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FDA Releases Draft FSMA Guidance; Clarifies Compliance Dates

Aug 24, 2016

The Food and Drug Administration is moving forward in implementing the Food Safety Modernization Act (FSMA), with the first major compliance dates beginning next month for large food facilities. FDA released yesterday new draft guidance to help industry comply with certain requirements in the Preventive Controls for Human Food rule. FDA also issued a final rule that extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules, including an extension for dairy facilities producing Grade “A” milk products to comply with the new modernized Current Good Manufacturing Practices (CGMPs) requirements.

While the provisions in the FSMA rules remain the same, the final rule released yesterday addresses technical issues and aligns the compliance dates across the rules for CGMPs and Preventive Controls for Human and Animal Food, the Foreign Supplier Verification Programs rule and the Produce Safety rule.

The changes will allow more time for manufacturers to meet requirements related to certain assurances that their customers must provide and more time for importers of food-contact substances to comply with foreign supplier verification requirements. The rule also provides other extensions to align compliance dates for various other food operations or to provide time for FDA to resolve specified issues.

CGMP Compliance for Grade “A” Plants

One of the several compliance deadline extensions announced by FDA is specific to the dairy industry. Facilities operating under the Pasteurized Milk Ordinance (PMO) will now have until September 17, 2018, to comply with the modernized Current Good Manufacturing Practices contained in the Code of Federal Regulations, title 21, part 117, subpart B. The rule expands the extension granted last year by FDA for Grade “A” plants that only applied to compliance with the preventive control provisions of the rule.

FDA noted it will continue to work with the National Conference on Interstate Milk Shipments (NCIMS) to modify the PMO to reflect the modernized CGMPs and the preventive control requirements. The extension will create a single compliance date for Grade “A” milk and milk products covered by the PMO. This specific extension applies only to Grade “A” milk and milk products covered by NCIMS under the PMO and not to the manufacturing, processing, packing or holding of other food produced in such facilities.

Draft Guidance on Preventive Controls for Human Food

The draft guidance, which is available for public comment, includes five chapters that explain FDA’s current thinking on how companies can comply with the requirements of the Preventive Controls for Human Foods rule. It covers guidance on conducting a hazard analysis and how to identify and implement preventive controls and associated preventive-control management components as part of a plant’s food safety plan.

FDA will release additional chapters of the draft guidance for public comment as they are completed. The agency plans to release all chapters by early 2018.

For more information, visit:

Members with questions may contact John Allan, IDFA vice president of regulatory affairs and international standards, at

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