The American Feed Industry Association submitted comments to the US Food and Drug Administration regarding FDA’s final rule amending the procedures for substances generally recognized as safe (GRAS).
FDA’s Center for Veterinary Medicine 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, according to AFIA.
“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.
CVM stated during several public forums that proof of utility of an ingredient must be published. However, AFIA said it believes that an absolute requirement for proof and publication of utility is inappropriate and unnecessary, claiming the pivotal issue is whether the ingredient is safe to feed to animals at the intended level. AFIA also said 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,” Wilkinson said.
In the third main issue commented upon, AFIA said it believes GRAS-notified substances reviewed by FDA without objection need to be listed in the Association of American Feed Control Officials' Official Publication. In its comments, AFIA strongly encouraged CVM to work with AAFCO and the industry to create a new section in the AAFCO Official Publication for GRAS-notified substances reviewed by CVM and found to present a sufficient basis for a GRAS conclusion.