The Food and Drug Administration last week opened public comments for draft guidance designed to help the industry comply with the Preventive Controls for Animal Food rule of the Food Safety Modernization Act.  The agency also released draft guidance clarifying which activities conducted by companies fall under its “farm” or “facility” classifications in every FSMA rule.

Even though many dairy companies do not produce animal food, they are subject to conditions in the FSMA Preventive Controls for Animal Food rule if they provide human food by-products for consumption by animals.

The “Human Food By-Products for Use as Animal Food” draft guidance, now available for public comment, explains FDA’s current thinking on how companies can comply with the Current Good Manufacturing Practices (CGMP) included in the rule’s requirements. It also includes information to help facilities determine what portions of the rule apply to their products.

Read Draft Guidance for Industry #239 - Human Food By-Products for Use as Animal Food.”

FDA released a second draft guidance document for public comment explaining its classification of food business activities as either “farm” or “facility” actions. Dairy farms that do not conduct any “manufacturing/processing” of milk are considered “farms” and are exempt from FDA’s facility registration requirements and therefore exempt from the Preventive Controls for Human Food rule. “Cooling” of bulk milk at the farm level is considered to be a “holding” activity, not “processing,” according to the draft guidance.

Read: “Draft Guidance for Industry for Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities.”

The comment period for the draft Human Food By-Products for Use as Animal Food guidance will close November 23, and comments on the draft Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities guidance are due by February 21, 2017.

IDFA encourages members with comments, questions or concerns to contact John Allan, IDFA vice president of regulatory affairs and international standards, at jallan@idfa.org.