WASHINGTON, Oct. 25, 2013 – FDA today released its fifth proposed rule under the Food Safety Modernization Act (FSMA), this one dealing with food for animals. Some on-farm operations, however, could be excluded from the proposed regulations.

The rule would establish new Current Good Manufacturing Practices (CGMP) guidelines for animal feed and pet food producers, as well as hazard analysis and preventative control requirements similar to the Hazard Analysis and Critical Control Points (HACCP) system currently regulating the juice and seafood industries.

As with previous proposed FSMA rules, this animal feed rule will be paperwork-intensive, with facilities expected to analyze on-site hazards to produce contingency plans in case of recall, cross-contamination and other foreseeable emergencies. Those plans would be reassessed every three years to keep them up to date, the agency says.

Some of the proposed guidelines would not, however, apply to a number of on-farm operations, after a February draft risk assessment by FDA determined those activities pose little threat to animal or human health.

Those exempt farm activities could include conveying, weighing, sorting, culling or grading grains, oilseeds and some other plant byproducts (like culled fruit and potatoes). Also possibly exempt: on-farm or farm-adjacent facilities that store dry grain; pack grain or oilseed; shell some products; label grain or oilseed; and cut or shred hay, among others.

FDA estimates compliance will cost industry $128.75 million per year.

Agriculture groups have yet to the respond to the specifics on the rule, but National Grain and Feed Association President Randy Gordon said he is “eager to work with FDA.”

"It will be vitally important that FDA's regulations provide the flexibility necessary for companies to continue to effectively address feed safety, as well as provide the necessary education and training of its inspectors and the regulated industry,” he said.

The rules, which also apply to pet food, are released as a difficult time for FDA’s animal food regulation team: The agency yesterday asked pet owners for help in determining why jerky pet treats from China have killed approximately 580 pets since 2007.

FDA’s Center for Veterinary Medicine (CVM) has conducted more than 1,200 tests on the treats, but said in an update yesterday,“[T]he exact cause of the illnesses remains elusive.”

 FDA will accept comments on the proposed food for animals rule for 120 days after it officially appears in the Federal Register (probably October 29). During that time, the agency will also host three public meetings in Maryland, Illinois and California.


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