For that reason, AFIA recently submitted comments to the U.S. Food and Drug Administration (FDA) regarding FDA’s final rule amending the procedures for substances Generally Recognized as Safe (GRAS).
FDA reopened the comment period in late 2010 to finalize the rule amending the procedures for GRAS. After 14 years of inaction on the proposed rule, this comment period was necessary to update feedback to the FDA regarding the proposed GRAS notification process. FDA’s Center for Veterinary Medicine (CVM) has only recently started to review GRAS submissions for new animal feed ingredients while the human food industry has had hundreds reviewed and allowed on the market.
“While the industry is still able to self-determine the GRAS status of a substance, it is in the best interest for all entities to work together. Finding a workable solution will ensure that the U.S. feed industry continues to be the world leader in bringing novel ingredients to market to help the animal agriculture industries safely feed the growing population,” said Leah Wilkinson, AFIA’s director of ingredients and state legislative affairs.
The U.S. feed industry has a long history of providing safe ingredients in animal feed, but recognizes the role that federal officials in the FDA-CVM and state feed control officials as part of the Association of American Feed Control Officials (AAFCO) can play in reviewing these ingredients.
CVM has stated during several public forums that proof of utility (i.e., functionality) of an ingredient must be published. AFIA believes that an absolute requirement for proof and publication of utility is inappropriate and unnecessary. Although AFIA understands that an intended use must be described and supported in the notice, the pivotal issue is whether the ingredient is safe to feed to animals at the intended level. Both industry and CVM resources could be better used demonstrating the safety of the intended use of the substance with a focus on establishing the worst-case exposure and relating it to available safety information in order to establish a margin of safety. As it stands, the requirement for and public documentation of the utility of an ingredient will predictably stifle innovation in the feed ingredient industry.
AFIA also believes that CVM should accept safety data extrapolated from other species, instead of requiring separate tests for each species. “The additional cost and time alone will deter companies from pursuing new feed ingredients or more efficient ways to produce existing feed ingredients regardless of the well-established safety of these ingredients. CVM should recognize that good scientific procedures can prevail to allow the use of other data or information in the available literature to extrapolate the safety data from one species to another,” stated Wilkinson.
In the third main issue commented upon, AFIA believes that GRAS-notified substances reviewed by FDA without objection need to be listed in the AAFCO Official Publication. Without a listing in the Official Publication, most states will not allow these ingredients to be used.
AFIA said it strongly encourages CVM to work with AAFCO and industry to create a new section in the AAFCO Official Publication for GRAS-notified substances that were reviewed by CVM and found to present a sufficient basis for a GRAS conclusion.