Are AAFCO and the Official Publication Headed for Extinction?
The American Association of Feed Control Officials (AAFCO)[1] was formed in 1909 by officials from individual State governments at a time when Federal oversight of animal feed ingredients and standards was virtually non-existent. Following passage of the Food Additives Amendment (FAA) in 1958, which put the Center for Veterinary Medicine (CVM) in charge of vetting animal feed ingredients, CVM saw the successful process AAFCO had developed for defining ingredients for consistency in labeling (termed feed ingredient definitions) and, instead of developing its own process, collaborated with AAFCO as a shadow reviewer. This collaboration allowed AAFCO to assume the risks of approving ingredients and leaving CVM with little or no accountability– a system that remained in place for sixty years. However, within the past few years, a chastened and newly invigorated CVM has advised AAFCO and industry that many of the feed ingredient definitions published in the AAFCO Official Publication (OP) are not compliant with Federal law and are therefore invalid at the Federal level. The fallout being that the substances defined in the OP and, the end products containing these substances, if not compliant with Federal law cannot enter into interstate commerce if they are identified (i.e., labeled) as an ingredient for or contained within animal feed of which FDA has oversight. Therefore, if AAFCO ingredient definitions are no longer valid, how does this decision affect the continued viability of AAFCO as an organization? The proposal described here shows that AAFCO’s extinction is avoidable, but only if AAFCO moves quickly.
Traditionally, feed ingredient regulation had been left up to the individual States, with AAFCO acting to coordinate state regulatory efforts as a single contact point for ingredient manufacturers to obtain a feed “ingredient definition.” The ingredient definition was to level the playing field between the states and eliminate the need for manufacturers to apply to each state for ingredient approval.[2]
When the 1958 FAA was put into practice, the human food side of FDA was largely ready to proceed with a system for reviewing ingredients as food additives and a parallel system of compliance with the law, called Generally Recognized As Safe, most commonly referred to by the acronym of GRAS. CVM seemed less prepared, appropriating some GRAS substances from the human food GRAS list and, as time progressed, feed additive petitions (FAP) were submitted to CVM and some converted into regulations. When the mandate from President Nixon’s office came for review of GRAS substances in the 1970’s, several hundred were converted from the original GRAS list to “affirmed as GRAS” on the human side, but only two of its previous GRAS lists were affirmed as GRAS by CVM. Most of the feed ingredient approvals still resided with the AAFCO process. Eventually CVM participated in the AAFCO approval system, even to the point of joining various AAFCO committees, offering informal advice and enforcement discretion. In so doing, CVM abdicated its mandate for oversight of a lawfully mandated federal system for review of feed ingredients and simultaneously ignored requests for GRAS affirmations (or even acknowledgement of GRAS determinations) by third parties. As a result, AAFCO became the default process for ingredient approval; however, this was all to change in the wake of a series of events.
The reformation of CVM and the unseating of AAFCO from a prime oversight position was likely the product of several events: (1) In the wake of the 2006-2007 melamine contamination of pet foods, the FDA Amendment Act of 2007 (§1002) was passed and the Secretary of Health and Human Services (through CVM) was compelled to have in place regulations governing ingredient standards and definitions with respect to pet food, something CVM had heretofore ignored – AAFCO had not and could not generate a genuine regulation (see also #4, below). (2) Further complicating matters was the impractical and un-pragmatic executive fiat by CVM that the Dietary Supplements Health and Education Act of 1994 did not pertain to animals, totally ignoring the fact the animal supplement market was awash with products – leaving AAFCO and the States with no solution to a burgeoning problem. (3) The announcement by CVM that it was initiating a GRAS notification program, based on a similar program on the human food side and reversing a CVM policy of ignoring independent GRAS determinations for 60 years. (4) In all probability, the lawsuit concerning the Department of Transportation et al. v. Association of American Railroads[3], originally brought about on the basis that the government cannot delegate rule-making (i.e., setting “metrics and standards”) to a private entity, in this case, it can be viewed that CVM delegated authority to AAFCO. At the end of the day, without CVM’s presumed approval of the ingredient definition, AAFCO is totally disenfranchised as an entity with any capacity to pass judgment on a new ingredient that is not either a food additive or GRAS. Also, if AAFCO is no longer able to set “metrics and standards” for a feed ingredient, it calls into question the ability for AAFCO to set standards for simple forage products. Coincidentally, all of the existing ingredient definitions promulgated by AAFCO that are not either GRAS or food additive substances are invalid, because AAFCO was engaging in an activity in which it was not authorized to participate.[4] So where does this leave AAFCO now that it has been kicked to the curb?
AAFCO still has the ability to make its voice heard, albeit on a smaller stage. What AAFCO has going for it is: (1) it can smooth the pathway for admittance of ingredients to the various States; (2) it can still supply a forceful voice in setting “metrics and standards” as advisors and; (3) it still controls the OP, the default compendium of “approved” ingredients and standards to the rest of the world.
Key to AAFCO’s continued success is the fact that CVM has historically been very prescriptive and fairly slow in moving FAP approvals along, neither of which is acceptable to manufacturers. Likewise, the GRAS Notification program has been repressive and dogmatic resulting in a 70% rejection rate[5] – a move likely designed to force ingredient approval to the food additive petition route. Lastly, the fact that CVM has decided to disengage meaningful interaction with AAFCO allows AAFCO to act as an independent body, unbeholden to CVM.
To survive in this new environment, AAFCO needs to look towards legitimizing the ingredient definitions by making them compliant with Federal Law through use of the GRAS process by manufacturers. In this scenario, a draft GRAS determination can be brought to the appropriate ingredient committee investigator, who can offer input on the needs of AAFCO, including compliance with AAFCO Model Guidance Documents. Once a conclusion of GRAS has been reached by an Expert Panel (and although not notified to CVM, is still compliant with Federal law), both the GRAS dossier and a separate dossier describing fulfillment of the AAFCO Model Guidance Documents can be submitted to AAFCO for its review and agreement, generation of a “model bill,” vote by the membership and inclusion into the OP. In this scenario, the GRAS determination serves as a safety review and fulfillment of compliance with Federal law; the AAFCO review serves to pave the way to State approval. In this way, the States do not assume responsibility for the safety of the product, but do have input consistent with AAFCO’s needs – the trade-off is generation of a model bill satisfactory to the States and a listing in the OP.
Once AAFCO looks inward to determine who they serve, the individual members will conclude they serve the States which employ them and collectively, the manufacturers of feed ingredients who wish nothing more than to respond to the animal care and production needs within the States. Thus, AAFCO needs to engage directly with manufacturers, accepting the legitimacy of GRAS conclusions and pave the way to State acceptance. Only if AAFCO develops a proactive engagement of industry, demonstrating less obsequience to CVM and behaving more as an equal partner and, accepting the legitimacy of GRAS, will AAFCO continue to survive.
[1] Although populated overwhelmingly by State employees, AAFCO is a private organization (a corporation), not an arm of any State or the Federal government.
[2] In point of fact, not all States observe all ingredient definitions, nor do all States even observe the most current OP, in part because many states must treat each ingredient as a law, requiring passage by the State legislature and signing by the Governor, rather than a regulation approved by a state regulatory body.
[3] 135 S.Ct. 1225 (2015). The US Court of Appeals for the DC Circuit held that the delegation of setting “standards and metrics” was unconstitutional because Amtrak was a private corporation, but the US Supreme Court reversed, holding that Amtrak was in fact a governmental entity. Also, “When it comes [to delegating] to private entities, however, there is not even a fig leaf of constitutional justification. Private entities are not vested with `legislative Powers.’… By any measure, handing off regulatory power to a private entity is `legislative delegation in its most obnoxious form” – in THE CENTER FOR POWELL CROSSING, LLC v. CITY OF POWELL, 2016 http://scholar.google.com/scholar_case?about=13210820904487601580&q=department+of+transportation+v.+association+of+american+railroads&hl=en&as_sdt=40006&as_vis=1 (site visited 21Nov2016)
[4] This would also invalidate any attempt to grandfather ingredient definitions as GRAS or food additives or, to simply change the law to include ingredient definitions.
[5] Because of this high rejection rate, manufacturers have taken to completing a GRAS determination by their own expert panels, then approaching each state individually in order to avoid prejudicial judgments by CVM.