Animal Feed Ingredient Regulations Turmoil and Trouble to No Good End?
Following the 1958 Amendment to the Federal Food Drug and Cosmetic Act (FFDCA or “the Act”), the Centers regulating human and animal foods took what are now seen to be radically divergent pathways. While the human food side had paid strict obeisance to the letter and spirit of the Act by implementing a food additive petition process, incorporated historically safe (generally recognized as safe or GRAS) substances into the CFR, eventually starting a GRAS affirmation process and, as granted by the Act, respected the right of non-FDA “experts qualified by scientific training and experience” to make GRAS determinations. In the middle 1990’s, following the affirmation of 200+ substances for direct addition to food, the GRAS affirmation process became bogged down and was discontinued, to be replaced by the GRAS Notification process in 1997.
The animal food side of the FDA, the Center for Veterinary Medicine (CVM), implemented a feed additive petition process and included a purged list of GRAS substances. However, instead of an active GRAS affirmation process (only two substances were eventually affirmed GRAS by CVM) or a notification process, the CVM engaged in a system of “enforcement or regulatory discretion” actions in which the agency would offer a letter of regulatory discretion if it did not feel the substance raised any safety concerns. Despite the same approval processes available for human foods, CVM encouraged manufacturers to participate in the American Association of Feed Control Officials (AAFCO) ingredient definition process. In the AAFCO process, CVM played the role of scientific advisor for this association of state regulators and instead of an affirmative decision on safety, CVM continued the use of regulatory discretion letters for ingredients submitted to AAFCO. The CVM/AAFCO arrangement was a natural association, as most feed manufacturing and regulation had historically been conducted at the state level and, in several states, feed ingredients are even required to be written into state law. AAFCO ingredients and standards are published in the “Official Publication,” seen in many countries as the default source for approved feed ingredients for the US.
While these processes for feed ingredient approval worked well for many years, a series of events precipitated the generation of a Memorandum of Understanding (MOU) in 2007 between CVM and AAFCO. This MOU acknowledged the participation of CVM in the AAFCO r