New animal food ingredient review process touts ‘twice as fast’ scientific evaluation

The Association of American Feed Control Officials (AAFCO) has introduced a new animal food ingredient review process after its memorandum of understanding (MOU) with the Food and Drug Administration (FDA) expired this past October. AAFCO does not approve, certify, or endorse any animal food products, and ultimate authority for regulating substances used in animal foods lies with the FDA and states.

AAFCO has partnered with the Kansas State University Olathe Innovation Campus (K-State Olathe or KSO) to create the Scientific Review of Ingredient Submissions (SRIS) program under an initial three-year agreement.

The SRIS program is intended to complement the FDA’s current generally recognized as safe (GRAS) designation and replaces AAFCO’s previous Ingredient Definition Request process.

In the AAFCO process, K-State Olathe assumes the role previously filled by the FDA’s Center for Veterinary Medicine.

SRIS program

“This [SRIS] program will offer a fast and accurate scientific assessment of new animal food ingredients that will be accepted by state regulators across the U.S.,” according to an April 22 AAFCO announcement. “Through SRIS, prospective ingredients will undergo scientific evaluation at twice the speed of traditional methods while upholding rigorous scientific standards and transparency.”

AAFCO and K-State Olathe jointly developed the new review process, which was approved by AAFCO membership in January. Haley Larson, who will lead the SRIS team at K-State Olathe, in the announcement called the new process “safe, scientific, and streamlined.”

A notable change with the SRIS program will be a new submission fee. Under the MOU, the FDA had conducted the scientific review as a function of the agency, and there was no associated cost.

“The new process is nongovernmental, so there are administrative costs incurred by AAFCO and KSO to hire qualified expert subject matter experts and staff to ensure that the innovative timelines can be met,” Austin Therrell, AAFCO executive director, told AVMA News. “These costs are comparable to the cost that a submitter might incur if they were seeking to hire a consultant to assist with a self-concluded GRAS determination outside of the new SRIS process.”

Fees will be announced closer to when AAFCO begins accepting ingredient submissions later in 2025.

Once submissions open, AAFCO will determine the appropriate review package and level. Then a scientific review panel, assembled by the K-State Olathe SRIS team, will evaluate the submissions and provide recommendations to AAFCO membership for final approval.

After ingredients are approved, they will be published in AAFCO’s Official Publication, widely recognized industrywide and by regulators as a comprehensive list of approved feed ingredients. AAFCO on June 11 announced a call for subject matter experts to apply to join its independent panel for the SRIS program.

Federal process

In January, the FDA released its own guidance for industry (GFI) #294, “Animal Food Ingredient Consultation (AFIC).” This document explains one way the FDA will work with firms that are developing animal food ingredients while the agency evaluates the food additive petition (FAP) for animal food and GRAS notification programs.

“The AFIC process provides an additional way for engagement with FDA regarding ingredients for which firms may otherwise have used the AAFCO ingredient definition process. AFIC will help FDA identify any potential safety concerns associated with such ingredients. The AFIC process also allows for public awareness of and input on such ingredients. In addition, this guidance describes FDA's enforcement policy for certain ingredients assessed using the AFIC process,” GFI #294 states.

The SRIS program adds an additional pathway for those seeking ingredient approval in addition to the FDA’s GRAS, FAP, and AFIC.

An FDA spokesperson told AVMA News: “The new AAFCO process will be distinct from the federal processes to recognize ingredients. As we read the AAFCO process, it will be most similar to a self-conclusion of GRAS. If the firm would like this recognized through a federal process, they would still need to submit it to us.”

The FDA spokesperson noted further guidance is “unlikely” in the near future “due to executive orders.”

Leah Wilkinson, the American Feed Industry Association’s (AFIA) chief policy officer, told AVMA News: “In the end, U.S. animal food safety remains unchanged, despite changes to the regulatory and political environment.”

Wilkinson added, “AFIA’s animal food industry members work daily to provide some of the world's safest, high-quality ingredients, complete feeds and pet foods. It starts from the research and development of ingredients to the manufacturing facility’s animal food safety plan, to regular quality checks throughout the day, to testing and verification before products are sold in the marketplace. While our industry has concerns with staffing levels in some of the key federal departments needed for reviewing new animal food ingredients, we have heard that inspections are still taking place as necessary and the FDA’s inspection force has not been affected by the staffing changes.”