overview of current approach to fsma section 104: performance standards mickey parish, ph.d....
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Overview of Current Approach to FSMA Section 104: Performance Standards
Mickey Parish, Ph.D.FDA/CFSAN/OFSSenior Advisor
FDA Food Advisory Committee
Monday, 29 Sept 2014
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FSMA Section 104
Performance Standards
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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.
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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.
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Current Thinking in FDA regarding 104(a)
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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.)
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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.
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Current Thinking in FDA
Guiding Principals for Determining MSFC:
1. Utilize objective public health data when available
2. Science-based3. Seek public input 4. Transparent process
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104(a) “…determine the most significant foodborne contaminants.”
Most significant foodborne contaminants = contaminants having significant public health impact
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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
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Current Thinking in FDA for 104(a)
Microbiological Contaminants
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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
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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
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Current Thinking in FDA for 104(a)22 Pathogens (includes Marine Biotoxins):
Anisakis GiardiaB. cereus Hep ABrucella Listeria monocytogenesC. botulinum Marine BiotoxinsC. perfringens NorovirusCampylobacter SalmonellaCryptosporidium ShigellaCyclospora StaphylococcusE. coli non-O157 STEC TrichinellaE. coli O157 STEC Vibrio spp.E. coli other Viruses (other)
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Current Thinking in FDA for 104(a)
Animal Food/Feed: PathogensAnalysis 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;
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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
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Current Thinking in FDA for 104(a)
Chemical contaminants
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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
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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
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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
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Questions?