Memorandum of Understanding
The Department of Health, Education, and Welfare
Food and Drug Administration
The Interstate Commerce Commission
The Food and Drug Administration is announcing that a Memorandum of Understanding has been executed with the Interstate Commerce Commission on April 14, 1976. The purpose of the memorandum is to provide a mechanism for the exchange of information concerning the shipment of food, drug, and cosmetic commodities by all carriers under the jurisdiction of the Interstate Commerce Commission.
Pursuant to the announcement published in the FEDERAL REGISTER of October 3, 1974 (39 FR 35697) that future memoranda of understanding between the Food and Drug Administration and others would be published in the FEDERAL REGISTER, the Commissioner of Food and Drugs is issuing this notice. The Memorandum of Understanding with the Interstate Commerce Commission reads as follows:
I. Background and Purpose. The Interstate Commerce Commission (ICC) is charged with regulating interstate carriers in transportation economics and service. In regulating transportation economics, the ICC primarily settles controversies over rates and charges among competing forms of transportation, shippers and receivers of freight, passengers, and others. It also has jurisdiction over the use, control, supply, movement, distribution, exchange, interchange, and return of railroad equipment.
The ICC grants the right to operate to railroads, trucking companies, bus lines, freight forwarders, water carriers, and transportation brokers.
The legal authority under which the ICC conducts regulatory activities is given by the Interstate Commerce Act (49 U.S.C. prec. 1 note), the Motor Carrier Act (49 U.S.C. 301), and the Transportation Acts of 1920 (41 Stat. 456) and 1940, (49 U.S.C. 65, 66) and other related acts.
The Food and Drug Administration (FDA) of the Department of Health, Education, and Welfare is charged with the enforcement of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) and sections 311, 361, and 368 of the Public Health Service Act (42 U.S.C. 243, 264, 271). In fulfilling its responsibilities under these acts, FDA's activities are aimed at protecting the nation's public health by ensuring that foods, drugs, and cosmetics are safe and wholesome, and otherwise meet all requirements of the acts mentioned above. These responsibilities are carried out in part by inspecting those places where rail cars or trucks are loaded or unloaded and inspecting foods and products in transit on these carriers.
The two agencies have certain related objectives in carrying out their respective responsibilities, and it is agreed that the objective of protecting the consumer by preventing the introduction, transmission, or spread of communicable disease requires that the statutory authorities, procedures, and other resources are employed to afford maximum protection. This will require exchange of information to the extent of the law as well as the careful selection of these procedures of both agencies that promise the greatest benefit to the public.
This memorandum of understanding is to provide a mechanism for the exchange of information concerning the shipment of food, drug, and cosmetic commodities by all carriers under the jurisdiction of the ICC. Those commodities that have been or may have been contaminated can be removed from the market place, and the possibility of contaminating foods, drugs, or cosmetics will be reduced if timely information is exchanged between the FDA and the ICC.
To provide for the exchange of complete information so that both agencies will be used to the maximum effectiveness in the public interest, each agency will designate a liaison officer to serve as a central contact. These liaison officers will be responsible for informing each other of their agency's proposed procedures and internal activities in the area of common interest.
II. Substance of Agreement. To facilitate the purpose of this agreement, it is specifically agreed that:
A. The ICC will provide to FDA information or reports of occurrences uncovered during routine activities that may indicate a possible violation of the Food, Drug, and Cosmetic Act and all other statutes administered by FDA.
B. The FDA will provide to the ICC information and reports that may indicate a possible violation of the Interstate Commerce Act and any other statutes that the ICC is responsible for carrying out.
C. Both agencies will:
1. Maintain close working relations with each other, both in headquarters and in the field.
2. Cooperate jointly and with industry in the improvement of sanitation and food-handling practices on rails cars and trucks.
3. Exchange Procedures and techniques used in determining compliance with appropriate regulations promulgated by each agency.
4. Cooperate in the enforcement efforts, thereby avoiding duplication of efforts, to assure the full safety and health protection of the public.
III. Name and Address of Participating Federal Agencies
A. For ICC:
Liaison Officer: Mr. Thomas J. Byrne,
Assistant to the Director,
Interstate Commerce Commission,
Bureau of Operations,
12th and Constitution Ave., NW.,
Washington, DC 20423,
Telephone number: (202) 343-7648.
B. For FDA:
Liaison Officer: Mr. Richard S. Nacewicz,
Chief, Interstate Travel
Food and Drug Administration,
Bureau of Foods,
200 C St., SW.,
Washington, DC 20204,
Telephone number: (202) 245-1505.
IV. Meetings to be Held. The respective liaison officers will hold meetings from time to time, but not less than annually, to discuss matters of concern to each agency, and they will be accompanied by whatever staff is necessary and appropriate.
V. Period of Agreement. A. This agreement, when accepted by both parties, covers an indefinite period of time and my be modified by mutual consent in writing by both parties, or terminated by either party upon thirty (30) day advance written notice.
A. This agreement will be reviewed annually by both agencies to ensure that it is still appropriate and that the terms and provisions are current.
B. Nothing in this agreement is intended to diminish or otherwise affect the authority of either agency to carry out its respective statutory function.
Approved and Accepted
Signed by: George M. Stafford
Date: April 14, 1976
Approved and Accepted
Signed by: Alexander M. Schmidt, M.D.
Date: April 14, 1976