FSMA Update – What’s the Latest?
Agenda ยง ยง ยง ยง ยง
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Produce Safety vs. Preventive Controls Produce Safety Rule Updates Preventive Controls Updates Supply Chain & FSVP Updates Key Resources & Tips
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Produce Safety vs. Preventive Controls
Produce Safety or Preventive Controls?
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ยง Long-standing debate since draft rule ยง Possibly most significant FSMA enforcement issue ยง Determines how FDA regulates an operation ยง Based on activity, ownership ยง Packing houses, Hullers, Dehydrators, and some Packers impacted
Categorizing Activities § Farm Activities § § § §
Fumigating Hulling Sizing / screening Drying
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§ Processor Activities § Roasting § Cutting, chopping § Grinding, extruding
§ Both § Holding (storing) § Packing § Transporting
Enforcement Discretion
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§ January 2018 § What is enforcement discretion? § For PC requirements as applicable to some facilities § Currently fall under PC rule due to ownership, coloring activities, or dried commodity § Conduct farm activities
§ Future rulemaking expected to modify definition of “farm”
What’s Changed
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Examples
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§ Grain elevators (were already exempt) § Facility storing, coloring, and packing oranges § Huller / sheller or dehydrator processing mostly products owned by others § On-farm storage, packing of dried fruit – considered processed; enforcement discretion in place § Packing produce RACs is still required to comply with GMPs (was already in place under 110)
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Produce Safety Rule Updates
Water Testing – The Big One!
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September 2017 - FDA published a Proposed Rule, “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E” § Reasoning: “to address questions about the practical implementation of compliance with certain provisions” § “…consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration's policies.”
Compliance Dates Extended ยง Four Year Delay for water
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Additional Testing Methods
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Enforcement Update
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§ Enforcement delayed an extra year § Starting date January 2019 § Currently conducting voluntary “On-Farm Readiness Reviews” § In CA, we largely expect CDFA to enforce
On The Horizon
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ยง FDA & PSA actively discussing soil amendments ยง Some discussion on animal controls as well ยง Research still being done to further define some items ยง E.g. guidance on raw manure pre-harvest interval
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Preventive Controls Updates
Human Food By-Products
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§ Current requirements for processors: § Clear labeling § Proper storage (under GMPs) § Not commingled with waste / trash
§ After the human food facility, products become part of animal food chain § Many later activities will fall under animal feed PC rule (21 CFR 507)
Human Food By-Products (At The Processor) § Enforcement discretion in place for:
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§ Drying, dehydrating, pressing, chopping, etc. to reduce bulk § Mixing / combining components
§ NOT in place for: § Process to address pathogens (e.g. heating, cooling) § Pelleting, extruding, or formulating § Further processing by human food facility § Processes which may introduce a hazard
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Supply Chain & FSVP Updates
First Things First
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§ FSMA rules consider FSVP rule equivalent to PC rule supply chain requirements (Subpart G) § A broker is not a supplier! “Supplier means the establishment that manufactures/ processes the food, raises the animal, or grows the food that is provided to a receiving facility without further manufacturing/processing by another establishment, except for further manufacturing/ processing that consists solely of the addition of labeling or similar activity of a de minimis nature.
§ A customer is a commercial customer (not a consumer)
Who Controls The Hazard?
Supplier
• Manufacturer, processor • Raise the animal • Grow the food
Receiving Facility • Manufacturer, processor
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Customer
• Manufacturer, processor or preparer
*Transparency & Communication* Source: Microsoft Office Clipart
FDA’s View on Controlling Hazards
Food
Identify Hazard (i.e. Salmonella)
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Controlled by Supplier (e.g. pasteurized)
Verify their program (validation, on-site audit, lab tests)
Controlled by my process (e.g. baking)
Control it (validate, monitor temp, lab tests, etc)
Controlled by My customer (e.g. roasting)
Documentation required (some deadlines delayed)
Written Assurances
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ยง PC Human Food, PC Animal Food, FSVP, and Produce Safety all include them ยง Communication from supplier is still required ยง Guarantee from customer to supplier is under enforcement discretion ยง FDA is reconsidering due to complexity of supply chain
How to Describe the Hazard
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§ Draft Guidance § Biological hazards, general is ok – “microbial pathogens”; “microorganisms of public health significance” § Chemical, physical should be specific – “stones”, “mycotoxins”, “aflatoxin”
§ ABC Example for Salmonella: § “Almonds are not processed to adequately reduce the presence of microorganisms of public health significance”
Food Contact Substances
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§ In contact with food but not expected to have any “technical effect” § Regulated as food under current definition § Requirement: hazard analysis, supplier evaluation, supplier verification § Enforcement discretion in place § FDA considers its existing premarket review to be adequate oversight
Co-Manufacturing & Supply Chain
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§ Human & Animal Food Preventive Controls, FSVP apply § The issue: co-manufacturers often do not manage their customer’s suppliers
Co-Manufacturing & Supply Chain
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ยง FDA has decided not to enforce supply chain provisions until Nov. 2019, if: ยง 1) Brand owner conducts supplier approval and verification activities ยง 2) Co-manufacturer describes this in its plan ยง 3) Any additional required activities are conducted
ยง Receiving controls still required!
Accredited Third Party Certification
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Supply Chain Resources
FDA Resources
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Guidance & Scientific Support § Food safety plan templates § Known potential hazards § FDA’s minimum expectation
§ Pathogen growth & toxin formation § Heat Treatment guidance § Control of Listeria
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Other Resources
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§ USP § Foodfraud.org § Food Chemicals Codex
§ Codex Alimentarius (EU) § USDA, other regulators as applicable § GMA, Almond Board, CFFA, PMA, and other guidance
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Thank You! Jon Kimble Senior Food Safety Manager Safe Food Alliance JonK@safefoodalliance.com
Corporate Office 710 Striker Avenue Sacramento, CA 95834 P. 916.561.5900