FDA Lays Out Ambitious Agenda in the Latest Draft of its Framework of the Animal Feed Safety System

By Ricardo Carvajal & Diane B. McColl –

In the fourth and most recent draft of the framework of its Animal Feed Safety System (“AFSS”), FDA provides a comprehensive overview of the system and of the significant gaps in that system that FDA intends to address (the AFSS is “FDA’s program for animal feed aimed at protecting human and animal health by ensuring production and distribution of safe feed,” and it covers both feed for food-producing animals and pet food).  FDA’s task is daunting, as illustrated by this partial list of items on FDA’s to-do list:

• In accord with the FDA Amendments Act of 2007 (“FDAAA”), FDA’s Center for Veterinary Medicine (“CVM”) intends to establish feed ingredient standards and definitions through notice-and-comment rulemaking.  Before enactment of the FDAAA, FDA had planned to establish a policy recognizing the acceptability of ingredients defined in the Association of American Feed Control Officials’ (“AAFCO”) Official Publication.

• CVM plans to develop process control regulations (e.g., HACCP) to address “feed safety issues associated with the manufacture, packaging, storage, and distribution of non-medicated feed ingredients and mixed feed” (such controls are already in place for medicated feed).

• CVM intends to modernize the GMP regulations for medicated feeds.

• As required by the FDAAA, CVM plans to issue a regulation that sets standards for the provision of nutrition and ingredient information on the label of pet foods.

The draft also confirms that CVM plans to start a pilot program to process voluntary notifications of self-determinations of Generally Recognized as Safe (“GRAS’) status for animal feed and pet food ingredients. An Ingredient Safety Team has been created in CVM’s Division of Animal Feeds to review the GRAS Notices. CVM's pilot GRAS Notice program is expected to commence upon publication of a forthcoming Federal Register notice, which we understand will explain the differences between the CVM GRAS Notice program and the Center for Food Safety and Applied Nutrition GRAS Notice program for human food ingredients.