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FDA issues draft guidance on FSMA customer written assurances

The U.S. Food and Drug Administration (FDA) has issued a draft guidance document covering the requirements for manufacturers when they convey responsibility for controlling a hazard that can affect human or animal health to a customer. These new rules, which require customer disclosure statements, are established under the Food Safety Modernization Act (FSMA).

The rules apply to Preventive Controls for Human Food, Preventive Controls for Animal Food, the Foreign Supplier Verification Program and Produce Safety.

The draft guidance outlines how entities should describe hazards in customer disclosures, as well as the types of documents in which such statements should be included.

The draft guidance document explains FDA’s current thinking on: 1) disclosure statements made when certain hazards have not been controlled by a manufacturer; 2) how to describe the hazard under each of the four rules; and 3) which documents the agency considers to be “documents of the trade” for the purpose of disclosure statements.

FDA published the draft guidance in the Federal Register on Oct. 31 with 180 days for stakeholder comment.

FDA on Aug. 24 issued a final rule that extended by two years the compliance dates for provisions within the FSMA rules related to customer written assurances when a manufacturer passes responsibility for control of a hazard to a customer. Although that rule extended the compliance dates for such written assurances, the rule did not extend the compliance dates for required disclosure statements.


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