Animal Feed Part#1: Navigating U.S. Animal Feed Ingredient Regulatory Changes

Join us for an insightful episode in our special podcast series, where we dive into recent shifts in the U.S. regulatory landscape for animal feed ingredients. Hosted by Brandon Walters, Scientific Consultant within Intertek's Food & Nutrition Group, and featuring fellow consultant Ryan Parente, this discussion unpacks the latest compliance pathways and requirements shaping the industry today. Tune in now!

Speakers:

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

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Transcript

00:14 --> 00:33
Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

Hello! Welcome to another Intertek Assuris Podcast series. I’m Ryan Parente, a scientific consultant with our safety & regulatory team and I am joined by Brandon Walters who is a scientific consultant focused on animal feed ingredients in the same group.  

00:33 --> 00:35
Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

Hey, everyone! 

00:35 --> 00:42
Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

Today we’ll be discussing the recent changes happening in the Animal feed ingredient regulatory space in the United States.  

00:42 --> 01:32
Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

That’s right. This podcast will be part of a series covering (1) the impact of the U.S. FDA ending their memorandum of understanding with the Association of American Feed Control officials, aka AAFCO; (2) the proposed FDA Animal Feed Ingredient Consultation process; and (3) the proposed AAFCO Approval Process; as well as (4) a look into the future with the proposed Innovative FEED Act introduced to the U.S. Congress last year. 

01:13 --> 01:24
Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

It’s a lot to cover but, I think we should start with the basics. So, Brandon, what is AAFCO and what is this memorandum? 

01:24 --> 02:01
Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

Yes. So, AAFCO is a U.S. association comprised of state, federal, and international feed regulators and operates through a committee-based system to develop and maintain an Official Publication that defines model bills, model regulations, ingredient definitions, and other information directly relevant to maintaining the safe use of animal feed.  Individual States have adopted the model bills and regulations into their own laws and utilize the ingredient definitions when their state feed control officials examine animal feed being manufactured within or imported into their jurisdiction. 

02:02 --> 02:08
Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

And if you want to market an ingredient that is not in the Official Publication? 

02:08 --> 02:33
Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

If the ingredient isn’t in the Official Publication or your ingredient is different in terms of use or how it is manufactured, State officials would likely take regulatory action against the ingredient. This might be a denial to market in their state, or additional red tape, slowing or stopping the ability to sell or use an ingredient in that state.  

02:33 --> 02:47
Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

OK, so, getting your ingredient into a State would pretty much require that it is listed in the AAFCO Official Publication. But animal GRAS and animal food additive petitions are still options, yes? 

02:47 --> 03:02
Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

Right, States will accept food additive regulations and AAFCO has a policy of including GRAS notices that received a “no questions” letter from the FDA into the Official Publication, which lets them be accepted at the state level. 

03:02 --> 03:11
Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

OK, you mentioned a memorandum of understanding between AAFCO and the FDA. How does that work? 

03:11 --> 03:58
Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

Until recently, ingredient definitions have been requested by industry and developed by AAFCO feed investigators while the safety and utility of those feed ingredients were evaluated by the FDA under a Memorandum of Understanding between the FDA and AAFCO. Under the same memorandum, the FDA did not take regulatory action against ingredients that met an AAFCO definition. This Regulatory Discretion was necessary since, as per the Federal Food, Drug, and Cosmetic Act, an ingredient that is not subject to a food additive regulation or has not been exempted through the GRAS process is considered an adulterant (i.e., not meeting federal compliance) and would otherwise be subject to regulatory action against it. 

03:58 --> 04:17
Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

So, to paraphrase, AAFCO would request the FDA evaluate the safety and efficacy of the new ingredient and in turn the FDA would exercise regulatory discretion to NOT take action against ingredients listed in the AAFCO Official Publication? 

04:17 --> 04:29
Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

Exactly. Except now, the FDA chose not to renew the memorandum.  Effective October 1st of this year (2024 if you’re tuning in from the future).  

04:29 --> 04:36
Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

Oh boy, what does that mean for ingredients in the AAFCO official publication right now? 

04:36 --> 05:24
Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

This is addressed in the guidance for industry (GFI) #293 FDA released specifically on the FDA’s enforcement policy for AAFCO-defined ingredients. 

Essentially, the U.S. FDA has decided to not take enforcement action against ingredients listed in the 2024 AAFCO official publication that are not food additives or GRAS. This effectively grandfathers in all ingredient definitions to this point. Of course, the ingredient must be used according to the intended use and meet any specifications and limitations stated in the ingredient definition in the 2024 Official Publication. 

It remains to be seen how the FDA will react to newly defined ingredients or modifications to existing ingredient definitions 

05:24 --> 05:27
Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

Certainly is a big shakeup for the industry 

05:27 --> 05:55
Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

Definitely. With the expiration of the memorandum industry currently has only the GRAS notice and food additive petition routes available for obtaining regulatory compliance for new ingredients going into animal feed. Though the FDA will be introducing a new regulatory process called the Animal Feed Ingredient Consultation (AFIC) process while AAFCO is considering a proposal for their own ingredient definition acceptance process without FDA’s evaluation  

05:55 --> 06:01
Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

Yes, I will be talking about the Animal feed ingredient consultation process in our next podcast episode. 

06:01 --> 06:25
Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris 

That sounds great. And in the meantime, if any of the listeners have any questions you can reach us at: food.assuris@intertek.com or Intertek.com/assuris/feed  

Thank you all for joining us today, we look forward to hearing from you