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Draft FSMA Guidance for Industry: Describing a Hazard that Needs Control because Permissibly Not Controlled Upstream

FDA has made available for comment a draft guidance for industry that sets forth its current thinking about compliance with provisions of four FSMA final rules that require an entity (e.g., supplier) to include a disclosure statement, in documents accompanying a food, that certain hazards requiring a control have not been controlled by that entity.  See generally Draft Guidance for Industry: Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing FSMA (Oct. 2016); see also Federal Register Notification of Availability (Oct. 31, 2016).  The four FSMA final rules to which the guidance ultimately would apply are:

While comments on any guidance may be submitted at any time, to ensure that FDA considers your comment on this draft guidance before it begins work on the final version, you must submit either electronic or written comments within the next six months.

FDA’s draft guidance provides recommendations about both (i) describing an identified hazard and (ii) documents of the trade fordoing so relative to each of the four regulatory situations.

  • Human Food
  • Describing the identified hazard:
    • FDA believes that most subject hazards for human food will be biological (rather than chemical or physical) in nature. It advises that these biological hazards may be identified generically (e.g.,  “microbial pathogens,” “microorganisms of public health significance”) or specifically (e.g., Salmonella or Listeria monocytogenes). 
    • If a physical/chemical hazard is not controlled, FDA advises that it should be identified specifically (e.g., “mycotoxins,” “aflatoxin,” “stones”).
  • Documents of the trade
    • Recommended: Labels, labeling, bill of lading, shipment-specific certificates of analysis, and other documents or papers associated with the shipment that a food safety manager for the customer is likely to read.
    • Not recommended: Websites, contractual agreements, letters of guarantee, specifications, or terms and conditions.
  • Animal Food
    • Describing the identified hazard: Same as above (for Human Food).
    • Documents of the trade: Same as above (for Human Food).
  • Produce
    • Describing the identified hazard: FDA will consider a farm that discloses “not processed to adequately reduce the presence of microbial pathogens,” or similar phrases, to be in compliance.
    • Documents of the trade: Same as above (for Human Food).
  • FSVP
    • Describing the identified hazard: Same as above (for Human Food).
    • Documents of the trade: Same as above (for Human Food).

The draft guidance, when finalized, will represent the thinking of FDA on this topic.  It will not establish any rights for any person and is not binding on the agency or the public.  You may use an alternative approach, if it satisfies the requirements of the FD&C Act and regulations.  If you want to discuss any alternative approach, contact FDA’s Technical Assistance Network.

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