April 2007 MOU FDA and AAFCO 

FDA Record # 225-07-7001 

MEMORANDUM OF UNDERSTANDING BETWEEN 

THE U.S. FOOD AND DRUG ADMINISTRATION AND 

THE ASSOCIATION OF AMERICAN FEED CONTROL OFFICIALS 

BACKGROUND 

The Food and Drug Administration (FDA) is the primary federal agency responsible for 

enforcing the Federal Food, Drug, and Cosmetic Act (the Act). Included within the 

FDA's responsibilities under the Act is the responsibility for regulation of animal 

fooddfeeds. This Act provides the authority for FDA to regulate essentially all 

ingredients and additives used in animal feed.' Depending on its intended purposeluse, 

an ingredientladditive could be classified as a food additive, a generally recognized as 

safe substance, a new animal drug, or a color additive. 

The Association of American Feed Control Officials (AAFCO) is a voluntary membership 

organization of the states in the U.S. and Federal government agencies, as well as 

government agencies from other countries, responsible for the execution of laws and 

regulations pertaining to the production, labeling, distribution, use, andlor sale of animal 

feed and feed ingredients The purpose of AAFCO is to provide a mechanism for 

developing and implementing uniform and equitable laws, regulations, standards, 

definitions, and enforcenient policies for the manufacturing, labeling, and sale of animal 

feeds and ingredients. AAFCO provides" model laws" and regulations that nearly all 

states have adopted as the basis for their feed control program. AAFCO membership 

consists of all frfty states, Puerto Rim, Costa Rica. Canada, FDA, U.S. Department of 

Agriculture and several universities. It is governed by Ofkers and a Board of Directors 

(known collectively as the Board) elected by the membership at the annual meeting of 

AAFCO. FDA is a member of AAFCO and serves in an advisory role on the AAFCO 

Board. 

AAFCO provides a process (herein called the AAFCO New and Modified Feed 

lngredient Definitions Process) to identify the suitability of ingredients used in animal 

feed. This process helps to ensure ingredients used in animal feed are suitable for that 

use and also establishes a common or usual name for the ingredients. This common.or 

usual identity is required on feed labels by both federal law and state regulations. The 

AAFCO New and Modified Feed Ingredient Definitions Process is operated by AAFCO. 

with FDA providing scientific and technical assistance. The result of this collaboration 

has been the establishment of an effective program of benefit to feed regulatory officials, 

the industry and the public. 

'some articles added to animal feed fall under the purview of other Federal agencies.. 

. Feed-through pesticides are regulated by the Environmental Protection Agency (EPA) 

and vaccines added to anlmal feed are the responsibility of the United States 

Department of Agriculture (USDA). 
Aprll2007 MOU FDA and AAFCO 

PURPOSE 

FDA Record # 225-07-7001 

The purpose of this memorandum is to facilitate FDA' s collaboration with AAFCO In 

the AAFCO New and Modified Feed Ingredient Definition Process by clarifying the 

responsibilities of FDA and AAFCO during the feed ingredient definition and providing 

mechanisms for resolving disputes that arise and for modifying the process when 

required. 

AGREEMENT 

The FDA and AAFCO agree to the following: 

A. AAFCO maintains definitions of various feed ingredients, which includes the 

ingredient name, description, and any appropriate limitations for its use, and 

publishes the currently accepted feed ingredient definitions annually in the 

AAFCO Official Publication (OP). 

B. Petitions for potential new feed ingredients or petitions to modify an existing feed 

ingredient definition are reviewed by AAFCO investigators chosen by the AAFCO 

Board and FDA scientists assigned by the Agency's Division Directorfleam 

Leader in the Division of Animal Feeds. 

C. AAFCO will seek advice and a letter of concurrence regarding the suitability of 

the feed ingredient for its proposed use from FDA prior. to adopting new feed 

ingredient definitions or amending existing ones. 

D. AAFCO will provide to FDA upon FDA's request (1) industry-generated petitions, 

and (2) requests from AAFCO for new feed ingredients and for modifications-of 

exist~ng definitions within 30 working days of AAFCO's receipt of the request. 

AAFCO's Board-assigned AAFCO feed investigator will make the initial contact 

with FDA. I 

E FDA will allow the AAFCO Board or Board-assigned AAFCO feed investigator to 

request consultation fmm-FDA on petitions for new feed ingredient definitions 

and modifications of existing def~nitions. AAFCO's initial contact will be the 

Director of the Division of Animal Feeds, Center for Veterinary Medicine, FDA. . FDA will provide within 30 working days its decision whether it will be able to . consult with AAFCO. 

F. If FDA determines it will publish a food additive regulation under section 409 of. 

the Act and FDA's implementing regulations in 21 CFR 571.1 for a feed 

ingredient, AAFCO will not include that ingredient in the AAFCO OP until FDA - 

comp!etes the regulation. I! - 

G. Disagreements on existing feed ingredient definitions, the establishment of new 

ingredient definitions, or modifications of existing definitions between FDA and . 
Apr1l2007 MOU FDA and AAFCO 

FDA Record # 22507-7001 

AAFCO will be referred to an arbitration board comprised of the two individuals 

appointed by the AAFCO Board of Directors; the Director, FDNCVM's Ofice of 

Surveillance and Compliance; and the Director, FDNCVM Division of Animal 

Feeds. 

-H. AAFCO will accept all requests from FDA to remove an ingredient definition from 

the AAFCO OP upon FDA presenting convincing information/scientifii evidence 

showing the ingredient is no longer suitable for its stated use. At that year's 

annual meeting. AAFCO will request a vote of the membership to remove the 

ingredient from the Feed lngredient Definitions section in the AAFCO OP. 

Disagreements between AAFCO and FDA would be handled as stated in section 

G. 

I. AAFCO is allowed, on its own initiative and with FDA concurrence, to request 

that an AAFCO Feed lngredient Definition be removed upon AAFCO providing 

convincing information/scientific evidence showing the ingredient is no longer 

suitable for its stated use. At that year's annual meeting, AAFCO will request a 

vote of the membership to remove the ingredient from the Feed lngredient 

Definitions section in the AAFCO OP. Disagreements between AAFCO and FDA 

would be handled as stated in section G. 

J. This Memorandum of Understanding will be reviewed annually by the AAFCO 

Board and FDA and may be modified by mutual consent of both parties. Parties 

will provide each other with a 30 working day advance written notice regarding 

the modifications being sought. Any modification will be published in the Federal 

Register. 

LIAISONS 

For the FDA. 

Sharon Benz, Ph.D. 

Supervisory Scientist, Division of Animal Feeds 

Center for Veterinary Medicine, FDA 

- 7519 Standish Place 

Rockville, MD 20855 

240-453-6864 

Sharon.benz@fda.hhs.gov 

. For the AAFCO. 

Sharon Krebbs 

765385-1 029 

Sharon@aafco.org 
April 2D07 MOU FDA and AAFCO 

FDA Record # 225-07-7001 

PERIOD OF AGREEMENT