FDA clarifies draft guidance for on-farm feed safety

FDA draft guidance does not address feed manufacture on farms.

On March 19, the U.S. Food & Drug Administration issued a draft guidance, "Guidance For Industry (GFI) #203," to help animal producers take steps to help keep animal feed safe on the farm. The draft guidance outlines steps animal producers can take to identify feed contaminants that are sometimes present in the farm production environment and to prevent them from jeopardizing the health of farm animals and the safety of human food derived from the animals.

According to FDA, draft guidance GFI #203 is intended to help animal producers identify:

* Important animal feed safety issues that typically are not covered by regulations (e.g., unexpected changes in animal feed consumption patterns that could indicate the presence of contaminants in the feed, or contaminants that may be present in bedding or fencing materials that animals might eat).

* A comprehensive approach to feed safety at the farm, beginning with acquisition of safe feed and maintenance of its safety until the feed is offered to animals. "Farm" means animal production units (e.g., integrated poultry grower operations, swine finishing units, cattle feedlots).

The draft guidance does not address the manufacture of feed on farms, FDA explained.

FDA’s guidance documents, including guidance GFI #203, do not establish legally enforceable responsibilities. Instead, guidance documents describe the agency’s current thinking on a topic and provide recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA guidances means that something is suggested or recommended but not required.

FDA is accepting public comments on this draft guidance through June 3. While comments are welcome at any time, they should be submitted by June 3 in order for FDA to consider the comments in drafting a final guidance.

To submit comments electronically to the docket, go to www.regulations.gov and type FDA-2014-D-1180 in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-D-1180 on each page of your written comments.

The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

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