[Senate Hearing 117-630]
[From the U.S. Government Publishing Office]
S. Hrg. 117-630
FOOD SAFETY AND THE FOOD AND DRUG ADMINISTRATION
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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
_________
U.S. GOVERNMENT PUBLISHING OFFICE
51-605 PDF WASHINGTON : 2022
COMMITTEE ON APPROPRIATIONS
PATRICK J. LEAHY, Vermont, Chairman
PATTY MURRAY, Washington RICHARD C. SHELBY, Alabama, Vice
DIANNE FEINSTEIN, California Chairman
RICHARD J. DURBIN, Illinois MITCH McCONNELL, Kentucky
JACK REED, Rhode Island SUSAN M. COLLINS, Maine
JON TESTER, Montana LISA MURKOWSKI, Alaska
JEANNE SHAHEEN, New Hampshire LINDSEY GRAHAM, South Carolina
JEFF MERKLEY, Oregon ROY BLUNT, Missouri
CHRISTOPHER A. COONS, Delaware JERRY MORAN, Kansas
BRIAN SCHATZ, Hawaii JOHN HOEVEN, North Dakota
TAMMY BALDWIN, Wisconsin JOHN BOOZMAN, Arkansas
CHRISTOPHER MURPHY, Connecticut SHELLEY MOORE CAPITO, West
JOE MANCHIN, West Virginia Virginia
CHRIS VAN HOLLEN, Maryland JOHN KENNEDY, Louisiana
MARTIN HEINRICH, New Mexico CINDY HYDE-SMITH, Mississippi
MIKE BRAUN, Indiana
BILL HAGERTY, Tennessee
MARCO RUBIO, Florida
Charles E. Kieffer, Staff Director
Bill Duhnke, Minority Staff Director
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Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies
TAMMY BALDWIN, Wisconsin, Chairman
JEFF MERKLEY, Oregon JOHN HOEVEN, North Dakota, Ranking
DIANNE FEINSTEIN, California MITCH McCONNELL, Kentucky
JON TESTER, Montana SUSAN M. COLLINS, Maine
PATRICK J. LEAHY, Vermont, (ex ROY BLUNT, Missouri
officio) JERRY MORAN, Kansas
BRIAN SCHATZ, Hawaii CINDY HYDE-SMITH, Mississippi
MARTIN HEINRICH, New Mexico MIKE BRAUN, Indiana
Professional Staff
Dianne Nellor
Rachel Erlebacher
Hannah Chauvin
Angela Caalim
Morgan Ulmer (Minority)
Patrick Carroll (Minority)
Elizabeth Dent (Minority)
Administrative Support
Ann Tait Hall
C O N T E N T S
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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
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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
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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.
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\1\ https://www.fda.gov/food/cfsan-constituent-updates/fda-limits-
use-certain-phthalates-food-packaging-and-issues-request-information-
about-current-food
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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.
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\2\ https://www.fda.gov/food/cfsan-constituent-updates/fda-limits-
use-certain-phthalates-food-packaging-and-issues-request-information-
about-current-food
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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.
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\3\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-preparation-premarket-submissions-food-
contact-substances-chemistry
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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.
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\4\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-estimating-dietary-intake-substances-food
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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.
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\5\ https://www.fda.gov/regulatory-information/search-fda-guidance-
documents/guidance-industry-preparation-food-contact-notifications-
food-contact-substances-contact-infant
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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]