1. Final Rule on Foreign Supplier Verification Programs http://www.fda.gov/fsma 1

2. Background FSMA Sec. 301 requires importers to have FSVPs and FDA to issue regulations. Proposed rule: July 29, 2013 Supplemental proposal: Sept. 29, 2014 Public comments: 300+ for proposed rule and 100+ for supplemental Final rule issued: Nov. 13, 2015 2

3. Key Principles of FSVP Rule 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 3

4. Purpose of FSVPs To provide adequate assurances that: –Foreign suppliers produce food using processes and procedures providing same level of public health protection as FSMA preventive controls or produce safety provisions –Food is not adulterated or misbranded (as to allergen labeling) 4

5. Who Must Comply? “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. 5

6. Exemptions from FSVP Firms subject to juice or seafood HACCP regulations Food for research or evaluation Food for personal consumption Alcoholic beverages and ingredients (when importer uses them to make an alcoholic beverage) 6

7. FSVP Exemptions (cont.) Food transshipped through U.S. Food imported for processing and export “U.S. food returned” Meat, poultry, and egg products subject to USDA regulation at time of importation 7

8. Importers in Compliance with Preventive Controls Importers are deemed in compliance with most of FSVP when they: –Comply with PC supply-chain provisions –Implement preventive controls under PC regulation for hazards in food they import –Are not required to implement a preventive control under certain PC provisions 8

9. Use of Qualified Individuals Must use a qualified individual to perform all required FSVP tasks –Must have education, training, or experience (or combination thereof) necessary to perform the activity –Must be able to read and understand the language of any records reviewed in performing an activity 9

10. Hazard Analysis Evaluate known or reasonably foreseeable hazards to determine if they require a control –Biological, chemical (including radiological), and physical hazards –Naturally occurring, unintentionally introduced, or intentionally introduced for economic gain May assess another’s hazard analysis 10

11. Evaluation of Food and Foreign Supplier To approve suppliers and determine appropriate supplier verification activities Consider: –Risk posed by the food (hazard analysis) –Entities controlling hazards or verifying control –Supplier characteristics (procedures, processes, and practices; FDA compliance; food safety history) 11

12. Supplier Verification Activities Procedures to ensure food is obtained from approved suppliers May use unapproved suppliers on temporary basis when subject food to verification Written procedures for verification activities 12

13. Verification Activities (cont.) Determine appropriate verification activities (and frequency) based on food and supplier evaluation –Activities may include: onsite auditing; sampling and testing; review of supplier records; other appropriate measures Annual onsite auditing is default approach when a food has a SAHCODHA hazard. 13

14. Reliance on Verification Activities Conducted by Others May rely on another entity’s determination or performance of appropriate verification activities (e.g., farm audits conducted by produce distributor) Must review and assess results of verification activities (importer’s own or others on which it relies) 14

15. Verification Activities (cont.) Onsite audits: –Must be conducted by “qualified auditor”; may be government employee –Consider applicable FDA food safety regulations (or laws and regulations of country with comparable or equivalent food safety system) –Substitute results of inspection by FDA or food safety authority in comparable or equivalent food safety system 15

16. Requirements for Special Circumstances The food cannot be consumed without application of control (e.g., coffee beans). Hazard controlled by importer’s customer or subsequent entity in US distribution. –Disclosure statement –Written assurance –Other system to ensure control of hazard at subsequent distribution step 16

17. Other FSVP Requirements Corrective actions Importer identification at entry Recordkeeping 17

18. Dietary Supplements Most standard requirements do not apply when an imported dietary supplement component or packaging meets specifications established in accordance with dietary supplement CGMPs. Other dietary supplements (including finished supplements): hazard analysis not required; verification standard is compliance with CGMPs. 18

19. Very Small Importers and Food from Certain Small Suppliers Very small importer (VSI) –Less than $1 million/yr. in human food sales –Less than $2.5 million/yr. in animal food sales Food from certain small suppliers –Qualified facility –Produce from certain small suppliers that are not covered farms –Shell egg producers with < 3,000 laying hens 19

20. VSIs and Importers of Food from Small Suppliers (cont.) Annually document eligibility Verification: Written assurances from suppliers Additional requirements for food from small suppliers: –Evaluate supplier compliance history –Approve suppliers –Ensure food is from approved suppliers 20

21. Countries with Comparable or Equivalent Safety Systems Most FSVP requirements would not apply when importing certain food from supplier in country whose food safety system FDA has officially recognized as comparable or determined to be equivalent. –Systems recognition initiative Applies to food that will not be processed further (packaged food; fresh produce) 21

22. Food from Countries with Comparable Systems (cont.) Importer must document that: –Foreign supplier is under oversight of comparable or equivalent food safety system. –Food is within scope of official recognition or determination. –Supplier is in good compliance standing with comparable or equivalent food safety authority. 22

23. Compliance Dates Compliance is the latest of: –18 months after final rule –If supplier is subject to the preventive controls or produce safety regulations, 6 months after the foreign supplier of the food is required to comply with the relevant regulations 23

24. Compliance Dates (cont.) –For an importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations, the date by which it has to comply with those provisions –A range of compliance dates were established in the preventive controls rules for the supply-chain program provisions, which vary based on the size of the receiving facility and when the receiving facility’s supplier is required to comply with the new FSMA regulations. 24

25. Guidance and Outreach Developing FSVP draft guidance for industry Food Safety Preventive Controls Alliance will develop course materials for FSVP. Webinars and meetings 25

26. Final Rule Accredited Third-Party Certification http://www.fda.gov/fsma 26 http://www.fda.gov/fsma

27. What Does This Rule Do? It establishes a voluntary program for the accreditation of third-party auditors, also known as certification bodies, to conduct food safety audits and issue certifications of foreign facilities and the foods for humans and animals they produce. 27

28. When Are Certifications Needed? Importers will not generally be required to obtain certifications. Certifications will be used for two purposes: 1.Facility certifications will be used by importers to establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which offers expedited review and entry of food. 28

29. When Are Certifications Needed? 2.Food or facility certifications will be used for admissibility of a food subject to a risk-based determination by FDA. Requires a specific determination by FDA under section 801(q) of the FD&C Act Factors include consideration of the capability of the regulatory system of the exporting nation to ensure compliance with U.S. safety standards for the food. Exemptions for certain alcoholic beverages and products subject to USDA oversight at import 29

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31. What Are Accreditation Bodies? An accreditation body can be a foreign government/agency or a private third- party. An accreditation body may use documentation of its conformance to ISO/IEC 17011, supplemented as necessary, in meeting FDA requirements. 31

32. What Must Accreditation Bodies Do? FDA requires accreditation bodies to: – Assess third-party certification bodies for accreditation –Monitor the performance of third-party certification bodies they accredit –Assess and correct problems in their own performance –Submit reports and other notifications to FDA –Maintain and provide FDA access to certain records 32

33. What Is Direct Accreditation? FSMA allows FDA to directly accredit third- party certification bodies if by two years after the program goes into effect, FDA has not recognized an accreditation body that meets the program needs. –Limited circumstances 33

34. What Are Certification Bodies? An CB can be a foreign government or other third-party entity. A CB may use documentation of its conformance with ISO/IEC 17021 or ISO/IEC 17065, supplemented as necessary, in meeting FDA requirements. 34

35. What Must Certification Bodies Do? –Ensure their audit agents are competent and objective –Verify the effectiveness of facilities’ corrective actions to address identified deficiencies –Assess and correct any problems in their own performance –Maintain and provide FDA access to certain records 35

36. Audit Requirements When performing audits under this program, accredited third-party CBs must: –Perform facility audits unannounced –Notify FDA on discovering a condition that could cause or contribute to a serious risk to public health –Submit regulatory audit reports (key data) –Maintain consultative audit reports in records, accessed only under section 414 36

37. Related FDA Actions Voluntary Qualified Importer Program (VQIP) draft guidance (June 2015) –Explains how VQIP will work and how importers can qualify for a program that would provide expedited entry of foods –In order to participate, importers must import foods from facilities certified by accredited third-party certification bodies participating in the FDA program. 37

38. Related FDA Actions Model Accreditation Standards draft guidance (July 2015) –Contains recommendations on the qualifications that third-party certification bodies and their agents should have in such areas as education and experience 38

39. Related FDA Actions Proposed rule establishing user fees for accreditation and certification bodies (July 2015) –FSMA requires that a user-fee program be established to reimburse the agency for its work in establishing and administering the third-party certification program. 39

40. Implementation Program will launch after the final user fee rule takes effect. Accreditation bodies could begin to apply when the program goes into effect. −Third-party certification bodies could seek accreditation after one or more FDA- recognized accreditation bodies begin accepting applications. 40

41. For More Information Web site: www.fda.gov/fsma Subscription feature available To submit a question about FSMA, visit www.fda.gov/fsma and go to Contact Us 41