1. Final Rule for Preventive Controls for Animal Food to Wild Bird Feed Industry Annual Meeting 2015 by Daniel G. McChesney, Ph.D. Director, Office of Surveillance and Compliance Center for Veterinary Medicine 1 THE FUTURE IS NOW

2. Background 2 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

3. Who is Covered? In general, facilities that manufacture, process, pack or hold animal food –Facilities required to register with FDA under sec. 415 of the FD&C Act –Not farms Applies to domestic and imported food There are some exemptions and modified requirements for certain facilities 3

4. 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 Revised Definition of a ‘Farm’ 4

5. 5 CGMPs FDA Action in Final Rule –Revised the CGMPs based on comments and existing industry standards –Modified the requirements to be less prescriptive while maintaining a baseline to protect animal food against contamination that would be harmful to public health

6. Good Manufacturing Practices Personnel Plant and grounds Sanitation Water supply and plumbing Equipment and utensils Plant operations Holding and distribution Holding and distribution of human food by-products for use as animal food 6

7. Requirement for Training Individuals who manufacture, process, pack, or hold animal food must be qualified to perform their assigned duties Qualifications can come from education, training, or experience (or combination) Must have training in principles of animal food hygiene and animal food safety Training must be documented 7

8. Food Safety Plan Hazard analysis Preventive controls Supply-chain program Recall plan Procedures for monitoring Corrective action procedures Verification procedures 8

9. Food Safety Plan – Hazard Analysis Identify potential hazards Evaluate the hazards in product produced Determination of a hazard(s) requiring a preventive control 9

10. Food Safety Plan – Hazard Analysis Hazard identification must consider known or reasonably foreseeable biological, chemical, and physical hazards –These could occur naturally, be unintentionally introduced, or be intentionally introduced for economic gain 10

11. Food Safety Plan – Hazard Analysis 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 11

12. Food Safety Plan – Hazard Analysis Outcome of the analysis –determination of whether a hazard(s) require a preventive control or not 12

13. Food Safety Plan – Preventive Controls Not required when hazard is controlled by another entity later in the distribution chain –Disclose that animal food has not been processed to control an identified hazard –Obtain assurances hazard will be controlled 13

14. Food Safety Plan – Preventive Controls Measures required to ensure that hazards are significantly minimized or prevented. These include: –Process controls –Sanitation controls –Supply-chain controls –Recall plan 14

15. Food Safety Plan – Other Elements PC management components Monitoring Corrective Actions and Controls Verification Validation Verification of Implementation/effectiveness Reanalysis of Food Safety plan 15

16. Qualified Facilities Very small businesses are qualified facilities exempt from the full requirements for hazard analysis and risk-based preventive controls (but still have some requirements) –Average less than $2.5M per year in sales of animal food plus the market value of animal food manufactured, processed, packed or held without sale 16

17. Requirements for a Qualified Facility Attestation the facility is a qualified facility; AND Attestation that hazards have been identified and that preventive controls have been implemented and are being monitored; OR Attestation facility is in compliance with an applicable non-Federal food safety law 17

18. Supply-Chain Program 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”). 18

19. Supplier Verification Activities 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 19

20. Compliance Dates Business SizeCGMP CompliancePC Compliance Other Businesses1 year2 years Small Business*2 years3 years Very Small Business◊3 years4 years 20 *Small Business – business with fewer than 500 full-time equivalent employees ◊ Very Small Business – Average less than $2.5M per year in sales of animal food plus the market value of animal food manufactured, processed, packed or held without sale

21. Definition of Holding Modified the definition of holding to include activities performed incidental to storage of an animal food (e.g., for safe or effective storage of that animal food and activities performed as a practical necessity for distribution of that animal food). These include blending the same RAC and breaking down pallets, but not activities that would transform a RAC into a processed food. 21

22. What is a Farm? Two definitions Primary Production Farm –Under one management in one general, but not necessarily contiguous, location –Devoted to the growing of crops, the harvesting of crops, the raising of animals, or any combination of these activities –Packs and holds raw agricultural commodities; may conduct certain manufacturing/processing activities, such as dehydrating grapes to produce raisins, packaging and labeling 22

23. What is a Farm? Two definitions Secondary Activities Farm –An operation not located on the Primary Production Farm that is also devoted to farming operations. It is majority owned by the Primary Production Farm(s) that supplies the raw agricultural commodities harvested, packed or held by the Secondary Activities Farm. 23

24. Exemptions: 507.5 (e) Subpart C of this part does not apply to on-farm packing or holding of animal food by a small or very small business if the only packing and holding are low-risk packing or holding activity/animal food combinations on animal food not grown, raised, or consumed on that farm mixed-type facility or another farm or farm mixed type facility under the same ownership (see list @ 507.5 (e) (g) Subpart C of this part does not apply to facilities that are solely engaged in the storage of raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing. (h) Subpart B does not apply to the holding or transportation of one or more raw agricultural commodities 24

25. Retail Food Establishment Establishment that sells food products directly to consumers as its primary function –may manufacture/process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufactures/processes, packs, or holds, directly to consumers Establishment's primary function is to sell food directly to consumers –the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers The term "consumers" does not include businesses 25

26. Human Food By-products for Use as Animal Food Human food by-products are not subject to animal food rule (except for provisions for holding and distribution) if: –Human food is produced in compliance with human food CGMPs and all applicable food safety requirements –Not further processed 26

27. Holding and Distribution of Human Food By-Products Must be held in a manner that protects against contamination –Containers cleaned as necessary –Must be accurately identified during holding –Labeling that identifies common or usual name must be affixed to or accompany when distributed Shipping containers examined before use 27

28. Further Processing of Human Food By-Product Further processing of by-products requires compliance with CGMPs Firm can choose to follow either the human food or animal food CGMPs for the processing Requires a hazard analysis If hazards identified, would need to implement a preventive control 28

29. Planned Guidances 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 29

30. For More Information Web site: http://www.fda.gov/fsma Subscription feature available To contact FDA about FSMA and find the new online form for submitting questions: http://www.fda.gov/Food/GuidanceRegulation/ FSMA/ucm459719.htm 30

31. Additional Background 31

32. Qualified End User Consumer of the food or a restaurant or retail food establishment –(i) In the same State or the same Indian reservation as the qualified facility that sold the food –(ii) Not more than 275 miles from such facility – and (2) Is purchasing the food for sale directly to consumers at such restaurant or retail food establishment. 32

33. Qualified Facility Facility that is a very small business as defined in this part, or a facility to which both of the following apply: – (1) During the 3-year period preceding the applicable calendar year, the average annual monetary value of the food manufactured, processed, packed, or held at such facility that is sold directly to qualified end-users during such period exceeded the average annual monetary value of the food sold by such facility to all other purchasers; –(2) The average annual monetary value of all food sold during the 3-year period preceding the applicable calendar year was less than $500,000, adjusted for inflation 33