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FDA Extends Certain FSMA Compliance Dates; Issues Draft Guidance

Wednesday, August 31, 2016

(North American Meat Institute)

The Food and Drug Administration (FDA) last week issued a final rule extending and clarifying the compliance dates for certain provisions in four of the seven foundational rules of the Food Safety Modernization Act (FSMA). The changes announced in the final rule impact the compliance dates for certain provisions in the two Current Good Manufacturing Practices and Preventive Controls rules for human and animal food, the Foreign Supplier Verification Programs (FSVP) final rule and the Produce Safety final rule. The final rule addresses technical issues regarding the practicality of compliance for certain companies and better aligns compliance dates across the four rules.

FDA also issued a new draft guidance document to help industry comply with the Current Good Manufacturing Practices and Preventive Controls rules for human food. The draft guidance explains FDA's current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls and specifies ways to establish food safety plans.

In addition, FDA issued " Draft Guidance for Industry #235 - Current Good Manufacturing Practice Requirements for Food for Animals ," which is intended to help facilities that manufacture, process, pack or hold animal food for consumption comply with Current Good Manufacturing Practices requirements in areas such as personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations and holding and distribution.

Meanwhile, " Draft Guidance for Industry #239 - Human Food By-Products for Use as Animal Food "will assist facilities that manufacture, process, pack or hold human food, and then subsequently provide the human food by-products for use as animal food, in determining the requirements in the Preventive Controls for Animal Food rule that apply to their human food by-product.

The final document, " Draft Guidance for Industry for Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities ," will help food businesses determine the FSMA rules that apply to their operations.

The draft guidance documents are available for public comment. FDA will release additional draft guidance chapters for public comment as they are completed.

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