The US Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) and the Association of American Feed Control Officials (AAFCO) have recently signed a memorandum of understanding (MOU) concerning the process by which AAFCO Feed Ingredient Definitions, including those intended for use in petfoods, are established, modified or removed. This document seems to be a first step toward CVM's formal recognition of AAFCO's list of defined ingredients.
A copy of the MOU is available here.
Feed ingredient definition process
CVM has long played an integral role in the AAFCO Feed Ingredient Definition process. While considered by CVM to be an informal procedure, an FDA Compliance Policy Guide (CPG) first written in 1980 regarded the AAFCO definitions as constituting the "common or usual" names for feed ingredients contemplated by the Federal Food, Drug and Cosmetic Act (www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg665-100.html). This was done despite preexisting federal regulations that provided a means to establish common or usual names outside of AAFCO (21 CFR Section 502).
Explicit acknowledgement that CVM had input in the AAFCO definition process came with amendment of the CPG in 1995 via the addition of this sentence: "Whenever ingredient definition changes are contemplated by AAFCO, CVM must concur in their suitability." That amendment roughly correlates with guidance first provided to AAFCO ingredient investigators in the 1993 Official Publication, which noted it was imperative that all materials relevant to an ingredient definition be submitted to CVM. However, while the original guidance directed the investigator to obtain CVM's opinion, language was changed soon after to ensure CVM's concurrence was sought.
Historically, the AAFCO definition process offered a rigorous but potentially less arduous and more timely means of establishing acceptable use of a feed ingredient compared to the more formal FDA procedures. These include the Food Additive and GRAS (Generally Recognized As Safe) Affirmation petitions. CVM's primary role had been that of a technical and scientific advisor to AAFCO, offering its much needed expertise in reviewing pertinent safety and utility data on feed ingredients.
Over the years, it is my impression that CVM has assumed more direct responsibility and control of the overall process. As a result, in many cases the differences between AAFCO's informal process and FDA's formal processes appear to have diminished considerably.
What's new in the MOU?
The MOU doesn't expressly alter much of the existing AAFCO process. A few new details are specified. For example, AAFCO now has a certain number of days to forward a request for a new or modified definition to CVM. Also, CVM agrees to let AAFCO know within a specified period whether it will be able to consult on a matter. (It's unclear what happens to a new or modified ingredient proposal if CVM is not willing or able to provide input). There are other details to address the removal of ingredients from AAFCO's published definitions and resolve disputes between the two parties.
The MOU does not expressly define the separate responsibilities of the parties in the definition process. For example, as written the petitions are reviewed by both CVM and the ingredient investigator without distinction in duties. Since in many cases the AAFCO investigator is also a CVM employee, that differentiation is often moot.
What the MOU appears to do is expressly grant what had been the trend: It bestows more direct control on CVM in establishing and maintaining ingredient definitions. AAFCO can still seek advice or consultation with CVM, but AAFCO must obtain a "letter of concurrence" before it can accept a new definition or amend an existing one. AAFCO also must obtain CVM concurrence on any action to remove an ingredient from its definition list and at the same time must accept any CVM request (assuming adequate reasons) to do the same. The only outlet if AAFCO does not abide by these rules is arbitration.
Why is the MOU needed?
CVM notes that the MOU allows CVM to formally recognize AAFCO's list of defined ingredients (www.fda.gov/cvm/cvm_updates/aafco_mou.htm). This step is reportedly necessary to give the list the force and effect of federal law, which will enhance CVM's feed safety goals (www.fda.gov/cvm/afss2nddraftrramework.html).
However, the only stated purpose of the MOU is to facilitate collaboration between CVM and AAFCO by "clarifying responsibilities and providing mechanisms for resolving disputes." Thus, it's unclear how the MOU accomplishes formal recognition by CVM. Also, a CPG that stipulated CVM's previous informal recognition of the AAFCO definitions has already existed for decades without an MOU.
Therefore, I presume CVM will take other steps to achieve formal recognition of AAFCO's feed ingredient definitions. There is indication that CVM will revise the current CPG to clarify its relationship with AAFCO and its list of animal feed ingredients, and AAFCO will revise its guidance to ingredient investigators. However, I would think that an amendment to the Code of Federal Regulations (CFR) to stipulate AAFCO's list of ingredients as acceptable by FDA for use in animal feed would be needed, too.
A good idea, but
All in all, I think the MOU and the move for more CVM control over the process is probably a good idea. While the safety of feed ingredients is admittedly of overriding importance, I am concerned about the effect this may have on the timeliness of response to proposals for new or amended AAFCO definitions. To help in this regard, I hope CVM moves forward with its plans to implement the GRAS Notification procedure with due haste.
I am also worried about the effect the MOU may have on the tendency for some feed control officials to reject anything not explicitly defined by AAFCO. This is especially true for petfoods, where many human food ingredients not on any list are commonly included in formulations. It must be remembered that by its very nature, any official list of acceptable feed ingredients cannot be considered exhaustive, and a means to establish ingredient names by common usage in the market is provided for in FDA regulations; see 21 CFR Sections 502.5(d), 570.30(d) and 582.1(a).
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