The Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) has signed a Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) that allows FDA to formally recognize AAFCO’s process to develop a list of feed ingredients and defines the role FDA can play in deciding on the suitability of feed ingredients offered for addition to AAFCO’s list.
FDA’s formal recognition of the AAFCO list is one of the specific recommendations made in a “Framework Document” drafted by FDA’s Animal Feed Safety System (AFSS) team. FDA created the ad hoc AFSS team four years ago to develop ways to modernize the feed safety system in the United States. The team has identified gaps in the current animal feed regulatory structure (including the fact that FDA regulations do not include a complete list of suitable feed ingredients) and offers recommendations for closing the gaps.
AAFCO is a voluntary organization comprised largely of regulatory officials responsible for enforcing their state’s laws and regulations concerning the safety of animal feeds. It is made up of members from each state in the United States and Puerto Rico, as well as from FDA, the U.S. Department of Agriculture, and the governments of Costa Rica and Canada.
A basic goal of AAFCO is to ensure the development and implementation of equitable laws, regulations, standards, definitions, and enforcement policies for regulating animal feed. AAFCO itself has no enforcement authority, but its members do. Although members of the feed industry and the public may participate with AAFCO and its committees, only regulatory agencies and officials are actually members and able to vote and conduct other official business.
AAFCO publishes an annual Official Publication (OP) that includes a list of all ingredients AAFCO has reviewed and found suitable for use in animal feeds. The OP also contains cross-references to certain sections of the Code of Federal Regulations that list approved food additives and ingredients that are generally recognized as safe for use in animal feed. The OP contains the most current and extensive list of common or usual ingredient names. FDA has informally cited the OP’s ingredient list and has acted as AAFCO’s scientific advisor in reviewing petitions for the addition of ingredients to the list or for changes in the ingredient definitions. However, although the OP ingredient list does have the force of law in those states that adopt it, it does not carry the force of law for FDA.
Under the MOU, CVM assigns scientists to work with AAFCO in reviewing petitions for new feed ingredients or for modifications to existing definitions. Also, before it adopts a new feed ingredient definition or amends an existing one, AAFCO will ask CVM for advice and a letter of concurrence. In addition, the MOU requires AAFCO to remove a definition from its OP if FDA provides convincing scientific evidence that the ingredient is no longer suitable for its intended purpose.
The MOU, published in the November 19, 2007, Federal Register, went into effect on August 30, 2007, and remains in effect until September 1, 2012.
AAFCO Ingredient Definitions: Setting the Standards
AAFCO first started defining feed ingredients in 1909, just as the commercial feed industry was beginning to take shape in the United States. Since then, the nature of feed ingredients has become increasingly complex, but AAFCO has continued its role of defining ingredients, and now the association has an agreement to formally work with scientists from the FDA to ensure the safety of ingredients.
Acceptable feed ingredients along with their definitions are listed in AAFCO’s OP. New ingredients are added or existing definitions changed by means of petitions submitted by industry representatives. The petitions are reviewed by an AAFCO investigator, who has the responsibility for the applicable category of ingredients. AAFCO has more than 30 feed ingredient investigators, each with a different ingredient specialty. Most of the investigators belong to state feed control agencies, but six, including Shannon Jordre, who is chair of AAFCO’s Ingredient Definitions Committee and a consumer safety officer with CVM, work for FDA.
When a petition arrives, an AAFCO investigator or FDA scientist reviews it to make sure it contains the information required by “The Guide to New and Modified Ingredient Definitions” in the OP, such as information about the ingredient and its intended use (including limitations). According to Jordre, the investigator also makes sure the petition includes copies of the scientific literature cited concerning the product’s safety, and presents any concerns about toxicity or carcinogenicity.
Jordre said that investigators submit nearly all petitions to FDA for a safety review. FDA may not need to review petitions requesting only simple changes, such as a change to an ingredient’s nomenclature, he added.
Any time an ingredient presents a safety concern to the animal that consumes it, or the use of the ingredient will create a food safety risk, FDA will recommend against AAFCO adopting a definition until the ingredient has been the subject of an approved food additive petition.
If FDA finds that a proposed new ingredient is suitable for use in animal feeds, the AAFCO investigator will then submit the request to AAFCO’s Ingredient Definitions Committee during one of two public meetings the association holds each year. If accepted, the definition will appear in the next edition of the OP. In the meantime, the sponsor may market a product after receiving a letter from FDA saying that the agency will use regulatory discretion and not take action against the use of the ingredient, when labeled and used as directed.
Copies of the OP are available from AAFCO through its Web site at www.aafco.org.
February 2008 Render