[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.
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    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.
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    \2\ http://nifa.usda.gov/sites/default/files/rfa/
FY%2015%20FSMA%20RFA_to%20post.pdf
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    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.
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    \3\ http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-16-005.html
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    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.]