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
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
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
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
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
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).
The intent was to educate regulators and industry about the Model Pet Food Regulations
Committees discussed key proposals such as a possible shift in the oversight of animal feeds
Public meetings invited comments and provided updates
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