1. Overview of Current Approach to FSMA Section 104: Performance Standards Mickey Parish, Ph.D. FDA/CFSAN/OFS Senior Advisor FDA Food Advisory Committee Monday, 29 Sept 2014

2. FSMA Section 104 Performance Standards

3. FSMA Section 104. Performance Standards (a) IN GENERAL.—The Secretary shall, in coordination with the Secretary of Agriculture, not less frequently than every 2 years, review and evaluate relevant health data and other relevant information, including from toxicological and epidemiological studies and analyses, current Good Manufacturing Practices issued by the Secretary relating to food, and relevant recommendations of relevant advisory committees, including the Food Advisory Committee, to determine the most significant foodborne contaminants.

4. FSMA Section 104. Performance Standards (b) GUIDANCE DOCUMENTS AND REGULATIONS.—Based on the review and evaluation conducted under subsection (a), and when appropriate to reduce the risk of serious illness or death to humans or animals or to prevent adulteration of the food under section 402 of the Federal Food, Drug, or Cosmetic Act (21 U.S.C. 342) or to prevent the spread by food of communicable disease under section 361 of the Public Health Service Act (42 U.S.C. 264), the Secretary shall issue contaminant-specific and science-based guidance documents, including guidance documents regarding action levels, or regulations. Such guidance, including guidance regarding action levels, or regulations— (1) shall apply to products or product classes; (2) shall, where appropriate, differentiate between food for human consumption and food intended for consumption by animals other than humans; and (3) shall not be written to be facility-specific.

5. Current Thinking in FDA regarding 104(a)

6. Current Thinking in FDA “Performance Standards” Strict interpretation: Set tolerances, action levels, log-reduction or end-point targets for hazards in foods. Broader interpretation: Engage in activities to inform risk prioritization efforts across the FVM Program. (Could include tolerances, log- reductions etc.)

7. Current Thinking in FDA “Performance Standards” Interpreted in a broad sense More than just setting tolerances, log- reductions or endpoints Address the needs for risk analysis to inform model development, sampling and surveillance, prioritization of activities, resource allocations, etc.

8. Current Thinking in FDA Guiding Principals for Determining MSFC: 1. Utilize objective public health data when available 2. Science-based 3. Seek public input 4. Transparent process

9. 104(a) “…determine the most significant foodborne contaminants.” Most significant foodborne contaminants = contaminants having significant public health impact

10. 104(a) “…determine the most significant foodborne contaminants.” Early considerations: Human food and Animal food/feed Microbiological pathogen contaminants and chemical/allergen contaminants Risk ranking approach

11. Current Thinking in FDA for 104(a) Microbiological Contaminants

12. Current Thinking in FDA for 104(a) Human Food: Microbiological Contaminants Pathogen – Food category pairing Based on CDC database and food categories Economic analysis based on total costs attributable to pathogen/food pairs Rank pathogens within food categories by financial impact to public health

13. Current Thinking in FDA for 104(a) 14 FDA-Regulated Food Commodity Groups from CDC: Finfish Crustaceans Mollusks Dairy Eggs Game meat Grains-Beans Oil-Sugar Fruit-Nuts Fungi Leafy vegetables Root vegetables Sprouts Vine-stalk vegetables

14. Current Thinking in FDA for 104(a) 22 Pathogens (includes Marine Biotoxins): AnisakisGiardia B. cereusHep A BrucellaListeria monocytogenes C. botulinumMarine Biotoxins C. perfringensNorovirus CampylobacterSalmonella CryptosporidiumShigella CyclosporaStaphylococcus E. coli non-O157 STECTrichinella E. coli O157 STECVibrio spp. E. coli otherViruses (other)

15. Current Thinking in FDA for 104(a) Animal Food/Feed: Pathogens Analysis criteria: Ability to cause illness in animals consuming the contaminated commercial feed or in humans exposed either to the feed or to the animals affected by the feed; Severity of the illness; The likelihood of exposure of the animal or human population to the contaminant through the food supply; The ability to mitigate contamination across the farm-to-fork continuum;

16. Current Thinking in FDA for 104(a) Animal Food/Feed: Pathogens considered – Brucella – Campylobacter – Clostridium – Cronobacter sakazakii – Cyanobacteria – Escherichia coli O157:H7 – Listeria monocytogenes – Yersinia

17. Current Thinking in FDA for 104(a) Chemical contaminants

18. Current Thinking in FDA for 104(a) Chemical contaminants in human food and animal food/feed Fewer public health data available Model development from IFT/RTI task order, including expert panel Chemicals divided into five bins: 1) allergens, 2) toxic elements, 3) mycotoxins, 4) pesticide residues, and 5) other chemicals

19. Current Thinking in FDA for 104(a) Chemical contaminants in human food and animal food/feed Model criteria: – Exposure: Likelihood or level of human or animal exposure to the chemical contaminant via food – Health Effects: Severity of illness or toxicity of the chemical contaminant – Controllability: Hazard characteristics that can or cannot be controlled in the manufacturing or processing environment, and existence of government policy controls. Model accounts for data uncertainty

20. Current Thinking in FDA for 104(a) Next Steps: Peer review micro and chemical approaches/models Public meeting or workshop Revise approaches/models Publish drafts Receive public comment Publish final documents More activity likely after final publication of current rules

21. Questions?