By David Fairfield, Senior Vice President, Feed
The ingredient definition process for animal feed and pet food ingredients was a major discussion topic at the Association of American Feed Control Officials (AAFCO) Annual Meeting conducted Aug. 7-9 in San Antonio, Texas.
In follow-up to announcements made on Aug. 2 that the Memorandum of Understanding (MOU) between the U.S. Food and Drug Administration (FDA) and AAFCO that currently facilitates AAFCO feed ingredient definitions and outlines the two organizations’ responsibilities within the process will not be renewed when it expires on Oct. 1, 2024, officials from FDA and AAFCO provided perspectives on transitions that will occur and how new animal food ingredients will be able to gain regulatory approval in the future.
During remarks at the meeting, Dr. Tim Schell, director of FDA’s Office of Surveillance and Compliance, acknowledged the decades-long success of the AAFCO ingredient definition process, but said FDA’s decision to not renew the current MOU was an outcome of the agency’s ongoing evaluation of its pre-market approval activities for animal food. Schell highlighted the agency’s commitment to ensuring that FDA’s departure from the current AAFCO process will not cause disruptions within the industry, and noted several outreach activities that FDA will conduct to receive stakeholder feedback regarding the agency’s future pre-market approval of feed ingredients. Among these activities will be opportunities to provide comment during agency listening sessions and on FDA’s new draft guidances for Animal Food Ingredient Consultation and the FDA Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients.
Austin Therrell, executive director of AAFCO, noted the expiration of the MOU will provide opportunities for AAFCO to consider and potentially develop a new ingredient definition process whereby ingredients could gain regulatory approval through adoption into state feed laws. If such a program were developed, Therrell said the scientific review of ingredients could potentially be completed by one or more land-grant universities with the appropriate scientific expertise. He noted that AAFCO would work to advance the concept of developing a new ingredient definition process and share additional details at its next meeting in January 2025.
AAFCO members during the meeting approved two resolutions related to future recognition of feed ingredients. The first resolution established that AAFCO may review ingredients recommended by FDA through its new Animal Food Ingredient Consultation Program for inclusion into the AAFCO Official Publication. The second resolution established that AAFCO may recognize an alternate (non-FDA) expert panel for the scientific review of new feed ingredients for acceptance, and further may review ingredients approved by other authorities, such as the Canadian Food Inspection Agency and European Food Safety Authority. The approval of the resolutions by state feed regulatory officials was not unanimous, but indicated general support for AAFCO to further explore the topics and make further recommendations that would be subject to additional votes of approval.
Under federal law, feed ingredients may gain approval through FDA’s animal food additive petition process or a determination of Generally Recognized as Safe (GRAS) status. In contrast, the long-standing AAFCO feed ingredient definition process has been characterized as an “informal review sanctioned” pathway whereby feed ingredients may be informally recognized by FDA as acceptable for use and gain approved legal status by adoption into state feed laws.
AAFCO is the professional organization of federal and state feed regulatory officials. NGFA interacts extensively with AAFCO, and NGFA feed industry members and staff serve as non-voting advisers to AAFCO committees. More than 425 industry representatives and regulatory officials participated in the San Antonio meeting.
Other Issues: Among the other issues addressed during the AAFCO meeting were:
Lot Identifiers: The Feed Labeling Committee voted to approve proposed model regulations that would establish requirements to include a “lot identifier” on the labels, invoices or other documents accompanying commercial feeds in distribution and maintain associated records to facilitate recalls and accurate tracing of the manufacturing and distribution history of the product. The proposed regulations will next be considered by the AAFCO Model Bills and Regulations Committee.
Copper Claims for Dog Food: During the AAFCO Pet Food Committee meeting a recap was provided regarding AAFCO activities associated with establishing model pet food regulations to address voluntary “controlled” copper claims on dog food labels. The committee previously held a virtual meeting on May 30 and voted to not proceed in creating the model regulations. At that time, the committee work group created to evaluate the topic also was disbanded.
Poultry Feed Label Requirements: The Model Bills and Regulations Committee considered proposed revisions to model regulations for poultry feed labels to expand the number of animal classes and establish corresponding definitions. However, concerns were raised about the accuracy of the proposed definitions and a work group was established to further review the topic.
Inspection Guidance: A work group within the Inspection and Sampling Committee is working on guidance on conducting inspections for compliance with the FDA rule for Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The work group likely will provide a report during the committee’s next meeting in January.
Enforcement Issues: An open meeting of AAFCO’s Enforcement Issues Committee was conducted to discuss:
—FDA’s regulatory discretion towards Bovaer. FDA previously announced that it does not intend to object to marketing of Bovaer, even though Bovaer is currently classified as an unapproved animal drug intended to reduce methane gas production in lactating dairy cows. FDA officials stated that feed mills utilizing Bovaer may handle and use the product as a feed ingredient, not as an animal drug. Representatives from Elanco, which markets Bovaer, stated that not all states at this time have accepted registration of Bovaer as a feed ingredient within their state.
—State licensing and registration/tonnage fees and schedules. Lack of uniformity among states regarding feed licensing, registration and tonnage processes and fees was addressed, and ways in which AAFCO potentially could facilitate more uniformity.
The open meeting was conducted to support harmonization of policies among states on regulatory issues.
Feed Ingredients: Among other actions taken related to feed ingredients were:
—Hempseed Meal: AAFCO membership voted to approvea new tentative definition for Hemp Seed Meal, Mechanical Extracted for use in diets of laying hens as a source of protein and fat at an inclusion of no more than 20 percent of the diet. The ingredient is to contain no more than 20 parts per million (ppm) of total cannabidiol and no more than 2 ppm of total tetrahydrocannabinol. The vote represents the first approval of a hemp-derived feed ingredient by AAFCO.
—Spent Bleaching Clay: The Ingredient Definition Committee approved a work group report that contained recommendations to add spent bleaching clay to the Technical Additives Table of the AAFCO Official Publication and revise several current oilseed meal definitions to accommodate the addition of spent bleaching clay at no more than 0.2 percent.
—FDA/AAFCO MOU: Given the upcoming expiration of the MOU, the Ingredient Definition Committee established a work group to begin evaluating changes that may be needed to Chapter 6 of the AAFCO Official Publication to accommodate ingredients that emanate from FDA’s new Animal Food Consultation Program.
—As-Fed/As-Is Terminology: A work group established by the Ingredient Definition Committee is still working on recommendations related to defining and differentiating between the terms “as-fed” and “as-is” that are used by regulatory officials within ingredient definition specifications and nutrient guarantee requirements.