Food Safety ASQ Milwaukee Section November 18, 2013

1. Food SafetyASQ Milwaukee SectionNovember 18, 2013 Nancy Berger EAGLE Food Registrations, Inc November 2013

2. Agenda • FSMA – what it means to the consumer • GFSI – what it is & how it is making the food chain safer • Food Safety – heading in the future

3. Challenges • Food Safety Crisis – global • Government FDA/USDA budget cuts/not enough manpower • Too many individual audits with different expectations • Recalls and Media • Consumer health # 1 priority

4. FSMA • FDA Food Safety Modernization Act (FSMA) • Signed into law January 4, 2011 • Most sweeping change in 70 years • Applies to human and animal food products • Special areas of the law for imports and produce • Helps the food chain build consumer confidence

5. FSMA • 7 Foundation Standards (such as food safety defense) • still under development, deadline 6/30/2015 for • feedback to finalize • 5 Areas of FSMA Law

6. FSMA • Prevention goal of the entire FMSA revisions: • Preventative rather than reactive approach • Stop it before it happens • Reduce the likelihood of bad product out in the industry • HACCP Program defined and implemented • Some exclusions apply (seafood; juice; small business less than $500,000 annual revenue) • Hazard Analysis Critical Control Points - Evaluate hazards; identify and implement preventive controls; monitor performance; maintain records • Sounds like a FMEA doesn’t it! Prevent Food Hazards!

7. FSMA • Inspection and compliance • -greater access to reports and plant • Catching up to USDA • USDA has been strong in this for a long time – USDA plants have inspection in each day; each shift

8. FSMA • Regulatory Response – stronger recall processes if reasonable probability of causing serious adverse health consequences or death to humans or animals • Registration of all food manufacturing facilities • Any manufacturer, processor, packer or warehouse/distribution • Not farms, restaurants, retail food establishment • Detainment of product or suspension if reasonable probability of causing serious adverse health consequences or death to humans or animals

9. FSMA • Import Safety is a big focus of FSMA • Foreign supply verification program - 3rd Party Audits • Importer will have to have the audit certificate on file • Set criteria for who can do the audits – approved government agencies/staff and approved auditing companies • Not enough FDA inspectors to do audits • Auditors will also have to be accredited • Starting with imports, but you know it will move to US manufacturers in near future ! Safety BIG Focus

10. FSMA • Enhanced Partnership • FDA staff will not be able to do it alone • Budget restraints • Look to other agencies and organizations involvement • State health agencies • Local health agencies • Third Party Certification Bodies or Groups • BRINGS US TO GFSI AUDITS

11. What is GFSI? • GFSI launched in 2000, following a directive from the CEOs in the food business • Now managed by The Consumer Goods Forum • Benchmarking process of schemes against guidance documents (by sectors) • Encourages stakeholders to share knowledge and strategy for food safety – develop best practices for common global framework

12. Benefits of an FSMS • Preventive system • Provides systematic approach to managing food safety • Provides standards and guidelines for food safety • Provides verification and validation of system • Improves compliance to regulatory standards • Provides confidence to consumers • Demonstrates due diligence by processor • Auditable

13. Oversight vs. Non-oversight • Non-oversight, Third-Party Audits • Audits which are the product of a specific company • Examples = AIB, Silliker, Cook & Thurber • These audits are created and controlled by the company who developed the audit criteria • Type of audit used at Peanut Butter Corporation of America • Oversight Third-Party Audits • All GFSI schemes

14. Certification Process • Which program is best for their company? • What are the reasons for seeking certification? • Required by customer • Global business • Mature vs. New FSMS • Standards are similar in a lot of ways, but unique • Let’s share some of them

15. Certification Process

16. Certification Process (continued) • Supplier Implements The System *System must be operational for minimum of two months so records are created and it can be verified and validated

17. Certification Process (continued) • Certification Steps • Different by Standards • FSSC: Stage 1 and Stage 2 • Readiness visit (1) Certification Audit (2) • SQF: Document Review & Certification Audit • Close out Findings • Certification Granted • Some GFSI audits are scored / some mirror ISO 9001 and are not scored • Surveillance and or recertification audits • Requirements by standard

18. GFSI Schemes • The Three Major FSMS in the U.S. are: • Safe Quality Food (SQF) • British Retail Consortium (BRC) • FSSC 22000

19. SQF – Overview • SQF = Safe Quality Food • Developed in Australia in 1994 • Food Marketing Institute purchased in 2003 • One code with defined modules for industry specific operations • 3 Levels of Certification (Benefit) • Level 1 = Food Safety Fundamentals (GMPs, PRPs) • Level 2 = Food Safety Plan (HACCP) • Level 3 = Food Quality Plan (HACCP driven)

20. SQF – Basic Facts & Benefits • All documentation is free on their website (Benefit) • Auditor approval controlled by scheme (Benefit) • Nine basic elements and HACCP based • Includes some elements found in 9001 and 22000 • Document Control, Management Review, Internal Audit, Corrective and Preventive Action • Standard by modules by food sector categories (Benefit) • Offers additional tools such as guidance documents for specific industries to strengthen program (Benefit)

21. SQF – Basic Facts & Benefits • Provides discipline for document control • SQF Practitioner responsible for program (Benefit) • Includes 12 Step HACCP Plan • Food Safety Fundamentals • Details for building and equipment design and construction • Specific PRPs with defined criteria • Special attention to identity of preserved foods (i.e.; Kosher, Organic) • Requires verification and validation of system • Includes quality – based on HACCP method (Benefit)

22. BRC - Overview • Developed in 1998 • Published by the British Retail Consortium • Developed in response to retailer demand • Developed by BRC with contributions from retail, manufacturing, industry associations, and certifying bodies • Edition 6 released 2011, effective 1/2012

23. BRC – Basic Facts & Benefits • Different schemes/standard by food sector categories • Eight fundamental requirements • HACCP based • Includes quality (Benefit) • Includes some elements found in ISO programs • Document Control, Management Review, Internal Audits, etc.

24. BRC – Basic Facts & Benefits • Provides discipline for document control • Includes 12 step HACCP plan • Very prescriptive PRPs • Special attention to foreign material control such as sharps control(Benefit) • Requires verification and validation of system • Auditor qualifications (Benefit) • Strong in Europe/Canada and for exporting there (Benefit)

25. FSSC 22000 - Overview • Newest of the three major GFSI standard • Combination of ISO 22000, PAS 220 (ISO 22002-1:2009) and a few more requirements in Part 1 of FSSC 22000 • ISO 22000 was published in September 2005 • Developed by joint effort of ISO & the food industry • Truly a global standard - 14 different countries represented

26. FSSC 22000 – Basic Facts & Benefits • 100% Food Safety driven (Benefit) • Does not include a quality component • HACCP based – very specific requirements • Includes pre-requisite programs PAS 220 (ISO 22002-1:2009) • Most aligned elements to 9001 (Benefit) • Document control, resource management, management review, internal audit • Not scored – aligns with 9001 progress (Benefit)

27. FSSC 22000 - Basic Facts & Benefits • Provides discipline for document control • Foundation for continual improvement • Creation of a Food Safety Team • Includes all steps in the development and implementation of a HACCP plan • Control of non-conforming product critical (Benefit) • Validation & verification of system • Traceability Worldwide Acceptance

28. FSSC 22000 – Basic Facts & Benefits • Last revision changes to FSSC22000 • Category M – food grade packaging - added to scope of standard with the use of PAS 223 • Previously it did not offer an approved GFSI standard to the packaging industry • Audit time requirements – minimum on site • Surveillance audit are FULL SYSTEM audits

29. Future of Food Safety • SQF, FSSC and BRC are benchmarking to FSMA • Show gaps • SQF completed GAP analysis and only a few FMS requirements fell short but they have many requirements that are more stringent • Copy of this comparison is on the SQF website – www.sqfi.com

30. Future of Food Safety • Complete roll-out of FSMS • More accountability • Proactive not Reactive Culture • GFSI keeping up with the changes in industry • Unannounced audit • Adding HACCP Hazards when identified • More involvement with certified client recalls from auditing requirements • Making a safer food chain!!!!

31. Contact Information Questions For more information please call 800.795.3641, visitwww.eagleregistrations.comor e-mail Nancy.berger@eagleregistrations.com