US REGULATORY UPDATE: IMPACT OF FSMA & VFD ON THE AQUACULTURE INDUSTRY CHARLOTTE E. CONWAY, MS, PAS DEPUTY DIRECTOR DIVISION OF ANIMAL FEEDS U.S. FOOD AND DRUG ADMINISTRATION 36th Fish Feed & Nutrition Workshop September 12, 2017

OVERVIEW Food Safety Modernization Act Veterinary Feed Directive

FSMA OVERVIEW

FSMA REGULATIONS (2015-16)

PREVENTIVE CONTROLS FOR ANIMAL FOOD - STATUS Guidance documents Technical assistance Training FSPCA for industry and regulators Regulator training (FDA and state regulators) Inspection of “Large” businesses

PCAF - COMPLIANCE DATES

PCAF - GUIDANCE DOCUMENTS

PCAF - TECHNICAL ASSISTANCE Established an FDA FSMA Technical Assistance Network (TAN) to provide central, consistent sources of outreach and technical assistance for industry & regulators Part 1: FSMA Rule Interpretation Questions Part 2: Food Safety Regulatory Community Leverage existing internal infrastructure, business processes and IT systems (Knowledge Management System - KMS)

PCAF - TRAINING Food Safety Preventive Controls Alliance (FSPCA) Training Training to assist companies in complying with PCAF Standardized curriculum recognized by FDA as one way to meet the requirements for a “preventive controls qualified individual (PCQI)” Regulator Training For FDA and state officials Required for inspectors prior to conducting PCAF related inspections

PCAF - INSPECTIONS Only inspections in FY18 will be for compliance with CGMPs for “large” and “small” businesses There will be no routine inspections for “large” business compliance with Preventive Controls CGMP inspections expected to start October 2017 We will NOT inspect all “large” and “small” businesses in first year

PCAF - INSPECTIONS Common questions about 1st compliance dates: Does the focus on education mean that companies won’t be held to these standards yet? What is best thing a facility can do to prepare Where can companies go wrong in preparation? What is the ultimate goal? http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm521171.htm

FSVP RULE Foreign Supplier Verification Program Rule Who is covered: 21 CFR part 1, subpart L Who is covered: “Importer” is U.S. owner or consignee of a food at time of U.S. entry. If no U.S. owner or consignee at entry, importer is U.S. agent or representative of the foreign owner or consignee, as confirmed in signed statement of consent. There are some exemptions and modified requirements for certain types of food or certain importers

FSVP – Key Principles Requires importers to share responsibility for ensuring safety of imported food Risk-based (according to types of hazards, importers, and suppliers) Flexibility in meeting requirements (assessing activities conducted by others) Alignment with PC supply-chain provisions

FSVP – General Requirements Use qualified individual to perform FSVP activities Hazard analysis Evaluate food and foreign suppliers Conduct foreign supplier verification activities Corrective action Maintenance of records

FSVP – Compliance dates Importers will be required to comply with FSVP no earlier than 18 months after issuance of the final rule (i.e. May 2017) If foreign supplier is subject to either of the preventive controls regulations or produce safety regulation, importer must comply with FSVP 6 months after supplier must meet the relevant regulation(s).

FSVP – What’s Next? Developing FSVP draft guidance for industry Food Safety Preventive Controls Alliance will develop course materials for FSVP Developing the “FDA Data Dashboard” to assist importers In interim, FDA has posted link for “supplier evaluation resources” to aid importers and facilities with supplier evaluation: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm516330.htm

FSVP – Inspections Routine FSVP inspections for animal food importers will not start until Fall 2018. Inspections will largely be paper-based and focused on a review of an importers FSVP records FDA may request these records be sent to FDA for review in FDA offices as opposed to onsite at the importers business (21 CFR 1.510(a)(3))

Other FSMA Programs of Interest

Voluntary Qualified Importer Program (VQIP) Voluntary program to provide for the expedited review of food imported by program participants Fee based program Participation is limited to importers who meet all eligibility criteria, including offering food from a facility certified under FDA’s accredited third party program Plans to accept applications for FY19 participants on January 1, 2018

Accredited Third Party Certification Voluntary program for accreditation of 3rd-party certification bodies (a.k.a. auditors) to conduct food safety audits and issue certifications of foreign food facilities Two purposes for certifications: Used by importers to establish eligibility to participate in VQIP FDA requires an imported food is accompanied by a certification because of a food safety concern Supporting documents: Model accreditation standards guidance Final rule on user fee to support 3rd party program

MEDICALLY IMPORTANT ANTIMICROBIALS IN ANIMAL AGRICULTURE AFTER JANUARY 1, 2017

VOLUNTARY CHANGES TO AFFECTED PRODUCTS Guidance for Industry #209, #213, VFD Rule Changes to Oral Dosage Form & Medicated Feed Products Two key principles outlined in Guidance #209: Limit use of medically important antimicrobial drugs in food-producing animal to those uses: Considered necessary for assuring animal health (therapeutic uses) That include veterinary oversight or consultation

VOLUNTARY CHANGES TO AFFECTED PRODUCTS Production (e.g., growth promotion) indications for the medically important antimicrobials were withdrawn from all applications that included such indications for use 292 new animal drug applications affected 84 applications completely withdrawn 115 applications for products intended for use in feed were converted from OTC to VFD status 93 applications for oral dosage form products used in water were converted from OTC to Rx status

VFD MEDICATED FEED 21 CFR 558 Medically important antimicrobials transitioned from OTC to VFD effective January 1, 2017 under authority of the VFD Rule Federal Law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian. In reporting year 2015 these applications accounted for about 74 % of sales of all medically important antimicrobials.

VFD MEDICATED FEED Extralabel Use – Minor Species (CPG 615.115) AMDUCA amended section 512 of the FD&C Act to permit extralabel uses of drugs under certain conditions except in animal feed However, when there are no approved treatment options available and the health of animals is threatened, and suffering or death would result from failure to treat the affected animals, extra label use of medicated feed may be considered for treatment of minor species In general, the Agency will not recommend or initiate enforcement action against the veterinarian, animal producer, feed mill, or other distributor when extralabel use is consistent with CPG 615.115 http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-ice/documents/webcontent/ucm074659.pdf

SUMMARY We are actively developing educational information for all FSMA rules We are also busy educating stakeholders on the substantial changes regarding use of medically important antimicrobials

THANK YOU! www.fda.gov/safefeed contact us: askCVM@fda.hhs.gov