The U.S. Food and Drug Administration recently issued draft guidance to assist industry with the implementation of the Preventive Controls for Animal Food rule and another draft guidance to assist businesses in determining whether the activities they perform are within the “farm” definition.

According to the FDA: “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 the 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 the FDA as food facilities. The draft guidance includes several examples of hypothetical operations.”

Two of the draft guidance documents are meant to assist domestic and foreign companies in complying with Current Good Manufacturing Practice (CGMP) requirements and with human food byproduct requirements under the FSMA Preventive Controls for Animal Food Rule.

Draft Guidance for Industry #235 – Current Good Manufacturing Practice Requirements for Food for Animals is intended to help facilities that manufacture, process, pack, or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 about 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Draft Guidance for Industry #239 – Human Food Byproducts for Use as Animal Food will assist facilities that manufacture, process, pack, or hold human food and then subsequently provide the human food byproducts for use as animal food in determining what requirements in the Preventive Controls for Animal Food rule apply to their human food byproduct. Common examples of human food byproducts used for animal food include wheat middlings, grain products from grain milling, and vegetable pulp.

The FDA plans to host a late September webinar to discuss these draft guidelines in more detail. Stay tuned for registration information.

Here are some upcoming compliance dates:

• Human food companies other than small and very small businesses will need to come into compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule by Sept. 19, 2016.
• Animal food companies other than small and very small businesses will need to come into compliance with Current Good Manufacturing Practices (CGMPs) under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule by Sept. 19, 2016, and with preventive controls by Sept. 18, 2017.