FDA Issues Three New Draft Guidelines under the FSMA


The U.S. Food and Drug Administration’s (FDA) issued three new Draft Guidances under the FDA Food Safety Modernization Act (FSMA).

The U.S. Food and Drug Administration (FDA) issued three new Draft Guidances under the FDA Food Safety Modernization Act (FSMA).

All three draft guidances are now available to the public and are meant to assist domestic and foreign food companies in complying with the Current Good Manufacturing Practice (CGMP) requirements, which include guidance in the following areas: personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, and holding and distributions.

The new draft guidelines require hazard prevention practices in human and animal food processing, packaging, and storage facilities. FSMA created a framework that holds manufacturers accountable for having a food safety plan, implementing it, verifying that it works, and taking corrective action when it does not.

Deadlines for human and animal food facilities to meet these preventive controls and CGMP requirements differ based on the size of the business. Smaller business will have anywhere from one to two years in additional time; however, bigger businesses must implement these requirements by September 19, 2016.

The FDA is planning on hosting a webinar later in September to discuss these draft guidances in more detail. In general, businesses that only perform activities within the “farm” definition are not subject to the FSMA Preventative Controls for Human Food and Animal Food rules. Instead, when activities involve covered produce, farms may be subject to the FSMA Produce Safety rule. These draft guidances, and the others, for the FSMA rules, will be further refined based on input the FDA receives from the public.

In a joint statement published on FDA Voices, Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition and Tracey Forfa, JD, acting director of the FDA’s Center for Veterinary Medicine said, “We meant what we said about “educating before and while we regulate,” since these new standards will ultimately transform the nation’s food safety system.” They go on to say, “Meeting the FSMA mandate involves cooperation between the FDA and the food industry. From the smallest food operation to the largest company, we want to be sure that we’re all on the same page and these draft guidances will help get us there.”

The FDA will consider comments received during the periods designated in the Federal Register notices before completing final versions of the guidances.

More information is available at the links below:

Federal Register Notice for the Draft Guidance for Industry on Current Good Manufacturing Practice Requirements for Food for Animals.

Federal Register Notice for the Draft Guidance for Industry on Human Food By-Products for Use as Animal Food.

Federal Register Notice for the Draft Guidance for Industry for Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities.

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