Memorandum of Understanding
Between The Food and Drug Administration
and The National Marine Fisheries Service
concerning Enforcement of Laws Against Illegal
Commerce in Molluscan Shellfish
The Food and Drug Administration (FDA) of the Public Health Service, U.S. Department of Health and Human Services and the National Marine Fisheries Service (NMFS) of the National Oceanic and Atmospheric Administration, U.S. Department of Commerce enter this Memorandum of Understanding to increase and to improve their cooperation in the enforcement of laws against the illegal harvest, transport, export, import, sale, and the purchase of molluscan shellfish. This Memorandum describes the arrangements that FDA and NMFS will follow to ensure that the activities of each agency under its respective authorities complement those of the other agency, and the cooperative methods that the two agencies will employ to deal with illegal commerce in molluscan shellfish.
FDA is responsible for enforcement of the Federal Food, Drug and Cosmetic (FD&C) Act (Act of June 25, 1938, as amended 21 U.S.C. Section 301 et seq.) and the Public Health Service Act (42 U.S.C. Section 201 et seq.). Under these Acts, FDA works to protect the health and welfare of the Nation by ensuring that foods, including molluscan shellfish, are safe and wholesome. In fulfilling this responsibility, FDA promulgates regulations dealing with the safety, quality, and identity of foods; establishes action levels and tolerances for natural defects and unavoidable defects; inspects the processing and distribution of foods; examines samples of foods to assure compliance with the Act; and conducts research to support these activities. The States and a number of foreign nations also have laws that relate to the illegal commerce in molluscan shellfish. FDA works with states and foreign nations to increase the effectiveness of these laws and coordinates its activities in this area with those of the States and foreign nations through its participation in the National Shellfish Sanitation Program (NSSP). FDA assists States and foreign nations with training, technical projects and the development of model ordinances and guidelines; and advises States and foreign nations as to the effectiveness of their public health control programs.
Under the authorities of the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.) and the Fish and Wildlife Act of 1956 (16 U.S.C. 742e et seq.), NMFS conducts a voluntary fishery products inspection program which is concerned with the safety, wholesomeness, and quality of fishery products, including molluscan shellfish. NMFS is also responsible for enforcement of the Lacey Act Amendments of 1981 (16 U.S.C. 3371 et seq.), as they apply to molluscan shellfish. In pertinent part, the Lacey Act prohibits and prescribes penalties for the transport, export, import, sale, and purchase of shellfish taken or possessed in violation of United States laws and regulations. The Act also forbids the transport, export, import, sale, purchase, receipt, acquisition, or possession in interstate or foreign commerce of molluscan shellfish taken, possessed, transported, or sold in violation of State or foreign law. False records, accounts, labels, and identifications of molluscan shellfish are also forbidden. NMFS conducts investigations of alleged illegal transactions in molluscan shellfish through its Office of Enforcement. These investigations can lead to the imposition of civil penalties by the National Oceanic and Atmospheric Administration, the referral of cases to the Department of Justice for criminal prosecution, and the forfeiture of illegal molluscan shellfish and the vessels and gear with which they were caught.
FDA and NMFS believe that it is in the public interest for them to cooperate more closely in carrying out these responsibilities and taking maximum advantage of their respective expertise.
III. SUBSTANCE OF AGREEMENT
A. FDA agrees to:
1. Provide periodically, preferably annually, summary reports of the status of State shellfish enforcement control programs which identify States with enforcement program weaknesses and illegal shellfish harvesting problems, and recommend priorities for Lacey Act investigations for the purpose of providing improved public health protection and industry integrity.
2. Support NMFS Lacey Act investigations to the extent that regulatory authority and resources allow. This may include conducting food sanitation inspections of suspect shellfish shippers, reviewing interstate shipping records and obtaining affidavits to the extent possible, collecting and analyzing shellfish samples to be used as evidence of violations, and removing adulterated shellfish from the marketplace.
B. NMFS agrees to:
1. Utilize FDA's report on State shellfish control programs and illegal shellfish harvesting problems when establishing planning priorities for potential Lacey Act investigations. To the extent that resources and agency policies allow, investigations for the purpose of protecting the public health and the integrity of the shellfish industry will be given a high priority.
2. Advise FDA when Lacey Act or other investigations reveal information of illegal shellfish harvesting problems in particular States, and when Lacey Act related arrests and prosecutions are undertaken by NMFS that relate to shellfish program activities.
C. FDA and NMFS agree to:
1. Consult regularly concerning enforcement of laws against illegal commerce in molluscan shellfish. These consultations will be guided by the considerations that FDA is in a favorable position to determine the situations most in need of enforcement attention from the public health perspective; and that NMFS has a particular expertise in investigations involving the harvesting, processing, and transportation of molluscan shellfish.
2. Coordinate their activities under this Memorandum with the public health and fisheries agencies of interested and affected States. Upon request of FDA, NMFS may authorize FDA personnel to assist NMFS in the enforcement of the Lacey Act as it applies to molluscan shellfish.
3. Coordinate activities to negotiate and implement agreements with agencies of foreign governments to eliminate illegal commerce in foreign molluscan shellfish and to assure the continued viability of domestic molluscan shellfish resources so that the authorities and expertise of both FDA and NMFS will be effectively utilized. In particular, FDA will consult with NMFS concerning the potential impact on domestic molluscan shellfish whenever FDA considers initial requests or negotiates agreements to import live molluscan shellfish into the United States without regard to the stated purpose of such importation.
4. Develop arrangements for the most effective use of the authorities and resources available to each agency for enforcement of laws against illegal commerce in molluscan shellfish. In particular, NMFS will seek appropriate administrative or criminal sanctions for violations of the Lacey Act with respect to molluscan shellfish that could adversely affect public health, the aquatic environment, or stability of aquatic resources; and FDA will, consistent with its resources, upon request provide expert testimony and scientific support necessary to demonstrate the actual or potential public health effects of such violations.
5. Designate a primary contact to implement this agreement and to assure regular communication concerning the activities of the agencies covered by the Memorandum. The primary contact for each agency will be responsible for ensuring that other agency employees who have an interest in activities under this Memorandum are informed of those activities. If either agency is unable to carry out any of its responsibilities under this Memorandum, the primary contact for that agency shall so advise the primary contact for the other agency promptly.
6. Have the primary contacts meet at least twice a year to discuss activities undertaken pursuant to this agreement and identify ways of fostering further cooperation between the two agencies. The primary contacts will prepare a joint written annual summary of activities undertaken pursuant to this Memorandum to present at the annual meeting of the Interstate Shellfish Sanitation Conference.
IV. PARTICIPATING PARTIES
A. National Marine Fisheries Service
1825 Connecticut Avenue, N.W.
Washington, D.C. 20235
B. Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
V. PRIMARY CONTACTS
A. National Marine Fisheries Service:
Director, Office of Enforcement
Mr. Morris M. Pallozzi
National Marine Fisheries Service
1825 Connecticut Avenue, N.W.
Washington, DC 20235
B. Food and Drug Administration:
Chief Shellfish Sanitation Branch
(currently, Mr. J. David Clem)
Center for Food Safety and Applied Nutrition
(formerly Bureau of Foods)
Food and Drug Administration
200 C Street, S.W.
Washington, DC 20204
VI. PERIOD OF AGREEMENT
This Memorandum will take effect upon its signature by the authorized representatives of both FDA and NMFS. It may be modified by consent of both agencies and terminated by either agency upon 30 days written notice to the other.
Approved and Accepted
for National Marine Fisheries Service
Signed by: James E. Douglas, Jr.
for William G. Gordon
Assistant Administrator for Fisheries
National Oceanic and Atmospheric Administration
U.S. Department of Commerce
Date: July 17, 1986
Approved and Accepted
for the Food and Drug Administration
Signed by: John M. Taylor
Acting Associate Commissioner
for Regulatory Affairs
Food and Drug Administration
Public Health Service
U.S. Department of Health and Human Services
Date: July 24, 1986