FDA Issues Draft Guidance for FSMA Rules, Extends Some Deadlines

FDA issued the first of its FSMA draft guidances this week, including the first five chapters of a multi-chapter guidance for the Preventive Controls for Human Food rule, two for the Preventive Controls for Animal Food rule and one for determining whether the activities they perform are within the “farm” definition.

• Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food. 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 The draft guidance explains FDA’s current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls and includes a discussion about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. FDA will release additional chapters of the draft guidance for public comment as they are completed. The agency plans on releasing all chapters of this draft guidance by early 2018.
• Draft Guidance for Industry #235 - Current Good Manufacturing Practice Requirements for Food for Animals is intended to help facilities that manufacture, process, pack or hold animal food for consumption in the United States comply with CGMP requirements in areas such as personnel, plant and grounds, sanitation, water supply and plumbing, equipment and utensils, plant operations, and holding and distribution. The guidance also includes information on training and related recordkeeping. The CGMPs required under the Preventive Controls for Animal Food rule are flexible to address the diversity of facilities and animal foods, the wide range of animal food activities, and the potential safety risks posed by some animal foods.
• Draft Guidance for Industry #239 - Human Food By-Products for Use as Animal Food will assist facilities that manufacture, process, pack or hold human food and then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 what requirements in the Preventive Controls for Animal Food rule apply to their human food by-product. Common examples of human food by-products used for animal food include wheat middlings, grain products from grain milling, and vegetable pulp.
• Draft Guidance for Industry for Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities is aimed at helping food businesses determine which of the FSMA rules apply to their operations. In general, businesses that only perform activities within the “farm” definition are not subject to the FSMA Preventive Controls for Human Food or Animal Food rules. Instead, when their activities involve covered produce, farms may be subject to the FSMA Produce Safety rule. Facilities conducting activities that are outside the farm definition generally need to register with FDA as food facilities (unless other exemption(s) apply, such as the exemptions for retail food establishments and restaurants) and may be subject to the FSMA Preventive Controls for Human Food or Animal Food rule. Farms, including those subject to the Produce Safety rule, are not required to register with FDA as food facilities. The draft guidance includes several examples of hypothetical operations.

All four draft guidances are available for public comment,and FDA is planning on hosting webinars later in September on its draft guidances.

Compliance Date Extensions

FDA has issued a final rule that extends and clarifies the compliance dates for certain provisions in four of the seven foundational rules. The changes are part of 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.

The changes impact the compliance dates for certain provisions in these four rules: the two CGMP and Preventive Controls rules for human and animal food, Foreign Supplier Verification Programs (FSVP), and Produce Safety and provide more time for manufacturers to meet requirements related to certain assurances that their customers must provide, more time for importers of food contact substances, and other extensions to align compliance dates for various other food operations or provide time for FDA to resolve specified issues. The rule also clarifies the timeframe for agricultural water testing.

For the specific extensions, see Compliance Date Extensions and Clarifications for FSMA Final Rules.