Health Law Daily FDA to exercise enforcement discretion for FSMA provisions
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Friday, January 5, 2018

FDA to exercise enforcement discretion for FSMA provisions

By Victoria Moran, J.D., M.H.A.

The FDA will exercise enforcement discretion for provisions in four rules implementing the Food Safety Modernization Act (FSMA) (P.L. 111-353). During this discretion period, the FDA will not enforce the provisions as applied to certain activities and entities to allow for further time to consider changes (Notice, 83 FR 598, January 5, 2018).

Background. Per the Final rule published August 24, 2016 (81 FR 57784), the FDA extended compliance dates for provisions in the following four FSMA rules to address concerns related to compliance feasibility, consider changes to the language of the regulations, and align compliance dates with other rules:

  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food;
  • Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Food for Animals;
  • Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; and
  • Foreign Supplier Verification Programs (FSVP) for Importers of Food or Humans and Animals.

The enforcement discretion discussed in the Guidance concerns provisions in these four rules.

Who is affected? As discussed in the Guidance, a number of concerns have arisen and the FDA has received feedback resulting in the need for additional time to consider changes to the application of the rules. The enforcement discretion applies to the following facilities and requirements:

  • facilities that would qualify as a "farm" except for various factors or activities;
  • written assurances under "customer provisions" in part 117 and related rules concerning the control of hazards and microorganisms posing potential public health risks;
  • requirements for the importation of food contact substances under the FSVP regulation; and
  • human food by-products for use as animal food, which includes the application of animal food preventive controls requirements on manufacturing and processing activities.

For further discussion of the FDA’s enforcement discretion decision, rationale for delaying enforcement, and tables summarizing the enforcement policies see the Guidance. The FDA also issued a fact sheet that simplifies the Guidance and provides explanations of how the FDA will continue to protect public health.

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