FDA Extends Certain FSMA Compliance Dates; Issues Draft Guidance

Preventive Controls for Human Food

The U.S. Food and Drug Administration (FDA) is moving forward with implementing the FDA Food Safety Modernization Act, with the first major compliance dates beginning next month for large food facilities.

While the major provisions of the FSMA rules are being implemented as planned, the FDA issued a final rule that extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules. These changes are part of the FDA’s continuing efforts to make the rules as practical as possible while still protecting public health. The final rule addresses technical issues and better aligns compliance dates across the four rules.

FDA published a draft guidance, available for public comment starting August 24th, five chapters of what will be multi-chapter guidance designed to help businesses comply with the CGMP and Preventive Controls for Human Food Rule. The draft guidance explains FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls and includes a discussion about establishing a food safety plan.

The FDA will release additional chapters of the draft guidance for public comment as they are completed. The agency plans on releasing all chapters of this draft guidance by early 2018.

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Preventive Controls for Animal Food

As the implementation of the FDA Food Safety Modernization Act (FSMA) continues, the agency issued two draft guidances to assist industry with the implementation of the Preventive Controls for Animal Food rule and another draft guidance to assist businesses in determining whether the activities they perform are within the “farm” definition.

For more information, see FDA Issues Draft Guidances under the FDA Food Safety Modernization Act for Animal Foods and the Classification of Activities for Farms and Facilities.