1. Proposed Rule for Preventive Controls for Animal Food 1

2. Why FSMA is Important Too many preventable foodborne illnesses Too many costly disruptions in the marketplace Loss of public confidence Global pressures on food safety and oversight system 2

3. Key FSMA Principles Primary industry responsibility for food safety Focus on farm-to-table prevention Science- and risk-based Focus on enhanced domestic inspection and modern import oversight Partnerships key to success 3

4. Who is Covered? Facilities that manufacture, process, pack or hold animal food In general, facilities required to register with FDA under sec. 415 of the FD&C Act Applies to domestic and imported food Some exemptions and modified requirements are being proposed

5. Farm-Related Exemptions Activities within the definition of “farm,” including farm activities that are covered by the proposed produce rule Certain low-risk manufacturing/processing, packing and holding activities conducted by small/very small businesses on farms for specific foods

6. Farm Definition (21 CFR 1.227) Farm means a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. The term "farm" would include: (1) Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership and (2) facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership. 6

7. Exemptions and Modified Requirements -1 “Qualified” facilities: –Very small businesses (3 definitions being proposed—less than $500,000, less than $1millon and less than $2.5 million in total annual sales) OR –Food sales averaging less than $500,000 per year during the last three years AND –Sales to qualified end users must exceed sales to others

8. Exemptions and Modified Requirements - 2 Certain storage facilities such as grain elevators and warehouses that only store raw agricultural commodities (other than fruits and vegetables) intended for further distribution or processing are exempt from hazard analysis and risk-based preventive controls. –Also exempt with respect to CGMPs

9. Summary of Requirements Establish, for the first time, Good Manufacturing Practices for animal food Hazard Analysis and Risk-Based Preventive Controls –Each facility would be required to implement a written food safety plan that focuses on preventing hazards in foods

10. New Current Good Manufacturing Practices Personnel Plant and grounds Sanitary operations Sanitary facilities and controls Processes and controls Equipment and utensils Warehousing and distribution 10

11. CGMP Elements cont’d Personnel –follow good hygiene practices –protection of food from contamination from personal effects Plant and grounds –including proper cleaning, maintenance, and pest control.

12. CGMP Elements cont’d Sanitary operations –includes maintaining clean and sanitary conditions of food contact surfaces, proper use and storage of toxic cleaning compounds, and exclusion of pests Sanitary facilities and controls –such as the plant's water supply, plumbing, and toilet and hand-washing facilities

13. CGMP Elements cont’d Processes and controls includes: –following adequate sanitation principles –proper labeling of ingredients and finished animal food –ensuring the safety of raw materials –prevention of contamination of animal food during processing

14. CGMP Elements cont’d Equipment and utensils –includes the cleaning and maintenance of such items and protecting animal food from contamination Warehousing and distribution –Includes protecting animal food against contamination and deterioration

15. CGMP Elements cont’d Spectrum of animal food producers and production facilities, and hazards and risks can vary greatly Requesting comment whether CGMPs related to human food are appropriate for animal food Requesting comment on CGMP requirements by types of animal food –Appropriate for some but not for others? –How can/should FDA distinguish between animal food types? 15

16. Specific Provisions 21 CFR 507 Subpart C Hazard Analysis and Risk-based Preventive Controls

17. Hazard Analysis and Risk- Based Preventive Controls

18. Hazard Analysis Identify known or reasonably foreseeable hazards for each food type to determine whether there are hazards that are reasonably likely to occur –Including an assessment of the severity of the illness or injury if the hazard were to occur Must consider hazards that may occur naturally or may be unintentionally introduced Must include biological, chemical, physical and radiological

19. Measures Under Consideration: Additional Verification We are seeking comment on –Finished product testing –Environmental testing –Supplier verification

20. Finished Product Testing Should FDA require finished product testing? “(3) Performance of scientifically valid finished product testing, when appropriate based on risk, to assess whether the preventive controls significantly minimize or prevent the hazards that are reasonably likely to occur” When and how is finished product testing an appropriate means of verifying that hazards are being effectively controlled?

21. Environmental Testing “(4) Performance of environmental monitoring for any environmental pathogens that are reasonably likely to occur, or for appropriate indicator organisms for such pathogens, at a frequency of not less than monthly, to assess whether the preventive controls significantly minimize or prevent the environmental pathogens that are reasonably likely to occur. Environmental monitoring must be scientifically valid and must include: Collecting and testing When and how is environmental testing an appropriate means of verifying that hazards are being effectively controlled?

22. Supplier Approval and Verification Should FDA require supplier approval and verification? –requirements for supplier verification are primarily based on who is to control the hazards that are reasonably likely to occur. When and how is a supplier approval and verification program an appropriate preventive control measure?

23. Effective and Compliance Dates Effective date: 60 days after the final rule is published Compliance Dates Small Businesses—a business employing fewer than 500 persons would have two years after publication of final rule

24. Compliance Dates cont’d Very Small Businesses—a business having less than $500,000 (or alternatively $1 million or $2.5 million) in total annual sales of food would have three years after publication to comply. -Very small businesses are considered “qualified” facilities and subject to modified requirements Other Businesses—a business that does not qualify for exemptions would have one year after publication of the final rule to comply.

25. How to Comment on the Proposed Rules www.regulations.gov Link to rules on www.fda.gov/fsma Comment period is 120 days Comment periods on other major FSMA proposals will be coordinated to enable comment on how the rules can best work together

26. More Information Available Web site: http://www.fda.gov/fsma Subscription feature available Send questions to FSMA@fda.hhs.govFSMA@fda.hhs.gov Comments on regulation: –www. regulations.gov