FDA releases final rule to implement FSMA intentional adulteration provisions for human food.

  • On May 26, 2016, FDA released its final rule to implement the intentional adulteration (or “food defense”) provisions of the FDA Food Safety Modernization Act (FSMA).  Click here for a pre-publication copy of the final rule.  Click here for an FDA fact sheet summarizing the final rule.
  • The final rule establishes various food defense measures that registered facilities are required to implement to protect against the intentional adulteration of food.  As a general matter, facilities must prepare and implement a written food defense plan that identifies significant vulnerabilities and actionable process steps, mitigation strategies, and procedures for food defense monitoring, corrective actions, and verification.  Facilities also have new training and recordkeeping requirements under the final rule.  Several types of facilities and activities are exempt from compliance.  Specifically, the new requirements do not apply to:  (i) very small businesses; (ii) the holding of food, except the holding of food in liquid storage tanks; (iii) the packing, re-packing, labeling, or re-labeling of food where the container that directly contacts the food remains intact; (iv) activities that fall within the definition of “farm”; (v) animal food; (vi) alcoholic beverages under certain conditions; and (vii) certain on-farm food/activity combinations performed by small or very small businesses.
  • The rule is scheduled for publication in the Federal Register on May 27, 2016 with an effective date 60 days thereafter.  Companies generally have 3 years after the effective date to comply with the new requirements (i.e., July 2019).  Small businesses will have an additional year to comply (i.e., July 2020).

With the issuance of this final rule, FDA has met its final court-imposed deadline under its settlement agreement to end a lawsuit premised on the Agency’s prior delay in issuing seven major rules to implement the core of FSMA.  Keller and Heckman is preparing a full analysis of the final rule.