[Senate Hearing 114-633]
[From the U.S. Government Publishing Office]
AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION AND
RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2016
----------
WEDNESDAY, SEPTEMBER 16, 2015
U.S. Senate,
Subcommittee of the Committee on Appropriations,
Washington, DC.
The subcommittee met at 2:06 p.m. in room SD-192, Dirksen
Senate Office Building, Hon. Jerry Moran (chairman) presiding.
Present: Senators Moran, Daines, Merkley, and Feinstein.
FDA Food Supply Safety Efforts
STATEMENT OF HON. DR. STEPHEN OSTROFF, ACTING
COMMISSIONER, FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
ACCOMPANIED BY:
MICHAEL TAYLOR, DEPUTY COMMISSIONER FOR FOODS AND
VETERINARY MEDICINE; FOOD AND DRUG ADMINISTRATION
WILLIAM TOOTLE, DIRECTOR, OFFICE OF BUDGET, FOOD AND DRUG ADMIN
opening statement of senator jerry moran
Senator Moran. Good afternoon to the witnesses, as well as
those in the audience. This hearing will come to order.
Today's hearing will focus on the Food and Drug
Administration's (FDA's) effort to improve and maintain safety
of our food supply. And I thank you, Commissioner Ostroff, for
your presence here today, Mr. Taylor and Mr. Tootle for
participating in this hearing. We are delighted for that. And,
Dr. Ostroff, I appreciate the warm working relationship that we
are developing, and I appreciate the conversations and dialogue
that we have had on a number of FDA issues over the last
several months. So thank you personally and professionally for
the way that you are treating me as the new chairman of this
subcommittee.
fsma
You note in your testimony, Commissioner, that nearly one
in six Americans fall victim to foodborne illness each year.
Americans expect that the food they purchase at a grocery store
or restaurant will be safe. And the FDA is largely tasked with
maintaining that confidence. Passage of the Food Safety
Modernization Act (FSMA) in 2010 gave your agency significant
new responsibilities in implementing a very sweeping set of
changes to the food safety laws, certainly the largest change
in the last 70 years. Our hearing today is timely as it follows
last week's publishing of the first two final rules for
preventive controls on human and animal foods.
In delivering these new regulatory responsibilities, your
private sector partners expect transparency and certainty from
the FDA. And when I speak to small businesses and agricultural
producers in my home State, their major concern is a Government
that limits job creation and stifles innovation through
burdensome regulations. I am pleased that the agency took many
of the suggestions and comments from the agricultural community
into account by re-proposing portions of the FSMA rules because
they were unworkable for farmers. And I thank you for that.
Modernizing the FDA's regulatory controls and educating
industry and consumers are at the heart of FSMA implementation,
and the issuance of the preventive control rules starts the
compliance process. It is vital that FDA continue its
collaboration with the industry and other Federal and State
agencies and issue proper regulatory guidance throughout this
process.
fsma funding
I also recognize that successful implementation--this is
the part that you want me to say, Mr. Commissioner. I also
recognize that successful implementation does not come without
a cost. And this subcommittee remains committed to investing in
FSMA's implementation within the resources that are at our
disposal and has done so since FSMA's enactment in 2011. I
think spending in the last 5 years has increased 8 percent,
something that cannot be said for many other Federal agencies.
But we know that you face additional challenges and additional
tasks, and we are interested in exploring how we can be more
helpful. And as the process continues for appropriations this
year, FSMA funding will undoubtedly play a significant role in
our deliberations and in establishing priorities.
prepared statement
I look forward to discussing FSMA and other food safety
topics with our witnesses today.
[The statement follows:]
Prepared Statement of Senator Jerry Moran
This hearing will come to order. Good morning. Today's hearing will
focus on Rural Development at the Department of Agriculture and its
strategic investments in rural America. Thank you Under Secretary
Mensah, Administrator Hernandez, Administrator Rikkers, and
Administrator McBride for being here today. Under Secretary Mensah, I
enjoyed visiting with you recently in Kansas and hope you will return
soon and often.
Agriculture remains one of the bright spots in our nation's
economy, supporting more than 16 million jobs nationwide and forming
the backbone of our rural communities. For those of us who grew up in
rural areas, it is a lifestyle we cherish and hope to preserve for our
children and future generations to come. Rural Development is largely
tasked with maintaining and improving that quality of life. Whether
it's providing loans for low-income families to own their first home,
spurring economic development with grants to small businesses, or
providing communities with financing to allow customers affordable
utility rates, Rural Development continues to serve a significant role
in the nexus between need and opportunity.
In my home state of Kansas, we determine economic development by
whether or not your town has a grocery store. Many issues facing rural
communities are unique to those areas in an ever-increasing urbanized
and technologically- advanced world. I look forward to discussing the
Rural Development mission and other relevant topics with our witnesses
today. We have a lot to cover this morning, so I will turn it over to
Senator Merkley for any remarks he may wish to give.
SenatorMoran. We have a lot to cover this afternoon, and I
turn now to my colleague, Senator Merkley, for any remarks that
he may wish to give.
STATEMENT OF SENATOR JEFF MERKLEY
Senator Merkley. Thank you very much, Mr. Chairman and
thank you for holding this hearing.
I thank you, Dr. Ostroff, Mr. Taylor, Mr. Tootle, for
attending.
FOOD SAFETY
The safety of our food supply is something that most
Americans take for granted. For parents that enter the grocery
store, for the most part, they do not have to give a second
thought to whether or not the food that they are picking up for
their family will make their family sick. America has and
continues to have the safest food supply in the world.
But that, of course, does not mean that it is perfect, as
anyone who has ever had a foodborne illness will testify to.
And we need to continually work to make sure we stay ahead of a
changing global marketplace. We do not think anything about
eating strawberries or melons out of season because we have
access to food from all over the globe. To stay ahead of this
is a monumental task, and there are multiple Federal agencies
involved, including the U.S. Department of Agriculture (USDA)
which regulates about 20 percent of our food supply, and FDA
which regulates 80 percent. Outside of the Federal Government,
State agencies, private businesses, and farmers are working
continually to make sure that the processes and procedures in
place will make sure a domestic onion is always safe to eat, as
well as an imported strawberry.
The Food Safety Modernization Act, which was signed into
law in 2011, was the most sweeping update of our food safety
laws in nearly 70 years. The law changed the way we look at the
issue of food safety. Prior to FSMA, an outbreak would take
place, and we would spend our time and resources tracking it
down. Now we are working to make sure that we prevent that
outbreak from occurring in the first place and giving FDA the
tools and the teeth it needs to do just that. It is a better
way to do business.
The law had about 50 specific deliverables, no small task
for any agency. And although it took longer than many would
like, FDA published two of the seven major final rules last
week, and the rest will be out, as I understand, by next
spring. We are at the point where the rubber meets the road,
and it is going to require a new way of thinking for food
inspectors who have been trained to look for an existing
problem instead of working with industry to make sure those
problems never materialize in the first place.
It is not always smooth sailing, and I know the folks at
FDA have learned a lot about production agriculture and food
processing along the way. I think most people would agree that
you have done a good job working with industry to make sure
that these new rules are effective while minimizing the
disruption.
So, again, thank you, Mr. Chairman, for holding this
hearing. It is timely and I am very interested to hear from our
witnesses.
Senator Moran. Dr. Ostroff, again, welcome and you may
commence your testimony. It is a significant number of pages,
and I have extended the deadline from the normal 5 minutes to
10. So please proceed.
SUMMARY STATEMENT OF DR. STEPHEN OSTROFF
Dr. Ostroff. Thank you, Senator Moran and other members of
the committee.
And I share your enthusiasm for the very warm working
relationship that we have been able to develop in the last
several months, and we look forward to continuing to work with
you not only on food safety issues but all the other issues
that FDA deals with.
So I am Steve Ostroff, the acting Commissioner of Food and
Drugs, and I really very deeply appreciate the opportunity for
Mike Taylor, who is sitting to my left, and me to be here to
talk about the Food Safety Modernization Act, also known as
FSMA.
I would also like to thank you for holding this hearing and
for the committee members and their ongoing interest in this
particular topic and for the strong and growing working
relationship that has developed between the committee and the
FDA to achieve our mutual goals of assuring the safest food
supply in the world for American consumers.
FOOD SAFETY
I hope that everybody in this room knows that this is Food
Safety Month, and I cannot think of a better way to celebrate
than by starting the process of bringing FSMA's important new
rules online as we did last week and by discussing with you
today the critical next steps that must be taken to realize the
goals of FSMA.
So although I have only been working at FDA for 2 years, I
actually began my public health career considerably before that
30 years ago when I was working at the CDC on food safety and
foodborne diseases, particularly at that time the newly
recognized and deadly pathogen, E. coli O157. While working in
Washington State close to Oregon, over a 2-year period, I
personally interviewed every person or a member of their family
in the State diagnosed with that particular infection and
visited a number of them in their homes. I subsequently did the
same with people with other illnesses from foodborne pathogens.
So I can say, without question, that I have a very deep
appreciation for the suffering and consequences of foodborne
illness and have carried that perspective throughout my career
as a public health practitioner and as a physician. In fact,
food safety was the reason that I joined FDA in 2013 at the
urging of the person sitting to my left.
Despite today having much improved technical methods to
detect and investigate foodborne illness from when I started my
career 30 years ago, along with some notable successes in
reducing the incidence of certain pathogens, there simply
remains too much foodborne illness. As you mentioned, nearly
one in six Americans fall victim to foodborne illness each
year. That is 48 million people. Of these, 128,000 are
hospitalized and 3,000 die. This burden of foodborne illness is
shared by each and every one of us, consumers and food
producers alike. The economic costs are also quite sizable.
Since we know that the illnesses, hospitalizations, and deaths
can be prevented, we must also, quite frankly, acknowledge that
it is simply time to start preventing them.
So over here on this side, the Centers for Disease Control
and Prevention's (CDC's) FoodNet data has shown that for many,
many years now, the burden of illness due to the major
foodborne pathogens remains essentially unchanged. As you can
see, the illness burden from some pathogens goes up while for
others it goes down. But looking at the poster over here on the
other side of the room, in total the line remains distressingly
flat. So I say to you that it is time to make that line start
bending in the right direction. We believe that we now have the
tool to be able to do that, and that tool is called the Food
Safety Modernization Act.
FSMA
During my time at FDA, I have been thrilled to be able to
participate in the process of modernizing our food safety
system. This agency has stepped up to solve problems by
identifying the best science and risk-based solutions that can
benefit both consumers and industry. That is what we do at FDA
when we are confronted by such problems. I know that Mike and
his team have embedded this concept in their work to modernize
the Nation's food safety system through FSMA so that it can
meet the challenges of a new global era.
The enactment of FSMA was unquestionably the product of
foresight and the recognition of common interests. Members of
Congress on both sides of the aisle came together with
consumers and with food industry leaders to enhance this
ability to protect the food supply in a modern, diverse world
of free-flowing commerce. FSMA stands for the proposition that
the standard across the food system should be to have processes
in place that we have learned work to prevent food safety
problems, practices that many food safety producers are already
implementing. This means having prevention-oriented standards
in place that are equally applied to domestic and foreign
producers, reasonable verification of compliance with those
standards, and accountability for those who are unable or
unwilling to comply. FSMA directs FDA to build a modern food
safety system based on these central ideas.
FDA has fully embraced a dynamic, collaborative approach to
implementing FSMA and is working very hard to build the new
partnerships and to strengthen existing ones. This effort
includes the food industry, from farmers and manufacturers to
transporters and importers whose capacity and responsibility
under FSMA for producing safe food is the absolute foundation
of the new system. It also includes the FDA's food safety
partners in other government agencies at the Federal, State,
tribal, and local levels, and it also includes foreign
governments, which can play an important role to help assure
that the foreign supplies to the U.S. market are being produced
in safe fashion. And it includes consumers and patient
advocates who have been victims of foodborne illness because
after all, ultimately, they are the ones that we are doing this
for.
PREVENTIVE CONTROL RULES
The two final preventive control rules we issued last week
are critical linchpins for building our new food safety system.
They focus on implementing modern food manufacturing processes
for both human and animal foods, thus ensuring the food
companies are taking a 24/7 365-day a year approach and working
with the FDA to prevent problems on the front end rather than
waiting until a problem is recognized through identifying
people with foodborne illness as you know happened in your
State of Kansas earlier this year.
These rules are important in their own right, but they are
only the first in a number of steps towards building a
comprehensive food safety system. Three more rules will be
finalized by the end of this year, those being the produce
rule, foreign supplier verification process, and accredited
third-party certification. Then the final tools will be issued
this spring, sanitary transport and intentional adulteration.
Together, these rules form the integrated holistic network for
food safety called for by FSMA, all based on the principle of
prevention.
Writing the rules is clearly a big step, but it is only the
first step. Right now, they exist on paper. The bigger
challenge ahead is implementing those rules and making them
exist on the ground. We strongly believe that if we do not
implement the new FSMA-mandated food safety system in the
comprehensive way that Congress envisioned right from the
start, that we will fail to achieve the FSMA goals of food
safety, strengthen consumer confidence and a level playing
field for U.S. producers. The line mentioned earlier will not
bend as it should and it must go.
PREPARED STATEMENT
So I am very proud of this work and I am proud of our team.
Mike Taylor alone has been a force of nature when it comes to
FSMA. So please continue to work with us to achieve the level
of funding that we need to accomplish on the ground what is set
in statute and in rule. American consumers are depending on us
and they expect this of us.
So I will just end by thanking you again for your support
of FDA and for the opportunity to be here to discuss FSMA with
you.
[The statement follows:]
Prepared Statement of Dr. Stephen Ostroff
introduction
Good morning, Chairman Moran and Members of the Subcommittee, I am
Dr. Stephen Ostroff, Acting Commissioner of Food and Drugs. I am
accompanied today by Michael Taylor, FDA's Deputy Commissioner for
Foods and Veterinary Medicine. Thank you for the opportunity to appear
before you today to discuss the Food and Drug Administration's (FDA)
implementation of the FDA Food Safety Modernization Act (FSMA) and our
role in ensuring food safety. I would like to thank the Subcommittee
for its past investments in FDA, which have helped us meet the demands
of our broad and increasingly complex mission.
I would also like to acknowledge that it was Congress' vision of a
safer America that fueled the enactment of FSMA in 2011. You shared,
and responded to, a widespread concern among consumers, industry, and
your fellow legislators about the deadly foodborne illnesses
thatendanger the public health.
today's food safety challenge and fda's changing role under fsma
FDA is a science-based public health regulatory Agency with
mandates from Congress that span the human and animal food supply,
human and animal drugs, medical devices, vaccines and other biological
products, cosmetics and tobacco--products that all have profound
implications for the health of consumers and the nation's economy. Like
other areas of FDA's responsibility, our mandate to ensure the safety
of the nation's food supply is of fundamental importance to the welfare
of consumers and the industries we regulate.
FDA's responsibility for food safety dates back to 1906, when
Congress first established prohibitions on the sale of adulterated food
and gave FDA authority to enforce those prohibitions. FDA has used
those authorities, which were largely unchanged until Congress passed
FSMA, to conduct inspections and take enforcement action in response to
specific cases of insanitation in food facilities, dangerous
contamination of food products, and outbreaks of foodborne illness.
Through these efforts and the commitment of the great majority of food
producers who want to produce safe food, we have long had one of the
safest food supplies in the world. And with the implementation of FSMA,
our food supply will become safer.
According to estimates by the Centers for Disease Control and
Prevention (CDC), every year nearly one in six Americans falls victim
to foodborne illness. That's 48 million people. Of these, 128,000 are
hospitalized, and 3,000 die. This burden of foodborne illness is
damaging to consumers and food producers alike. And the tragedy
underlying the numbers is magnified by the fact that most of these
illnesses and deaths are preventable.
In the years leading up to the enactment of FSMA, a series of major
illness outbreaks, contamination incidents, and product recalls--
involving both domestic and imported food--focused the food industry
and government on how the food safety system could work more
effectively to prevent food safety problems, rather than relying so
much on response after the fact. The food industry developed best
practices, involving such measures as the implementation of preventive
controls in food facilities, and government took incremental steps to
require such controls for FDA-regulated seafood and juice processors
and in meat and poultry facilities regulated by the U.S. Department of
Agriculture (USDA).
Other than those incremental changes affecting a few food
categories, FDA's reactive approach to food safety had changed little
over the years, despite radical change in the food system. Compared to
1906, we now have a vast, complex and global food system in which
changing technology, changing consumer preferences and behavior, and
supply chains that extend around the world make food safety a bigger
challenge than ever before. We also have seen rapid expansion in the
local food movement, with many small-scale growers and processors
coming into the market in response to consumer demand for locally and
sustainably grown food.
All of this change and diversity in the food system is good for
consumers, and creates great opportunity for American business. But it
also places added pressure on our food safety system because consumers
and industry alike agree: we all want food to be as safe as we can make
it, and we all want to have confidence in the safety of our food,
whether it comes from around the corner or from the other side of the
world.
That alignment of interests is what led to the enactment of FSMA.
FSMA stands for the proposition that what we have learned works to
prevent food safety problems--practices that many food producers are
already implementing--should be the norm across the food system. This
means having prevention-oriented standards that apply equally to
domestic and foreign producers, reasonable verification of compliance
with those standards, and accountability for those who are unable or
unwilling to comply.
FSMA directs FDA to build a modern food safety system based on
these central ideas. As outlined below, this has involved developing
new regulations requiring modern preventive controls in facilities
producing all types of food commodities, not just a few, and
establishing requirements where they haven't existed before, most
notably for produce growers, food importers, and food transporters.
FSMA also directs FDA to do its food safety work in new ways, with
a heavy emphasis on collaboration and partnership. This collaboration
includes the food industry--from farmers and manufacturers to
transporters and importers--whose capacity and responsibility under
FSMA for producing safe food is the foundation of the new system. It
also includes FDA's food safety partners in other government agencies
at the Federal, state, tribal, and local levels, with which Congress
directed FDA to build upon our history of collaboration to ensure
effective and efficient implementation of FSMA. And it includes foreign
governments, which can play an important role in helping to ensure that
foreign suppliers to the U.S. market are producing safe food. FDA
strongly embraces this collaborative approach and is working hard to
build new partnerships and strengthen existing ones.
FDA recognizes, however, that part of the change that has to happen
for FSMA to succeed must happen within FDA and in how FDA conducts its
food safety oversight program. To that end, and as discussed below, FDA
has developed a strategy for implementing the new FSMA rules that is a
fundamental departure from the past.
We believe that we will achieve high rates of compliance more
quickly and efficiently by tapping into the fact that the great
majority of firms we regulate want to produce safe food and want to
comply. That's why our strategy takes an ``educate before and while we
regulate'' approach, especially in the produce area, so that, through
FDA guidance, outreach, and technical assistance, we can help food
producers understand and accomplish what is required. It entails an
approach to inspection that is aimed first at fostering and
facilitating compliance, rather than at finding and penalizing
regulatory violations. We will of course take swift regulatory action
when needed to protect consumers when we find dangerous practices, but
our focus is on prevention.
FDA is firmly committed to implementing FSMA the right way from the
start. This means investing in the food safety culture change that is
happening within FDA, but it also means being faithful to the
comprehensive, holistic vision of food safety modernization laid out in
FSMA. Congress directed FDA to build a modern food safety system,
addressing food safety challenges across the spectrum of farms,
manufacturers, and transporters of food, both domestic and foreign. The
pieces of this system are closely interconnected. We cannot credibly
hold domestic producers to the new standards if we are not doing the
same for importers and their foreign suppliers. Nor can we do the
reverse, holding importers and foreign suppliers, but not domestic
producers, to new requirements. We believe that if we do not have the
resources necessary to implement the new FSMA-mandated food safety
system in the comprehensive way Congress envisioned, from the start, we
will fail to achieve the FSMA goals of food safety, strengthened
consumer confidence, and a level playing field for U.S. producers.
In the remainder of this testimony, I will outline our achievements
to date in developing the FSMA rules and planning for their
implementation, and I will explain why the President's fiscal year 2016
budget request is so essential to the success of FSMA.
seven foundational fsma rulemakings
As a first major step toward making the promise of FSMA a reality,
FDA has proposed seven foundational rules, starting in January 2013.
Together, they will provide a modern food safety foundation that brings
to bear the most recent science, that is risk- based and focuses effort
where the hazards are reasonably likely to occur, and that is flexible
and practical given our current knowledge of food safety practices. We
have designed the rules to be both effective for food safety and
workable across the great diversity of our food system.
Last week, FDA issued the first two of the final rules listed below
and is on target for finalizing the remaining five in the coming
months.
1. Preventive Controls for Human Food. This rule will improve the
safety of manufacturing, processing, packing, and holding human food in
two key ways. First, it modernizes FDA's longstanding Current Good
Manufacturing Practice (CGMP) regulations. Second, it requires
facilities to have written plans that identify hazards, specify the
steps that will be put in place to minimize or prevent those hazards,
and specify actions to correct problems that arise. The rule is
designed to be flexible, practical, public health protective, and
consistent with industry best practices.
2. Preventive Controls for Animal Food. This rule will improve the
safety of animal food, including pet food, livestock food, and raw
materials and ingredients used in food for animals, by establishing
general CGMPs for the first time, tailored to animal food, and
establishing the same, flexible requirements for risk-based hazard
analysis and preventive controls as the Preventive Controls for Human
Food rule.
3. Produce Safety Standards. This rule will improve the safety of
produce--fruits and vegetables that are typically consumed raw--by
establishing science-based standards for growing, harvesting, packing,
and holding produce on farms. The rule addresses identified routes of
microbial contamination, including agricultural water, biological soil
amendments of animal origin, health and hygiene of farm personnel,
animals in the growing area, and equipment, tools, and buildings.
4. Foreign Supplier Verification Programs. This rule will
strengthen the oversight of foods imported for U.S. consumers by
requiring importers to perform risk-based activities to verify that
food imported into the United States has been produced in a manner that
provides the same level of public health protection as that required of
domestic food producers. This rule is the foundation for the multi-
faceted new import safety system that Congress mandated to protect food
safety, strengthen consumer confidence, and maintain a level playing
field for U.S. food producers.
5. Accredited Third Party Certification. This rule will improve the
safety of imported food and allow more efficient use of FDA resources
by providing an opportunity for foreign food producers to voluntarily
become certified by third-party certification bodies accredited under
FDA's oversight. FDA may in turn use that certification to determine
whether an importer is eligible to participate in FSMA's voluntary
qualified importer program, or whether to admit certain imported food
into the United States that FDA has determined poses a food safety
risk. Both accreditation bodies and auditors must meet standards for
legal authority, competency and capacity, impartiality/objectivity,
quality assurance, and records procedures.
6. Sanitary Transportation. This rule will help ensure the safety
of human and animal food during transportation by establishing
requirements for shippers, carriers, and receivers of food in the U.S.
Those requirements include ensuring that the design and maintenance of
vehicles and equipment does not leave foods vulnerable to
contamination, and taking measures during transportation to ensure that
food is not handled improperly or contaminated, including using
adequate temperature controls and separating food from non-food items
in the same load.
7. Intentional Adulteration. This rule will help to ensure the
safety and security of the food supply by requiring facilities to
address vulnerable processes in their operations in order to prevent
acts on food intended to cause large-scale public harm (e.g., acts of
terrorism).
fda's commitment to stakeholder engagement
Throughout the rulemaking process, outreach and stakeholder
engagement have been central to developing rules that are both
practical and protect the public health. FDA has worked intensively
with industry stakeholders, consumers, and regulatory partners to be
sure we get the rules right and to set the stage for successful
implementation of the rules once they are final.
Since FSMA was enacted in 2011, FDA has been involved in
approximately 600 engagements with stakeholders on FSMA and the
proposed rules, including public meetings, webinars, listening
sessions, farm tours, and extensive presentations and meetings with
various stakeholder groups. Even before publishing the proposed rules,
FDA held public meetings to gather input on the rules' content. Since
the release of the proposed rules beginning in early 2013, we have
continued our commitment to outreach, engaging various industry,
consumer, and other interested groups across the country and
internationally.
We have heard the concerns raised by stakeholders and have adjusted
the rules to include solutions to those concerns. As part of this
stakeholder dialogue, FDA took the unusual step of issuing four
supplemental notices of proposed rulemaking to share our current
thinking on key issues and get additional stakeholder input on revised
language. Again, after the supplemental notices were issued, we engaged
stakeholders to make sure our final rules would be where they needed to
be. As a result of this extensive public engagement, along with our
consideration of tens of thousands of formal written comments submitted
to the public dockets on the rules, we are confident the rules that
have been finalized and the five remaining final rules in development
are flexible, practical, and consistent with industry best practices,
while also being public health protective and consistent with our
statutory mandate.
As we move forward into the next phase of FSMA implementation, we
intend to continue this dialogue and collaboration with our
stakeholders through guidance, education, training, and technical
assistance, to ensure that everyone understands and successfully plays
their role in food safety. FDA believes that these seven foundational
final rules, when implemented, will fulfill the paradigm shift toward
prevention that was envisioned in FSMA and will be a major step forward
for food safety that will protect consumers into the future.
ensuring successful fsma implementation
The success of building a modernized food safety system depends on
FDA and industry working together, as well as working with State and
other regulatory and public health partners, after the final FSMA rules
are issued. In May 2014, FDA released a FSMA Operational Strategy
Document (attached as an appendix to this testimony) that focuses on
how FDA intends to implement FSMA, by prioritizing prevention,
voluntary compliance, risk-based oversight, and expanded collaboration
across the food safety community. Effective FSMA implementation will
require a sea change in how FDA, as an agency, approaches regulatory
oversight of the food industry.
Inspection and compliance will be specialized, strategic, and risk-
based. FDA isreshaping itself to oversee industry compliance in a
manner that is strategic and based on risk. We are developing a new
inspection paradigm focused on whether firms are implementing systems
that effectively prevent food contamination, requiring fundamentally
different approaches to food safety inspection and compliance. To
effectively leverage our resources, we will use more targeted, risk-
based inspection models to screen firms for food safety performance and
to guide inspection priority, frequency, depth, and approach.
Inspections will be systems-based, with noncompliance viewed in the
context of the performance of the firm's overall food safety system and
the risk to public health. In addition, FDA's inspection and compliance
staffs will be trained to be specialists in food oversight, rather than
covering the broad spectrum of FDA-regulated products. Members of these
staffs will be teamed with FDA subject matter experts to facilitate the
timely correction of problems and consistent, informed enforcement of
the new FSMA regulations. Finally, FDA intends to continuously improve
its inspection strategy through targeted data collection, timely
analysis, and regular program evaluation.
FDA will educate before and while we regulate. Stakeholder
engagement hasbeen a cornerstone of the FSMA rulemaking process, and
FDA will continue to work closely with industry and other stakeholders
to achieve widespread compliance with the rules through education and
technical assistance. We are currently drafting general guidance on
each rule, guidance for small entities, guidance for specific
commodities and sectors, and guidance on key provisions, to help
industry understand their new regulatory obligations under FSMA. We are
also developing a comprehensive training strategy to give food
producers, focusing on small and mid-size operators, the tools they
need tomeet the FSMA requirements that apply to them.
For example, FDA created three alliances, or public-private
partnerships, to develop training materials and create an education and
technical assistance network. The Food Safety Preventive Controls
Alliance and the Sprouts Safety Alliance are being coordinated by the
Illinois Institute of Technology, and the Produce Safety Alliance is
being coordinated by Cornell University. All three alliances bring
together FDA, local and state food protection agencies, the food
industry, and academia to determine what will work best to help prepare
food facilities and farms to implement FSMA.
FDA has also joined with USDA's National Institute of Food and
Agriculture to manage a competitive grant program that will provide
food safety training, education, extension, outreach, and technical
assistance to farm owners and operator, small food processors, and
small fruit and vegetable merchant wholesalers. FDA plans to fund
additional training programs through cooperative agreements.
Finally, FDA is building a technical assistance network to provide
rapid support to food producers, providing answers to any questions
they have about how to comply with the new regulations.
FDA will work closely with governmental and other stakeholder
partners. A key element of our stakeholder outreach during the
development of the FSMA rules has been outreach to our regulatory
partners. As we transition to implementation, our partnerships with
Federal, state, tribal, territorial, local, and international
regulatory and public health agencies will be even more vital. We are
continuing to build a National Integrated Food Safety System to ensure
the quality, consistency, and effectiveness of local, state, and
Federal efforts to protect the food supply. In addition, FDA will be
relying heavily on state agriculture and health departments and other
state and tribal agencies with food safety responsibilities, especially
for the new and unique challenges of implementing the forthcoming
produce safety rule on farms. We recognize the importance of harnessing
the food safety commitment, knowledge of local conditions and
practices, and local presence of these other regulatory entities to
provide training, technical assistance, and compliance oversight in an
effective manner.
Successful FSMA implementation is dependent on FDA's continued
engagement with states, industry, consumer groups, and foreign partners
throughout the process, to ensure that we continue to do our job in a
practical, effective, and risk-based way.
how fsma will make a difference
The prevention model for food safety adopted by Congress in FSMA is
widely recognized in the food industry and among government and
academic food safety experts as the optimal approach to minimizing food
safety hazards and managing problems when they do occur. FSMA also
transforms FDA's oversight by focusing us on prevention and giving us
new tools to verify and ensure that prevention is happening. Two recent
incidents from just this year illustrate why we need the preventive
system envisioned by FSMA.
Preventive Controls in Food Facilities: Blue Bell Creamery
This case involved the presence of the unusually dangerous
bacterium Listeria monocytogenes (Lm) in the manufacturing plants of an
ice cream company. The resulting contamination of products was
associated with the deaths of three people in Kansas and caused
numerous illnesses in at least three other states. Under current
industry best practices, manufacturers of ready-to-eat products like
ice cream should have a sanitation plan and standard operating
procedures that are adequate to ensure that Lm does not become
entrenched in the facility, and they should conduct sampling and
testing under an appropriate environmental monitoring program to verify
that the presence of Lm and the potential for product contamination
have been minimized.
Under the pre-FSMA food safety system, however, no such plans,
procedures or monitoring were specifically required. The burden rested
on FDA to find the problem, through inspection or, as in this case, via
reports of product contamination and illness. Moreover, during pre-FSMA
inspections, FDA could not require access to the company's production
and food safety records to look for evidence of problems or for
documentation that the firm was doing its food safety job
appropriately. FDA could only observe what the company was doing on the
days of the inspection. FDA was basically in a reactive mode, with the
burden on FDA to find problems, often investigating problems after the
harm was done, and being limited largely to finding evidence of legal
violations suitable for taking cumbersome and time consuming court
enforcement action.
Under FSMA and the preventive control rules FDA issued last week,
we now have requirements for sanitation controls, environmental
monitoring, and corrective actions that will apply to facilities making
ready-to-eat foods such as ice cream. The preventive controls rules
define the framework within which companies must put in place a food
safety program that is appropriate for the hazards in their products
and facilities. Companies will now be legally accountable to FDA for
doing the right thing to minimize hazards like Lm, and FDA will be able
not only to inspect the operations and conditions in the facility, but
also to examine, on an ongoing basis, the company's records documenting
the design and proper implementation of its food safety plan. With
these new requirements, enhanced records access, and FSMA's
administrative enforcement tools, there will be real accountability for
prevention in food manufacturing facilities.
Produce Safety and Imports: Cilantro from Mexico
Mexico is a major source of a wide range of produce commodities,
from staple fruits and vegetables to peppers and herbs, on which
Americans depend for year-round access. FDA and our Mexican
counterparts have long recognized the challenge of adequately ensuring
and verifying the safety of produce in general, and the large volume of
produce crossing the U.S.-Mexico border, a challenge exemplified by a
series of outbreaks of illness in 2012, 2013, 2014 and 2015 caused by
the parasite Cyclospora associated with fresh cilantro from the Puebla
region of Mexico. This year's outbreak has resulted in approximately
500 confirmed cases of illness in 30 states. Like most produce safety
problems, we have learned that the risk of contamination can be reduced
by following recognized practices related to water quality, employee
hygiene, biological soil amendments, animals in growing areas, and
harvesting and packing of produce.
Before FSMA, there were no regulatory standards for such preventive
practices, only voluntary guidelines. Moreover, to oversee the safety
of imported produce, prior to FSMA FDA has had to rely on computer
screening and on inspectors at the border physically checking a small
percentage of import shipments, looking for problems. If FDA can find
the problem, it can keep the problem out, but this reactive approach is
widely recognized to be inadequate for the huge volume of produce and
other commodities flowing into the United States from scores of
countries. In the case of cilantro from Mexico, the contamination has
to be prevented at its source.
Under FSMA, we will soon have prevention-oriented produce safety
requirements that apply to both domestic and imported produce,
including cilantro. Moreover, the Foreign Supplier Verification
Programs (FSVP) requirement under FSMA will, for the first time, make
importers an accountable part of the food safety system. Instead of
relying primarily on FDA and its inspectors to detect and correct
problems at the border, we will also be able to hold importers, and in
turn their foreign suppliers, accountable for preventing the problems.
This will make a big difference for food safety.
Recognizing the challenge of produce safety and the importance of
FSMA's success, in 2014 we launched with our Mexican regulatory
counterparts a Produce Safety Partnership. This partnership is grounded
in our common interest in ensuring the safety of Mexican produce, our
shared commitment to FSMA's prevention strategy, and the directive in
FSMA for FDA to collaborate on food safety with foreign governments.
The partnership with Mexico includes collaboration with the U.S. and
Mexican produce industry so that we can coordinate with and take
advantage of industry's own efforts to improve the safety of imported
produce.
Such partnerships are resource intensive for FDA, but can pay big
dividends when, as in the case of Mexico, we can leverage the efforts
of regulatory partners who are also real food safety partners. In the
current cilantro case, we are implementing jointly with Mexican
authorities a program that includes continued FDA oversight at the
border, but that also requires future shipments entering the U.S. from
Puebla to come only from farms that have been inspected and certified
by the Mexican authorities to be operating in accordance with sound
food safety practices.
fda's fiscal year 2016 president's budget request for food safety
The fiscal year 2016 President's Budget includes a $109.5 million
increase in budget authority, a total of $1.3 billion, for FSMA
implementation, and a total of $1.5 billion when accounting for all
resources requested in fiscal year 2016. Full funding of the
President's budget authority request is essential to maintaining
momentum toward the timely implementation of FSMA in the most effective
way possible. This goal could be undermined if FDA, the states and the
industry are not adequately prepared to get implementation right. The
three major program areas where successful implementation hinges
crucially on the fiscal year 2016 budget authority request are
preventive controls in food facilities, produce safety, and imports.
For preventive controls, the essential investments are for
inspector training and modernization of the inspection process, as
conducted both by FDA and the states, and essential guidance and
technical assistance for industry so firms can know what is expected
and can be supported in complying with the new requirements. This is
especially crucial for small and mid-size firms. These investments are
time sensitive because the preventive controls rules are the first to
go into effect, and FDA is mandated by FSMA to conduct inspections in
the covered food facilities at a certain frequency. If these
investments are not made, industry could experience inconsistency,
inefficiency, and potential disruption stemming from FDA staff who are
not adequately prepared for the new system.
Produce safety is one of our most important public health
priorities: we want people to consume more fresh produce, yet we
continue to experience an unacceptable number of illness outbreaks from
both domestic and imported produce. The top domestic produce safety
investment priority in fiscal year 2016 is for states to have the
capacity to be FDA's on-the-ground partner in implementing the FSMA
produce safety rule that will be issued later this fall. As Congress
envisioned in FSMA, our implementation strategy for produce is based on
the states playing a key role in working with growers to provide
education and technical assistance, and they will also be the primary
provider of inspections to verify compliance. In support of this
strategy, FDA and the National Association of State Departments of
Agriculture (NASDA) have entered into a five-year cooperative agreement
through which we are jointly planning implementation of the produce
safety rule from the ground up.
The states' role is essential to success, but they cannot perform
the role without resources. Investment is essential in 2016. We will
have a produce safety rule on the books by this November, but, because
this is a new area of regulation, we are having to build an
implementation system from the ground up. Growers, especially small and
mid-size operators, are already seeking education, training and
technical assistance, which states simply lack the capacity to provide.
States also need resources now to build the capacity they will need to
carry out meaningful on-farm compliance assessments and inspections in
2016 and 2017.
Finally, for imports, FDA must have new resources to adequately
implement FSMA's groundbreaking new FSVP requirement. There is no more
essential element of FSMA and its successful implementation than
this.FSVP is the crucial tool that FSMA provides FDA to hold importers
accountable for the safety of the food they bring into the United
States. They must meet this responsibility by verifying the adequacy of
the food safety controls being implemented by their foreign suppliers,
which means that FSVP is also the primary means of holding foreign
suppliers to the same food safety standards as domestic producers, as
FSMA intends. For the FSVP requirement to fulfill its purpose, FDA must
have funding in fiscal year 2016 to retrain existing staff, to hire new
staff with the skills needed to evaluate complex global supply chain
management systems, and to deliver education, training and technical
assistance to the importers we estimate are subject to the FSVP rule.
This funding will also provide the foundation for building the
multi-faceted new import safety system called for by FSMA, including
more foreign inspections by FDA, expanded collaboration with foreign
food safety authorities, and capacity building in countries where that
will help protect food safety in the U.S. Receiving this funding is
essential in fiscal year 2016 in order to align implementation of FSVP
with the preventive controls and produce safety rules.
In sum, FSMA directs FDA to build a comprehensive new food safety
system, based on what we know works to prevent problems--a system that
is effective regardless of where food comes from. In order for the
system to function properly, no key elements can be missing or lag
behind. And FSMA won't achieve its purpose if the program is so
inadequately funded that the system as a whole falters and fails. We
want to be very clear that we cannot successfully build the new food
safety system that Congress has called for without the new resources
requested in the President's Budget. That is what's at stake in the
fiscal year 2016 FSMA funding request.
conclusion
We appreciate your strong interest in food safety, Chairman Moran,
and this committee's support to date for FSMA and its effective
implementation. We look forward to continue working with you to make
FSMA a success. We would be happy to answer your questions.
Senator Moran. Commissioner, thank you very much.
Let me begin just by asking. You outlined the scenario by
which these rules will be announced. What was the basis for
their prioritization? Is there something about these two rules
that make them more difficult, easier, more significant to
pursue? What do we expect in the future?
Dr. Ostroff. Well, I will just say that they are all
important. The preventive control rules are probably amongst
the most important of all of these rules, and they are the ones
that are expected to be implemented first. And so these had the
priority to be issued. And the other ones will come shortly
after that.
Senator Moran. And the process you have been through will
be the same process for the next promulgation?
Dr. Ostroff. I will let Mike answer that. The essential
answer is yes, we will issue these. The deadlines for these are
set by court.
Senator Moran. Court order.
Dr. Ostroff. We are obligated to be able to meet all of
them, and we will meet all of them. I can assure you of that.
Mr. Taylor. I will just add that as the Commissioner
indicated, these rules are from a holistic package of standards
that Congress mandated to frame this comprehensive preventive
system, and so we have been through a dialogue with our
stakeholders that has really addressed all of these rules
because they have to fit together. And so we have to have a
coherent package of regulations. So we are at the end of the
process for all seven rules in terms of having gone through the
notice and comment, public meetings, dialogues, and so now we
are able to actually issue the rules in final. So the
sequencing has something to do as well with just the capacity
to get rules out the door and give a little breathing room
between rules. So we are on track to get these rules out on
that timeline, just as the Commissioner indicated.
Senator Moran. Thank you very much, Mr. Taylor.
Dr. Ostroff. So, Mr. Chairman, if I might.
Senator Moran. You may.
Dr. Ostroff. Mike just can make a couple comments about the
implementation plan, and that may help to put some of this in
context.
FSMA IMPLEMENTATION PLAN
Mr. Taylor. Well, again, this is a large topic, and I am
sure your questions will draw it out in detail. But we are
embarking on implementation and deeply cognizant of the
challenges, the hundreds of thousands of facilities, and the
complexity of supply chains. But we know that we can meet this
challenge because we have got the alignment of stakeholders, we
have done the homework, we have had the dialogue. And I think
the thing that I would just provide at the Commissioner's
suggestion is an overview. Some of the themes that we are
pursuing undergirding the implementation that we think is
crucial to success--and I think it is just crucial that we
stick with these themes.
COMPLIANCE
First is this commitment, as we implement, to provide
clarity through outreach and guidance about the new rules, what
they require, and to be supporting of the industry in achieving
what is expected through education, through technical
assistance. We have said on any number of occasions that we
will educate before and while we regulate, and we absolutely
mean that. So that is the first theme, clarity and support for
compliance.
INSPECTION
The second theme we need to do thematically, as you have
indicated and the Commissioner indicated, is just fundamentally
revamp how we conduct our inspections, how we conduct our
oversight and compliance activities so that we are targeting
our efforts based on risk and actively fostering and supporting
voluntary compliance through frontline oversight that
historically has been enforcement and reaction-oriented. Now it
needs to be prevention-oriented and supporting compliance.
I always need to add the caveat. As much as we want to work
with industry, if we encounter conditions where consumers are
being put at risk, FSMA expects and has given us new rules to
take swift action to protect consumers. But the goal has to be
compliance in food safety not just enforcement as an end in
itself.
PARTNERSHIPS
The third theme that I will emphasize, again picking up on
what the Commissioner has said, is strengthening and expanding
our partnerships with State agriculture and health departments.
This is absolutely essential. We have a mandate from Congress
to establish a national integrated food safety system. And we
fundamentally understand that FDA cannot possibly implement
this law successfully by itself. It has to work with our State
and local partners.
And finally, I just reemphasize--and I think this is
crucial--the commitment that I think we all need to have to
this integrated, comprehensive implementation of FSMA. This
system is a system. It does not work if we tease out parts or
delay parts or do not integrate this in a holistic way. I think
the import safety provisions are particularly a crucial part of
this overall system of prevention. This is how we will get a
level playing field for U.S. producers. We will meet the
expectations of consumers that the food that is imported into
this country is as safe as food that is produced here.
So these are themes that we hope to come back to, and we
want our feet held to the fire with respect to pursuing this in
this way. And I think if we do this, as daunting as it may seem
with the hundreds of thousands of folks we are seeking to bring
into a new system, we think we can do it sticking with these
themes.
Thank you, Mr. Chairman.
Senator Moran. Mr. Taylor, thank you.
Commissioner, your charts, particularly this one--what is
the explanation? What is the cycle that occurs here. You said
there were ups and downs. We have had reductions and increases
both. Is there a cause and effect that you could describe to me
why that is with one particular pathogen?
Dr. Ostroff. Yes. Well, it is a good question. I think if
you look over here, one of the other things that I think is
quite notable from this particular graph is that for many of
these pathogens, that many of the reductions, the reductions
being the ones that you see that are lower than one, occurred
during the very early years of implementation of some new food
safety activities in the late 1990s. And really if you follow
that along into the 2000s, for many of these it has really been
incredibly flat.
Now, I think it is important to recognize that food safety
and foodborne illness is an incredibly dynamic area. We have
new challenges. We have an incredibly diverse food supply. I
would venture to say it is much, more diverse than what we had
back in the 1990s when we started keeping some of these
statistics. Increasingly the proportion that comes from
overseas has grown. Sort of the locally grown phenomenon has
increased over that time period. And so there are a lot of
things that are challenging the food safety system and
influencing the occurrence of foodborne disease. But I think
the bottom line is that as these trends have changed over time,
we have basically been treading water, and it is time that we
no longer tread water, that we actually do things that we know
will work to make these numbers look different as we go
forward.
Senator Moran. And you believe FSMA will bend that curve?
Dr. Ostroff. I believe FSMA will bend that curve. I mean,
if you look at several of the major food safety problems that
we have experienced this year, including the most recent one
that we have seen with the cucumbers that were imported from
Mexico, the various provisions that are in FSMA are
specifically designed to address the challenges that we have
seen in all of those outbreaks. And so we should be able to
influence not only the outbreaks that are occurring but more
importantly I think the day in and day out sporadic foodborne
illness which forms the bulk of this particular data.
I do also think it is important to say that while we
certainly believe that all of the activities encompassed under
FSMA will work to drive these numbers down, it does not absolve
consumers of doing the right thing once this food gets into
their kitchens because a lot can happen even if the food as it
comes into the kitchens is safe. And so it is a comprehensive
approach that must be taken to assure that foodborne illness
does not occur.
Senator Moran. Let me turn now to Senator Merkley.
Senator Merkley. Thank you, Mr. Chairman.
Dr. Ostroff, in your testimony, you note that FDA's
strategy is taking an ``educate before and while you regulate''
approach. I note that you are currently working on guidance
documents. This is very important considering the first two
final rules are about 1,500 pages, so a substantial amount. And
these guidance documents will be critical for businesses to
understand and comply with the new law and they need to be
timely. So folks in Oregon are asking when these documents will
become available, and I will just give you a chance to answer
their question.
Dr. Ostroff. To best answer that question, I am going to
turn to the person who is actually writing them.
GUIDANCE
Mr. Taylor. I have a large and able team back home writing
them as we speak. Guidance is absolutely essential to the
success of implementing these rules, and we are investing a lot
of resources in that now. We have been doing that even as we
have been preparing the rules themselves.
One thing I would note in the 1,500 or so pages, this is 8
and a half by 11, double spaced, but the vast majority of those
pages are a preamble, are themselves guidance and explanation
of what the rules actually mean and how we expect them to be
applied. And so that is the first place folks should go to
really get an understanding of what the codified rule language
itself actually is intended to mean in practice. But that is
just the first step in guidance.
So as you know, we are developing a number of guidance
documents, some of which are the key foundational ones. So
there will be a comprehensive guidance on the human preventive
controls rule that will be almost kind of an operator's manual
for those who are not yet implementing modern preventive
controls like many in industry already are. For those who are
not there yet, this is going to be a very helpful operating
guide essentially for implementing the rules.
They will be doing a similar guidance for animal food, at
least a similar guidance for both the animal food preventive
controls--
Senator Merkley. I am just going to cut to the chase and
say I am glad it is going to have this guidance. When will
folks see that?
Mr. Taylor. These major guidances will be coming out early
to mid next year, well ahead of folks' obligation to comply.
Senator Merkley. Great.
Mr. Taylor. And they will be open for comment. It will be
an ongoing process of dialogue, but our best thinking will be
out there in a timely way for implementation.
Senator Merkley. Okay, great.
FSMA AND FOREIGN SUPPLIERS
I have heard from constituents and that there are concerns
that foreign businesses may not be as closely monitored as U.S.
businesses, and consequently there might be greater risks from
foreign products than from U.S. products. And additionally, it
could put U.S. businesses at an economic disadvantage because
of the clients' costs for FSMA.
In your testimony, you state that FDA cannot credibly hold
domestic producers to the new standards if we are not doing the
same for importers and their foreign suppliers and vice versa.
So I know you are aware of these concerns. And this all may get
further discussed when the foreign supplier verification rule
is finalized next month. But to the degree you can tell us now,
how will the FDA adequately ensure the safety of foreign food
products, and will that oversight be as rigorous as the
oversight for U.S. businesses?
Dr. Ostroff. Well, I am going to allow Mike to give you
some of the details. But all I can say is that one of the
fundamental tenets of FSMA is that we assure that the safety of
foreign-sourced food is equivalent to domestically produced
food. I think that we have that obligation to create that
equity. We know that to certain degrees our tools available to
us to be able to deal with imported food have been limited, but
this rule, this law will not successfully work unless we can
assure total equity between food that is produced overseas with
food that is produced domestically. And one of the critical
elements of that is that the importers that are bringing this
food into the United States assure that the procedures that
were in place to produce that food are equivalent to the
procedures that are in place for food that is produced
domestically.
Let me let Mike give you some more detail.
Mr. Taylor. So Congress did provide really a multifaceted
toolkit for strengthening import oversight, and the
Commissioner has referred to the central, really the
foundational part of that which is this foreign supplier
verification and requirements so that importers will now, for
the very first time, have a food safety responsibility to be
accountable to us for knowing their source of supply and
verifying that those foreign suppliers are producing under our
standards. That is a paradigm shift if we can implement it
well. It is combined, though, in the design of Congress with
much more overseas presence by FDA, so more foreign
inspections, more partnership with foreign governments, more
investment in foreign food safety capacity where that will
contribute to food safety here. We think this toolkit, if
implemented properly, will work to provide that equal rigor.
The question is implementation. Can we make the investments
needed to carry this out as intended?
FOREIGN INSPECTIONS
Senator Merkley. So, Mr. Taylor, you mentioned the foreign
inspections, and FSMA mandated 600 inspections in 2011, with a
doubling of the previous year's inspection level for the
subsequent 5 years, which would mean that in fiscal year 2015,
we would have about 19,000 foreign inspections. And in fact, I
believe that the Department plans to only conduct about 1,200.
So 19,000 under FSMA versus 1,200. This lack of foreign
inspections is adding to the concern that really different
standards are going to be, if you will, practiced in foreign
countries because there are not enough inspections to hold them
accountable. Your thoughts on that?
Mr. Taylor. You put your finger on a huge challenge, and
that is how do we target our resources with the resources we
get to implement this law effectively for food safety. So we
have increased our foreign inspections from less than 300
before enactment to in the 1,200 to 1,400 range currently. And
those have been very important. But they are part of the larger
system. And so the inspections are not inherently preventive in
the sense that the foreign supplier verification program
requirement is. So in terms of priorities for implementing the
import system, we have got to get 88,000 importers up to speed
in terms of doing their prevention-oriented verification. And
so that will be a priority for funding.
We would like to do more foreign inspections, but we also
think that we can leverage the inspection activity of foreign
governments through mechanisms like a systems recognition tool
that we have developed where for countries who have advanced
food safety systems, we want to recognize that and be able to
rely, engage in a mutual reliance sort of relationship where we
can rely on their inspections and not duplicate their efforts.
So there are multiple elements of this.
One of the major investments we have made over the last few
years with increased funding from Congress is to strengthen our
foreign offices overseas, which again are going to play a vital
role in us building the relationships with foreign governments,
outreach to foreign industry, all those things that we can
leverage our limited resources to maximize prevention activity
overseas. So we would love to continue the dialogue about how
we increase the inspection numbers, along with these other
activities.
Dr. Ostroff. The one thing that I do have to emphasize,
though, is that part of the request that we made in fiscal year
2016 for the full amount of funding, which was $109 million,
was to be able to assure that we could carry out the
requirements, especially for foreign-produced food. You know,
with a number that is significantly lower than that, we will be
challenged--I think that there is little question--of being
able to implement the various rules that will be coming out
over the coming months in the way that we envision that they
need to be rolled out.
Senator Merkley. And I think one of those areas that the
funding is impacting the United States is in filling those
foreign offices. You mentioned an increase, but I believe the
vacancy rate right now is 40 percent of foreign offices are
vacant. Is that primarily a funding issue or a prioritization
issue?
Dr. Ostroff I will say that it is expensive for us to be
able to place people overseas. However, actually placing people
full-time in these offices is only one of the strategies that
we have been using to carry out those responsibilities. So we
do cycle in people for short-term assignments to be able to
assure that we can carry out the things that we need to do in
those locations.
Senator Merkley. Thank you.
Senator Moran. The Senator from California, Senator
Feinstein.
Senator Feinstein. Thank you very much, Mr. Chairman. I
really appreciate the opportunity to talk with you,
Commissioner, for a few moments.
I have long been interested in this, actually before my
colleagues came on, and have tried to be helpful in getting
more ag inspectors at our border. But that is a long time ago.
California, as you know, is a huge--it is the number one
agricultural production State. Can you give me any percent or
any measurement of Salmonella and Campylobacter in California-
produced produce?
CALIFORNIA PRODUCE
Dr. Ostroff. That probably is not a number that I would
have off the top of my head. Given my extensive time at the
CDC, I am pretty familiar with the systems that they use to
collect the data, including the data that went into the FoodNet
report, in which California is one of the participants in that
system. And so there are data that are broken out by State for
the various FoodNet sites in terms of the incidence of some of
the pathogens that you see on these lists. I cannot tell you
whether or not it is done on a commodity-specific basis.
Senator Feinstein. Okay.
CUCUMBER SALMONELLA OUTBREAK
Now, the latest Salmonella outbreak for us is the cucumbers
imported from Mexico. And I gather that is 418 illnesses across
30 States, and we have seen the most illnesses of any State, 89
illnesses, 17 hospitalizations, and one death. I am concerned
that year after year, the Centers for Disease Control reports
that the United States has not made progress in reducing the
number of foodborne Salmonella infections that occur.
I was listening and also reading your comments how these
new food safety regulations, FSMA, that you are finalizing will
prevent outbreaks from happening with specific products. Take
the cucumber as an example. How will you work it both at the
border and in a foreign country with the farm operation in
Mexico that is producing these crops?
Dr. Ostroff. Well, I will preface my statement by saying
that that particular outbreak is still under investigation, and
so we do not know all of the specific details that may have led
to it happening.
But having said that, I think that if you think of two of
the major outbreaks that we have experienced this year, one of
them being the Salmonella associated with the cucumbers and a
few months earlier a parasitic pathogen, Cyclospora, that was
associated with cilantro that also was imported from Mexico,
you know, there are some themes about the quality and
implementation of measures to prevent problems from occurring
in the first place and that is at the heart of what it is that
we are trying to accomplish under the produce rule. And so that
produce rule establishes a number of standards that producers
overseas that and producers domestically need to adhere to.
Senator Feinstein. Could you give us an example of the
standards?
Dr. Ostroff. Well, you know, some of them are the water
that is being used to irrigate the crops. One of them has to do
with the access of animals to various locations. There is
another aspect that deals with the hygiene of the workers that
are working on these particular farms. And so it is a whole
variety of requirements that will be in place under the produce
rule that any producer who is importing food into the United
States will be expected to meet.
Mr. Taylor. If I just may add. The difference FSMA will
make is that we have known for years what these practices are,
and FDA has provided guidance, voluntary guidance, but there
have been no enforceable standards, whether for domestic or
foreign producers, and thus no accountability for doing the
right thing. And so what FSMA does is create enforceable
standards and then also verification that those standards are
being met. I mean, it is that simple, but it is a profound
difference from where we have been before where it was
incumbent upon FDA to find and react to the problem in the
absence of clear standards for prevention. It is a real game
change that for cucumbers, that kind of example, will make a
huge practical difference.
Senator Feinstein. Right.
FSMA COORDINATION WITH USDA
Now, I gather produce is about 46 percent of foodborne
illnesses, and that is under your jurisdiction, and the rest of
it, meat, chicken, pork, is under USDA, if I understand that
correctly. Do you coordinate in standards between the two of
you or are the standards different?
Dr. Ostroff. One of the critical requirements of being
successful with FSMA is to be able to work closely with a whole
variety of partners, and it is not only partners that are at
the Federal level, but it is also down at the State and local
level where a lot of the day in and day out work with farmers
occur. And so, yes, it is very important that we work quite
closely with USDA to ensure the success of what we do.
Senator Feinstein. With produce--for example, I have had
Campylobacter, and I know how serious it can be. And it was
from eating not thoroughly cooked chicken. And so I asked my
staff to look into it. Now, this is not your jurisdiction, but
it is interesting to me that up to 40 percent of the ground
chicken in markets may have Salmonella. And I talked to a large
chicken grower in my State, and I said, what about this? And he
said, well, everybody knows you have to cook chicken to 165
degrees until you eat it. I said, well, I did not know. And I
do not think everybody knows.
So it raises the question of how these two agencies
interact. I really think you have a good thing going in what I
have read on FSMA, and I like very much how you are going about
it. I worry very much about particularly chicken because
chicken has become such a high item for people in terms of
eating. And it does not seem to me that we make much progress
year over year, year after year.
But with respect to this, what you mentioned, cilantro,
cucumbers, ice cream, tuna, caramel apples, and these five
outbreaks alone are almost 1,000 cases of illness and 12
deaths. Do you think that there is anything that USDA can begin
to learn from FSMA? Do you think it is relevant?
Dr. Ostroff. Again, we work very closely with USDA without
question. Far be it for me to provide advice to them related to
things that we ourselves do not regulate. All I can say is that
they too are working quite arduously in putting in place
additional strategies to be able to address those products that
are under their jurisdiction. And there are a lot of
similarities to things that we are doing in FSMA to things that
USDA is doing, you know, because again, from the consumers'
perspective, if they end up with Salmonella, they end up with
Salmonella and they are not so much interested----
Senator Feinstein. That is exactly the point.
Dr. Ostroff. [continuing] In what the source is as to what
we do keep it from happening.
Senator Feinstein. Right. And we have two big agencies. One
handles the meat products and one handles the fresh produce
products. And I have often wondered is that the best way to do
it. I think you are taking action, and I am very pleased to see
that.
ANTIBIOTICS IN PRODUCTS
I am also concerned about antibiotics in products and what
has been happening in that human stream of consuming products
that have antibiotics. Could you talk a little bit about that
and what your agency is doing?
Dr. Ostroff. Sure. As you know, this is also a very
important aspect of food safety. We have had a multi-agency
activity in place called NARMS (National Antimicrobial
Resistance Monitoring System) that monitors not only the
occurrence of various pathogens in a variety of food products,
particularly meat that is sold at the retail level, but also
monitors the patterns of antimicrobial resistance. We look at
isolates that come from products that we regulate. USDA looks
at isolates that come from products that they regulate, and CDC
also incorporates information from human isolates of the same
pathogens so that we can compare those patterns and look at
those patterns over time.
As you know, we also have been working quite hard to be
able to address the issue of antimicrobial resistance from
foodborne pathogens. That is a whole other large component to
their activities, especially by reducing the use of medically
important antibiotics used in food-producing animals,
particularly when used for growth promotion purposes. And so we
have put out a number of guidances and rules specifically
designed to address reductions in the use of antibiotics for
those purposes. This has been a multi-year process to put those
rules in place. We have done this on a voluntary basis to have
all of the marketers of these antibiotics for use in food
animals make labeling changes to remove growth promotion as an
indication for the use of these antibiotics, and they have all
voluntarily complied. The phase-in period to make those changes
in the labels is to start at the end of this year. So we would
look to see changes start to occur as a result of those
practices.
And the other very important point of those requirements is
to make sure that the use of those antibiotics for other
purposes is under the direction of a veterinarian.
So both of them I think will be very helpful in terms of
addressing the problem.
Senator Feinstein. Thank you very much, Commissioner.
Thank you, Mr. Chairman.
Senator Moran. You are welcome, Senator Feinstein. Thank
you very much.
Just to educate myself in a more general way, let me raise
a couple of topics that are a result of the questions and the
testimony.
FOOD ILLNESS DEATHS
One of the things I wanted to ask about is the cause of
death. You cite the CDC statistics, the 128,000 hospitalized,
3,000 die related to foodborne illness. Is there a breakdown of
those deaths or hospitalization related to consumer preparation
versus the food that was tainted prior to preparation? Do we
know where the cause lies with the consumer versus the
provider?
Dr. Ostroff. It is not a very easy question to answer,
especially when you are sometimes talking about a relatively
long period between the time that the exposure may have
occurred and when certainly the illness occurs and when the
death occurs.
Having said that, we deal with a whole variety of different
pathogens, some of which deal with items that are supposed to
be cooked. Sometimes you are dealing with raw commodities like
in the produce space. And so ultimately in most instances what
you want to try to do--and I think what FSMA is designed to
do--is to try to keep it from being there in the first place.
And I think if you can successfully do that in many of these
commodity areas, then you will successfully be able to have an
impact in reducing these problems from occurring.
Senator Moran. So there is a reduction that could occur in
the likelihood of the problem that reduces the importance of
consumer preparation of the food item.
Dr. Ostroff. Let me just say without question that you
never want to send any suggestion that consumers can become lax
in the way that they handle their food because I do not think
that we would want to ever send such a message. I think what we
do want to do is to be able to enhance consumer confidence that
the food that comes into their kitchens does not contain
pathogens----
Senator Moran. That was very artful. I will reask my
question which would be there is no way--is there, Dr.
Ostroff--that consumer preparation is not important regardless
of what arrives in the consumer's home.
Dr. Ostroff. You said it perfectly.
Senator Moran. Thank you.
DOMESTIC AND IMPORTED FOODS
You indicate--well, first of all, I wanted to follow up on
Senator Merkley's point about imported food versus domestic
food. And he was asking for equity. An indication that you had
indicated in your testimony that there is an importance to
making sure that there is not an economic disadvantage to
domestic producers. There is not a double standard I think is
the way we would say it in Kansas. Does that double standard
exist today? Is there a difference in the nature and the
likelihood of foodborne illnesses from imported food versus
domestic food?
Dr. Ostroff. Since I have been answering those through the
questions, I am going to turn that one over to my colleague.
Mr. Taylor. I think the answer is that under current law
pre-FSMA, but also under FSMA, the standards are the same. I
mean, Congress has made it very clear in FSMA that the same
standards are to be applied. The same safety is to be achieved
whether foreign or domestic.
The real difference and where there is a different
challenge is in the ability to verify that those standards are
being met, and we have very different challenges with imports
than we do with domestic because we have an inspection force
here. We can legally go into facilities. We can directly hold
firms legally accountable. We have a whole set of relationships
with the States who go into these facilities all the time. We
can really cover that. There is no amount of foreign inspection
that Congress will ever pay for us to do that would provide a
comparable level of oversight through inspection overseas. And
so that is why we have got this multifaceted toolkit of foreign
supplier verification, more foreign inspections but very much
collaborating with foreign governments. So the difference is
really not so much the standards. They are the same standards.
The question is how do you verify. And the imports provide a
different verification and challenge than domestics.
Senator Moran. And, Mr. Taylor, under FSMA the ability to
enforce those standards is going to, in large part, rely on the
certification of those who are importing food that their
providers, their foreign suppliers, are in compliance.
Mr. Taylor. Well, that is the foundation for the new system
because the U.S.-based importer is legally directly accountable
to us. We can hold them legally accountable for doing that job
properly. So that is where we have the direct legal handle. But
then we can go over and again inspect foreign facilities. If we
see a problem, we can keep that food from coming in. We can
work with foreign governments again to foster good practices
and to rely on their inspection activity. But, yes, the direct
legal accountability for imports, in terms of private sector
responsibility, is on that U.S.-based importer. So that is why
that foreign supplier rule and its proper implementation is
just so foundational.
Senator Moran. What does that mean the importer is most
likely to do to be able to sign that certification? What is
that company going to do in a foreign country to make certain
that when they attest that standards are being met, that they
are actually being met?
Mr. Taylor. So under the regulation that we have proposed
and you will see coming forward--and I am not here announcing
the final content of the regulation, but I think the elements
of it are evident from the proposals that we have put out and a
supplemental proposal that we put out last year. But the whole
idea is that--and again, this is just following the
congressional mandate--the importer must have a program, a
documented program where they have identified their suppliers,
they have come to understand their suppliers' capabilities for
food safety, they have approved their suppliers, they know the
practices the supplier is undertaking, and they look at
records. And under some circumstances, when justified by risk,
because it is intended to be a risk-based foreign supplier
verification program, we would envision the U.S.-based importer
doing an audit, actually having an audit conducted of that
foreign supplier and on site onto that foreign producer. So it
is having a real program that we can then audit and then,
obviously, go behind that and sample product when it is coming
in, go behind that and actually inspect the foreign facility,
if we choose to. But it is that accountability for the importer
that is the new feature that is so crucial.
Senator Moran. The word ``audit'' has a different meaning
than the word ``inspect.'' Is that true?
Mr. Taylor. Yes.
Senator Moran. So when the importer is auditing, that
importer is not inspecting. They would not be doing the same
thing that an FDA inspector would be doing in a foreign
country.
Mr. Taylor. Well, it is different because when you talk
about inspection where we are used to going in and looking at
facilities and conducting a physical exam of a physical place--
the ``audit'' term that we are using applies to auditing the
program, checking the records, being able to get confidence
from examining the records and talking to the importer that
they know what they are doing and they are doing the right
thing. And so in that sense, it is a very records-intensive
audit activity that will be at least a major component of
ensuring this is being done properly.
Senator Moran. Mr. Taylor, thank you.
I have more questions, Senator Merkley, but maybe a way to
accommodate your schedule is to turn now to you, and if you are
unable to stay for my final round, I would not be offended.
Senator Merkley. Thank you very much, Chairman.
VIBRIO INCIDENCE
I wanted to draw attention to the report that you have all
displayed, the 2014 Food Safety Progress Report. For folks who
are numerically challenged, you have boiled it down to happy
faces, grim faces, and very unhappy faces. And the unhappiest
of all is the face representing Vibrio. And over on the other
chart that you have provided, you show that while every other
disease has decreased since the 1998-till-now time period,
there is one disease that has increased in incidence and that
is Vibrio. What is the story? What particulars should we know
about the challenge this disease represents?
Dr. Ostroff. Well, Vibrio can also be a significant
disease. It comes in a couple of different forms. There are
several different pathogens that are encompassed under the
label of Vibrio, and they are, in general, associated with
seafood products. Now, I think it is important to put in
context that in terms of the overall numbers, the number of
illnesses associated with Vibrio was actually quite small and
certainly a very small fraction of what we see in the United
States from either Salmonella or Campylobacter. Some of this is
associated with actual spread of Vibrio. In some instances, it
was largely confined to certain areas of the country, and
because of movements that occur with emerging diseases, it
spread to other areas where it traditionally has not been. But
it is a trend that we have been seeing particularly along the
east coast.
Senator Merkley. I was reading an article recently about
the ponds where shrimp are farmed on land in Asia and where
massive amounts of antibiotics are used to control the various
diseases that are rampant in those ponds. Is that import of
shrimp from these farms one of the factors contributing to the
Vibrio expansion?
Dr. Ostroff. I would have to get you specific information
about whether or not that is contributing, but by and large, to
my knowledge, most of the Vibrio-related illnesses are not
associated specifically with imported shrimp.
[The information follows:]
While Vibrio related illnesses have been increasing in the United
States in recent years, investigations conducted by state and local
health departments have associated these infections with consumption of
raw oysters and other raw forms of molluscan shellfish in the week
before illness. A summary of these infections, including their recent
increased recognition along the Atlantic coast, can be found on the
website of the Centers for Disease Control and Prevention at
www.cdc.gov/vibrio/investigations/index.html. Vibrio infections are
most common during warmer months when the organism is more prevalent in
the marine environment. Infections can be greatly minimized by
consuming only thoroughly cooked molluscan shellfish.
Senator Merkley. Thank you.
SALMONELLA IN PEANUT BUTTER OUTBREAK
Back when we were working on this bill, a young man and his
father came out from Oregon to testify. The father was a police
officer. The son, when he was 3--his name is Jacob Hurley. He
had experienced a life-threatening case of Salmonella from
contaminated peanut butter. And he was one among more than 700
who were sickened by contaminated peanut products in 2009. I
believe that the company involved in that was the Peanut
Corporation of America.
If we look back on that particular, well-publicized
incident, how would the preventive controls rule that we have
just passed have made a potential significant difference in the
risk of that disease?
Mr. Taylor. So that is an unusual case in many respects in
part because of the vast scale of the damage that it did and
the thousands of products that had to be recalled because this
firm was selling not only peanut butter in bulk but peanut
ingredients that went out into thousands of processed foods. It
was a catastrophic event for the food system.
It also involved intentional conduct by the owner and
operator of that facility and the well-publicized subsequent
criminal prosecution and conviction.
What FSMA will do, even in that situation, is provide a
much stronger basis for inspectors, when they go into
facilities, to not be reliant just on looking around at the
facility conditions, and pre-FSMA with no access to the records
of the facility, under FSMA we will have a much stronger
ability as investigators to go into facilities and make
assessments of the system and to be able to detect and find
records that might actually document positive analytical
results such as those that occurred in this particular case
that would reveal a problem that needs to be addressed. So
there is always going to be that rare instance where purposeful
criminal behavior happens, and there needs to be swift remedies
for that.
But I think even in these cases, we will be able to be more
effective in our investigatory role in assessing systems and
whether this sort of practice is going on in facilities that
needs to be addressed very forcefully, and FSMA gives us new
rules for addressing that sort of situation forcefully. If we
identify this sort of problem through inspection, under FSMA we
can actually suspend the registration of that facility and shut
the facility down administratively. And that is an important
tool in these sorts of extreme cases.
Senator Merkley. So as you note, there were exceptional
circumstances, leaky roof, mold, animal contamination, so on
and so forth, kind of egregious behavior regarding some known
problems. But in terms of the inspections you mentioned and the
ability to kind of have teeth, that matters.
PREVENTIVE CONTROL RULE AND TRACE ABILITY
But there is another element of the preventive controls
rule--I believe it is in the preventive controls rules--that
involves developing a tracking system for ingredients that go
into processed foods. And can you just comment on whether you
believe that is going to make a difference?
Mr. Taylor. So FDA has historically--since the Bioterrorism
Act in 2001 was enacted, it has had authority to require firms
to keep records of where their incoming materials came from and
where their finished products have gone, one up, one down
recordkeeping. FSMA adds somewhat to our authority in this area
by giving us the authority to set standards for how that firm
connects the dots between the incoming and the outgoing. And so
that will be a step, and that is a rulemaking that is underway
to put that in place.
FSMA frankly put some constraints on FDA in terms of
traceability because it precludes us from requiring essentially
a farm-to-table pedigree or the kind of tracing that is done by
UPS and FedEx. We are precluded from requiring that sort of use
of technology to improve traceability. So from our standpoint,
traceability is crucial. It is how we can investigate outbreaks
much more expeditiously and get to the cause of problems and
solve them.
But traceability is going to have to come into the modern
era fully through public-private collaboration, finding ways to
harness industry innovation with the support of us and dialogue
so we can be sure whatever they do helps our investigators, as
well as the firms themselves. But the work to be done yet is in
that area.
Senator Merkley. Thank you very much, Mr. Taylor, Dr.
Ostroff, Mr. Tootle. I appreciate it. Thank you.
FSMA COLLABORATION
Senator Moran. One of the things I read in your testimony
that I wanted to highlight and ask you to confirm to me how
serious you are about this and how confident I can be that it
will remain the policy, and that is, you indicate the approach
to inspection is aimed first at fostering and facilitating
compliance rather than finding and penalizing regulatory
violations. That is a policy, in my view, that every regulatory
Federal agency should adopt. The goal is to make improvements
in cooperation with the regulated. And it seems to me--and we
have had this in other agencies previously in which they seem
to be that was the direction they were going, but over time,
the joy of penalizing became too great and the attitude of
cooperation disappeared.
Is there some assurance that you mean what you say in your
testimony and that it will last as part of the nature of the
Food and Drug Administration as it implements and enforces
FSMA?
Dr. Ostroff. Well, all I can say is that we do believe that
the approach that is expressed in FSMA, which is to work
collaboratively with regulated industry--and when I say
``regulated industry,'' we mean from the farm to the transport
into people's homes--that we work collaboratively to encourage
them and to work with them to do it right. And we know that
ultimately doing it right has tremendous impact. That is not to
say because, you know, you always have to--and I am sure you
are quite aware. There is the carrot and the stick. And we know
that the carrot is quite an effective way to promote
improvements in food safety, but that does not mean that we are
not going to use the stick when we need to use the stick.
Mr. Taylor. If I could just add why I believe this will
remain the policy over time regardless of who happens to be
sitting in these chairs, partly we have put it in writing. We
have made this commitment to the industry and to the public,
and people support this externally. But equally important for
your purpose, the people at FDA embrace this wholeheartedly.
The people who are at the front line in our agency are public
health people. Enforcement is a tool, and that has been the
culture of the agency given the statute we have had and the
framework for food safety, which has basically been an
enforcement-oriented statute and program. But with FSMA, we are
now public health at the front line, and our front line people
love that. They would much rather be getting good food safety
outcomes and doing public health than trying to rack up
enforcement numbers. That is just not the fundamental mentality
of that cadre of people, including the young people coming into
the agency. It is an extraordinarily exciting time for them and
for the whole agency. So I think the future is here in terms of
the culture change that is going on, and we are working in many
ways to institutionalize that and embed that in the practices
of the agency.
Senator Moran. Well, would it not be fair--I mean, I
recognized when I asked that question, it may sound as if you
are trying to take care of business or farmers, but is the
reality not that we end up with a safer food supply system when
this is the attitude?
Mr. Taylor. We know and you know, and if you talk to the
people in the food business, it is just obvious the vast
majority want to produce safe food at a personal level and it
is in their intense business interest to do that. And so our
whole strategy is based upon that assumption. We need to work
with that vast majority who want to comply, support that
compliance, verify that it is happening. And for those who are
not complying, we will act swiftly and we will take whatever
action is needed to protect consumers, and in these extreme
cases like Peanut Corporation of America, invoke punitive
remedies as a deterrent. But, no, I think working with those
whose interest is aligned with ours on food safety is how we
will get the best public health----
Senator Moran. If I can respond to that before Dr. Ostroff
speaks, in the world I come from in Kansas, the rumor of food
disease or animal-borne diseases causes dramatic consequences
to farmers, to ranchers. It does not take an actual case. Just
the thought that something may be wrong. And so I am certainly
not opposed to strictly strongly enforcing penalties and
putting bad actors out of business because they have a huge
consequence certainly to the consumer and the safety of our
food supply, but for those same business men and women, those
same farmers and ranchers, they cannot afford financially to
have the rumor the reality that there is something wrong with
what they produce.
Mr. Taylor. And our strategic interests are fully aligned
on that.
Dr. Ostroff. And I think you are absolutely right. We know
that the ramifications from foodborne outbreaks that occurred
years ago still ripple through certain commodities.
The other thing that I will say is that the approach that
we will be taking under FSMA is really a fundamentally
significant change to the way that we approach food safety, and
it is really critical because a number of things that are
encompassed in the funding request that we have made to
Congress is designed to ensure that up and down the system, we
can reorient the workforce to be able to implement the things
that you were saying in terms of being able to work
collaboratively with industry, being able to educate industry,
and being able to oversee and ensure that what they are doing
is up to standards takes resources. And I do not know any other
way to say it. And we do know, without question, that unless we
receive the total amount of the request, that something is
going to have to give in some aspect of what we are doing.
Senator Moran. You could not help yourself.
Dr. Ostroff. I could not help myself.
Senator Moran. And I will be happy to visit about that
topic. Let me finish up a couple other items.
STATES ROLE IN FSMA IMPLEMENTATION
When it comes to the State of Kansas, the State of Oregon,
the State of California, what will the role be for those States
as a result of FSMA and its implementation? What happens
different at the Kansas Department of Health and Environment?
Dr. Ostroff. Well, the approaches that are being taken at
the Federal level--those same types of changes will also occur
at the State level. The States and localities are really very
critical partners in implementing FSMA as it is designed to be
implemented. They are our front line eyes and ears. They carry
a lot of the workload in not only working with their regulated
industries at the State and local level, but particularly in
certain areas. And the one that comes to mind most is the
produce rule. We will look very much towards working with the
States to be able to provide the type of front line support to
all of the farmers within their States to be able to
appropriately implement the new requirements for FSMA. And so
they are really critical to the success of this endeavor.
ANIMAL FEED RULE
Senator Moran. Let me ask one question related to the
animal feed rule and contract farmers. Doctor, you indicated--
Commissioner, you indicated to me that in advance of this
hearing, that what I was going to hear from the folks out there
in that world would be all requests to make sure that Congress
appropriated sufficient funds to implement FSMA, and that you
had worked your way through many of the challenges and had a
lot of input from stakeholders, as you described. And I
appreciate that, and it seems to me that that is in large part
the reality.
One area that I have heard concern about is the definition
of what a farm or farmer is. And you are shaking your head and
so maybe I do not need to describe the issue. Is there
something afoot that I ought to know about the direction that
you are going? What I have heard, that there is concern from
farmers who have no involvement in anything other than raising
the livestock, the animal, that FSMA will affect their
operations as well when all the processing and everything
occurs downstream. And in fact, the feed, most importantly, is
not grown or provided by them. It is provided by upstream
buyers of those they have contracted with. This is an issue--
have I described it adequately. You were once smiling. Now you
are frowning.
Dr. Ostroff. Well, no, because the specific way that a
farmer is defined is really critical to certain parts of these
rules, not only the preventive controls but also to the produce
rule. And so we have worked quite closely with those that will
be impacted by this rule to make sure we can get it about as
right as we possibly can.
I will ask Mike because I know he has been immersed in this
particular issue for the last several years.
Mr. Taylor. I do know the issue very well, and the fact
that there is presumably still some folks who have some
concerns just shows that there is an exception to every rule--
but stakeholder support for the rules.
But I think that what you are talking about is the
situation where there are vertically integrated poultry
operations where a Perdue or a Tyson will own the chickens.
They will manufacture and own the feed. They will provide it to
contract growers who own----
Senator Moran. The growers only grow.
Mr. Taylor. The growers only grow.
The growers--if they have a concern that they are affected
by this, I have not heard that and I do need to hear that. The
affected party is the operator of that feed mill, that is not
being managed on or by a farm operation but rather by this big
vertically integrated poultry enterprise. That feed mill is
subject to the animal feed preventive controls rule. The
requirement is very practical and risk-based and so do not
address issues that do not need to be addressed in terms of
ensuring the safety of animal feed. But those feed mills are
subject to preventive controls. If the poultry operator or any
farmer--and this is the common practice for poultry--is growing
or processing their own feed on their farm in their feed mill
for their animals, that is part of the farm operation and would
not be subject to the preventive controls rules.
So I would be happy to engage whoever has the concern and
connect them with our Center for Veterinary Medicine and work
through whatever the question is. But that is basically the way
the rule----
Senator Moran. You answered the question better than I
asked it, and I think that is the assurance that they were
having to hear.
Mr. Taylor. Okay. Well, again, I am happy to talk to them
if that would help.
BUDGET REQUEST
Senator Moran. Let me talk just a moment about the
appropriations process. And I indicated in my opening statement
this will continue to be a priority certainly of mine and I
think of this subcommittee. And you mentioned specifically the
amount of money that the President's budget requests and our
ability to meet that at this point has not occurred. But we
worked hard to put more money into FSMA implementation as we
prioritize within the dollars that we have within our
jurisdiction. And if those dollar amounts change, we are
interested in reviewing and reprioritizing based upon what the
needs are of FDA and others to try to make certain we make the
right priority decisions.
But let me ask a couple of things about how the money has
been spent in the past. As I indicated in my opening statement,
the number, I believe, is an 8-percent increase over the last 5
years for implementation of FSMA at FDA. Mr. Tootle, am I
saying that correctly?
Mr. Tootle. I think it is 4 percent, sir.
Senator Moran. Of course, you do.
FSMA SPENDING
Senator Moran. Well, let me ask how that money has been
spent in implementation and how has it been allocated. Is it
across food safety inspections, foodborne disease surveillance,
detection? How have you decided how to spend that money over
the past 5 years? And I will consult with my expert.
Dr. Ostroff. So the total amount since 2010 that has been
allocated specifically for FSMA--I believe the number is
approximately $162 million over that time period. It has been
used in a whole variety of ways, but as you probably recognize,
there has been a tremendous effort on our part to be able to
appropriately lay the groundwork to get these rules to a place
where those rules are both implementable and will work. And
that is no mean task. As you know, we have had tremendous
numbers of outreach activities to the various stakeholder
groups. There have been somewhere in the range of 600 or so
meetings that have occurred, either public meetings,
interactions with regulated industries, various trade
associations. As you know, we have walked facilities and farms
from one coast to the other. There has been a significant
effort to actually do all the writing that it takes to get
these rules to the place where they were. As you know, we
issued a number of supplemental rules. And so that has heavily
contributed to a lot of the resources that we have used to get
to the point where we can actually get to where we are now,
which is to start implementing.
Mr. Taylor. In addition, there are a number of programmatic
and capacity investments that we have made that I think are
very significant as well. Some of it includes technical
staffing, increasing technical staffing at the agency, so we
can support the industry, our State partners, our own
inspectors as they implement this. So this is at our Center for
Food Safety and Applied Nutrition principally. We have doubled
the investment in the States to close to $50 million over the
last few years. We have been able with the resources we got,
including these increases, to meet the FSMA mandate for high-
risk inspections, the frequency mandate, and exceed that and do
that earlier than expected. We think that has been an important
part of getting ourselves in a position to succeed under FSMA.
And then the import area has been an area of investment. We
have significantly increased the number of inspections, as I
mentioned. We have expanded the foreign offices, things we have
talked about. So there have been some significant programmatic
investments in capacity for ourselves and the States to be
ready to implement FSMA. It is part of an ongoing sort of
buildup so we can succeed going forward.
Senator Moran. Thank you, Mr. Taylor.
Mr. Tootle, it is apparently one of those circumstances in
which both are right.
The desired outcome has been achieved. Food has increased
by 8 percent, FSMA by 4.
REPRIORITIZING FUNDING
I think this is my final question. Is there any
opportunities--let me ask that differently because there has to
be. As you implement FSMA, are there opportunities for
reprioritizing existing spending that that spending is no
longer necessary because you are headed down a different path
than the way the FDA operated in the past? So are there any
savings to occur as a result of the implementation of FSMA?
Mr. Taylor. My Commissioner is looking at me, so I will say
something.
Dr. Ostroff. Because my short answer would be no.
Mr. Taylor. I think I am going give yes. That is a no
because I want to try to explain, though. If you look at the
overall funding of the foods program, about three-quarters of
it pre-FSMA goes into the field based activities that relate to
food safety but doing it the old way. What we are talking about
is adding frankly incrementally to that base resource so we can
reorient, redeploy all of that resource to doing food safety in
the way envisioned by FSMA.
Senator Moran. It is not the best answer.
Mr. Taylor. I wanted to get credit for the fact that we are
not just continuing to do all the old stuff and then add on the
new thing.
Senator Moran. That is the nature of my question.
Mr. Taylor. Yes, sir. And the answer is we are redeploying
but it does not mean we can stop spending the money that is
needed to support that workforce. We have to, in fact, invest
in it so it can work in this modern prevention-oriented way in
a much more sophisticated regulatory framework. So, yes. So it
is redeployment as opposed to adding on resources on top of
resources that are still deployed doing the old thing.
Senator Moran. That is what I want to hear. And since you,
Dr. Ostroff, wanted to answer no, I will give you the
opportunity to say yes.
Is the reality not, is the truth not that we can now--as we
do things differently, you redeploy assets, resources that were
directed in the old way of doing business to the new way of
doing business?
Dr. Ostroff. So this is not going to require fewer people
to be successful. It is just going to require that those people
do things differently than they have been doing them, but the
people that we need to be successful for FSMA will not--you
know, we are not going to have people go away. And in point of
fact, given the various responsibilities that we have under
these rules, we need every single one of those people to be
successful in implementing this. So from the standpoint of what
we have been doing with our field force and what we have been
doing with our laboratories, those responsibilities do not
disappear under FSMA.
Senator Moran. Dr. Ostroff, thank you for your testimony.
Mr. Taylor, thank you for being here. Mr. Tootle. Anything you
would like to make certain that is included in the record
before we close this hearing?
Dr. Ostroff. Well, I will just close by saying I am the
eternal optimist. The request that we made for this fiscal year
for FSMA implementation from my perspective is absolutely
critical to its success. And to make this have its maximal
impact, which we hope that it will have to change some of these
graphs that you see here on the right and the left, every
component of that request is vitally important to the success
of this endeavor. And so we will have some incredibly difficult
choices to make if we cannot get that particular request. And
so I recognize that you have been an ardent supporter of the
success of FSMA, and we certainly are totally appreciative of
the efforts that you have made to this point, and we are very,
very appreciative of the resources that did show up in the
subcommittee's and full appropriation for FSMA implementation.
All I can say is that there will be some significant shortfalls
that will result with that particular number, which will make
it very challenging for us to be able to put in place right
from the get-go what we need to do to be successful in this
endeavor.
ADDITIONAL COMMITTEE QUESTIONS
Senator Moran. Doctor, thank you very much. I appreciate
your testimony. Thank you for being here. I appreciate the
presence of my colleagues. And for members of the subcommittee,
either those that were here or who were not, any questions that
they would like to submit for the record should be turned into
the subcommittee staff within 1 week, which is Wednesday,
September the 23rd, and we would appreciate having a response
back from FDA within 4 weeks subsequent to that point in time.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted by Senator Jerry Moran
produce safety
Question. Please provide a food safety risk rationale why FDA
concluded that Produce Safety provides adequate regulatory oversight
for on-farm packinghouses that pack any amount of produce not grown on
the same farm, and ``secondary activities farms'' that are majority
owned by the primary production farm(s) that provide a majority of the
produce packed, but an off-farm packinghouse that performs the same
activities on the same commodities requires the added complexity of the
Preventive Controls rule if more than a majority of fresh produce
packed is not grown by the packinghouse majority owner(s).
Answer. Produce packing houses that fall under the new farm
definition and pack covered produce would be covered by the forthcoming
produce safety rule. Produce packing houses that do not fall under the
new farm definition would be facilities covered by the preventive
controls for human food rule. We recognize that this means that
establishments performing basically the same activities will be
governed by different regulatory regimes. We are limited by our
statutory authority. FSMA sets up a dichotomy, where farms packing and
holding covered produce are subject to the produce safety rule, with
its regulatory structure, and facilities required to register are
subject to the preventive controls for human food rule, with its
regulatory structure. We have expanded the farm definition as far as we
think we can, while still reflecting what a farm is in the real world.
However, we expect that the specific steps necessary to ensure the
safety of produce would generally be the same for on-farm and off-farm
packing houses. For example, the preventive controls rule allows a
packing house, for produce covered by the produce rule, to comply with
the applicable requirements for packing and holding under the produce
rule rather than to comply with the Current Good Manufacturing Practice
(CGMP) requirements. In addition, although an off-farm packing facility
would be required to establish and implement a food safety plan and
establish preventive controls for food safety management components, we
expect that, in general, off-farm packing houses can look toward the
produce safety rule for guidance as to what to include. We expect that
an off-farm packing facility's food safety plan would focus on a few
key preventive controls with counterparts in the proposed produce
safety rule. For example, we expect that the food safety plan for an
off-farm packing facility would include preventive controls such as
maintaining and monitoring the temperature of water used during
packing. We also expect that an off-farm packing facility would
establish sanitation controls to address the cleanliness of food-
contact surfaces (including food-contact surfaces of utensils and
equipment) and the prevention of cross-contamination from insanitary
objects and from personnel to food, food packaging material, and other
food-contact surfaces. These preventive controls have counterparts in
the proposed produce safety rule.
animal feed
Question. In regard to the Rule for Preventive Controls for Animal
Feed, the FDA has indicated it did not intend to regulate farmers/
growers of animals. However, it appears that the Animal Feed rule will
cover a significant number of contract farming operations, even though
the owners of the animals have 100 percent control over feed
manufacturing.
How many feed mills and/or farm operations do you expect this rule
to cover?
Answer. The Preventive Controls for Animal Food (PCAF) rule applies
to all facilities that are required to register with FDA under section
415 of the FD&C Act because they manufacture, process, pack, or hold
animal food for consumption in the US. Farms are not required to
register and therefore are not covered by the PCAF rule. Whether a feed
mill is covered by the PCAF rule depends in part on whether it is
considered part of a farm. FDA's Food Facility Registration database
tracks the number of registered facilities. As of August 9, 2015, there
were 5,919 domestic animal food facilities registered and 9,804
domestic facilities that were registered as human and animal food
facilities. The 5,919 domestic animal food facilities are covered and
likely a portion of the facilities that are registered to produce both
human and animal food. The facilities that produce both human and
animal food may choose to follow human food current good manufacturing
practice and preventive control requirements throughout their facility
instead of following the requirements of the PCAF rule for their animal
food (as long as any hazards for the animal food are addressed). Within
the total of domestic registered facilities, there may be some
facilities that are subject to one or more exemptions from the PCAF
rule or are subject to modified requirements.
Question. Are you going to prioritize regulatory oversight on the
animal food rule, and does the agency plan provide guidance to clarify
this issue?
Answer. Full funding as requested in the fiscal year 2016
President's Budget is necessary for FDA to implement all of the FSMA
rules, including PCAF, in a holistic, risk-based way. FDA has been
developing implementation plans for the PCAF rule, and we are also
currently working on development of regulator training and guidance
documents. FDA is planning guidance documents to help industry comply
with the requirements of the PCAF rule. The first guidance will be for
implementation of the Current Good Manufacturing Practices provisions,
closely followed by a guidance document on human food by-products for
use as animal food. FDA will make available another guidance document
that will address the hazards associated with different foods and how
to apply the preventive controls requirements. There will also be a
Small Entity Compliance Guide that explains the actions a small or very
small business must take to comply with the rule.
import safety
Question. How many foreign manufacturing facilities are there and
what are the top countries that export to the United States?
Answer. There are approximately 118,104 registered foreign food
facilities. The following table provides the top ten countries that
export to the United States in order from most to least food import
lines. The top two countries are Mexico and Canada.
Question. What is the process to inspect/approve products from
these facilities? How does FDA interact with foreign governments, and
their inspection regimes?
Answer. The process of inspecting foreign food facilities begins
with the Center for Food Safety and Applied Nutrition (CFSAN), which
identifies foreign facilities for FDA inspection based on risk factors
including whether or not they produce high-risk commodities or employ
high-risk practices in the manufacturing process. Specific foreign
countries are not targeted for inspection unless there are specific
disasters, events, or country-wide practices associated with production
that may pose a unique risk. FDA foreign food facility inspections are
conducted by dedicated foreign food inspection cadre/investigators,
domestic food inspection investigator volunteers, and foreign office
investigators based overseas. The Office of Regulatory Affairs (ORA)
plans and conducts foreign inspections for U.S.-based investigators,
whereas inspections conducted by overseas-based investigators are
planned by the relevant FDA foreign office (FDA has investigators based
overseas within FDA's foreign offices in China, India, and Latin
America). Specific foreign inspections trips are planned based on firm
location, availability, reason for inspection, and commodity. After the
completion of a foreign inspection, FDA may take steps such as placing
a firm's product on Import Alert, based on observed and documented
violations. FDA regularly interacts with foreign governments and their
inspection/regulatory regimes. When FDA intends to conduct inspections
of facilities in foreign countries, CFSAN informs the foreign
government regulatory authorities and invites the foreign authorities
to observe the FDA inspections. ORA or an FDA foreign office provides
the foreign regulatory authority with information that includes the
timeframe of the inspections, the list of firms to be inspected, and
final itineraries if desired. Foreign regulatory authorities often
accept invitations to observe FDA inspections, which provide learning
experiences for the foreign authorities.
FDA's India Office and the Indian drug regulatory authority will
collect data pertaining to either regulatory agency's observations of
the other's inspections in the future. This data-gathering exercise
will facilitate data analyses for developing a better understanding of
current inspectional and regulatory practices of each regulatory agency
and developing strategies to better cooperate on matters of mutual
regulatory concern.
The Latin America Office has conducted foreign inspections and
environmental assessments accompanied by foreign counterparts. These
activities are conducted in an effort to leverage our combined
resources, ensure the application of standards, and increase regulatory
capacity. During accompanied inspections, the foreign regulatory
authority and FDA conduct concurrent inspections of an establishment.
During the inspections, there is constant communication and discussion
between the two authorities. We have seen certain foreign authorities
take regulatory action on the spot when conditions that pose a serious
risk to the health of consumers are encountered. Foreign regulatory
authorities have taken their own samples and have ordered the
destruction of potentially contaminated products. The same situation
occurs when a collaborative/joint environmental assessment in response
to a foodborne illness outbreak or a food contamination event is
performed. If FDA subject matter experts find a major violation,
foreign counterparts may be able to take immediate regulatory actions.
They may also conduct a follow-up inspection at the firm to ensure that
corrective actions were implemented.
The China, India and Latin America Offices have shared information,
as appropriate, with regulatory counterpart organizations in China,
India and Mexico after inspections in those countries. This has
resulted in actions by the regulatory counterpart organizations based
on violations observed by FDA.
In 2014, FDA signed the following arrangements with Chinese,
Indian, and Mexican regulatory authorities that affect FDA's
interactions with those authorities regarding food safety inspections:
--Two Implementing Arrangements with Chinese regulatory counterparts
that outline cooperation regarding inspections of food and drug
facilities in each other's countries. Since the signing of the
two Implementing Arrangements, cooperation and the exchange of
regulatory enforcement information have increased. The number
of FDA inspections that Chinese regulatory counterparts have
observed has also increased. Additionally, FDA received visas
for new inspectional staff whose visas had been previously
delayed.
--A Memorandum of Understanding (MOU) with Indian regulatory
authorities that will improve cooperative activities in the
area of food safety. The India Office also conducts quarterly
meetings with Export Inspection Council (EIC) to advance the
implementation of the MOU and share information for regulatory
and/or risk-based decisionmaking.
--A Statement of Intent with Mexican authorities to develop and
implement a Produce Safety Partnership that aims to achieve
mutual confidence in one another's produce safety systems.
Under the Statement of Intent, five working groups were
established. Two of these working groups have focused on
inspections: Exchange of Information and Training of Auditors/
Inspectors and Outbreak Response. These two working groups have
conducted thorough, in-depth discussions that have led to
enhanced interaction when FDA conducts inspections in Mexico.
FDA's China, India, and Latin America Offices have also engaged in
technical workshops with our foreign regulatory counterparts to
strengthen the regulatory understanding and capabilities of
inspectorates abroad.
--FDA's China Office has engaged with Chinese regulatory authorities
regarding data integrity and compliance in the area of Low-Acid
Canned Foods (LACF) by holding classroom training on FDA's
regulations and inspection training at a facility. A total of
30 Chinese inspectors attended, including one inspector from
each of the Chinese provinces that export LACF products to the
United States as well as 10 inspectors and several managers
from various Guangdong authorities' offices where the training
was held.
--FDA's India Office partners with Indian regulators to train them on
food- and drug-related issues and inspectional techniques, good
manufacturing practices, and the detection of data integrity
issues.
--The Latin America Office has facilitated participation by foreign
regulatory officials/inspectors in courses provided by FDA's
Office of Regulatory Affairs training component (ORA-U),
thereby helping enhance the knowledge, skills and capabilities
of foreign regulators, as well as helping them better
understand the U.S. food safety system.
--FDA's Europe Office does not include investigators among its staff,
yet it facilitates FDA inspections of facilities in Europe by
cultivating and maintaining relationships with regulatory
counterparts in Europe and working with U.S. governmental
agencies in-country with complementary missions, e.g., the U.
S. Department of Agriculture's Foreign Agricultural Service.
In addition, FDA's overseas offices contribute to FDA's
international inspections by analyzing reports/audits by foreign
regulatory counterparts to aid in facility selection.
Question. How do you propose to support and build upon these
efforts to open FDA offices in foreign countries? Could you provide
more detail on the types of activities these offices should be carrying
out, and what benchmarks we might use to measure the success of these
activities?
Answer. Since 2009, FDA has operated foreign posts strategically
located around the globe, including in China, India, Mexico, Belgium,
United Kingdom, Costa Rica and Chile. The India and China posts have
significant numbers of investigators in the foods/feeds and medical
areas. The goals of the foreign posts include:
--Building FDA knowledge around the foreign competent authority's
(CA's) capacity, the role industry(ies) plays in the country,
and the dynamics between these two.
--Strengthening FDA linkages with CAs and public and private
stakeholders for increased and more timely information and
collaborative approaches to tackling issues of concern to FDA.
--Increasing awareness of foreign governments, industry and others
about FDA regulatory requirements, as well as new legislation
such as the FDA Food Safety Modernization Act and the Food and
Drug Administration Safety and Innovation Act.
--Conducting FDA inspections and investigations in country, including
for-cause and surveillance inspections. FDA encourages CAs to
observe our foreign inspections, which provide learning
opportunities for foreign regulators.
Measuring impact is a complex process(es). The Office of
International Programs is developing metrics to benchmark and better
measure success of these types of activities performed at FDA foreign
posts. These could include the number of FDA inspections conducted in
the country or region, but optimally would measure the impact of FDA
inspections, workshops and other collaborative activities on the rate
of violative products from the country or region and capacity of
foreign regulators conducting inspectional work.
Question. What, specifically, are obstacles these offices face in
monitoring foreign food production and foreign food safety systems?
Answer. The food safety systems in some countries are complex and
involve multiple regulatory authorities at the central and regional/
state/local levels. Responsibility for regulatory oversight may not be
well-defined or able to be measured. Implementation of food safety
standards and enforcement activities may vary significantly by region.
Thus it can be challenging to monitor and, more importantly, understand
the regulatory systems, regulatory capacity and national policy
dynamics.
Language and cultural contexts are also challenges in building FDA
knowledge around foreign food production and food safety systems,
particularly given the difficulty of translating often nuanced policies
written in a foreign language.
Question. What types of authorities and resources will those
offices need in order to be effective?
Answer. FDA is currently evaluating if additional authorities and/
or resources will be needed in fiscal year 2017.
______
Questions Submitted by Senator Jeff Merkley
Question. How has FDA worked with NIFA at USDA on outreach and
training for FSMA? Do you expect that small local organizations will be
able to compete for FSMA training dollars, both at USDA and FDA?
Answer. FDA and USDA's National Institute of Food and Agriculture
(NIFA) have joined in a collaborative partnership to administer and
manage the National Food Safety Training, Education, Extension,
Outreach, and Technical Assistance Program using competitive grants,
with the goal of providing training and technical assistance to owners
and operators of small and medium-sized farms, beginning farmers,
socially-disadvantaged farmers, small processors, and/or small fresh
fruit and vegetable merchant wholesalers, as mandated in Section 209 of
FSMA. Community-based organizations (CBOs) are among the eligible
entities to receive grant funding, and the requests for applications
have specified that this program will provide significant opportunities
for funding through subcontracts and for partnerships with eligible
stakeholder groups who work directly with the target audiences.
The joint program will first award competitive grant funds that
enable an awardee to establish a National Coordination Center (NCC) for
Food Safety Training, Education, Extension, Outreach, and Technical
Assistance and then award grants for the establishment of four Regional
Centers (RCs) across the country. The RCs will work with local
communities to ensure that the training teams include representatives
from non-governmental organizations, CBOs, cooperative extension
services, food hubs, local farm cooperatives, and other entities that
can address the specific needs of the communities they serve.
FDA issued a request for grant applications for the establishment
of the NCC on December 31, 2014, which closed on March 16, 2015.\1\ FDA
has awarded the International Food Protection Training Institute a
grant of up to $600,000 over 3 years to establish the NCC.
---------------------------------------------------------------------------
\1\ http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-15-003.html
---------------------------------------------------------------------------
NIFA published a request for grant applications for the
establishment of two of the Regional Centers--one in the Southern
Region and one in the Western Region--on May 18, 2015, which closed on
June 29, 2015.\2\ NIFA has awarded more than $2 million in grants to
establish these RCs. The University of Florida in Gainesville will
establish the Southern Regional Center, with Oregon State University in
Corvallis charged with establishing the Western Regional Center.
---------------------------------------------------------------------------
\2\ http://nifa.usda.gov/sites/default/files/rfa/
FY%2015%20FSMA%20RFA_to%20post.pdf
---------------------------------------------------------------------------
Additionally, on August 27, 2015, FDA published a request for grant
applications for the establishment of the other two Regional Centers,
one in the Northeast Region and one in the North Central Region.\3\
This request is open through November 2, 2015, and eligible applicants
can be found at the link provided.
---------------------------------------------------------------------------
\3\ http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-16-005.html
---------------------------------------------------------------------------
Question. In your statement, you say that FDA plans to fund
additional training programs through cooperative agreements. Please
provide more detailed information.
Answer. FDA-funded cooperative agreements encompass a range of
actions to support implementation of the FSMA rules.
--The agency has entered into a five-year cooperative agreement with
the National Association of State Departments of Agriculture
(NASDA) that brings together a range of state partners to
collaboratively plan implementation of the forthcoming Produce
Safety rule.
--Experts from FDA and NASDA are working together to develop a
set of best practices for implementation of the produce rule. A
coalition of states with strong interest in leading this
implementation effort is actively participating in the
development of these practices.
--NASDA will help facilitate industry training and will also play
a role in the delivery of training to state regulators.
--To accommodate alternate approaches to FSMA readiness, the FDA
plans to fund development of specific training programs through
cooperative agreements. The agency's goal is to work with
groups that understand the special needs of and have direct
access to businesses that face unique circumstances and
challenges in implementing FSMA. These training programs would
include providing an awareness of the underlying reasons for
the new standards and would ensure that training addresses the
unique needs of the target audiences.
Specifically, cooperative agreements are planned to support
curricula development and dissemination among two such communities:
local food producers, including those engaged in direct marketing, and
tribes.
--The agency plans to allocate fiscal year 2016 funds for the
development of training curricula and delivery, in addition to
education and outreach, with a focus on small and mid-size
businesses involved in local food production, including those
that engage in sustainable and organic farming. Eligible
entities will include community-based organizations and other
grassroots organizations that work directly with the intended
audience.
--The FDA anticipates funding a similar cooperative agreement for
the development of training curricula and dissemination in
tribal communities. Tribal governments and community-based and/
or non-governmental organizations will be among those eligible
to receive the funding.
--The FDA will be involved in facilitating communications between
the Alliances and the participants in the new cooperative
agreements to maximize use of materials that are already
developed, when appropriate.
Question. FDA officials have stated that if FDA doesn't get its
full budget request, all of the increase provided will go toward the
two rules just published, and produce safety will have to wait. Why
shelve one very important item completely instead of taking a more pro-
rata approach?
Answer. The fiscal year 2016 President's Budget requested for each
of its six proposed FSMA funding categories is the minimum amount FDA
needs to effectively make progress on the critical implementation tasks
in each category. All of the funding categories are vital to achieving
FSMA's goals of a modern, preventive food safety system that protects
consumers, strengthens public confidence, and reduces cost to industry
from food safety problems. A significant shortfall of funding in these
categories will unavoidably disrupt and delay FDA's plans for
implementation of FSMA.
The urgency of receiving full funding in fiscal year 2016 is that
it is the year that both preventive controls regulations are scheduled
to become effective and, thus, the last year to make investments that
are crucial to orderly, effective, and timely implementation. In FDA's
own estimate of funding need, enactment of the President's request for
a budget authority increase of $109.5 million, for a total of $1.3
billion in Budget Authority, and total Program Level of $1.5 billion
when accounting for all requested resources, would make it possible for
FDA to move forward in 2016 toward successful implementation of FSMA.
If FDA were to receive less than full funding requested in the
President's Budget for FSMA implementation in fiscal year 2016, FDA
would focused on the highest priority activities. FDA's prioritization
of activities aligns with the President's Budget policies related to
FSMA. These priorities were decided with the full knowledge of the
compliance implementation dates for the FSMA regulations identified.
FDA would prioritize its focus on the FDA and state inspection
modernization, training and industry assistance investments needed to
implement preventive controls in all food facilities effectively and
efficiently.
FDA will make the best possible use of any available resources, but
failing to make the proposed investments in any of these priority areas
will force decisions to delay implementation of key elements of the new
food safety system.
Question. Will your revised proposal for irrigation standards for
fresh cured onions remain when the final rule is published?
Answer. As mentioned in the originally proposed produce safety rule
(2013), we proposed to adopt an approach focusing on the likelihood of
contamination of produce posed by the agricultural practices applied to
the crop. We conducted a qualitative assessment of risk (QAR) of
hazards related to produce production and harvesting. The draft QAR
indicated that all produce commodities are potentially subject to
similar microbiological hazard pathways: commodities can potentially
become contaminated from, for example, direct exposure to contaminated
water or soil amendments. Use of poor agricultural practices could lead
to contamination and illness, even where the potential for
contamination is otherwise relatively low. Therefore, we proposed to
adopt a regulatory approach for minimizing the risks associated with
those hazards and, as appropriate, provided flexibility for the use of
alternative measures that would provide the same level of public health
protection as the proposed standard.
We received many initial comments and questions on this approach
and on the topic of agricultural water, some of which were submitted by
the onion industry. We are considering these comments as we continue to
develop our thinking surrounding food safety on the farm. With regard
to your question on the proposal for irrigation standards and onions,
we also heard many concerns regarding the treatment of onions under the
rule during our listening sessions and meetings with growers. The
proposed rule provides a staggered compliance approach which allows an
additional two-year compliance period for farms to comply with certain
agricultural water standards.
We have also evaluated the comments received to the docket for the
Supplemental Notice and are carefully considering them in developing
final requirements. Our goal is to determine an approach to
agricultural water standards that will provide flexibility to allow the
standards to be applicable to diverse irrigation and growing
conditions, while still protecting public health.
Question. For irrigation water testing, the growers in my state
were hopeful that FDA or USDA could look into ways to identify local,
federally-approved, resources that could test irrigation waters
strategically for an entire system, instead of requiring individual
owners to test the waters of every ditch and pipe. Are you considering
ideas such as this?
Answer. As outlined in our Supplemental Notice, we proposed to
allow data sharing among farms if the farms are taking samples from the
same water source and no there is no reasonably identifiable source of
likely microbiological contamination between sampling sites and the
points at which the farms draw their water. In fact, we encourage such
sharing when appropriate. We included a proposed provision
(Sec. 112.45(e)) that would explicitly allow data sharing under certain
circumstances.
Under proposed provision Sec. 112.45(e), we are proposing that a
farm may meet the requirements related to agricultural water testing
using the farm's own test results or data collected by a third party or
parties, provided the water source(s) sampled by the third party or
parties adequately represent the farm's agricultural water source(s)
and all other applicable requirements of part 112 are met. This
provision would provide flexibility for a farm to determine the
appropriate means by which to meet the proposed testing requirements in
proposed Sec. ?1A112.45.
Under the supplemental proposed rule, farms using data collected by
a third party or parties would still need to satisfy all applicable
requirements of the proposed rule related to agricultural water
testing. For example, the proposed rule includes requirements related
to the timing of collection of samples, the number of samples
collected, and specified analytical method to be used for testing, and
recordkeeping.
We are currently evaluating the comments received on the topic and
are carefully considering them in our efforts to determine an approach
to agricultural water standards that will provide flexibility to allow
the standards to be applicable to diverse irrigation and growing
conditions, while still protecting public health.
______
Questions Submitted by Senator Patrick Leahy
First, I want to thank the Department and Deputy Commissioner for
Foods and Veterinary Medicine Michael Taylor for continuing to engage
with the state of Vermont and our farmers and specialty producers. I
hope that the Deputy Commissioner's many visits to the state have
helped you to develop the best program possible for the industry,
farmers, and consumers.
But states and farmers are nervous, and rightfully so. There are
serious price tags attached to these food safety rules, not only for
the Federal Government, but also for the states, and for our farmers of
all sizes who do not have the infrastructure in place to meet these new
rules. I think we need to acknowledge that we cannot implement these
rules without adequate funding. The FDA cannot implement FSMA on its
own without involvement from the states, and we cannot ask our states
to take on this burden on their own. Finally, we cannot expect farmers
to make such monumental changes on their farms without technical and
financial support.
state budget concerns
Question. Vermont is one of 25 states that do not have any
authority or capacity, or framework for that matter, to regulate the
produce industry. With no guarantee that there will be Federal funds to
support them in this work, I hope you can understand the reluctance
these states have to develop a new produce program ahead of that
promise of support and any funding.
What assurances can you give to this Committee and states like
Vermont that the FDA will prioritize this food safety work in your
fiscal year 2017 budget request?
Answer. The continued implementation of FSMA remains a key priority
for FDA and fiscal year 2017 will be an important year for FSMA
implementation. In particular, FDA plans are currently focused on areas
such as implementation of the Produce Safety rule and continuing to
enhance our import safety systems.
FDA is currently working with the Administration to determine the
appropriation level of food safety funding to include in the fiscal
year 2017 President's Budget. We are looking forward to discussing our
future budget needs in more detail when that determination is complete.
Question. What will you be able to do if we continue to face lean
Federal budget years and we are not able to fully fund this work
through the appropriations process?
Answer. In FDA's own estimate of funding need, enactment of the
President's budget authority request for food safety of $1.3 billion,
an increase of $109.5 million above fiscal year 2015 would make it
possible for FDA to move forward in fiscal year 2016 toward successful
implementation of FSMA. At this time, FDA would focus its efforts on
the Preventive Controls rules which were finalized in September. We
must continue our education and outreach efforts to ensure that
industry is prepared to comply with these finalized rules. Beyond
fiscal year 2016, without the additional funding requested in the
President's Budget, FDA would need to reexamine FSMA implementation
efforts.
The success of building a modernized food safety system depends on
FDA and industry working together, as well as working with State and
other regulatory and public health partners, after the final FSMA rules
are issued. Full funding of the President's budget authority request is
essential to maintaining momentum toward timely and comprehensive
implementation of FSMA and avoiding the disruption and loss of
effectiveness that would result if FDA, the states and the industry are
not adequately prepared to get implementation right. Without adequate
funding to support this strategy, FDA will be unable to perform its job
under FSMA, and the American people will not see the full public health
benefits of the law.
FDA is firmly committed to implementing FSMA the right way from the
start. This means investing in the food safety culture change that is
happening within FDA, but it also means being faithful to the
comprehensive, holistic vision of food safety modernization laid out in
FSMA. Congress directed FDA to build a modern food safety system,
addressing food safety challenges across the spectrum of farms,
manufacturers, and transporters of food, both domestic and foreign. The
pieces of this system are closely interconnected and FDA cannot
credibly hold domestic producers to the new standards if we are not
doing the same for importers and their foreign suppliers. Nor can FDA
do the reverse, holding importers and foreign suppliers, but not
domestic producers, to new requirements. FDA believes that if we do not
implement the new FSMA-mandated food safety system in the comprehensive
way Congress envisioned, from the start, we will fail to achieve the
FSMA goals of food safety, strengthened consumer confidence, and a
level playing field for U.S. producers.
Question. Are there ways to ease into the regulatory work the
states will need to do until the FDA can provide them with the
necessary amount of support?
Answer. The states will play a key role in gaining and maintaining
compliance with the produce safety rule in the farming community, if
funding permits. FDA is committed to working with our state partners to
make this a reality. FDA is aware that there may be a variety of ways
that states plan to assist and engage in facilitating and overseeing
industry compliance with the produce regulation. These activities span
from outreach and education to inspections on behalf of FDA or
enforcement of comparable state requirements. FDA is also aware that
the timeframe for states to engage in produce safety regulatory
activities may vary widely. FDA is working with state representatives
to develop implementation plans that provide for different
collaboration models consistent with individual state's level of
engagement in the produce safety regulatory paradigm. FDA is also
exploring different mechanisms to oversee industry compliance in the
event the state chooses to focus its activities solely on outreach and
education or when additional time is needed by the state to establish
an inspection program or to establish and enforce comparable state
requirements.
support for farmers
Question. In Vermont, where we are historically a dairy state,
there are a lot of new diversified produce farms that are working on
older dairy farms. That means they may not have metal processing
equipment, or equipment they can sanitize, and there are exposed beams.
Production agriculture most often takes place side-by-side with value
added processing. For these farms, some of your rules will be a real
challenge to meet as they look to modernize their operations. In a
small state like Vermont, these requirements may cost upwards of
hundreds of millions of dollars, funds these farmers simply don't have.
I am struck that we do not have a ``NRCS-like'' agency at USDA or FDA
to help the farmers to address food safety issues that are highlighted
by these new rules. Running these farms out of business because of
these costs cannot be the answer.
What partnerships can you develop with the U.S. Department of
Agriculture (USDA) to help farmers make these infrastructure
improvements?
Answer. FDA has been working with USDA for several years on all
aspects of our produce safety regulatory program. For those small
farmers that may need to add new food safety practices to their
operations, FDA, in collaboration with USDA and other stakeholders,
plans to offer guidance and other support to help them achieve
compliance. More specifically, USDA staff worked with FDA to develop
and review provisions of the produce safety regulation, and USDA staff
are working with FDA and our state partners to develop post final rule
implementation strategies and best practices that will enable state
organizations to use their resources effectively. As mentioned above,
FDA and USDA-NIFA are also co-funding one national and four regional
coordinating centers for food safety training, which will focus on
providing needed education and technical assistance to small and
medium-sized farmers. FDA and USDA also jointly fund the Produce Safety
Alliance, which is tasked with creating standardized curriculum
covering FSMA requirements and good agricultural practices. The
curriculum will include materials on understanding and performing a
risk assessment for individual farms to consider in determining if
infrastructure improvements may be needed. In addition, USDA
administers a variety of grant, loan and other financial assistance
programs for which farmers may be eligible to apply.
Question. What new programs or authorities are needed to help our
farms to modernize to comply with these new rules?
Answer. FDA is working at many levels to support programs aimed at
assisting very small and small farmers to understand and comply with
the produce safety rule. More specifically, FDA and USDA are funding
educational opportunities to provide food safety training to produce
farmers, such as training developed through the Produce Safety
Alliance, so that they understand the basis of the requirements of the
produce safety regulation and how to comply with the requirements. In
addition, FDA has established a Technical Assistance Network to serve
as a resource to respond consistently to questions from farmers and
other stakeholders about interpretation and implementation of the
produce safety regulation.\1\ FDA is also working closely with our
state partners to develop education and outreach programs that will
provide important educational resources and tools to help farmers
comply with the requirements.
---------------------------------------------------------------------------
\1\ For more information, see http://www.fda.gov/Food/
GuidanceRegulation/FSMA/ucm459719.htm.
---------------------------------------------------------------------------
Question. What should we tell a farmer in Vermont who cannot afford
to make these improvements without Federal support?
Answer. It is FDA's intention to target our education efforts to
the smaller businesses that may not be as familiar with our
requirements, as well as some of the larger farms, so that they
understand the regulations and have training and tools to comply with
them.
Based on our outreach efforts and public comments, we proposed in
September 2014 revisions to several key requirements of the original
proposed rule on produce safety to be more flexible and less burdensome
in key areas. For instance, we proposed a tiered and more targeted
approach to water testing and revisions to the microbial standard for
agricultural water used during growing produce (other than sprouts)
that will be more flexible and less burdensome on farmers while still
protective of public health. We removed the nine-month proposed
minimum-time interval between the application of untreated biological
soil amendments and harvesting until the agency collects and reviews
further scientific evidence. We modified the definition of ``farm'' to
help reduce the burden on a farm that packs or holds produce grown on
another farm such that it would be subject to the produce safety rule
and not also the preventive controls rule. The proposed rule also
reduces the burden on small entities in part through the use of certain
exemptions and limitations, and provides all farms flexibility for
alternative practices to be used for certain requirements with adequate
scientific support. In addition, States (including the state of
Vermont, for example) could also submit a request for a variance for
one or more requirements of the proposed rule. Finally, we proposed to
provide farms that meet the definition of small and very small
businesses an additional two and 3 years to comply with most provisions
of the rule.
We recognize that it will take time and a concerted, community-wide
effort for the wide range of farms to come into full compliance with
the new requirements. FDA is committed to working with the produce
community and with partners in the USDA, state and local agencies, and
foreign governments to facilitate compliance through education,
technical assistance and guidance.
At the Federal level, USDA has opportunities designed to assist
farmers with developing and growing their businesses. These
opportunities come in several forms--including education; outreach; and
grant, loan and other financial assistance programs--all of which are
designed to provide farmers with resources to meet their individual
needs. Further, FDA established the Technical Assistance Network that
we intend to link to external Technical Assistance Networks; these
networks will collectively serve as a resource for anyone subject to
the regulations who needs assistance with rule interpretation and
specific technical or scientific questions. We are counting on USDA's
Cooperative Extension personnel, among others, to play a key role in
the external Technical Assistance Networks to help provide assistance
to the industry.
(Additional information to USDA's various grant programs is
available at: http://
www.ams.usda.gov/AMSv1.0/
ams.fetchTemplateData.do?template=TemplateA&
navID=AMSGrants&leftNav=AMSGrants&page=AMSGrants&acct=AMSPW;
http://www.grants.gov/search-
grants.html?agencies%3DUSDA%7CDepartment
%20of%20Agriculture).
Again, FDA's ability to achieve our goal of successfully supporting
farmers in compliance efforts is dependent on adequate funding.
The FDA is working with the USDA to establish one national and four
regional food safety training centers. I am concerned that limiting
delivery of food safety training nationwide to just these 5 centers may
not effectively reach the grass-roots level and the targeted, intended
beneficiaries.
Question. Will the FDA also provide funding for on-the-ground food
safety training to be delivered by university extension programs, non-
governmental organizations, and associations representing farms and
small food processors/wholesalers?
Answer. The Agency recently released a FSMA training strategy \2\,
which outlines training options and delivery formats as well as
introduces the partners in government, industry, and academia who are
working with FDA on the development and delivery of training to the
global community of food suppliers.
---------------------------------------------------------------------------
\2\ http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm461513.htm
---------------------------------------------------------------------------
Industry training will be an important component of successful
implementation of FSMA. The needs of small- and mid-sized farms and
facilities are at the center of FSMA training development and will be
met through multiple efforts:
--FDA has funded the creation of public-private Alliances (e.g., the
Produce Safety Alliance, Food Safety Preventive Controls
Alliance, and Sprout Safety Alliance) as a resource for
industry and to facilitate widespread understand of the new
requirements to support compliance.
--FDA is partnering with USDA's National Institute of Food and
Agriculture (NIFA) to provide grants for food safety training,
education, extension, outreach, and technical assistance to
owners and operators of farms, small food processors, and small
fruit and vegetable merchant wholesalers. Community-based
organizations (CBOs), non-governmental organizations.
Cooperative extension programs are among the eligible entities
to receive grant funding, and the requests for applications
have specified that this program will provide significant
opportunities for funding through subcontracts and for
partnerships with eligible stakeholder groups who work directly
with the target audiences
--Recognizing the great diversity among members of the food industry,
FDA will be funding cooperative agreements that will develop
training options for local food production systems and tribal
operations.
--The agency is partnering with the National Association of State
Departments of Agriculture (NASDA) to collaboratively plan
implementation of the produce safety rule. NASDA will help
facilitate industry training while also having a role in the
delivery of training to state regulators.
It will take time and adequate resources to make these efforts
work. FDA is committed to making sure that everyone in the food supply
chain knows what training and education resources are available, and
how to gain access to them.
risk assessments for soft-ripening and raw milk cheese
Question. I have heard from many Vermont cheese producers who are
concerned about regulations the FDA may develop that will impact the
production of soft-ripening or raw milk cheese. These concerns were
highlighted in comments submitted to the FDA by Allison Hopper, CEO of
Vermont Butter & Cheese Creamery, who is a producer of soft-ripened
cheese, and a member and past president of the American Cheese Society,
and Catherine Donnelly, PhD, a University of Vermont professor and
expert on the microbiological safety of food who has developed an
extensive knowledge concerning sources of and mitigation strategies for
control of Listeria in cheese making facilities. I will also include
these comments in this hearing record.
I hope these comments will help inform the Quantitative Risk
Assessment the FDA is developing. Specifically, I would like to
highlight a point that I hope the FDA will take to heart. Your risk
assessments on soft-aged cheeses and raw milk cheeses include data
relating to illegal, unlicensed producers. These producers are
operating outside of the law, and will likely do so regardless of any
regulatory changes. However, as Deputy Commissioner Taylor has seen
first-hand, our small artisanal cheese makers in Vermont undertake
extensive quality and safety programs to ensure their cheeses are safe.
I fear that any regulatory change could have severe impacts on these
Vermont cheese makers, even though they currently meet or exceed
current regulations. These risk assessments are no doubt limited by a
lack of information, but they could also be prejudiced by these cases
of illegal or un-licensed producers.
What assurances can you give me, and to Vermont cheesemakers, that
you will work to remove any data pertaining to these illegal or un-
licensed producers from the final risk assessment so they do no create
an unfounded bias against the careful work and processes done by our
legal cheese producers?
Answer. FDA recognizes the broad diversity in cheese manufacturing
operations and approaches and has been working with the American Cheese
Society in particular to learn more about artisanal cheeses and
measures that cheesemakers take to ensure their products are safe. In
conjunction with the July 2015 release of the joint FDA/Health Canada
risk assessment on Listeria monocytogenes in soft-ripened cheeses, we
announced a request for comments that would assist our efforts to
identify and evaluate measures that might minimize the impact of
harmful bacteria in cheeses made from unpasteurized milk. The Agency is
committed to working and sharing an open dialogue with the artisanal
cheesemaking community as we work on these efforts.
The joint FDA/Health Canada risk assessment published in July 2015
was first released as a draft risk assessment in 2012, and public
comments were solicited. The public comments were considered and
incorporated in the final assessment, as appropriate. In conducting the
risk assessment, FDA followed best practices established by national
and international institutions, which include taking steps to reduce
any possible bias that could be introduced by the data used, conducting
a peer-review process, and providing an opportunity for public comment.
Question. I and others have worked hard to support and cultivate
the artisanal cheese industry here in the United States. How are you
working to harmonize our cheese regulations with the European Union so
that we do not create trade barriers or risk American jobs?
Answer. FDA is not currently undertaking efforts to harmonize its
cheese regulations with those of the European Union. As far as FDA
knows, not harmonizing our cheese regulations with those of the
European Union is not having a detrimental impact. That being said, FDA
welcomes feedback on this issue and is committed to working and sharing
an open dialogue with the artisanal cheesemaking community. The Agency
remains dedicated to ensuring a safe and wholesome food supply using
the latest science to protect human health, and promoting dialogue with
industry, consumers and other interested parties.
SUBCOMMITTEE RECESS
Senator Moran. Again, thank you for your testimony. Thank
you for the way that you have answered questions today and have
presented testimony. And please express my gratitude to the
folks at FDA for the outreach that has occurred in the
development of these orders of control.
With that, the subcommittee stands adjourned.
[Whereupon, at 3:26 p.m., Wednesday, September 16, the
subcommittee was recessed, to reconvene subject to the call of
the Chair.]