1. FDLI - 55 th Annual Meeting April 24, 2012 Food Safety Modernization Act The Role of 3 rd Party Auditing Bruce Silverglade, Esq. Principal Olsson Frank Weeda Terman Matz

2. FSMA and 3 rd Party Auditing What the law says - What is the reality? What should industry do?

3. FSMA Provisions Regarding 3 rd Party Auditing FDA may require certification of imports under section 801(q) Certification must be provided by the government in the originating country, or An accredited 3 rd party auditor

4. FSMA Provisions Regarding 3 rd Party Auditing Foreign Supplier Verification Program (FSVP) Section 805 – relation to 3 rd Party Auditing FDA must establish a voluntary qualified importer program (VQIP) under section 806 - requires a facility certification by FDA or an accredited third party auditor

5. FSMA - Accrediting Auditors FDA must establish a system for recognition of accreditation bodies that accredit third-party auditors by January, 2013 But can directly accredit auditors starting at that time

6. FSMA - Accrediting Auditors FDA must publish model accreditation standards by July 2012 (Delayed) FDA must publish regulations preventing conflicts of interest between 3 rd party auditors and food companies by July 2012 (Delayed)

7. FSMA - Other 3 rd Party Auditing Provisions FSMA contains provisions for: –Regulatory audits v. consultative audits –Requirements for submitting audits to FDA –Provisions regarding conflict of interest –Provisions for withdrawing accreditation Statutory requirements need to be detailed further in regulations

8. Developments at FDA – Agency Says Priorities Are: Determining the right level of training and experience for an accredited auditor, how much specialized knowledge auditors need to demonstrate competence, and the most predictive measures of an auditor’s competence Ensuring the independence and objectivity of private certification bodies and auditors »Mike Taylor, GFSI conference, February 16, 2012

9. Developments at FDA – Agency Says Priorities Are: Determining what information from audits should be provided to FDA and what information should be made public Establishing how FDA should structure the relationship with accrediting bodies -- What are the thresholds of expertise, experience and capacity that must be reached to be recognized by FDA as an accrediting body? »Mike Taylor, GFSI conference, February 16, 2012

10. Developments at FDA FDA has not ruled out starting a pilot program where the Agency would act as its own accreditor FDA has funded the NEHA to develop a personnel certification credential for food auditors. Intent initially is for use for federal and state government auditors, but could form basis for standards applied to 3 rd party auditing industry

11. Accreditation Body GFSI Guidance Document SQF Licensed Accredited Certification Body BRC Licensed Accredited Certification Body Other GFSI Schemes Licensed Accredited Certification Body ISO/IEC Guide 65 IAF Members The Accreditation Process - NOW Verifies Scheme Compliance to GFSI Guidance Document Licenses Certification Body to perform audits IAF Members peer review Member Accreditation Bodies Certified Supplier Verifies CB Compliance to ISO/IEC Guide 65 and Scheme requirements Audits and certifies suppliers to scheme requirements; Performs 2 nd party and 3 rd party audits SO Approves AB’s to accredit Certification Bodies 11

12. Accreditation Body GFSI Guidance Document SQF Accredited Third party auditor BRC Accredited Third Party Auditor Other GFSI Schemes Accredited Third-Party auditor ISO/IEC Guide 65 IAF Members The Accreditation Process After FDA Issues FSMA Regulations... ? GFSI Verifies Scheme Compliance to GFSI Guidance Document Licenses Certification Body to perform audits IAF Members peer review accreditation bodies Certified Supplier Verifies CB Compliance to ISO/IEC Guide 65 and Scheme requirements Audits and certifies suppliers to scheme requirements; Performs regulatory and consultative Audits. SO Approves AB’s to accredit Certification Bodies 12 FDA Foreign Government

13. FSMA – 3 rd Party Auditing Delays New York Times reports on April 2 that White House is delaying FDA proposed rules in numerous areas involving food, drug, cosmetics Delay includes a package of four proposed regulations implementing FSMA including the FSVP Administration is concerned about impact on November election – requests economic impact data from FDA

14. FDA’s Plan for FSMA Implementation The four delayed proposed regulations: –Preventive controls (human food) –Preventive controls (animal feed) –Fresh produce safety –Foreign Supplier Verification Program for importers Delaying the issuance of these four FDA proposed rules also delays FDA issuance of proposed rules for 3 rd party auditors which the agency said would be next in line for release

15. FSMA Delays First four proposed rules sent to OMB November 2011, but review extended Mike Taylor first said rules will be out in “next few weeks,” Mike Landa said “in next few months,” other FDA officials said “this summer” Reality may be not until after the election

16. Diverse Interests Press to End Delay Global Food Safety Initiative urges HHS to Act Consumer groups urge Administration to release rules Unusual alignment of interests

17. Diverse Interests Urge Administration to Act FOR IMMEDIATE RELEASE Contact: Chris Waldrop March 19, 2012 202-797-8551 Consumer Federation of America Member Groups Urge Release of Delayed Food Safety Proposals Consumer Federation of America today announced that as part of CFA’s annual meeting held last week, its members voted to support a resolution urging the Obama Administration to issue four proposed food safety rules that have now been delayed for over two months. “On behalf of CFA’s nearly 300 members, we urge the Administration to immediately issue these important food safety proposals,” said Chris Waldrop, Director of CFA’s Food Policy Institute. “The longer these proposals are delayed, the longer it will take to fulfill the promise of the Food Safety Modernization Act, which is intended to better protect consumers from food borne illness.” The Administration is now two and a half months overdue on meeting deadlines mandated by Congress. In late February, the White House Office of Management and Budget (OMB) announced t

18. Additional Developments - FSSP Formation of the Food Safety Service Providers

19. Additional Developments – Pew Charitable Trusts Collaborative Food Safety Forum on imports and third party certification FDA participated with industry and consumer groups Report issued March 2012

20. Congressional Developments January 10, 2012 letter from Democratic House minority coalition to FDA

21. Congressional Developments FSMA “requires that with respect to imported foods, FDA establish an accreditation system and model auditing standards for third party audits. While the law requires these steps only for imported foods, industry officials told the Committee that the FDA standards will influence the actions of auditors inspecting domestically grown products (produce) as well...

22. Congressional Developments “We hope that FDA will consider our findings when drafting these rules, and we suggest that FDA consider developing a voluntary model program for domestic auditors that could become the standard of care for third-party auditing programs in the United States.”

23. Congressional Developments DeLauro/Latham establish Congressional Food Safety Caucus Bipartisan effort – may be used to influence implementation of FSMA

24. What to Do Wait and see... [NO!] Instead... Ascertain alignment of interests Develop a position Determine how to make best use of delay Be proactive

25. Olsson Frank Weeda Terman Matz Bruce Silverglade, Principal Bsilverglade@ofwlaw.com 202-518-6316