1. Best Practices: Where Industry Should Lead on Ensuring Proper Testing & Auditing Stephen F. Sundlof, DVM, PhD Senior Advisor for Animal and Food Safety EAS Consulting Group, LLC.

2. Topics FSMA Changes Foreign Supplier Verification Domestic Supplier Verification Accredited Third Party Audits Accredited Laboratories New Dietary Ingredients vs GRAS substances

3. FSMA Changes Functional Foods: Major changes –Preventive Controls –Foreign Supplier Verification –Third Party Audits Dietary Supplements: Minor changes –Biennial Registration –Maintain list of foreign suppliers –Ensure importer identification at entry –Maintain records

4. What FSMA does not mandate (yet) Product testing Environmental monitoring Domestic supplier approval and verification

5. Supplier Qualification/Verification Programs DS Ingredient Supplier Qualification Food Foreign Supplier Verification Food Supplier Approval and Verification

6. Dietary Supplement Supplier Qualification DS manufacturer responsible for to verify supplier’s compliance to GMPs Standards for “qualification” not clearly defined Private third party auditors and certification bodies developing their own standards

7. Foreign Supplier Verification (FSVP) FSMA requires food importers to verify that their foreign suppliers produce food at the same level of public health protection as required by domestic producers by: –Annual on-site auditing??? –Sampling and testing –Review of foreign supplier food safety records –Other appropriate procedures

8. FSVP – 2 Options Proposed rule on FSVP presents 2 options: –Option 1 Requires importer to conduct annual on site audit of the foreign supplier if there is a reasonable probability that the food will cause serious adverse health consequences in humans or animals –Option 2 On site audit is an option but not a requirement for all foods except those requiring certification or as part of a Voluntary Qualified Importer Program

9. Supplier Approval & Verification Applies to domestic suppliers of food and food ingredients Not required under FSMA, but FDA has requested comments in the Preventive Controls proposed rule as to whether it should be mandatory If required in the final rule, will be very similar to FSVP

10. Industry Leadership Should the food and DS industries petition FDA to harmonize supplier qualification/verification programs? If a supplier produces ingredients for both dietary supplement and food manufacturers, is the supplier subject to both food and DS qualification/verification?

11. Accreditation of Third-Party Auditors/Certification Bodies Private third party auditing of food and DS suppliers and manufactures is a rapidly growing enterprise Quality of third party audits range from rigorous to poor Until FSMA, FDA did not recognize third party audits and did not establish standards for accreditation or certification

12. Accreditation of Third-Party Auditors/Certification Bodies Proposed rule sets out a framework for how FDA will: –Recognize accreditation bodies –Provide accreditation of third-party auditors/certification bodies to conduct food safety audits Applies only to foreign food facilities

13. Accreditation of Third-Party Auditors/Certification Bodies FDA accredited third-party certification required when: –Importing high risk foods that require certification –Importers establish eligibility for the Voluntary Qualified Importer Program (VQIP) Certified audits may be used to comply with FSVP requirements

14. Cost of Accredited vs. Unaccredited Audits Accredited $3,600 Unaccredited $2,700

15. Benefits of a Single Standard “Widespread participation and broad acceptance of audits and certifications under the FDA program help increase efficiency and reduce costs, by eliminating redundant auditing to assess foreign suppliers’ compliance with the Federal Food, Drug, and Cosmetic Act.”

16. Industry Leadership FDA third-party accredited audits are likely to become the “gold standard” for the food industry Should FDA create a similar accreditation program for the DS industry?

17. Laboratory Accreditation FSMA requires certain food testing to be carried out by accredited laboratories and directs FDA to establish a program for laboratory accreditation to ensure that U.S. food testing laboratories meet high- quality standards

18. Laboratory Accreditation FDA has not yet fully developed its thinking or rulemaking on the FSMA requirement for laboratory accreditation so any interpretations of requirements are premature at this time.

19. Industry Leadership When FDA promulgates standards for laboratory certification they will likely become the “gold standard” for the food industry Should FDA create a similar certification program for the DS industry?

20. New Dietary Ingredients vs GRAS Substances/Food Additives New Dietary Ingredient GRAS Substance Food Additive Premarket Approval NoNo/YesYes NotificationYes No Self-AffirmationNoYesNo General Recognition NoYesNo

21. Safety Standards: A Distinction without a Difference??? GRAS and Food Additives: –Reasonable Certainty of No Harm New Dietary Ingredients: –Reasonable Expectation of Safety <25% of NDI notifications receive “no objection” letters from FDA

22. GRAS Workaround A legal theory to avoid NDI notification* 1.Self-affirm that the NDI is GRAS 2.Introduce the GRAS substance into food 3.Market food containing the GRAS substance for some period of time 4.NDI now exempt from notification requirements because of GRAS status * I neither condone nor recommend this approach

23. Industry Leadership Request that FDA clearly delineate/differentiate Reasonable Certainty of No Harm from Reasonable Expectation of Safety Provide FDA with suggestions on how to differentiate, e.g. greater reliance on published studies for NDIs

24. Summary Changes brought about by FSMA will have significant impact on DS and functional food industries –Alignment of supplier qualification/verification programs –FDA recognition of third-party audits/certification –FDA certification of laboratories NDI notification requirements substantially same as GRAS/Food Additives

25. Thank You