Animal Feed Part#3: Dissecting the Proposed New Regulatory Pathway for AAFCO New Ingredient Definitions Artwork

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Animal Feed Part#3: Dissecting the Proposed New Regulatory Pathway for AAFCO New Ingredient Definitions

November 25, 2024 • Intertek Assuris • Season 7 • Episode 39

Welcome to the Intertek Assuris Podcast series! In this episode, join scientific consultants Brandon Walters and Ryan Parente from Intertek’s Safety & Regulatory team as they explore how AAFCO plans to adapt, maintain regulatory consistency, and uphold safety and innovation in the animal feed industry amid these evolving animal feed ingredient regulatory dynamics.

Speakers:

Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris
Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

00:14 --> 00:34
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Hi, everyone! Welcome to our special podcast series about the shifting U.S. regulations on animal feed ingredients.

My name is Brandon Walters. I’m a Scientific Consultant within the Food & Nutrition Group here at Intertek, and today I’m with Ryan Parente, a fellow Scientific Consultant at Intertek, who is going to help us dig into the latest updates in the animal feed world.

00:34 --> 00:37
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Thanks, Brandon. Happy to be here.

00:37 --> 01:07
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

So, in the last episode we discussed the new AFIC program. As our listeners may recall, this is the Animal Feed Ingredient Consultation program that is being established by the U.S. FDA following the end of the Memorandum of Understanding between AAFCO and the FDA. We ended that episode with a teaser as to what AAFCO plans to do now that the FDA’s no longer conducting scientific reviews of AAFCO ingredient definitions. I think you have some details you’d like to share regarding AAFCO’s plans?

01:07 --> 01:25
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes, that’s right, on October 1st of this year—2024—AAFCO announced that it is considering a proposal from Kansas State University's K-State Olathe Innovation Campus to provide scientific reviews for AAFCO’s new animal food ingredient submission pathway.

01:25 --> 01:32
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Interesting. So, this is just a proposal and a new approval process is not being implemented just yet?

01:32 --> 01:57
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Correct. AAFCO accepted comments on KSU’s proposal through the end of October, though my understanding is that this has been in the works for some time. AAFCO likely received proposals from other institutions but has decided to move forward with KSU’s. Assuming there are no delays, the earliest that the program could receive submissions is mid-2025.

01:57 --> 02:25
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Okay, so there’s a good amount of time for the feed ingredient industry to understand this new AAFCO process. How does it compare to other pre-market approval programs? And how exactly does it fit in with GRAS Notifications, Feed Additive Petitions, and the AFIC program?

02:25 --> 03:27
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Great question. To answer it, I believe we need to re-examine the GRAS provision. In short, any substance that is intentionally added to food is a food additive, unless it is generally recognized as safe, among qualified experts, under the conditions of its intended use. So, typically, to conclude that an intended use of an ingredient is GRAS, either (A) a panel of experts needs to be convened, or (B) all the information pertaining to the safety of the ingredient (for example the specifications, manufacturing process, stability, intake assessment, and safety data) must be published in a peer-reviewed, safety-focused scientific journal. It is often helpful to notify the conclusion to the FDA (an optional process) as a means to determine whether the FDA would have any questions regarding the ingredient’s safety-in-use when they conduct their post-marketing analysis of the product labelling. So AAFCO and KSU are looking to capitalize on Part A of this provision.

03:27 --> 03:37
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

I see. So in short, companies will need to compile documentation supporting the GRAS status of their ingredient, and KSU will review it?

03:37 --> 04:00
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Sort of. KSU intends to contract various subject matter experts in the field of animal nutrition, veterinary science, and food safety to serve on scientific review panels, essentially becoming the GRAS Panel. KSU will manage panel reviews and provide final reports regarding the Review Panel’s findings.

04:00 --> 04:10
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Okay, that makes sense. And AAFCO will facilitate inclusion of the ingredients in the Official Publication, assuming the Review Panel has no objections to the GRAS conclusion?

04:10 --> 04:12
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Precisely.

04:12 --> 04:20
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Okay, this proposed process makes sense from a regulatory standpoint. In terms of cost and timeline, what are we looking at?

04:20 --> 05:19
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

For the Panel review process alone, the proposed timeline is 90 to 120 days from receipt to recommendation to AAFCO for inclusion in the Official Publication. Once the ingredient is recommended for inclusion, it goes through committee and director approval within AAFCO before being approved and published in the Official Publication. The entire process, from beginning to end, is projected to take 9 months, which AAFCO claims is half the time of the former ingredient definition approval process. This is largely due to the removal of the “tentative” definition process, wherein ingredients would be “tentatively” approved and published in the Official Publication at AAFCO mid-year or annual meetings, before being officially approved and published at the following mid-year or annual meeting.

05:19 --> 05:24
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes, I can see how that could really impact timelines. And what about cost?

05:24 --> 05:59
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes, of course. The cost depends on the submission tier. For a full submission package for a new ingredient intended for 3 or more target species, the cost is $50,000 USD to be paid to AAFCO and KSU. If the submission is a minor package--that is, if it’s for only 1 or 2 target species—the cost is $30,000 USD. For a basic scientific review of an existing AAFCO definition in a new target species, the cost is $15,000 USD.

05:59 --> 06:13
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Alright, so there are various fees associated with the proposed approach in contrast to the FDA notification, which does not have any fees. I suppose the advantage here is the review time?

06:13 --> 06:28
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes. I believe the selling point is an expedited review for inclusion in the AAFCO Official Publication. GRAS Notices with “no questions” letters from the FDA are also included in the Official Publication, but the timeline is a bit longer.

06:28 --> 06:39
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

I see. Well, it’s always good to have options, though there is the possibility that the FDA may not agree with the AAFCO-KSU Review Panel’s conclusion, right?

06:39 --> 06:45
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes, that’s true. Even if unlikely, it’s not clear how FDA feels about this proposal.

06:45 --> 07:02
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Hmmm. Definitely something to consider moving forward. I had a chance to review the proposal myself, and in terms of data requirements, it seems there isn’t anything additional needed outside a typical GRAS conclusion. Was this your impression as well?

07:02 --> 07:18
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes. The data requirements are in-line with a typical GRAS conclusion for animal feed ingredients, meaning Intertek can assist your company with compiling your GRAS conclusion and facilitating review by the AAFCO-KSU Scientific Review Panels.

07:18 --> 07:40
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Great, I think that wraps it up nicely. If you have any questions, you can reach us at: food.assuris@intertek.com or https://Intertek.com/assuris/feed

On our next podcast, I’ll discuss a bill in Congress that could generate a regulatory approval pathway for zootechnical feed ingredients.

07:40 --> 07:44
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

That’ll be an interesting topic. Looking forward to it.

07:44 --> 07:51
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Me too. We look forward to you joining us next time for our final podcast in this series.