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GRAS Notification for Animal Feed Ingredients

The FDA’s Center for Veterinary Medicine (CVM) has announced it will begin accepting generally recognized as safe (GRAS) Notifications for animal feed ingredients in the near future – this has the potential to be a genuine game-changer, but only if CVM can exercise some flexibility and common sense – an inflexible rule set is going to defeat the purpose of the process.

In the past, there were basically two methods for approval of a previously unapproved substance to animal feed. One pathway was to submit a food additive petition (FAP) to CVM, which it would thoroughly examine the FAP and establish a regulation. Alternatively, a feed ingredient could be approved via the definition process of the Association of American Feed Control Officials’ (AAFCO) Ingredient Definitions Committee (IDC). CVM maintained a role in the AAFCO process by consulting with AAFCO on safety, utility of the ingredient, manufacturing process and analytical method, submitted by the firm to AAFCO.

In a departure from ~30 years of practice, CVM will take more ownership of the non-FAP approval process. That is, a GRAS Notified substance to which CVM does not object, would become legitimate for use within the parameters of the GRAS. CVM has indicated that its decisions on Notifications will be posted on the internet for all to see, including AAFCO. Because AAFCO is not a government organization, but a private organization, no special considerations will be made for notifying AAFCO and it is assumed the state regulators will make their own decisions accommodating the GRAS “No Objection” statement. As indicated above, this Notification system could be a game changer, but there are some important points that should be uppermost in its process of implementation.

The first point is to capitalize on the experiences of the Center for Food Safety and Nutrition (CFSAN) in its implementation of the first GRAS Notification process in 1997.  It is essential to understand that GRAS Notification is different from the food additive petition (FAP) process or now defunct GRAS Affirmation process. In the latter two instances, FDA takes upon itself the determination of safety and thoroughly examines all the data supporting safety – this is a laborious and time consuming event. In contrast, the Notification process involves a decision on whether or not CFSAN objects to the Notification, and importantly, CFSAN does not agree something is GRAS only that it does not object to the finding of GRAS. Alternatively, CFSAN could determine that the information supplied by the notifier does not support a conclusion of GRAS. Exactly how a Notification supports a GRAS determination is not a totally transparent process, but should theoretically only involve: (1) a proper description of the substance (including specifications), (2) the utility or technical effect of the ingredient (again, flexibility is required, see below), (3) a rationale describing safety-in-use for all species indicated and, (4) the credentials of the experts making the determination of safety. CVM needs to follow this same general process and avoiding getting “down in the weeds” inspecting every data point – such actions would defeat the purpose of GRAS and every submission would essentially become an FAP.

Not related to CFSAN’s experience and unique to CVM is the point that it is important to separate out criteria for approval of ingredients for use in production animals that enter the food chain (as meat, milk or eggs) from pets (predominantly cats and dogs), wherein with the latter, substance residue limits do not need to be established. Also, production animals are at least somewhat forage animals and most of the feed for production animals is produced on a local or regional basis to account for regional differences in nutrients. Pets are not forage animals and therefore not subject to regional differences in nutrients; pet nutritional needs are universal throughout the US and often produced at a single plant as opposed to the hundreds of local feed mills that produce the majority of production animal feed.

As a subset of separating out criteria for addition to feed for pets, is that ingredients for pet food should not be confined to aroma, taste, nutritive value or technical effect (such as a buffering agent, texturizer or preservative).  If an ingredient is safe, it should be allowed for addition to food. Sometime ago, CFSAN did not allow addition to foods that did not meet criteria similar to those cited above, but following a realistic analysis of the situation, decided to allow substances such as oligosaccharides (and other fibers and prebiotics), probiotics, lutein or lycopene to be added to food; none of these substances fit the four criteria above or even the most liberal interpretation of the 32 physical or technical effects listed in 21 CFR 170.3(o). CFSAN made the pragmatic decision that if a substance is safe, CFSAN will exercise regulatory discretion and allow addition of the substance to food if consumers want it – let the marketplace sort out the winners and losers.

Realistically, many ingredients are already added to pet food only to appeal to the purchaser of the pet food, not the pet, and include the odor of the food (which often must sit out all day), texture for easy dispensing (such as allowing the food to slide out of the can easier), an esthetically non-offensive appearance and importantly, the color, odor, texture and appearance of the pet’s fecal material. Technically, ingredients added for such purposes are Trojan horses and in violation of the regulations, but to the credit of CVM, this is an area where CVM has rightfully exercised regulatory discretion.

Lastly, CVM has historically expressed some trepidation about the confidence it has in the industry to police itself vis à vis GRAS determinations. There is some substance to this concern, inasmuch as a company employee may be an expert, but may also have emotional equity or business/career interests in the success of a GRAS determination that might be perceived as a potential conflict. This very situation is a place where a disinterested third party can play a valuable role in developing and organizing the rationale for GRAS and, for another layer of confidence, independent experts would be used for the final decision. CVM has already authorized the existence and validity of third party certification programs for foods and feeds and an extension of this confidence to third party GRAS determinations is equally justified.

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