1. Food Safety Modernization Act (FSMA) Overview Leah Wilkinson Vice President, Legislative, Regulatory & State Affairs American Feed Industry Association

2. Page 2 What is FSMA? Food Safety Modernization Act The most sweeping reform of our food safety laws in more than 70 years Signed into law by President Obama on January 4, 2011 It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it Covers both human food and animal food

3. Page 3 FSMA for Animal Food: Background Part 507 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals Originally proposed: October 29, 2013 Supplemental proposal: September 29, 2014 Public comments: More than 2,400 for the original proposal; more than 140 for the supplemental proposal Final rule: September 17, 2015

4. Page 4 AFIA and FSMA AFIA was actively engaged from early on Worked with Congress – as they wrote law, now as they fund and oversee implementation Worked with CVM, FDA, OMB and other agencies – before, during and after rule-making stages Member involvement reviewing rules 80+ individuals representing 65 AFIA member companies on 2 work groups and 8 subgroups Education and awareness More to come…

5. Page 5 Food Safety Modernization Act Who’s covered? Facilities that manufacture, process, pack or hold animals food and required to register with FDA under Bioterrorism Act Exemptions Farms – as defined in § 1.227 Qualified facilities (very unlikely for animal food) Other specific exemptions § 507.5 Animal food means food for animals other than man and includes pet food, animal feed and raw materials and ingredients

6. Page 6 FSMA: Key Areas Addressed Establish Current Good Manufacturing Practices (CGMPs) Hazard Analysis and Risk-Based Preventive Controls Each facility is required to implement a written food safety plan that focuses on preventing hazards in animal foods

7. Page 7 FSMA: CGMP’s Animal Food CGMPs FSMA Address building, grounds, equipment, personnel, etc. Mainly observational, and address routine operations No specific record keeping requirements in the CGMP section of the rule

8. Page 8 Not always a clear distinction and can depend on approach and context. Focus on end game A way to think about the 3 in the FSMA context CGMPs: observational, routine, facility and staff focused Prerequisite program: keeps/limits something entering the process PC: occurs in the process and controls or eliminates hazard CGMPs vs. Prerequisite Programs vs. PC

9. Page 9 “Please show me your Animal Food Safety Plan.” FDA

10. Page 10 Animal Food Safety Plan: Are You Ready? Tell your story Walk the FDA inspector through your documents Don’t dump what you’re doing now - repackage

11. Page 11 Hazard analysis SOP’s to mitigate risk Preventive controls if necessary Supply-chain program Recall plan Procedures for monitoring Corrective action procedures Verification and validation procedures Food Safety Plan

12. Page 12 Hazard identification must consider known or reasonably foreseeable biological, chemical, and physical hazards Evaluation of hazards must include: consideration of likelihood of occurrence in the product subject to the analysis Impact of prerequisite programs, formulation, ingredients, equipment, etc. consideration of severity of illness/injury and probability of occurrence in absence of preventive controls Food Safety Plan – Hazard Analysis

13. Page 13 Food Safety Plan – Hazard Analysis The hazard evaluation must consider the effect of the following on the safety of the finished animal food for the intended animal: The formulation of the animal food The condition, function, and design of the facility and equipment Raw materials and ingredients Transportation practices Manufacturing/processing procedures Packaging activities and labeling activities

14. Page 14 What is AFIA doing to help? AFIA’s foundation, the Institute for Feed Education and Research, agreed to fund development of a generic feed mill (and possibly ingredient mill) hazard analysis (HA) with the University of Minnesota’s Center for Animal Health and Food Safety in the College of Veterinary Medicine. Companies will be able use this generic hazard analysis as a guide to develop their own Food Safety Plan – Hazard Analysis

15. Page 15 Current Good Manufacturing Practices (CGMP’s) or other prerequisites ensure that all food, including animal food, is manufactured under conditions and practices that protect against contamination with undesirable biological, chemical, physical, and radiological agents. Preventive Controls means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. What Mitigates the Risk of Hazards?

16. Page 16 Manufacturing/processing facilities must have a risk-based supply-chain program to ensure control of hazards in raw materials and other ingredients when the control is applied before receipt (“supply-chain applied control”). Supply-Chain Program

17. Page 17 Onsite audits (default for most serious hazards) Sampling and testing Review of relevant food safety records Other as appropriate Activity and frequency based on nature of hazard, where it is controlled and supplier performance Supplier Verification Activities

18. Page 18 Compliance Dates Business SizeCGMP Compliance DatePC Compliance Date Business other than small and very small 1 year – Sept. 19, 20162 years – Sept. 18, 2017 Small business (a business (incl. any subsidiaries and affiliates) employing fewer than 500 full-time equivalent employees) 2 years – Sept. 18, 20173 years – Sept. 17, 2018 Very small business (a business averaging less than $2,500,000, per year, during the 3-yr period preceding the applicable calendar year in sales of animal food plus the market value of animal food manufactured, processed, packed, or held without sale (e.g., held for a fee or supplied to a farm without sale) 3 years – Sept. 17, 20184 years – Sept. 17, 2019 Except for retaining records to support its status as a very small business (January 1, 2017) TABLE 32 – 80 FR 56170 at 56329

19. Page 19 Supply-Chain Compliance Dates SituationCompliance Date A receiving facility is a small business and its supplier will be subject to the CGMPs, but not the preventive control requirements, of the animal food preventive controls rule. 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with the CGMP requirements of this rule. A receiving facility is a small business and its supplier is subject to the animal food preventive controls rule. The later of: September 17, 2018 or 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with this rule. A receiving facility is not a small business or a very small business and its supplier will be subject to CGMPs, but not the preventive control requirements, of the animal food preventive controls rule. 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with the CGMP requirements of this rule. A receiving facility is not a small business or a very small business and its supplier will be subject to the animal food preventive controls rule. The later of: September 18, 2017 or 6 months after the receiving facility’s supplier of that raw material or other ingredient is required to comply with the applicable rule. TABLE 33 – 80 FR 56170 at 56329

20. Page 20 Food Safety Modernization Act What do you need to do at your facility? Create CGMPs; Train staff (qualified individuals) Perform a hazard analysis (IFEEDER/NGFA Foundation contracting on generic hazard analysis by U of MN that facilities can start with) Determine what hazards need controlling Determine if all your hazards can be mitigated by CGMPs, which AFIA believes is true for feed mills Develop your Animal Food Safety Plan Have it reviewed and authorized by your preventive controls qualified individual (PCQI) Create a supply-chain management plan Create and maintain the records under your plan

21. Page 21 Foreign Supplier Verification Program Requires importers to share responsibility for ensuring safety of imported food Risk-based Flexibility in meeting requirements Alignment with PC supply-chain provisions

22. Page 22 Sanitary Transportation Final Rule published in Federal Register April 6, 2016 Covers: Shippers, receivers, loaders and carriers transporting food (including animal food) in the U.S. by motor or rail vehicle Shippers in other countries who ship to U.S. by motor, rail, ship or air and transfer intact container onto motor or rail for consumption in U.S. Transportation of food intended for export until reaches port or U.S. border

23. Page 23 Sanitary Transportation Establishes requirements: Vehicles and transportation equipment – suitable and adequately cleanable Transportation operations – measures to ensure food safety: temperature control, protect from contamination by non-food items in same or previous load Training – required when carrier and shipper agree the carrier is responsible for sanitary conditions Records – depends on type of records, not to exceed 12 months

24. Page 24 Sanitary Transportation Exemptions: Shippers, receivers or carriers less than $500,000 in annual revenue Transportation activities performed by a farm (hauling grain) Transportation of human food byproducts for animal food without further processing Transportation of live animals, except molluscan shellfish Transportation of compressed food gases and food contact substances Transportation of food completely enclosed by a container (think sealed/sewn packages, not a closed bulk truck) except if it requires temperature control

25. Page 25 Sanitary Transportation Compliance dates: April 2017 for large or businesses other than small April 2018 for small business (less than 500 employees) and motor carriers less than $27.5 million in annual receipts Industry wins: No 21 CFR, part 11 (electronic records) requirement Info on one previous load instead of three as originally proposed

26. Page 26 Upcoming Rulemakings May 31, 2016 – Intentional Adulteration (animal food exempt thus far) Planned guidance documents: Current Good Manufacturing Practices Human Food By-Products for Use as Animal Food Hazard Analysis and Preventive Controls A Small Entity Compliance Guide that explains the actions a small or very small business must take to comply with the rule

27. Page 27 Training Coming Soon! Later this year, three, 2.5 hour webinars of the entire animal food rule After UMN issues Hazard Analysis report, one full day workshop in December and one in January When FDA releases the framework training for PCQIs, and AFIA has a lead instructor trained, AFIA will hold a series of PCQI trainings across the U.S. in conjunction with universities and others. Other short videos planned on Qualified Individual training for feed safety/hygiene

28. Page 28 What Should You Do? www.safefeedsafefood.org

29. THANK YOU