Time is running out for pet food ingredient suppliers to conform to Federal regulations for their ingredients. The choices are either a Food Additive Petition (FAP) or a Generally Recognized As Safe (GRAS) determination – the only two processes by which compliance to Federal law can be assured. Current American Association of Feed Control Officials (AAFCO) definitions in its Official Publication (OP) that are not the subject of a FAP, Food and Drug Administration (FDA) GRAS or FDA GRAS affirmation or, an FDA Prior Sanction, will eventually be declared “unapproved feed additives” for which the law requires they be eliminated from the food supply. The demand for immediate removal of 500+ ingredients from the animal feed supply chain will be a monumental calamity for ingredient suppliers, pet food manufacturers and consumers. The aftershocks will include the public’s lack of faith in regulators (i.e., FDA) and accusations of rapacious greed and carelessness on the part of pet food manufacturers. How did we get to this point and what can we do?
This path started around 1900, when the agricultural economy in the US had expanded sufficiently. Animal feed was sold in interstate commerce, but there were few or no standards, such as the amount of protein in alfalfa or the definition of gluten and adulteration frequently occurred. Because there was rather weak Federal oversight at that time, the State Agriculture officials of various states formed an organization for setting standards for various commodities (this organization later became known as AAFCO). AAFCO set standards for various commodities by conferring what became known as “feed ingredient definitions,” which persist to this day and are published in the annual AAFCO OP.
Although it seems incredible to believe, there was very little Federal oversight of ingredients added to human or animal food until 1958. By this time, hundreds of ingredients (including flavors, spices, preservatives, etc.) were known to be added to both human food and animal feed. Congress realized that if all substances were required to go through the food (or feed) additive petition process, it would take nearly a century to achieve approval through the FDA. However, because many ingredients, such as spices, had been in use for millennia, there was no practical reason to subject these foods to a vetting process; so, Congress determined there should be a more pragmatic pathway for these ingredients to be approved, although a blanket grandfathering of ingredients already in use was immediately ruled out. As a result, when the law was finalized in 1958, the law stated that all ingredients added to food were “food additives” and must go through FDA for approval, unless the substances were generally recognized as safe (GRAS). A GRAS determination could be made on the basis of historical use (i.e., common use in food prior to 1958) or through “scientific procedures” (i.e., animal testing, demonstrating safety); by either process, the judgment of safety had to be carried out by experts qualified by appropriate training and experience. All substances, whether as food additives or GRAS, must meet the safety standard of a “reasonable certainty of no harm.” Importantly, “reasonable certainty” was used as the standard as opposed to “absolute certainty” which was implied by a previous version of the law governing food. Interestingly, substances can be determined GRAS by the FDA or by independent groups of impartial scientists; in fact, there is no obligation on the part of the manufacturer to even notify the FDA that a substance has been determined GRAS; although, many manufacturers have submitted their independent GRAS determinations to FDA as a Notification.
While the human food side of FDA required all ingredients either to be food additives or have GRAS status, the animal side of FDA (the Center of Veterinary Medicine, CVM), incorporated some human food ingredients into its formulary of approved substances (identifying them as GRAS and are listed in 21 CFR § 582 et seq.) in 1960. However, for all new ingredients (after 1960), CVM employed the food additive petition method of approval, albeit only for a few substances, while primarily relying on the AAFCO system of ingredient definition for most of the others, in which CVM participates. This (AAFCO) alternative was utilized by CVM for several possible reasons: (1) the AAFCO system was already in place by the time the law was amended in 1958, was successful and was not particularly demanding or time-consuming for CVM; (2) a food additive petition was very resource intensive for CVM, requiring considerable manpower and; (3) with the AAFCO system, CVM did not have to commit itself on whether a substance was “officially” safe or not ― this was a near perfect bureaucratic solution — not much work and no decision would have to be made officially approving a substance. Also, because the AAFCO system of approval was initiated over one hundred years ago, in many states the requirement for AAFCO approval is written into state law; that is, a substance must be approved by AAFCO and/or accepted by the State before it can be sold in that particular State. These laws are archaic, but still exist. AAFCO likes the idea of CVM participation to review safety (because AAFCO or the individual states do not have toxicologists to review substances and relies on CVM’s informal input) and this system allows AAFCO (a private organization) to hold primacy in the approval of feed ingredients. The participation of CVM in the AAFCO process is the subject of a “Memorandum of Understanding” and, although it has had several extensions since first issued in 2007, is set to expire in September 2015 along with CVM participation in the AAFCO process.
While an ingredient in the AAFCO OP may be approved for use in various states (and not all states agree with the ingredient definitions proposed by AAFCO), the AAFCO definitions are not at all compliant with Federal law and technically, cannot be sold in interstate commerce. A feed ingredient cannot be transferred from the State of manufacture to another State for use in feed in the absence of Federal approval (i.e., a GRAS for feed additive regulation). Also, a feed ingredient approved under Federal law must be accepted by the States, according to the Supremacy Clause of the US Constitution. This supremacy clause provides that these Federal statues, treaties, etc., are the highest form of law in the U.S. legal system, and mandates that all State judges must follow Federal law when a conflict arises between Federal law and either the State constitution or State law of any state. Also operable here is the so-called “Dormant Commerce Clause” that prohibits states from passing legislation that will adversely impact interstate commerce in the absence of federal law granting permission for them to do so. This means that States are not allowed to pass laws that discriminate against products from other States.
The problem with the AAFCO approval system is that an AAFCO definition is not recognized by Federal law. Any substance added to food (animal or human) must either be a food additive or have GRAS status ― a point even CVM has made on several occasions. To our knowledge, the system of a State requirement for approval of animal feed ingredients approved according to Federal law has never been challenged. This lack of a challenge is most likely for two reasons: (1) all CVM feed additive regulations (21 CFR §573), CVM GRAS determinations (§582) and CVM GRAS affirmations (§584) have been automatically included in the AAFCO Official Publication and; (2) to our knowledge, CVM has never supported an independent GRAS determination for an animal feed ingredient for adoption by AACFCO and has likely discouraged AAFCO from accepting an independent GRAS determination as a valid pathway. However, CVM has been forced by internal legal counsel to change policy and is disengaging with AAFCO while also reluctantly accepting the validity of an independent GRAS determination. Because the AAFCO OP is owned by a private organization (i.e., AAFCO), CVM has no authority to force AAFCO to include GRAS determinations and, to date, AAFCO has refused to publish non-FDA GRAS determinations in the OP.
As mentioned above, the AAFCO book lists ingredients approved by CVM as feed additives or as GRAS (albeit only those determined GRAS by CVM), but the majority of ingredients do not have feed additive or GRAS status and are therefore, not compliant with Federal law, regardless of what a State law might say regarding use of a substance in a particular State. Exactly what will happen to those ingredients in the AAFCO OP that are not feed additives or GRAS substances is a matter of considerable debate.
Unrealistic claims have been made by some that a miraculous, unprecedented event will occur to save the day and legitimize OP ingredients. These deus ex machina solutions include: (1) (perpetual) extension of the Memorandum of Understanding (MOU) — but this only perpetuates the problem, not solving it, as the MOU does not confer the needed GRAS or FAP status and, CVM has indicated the MOU will not be renewed perpetually; (2) CVM will “grandfather” OP substances – this is a solution totally devoid of possibility because (a) the law requires anything to be grandfathered be in use prior to January 1, 1958 and have proof of safety (note that lack of harm is not the same as proof of safety) and (b) in the last 60 years, CVM has only GRAS affirmed two substances ― there is nothing in its history to indicate CVM would consider GRAS affirmation for over 500 substances; (3) CVM will confer GRAS status on all outstanding OP substances – this is not an option, as it is probable that much of the safety information contained in an AAFCO feed ingredient petition was never published and considering the fact that CVM will agree only to a few of the submitted GRAS notifications that contain a plethora of published information, where will CVM get the quality and quantity of data it has demanded from independent GRAS notifications so it could logically confer GRAS status on 500+ substances? ― in high probability, the information is just not available and; (4) the “regulatory” or “statutory” fix as a solution ― but despite periodic flogging of Congress on this possibility, Congress sees this alternative as no more than a de facto grandfathering of OP substances and has no more of an appetite for retroactive approval of ingredients outside of FAP or GRAS status than does CVM. While the dreamers fantasize about an easy solution, the doers know there is no quick answer. There will be no miraculous solution descending from the heavens – a substance must gain approval via an FAP or obtain GRAS status (period).
At Burdock Group, we have been urging companies to obtain GRAS status for their ingredients, so these ingredients will be compliant with Federal law and cannot be declared adulterants. A few states have seen the inevitability of allowing non-FDA GRAS substances and have agreed to review independent GRAS determinations. The fear of industry should be that consumer interest groups or the avaricious American tort bar will start legal action against animal feed ingredient suppliers and manufacturers for sale of unapproved ingredients, fraud of consumers and unfair competition compared to a competitor whose product may be composed of Federally-compliant ingredients. As a result, many non-compliant products could be forced off the market. Companies would be put in a position of having to gain Federal compliance or leave the market place. But getting back to market would be time consuming ― the lack of animal testing data to support safety of many substances will preclude any GRAS determination until the tests are completed and GRAS dossier approved by experts – testing alone may amount to a year or two and GRAS dossiers another 90-150 days. As a result, many companies could suffer huge financial losses while waiting for completion of a GRAS determination and it would be financially very burdensome for each company to proceed on its own.
A solution exists wherein manufacturers with a common interest in a specific ingredient form an ad hoc interest group and pool resources (sharing costs on the basis of market share), sponsor the testing (if needed) and the GRAS determination. Each participating manufacturer in in the committee receives a copy of the GRAS and manufacturers not participating would not receive a copy of the GRAS. When a state questions the regulatory compliance of the substance, the manufacturer produces the GRAS determination, asking that it be kept confidential and a reminder to the State of the supremacy of a Federally-compliant approval. A manufacturer not part of the ad hoc interest group will be forced to either withdraw from the market or finance his own GRAS determination. While the States have the right to collect a tax or fee for ingredients coming into their states, just as they would for any alcohol or tobacco products, the States can no more prohibit sale and distribution of a GRAS determination any more than a feed additive regulation. States resisting the Constitution would most likely be quickly defeated in court.
The solution to the elephant in the room is as simple as it is hard to accept – become Federally-compliant by means of a GRAS determination. Hard to accept because of the expense, but as explained above, cost sharing is possible and is a routine undertaking by many organizations, notably the Flavor and Extract Manufacturers’ Association (FEMA), the Certified Color Manufacturers’ Association (now known as the International Association of Color Manufacturers), the International Pharmaceutical Excipients Council, and any number of associations and groups with a common interest who share the costs of maintaining their market. There is no deus ex machina or superhero to save the day, animal feed ingredients must be made compliant with Federal law.