1. 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

2. OVERVIEW
Food Safety Modernization Act
Veterinary Feed Directive

3. FSMA OVERVIEW

4. FSMA REGULATIONS ( )

5. 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

6. PCAF - COMPLIANCE DATES

7. PCAF - GUIDANCE DOCUMENTS

8. 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)

9. 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

10. 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

11. 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?

12. 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

13. 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

14. 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

15. 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).

16. 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:

17. 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))

18. Other FSMA Programs of Interest

19. 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

20. 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

21. MEDICALLY IMPORTANT ANTIMICROBIALS IN ANIMAL AGRICULTURE AFTER JANUARY 1, 2017

22. 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

23. 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

24. 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.

25. 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

26. 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

27. THANK YOU!
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