The Food and Drug Administration will no longer rely on state feed control officials for help with animal food ingredient approvals after choosing not to renew a long-standing agreement.
A Memorandum of Understanding between FDA and the Association of American Feed Control Officials, a group that represents state-level regulators, expired at the beginning of October, leaving feed companies with one less way to secure regulatory approval to sell their products.
"It's an FDA-driven process from here on out," Austin Therrell, AAFCO's executive director, told Agri-Pulse.
When Tracey Forfa, director of FDA's Center for Veterinary Medicine, announced the decision to let the agreement lapse, it was a shock to some. The MOU had been in place for 17 years, although AAFCO's ingredient definition process dates back nearly a century, Therrell said.
In a letter to stakeholders, Forfa wrote that that the relationship between the two entities "is not ending, but will be evolving." She said FDA will continue to participate in AAFCO meetings and collaborate with the group on feed safety.
"The expiration of the MOU presents an opportunity for FDA to begin a thorough evaluation of its pre-market animal food review programs, in hopes of adapting to better serve public health and the needs of all stakeholders," Forfa said in the Aug. 2 letter.
The agreement allowed ingredients defined in AAFCO's "official publication" to not only be officially recognized by FDA, but also by states that maintain individual feed control laws.
Under the now-defunct pathway, AAFCO investigators worked with companies to gather ingredient data, which it then sent to FDA for scientific review, Therrell said. FDA would study the data and provide recommendations, which AAFCO members would then vote on.
“The old MOU process was very successful," Therrell said. "I think it’d be safe to say that we were fairly disappointed in this. But at the end of the day, we support FDA and we continue to work with them in a lot of ways. So we’ll continue to do that."
Historically, there have been three main regulatory pathways used by FDA for reviewing animal food ingredients: AAFCO's ingredient definition process, the Generally Recognized as Safe (GRAS) Notification Program and the Food Additive Petition Process.
The MOU's expiration effectively removes what American Feed Industry Association vice president of public policy and education Leah Wilkinson said was likely the "most popular pathway for ingredients" among AFIA members, leaving a "void in the system."
Leah Wilkinson, AFIA"To cut out one of those pathways leaves our industry with that void and uncertainty of how to bring new products into the market, which then ultimately impacts our agricultural producers or our companion animals," Wilkinson said.
“We just hope that they can come out with something that will fill that void,” she said, adding she hopes to see the same from AAFCO. “Our industry really needs it in order to remain competitive and bring those innovations forward.”
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In August, FDA issued a draft Animal Food Ingredient Consultation (AFIC), intended as an interim replacement for the AAFCO process. It should allow the agency to review plant materials, grains or human food byproducts that would have previously fallen under the AAFCO process, according to draft guidance by the agency.
Under the AFIC framework, FDA "generally would not intend to take enforcement action against an ingredient for being an unapproved animal food additive if the FDA has sent an AFIC 'consultation complete' letter, provided the ingredient is used in accordance with the terms described in the letter and there continue to be no questions or concerns about the safety of the ingredient," according to an agency press release.
FDA received 28 comments on its proposal, including criticism from AAFCO. "The interim AFIC process lacks transparency and input from state regulators," Therrell said in the group's comment.
The draft guidance "states that stakeholders will be able to provide input on the consultation inventory; however AAFCO members believe that written submission through a docket doesn’t carry the same weight or value that open dialogue added within the AAFCO process," he added in the comment. "AAFCO would respectfully encourage FDA to consider how state regulators can be consulted directly through the AFIC process."
Therrell told Agri-Pulse that said state feed control officials will vote in January on a mechanism that would allow ingredients approved through the AFIC process to be included in the organization's official ingredient publication, which allows them to be recognized within a number of states.
FDA is also reviewing the effectiveness of both the GRAS and Food Additive Petition processes — the two other pathways in place for ingredient reviews — after its decision to end the AAFCO partnership, the draft guidance said. Dana Brooks, president and CEO of the Pet Food Institute, said it is "fortunate" that the two systems remain.
Dana Brooks, Pet Food Institute
“As long as we have working pathways for us or for ingredient suppliers, we’re comfortable with the change," Brooks told Agri-Pulse. "But what’s most important for us is that we do have a process that’s modernized, provides transparency and consistency.”
FDA's decision to let the agreement expire leaves food regulators searching for a new way to get state-level approvals for feed ingredients, which the FDA-AAFCO process had helped accomplish. Therrell said AAFCO is considering partnering with Kansas State University, which could provide the "scientific review" needed under a new food ingredient submission pathway.
The proposal on the table would create a scientific review panel made up of university faculty and independent consultants from across the nation, which will evaluate potential ingredient submissions and send them back to AAFCO membership for approval.
One of the benefits of this system, Therrell said, would be reduced approval times, since both AAFCO and Kansas State have “a little bit more flexibility” with their non-governmental status.
He added that the requirements are based off of FDA’s GRAS notice program, which should help the substances make it through the separate FDA approval process.
Brooks said PFI is not opposed to AAFCO's proposed state-level replacement, but does have "a ton of questions and concerns" with how it would work.
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