Memorandum of Understanding
Between the
National Conference on Interstate Milk Shipments
And the
Food and Drug Administration

Background:

The Food and Drug Administration (FDA) is the federal agency responsible for enforcing the Federal Food, Drug, and cosmetic Act, 21 U.S.C. 301 et seq. Included within the FDA’s responsibilities under the Act is the responsibility for regulation of foods shipped in interstate commerce, including milk and milk products.

The National Conference on Interstate Milk Shipments (NCIMS) is a voluntary organization directed and controlled by the member States and open to all persons interested in its objective of promoting the availability of a high quality milk supply. It is governed by an Executive Board whose members include representatives from state departments of health and agriculture, the FDA, the U.S. Department of Agriculture and industry.

Through their collaborative efforts, the FDA and the NCIMS have developed a cooperative, federal-state program (the Interstate Milk Shippers Program) to ensure the sanitary quality of milk and milk products shipped interstate. The Program is operated primarily by the States, with FDA providing varying degrees of scientific, technical, and inspection assurance as provided by FDA Publication No. 72-2022, Procedures governing the Cooperative Federal-State Program for Certification of Interstate Milk Shippers (“Procedures Manual”). The result has been the establishment of a viable and effective certification and enforcement program which has been of significant benefit to consumers.

The Interstate Milk Shippers Program relies upon the Grade “A” Pasteurized Milk Ordinance and related technical documents referred to in the Procedures Manual for the sanitary standards, requirements and procedures it follows to ensure the safety and wholesomeness of Grade “A” milk and milk products. FDA considers these standards, requirements, and procedures to be adequate for the protection of the health and safety of the consumer. Sources of Grade “A” milk and milk products intended for use on interstate conveyances and subject to the Interstate Conveyance Sanitation Regulations (21 CFR 1250 et seq.) promulgated pursuant to the Public Health Service Act (42 U.S.C. 264) are considered approved sources for purposes of 21 CFR 1250.26 if they have a State or local permit, are under the routine inspection of a State or local regulatory agency and meet the provisions of the Procedures Manual.

PURPOSE

The purpose of this Memorandum is to strengthen the Interstate Milk Shippers Program by stating the responsibilities of the FDA and NCIMS for execution of the Program, the means for resolving questions of interpretation that may arise in the execution of the Program, and the means for making modifications in the Program.

AGREEMENT

The FDA and the NCIMS have agreed upon the following principles:

A. The Interstate Milk Shippers Program shall be governed by the provisions of the current FDA Publication No. 72-2022, Procedures Governing the Cooperative Federal-State Program for Certification of Interstate Milk Shippers, and by the documents referenced therein.  Copies of all governing documents are available for review in the office of the Food and Drug Administration, Hearing Clerk.

B. The responsibilities of the NCIMS, the participating States, and FDA for execution of the Interstate Milk Shippers Program shall be as stated in the above referenced Procedures Manual.

C. Failure on the part of any certified state milk sanitation rating officers, state milk laboratory survey officer, or state sampling surveillance officer to comply with the provisions of this Memorandum or the Procedures Manual shall be sufficient cause for FDA to proceed to a hearing to provide said rating officer, laboratory survey officers, or sampling surveillance officer an opportunity to show cause why his/her certification or approval should not be revoked.

D. It shall be the right of the NCIMS and each participating State to request and receive consultation with the appropriate representative of the FDA to discuss the provisions of this Memorandum or problems encountered in execution of the provisions of the Procedures Manual.  The initial contact office at FDA for all inquiries pertaining to the Program is the Bureau of Foods (HFF-415) at the address indicated in paragraph D, above.

E. It shall be the right of the FDA to request and receive consultation with appropriate officials of the NCIMS or any of its member States to discuss the provisions of this Memorandum or problems encountered in the execution of the provisions of the Procedures Manual.  The Executive Board of NCIMS can be contacted by FDA personnel through the Bureau of Foods (HFF-415) at the address indicated in paragraph D, above.

F. Problems of interpretation regarding provisions of the Procedures Manual and the documents referenced therein, or their application, shall be subject to resolution by mutual agreement of the parties.

G. Changes in the provisions of the Procedures Manual and the documents referred to therein shall be mutually concurred in NCIMS and FDA.

H. This Memorandum of Understanding may be modified by mutual consent of the parties and may be terminated by either party upon a thirty (30) day advance written notice to the other.  Any modification or notice of termination will be published in the FEDERAL REGISTER.

For the FDA:

/S/
Donald Kennedy
Commissioner of Food and Drugs
August 5, 1977

/S/
Joseph P. Hile
Associate Commissioner for Compliance
September 12, 1977

For the NCIMS:

/S/
H.H. Vaux
Chairman, NCIMS
June 28, 1977