benefit the public health. Yet at the same time, FDA has confronted a 
series of challenges that have tested our regulatory frameworks and 
stressed the Agency's operations, prompting me to take a closer look at 
how we do business.
    As part of this effort, I commissioned an external review of the 
Human Foods Program to assess fundamental questions, including 
structure, function, funding, authorities, and leadership. This review 
was led by Dr. Jane Henney, who served as Commissioner from 1999-2001, 
along with an independent panel of experts, through the Reagan-Udall 
Foundation, an independent partner organization for the Agency. I will 
make final decisions regarding the future of the Human Foods Program 
after reviewing the report and consulting with stakeholders both 
externally and internally.
    Question. I am concerned about the significant reduction in food 
safety inspections by FDA and the impact on Americans. I recognize that 
the coronavirus pandemic has dramatically impacted your agency, but 
this trend was occurring even before the pandemic began.
    From 2011 to 2019, the FDA received an average budgetary increase 
of 3.2 percent for its Center for Food Safety and Applied Nutrition. 
Yet, FDA food inspections decreased by an annual average of 2.5 percent 
over the same period.
    Where are these funding increases going, if not to field 
inspections? What steps are you taking to ensure that the funds 
provided by this Committee are put to good use protecting American 
consumers, including through more inspections?
    Answer. It should first be noted that facility inspections are just 
one of many tools that FDA uses to keep food safe, and that the foods 
consumed by Americans are safer now than they have ever been. The 
Office of Regulatory Affairs (ORA) is the lead office for all of FDA's 
field activities including food inspections; ORA has its own 
appropriation which supports food inspections. FDA's Center for Food 
Safety and Applied Nutrition's (CFSAN) budget supports the development 
of regulations, guidance and standards related to the composition, 
quality, nutrition, and safety of food as well as several other core 
activities including premarket notification and review, surveillance, 
response, compliance and enforcement, and regulatory science. Both ORA 
and CFSAN, in conjunction with FDA's field staff, continue to work on 
successfully carrying out its mission to address food safety hazards 
and prevent food risks from farm to table, despite the everchanging 
complexities of the inspection processes that require new resources, 
regulatory tools and workforce needs to help continue to address 
current and emerging challenges.
    The decline in the number of food facility inspections from 2011 to 
2019 can be attributed to several factors, including vacancies and 
hiring challenges, competing priorities of foreign facility inspections 
and outbreak investigations, as well as external challenges such as 
lapses in appropriations or responding to natural disasters. Hiring and 
retention challenges, in particular, have had a significant impact on 
FDA's ability to carry out these responsibilities. ORA must compete 
with other potential employers, and the Agency's Foods Program also 
does not have some of the hiring authorities that FDA has in its 
medical product offices. Beginning in fiscal Year 2019, ORA had Direct 
Hire Authority for investigators, which significantly increased the 
ability to hire investigative staff in the human and animal food 
programs, but this authority expired at the end of fiscal Year 2021.
    FDA has taken a number of steps to address inspections challenges, 
particularly in light of the COVID-19 pandemic. For example, the Agency 
now has greater remote oversight capabilities that give us insight into 
human and animal food importers, such as the Foreign Supplier 
Verification Program (FSVP). FDA conducted 1,672 FSVP inspections 
during fiscal Year 2021 and nearly twice that number in fiscal Year 
2022. We also began conducting voluntary Remote Regulatory Assessments 
(RRA) in fiscal Year 2021, which entails asking foreign food facilities 
to provide certain records and information about their operations. 
Among other benefits, the RRA program has helped direct our oversight 
resources to higher risk areas. FDA is also making greater use of 
regulatory partnerships that will strengthen food safety in all global 
environments. Since October 2022, FDA has been returning to a normal of 
cadence of human and animal food inspections, but these and other novel 
tools developed during the pandemic will continue to complement our 
cumulative oversight approach to ensuring the safety of the Nation's 
food supply.
    Question. On May 19, 2022, FDA issued a request for information 
about the dietary exposure and safety data for nine phthalates still 
authorized to be used in products that come in contact with food, such 
as food packaging. In the announcement, FDA acknowledged the original 
safety assessments of these specific phthalates and the agency's 
decision to allow their continued use in food contact products were 
based on data provided more than 37 years ago during the 1961-1985 
period.
    Recent and more relevant research has drawn clear association 
between exposure to currently authorized phthalates and serious adverse 
health effects, including cancer recurrence and poor survival in breast 
cancer patients, insulin resistance and diabetes, developmental delays 
in boys, and increased risk of preterm birth.
    What is FDA's timeline for its review process and evaluation of the 
safety information submitted in response to the agency's May 2022 
request?
    Answer. FDA is committed to a complete, science-based review of the 
data and scientific information that we received from our May 2022 
request for information (RFI). The RFI explained that, while we are 
generally aware of updated toxicological and use information on 
phthalates that is publicly available, we recognize that stakeholders 
may have access to information that is not always made public. We are 
interested in this information to support our review of the current use 
levels, as well as safe use of these phthalates in food contact 
applications. Furthermore, in response to stakeholder requests, on 
September 26, 2022, FDA announced \1\ the reopening of the RFI comment 
period to provide stakeholders with additional time to submit data and 
information on this topic. The notice of the reopening was published in 
the Federal Register on September 27, 2022, and the new deadline for 
comments is December 27, 2022 (87 FR 58502). As of October 28, 2022, 
the docket contains nearly 24,000 comments. We have started our review 
of these comments; however, we do not have a timeline we can share for 
when our review will be complete. This issue remains a priority for 
FDA, and we will continue to work expeditiously to review all data and 
information submitted to help inform our review.
---------------------------------------------------------------------------
    \1\ https://www.fda.gov/food/cfsan-constituent-updates/fda-limits-
use-certain-phthalates-food-packaging-and-issues-request-information-
about-current-food
---------------------------------------------------------------------------
    Question. By what date will the agency publicly issue its 
evaluation of the safety information it received and a determination of 
whether it will revoke authorizations for the nine phthalates currently 
authorized by FDA to be used in products that come in contact with 
food?
    Answer. As noted above, in response to stakeholder requests, on 
September 26, 2022, FDA announced \2\ the reopening of the RFI comment 
period to provide stakeholders with additional time to submit data and 
information on this topic. The notice of the reopening was published in 
the Federal Register on September 27, 2022, and the new deadline for 
comments is December 27, 2022 (87 FR 58502). As of October 28, 2022, 
the docket contains nearly 24,000 comments. We have started our review 
of these comments; however, we do not have a timeline we can share for 
when our review will be complete. We will continue to work 
expeditiously to review all data and information submitted to help 
inform our review, and we look forward to discussing our findings with 
you once our evaluation is completed.
---------------------------------------------------------------------------
    \2\ https://www.fda.gov/food/cfsan-constituent-updates/fda-limits-
use-certain-phthalates-food-packaging-and-issues-request-information-
about-current-food
---------------------------------------------------------------------------
    Question. Exposure to phthalates can come from multiple sources 
simultaneously, and numerous studies demonstrate that the migration of 
phthalates into food can depend on a number of factors, including the 
type of materials used and the fat composition of the food.
    What is FDA's protocol to account for these factors when it 
investigates and tests products available on the U.S. market for the 
presence of phthalates and analyzes consumer exposures to phthalates?
    Answer. FDA's RFI requests updated information on dietary exposure 
from the current food contact uses of phthalates. When assessing 
safety, FDA considers the available data of total dietary exposure to 
that substance, which includes data from all authorized food contact 
uses. Prior to the authorization of a food contact substance, FDA 
requires information on the amount of a substance that will migrate to 
food as a result of its intended use. This can either take the form of 
assuming 100 percent of the substance will migrate to food, migration 
modeling, or analytical studies that determine the amount of the 
substance that will migrate to food as a result of its use in food 
contact articles.
    FDA's safety assessments account for multiple factors, including 
the differences in physicochemical properties of the substance and the 
material the substance will be used in, as well as factors related to 
the intended use of the finished food contact article such as 
temperature and the types of food (e.g., aqueous foods, fatty foods, 
etc.). FDA then calculates exposure by combining this migration 
information with market information on how different types of finished 
food contact articles are used. Using this approach, FDA ensures that 
exposure estimates, combined with safety data, are conservative and 
protective of human health. Information about specific testing 
protocols for assessing migration of a substance to food and methods 
for calculating dietary exposure are provided in our Guidance for 
Industry: Chemistry \3\ document.
---------------------------------------------------------------------------
    \3\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-preparation-premarket-submissions-food-
contact-substances-chemistry
---------------------------------------------------------------------------
    In addition, as part of its post-market monitoring, FDA can 
supplement information from pre- authorization assessments with 
information on the actual concentration of a substance in the diet as 
determined by dietary surveys, market information on actual use, or 
detected levels in finished food contact articles. FDA has and will 
continue to analyze for the presence of phthalates in numerous samples 
of the types of food contact articles in which phthalates have 
historically been utilized.
    Question. What best practices, guidance and/or good manufacturing 
practices are available to manufacturers of products that are required 
to or would like to test for the presence of phthalates?
    Answer. As discussed above, FDA has issued guidance on analytical 
procedures to determine the extent of migration of a substance from 
food contact articles into food.
    In addition, FDA has analyzed numerous samples of food contact 
articles in which phthalates have previously been utilized; 
historically, phthalates have been added to ridged plastics, 
specifically poly(vinyl chloride) (PVC), to increase the plastic's 
flexibility. Over the last few years, FDA has conducted multiple 
sampling surveys of PVC and non-PVC finished food contact articles 
including single-use food packaging (e.g., beverage bottle gaskets), 
repeat-use articles (e.g., gaskets, tubing and conveyer belts for food 
processing equipment) and fast-food packaging on the U.S. market. 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. Recent 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.
    These studies also report validated testing methodologies for the 
presence of phthalates in various food packaging materials. In addition 
to the surveys mentioned above, we also evaluated the effectiveness of 
portable devices that both industry and FDA could use to identify 
plasticizers, including phthalates, in PVC tubing and bottle caps as 
part of our continued efforts to identify current use of phthalates in 
food packaging and food processing materials.
    Question. A recent NIH study published in the Journal of the 
American Medical Association found that pregnant women who were exposed 
to multiple phthalates during pregnancy had an increased risk of 
preterm birth. NIH researchers also noted that participants with higher 
concentrations of phthalates were associated with higher odds of 
preterm births. In a separate recent study published in Environmental 
Science & Technology, researchers found that Latina pregnant women had 
higher levels of phthalates than women of other race/ethnicities. 
Previous studies have also found that Black women are 
disproportionately exposed to phthalates in consumer products.
    How is FDA incorporating in its decision-making framework the 
impact phthalate exposure has on maternal and infant health as well as 
the disproportionate exposure of products containing phthalates to 
members of communities of color as well as its continued review of the 
latest available data?
    Answer. FDA's RFI requests updated information on dietary exposure 
from the current food contact uses of phthalates. In addition, FDA may 
estimate exposure to phthalates using food survey data which provides 
information on the actual concentration of the substance in sampled 
foods representative of the diet, along with the percentage of the 
total diet each sampled food represents for the general population as 
well as specific subpopulations such as infants, toddlers, children, 
and women of child-bearing age. In this manner, FDA can account for the 
specific dietary exposure of various subpopulations that may be 
sensitive to or relevant for toxicological effects associated with 
dietary exposure to a substance. FDA may calculate both the mean and 
90th percentile exposures for these various subpopulations, which 
allows FDA to account for demographics within these subpopulations that 
may have disproportionate exposure to the substance. FDA has also 
published guidance \4\ on this approach for calculating dietary 
exposure to substances from food survey data.
---------------------------------------------------------------------------
    \4\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-estimating-dietary-intake-substances-food
---------------------------------------------------------------------------
    FDA's RFI also requests updated safety information on phthalates 
currently used in food contact applications. As part of any safety 
assessment, FDA considers all available information to determine 
whether a substance is safe under its intended conditions of use, 
including any available studies relevant to maternal and infant health 
as applicable. The resulting safety assessment for a food contact 
substance incorporates both the information from the toxicology studies 
and applicable safety factors to assess whether there is a reasonable 
certainty of no harm for consumers.
    Additionally, FDA published specific guidance \5\ pertaining to the 
safety assessment for the use of a substance in contact with infant 
formula and/or human milk. This guidance addresses topics specifically 
relevant to infant health, including the potential for elevated 
exposures on a body weight basis and the need to consider that first 6 
months of life are an important developmental period resulting in 
additional parameters to be considered when assessing the safety of 
components of food contact articles in contact with infant food.
---------------------------------------------------------------------------
    \5\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-preparation-food-contact-notifications-
food-contact-substances-contact-infant
---------------------------------------------------------------------------
    Question. On May 19, 2022, FDA issued denials to food additive and 
citizen petitions requesting agency action on phthalates in food 
contact products.
    On what date will FDA hold a public hearing on the agency's May 
2022 decision to deny the petitions to ban food-contact uses of 
phthalates, as required by the Food, Drug, and Cosmetic Act?
    Answer. FDA is currently evaluating the request for a public 
hearing, and we plan to respond to the request as expeditiously as 
possible. Issues that FDA must consider in determining whether to hold 
a hearing include whether any objections raise genuine and substantial 
issues of fact that can be resolved at a hearing (Community Nutrition 
Inst. v. Young, 773 F.2d 1356, 1364 (D.C. Cir. 1985); 21 CFR 12.24).

                          SUBCOMMITTEE RECESS

    Senator Baldwin. And with that this hearing is adjourned.
    [Whereupon, at 11:46 a.m., Wednesday, July 20, the 
subcommittee was recessed to reconvene subject to the call of 
the Chair.]

                                   [all]