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 DrugAdministration (FDA) is the primary federal agency responsiblefor enforcingthe Federal Food, Drug, and Cosmetic Act (the Act). Includedwithin the FDA's responsibilitiesunder the Act is the responsibility for regulation of animal fooddfeeds. This Act providesthe authority for FDA to regulate essentially all ingredientsand additives used in animalfeed.' Depending on its intended purposeluse, an ingredientladditivecould be classified as 

### a food additive, a generally recognized as safe substance, a new animal drug, or a color additive. The Associationof American Feed Control Officials (AAFCO) is a voluntary membership organizationof the states inthe U.S. and Federalgovernment agencies, as well as government agenciesfrom other countries, responsiblefor 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 mechanismfor developingand implementing uniform and equitable laws, regulations, standards, definitions, and enforcenient policiesfor 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. Departmentof 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 memberof AAFCO and serves in an advisory role onthe 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 ingredientsused in animal feed are suitable for that use and also establishes a common or usual namefor the ingredients. This common.or usual identity is requiredon 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 addedto animal feed fall under the purview of other Federal agencies..



# .Feed-through pesticides are regulatedby the 

### Environmental ProtectionAgency (EPA)

and vaccines added to anlmal feed are the responsibilityof the United States Department of Agriculture (USDA).Aprll2007 MOU FDA and AAFCO

PURPOSE FDA Record 

### # 225-07-7001

The purpose of this memorandum isto facilitate FDA' s collaboration with AAFCO In the AAFCO New and Modified Feed Ingredient Definition Process by clarifying the responsibilitiesof FDA and AAFCO during the feed ingredient definition and providing mechanisms for resolving disputes that arise and for modifyingthe processwhen 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 inthe AAFCO Official Publication (OP). B. Petitionsfor potential newfeed ingredientsor petitions to modify an existingfeed ingredient definitionare reviewed byAAFCO investigators chosen by the AAFCO Board and FDA scientists assigned by the Agency's Division Directorfleam Leader inthe Division of Animal Feeds. C. AAFCO will seek advice and a letterof concurrence regarding the suitabilityof the feed ingredientfor its proposed use from FDA prior.to adopting new feed ingredient definitionsor amending existing ones. D. AAFCO will provide to FDA upon FDA's request (1) industry-generated petitions, and (2) requestsfrom 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-assignedAAFCO feed investigatorwill make the initialcontact with FDA. I E FDAwill allow

### the AAFCO Board or Board-assigned AAFCO feed investigatorto request consultation fmm-FDAon petitions for new feed ingredient definitions and modifications of existing def~nitions. AAFCO's initialcontact will be the Director of the Division of Animal Feeds, Center for Veterinary Medicine, FDA.



### . FDAwill 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 inthe AAFCO OP until FDA 

### - comp!etes the regulation. I!- G. Disagreementson 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 Divisionof Animal Feeds. 

### -H. AAFCO will accept all requests from FDA to remove an ingredient definition from the AAFCO OP upon FDA presenting convincing information/scientifiievidence showing the ingredient is no longer suitablefor its stated use. At that year's annual meeting. AAFCO will request a vote of the membershipto remove the ingredientfrom the Feed lngredient Definitions section in the AAFCO OP. Disagreements betweenAAFCO 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 inthe AAFCO OP. Disagreements betweenAAFCO and FDA would be handled as stated in section 

### G. J. This Memorandum of Understandingwill 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 inthe Federal Register.

LIAISONS Forthe FDA. Sharon Benz, Ph.D. Supervisory Scientist, Division ofAnimal Feeds Center for Veterinary Medicine, FDA

- 7519 Standish Place Rockville, MD 20855 240-453-6864 Sharon.benz@fda.hhs.gov



### . Forthe AAFCO. Sharon Krebbs 765385-1 029 Sharon@aafco.orgApril 2D07 MOU FDA and AAFCO 

### FDA Record # 225-07-7001



### PERIOD OF 

### AGREEMENT