FSC36 Safe Feed/Safe Food: Guidance Document Version 7.0 Training June 2017

1. FSC36 Safe Feed/Safe Food:Guidance Document Version 7.0 TrainingJune 2017

2. FSC36 Safe Feed/Safe Food Training AGENDA • Very Quick Review Food Safety Modernization Act • Guidance Document: Old vs. New • Questions Please ask Questions as we cover the information. GOAL: address your questions and help you understand the version 7.0 Guidance Document

3. FSMA Snap Shot Signed into law January 4, 2011 • The current food safety system has opportunity for improvement. • 1 in 6 Americans (48 million) sickened; 128,000 hospitalized; 3,000 die each year from foodborne diseases (CDC, 2011) • Identified by FDA as the most sweeping reform of food safety laws in more than 70 years. • GOAL: Aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

4. Preventive Controls for Animal Food Timeline • January 2011: FSMA signed into law • October 2013: First version issued (Proposed Rule) • September 2014: Second version issued (Revised Rule) • September 2015: Final rule published

5. Who Must Comply? • Facilities that manufacture, process, pack, or hold animal food for consumption in the United States • In general, those that register under Section 415 of the Federal Food, Drug, and Cosmetic Act (Bioterrorism Act). • Not complying is considered a prohibited act. • Animal food covered by specific CGMP regulations must still comply with those regulations • Low-acid canned food • Medicated feed

6. 21 CFR Part 507 Preventive Controls for Animal Food • Subpart A – General Provisions • Subpart B – Current Good Manufacturing Practice • Subpart C – Hazard Analysis and Risk-Based Preventive Controls • Subpart D – Withdrawal of a Qualified Facility Exemption • Subpart E – Supply-Chain Program • Subpart F – Requirements Applying to Records That Must Be Established and Maintained

7. Food Safety Modernization Act More Quality & Food Safety Certifications BENEFIT: Certified facilities are considered lower risk. END RESULT: More facilities will obtain 3rd party certifications for quality & food safety to ensure compliance with FSMA requirements FSMA GOAL: Develop a proactive program to reduce potential animal food safety risks versus a reactive approach to failures or nonconformities Facility

8. FSC36 Safe Feed/Safe Food Updates – Version 7.0 Good News! Requirements for FSC36 Safe Feed/Safe Food are not changing. However, the expectations relative to FSMA compliance are clearer.

9. FSC36 Safe Feed/Safe Food Updates – Version 7.0 More direct references to FSMA animal food rule requirements • After comparing FSMA animal food rule to FSC36 guidance document, there seemed to be several gaps. • CGMP requirements were not specifically identified although the expectations were generally called out within the various requirements.   • The requirements for records (subpart F of the animal food rule) have been incorporated into clause 2.3 Records. • FSMA requirements for the food safety plan and preventive controls have been added to the guidance document.

10. FSC36 Safe Feed/Safe Food Updates – Version 7.0 “Auditing Guidance” was removed while “Implementation Guidance” was maintained • Within version 7.0, the auditing guidance will be removed because this has been a point of confusion for auditors as well as facilities seeking certification.  • Many auditors and auditees have interpreted this information as the only items that are relevant to the audit • Auditing guidance will be an individual/stand-alone document. This allows changes or additions as needed to help auditors maintain consistency and improve the quality of audits.

11. FSC36 Safe Feed/Safe Food Updates – Version 7.0 Reference to clauses has been updated • In version 6.0, there were sections with the same number within the document. As an example, Section 2.3 = “Auditing Duration Guide” while within the scheme requirements in Section 5.0, 2.3 = “Document Control (M)”.  • In version 7.0, “SF/SF” will be added in front of each clause for Safe Feed/Safe Food requirements in Section 5.0.

12. Updated FSC36 Safe Feed/Safe Food 84 clauses with requirements for compliance divided among 10 areas

14. FSC36 Safe Feed/Safe Food Updates – Version 7.0 Remains the same with 2017 update OBJECTIVE: Ensure management commitment and engagement with the quality and animal food safety program

15. FSC36 Safe Feed/Safe Food Updates – Version 7.0 Clause removed in 2017 update Updated with FSMA language (more detail) OBJECTIVE: Ensure the facility maintains the “tools” to implement an effective quality and animal food safety program

16. FSC36 Safe Feed/Safe Food Updates – Version 7.0 New Clauses Added to Cover CGMP’s

17. FSC36 Safe Feed/Safe Food Updates – Version 7.0 ALL NEW CLAUSES – LANGUAGE TAKEN FROM FSMA OBJECTIVE: Ensure the facility complies with FSMA CGMP requirements (less emphasis on “records” – more emphasis on “actions”)

18. FSC36 Safe Feed/Safe Food Updates – Version 7.0 NEW OBJECTIVE: Ensure the personnel are properly prepared, facilities are adequate and visitors are controlled

19. FSC36 Safe Feed/Safe Food Updates – Version 7.0 OBJECTIVE: Ensure the facility is properly designed and maintained for its intended purpose, ensure work areas are sufficient and pest management is properly implemented

20. FSC36 Safe Feed/Safe Food Updates – Version 7.0 No changes in Product Realization

21. FSC36 Safe Feed/Safe Food Updates – Version 7.0 No changes in Product Realization

22. FSC36 Safe Feed/Safe Food Updates – Version 7.0 No changes in Product Realization OBJECTIVE: Ensure food safety concerns are considered and records maintained for developing products, receiving materials and manufacturing finished products; ensure appropriate information is received from and provided to customers; ensure food safety is maintained during storage

23. FSC36 Safe Feed/Safe Food Updates – Version 7.0 No changes in Purchasing Processes and Controls OBJECTIVE: Ensure processes are implemented for vendor (supplier) approval and that appropriate communications are maintained to provide the desired materials

24. FSC36 Safe Feed/Safe Food Updates – Version 7.0 Changed Updated with FSMA language Changed OBJECTIVE: Ensure appropriate validation and verification is completed for equipment, monitoring devices and finished products

25. FSC36 Safe Feed/Safe Food Updates – Version 7.0 No changes OBJECTIVE: Ensure appropriate validation and verification is completed for equipment, monitoring devices and finished products through internal auditing, product identification and traceability; ensure an animal defense/biosecurity plan has been developed

26. FSC36 Safe Feed/Safe Food Updates – Version 7.0 Updated with FSMA language OBJECTIVE: Ensure an animal food safety plan has been developed CAUTION: Animal Food Safety Plan is not required by FSMA until Sept 2017 for Large Businesses and Sept 2018 for Small Businesses

27. FSC36 Safe Feed/Safe Food Updates – Version 7.0 OBJECTIVE: Ensure the Safe Feed/Safe Food logo is used appropriately and proper statements are provided on packaging or labels

29. THANK YOU