Animal Feed Part#2: Understanding the FDA's Proposed Animal Feed Ingredient Consultation Process Artwork

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Animal Feed Part#2: Understanding the FDA's Proposed Animal Feed Ingredient Consultation Process

November 21, 2024 • Intertek Assuris • Season 7 • Episode 38

In this episode, join scientific consultants Ryan Parente and Brandon Walters from Intertek’s Safety & Regulatory team as they delve into the latest developments in U.S. animal feed ingredient regulations. Together, they explore the proposed FDA Animal Feed Ingredient Consultation process, shedding light on key compliance updates and what they mean for industry stakeholders.

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

00:14 --> 00:39
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Hi, everyone! Welcome to our special podcast series about recent changes happening in the Animal feed ingredient regulatory space in the United States.

My name is Brandon Walters. I am a Scientific Consultant within the Food & Nutrition Group here at Intertek, and today I am sitting with Ryan Parente, a fellow Scientific Consultant, who is going to help us dig into these changes to U.S. feed ingredient compliance pathways.

00:39 --> 00:41
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Thanks, Brandon. Happy to be here.

00:41 --> 00:48
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

So, last time we discussed the end of AAFCO’s Memorandum of Understanding with the FDA.

00:48 --> 01:30
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes, that’s right, FDA chose not to renew the Memorandum of Understanding, ending what was known as the AAFCO ingredient definition approval program. Instead, FDA has implemented a new program known as the Animal Feed Ingredient Consultation program, or AFIC program. This program will provide an additional way to engage with FDA outside the animal Food Additive Petition (FAP) and GRAS Notification programs. The FDA has indicated that the AFIC process will be available for the assessment of ingredients for which firms may have otherwise utilized the AAFCO ingredient definition process.

01:30 --> 01:32
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

So, tell me what we know about this program.

01:32 --> 02:13
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Well, the program apparently started October 1st with the end of the MOU; however, little has been publicly posted regarding specific details of the process. It’s my understanding that FDA will update their website with more details once a submission is actually filed. In the meantime, FDA has released a guidance document which contains non-binding recommendations of FDA’s current thinking on the topic. The guidance is relatively short, being only 4 pages in length. It describes the background, the planned new program, and enforcement policy of the FDA.

02:13 --> 02:16
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Interesting, so what does the guidance say?

02:16 --> 03:08
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

The guidance states that AFIC is intended be an interim process that occurs while FDA evaluates the animal Food Additive Petition and GRAS Notification programs. AFIC will provide an additional way for firms to consult with FDA regarding these animal food ingredients and for FDA to review such ingredients and identify any safety concerns associated with them. The guidance document states that this would include ingredients that make up a significant proportion of an animal’s diet, such as, but not limited to, plant materials, grains, or human food by-products. AFIC also will allow for public awareness of and input on ingredients for which FDA is providing consultation.

03:08 --> 03:12
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Hmmm okay. And what is the timeline for this type of submission?

03:12 --> 03:59
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Within 30 calendar days of receipt, FDA will determine if the submission is appropriate for the AFIC process and if there is sufficient information to facilitate a consultation. If the submission is incomplete or if the substance is not appropriate for the AFIC process, FDA will notify the submitter. Upon receipt of sufficient information, CVM will accept the consultation, provide the submitter with the assigned AFIC number, and post details of the submission to the “pending inventory” list on the AFIC web page. Overall, FDA intends the review period to last no more than 180 days.

03:59 --> 04:09
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

I see, so it’s definitely shorter than a food additive petition. Can you tell us a little bit more about that the data requirements for an AFIC submission?

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

Sure thing. Overall, the data requirements outlined in the guidance document is extensive, and includes: a description of the ingredient, manufacturing information, specifications and batch analyses, stability information, and purpose of the ingredient.

04:27 --> 04:38
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Okay, so far this sounds pretty typical of premarket review requirements for feed ingredients. I’m assuming the purpose of the ingredient will include the intended use and target species?

04:38 --> 05:02
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yep, and data supporting that intended use should be provided. Additionally, a comprehensive safety assessment of the ingredient should be provided. This includes things like target animal studies, an exposure assessment, human food safety if the target species produces a human food, and an environmental risk assessment.

05:02 --> 05:10
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Okay, so for example, an ingredient intended for dairy cows would need a safety assessment of milk produced by the cow?

05:10 --> 05:12
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes, exactly.

05:12 --> 03:12
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Okay. Any other requirements?

05:10 --> 05:26
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Copies of cited literature and unpublished reports should be included, along with a draft label.

05:26 --> 05:35
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Oh I see. And how much of this information will be publicly available? I’m not sure how many firms would appreciate confidential information being posted by FDA.

05:35 --> 06:07
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Definitely! Well, FDA intends to post inventories of pending and completed AFICs on their website. Based on the guidance document, the AFIC pending and completed inventories webpage will identify the substance, intended use, intended species, and submitter; therefore, firms making a submission should not expect that this specific information will be kept confidential.

06:07 --> 06:17
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Ok, that’s great information to have. Overall, the data requirements sound similar to the animal Food Additive Petition and GRAS Notification programs.

06:17 --> 07:02
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes, exactly. The types and quality of data needed for the AFIC process is consistent with the current FAP and GRAS Notification processes, with potentially shorter review times. Intertek has assisted companies through both the FAP and GRAS processes, and the AFIC program is definitely something that Intertek can assist with. If you have any questions you can reach us at: food.assuris@intertek.com or https://Intertek.com/assuris/feed

On our next podcast, we’ll discuss AAFCO’s proposed new ingredient approval program.

07:02 --> 07:04
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

I’m looking forward to it.

07:04 --> 07:06
Speaker 2 – Ryan Parente, Scientific Consultant 2 – Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Yes, me too.

07:06 --> 07:10
Speaker 1 – Brandon Walters, Scientific Consultant 2, Safety & Regulatory Affairs, Food & Nutrition Group, Intertek Assuris

Thanks a lot for the interesting discussion. We’ll talk again soon.