1. FDA’s Growing Regulatory Presence on the Farm

2. FSMA, Preventive Controls and FDA Enforcement

3. The U.S. Food and Drug Administration

4. What Is the FDA? 1906 $4.5 billion 95$2 trillion14,000

5. CDERCBERCDRHCFSANCVMCTP Agency Structure and Authority

6. “FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” “[USDA] provide[s] leadership on food, agriculture, natural resources, rural development, nutrition, and related issues based on sound public policy, the best available science, and efficient management.” What the FDA Is Not: USDA

7. The Food Safety Modernization Act

8. Change is coming. It’s not going to be overnight. We’ve got time to implement this in a thoughtful way. But we know change is coming … Origins of FSMA

9. Response Inspection and Compliance Imports Prevention Mandatory preventive controls for food facilities Mandatory produce safety standards Authority to prevent intentional contamination Mandated inspection frequency Records access Testing by accredited laboratories Mandatory recall Expanded administrative detention Suspension of registration Enhanced product tracing abilities Additional recordkeeping for high risk foods Importer accountability Third Party Certification Certification for high risk foods Voluntary qualified importer program Authority to deny entry Overview of FSMA’s Requirements

10. The Final Rule on Preventive Controls for Human Food

11. Registered Food Facilities Any “facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States” must register with FDA. A “facility” is any “factory warehouse, or establishment … that manufacturers, processes, packs, or holds food.” Who Is Covered by the Final Rule? Not included in the definition of facility: restaurants and other retail food establishments, nonprofit food establishments, fishing vessels, and farms.

12. An operation under one management in one general, but not necessarily contiguous, location devoted to the growing of crops, the harvesting of crops, the raising of animals (including seafood), or any combination of these activities. It can pack or hold raw agricultural commodities such as fresh produce and may conduct certain manufacturing/processing activities, such as dehydrating grapes to produce raisins and packaging and labeling raisins. Primary Production Farm An operation not located on the Primary Production Farm that is devoted to harvesting, packing and/or holding raw agricultural commodities. It must be majority owned by the Primary Production Farm that supplies the majority of the raw agricultural commodities harvested, packed, or held by the Secondary Activities Farm. FDA provided this definition, in part, so that farmers involved in certain formerly off-farm packing now fit under the definition of “farm,” as the packing is still part of the farming operation. In addition to off-farm produce packing operations, another example of a Secondary Activities Farm could be an operation in which nuts are hulled and dehydrated by an operation not located at the orchard before going to a processing plant. If the farmer that owns the orchards and supplies the majority of the nuts is a majority owner of the hulling/dehydrating facility, that operation is a Secondary Activities Farm. Secondary Activities Farm What Is a Farm?

13. FSMA and FDA Enforcement

14. AdulterationMisbranding Failure to Register Failure to Keep Records Prohibited Acts Under the Federal Food, Drug, and Cosmetics Act

15. Injunction Seizure Recall Administrative Detention Warning Letter Regulatory Meeting Form 483 FDA’s Civil Enforcement Toolbox

16. “[P]revention – prevention of food safety problems, prevention of food-borne illness – is the fundamental goal of [FSMA] and of FDA’s implementation of it.” The FSMA Game-Changer: Proactive Versus Reactive Enforcement Food Safety Plan Hazard Analysis Preventive Controls Monitoring Corrective Actions Verification

17. Strict Liability Park Doctrine Adulteration Prospects for Criminal Indictments

18. Looking Ahead: What’s Next for FSMA?

19. What’s Finished? Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals What’s Still to Come? Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Sanitary Transportation of Human and Animal Food Focused Mitigation Strategies to Protect Food Against Intentional Adulteration User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications Food Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Moving Toward Full Implementation

20. The Veterinary Feed Directive Regulation

21. “According to the Centers for Disease Control and Prevention (CDC), in the United States alone, at least 2 million people become infected annually with bacteria that are resistant to antibiotics. … … And at least 23,000 people die each year as a result of these infections. … … The non-therapeutic use of antimicrobial drugs in animals that enter the food supply contributes to this problem.” Background to the New Rule Animal Drug Availability Act (1996) Rule on Veterinary Feeds Directive Drugs (2000) Guidance #209 – Judicious Use Strategy (2012) Guidance #213 – Implementation Recommendations (2013) Revised Rule on VFD Drugs (2015)

22. “The actions the FDA has taken to date represent important steps toward a fundamental change in how antimicrobials can be legally used in food-producing animals. … Judicious Use Strategy: Limit medically important antimicrobial drugs to therapeutic purposes (i.e., those uses considered necessary for ensuring animal health); Require veterinary oversight or consultation for such therapeutic uses in food-producing animals. … The VFD final rule takes another important step by facilitating veterinary oversight in a way that allows for the flexibility needed to accommodate the diversity of circumstances that veterinarians encounter, while ensuring such oversight is conducted in accordance with nationally consistent principles.” --Michael Taylor, June 2, 2015 Medically Important: antimicrobial drugs that are considered important for therapeutic use in humans Core Principles

23. A written statement issued by a licensed veterinarian in the course of the veterinarian’s professional practice that orders the use of a VFD drug in or on an animal feed. Veterinary Feed Directive (VFD) An FDA-approved new animal drug for use in or on animal feed. VFD Drug A veterinarian has assumed the responsibility for making medical judgments regarding the health of animals and the need for medical treatment, and the client has agreed to follow the instructions of the veterinarian; The veterinarian has sufficient knowledge of the animals to initiate at least a general or preliminary diagnosis of any medical conditions; and The veterinarian is readily available for follow-up in case of adverse reactions or failure of the regimen of therapy. Such a relationship can exist only when the veterinarian has recently seen and is personally acquainted with the keeping and care of the animals by virtue of examination of the animals, and/or by medically appropriate and timely visits to the premises where the animals are kept. Veterinarian-Client-Patient Relationship Key Terms

24. Questions?