Feed Bites

CVM Needs to Be Involved With AAFCO Processes

Written by: AFIA Editor   |   February 9, 2023

Federal agencies

Today, the American Feed Industry Association’s Leah Wilkinson participated in a virtual public meeting on the Food and Drug Administration's Center for Veterinary Medicine's (CVM) role in the Association of American Feed Control Officials’ (AAFCO) feed ingredient definition process. This issue is of importance to the animal food industry as the AFIA strongly believes that AAFCO and CVM should continue to work together to ascertain the safety of our animal food products.

Wilkinson’s full remarks are below.

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Good afternoon, I’m Leah Wilkinson, vice president of public policy and education for the American Feed Industry Association. Thank you for holding this public meeting on a topic that is very important to the animal food industry and for the opportunity to provide comments.

The American Feed Industry Association, or the AFIA, is the world’s largest organization devoted exclusively to representing the business, legislative and regulatory interests of the U.S. animal food industry and its suppliers. AFIA’s members include over 650 domestic and international companies who manufacture feed and pet food and those who supply the ingredients or equipment used by our industry.

The AFIA was founded in 1909, three years after the first law which gave federal officials the authority over feeds shipped in interstate commerce. At the same time, 30 states had developed their own feed laws. The industry had trouble reconciling conflicting requirements which led to difficulties conducting business across state lines. As we heard earlier, the states were also challenged with this variation and established their own association, the Association of American Feed Control Officials (AAFCO), to also seek harmonization and unity across feed legislation and regulation.

That was one hundred and thirteen years ago. And still today, regulators and industry face the same problems of harmonization.

Animal food regulation remains the joint responsibility of the states and federal government. AAFCO provides the mechanism to develop and implement uniform laws, regulations, definitions and enforcement policies that we all strive for -- either to regulate or be regulated. These discussions take place in a public and transparent manner with all stakeholders present through AAFCO.

Given the intertwined nature of the way animal food is regulated, states cannot do it alone. And, the Food and Drug Administration cannot regulate animal food without AAFCO and the states. Each needs the other and AAFCO is the mechanism.

The AAFCO ingredient review process is one of three pathways industry can utilize for the safety review of animal food ingredients for an intended use. While there are many challenges that are hindering the ability to bring new products to the market that are outside the scope of this meeting, what I want to focus on today is more around why it is important for the CVM to be a part of the AAFCO ingredient review process.

The memorandum of understanding (MOU) between AAFCO and CVM confirms the commitment necessary to make the ingredient review system work. The MOU describes the expertise and responsibilities of each organization and removes confusion of how the process works. The animal food industry needs the AAFCO ingredient review process to work efficiently and the AFIA remains dedicated to ensuring this working relationship between AAFCO and CVM continues.

We urge AAFCO and CVM to reaffirm this via extending or updating the current MOU in the name of feed and food safety.

The partnership between AAFCO and CVM allows each organization to share resources and expertise. For example, AAFCO and most states do not have the expertise or resources to conduct the safety review for an AAFCO ingredient definition submission and rely on CVM for the review. By being involved, it affords CVM the knowledge to accept these definitions which are legal ingredients per state feed laws.

Some are questioning CVM’s involvement or why it’s necessary. The AFIA firmly believes that the ingredient review system, while not perfect, it works. The system builds and holds confidence across the food chain that our animal food products are safe which is the ultimate necessity for our customers.

As CVM looks for mechanisms to improve their relationship and agreement with AAFCO, we offer the following points to consider:

  • We have seen what happens when CVM and AAFCO don’t cooperate on AAFCO ingredients.

    Thirteen years ago, when CVM’s commitment to AAFCO was questioned and stopped for a brief time, it created chaos and a backlog of ingredient submissions that greatly impacted the ability to bring new animal food ingredients to the market. We do not want that repeated. The AFIA encourages a strong statement affirming the on-going commitment to be completed before the current MOU expires.
     
  • Next, AFIA members desire the three ingredient review pathways available in the U.S. to be speedy, efficient and predictable.

    While there are different reasons for why there are three different pathways, what remains the same is that they ALL need to work. If one doesn’t, it puts undue burden on another pathway with unintended consequences. CVM needs to prioritize and review AAFCO ingredients with equal importance to food additive petitions and GRAS notifications.
     
  • Regarding improving stakeholder understanding of FDA’s engagement with AAFCO, industry will always desire additional public guidance and information detailing what is required for an ingredient submission; however, we recognize the challenge to provide enough detail but remain flexible while considering the wide variety of products and species covered.

    The challenge is communicating these requirements.

    The recent workshops and online course from AAFCO have tremendously helped provide an updated view of the CVM review process and requirements.

    Companies should take advantage of CVM’s review of protocols or pre-submission consultations before a submission is made and utilize the expertise of the AAFCO product investigator.

    CVM could also make the International Cooperation for the Convergence of Technical Requirements for the Assessment of Feed Ingredients (ICCF) guidelines on harmonized data and study requirements into guidance for industry, like is done on the animal drug side.
  • Lastly, regarding transparency, the AFIA believes that the AAFCO process is appropriately transparent today given the fact that products and data are driven from proprietary submissions and data -- and the non-proprietary nature of the resulting ingredient definition.

    If CVM were to make a list public, that list could state the date the submission was received by the AAFCO product investigator, the date received by CVM and the category of ingredients the product falls under (for example, fermentation products or special purpose products). It should not provide any names or product information. To include names or product information will jeopardize the very short proprietary advantage a company may have by utilizing the AAFCO process, rendering it useless.

    The AFIA understands the desire to provide public transparency in the process and believes that the current process defined within AAFCO of committee discussion, review, voting, board recommendation and membership vote – all which are public for at least 7 months – is sufficient. The AAFCO process of establishing definitions as tentative definitions first and then moving to official after a year also provides public notification and opportunity to comment.

    The AFIA believes that a balance can be reached on this and we stand ready to discuss this further with AAFCO and CVM.

In conclusion, the AFIA strongly believes that AAFCO and CVM should continue to work together to ascertain the safety of our animal food products. It makes sense from a resource perspective and it is necessary to maintain confidence in our regulatory system, which is highly regarded around the world.

We appreciate you holding this meeting and our ability to share how important this is to the animal food industry and our suggestions to improve the system.

Thank you for your time.

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