Animal Feed Part#4: Insights on Innovative Feed Enhancement and Economic Development Act

In this episode, join scientific consultants Ryan Parente and Brandon Walters from Intertek’s Safety & Regulatory team as they delve into the proposed Feed Enhancement and Economic Development Act, or Innovative FEED Act of 2023. They will explore what it is, where it stands in the U.S. Congress, and what it could mean for future regulatory activities within the U.S.

 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 --> 00:32
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Hello! Welcome to another Intertek Assuris podcast episode. I’m Ryan Parente, a Scientific Consultant with our Safety & Regulatory Team, and I’m joined by my teammate Brandon Walters, who is a Scientific Consultant focused on animal feed ingredients.  

00:32 --> 00:34
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Hello. Glad to be here! 

00:34 --> 01:21
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

This is the fourth—and last—episode in our podcast series on the recent changes happening in the animal feed ingredient regulatory space in the United States. So far, we’ve discussed the end of the Memorandum of Understanding between the Association of American Feed Control Officials, or AAFCO, and the FDA. We’ve also touched on the new FDA Animal Feed Ingredient Consultation process and the proposed revisions to the AAFCO ingredient definition process, which aims to accept generally recognized as safe, or GRAS, ingredients using a Review Panel coordinated by Kansas State University.  

So, what is the final topic of this series going to be? 

01:21 --> 01:39
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Great question. While it’s not as new of a development as the other topics in this series, we are now going to take a look at the Innovative Feed Enhancement and Economic Development Act, or Innovative FEED Act of 2023. We’ll talk about what it is, where it stands, and what it could mean for future regulatory activities within the U.S.  

01:39 --> 01:46
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Sounds good. I’ve briefly looked at the Act, and it seems complex. Let’s get into it. 

01:46 --> 02:06
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Absolutely. So, let’s start at the beginning. The Innovative FEED Act was introduced in the U.S. Senate as Senate Bill S.1842 in the summer of 2023 and received bipartisan support. It was referred to the Committee on Agriculture, Nutrition, and Forestry. Presently, the Bill has not had an opportunity to be voted on by the Committee.  

02:06 --> 02:21
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes. It’s my understanding that the Bill was attached as a rider to the Animal Drug User Fee Act Amendments of 2023 but was removed to expedite the Drug User Fee Act Amendment. 

02:21 --> 02:45
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes, that’s right. Following the removal of the rider on the Senate side, the Innovative FEED Act was introduced on the House side of Congress as Resolution 6687 in December of 2023. It was referred to the House Committee on Energy and Commerce, who referred it to the Subcommittee on Health. Therefore, very similar bills have been introduced and are in Committee on both sides of Congress.  

02:45 --> 02:51
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

That’s quite a journey. Has anything happened since December 2023? 

02:51 --> 03:06
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Not that we can tell. The current bipartisan support of 31 Cosponsors in the House and 9 Cosponsors in the Senate seems to indicate that the Innovative FEED Act has a good chance of moving forward – the delays appear to be procedural and political. 

03:06 --> 03:12
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Okay, so I guess this begs the question, what is so important about this Act? 

03:12 --> 03:49
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

The Innovative FEED Act provides a framework to the FDA for the regulation of certain substances as feed ingredients that historically were regulated as animal drugs. The December 2023 version of the Act defines the term “zootechnical animal food substance” and would incorporate it into the Federal Food, Drug, and Cosmetic Act: 

First, the term “zootechnical animal food substance” means a substance that: 

Is added to the food or drinking water of animals; 

Achieves its intended effect by acting solely within the gastrointestinal tract of the animal; and 

Provides 1 of 3 intended uses. 

03:49 --> 03:54
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

You mentioned 3 intended uses…could you elaborate a bit more on that? 

03:54 --> 04:16
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

That’s a good idea. So, one intended use is to “affect the byproducts of the digestive process of an animal.” This could include substances that reduce methane emissions, which is a big area of interest for meeting environmental targets.  

Another intended use would be to reduce the presence of foodborne pathogens of human health significance in an animal intended to be used for food. 

04:16 --> 04:24
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Such as a substance that reduces E. coli or Salmonella in the gut of animals? 

04:24 --> 05:03
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Those are some possible cases.  

The final intended use includes substances that affect the structure or function of the body of the animal other than by providing nutritional value, by altering the animal’s gastrointestinal microbiome. So-called probiotics and prebiotics could fall within this category. 

So, with this definition and the allowable intended uses in mind, we come to how these substances would be regulated. That is that the Bill identifies zootechnical animal food substances as food additives. So these zootechnical animal food substances will fall within an existing framework. 

05:03 --> 05:24
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Let’s break that down. From what’s written, it looks like the Act will introduce 3 new uses of ingredients that will be regulated as animal food additives. Are there any exclusions to what can be a “zootechnical animal food substance”? 

05:24 --> 05:55
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes, and that’s very important to address. The proposed definition states that zootechnical animal food substances cannot be drugs, hormones, ionophores, or substances otherwise excluded by the Secretary of Health and Human Services through notice and comment rulemaking. So going back to your intended use example about substances intended to reduce E. coli and Salmonella, the zootechnical animal food substance would have to lower levels in healthy animals so that it is not treating or preventing a disease. 

05:55 --> 06:09
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

From what I understand, there are some restrictions. The Act also very clearly does not want to allow substances that are regulated as drugs to be regulated as animal feed. 

06:09 --> 06:42
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

That’s correct. We have to think back to the now withdrawn FDA policy and procedure manual about the regulation of certain substances as feed or drugs. The FDA had concluded, based on the language in the current Food, Drug, and Cosmetic Act, that substances that modify the structure or function of an animal, including its microbiome, through non-nutritive means, would be regulated as drugs.  

The Innovative FEED Act pulls those substances out to be regulated as feed now, but is careful to not let other substances subject to that FDA policy follow along. 

06:42 --> 07:06
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Classification of these substances as food additives is certainly more clear and is in line with what we are seeing in Europe and Canada. As food additives, it would mean interested parties will have to submit a Food Additive Petition and receive an approval before they can market the substance for these new uses, correct? 

07:06 --> 07:36
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Correct. The Innovative FEED Act would also amend the section of the Federal Food, Drug, and Cosmetic Act to include 2 additional requirements for food additive petitions of zootechnical animal food substances. 

The first is a requirement to provide all data on the intended effects of the zootechnical animal food substance, as well as the quantity required to produce the intended effect. The second is a requirement to provide full reports for the data on the intended effects, including the methods and controls used in the investigation. 

07:36 --> 07:52
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

It’s very interesting that the Innovative FEED Act specifically calls out the requirement to provide information on the methods and controls used in the utility studies. That’s a bit different from current animal food additive petition requirements.  

07:52 --> 08:07
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes, but we need to remember this is still a proposed bill and the language could change. Though the requirement for additional utility data is understandable because the intended function is the defining characteristic of a zootechnical animal food substance.  

08:07 --> 08:13
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Did we miss covering anything else in the Act?  

08:13 --> 08:34
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

There are some additional labelling requirements. Zootechnical animal food substances must include on the label that it is “not for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.” 

Also, the label may include a statement regarding the intended effect of the substance on the structure or function of the animal’s body. 

08:34 --> 08:50
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

From a marketing perspective, that would be really helpful. Currently, any substance that could have a zootechnical effect cannot be intended (i.e., marketed) to be administered for that zootechnical effect and cannot include those functions on the label. 

08:50 --> 08:58
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes, the innovative FEED Act provides more options to industry while maintaining the regulatory oversight by the FDA. 

08:58 --> 09:04
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

I guess the question everyone has on their mind is “When will this Act become law”? 

09:04 --> 09:27
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Well, it is anyone’s guess. As I said at the top of the episode, the Innovative FEED Act has bipartisan support. It’s partly a matter of working through the legislative process, and partly dependent on whether there is majority support in the House, Senate, and Executive levels. As this is an election year, we can expect that it will not get passed until the new Congressional session.  

09:27 --> 09:29
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Well, I think industry would be looking forward to this.  

09:29 --> 09:48
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

We’ve seen groups such as the American Feed Industry Association, the Agricultural Retailers Association, and the National Association of State Departments of Agriculture, to name a few, publish letters in support of the Innovative Feed Act. Numerous individual companies have also signed on to these or similar letters. 

09:48 --> 10:24
 Speaker 1 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Wow. That definitely shows Congress, both the Senate and the House, that there is interest in seeing this Act move forward. It will be interesting to see whether progress is made in the near future in moving these bills through Congress.  

Well, that’s the end of our series on the recent changes to the regulation of animal feed ingredients in the U.S.  

We hope that this series was informative. If you have any questions about the topics we discussed, you can reach us as food.assuris@intertek.com or visit Intertek.com/assuris/feed. 

10:24 --> 10:28
 Speaker 2 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Thanks for listening. We look forward to connecting with you again.